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AUSTIN COMMUNITY COLLEGE DEPARTMENT OF DENTAL HYGIENE OSHA REGULATORY COMPLIANCE MANUAL Austin Community College – Department of Dental Hygiene Regulatory Compliance Manual Table of Contents General Information Introduction .................................................................................................................................1 General Industry Standard on Personal Protective Equipment ..................................................2 General Industry Standard on Compressed Gases....................................................................5 General Industry Standard on Formaldehyde ............................................................................. 10 OSHA General Standard for Emergency Action Plans .............................................................14 OSHA Training and Records .....................................................................................................20 If ACC-DH Receives a Telephone Call or Letter from OSHA ...................................................22 Form A – Certificate of Hazard Assessment ............................................................................24 Form B – Certificate of Employee Training in PPE ..................................................................... 25 Appendices: General Information A. OSHA Standards on General Requirements on Personal Protective Equipment and Hand Protection.....................................................................................1 B. General Industry Standard on Compressed Gases .......................................................5 C. General Industry Standard on Formaldehyde .................................................................. 7 D. General Industry Standard on Emergency Action Plans ..............................................33 E. OSHA Fact Sheet – Formaldehyde ................................................................................. 35 F. OSHA Plans per State .................................................................................................. 37 G. Glossary of Terms and Abbreviations Used in the Compliance Manual ......................43 H. Emergency Action Plan Checklist................................................................................. 47 I. 01/2015 Sample Emergency Action Plan ...................................................................................... 49 I Table of Contents Bloodborne Pathogens Exposure Control Plan for This Dental Setting ........................................................................1 Hepatitis B Vaccination/Postexposure Procedures...................................................................18 Labeling .....................................................................................................................................25 Training...................................................................................................................................................26 Recordkeeping ................................................................................................................................33 Appendices: Bloodborne Pathogens A. Bloodborne Pathogens Standard ...................................................................................1 B. Summary of CDC’s Guidelines for Infections Control .................................................. 31 in Dental Health-Care Settings C. Methods for Sterilizing and Disinfecting Patient-Care ..................................................35 Items and Environmental Surfaces D. CDC Guidelines for Infection Control in Dental Health-Care Settings, 2003 ............... 37 E. ADA Statement on Infection Control in Dentistry..........................................................93 F. Updated US Public Health Service Guidelines for the Management ...........................95 of Occupational Exposures to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis G. Needlestick Safety and Prevention Act FAQ ....................................................................... 115 H. OSHA Standard on Access to Employee Exposure and ............................................ 119 Medical Records Hazard Communications Hazard Communication Program for ACC-DH .........................................................................1 List of Hazardous Chemicals ......................................................................................................3 Hazard CommunicationTraining Program ...................................................................................9 01/2015 2 Table of Contents Appendices: Hazard Communications A. Hazard Communication Standard ..................................................................................1 B. OSHA Quick Card: Hazard Communication Standard Pictogram ................................. 3 C. OSHA Quick Card: Hazard Communication Standard Labels ....................................... 5 D. OSHA Quick Card: Hazard Communication Safety Data Sheets .................................. 7 E. Hazard Communication Standard: Labeling of Chemicals.............................................9 Waste Management ACC Hazardous Waste Management Program............................................................................. 1 Appendices A. Medical Waste Tracking Form ........................................................................................1 B. Generator Shipment Log ................................................................................................3 C. ADA Directory of Dental Waste Recyclers .....................................................................5 D. ADA Best Management Practices for Amalgam Waste ................................................. 15 Other Regulatory Issues Backflow Prevention ........................................................................................................................ 1 CDC Statement on Backflow Prevention ....................................................................................... 2 Radiation Safety ..........................................................................................................................6 Ergo Tips .....................................................................................................................................7 01/2015 3 Table of Contents Austin Community College Department of Dental Hygiene Introduction Austin Community College – Department of Dental Hygiene (known in this manual as ACC-DH) is dedicated to providing a safe and healthful environment for employees, students and patients, protecting the public and preserving our assets and property. At ACC-DH our most valuable resources are the people who work for us, the students who attend our program and the patients who we treat in our clinic. Injuries can be prevented. To achieve this objective, ACC-DH will make all reasonable efforts to comply with all government regulations pertaining to safety and health issues. An effective Safety and Health Program will be carried out throughout our clinic. The Safety and Health Program will assist management and non-supervisory employees and students in controlling hazards and risks which will minimize employee, student and patient injuries, damage to their property and damage or destruction of ACC-DH property. All employees and students will follow this program. This program is designed to encourage all employees and students to promote the safety of their fellow employees, students and patients. To accomplish our safety and health goals, all members of management are responsible and accountable for implementing this policy, and to insure it is followed. ACC-DH is sincerely interested in the employee’s and student’s safety. The policy of ACC-DH is to provide safe equipment, adequate tools and training, and the necessary protective equipment. It is the employee’s and student’s responsibility to follow the rules of safety as established for their protection and the protection of others, and to use the protective devices, which ACC-DH provides. 01/2015 1 General Information General Industry Standard on Personal Protective Equipment OSHA’s general industry standards on personal protective equipment (PPE) impose compliance obligations on dentists. The material on the following pages explains these obligations and what you must do to comply if you are an employer with one or more employees. As you know, the use of personal protective equipment to protect against bloodborne pathogens (e.g., gloves, gowns, masks and eyewear) is already covered under OSHA’s Bloodborne Pathogens Standard. These requirements are described in the section of this Manual on Bloodborne Pathogens under the tab “Methods of Compliance.” However, OSHA also has what are called “general industry standards” on personal protective equipment that apply to other kinds of hazards. These standards would apply, for example, in situations where employees handle hazardous chemicals or to employees who operate dental equipment. They might require employees working with high viscosity silicone impression material to wear gloves and protective eyewear or to wear safety glasses when operating a dental lathe or model trimmer. These rules require employers to: • Conduct a formal hazard assessment to determine whether and what PPE is needed; • Train employees in proper selection and use of PPE; and • Certify that the assessment and training have been done. General Requirements for Personal Protective Equipment Portions of the standard on general requirements for personal protective equipment (PPE) can be found in Appendix A of this section. However, the main idea of this document as it applies to your office is outlined below. The full text is available at: www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=FEDERAL_REGISTER&p_ id=13370 . Additional information on this subject is available from OSHA in the free booklet, “Personal Protective Equipment” (OSHA 3151). Dentists may request this publication from their area OSHA office, or they may obtain a copy at www.osha.gov. What the Standard (29 CFR §1910.132) Says: • Personal protective equipment (PPE) must be provided, used and maintained in a sanitary and reliable condition wherever it is needed to protect employees against chemical hazards, radiological hazards or mechanical irritants. Note: Employers must not only provide PPE, they must take reasonable steps to ensure that employees use it. For example, OSHA might require an employer to periodically check on employee compliance. 01/2015 2 General Information • Employers must assess the hazards present in their workplaces and select the equipment that will protect employees from any hazards they find. Guidelines for conducting the assessment and selecting appropriate equipment are provided in non-mandatory Appendix B to the standard (Appendix 1). Note: This is a performance standard. Employers are required to select the equipment that is appropriate in light of the tasks to be performed, the conditions present, the duration of the use and the hazards and potential hazards identified. However, the selection guidelines in Appendix B to the General Industry Standard (Appendix 1) should be helpful to dentists in determining what is appropriate in their particular offices. • Employers must communicate their selection decisions to affected employees. Note: The rule does not specify how this information should be communicated. Perhaps the best way would be as part of the required employee training program. Dentists would be wise to document the discussion as part of their training record. • Employers must select equipment that fits each affected employee (e.g., small gloves for small hands, large glasses for wide faces.) • Employers must certify in writing that the required hazard assessment has been performed. • The certificate (which the employer must make available to OSHA upon request) must contain: o The identity of the workplace; o The identity of the person certifying that the evaluation was performed; and o The date(s) of the evaluation. The certificate must also state that it is a certificate of hazard assessment. A sample hazard assessment certificate is included at the end of this summary. (Form A, page 29). • Defective or damaged PPE may not be used (e.g., torn gloves or scratched glasses that obscure the wearer’s vision). • Employers must provide training to employees who are required by this section to use PPE. Training in PPE required under the bloodborne pathogens standard is governed by that standard, not this one. • Employees must be trained to know: o When PPE is necessary; o What PPE is necessary; o How to properly don, doff, adjust and wear PPE; o The limitations of the PPE; and o The proper care, maintenance, useful life and disposal of the PPE. 01/2015 3 General Information Following the training, employees must be able to demonstrate they understood the training and know how to use the PPE properly before using the PPE in actual practice. Note: New employees should be trained before they begin work requiring the use of PPE. Retraining is required when the employer has reason to believe an employee does not have the understanding and skill to use PPE properly or when there are changes in the workplace or the types of PPE used that make the previous training obsolete. Employers must certify in writing that each affected employee has received and understood the required training. The certificate (which must be made available to OSHA upon request) must contain: o The name of each employee trained; and o The dates of training. The certificate must also state that it is a training certificate. What ACC-DH Has Done to Comply A hazard assessment of the ACC-DH clinic was done to determine the need for PPE. A certificate has been completed and is on file verifying that the evaluation was done. Form A on page 24 is included for this purpose. Employees and students are trained in the use of any PPE the ACC-DH clinic determines is needed and required to demonstrate their understanding of what they have learned. ACC-DH has completed and has on file a certificate verifying the training was done. Form B on pages 25 – 30 is included for this purpose. 01/2015 4 General Information General Industry Standard on Compressed Gases A compressed gas is a gas or mixture of gases stored under pressure in cylinders. Examples of compressed gases that may be found in a dental office include nitrous oxide and oxygen. Dental staff should handle, maintain, and store compressed gases with caution. Possible hazards include oxygen displacement, fires, explosions, and toxic gas exposures. When damaged or broken off, regulators and cylinder valves could fly off, wounding someone with the force of a bullet. Broken valves might also cause cylinders to pinwheel or become missilelike projectiles. Falling, heat, vibration, corrosion, or anything that may weaken or cause a crack in the cylinder wall or shell can cause damage to cylinders. Maintenance and storage of compressed gas cylinders is of the utmost importance for the safety of your office. Fortunately, it is also relatively easy. TYPICAL CYLINDER PRESSURE REGULATOR The full text of the standard is available at: www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9747 This document is also included in its entirety in the appendices following this section. What the Standard (29 CFR§1910.101) Says: • Employers are responsible for visually inspecting their compressed gas cylinders to ensure they are in a safe condition • Handling, storage and use of all compressed gases in cylinders should be in accordance with Compressed Gas Association Pamphlet P-1-1965. Note: The contents of this pamphlet as they apply to the dental office are outlined below. • Compressed gas cylinders will have pressure relief devices installed and maintained in accordance with Compressed Gas Association Pamphlets S-1.1-1963 and 1965 addenda and S-1.2-1963 Note: The maintenance requirements as they apply to the dental office are outlined below. 01/2015 5 General Information Labeling All compressed gas cylinders must be clearly labeled. Always check the labels of the cylinders when they are delivered. The name of the gas should be stenciled or stamped on the cylinder or on a label on the cylinder. Do not accept cylinders that are not identified with a legible label of the contents. If you encounter this problem, return the cylinder to the supplier after marking it with the label “contents unknown.” Do not use a cylinder’s color as the basis for identifying the gas. Different suppliers may use different colors. Also do not trust labels on a cylinder’s cap for identification because cylinder caps are interchangeable. You should also label the gas lines leading to the cylinder. The gas lines should be clearly labeled with the name of the gas, the area served, and any possible hazards, such as flammable, corrosive or toxic. Signs identifying the gas and noting these hazards should also be posted in the area where the gas is used or stored. Storage Secure cylinders at all times to avoid jostling or tipping. Cylinders are heavy and may cause serious injury if they fall on someone. Or if a cylinder falls over and a valve breaks off, high pressure gas may escape, and the cylinder could become a projectile. Cylinders may be secured with straps or chains connected to a wall bracket, or using special racks or stands specifically designed for this purpose. In addition to securing cylinders, there are several other considerations. Use the following guidelines to ensure that cylinders are stored safely: • Cylinders should always be stored in an upright position with cylinder valves in the closed position and cylinder valve caps securely attached. • Keep cylinders in a temperature-controlled area that is cool, dry, well-ventilated and isolated from any potential fire or electrical hazards. The area should be free of corrosive materials. • Do not store cylinders in hallways or other public areas. • Separate cylinders by their contents. • There are special considerations for oxygen cylinders. Oxygen cylinders must be stored at least 20 feet from any cylinders containing other flammable gases or combustible materials. Oxygen cylinders may also be separated by a noncombustible barrier with a height of at least five feet and a fire-resistance rating of at least 30 minutes. • Store empty and full cylinders separately. 01/2015 6 General Information Transporting Cylinders There are also special recommendations for transporting cylinders. Follow them to keep you and your office staff safe: • Cylinders should only be moved or transported using a cart or basket designed for this purpose. • Make sure that the cylinder valves are off and that valve caps are securely attached. • Do not transport the cylinder with the regulator in place. • Do not drop or strike a cylinder — this may cause an explosion. • Do not try to lift a cylinder by its valve cover. The valve could become loose or come off. • Never roll a cylinder on its side to move it. • Make sure that the cylinder is secure before you attempt to transport it. Using Compressed Gases Only properly trained staff should use compressed gas cylinders. • Before you use a compressed gas: o Inspect all cylinders, valves, regulators, and hoses. o Make sure all the connectors are free from oil and grease. o Move the cylinder valve end into the up position. o Before you attach any regulators, hoses or piping, vent the cylinder by slightly opening the valve. Do not position yourself in front of the valve when you do this. o Make sure the regulator is the correct one for the cylinder you are using. Do not force connections that do not fit. o Open all valves slowly. • After you use a compressed gas: o Close all cylinder valves. Make sure they are closed tightly. o Remove the regulator, but only after you have closed the valves and released all the pressure. o When closing needle valves, make sure you only close them finger tight so you don’t damage the valve or valve stem. Leaks If you suspect a cylinder may be leaking, take the following precautions, move the cylinder to an isolated, well-ventilated area away from potentially flammable sources. Post warnings around the area. Wait for the gas to discharge. Do not try to repair the cylinder. Contact the supplier for further instructions. 01/2015 7 General Information Disposal Remove the cylinder to a storage area that is designated for empty cylinders. Do not store it with cylinders that still hold compressed gas. Replace the cap on the cylinder. Label it with a tag so that everyone will know it is empty. You can use chalk to mark it with the letters “MT” and the date. Empty cylinders may still have residual pressure, so handle them as if they were full. Never refill an empty cylinder Personal Protective Equipment (PPE) When using compressed gases, users should wear safety glasses or faceshields. This is especially important when disconnecting regulators and lines. Training OSHA does not require any specific staff training on compressed gases. However, the more your staff knows about handling cylinders correctly, the safer everyone will be. Additionally, the General Industry Standard on Compressed Gases is also one of the most frequently cited standards during OSHA inspections of dental offices. The following questions can be used for discussion and action with dental staff: Why do we take such careful precautions when handling compressed gases? What are the compressed gases used in your office? Where are they stored? Who are the suppliers and what is their contact information in case of an emergency? (A worksheet is provided on the following page to document this information.) Are the cylinders in your office labeled correctly and legibly? What would you do if a supplier delivered a cylinder with no label or an illegible label? Where do you look for a label? Are the cylinders in your office stored upright in stands, racks, or secured with straps and chains to a wall? Are the cylinders stored away from potential fire or electrical hazards? What special considerations are there for compressed oxygen? What should you do if you suspect a cylinder is leaking gas? What do you do with an empty cylinder? What are some steps to take before you use a compressed gas? What are some steps when you are done using a compressed gas? An additional resource on compressed gas safety is available at: www.wsmr.army.mil/PDF/compressedgassafety.PDF. 01/2015 8 General Information Compressed Gases in this Office What is the gas? Where is it stored? Supplier’s Name Oxygen 8100.5 hallway closet Precision Oxygen & Supply Nitrous Oxide 8100.5 hallway closet Precision Oxygen & Supply 01/2015 9 Supplier’s Contact Information 4927 E. 5th St Austin, TX 78702 512-385-2247 4927 E. 5th St Austin, TX 78702 512-385-2247 General Information General Industry Standard on Formaldehyde Formaldehyde is a colorless gas with a strong, pungent smell. It is commonly found as part of water-based solutions. Typical uses of formaldehyde-containing agents in a dental office include Formalin for tissue fixation and formocresol for endodontic procedures. The National Institute of Environmental Health Sciences (NIH-HHS) classifies formaldehyde as a known carcinogen. However, you can train your staff to handle formaldehyde safely to limit their exposure. Symptoms of exposure or overexposure to formaldehyde include: • • • • • Watery eyes Burning sensations in the eyes, nose and throat Coughing Wheezing Skin irritation It is important to note that sensitivity to formaldehyde varies from person to person. At the same exposure level, one person may experience an adverse reaction, while a different person may not react at all. The portions of the standard that apply to a dental office are summarized in the following pages. The full text is available at: www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10075. An OSHA factsheet is also available online at: www.osha.gov/OshDoc/data_General_Facts/formaldehyde-factsheet.pdf Both of these documents are included in their entirety in the appendices following this section. What the Standard (29 CFR§1910.1048) Says: • The permissible exposure limit for formaldehyde in the workplace for employees is 0.75 parts formaldehyde per million (ppm) measured as an eight hour time-weighted average. The short-term exposure limit is two parts per million allowed during a 15 minute time period. • Employers must monitor employees to determine their exposure to formaldehyde. • The employer will have regulated areas where concentration of airborne formaldehyde exceeds the time-weighted average or the short-term exposure limit. Access will be limited to employees who have been trained to recognize the hazards of formaldehyde. Signs with the following language will be posted at all entrances and access areas: DANGER! FORMALDEHYDE MAY CAUSE CANCER. CAUSES SKIN, EYE, AND RESPIRATORY IRRITATION AUTHORIZED PERSONNEL ONLY. 01/2015 10 General Information • Employers will use engineering controls and work practice controls to reduce and maintain employee exposure to formaldehyde at or below the time weighted average of the short-term exposure limit. If employers cannot reduce exposure at or below permissible exposure limits, they must provide respirators to staff. • All mixtures or solutions composed of greater than 0.1 percent formaldehyde and materials capable of releasing formaldehyde into the air at concentrations reaching or exceeding 0.1 ppm must be labeled. For all materials capable of releasing formaldehyde at levels above 0.5 ppm during normal use, the label must contain the words “potential cancer hazard.” • Employers must provide personal protective equipment (PPE) at no cost to employees and make sure that employees use the equipment. • Employers will regularly provide maintenance of equipment, including checking for leaks. They will also provide provisions for spills, decontamination, and waste disposal in the work areas where formaldehyde is used. Spills will be cleaned by trained employees who are wearing the appropriate PPE. • If an employee develops signs and symptoms of overexposure to formaldehyde, the employer will provide examination and follow-up by a medical professional at no cost to the employee. • The employer will provide training to all employees who are at risk possible exposure to formaldehyde. The training will take place annually, when a new employee is hired or assigned to a task with possible formaldehyde exposure, and whenever a new exposure to formaldehyde is introduced in the workplace. Engineering Controls Examples of engineering controls and work practice controls include the following: • Always use formaldehyde in areas with proper ventilation. • Store formaldehyde in closed containers in well-ventilated areas • Use a tray when working with formaldehyde to contain potential spills • Clearly label formaldehyde containers with the proper health hazards • Do not eat or drink where formaldehyde is handled, processed or stored • Use only as much formaldehyde as is necessary to perform the task at hand • Always wash hands thoroughly after using formaldehyde, even if you were wearing gloves 01/2015 11 General Information Personal Protective Equipment (PPE) Appropriate PPE for handling formaldehyde includes gloves, goggles and faceshields. When using liquids than contain a percentage of formaldehyde that is one percent or greater, impermeable gloves must be used. Latex gloves may be used only in instances of short-term, incidental contact. PPE and clothing that has been contaminated with formaldehyde must be laundered before it is used again. Employers will provide a storage area for contaminated PPE and clothing, and will label it with the following: DANGER FORMALDEHYDE-CONTAMINATED [CLOTHING] EQUIPMENT MAY CAUSE CANCER CAUSES SKIN, EYE, AND RESPIRATORY IRRITATION DO NOT BREATHE VAPOR DO NOT GET ON SKIN Labeling Label all mixtures or solutions composed of greater than 0.1 percent formaldehyde and materials capable of releasing formaldehyde into the air at concentrations reaching or exceeding 0.1 ppm. For all materials capable of releasing formaldehyde at levels above 0.5 ppm during normal use, the label must contain the words “may cause cancer.” These label requirements will be met by the chemical manufacturer. If you keep the formaldehyde product in its original container and the original label remains intact, the original label should be sufficient. Here is an example of a sample manufacturer’s label for Formalin, a product containing formaldehyde: Products containing formaldehyde may not be poured or used in any non-labeled containers. Storage Products containing formaldehyde should be kept in their original, labeled containers. They should be stored in a dry, well-ventilated area that is temperature controlled. Keep these products out of direct sunlight. They must also be kept away from heat; combustible and flammable materials; and incompatible materials. 01/2015 12 General Information Training Training on the safe handling of formaldehyde should be conducted at least annually. The following situations also require training: • When you hire someone new whose duties include tasks with potential formaldehyde exposure • When a current employee’s duties expand to include tasks with potential formaldehyde exposure • When a new product with the risk of formaldehyde exposure is introduced into the office The following checklist describes the information that should be included in your training program: A description of the health hazards of formaldehyde exposure, as well as the signs and symptoms of formaldehyde exposure Descriptions of how to safely work in an area where formaldehyde is present, as well as the explanation of safe work practices to limit exposure to formaldehyde in each job where it is used The purpose and proper use of PPE when handling formaldehyde Instructions on handling spills, emergencies, and clean-up procedures An explanation of engineering and work practice controls and how to use them A review of emergency procedures, including individual employee assignments in the event of an emergency Instructions for immediately reporting to the employer any signs or symptoms that the employee suspects are due to formaldehyde exposure A review of the Safety Data Sheets of products containing formaldehyde The location of the training materials for future reference 01/2015 13 General Information OSHA General Standard for Emergency Action Plans OSHA requires an emergency action plan (EAP) for dental offices. Compliance is simple, and can be easily accomplished in the steps outlined below. The full text of the standard is available at: www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=9726&p_table=STANDARDS This document is also included in its entirety in the appendices following this section. What the standard (29 CFR§1910.101) says: • Employers must have an emergency action plan where OSHA requires one • The emergency action plan must be kept in writing where it is accessible by employees. However, if there are fewer than 10 employees, the emergency action plan can be communicated orally. • The emergency action plan must contain the following at a minimum: o Procedures for reporting a fire or other emergency o Procedures for emergency evacuation, including the evacuation type and exit route assignments o Procedures to be followed by employees who remain behind to operate critical operations before they evacuate o Procedures to account for each employee after evacuation o Procedures to be followed by employees who perform rescue or medical duties o The name and job title of every employee who may be contacted by employees who need more information about the plan or an explanation of their duties under the plan • An employer must have and maintain an employee alarm system. The employee system must use a distinctive signal for each purpose • An employer must designate and train employees to assist in a safe and orderly evacuation of other employees • An employer must review the emergency action plan with each covered employee when: o The plan is developed or the employee is initially assigned to a job o When an employee’s responsibilities under the plan change o When the plan changes 01/2015 14 General Information Developing an Emergency Action Plan STEP 1: CONDUCT A WORKPLACE EVALUATION The first step in developing an emergency action plan is to conduct a workplace evaluation. According to OSHA, your workplace evaluation should include an assessment of the following: • Design and construction requirements for exit routes • Maintenance, safeguards and operational features for exit routes • Your current emergency action plan • Your fire prevention plan • Fire extinguishing systems o Portable extinguishers o Fixed systems • Fire detection systems • Emergency alarm systems STEP 2: GATHER STAFF INPUT In order to have an effective emergency action plan, you must gather input from a diverse range of staff, from the front desk staff to the clinical staff to the office management. You may be surprised at the different concerns that each group has. Maybe the administrative staff is focused on backing up data systems, while the clinical staff is more aware of securing equipment. Discuss the types of emergencies that could occur in your area. Consider both natural and manmade emergencies. For example, is your geographic region prone to earthquakes, tornadoes, or other natural disasters? Is there a nuclear power plant near your town? What types of precautions are necessary in your locale? Also think about who may need extra help if an evacuation is necessary, as well as if anyone will stay behind to operate critical plant operations prior to evacuating. STEP 3: ASSIGN STAFF ROLES • Who is in charge during an emergency? • Who will account for each staff member after everyone has been evacuated? • Who will stay behind to operate critical plant operations before evacuating? • What are the names and job titles of people who can be contacted for further information on the emergency action plan? • Which employees will assist in the safe and orderly evacuation of other employees? 01/2015 15 General Information • Who in the office has had CPR training and how can they be of assistance during an emergency? STEP 4: DECIDE HOW YOU WILL REPORT FIRES AND OTHER EMERGENCIES Before an emergency occurs, decide how it will be reported. Often, calling 911 is enough to alert the appropriate authorities. STEP 5: TRAIN STAFF OSHA does not require any special training on emergency action plans for office staff. However, familiarizing your staff with the emergency action plan is a good idea to ensure everyone’s safety. OSHA suggests including the following information in a general employee training: Clearly communicate who is in charge during an emergency. This will reduce confusion if an emergency arises. Assign individual roles and responsibilities. Your employees should know who is in charge of what. Discuss potential threats, hazards, and protective actions Explain the notification, warning, and communications procedures you have in place Review emergency response procedures Talk about evacuation, shelter and accountability procedures Go over the location and use of common emergency equipment Examine the emergency shutdown procedures In order for employees to retain the information you have provided, conducting an annual emergency action plan training is ideal. Remember: though a yearly training is not required, OSHA mandates that employers review the emergency action plan with each covered employee when the plan is developed; when the plan changes; when an employee is initially assigned to a job; or when an employee’s responsibilities change under the plan. 01/2015 16 General Information Emergency Action Plan Training Log Date of Training Employee Name Employee Signature Reason for Training (Annual training, training for updated EAP, new employee training, training for new responsibilities, etc.) 08/25/2015 Renee Cornett Annual Training 08/25/2015 Kellie Murphree Annual Training 08/25/2015 Gary Wright Annual Training 08/25/2015 Michelle Landrum Annual Training 08/25/2015 Kate Goin Annual Training 08/25/2015 Kimberly McDougall Annual Training 08/25/2015 Sima Sohrabi Annual Training 08/25/2015 Debra Segen Annual Training 08/25/2015 Rita Snodell Annual Training 08/25/2015 David Reeves Annual Training 08/25/2015 Tina Stein New employee training 08/25/2015 Andrea Kovarik New employee training 01/2015 17 General Information Emergency Action Plan Training Log Date of Training Student Name Reason for Training (Annual training, training for updated EAP, new employee training, training for new responsibilities, etc.) 08/29/2016 Monique Alarcon New student training 08/29/2016 Rachel Dickens New student training 08/29/2016 Sunena Gagneja New student training 08/29/2016 Lacie Herrin New student training 08/29/2016 Dylon Hopper New student training 08/29/2016 Cydnie Johnson New student training 08/29/2016 Julia Levitt New student training 08/29/2016 Stephanie Liu New student training 08/29/2016 Kristi Madrid New student training 08/29/2016 Katie Natale New student training 08/29/2016 Aneesa Patel New student training 08/29/2016 Lee Pepe New student training 08/29/2016 Jennifer Rice New student training 08/29/2016 Shaunda Talamantez New student training 08/29/2016 Yulia Voznesenskaya New student training 08/29/2016 Jeremiah Wallace New student training 08/29/2016 Allyson Walter New student training 08/2016 18 General Information Emergency Action Plan Training Log Date of Training Employee Name Student Signature Reason for Training (Annual training, training for updated EAP, new employee training, training for new responsibilities, etc.) 08/24/2015 Jason Blunck New student training 08/24/2015 Wendy Bushman New student training 08/24/2015 Josette Chen New student training 08/24/2015 Amy Deng New student training 08/24/2015 Becca Eiserer New student training 08/24/2015 Zainab Jabr New student training 08/24/2015 Laura Jaimes New student training 08/24/2015 Whitney Jones New student training 08/24/2015 Molly Keith New student training 08/24/2015 Shari Langerhans New student training 08/24/2015 Jessica Lee New student training 08/24/2015 Carrie Nunnally New student training 08/24/2015 Jess Ross New student training 08/24/2015 Azadeh Samani New student training 08/24/2015 Elya Singler New student training 08/24/2015 Allyson Walter New student training 08/24/2015 Stacy Weiner New student training 08/24/2015 Jason Whittley New student training 08/2015 19 General Information OSHA Training and Records Below is a list of the ACC-DH policies for training and keeping records up-to-date to fully comply with OSHA standards. When a New Employee is Hired or a New Class of Students Enter the Program • It is determined whether the employee or student has “occupational exposure” to bloodborne pathogens and any necessary changes in the written exposure determination are made. • A confidential medical record for the employee or student is created, to include the employee’s or student’s name, social security number and hepatitis B vaccination status; the employee or student is informed of their right of access to this record and how to exercise that right. • The level of training already obtained in prior employment is determined. • Required training depending on the specific hazards in our office to which the employee or student is exposed (e.g., bloodborne pathogens, hazardous chemicals, fire, etc.) is provided; a written record of all training is maintained. When There is a Change in Office Procedure Sometimes employees or students take on new responsibilities, a change occurs in office tasks or procedures (e.g., we switch from a one-handed “scoop” method of recapping needles to a mechanical device) or a new hazard is introduced in the work place (e.g., a new product containing a hazardous chemical). When this happens: • The relevant plan (e.g., exposure control, hazard communication) is updated • Training of affected employees or students is updated When an Accident or Illness Occurs • A record of any “exposure incident,” e.g., a needlestick is made; the incident is evaluated to determine if the employee or student needs additional training (all of the other steps required for post-exposure evaluation and follow-up are completed and documented). • A copy of the incident report and the health care professional’s written report (if any) is filed in the employee’s or student’s medical record. • As of January 1, 2015, new reporting requirements went into effect for the following situations: o Fatalities o In-patient hospitalization o Loss of an eye o Amputations 01/2015 20 General Information Work-related fatalities must be reported to OSHA within eight hours of the event. Work-related in-patient hospitalizations, loss of an eye, or amputations must be reported within 24 hours of the incident. We can report the incident to OSHA by phone or online: o Call the 24-hour OSHA hotline at 1.800.321.OSHA o Report the incident online at www.osha.gov/report_online Once a Year • The exposure control plan is reviewed and updated. This includes documentation that we have evaluated safer needle devices and that representative exposed employees were involved in the process. For information and forms to help us evaluate devices, see the CDC’s web page at www.cdc.gov/OralHealth/infectioncontrol/forms.htm. • Bloodborne pathogens training and a refresher on hazard communication and other OSHA standards, too are provided. • Employees and students are reminded they have right of access to their medical records and a record that we did so is kept. • Any employees or students who are expected to use fire extinguishers are trained in their use. • A maintenance check for any portable fire extinguishers is provided and the maintenance date is recorded. Monthly • Any portable fire extinguishers are visually inspected; a record of the inspection is maintained. Periodically • A periodic mock inspection of our own dental clinic is conducted, using the ADA’s OSHA checklist as a guide for compliance with OSHA’s most significant requirements. The mock inspection is also used to check for other potentially unsafe conditions, such as torn carpeting or loose handrails, which are not specifically covered in the checklist. 01/2015 21 General Information If ACC-DH Receives a Telephone Call or Letter from OSHA In an effort to streamline the inspection process, OSHA inspectors may investigate certain complaints by telephone or by letter. ACC-DH has developed an office protocol for dealing with either such contact. Background OSHA separates complaints into two categories: formal and nonformal. A formal complaint must: 1. Be in writing 2. Allege that an imminent danger or a violation threatening physical harm exists (i.e., a complaint of a recordkeeping violation would not meet this requirement) 3. Set forth with reasonable particularity the grounds on which the complaint is based 4. Be signed by at least one current employee, a representative of an employee (such as unions, attorneys, elected representatives, and family members), or present employee of another company if that employee is exposed to the hazards of the complained-about workplace (former employees can only submit nonformal complaints) A nonformal complaint is any complaint that does not meet the requirements of a formal complaint, e.g. unsigned or oral complaints by current employees, written and oral complaints by most nonemployees or former employees. Letters from OSHA OSHA’s procedure has been to conduct an unannounced workplace inspection in response to a formal complaint. When OSHA receives a nonformal complaint, it typically sends the employer a letter, informing him/her of the alleged violations and asking the employer to investigate and respond within a specified time. The language of the letter is usually the same; only the list of alleged violations varies. More dentists will receive a letter from OSHA than will ever see an inspector. OSHA will usually share a copy of the response with the complainant and ask him or her to comment. If it appears that no violation exists, or that the employer has taken appropriate corrective action, OSHA will usually close the file with no further action. In one out of 10 cases, OSHA will conduct a follow-up inspection to verify the information provided. OSHA selects these cases on a random basis from a pool consisting of all employers, not just dentists. OSHA will always conduct an inspection if the employer fails to respond or his or her response is inadequate. Phone Calls from OSHA Under an alternative procedure, an investigation of a nonformal complaint may be conducted by telephone, as well as by letter, if the complaint alleges a condition that is not serious and can be satisfactorily resolved in this manner. 01/2015 22 General Information ACC-DH Office Protocol 1. Only the Dental Hygiene Department Chair (known as the DHDC) will answer telephone inquiries from an OSHA inspector. Office staff who may answer the phone are instructed to immediately contact the DHDC if an OSHA inspector calls. If the DHDC is not in the office, staff are instructed to tell the inspector that the DHDC will call the inspector back. 2. Take the inspector’s name and the name of the OSHA area office from which the inspector is calling. Verify the phone number of the area office from directory assistance and then the DHDC will call the inspector back. The caller should be informed that this precaution is being taken as a necessary step to avoid scams. Unscrupulous suppliers have been known to identify themselves as OSHA officials in order to gain access to dental offices. 3. When the DHDC has verified the identity of the caller, find out whether the call is in response to a formal complaint or a nonformal complaint. 4. Ask the inspector to send a copy of the complaint or, in the case of an unwritten complaint, a list of the alleged violations. This will allow careful review of the allegations and time to conduct any necessary investigation before responding. (If you receive a copy of a complaint, the complainant’s name will be deleted.) 5. As with responses to OSHA letters, the conversation will be confined to the violations alleged in the complaint. Each alleged violation will be discussed in turn. 6. If the inspector’s questions start to go beyond the scope of the complaint, the DHDC will object, courteously but firmly. 7. The DHDC will not get into an argument with the inspector. If the inspector is being difficult, ask to speak to his or her supervisor. 8. The DHDC will be truthful. OSHA will verify information provided and will inform the complainant of the response. 9. The DHDC will not make any disparaging comments about the person suspected of filing the complaint. OSHA’s mission is to protect employees. Comments which OSHA interprets as broadly anti-employee could make a bad impression. 10. Upon request, send the inspector documentary evidence that is relevant to the violations alleged in the complaint. Examples might be invoices for glove purchases or copies of training records. Again, know where to stop. Anything that does not relate specifically to the violations complained of should not be provided. Photographs are particularly tricky in this regard, because it is difficult to keep extraneous material out. 01/2015 23 General Information Form A Certificate of Hazard Assessment Pursuant to 29 CFR § 1910.132 I, Kate Goin, BA, RDH, certify that the dental office of: Austin Community College, Department of Dental Hygiene was evaluated on: 09/14/2016 for hazards which are present, or are likely to be present, which necessitate the use of personal protective equipment. (signature) 09/14/2016 (date) 01/2015 24 General Information Form B Certificate of Employee Training in PPE Use Pursuant to 29 CFR § 1910.132 I, Kate Goin, RDH certify that on 09/04/2012 the following employees/students received the training required under OSHA’s standard on personal protective equipment 1. Renee Cornett, RDH 2. Kellie Murphree, RDH 3. Joe Wright, DDS 4. David Reeves, DMD 5. Michelle Landrum, RDH 6. Sima Sohrabi, RDH 7. Debra Segen, RDH 8. Rita Snodell, RDH As part of this training, employees were informed about the safe and proper use of personal protective equipment selected by this office. I further certify that each employee listed above has demonstrated his/her understanding of this training. (signature) 05/26/2015 (date) 01/2015 25 General Information Form B Certificate of Employee Training in PPE Use Pursuant to 29 CFR § 1910.132 I, Kate Goin, RDH certify that on 08/31/2015 the following employees/students received the training required under OSHA’s standard on personal protective equipment 1. Kimberly McDougall, RDH 2. Tina Stein, RDH 3. Andrea Kovarik, RDH 4. Veronica Ledesma, RDH on 9/7/2016 as new employee 5. Teri Frank, CDA on 9/13/2016 as new employee 6. 7. 8. As part of this training, employees were informed about the safe and proper use of personal protective equipment selected by this office. I further certify that each employee listed above has demonstrated his/her understanding of this training. (signature) 09/10/2015 (date) 01/2015 26 General Information Form B Certificate of Employee Training in PPE Use Pursuant to 29 CFR § 1910.132 I, Kate Goin, RDH certify that on 09/07/2016 the following employees/students received the training required under OSHA’s standard on personal protective equipment 1. Monique Alarcon 2. Rachel Dickens 3. Sunena Gagneja 4. Lacie Herrin 5. Dylon Hopper 6. Cydnie Johnson 7. Julia Levitt 8. Stephanie Liu 9. Kristi Madrid As part of this training, employees were informed about the safe and proper use of personal protective equipment selected by this office. I further certify that each employee listed above has demonstrated his/her understanding of this training. (signature) 09/13/2016 (date) 09/2015 27 General Information Form B Certificate of Employee Training in PPE Use Pursuant to 29 CFR § 1910.132 I, Kate Goin, RDH certify that on 09/07/2016 the following employees/students received the training required under OSHA’s standard on personal protective equipment 1. Katie Natale 2. Aneesa Patel 3. Lee Pepe 4. Jennifer Rice 5. Shaunda Talamantez 6. Yulia Voznesenskaya 7. Jeremiah Wallace 8. Allyson Walter As part of this training, employees were informed about the safe and proper use of personal protective equipment selected by this office. I further certify that each employee listed above has demonstrated his/her understanding of this training. (signature) 09/13/2016 (date) 09/2015 28 General Information Form B Certificate of Employee Training in PPE Use Pursuant to 29 CFR § 1910.132 I, Kate Goin, RDH certify that on 08/31/2015 the following employees/students received the training required under OSHA’s standard on personal protective equipment 1. Jason Blunck 2. Wendy Bushman 3. Josette Chen 4. Amy Deng 5. Becca Eiserer 6. Zainab Jabr 7. Laura Jaimes 8. Whitney Jones 9. Molly Keith As part of this training, employees were informed about the safe and proper use of personal protective equipment selected by this office. I further certify that each employee listed above has demonstrated his/her understanding of this training. (signature) 09/10/2015 (date) 09/2015 29 General Information Form B Certificate of Employee Training in PPE Use Pursuant to 29 CFR § 1910.132 I, Kate Goin, RDH certify that on 08/31/2015 the following employees/students received the training required under OSHA’s standard on personal protective equipment 1. Shari Langerhans 2. Jessica Lee 3. Carrie Nunnally 4. Jess Ross 5. Azadeh Samani 6. Elya Singler 7. Allyson Walter 8. Stacy Weiner 9. Jason Whittley As part of this training, employees were informed about the safe and proper use of personal protective equipment selected by this office. I further certify that each employee listed above has demonstrated his/her understanding of this training. (signature) 09/10/2015 (date) 09/2015 30 General Information Appendix A: Standards on General Requirements on Personal Protective Equipment and Hand Protection U.S. Department of Labor Occupational Safety & Health Administration www.osha.gov [skip navigational links] Search Advanced Search Regulations (Standards - 29 CFR) General requirements. - 1910.132 Regulations (Standards - 29 CFR) - Table of Contents • • • • • • Part Number: Part Title: Subpart: Subpart Title: Standard Number: Title: 1910 Occupational Safety and Health Standards I Personal Protective Equipment 1910.132 General requirements. 1910.132(a) $SSOLFDWLRQ3URWHFWLYHHTXLSPHQWLQFOXGLQJSHUVRQDOSURWHFWLYHHTXLSPHQWIRUH\HVIDFH KHDGDQGH[WUHPLWLHVSURWHFWLYHFORWKLQJUHVSLUDWRU\GHYLFHVDQGSURWHFWLYHVKLHOGVDQG EDUULHUVVKDOOEHSURYLGHGXVHGDQGPDLQWDLQHGLQDVDQLWDU\DQGUHOLDEOHFRQGLWLRQZKHUHYHU LWLVQHFHVVDU\E\UHDVRQRIKD]DUGVRISURFHVVHVRUHQYLURQPHQWFKHPLFDOKD]DUGV UDGLRORJLFDOKD]DUGVRUPHFKDQLFDOLUULWDQWVHQFRXQWHUHGLQDPDQQHUFDSDEOHRIFDXVLQJ LQMXU\RULPSDLUPHQWLQWKHIXQFWLRQRIDQ\SDUWRIWKHERG\WKURXJKDEVRUSWLRQLQKDODWLRQRU SK\VLFDOFRQWDFW 1910.132(b) (PSOR\HHRZQHGHTXLSPHQW:KHUHHPSOR\HHVSURYLGHWKHLURZQSURWHFWLYHHTXLSPHQWWKH HPSOR\HUVKDOOEHUHVSRQVLEOHWRDVVXUHLWVDGHTXDF\LQFOXGLQJSURSHUPDLQWHQDQFHDQG VDQLWDWLRQRIVXFKHTXLSPHQW 1910.132(c) 'HVLJQ$OOSHUVRQDOSURWHFWLYHHTXLSPHQWVKDOOEHRIVDIHGHVLJQDQGFRQVWUXFWLRQIRUWKH ZRUNWREHSHUIRUPHG ..1910.132(d) 1910.132(d) +D]DUGDVVHVVPHQWDQGHTXLSPHQWVHOHFWLRQ 1910.132(d)(1) 7KHHPSOR\HUVKDOODVVHVVWKHZRUNSODFHWRGHWHUPLQHLIKD]DUGVDUHSUHVHQWRUDUHOLNHO\WR EHSUHVHQWZKLFKQHFHVVLWDWHWKHXVHRISHUVRQDOSURWHFWLYHHTXLSPHQW33(,IVXFKKD]DUGV DUHSUHVHQWRUOLNHO\WREHSUHVHQWWKHHPSOR\HUVKDOO 1910.132(d)(1)(i) 6HOHFWDQGKDYHHDFKDIIHFWHGHPSOR\HHXVHWKHW\SHVRI33(WKDWZLOOSURWHFWWKHDIIHFWHG BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[$ *HQHUDOUHTXLUHPHQWV 3DJH RI HPSOR\HHIURPWKHKD]DUGVLGHQWLILHGLQWKHKD]DUGDVVHVVPHQW 1910.132(d)(1)(ii) &RPPXQLFDWHVHOHFWLRQGHFLVLRQVWRHDFKDIIHFWHGHPSOR\HHDQG 1910.132(d)(1)(iii) 6HOHFW33(WKDWSURSHUO\ILWVHDFKDIIHFWHGHPSOR\HH1RWH1RQPDQGDWRU\$SSHQGL[% FRQWDLQVDQH[DPSOHRISURFHGXUHVWKDWZRXOGFRPSO\ZLWKWKHUHTXLUHPHQWIRUDKD]DUG DVVHVVPHQW 1910.132(d)(2) 7KHHPSOR\HUVKDOOYHULI\WKDWWKHUHTXLUHGZRUNSODFHKD]DUGDVVHVVPHQWKDVEHHQSHUIRUPHG WKURXJKDZULWWHQFHUWLILFDWLRQWKDWLGHQWLILHVWKHZRUNSODFHHYDOXDWHGWKHSHUVRQFHUWLI\LQJ WKDWWKHHYDOXDWLRQKDVEHHQSHUIRUPHGWKHGDWHVRIWKHKD]DUGDVVHVVPHQWDQGZKLFK LGHQWLILHVWKHGRFXPHQWDVDFHUWLILFDWLRQRIKD]DUGDVVHVVPHQW 1910.132(e) 'HIHFWLYHDQGGDPDJHGHTXLSPHQW'HIHFWLYHRUGDPDJHGSHUVRQDOSURWHFWLYHHTXLSPHQW VKDOOQRWEHXVHG ..1910.132(f) 1910.132(f) 7UDLQLQJ 1910.132(f)(1) 7KHHPSOR\HUVKDOOSURYLGHWUDLQLQJWRHDFKHPSOR\HHZKRLVUHTXLUHGE\WKLVVHFWLRQWRXVH 33((DFKVXFKHPSOR\HHVKDOOEHWUDLQHGWRNQRZDWOHDVWWKHIROORZLQJ 1910.132(f)(1)(i) :KHQ33(LVQHFHVVDU\ 1910.132(f)(1)(ii) :KDW33(LVQHFHVVDU\ 1910.132(f)(1)(iii) +RZWRSURSHUO\GRQGRIIDGMXVWDQGZHDU33( 1910.132(f)(1)(iv) 7KHOLPLWDWLRQVRIWKH33(DQG 1910.132(f)(1)(v) 7KHSURSHUFDUHPDLQWHQDQFHXVHIXOOLIHDQGGLVSRVDORIWKH33( BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[$ *HQHUDOUHTXLUHPHQWV 3DJH RI 1910.132(f)(2) (DFKDIIHFWHGHPSOR\HHVKDOOGHPRQVWUDWHDQXQGHUVWDQGLQJRIWKHWUDLQLQJVSHFLILHGLQ SDUDJUDSKIRIWKLVVHFWLRQDQGWKHDELOLW\WRXVH33(SURSHUO\EHIRUHEHLQJDOORZHGWR SHUIRUPZRUNUHTXLULQJWKHXVHRI33( 1910.132(f)(3) :KHQWKHHPSOR\HUKDVUHDVRQWREHOLHYHWKDWDQ\DIIHFWHGHPSOR\HHZKRKDVDOUHDG\EHHQ WUDLQHGGRHVQRWKDYHWKHXQGHUVWDQGLQJDQGVNLOOUHTXLUHGE\SDUDJUDSKIRIWKLVVHFWLRQ WKHHPSOR\HUVKDOOUHWUDLQHDFKVXFKHPSOR\HH&LUFXPVWDQFHVZKHUHUHWUDLQLQJLVUHTXLUHG LQFOXGHEXWDUHQRWOLPLWHGWRVLWXDWLRQVZKHUH 1910.132(f)(3)(i) &KDQJHVLQWKHZRUNSODFHUHQGHUSUHYLRXVWUDLQLQJREVROHWHRU ..1910.132(f)(3)(ii) 1910.132(f)(3)(ii) &KDQJHVLQWKHW\SHVRI33(WREHXVHGUHQGHUSUHYLRXVWUDLQLQJREVROHWHRU 1910.132(f)(3)(iii) ,QDGHTXDFLHVLQDQDIIHFWHGHPSOR\HH VNQRZOHGJHRUXVHRIDVVLJQHG33(LQGLFDWHWKDWWKH HPSOR\HHKDVQRWUHWDLQHGWKHUHTXLVLWHXQGHUVWDQGLQJRUVNLOO 1910.132(f)(4) 7KHHPSOR\HUVKDOOYHULI\WKDWHDFKDIIHFWHGHPSOR\HHKDVUHFHLYHGDQGXQGHUVWRRGWKH UHTXLUHGWUDLQLQJWKURXJKDZULWWHQFHUWLILFDWLRQWKDWFRQWDLQVWKHQDPHRIHDFKHPSOR\HH WUDLQHGWKHGDWHVRIWUDLQLQJDQGWKDWLGHQWLILHVWKHVXEMHFWRIWKHFHUWLILFDWLRQ 1910.132(g) 3DUDJUDSKVGDQGIRIWKLVVHFWLRQDSSO\RQO\WRDQG 3DUDJUDSKVGDQGIRIWKLVVHFWLRQGRQRWDSSO\WRDQG >)5-XQHDVDPHQGHGDW)5$SULO)5-XO\ )5-XO\@ Next Standard (1910.133) Regulations (Standards - 29 CFR) - Table of Contents Back to Top www.osha.gov www Contact Us | Freedom of Information Act | Customer Survey Privacy and Security Statement | Disclaimers Occupational Safety & Health Administration BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[$ +DQG3URWHFWLRQ 3DJH RI U.S. Department of Labor Occupational Safety & Health Administration www.osha.gov Search [skip navigational links] Advanced Search_A-Z Inde Regulations (Standards - 29 CFR) Hand Protection. - 1910.138 Regulations (Standards - 29 CFR) - Table of Contents • • • • • • Part Number: Part Title: Subpart: Subpart Title: Standard Number: Title: 1910 Occupational Safety and Health Standards I Personal Protective Equipment 1910.138 Hand Protection. 1910.138(a) *HQHUDOUHTXLUHPHQWV(PSOR\HUVVKDOOVHOHFWDQGUHTXLUHHPSOR\HHVWRXVHDSSURSULDWHKDQG SURWHFWLRQZKHQHPSOR\HHV KDQGVDUHH[SRVHGWRKD]DUGVVXFKDVWKRVHIURPVNLQDEVRUSWLRQ RIKDUPIXOVXEVWDQFHVVHYHUHFXWVRUODFHUDWLRQVVHYHUHDEUDVLRQVSXQFWXUHVFKHPLFDO EXUQVWKHUPDOEXUQVDQGKDUPIXOWHPSHUDWXUHH[WUHPHV 1910.138(b) 6HOHFWLRQ(PSOR\HUVVKDOOEDVHWKHVHOHFWLRQRIWKHDSSURSULDWHKDQGSURWHFWLRQRQDQ HYDOXDWLRQRIWKHSHUIRUPDQFHFKDUDFWHULVWLFVRIWKHKDQGSURWHFWLRQUHODWLYHWRWKHWDVNVWR EHSHUIRUPHGFRQGLWLRQVSUHVHQWGXUDWLRQRIXVHDQGWKHKD]DUGVDQGSRWHQWLDOKD]DUGV LGHQWLILHG >)5$SULO@ Next Standard (1910 Subpart I App A) Regulations (Standards - 29 CFR) - Table of Contents www.osha.gov Back to Top www Contact Us | Freedom of Information Act | Customer Survey Privacy and Security Statement | Disclaimers Occupational Safety & Health Administration 200 Constitution Avenue, NW Washington, DC 20210 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[$ General Information Appendix B: General Industry Standard on Compressed Gases 1/16/2014 Compressed gases (general requirements). - 1910.101 $ WR = ,QGH[ _ (Q HVSDxRO _ &RQWDFW 8V _ )$4V _ $ERXW 26+$ 26+$ 1HZVOHWWHU 566 )HHGV 3ULQW 7KLV 3DJH 7H[W 6L]H :DV WKLV SDJH KHOSIXO" :KDW V 1HZ _ 2IILFHV +RPH :RUNHUV 5HJXODWLRQV (QIRUFHPHQW 'DWD 6WDWLVWLFV 7UDLQLQJ 3XEOLFDWLRQV 1HZVURRP 6PDOO %XVLQHVV 5HJXODWLRQV 6WDQGDUGV &)5 7DEOH RI &RQWHQWV 3DUW 1XPEHU 3DUW 7LWOH 6XESDUW 6XESDUW 7LWOH 6WDQGDUG 1XPEHU 7LWOH 2FFXSDWLRQDO 6DIHW\ DQG +HDOWK 6WDQGDUGV + +D]DUGRXV 0DWHULDOV &RPSUHVVHG JDVHV JHQHUDO UHTXLUHPHQWV D ,QVSHFWLRQ RI FRPSUHVVHG JDV F\OLQGHUV (DFK HPSOR\HU VKDOO GHWHUPLQH WKDW FRPSUHVVHG JDV F\OLQGHUV XQGHU KLV FRQWURO DUH LQ D VDIH FRQGLWLRQ WR WKH H[WHQW WKDW WKLV FDQ EH GHWHUPLQHG E\ YLVXDO LQVSHFWLRQ 9LVXDO DQG RWKHU LQVSHFWLRQV VKDOO EH FRQGXFWHG DV SUHVFULEHG LQ WKH +D]DUGRXV 0DWHULDOV 5HJXODWLRQV RI WKH 'HSDUWPHQW RI 7UDQVSRUWDWLRQ &)5 SDUWV DQG &)5 SDUW :KHUH WKRVH UHJXODWLRQV DUH QRW DSSOLFDEOH YLVXDO DQG RWKHU LQVSHFWLRQV VKDOO EH FRQGXFWHG LQ DFFRUGDQFH ZLWK &RPSUHVVHG *DV $VVRFLDWLRQ 3DPSKOHWV & DQG & ZKLFK LV LQFRUSRUDWHG E\ UHIHUHQFH DV VSHFLILHG LQ 6HF E &RPSUHVVHG JDVHV 7KH LQSODQW KDQGOLQJ VWRUDJH DQG XWLOL]DWLRQ RI DOO FRPSUHVVHG JDVHV LQ F\OLQGHUV SRUWDEOH WDQNV UDLO WDQNFDUV RU PRWRU YHKLFOH FDUJR WDQNV VKDOO EH LQ DFFRUGDQFH ZLWK &RPSUHVVHG *DV $VVRFLDWLRQ 3DPSKOHW 3 ZKLFK LV LQFRUSRUDWHG E\ UHIHUHQFH DV VSHFLILHG LQ 6HF F F 6DIHW\ UHOLHI GHYLFHV IRU FRPSUHVVHG JDV FRQWDLQHUV &RPSUHVVHG JDV F\OLQGHUV SRUWDEOH WDQNV DQG FDUJR WDQNV VKDOO KDYH SUHVVXUH UHOLHI GHYLFHV LQVWDOOHG DQG PDLQWDLQHG LQ DFFRUGDQFH ZLWK &RPSUHVVHG *DV $VVRFLDWLRQ 3DPSKOHWV 6 DQG DGGHQGD DQG 6 ZKLFK LV LQFRUSRUDWHG E\ UHIHUHQFH DV VSHFLILHG LQ 6HF > )5 0DUFK @ 1H[W 6WDQGDUG 5HJXODWLRQV 6WDQGDUGV &)5 7DEOH RI &RQWHQWV )UHHGRP RI ,QIRUPDWLRQ $FW _ 3ULYDF\ 6HFXULW\ 6WDWHPHQW _ 'LVFODLPHUV _ ,PSRUWDQW :HE 6LWH 1RWLFHV _ ,QWHUQDWLRQDO _ &RQWDFW 8V 86 'HSDUWPHQW RI /DERU _ 2FFXSDWLRQDO 6DIHW\ +HDOWK $GPLQLVWUDWLRQ _ &RQVWLWXWLRQ $YH 1: :DVKLQJWRQ '& 7HOHSKRQH 26+$ _ 77< ZZZ26+$JRY BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[% General Information Appendix C: General Industry Standard on Formaldehyde Occupational Safety and Health Admin., Labor potentials, other organic compounds may be ionized. The lower the lamp energy, the better the selectivity. As a continuous monitor, photoionization detection can be useful for locating high concentration pockets, in leak detection, and continuous ambient air monitoring. Both portable and stationary gas chromatographs are available with various types of detectors, including photoionization detectors. A gas chromatograph with a photoionization detector retains the photionization sensitivity, but minimizes or eliminates interferences. For several GC/PID units, the sensitivity is in the 0.1–0.2 ppm EtO range. The GC/PID with microprocessors can sample up to 20 sample points sequentially, calculate and record data, and activate alarms or ventilation systems. Many are quite flexible and can be configured to meet the specific analysis needs for the workplace. DuPont presented their laboratory validation data of the accuracy of the QaziKetcham charcoal tube, the PCB charcoal tube, Miran 103 IR analyzer, 3M #3550 monitor and the Du Pont C–70 badge. Quoting Elbert V. Kring: We also believe that OSHA’s proposed accuracy in this standard is appropriate. At plus or minus 25 percent at one part per million, and plus or minus 35 percent below that. And, our data indicates there’s only one monitoring method, right now, that we’ve tested thoroughly, that meets that accuracy requirements. That is the Du Pont Pro-Tek badge* * *. We also believe that this kind of data should be confirmed by another independent laboratory, using the same type dynamic chamber testing (Tr. 1470) erowe on DSK5CLS3C1PROD with CFR Additional data by an independent laboratory following their exact protocol was not submitted. However, information was submitted on comparisons and precision and accuracy of those monitoring procedures which indicate far better precision and accuracy of those monitoring procedures than that obtained by Du Pont (Ex. 4–20, 130, 11–68, 11–133, 130, 135A). The accuracy of any method depends to a large degree upon the skills and experience of those who not only collect the samples but also those who analyze the samples. Even for methods that are collaboratively tested, some laboratories are closer to the true values than others. Some laboratories may meet the precision and accuracy requirements of the method; others may con- § 1910.1048 sistently far exceed them for the same method. [49 FR 25796, June 22, 1984, as amended at 50 FR 9801, Mar. 12, 1985; 50 FR 41494, Oct. 11, 1985; 51 FR 25053, July 10, 1986; 53 FR 11436, 11437, Apr. 6, 1988; 53 FR 27960, July 26, 1988; 54 FR 24334, June 7, 1989; 61 FR 5508, Feb. 13, 1996; 63 FR 1292, Jan. 8, 1998; 67 FR 67965, Nov. 7, 2002; 70 FR 1143, Jan. 5, 2005; 71 FR 16672, 16673, Apr. 3, 2006; 71 FR 50190, Aug. 24, 2006; 73 FR 75586, Dec. 12, 2008] § 1910.1048 Formaldehyde. (a) Scope and application. This standard applies to all occupational exposures to formaldehyde, i.e. from formaldehyde gas, its solutions, and materials that release formaldehyde. (b) Definitions. For purposes of this standard, the following definitions shall apply: Action level means a concentration of 0.5 part formaldehyde per million parts of air (0.5 ppm) calculated as an eight (8)-hour time-weighted average (TWA) concentration. Assistant Secretary means the Assistant Secretary of Labor for the Occupational Safety and Health Administration, U.S. Department of Labor, or designee. Authorized person means any person required by work duties to be present in regulated areas, or authorized to do so by the employer, by this section, or by the OSH Act of 1970. Director means the Director of the National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designee. Emergency is any occurrence, such as but not limited to equipment failure, rupture of containers, or failure of control equipment that results in an uncontrolled release of a significant amount of formaldehyde. Employee exposure means the exposure to airborne formaldehyde which would occur without corrections for protection provided by any respirator that is in use. Formaldehyde means the chemical substance, HCHO, Chemical Abstracts Service Registry No. 50–00–0. (c) Permissible Exposure Limit (PEL)— (1) TWA: The employer shall assure that no employee is exposed to an airborne concentration of formaldehyde which exceeds 0.75 parts formaldehyde 357 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00367 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 *HQHUDO,QIRUPDWLRQ$SSHQGL[& 3DJH VerDate Nov<24>2008 erowe on DSK5CLS3C1PROD with CFR § 1910.1048 29 CFR Ch. XVII (7–1–09 Edition) per million parts of air (0.75 ppm) as an 8-hour TWA. (2) Short Term Exposure Limit (STEL): The employer shall assure that no employee is exposed to an airborne concentration of formaldehyde which exceeds two parts formaldehyde per million parts of air (2 ppm) as a 15-minute STEL. (d) Exposure monitoring—(1) General. (i) Each employer who has a workplace covered by this standard shall monitor employees to determine their exposure to formaldehyde. (ii) Exception. Where the employer documents, using objective data, that the presence of formaldehyde or formaldehyde-releasing products in the workplace cannot result in airborne concentrations of formaldehyde that would cause any employee to be exposed at or above the action level or the STEL under foreseeable conditions of use, the employer will not be required to measure employee exposure to formaldehyde. (iii) When an employee’s exposure is determined from representative sampling, the measurements used shall be representative of the employee’s full shift or short-term exposure to formaldehyde, as appropriate. (iv) Representative samples for each job classification in each work area shall be taken for each shift unless the employer can document with objective data that exposure levels for a given job classification are equivalent for different work shifts. (2) Initial monitoring. The employer shall identify all employees who may be exposed at or above the action level or at or above the STEL and accurately determine the exposure of each employee so identified. (i) Unless the employer chooses to measure the exposure of each employee potentially exposed to formaldehyde, the employer shall develop a representative sampling strategy and measure sufficient exposures within each job classification for each workshift to correctly characterize and not underestimate the exposure of any employee within each exposure group. (ii) The initial monitoring process shall be repeated each time there is a change in production, equipment, process, personnel, or control measures which may result in new or additional exposure to formaldehyde. (iii) If the employer receives reports of signs or symptoms of respiratory or dermal conditions associated with formaldehyde exposure, the employer shall promptly monitor the affected employee’s exposure. (3) Periodic monitoring. (i) The employer shall periodically measure and accurately determine exposure to formaldehyde for employees shown by the initial monitoring to be exposed at or above the action level or at or above the STEL. (ii) If the last monitoring results reveal employee exposure at or above the action level, the employer shall repeat monitoring of the employees at least every 6 months. (iii) If the last monitoring results reveal employee exposure at or above the STEL, the employer shall repeat monitoring of the employees at least once a year under worst conditions. (4) Termination of monitoring. The employer may discontinue periodic monitoring for employees if results from two consecutive sampling periods taken at least 7 days apart show that employee exposure is below the action level and the STEL. The results must be statistically representative and consistent with the employer’s knowledge of the job and work operation. (5) Accuracy of monitoring. Monitoring shall be accurate, at the 95 percent confidence level, to within plus or minus 25 percent for airborne concentrations of formaldehyde at the TWA and the STEL and to within plus or minus 35 percent for airborne concentrations of formaldehyde at the action level. (6) Employee notification of monitoring results. The employer must, within 15 working days after the receipt of the results of any monitoring performed under this section, notify each affected employee of these results either individually in writing or by posting the results in an appropriate location that is accessible to employees. If employee exposure is above the PEL, affected employees shall be provided with a description of the corrective actions being taken by the employer to decrease exposure. 358 VerDate Nov4>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00368 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& Occupational Safety and Health Admin., Labor (7) Observation of monitoring. (i) The employer shall provide affected employees or their designated representatives an opportunity to observe any monitoring of employee exposure to formaldehyde required by this standard. (ii) When observation of the monitoring of employee exposure to formaldehyde requires entry into an area where the use of protective clothing or equipment is required, the employer shall provide the clothing and equipment to the observer, require the observer to use such clothing and equipment, and assure that the observer complies with all other applicable safety and health procedures. (e) Regulated areas. (1) The employer shall establish regulated areas where the concentration of airborne formaldehyde exceeds either the TWA or the STEL and post all entrances and accessways with signs bearing the following information: erowe on DSK5CLS3C1PROD with CFR DANGER FORMALDEHYDE IRRITANT AND POTENTIAL CANCER HAZARD AUTHORIZED PERSONNEL ONLY (2) The employer shall limit access to regulated areas to authorized persons who have been trained to recognize the hazards of formaldehyde. (3) An employer at a multiemployer worksite who establishes a regulated area shall communicate the access restrictions and locations of these areas to other employers with work operations at that worksite. (f) Methods of compliance—(1) Engineering controls and work practices. The employer shall institute engineering and work practice controls to reduce and maintain employee exposures to formaldehyde at or below the TWA and the STEL. (2) Exception. Whenever the employer has established that feasible engineering and work practice controls cannot reduce employee exposure to or below either of the PELs, the employer shall apply these controls to reduce employee exposures to the extent feasible and shall supplement them with respirators which satisfy this standard. (g) Respiratory protection—(1) General. For employees who use respirators required by this section, the employer § 1910.1048 must provide each employee an appropriate respirator that complies with the requirements of this paragraph. Respirators must be used during: (i) Periods necessary to install or implement feasible engineering and workpractice controls. (ii) Work operations, such as maintenance and repair activities or vessel cleaning, for which the employer establishes that engineering and work-practice controls are not feasible. (iii) Work operations for which feasible engineering and work-practice controls are not yet sufficient to reduce employee exposure to or below the PELs. (iv) Emergencies. (2) Respirator program. (i) The employer must implement a respiratory protection program in accordance with § 1910.134(b) through (d) (except (d)(1)(iii), (d)(3)(iii)(b)(1), and (2)), and (f) through (m), which covers each employee required by this section to use a respirator. (ii) When employees use air-purifying respirators with chemical cartridges or canisters that do not contain end-ofservice-life indicators approved by the National Institute for Occupational Safety and Health, employers must replace these cartridges or canisters as specified by paragraphs (d)(3)(iii)(B)(1) and (B)(2) of 29 CFR 1910.134, or at the end of the workshift, whichever condition occurs first. (3) Respirator selection. (i) Employers must: (A) Select, and provide to employees, the appropriate respirators specified in paragraph (d)(3)(i)(A) of 29 CFR 1910.134. (B) Equip each air-purifying, full facepiece respirator with a canister or cartridge approved for protection against formaldehyde. (C) For escape, provide employees with one of the following respirator options: A self-contained breathing apparatus operated in the demand or pressure-demand mode; or a full facepiece respirator having a chin-style, or a front-or back-mounted industrial-size, canister or cartridge approved for protection against formaldehyde. (ii) Employers may substitute an airpurifying, half mask respirator for an air-purifying, full facepiece respirator 359 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00369 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& erowe on DSK5CLS3C1PROD with CFR § 1910.1048 29 CFR Ch. XVII (7–1–09 Edition) when they equip the half mask respirator with a cartridge approved for protection against formaldehyde and provide the affected employee with effective gas-proof goggles. (iii) Employers must provide employees who have difficulty using negative pressure respirators with powered airpurifying respirators permitted for use under paragraph (g)(3)(i)(A) of this standard and that affords adequate protection against formaldehyde exposures. (h) Protective equipment and clothing. Employers shall comply with the provisions of 29 CFR 1910.132 and 29 CFR 1910.133. When protective equipment or clothing is provided under these provisions, the employer shall provide these protective devices at no cost to the employee and assure that the employee wears them. (1) Selection. The employer shall select protective clothing and equipment based upon the form of formaldehyde to be encountered, the conditions of use, and the hazard to be prevented. (i) All contact of the eyes and skin with liquids containing 1 percent or more formaldehyde shall be prevented by the use of chemical protective clothing made of material impervious to formaldehyde and the use of other personal protective equipment, such as goggles and face shields, as appropriate to the operation. (ii) Contact with irritating or sensitizing materials shall be prevented to the extent necessary to eliminate the hazard. (iii) Where a face shield is worn, chemical safety goggles are also required if there is a danger of formaldehyde reaching the area of the eye. (iv) Full body protection shall be worn for entry into areas where concentrations exceed 100 ppm and for emergency reentry into areas of unknown concentration. (2) Maintenance of protective equipment and clothing. (i) The employer shall assure that protective equipment and clothing that has become contaminated with formaldehyde is cleaned or laundered before its reuse. (ii) When ventilating formaldehydecontaminated clothing and equipment, the employer shall establish a storage area so that employee exposure is minimized. Containers for contaminated clothing and equipment and storage areas shall have labels and signs containing the following information: DANGER FORMALDEHYDE-CONTAMINATED [CLOTHING] EQUIPMENT AVOID INHALATION AND SKIN CONTACT (iii) The employer shall assure that only persons trained to recognize the hazards of formaldehyde remove the contaminated material from the storage area for purposes of cleaning, laundering, or disposal. (iv) The employer shall assure that no employee takes home equipment or clothing that is contaminated with formaldehyde. (v) The employer shall repair or replace all required protective clothing and equipment for each affected employee as necessary to assure its effectiveness. (vi) The employer shall inform any person who launders, cleans, or repairs such clothing or equipment of formaldehyde’s potentially harmful effects and of procedures to safely handle the clothing and equipment. (i) Hygiene protection. (1) The employer shall provide change rooms, as described in 29 CFR 1910.141 for employees who are required to change from work clothing into protective clothing to prevent skin contact with formaldehyde. (2) If employees’ skin may become spashed with solutions containing 1 percent or greater formaldehyde, for example, because of equipment failure or improper work practices, the employer shall provide conveniently located quick drench showers and assure that affected employees use these facilities immediately. (3) If there is any possibility that an employee’s eyes may be splashed with solutions containing 0.1 percent or greater formaldehyde, the employer shall provide acceptable eyewash facilities within the immediate work area for emergency use. (j) Housekeeping. For operations involving formaldehyde liquids or gas, the employer shall conduct a program to detect leaks and spills, including regular visual inspections. (1) Preventative maintenance of equipment, including surveys for leaks, 360 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00370 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& erowe on DSK5CLS3C1PROD with CFR Occupational Safety and Health Admin., Labor shall be undertaken at regular intervals. (2) In work areas where spillage may occur, the employer shall make provisions to contain the spill, to decontaminate the work area, and to dispose of the waste. (3) The employer shall assure that all leaks are repaired and spills are cleaned promptly by employees wearing suitable protective equipment and trained in proper methods for cleanup and decontamination. (4) Formaldehyde-contaminated waste and debris resulting from leaks or spills shall be placed for disposal in sealed containers bearing a label warning of formaldehyde’s presence and of the hazards associated with formaldehyde. (k) Emergencies. For each workplace where there is the possibility of an emergency involving formaldehyde, the employer shall assure appropriate procedures are adopted to minimize injury and loss of life. Appropriate procedures shall be implemented in the event of an emergency. (l) Medical surveillance—(1) Employees covered. (i) The employer shall institute medical surveillance programs for all employees exposed to formaldehyde at concentrations at or exceeding the action level or exceeding the STEL. (ii) The employer shall make medical surveillance available for employees who develop signs and symptoms of overexposure to formaldehyde and for all employees exposed to formaldehyde in emergencies. When determining whether an employee may be experiencing signs and symptoms of possible overexposure to formaldehyde, the employer may rely on the evidence that signs and symptoms associated with formaldehyde exposure will occur only in exceptional circumstances when airborne exposure is less than 0.1 ppm and when formaldehyde is present in material in concentrations less than 0.1 percent. (2) Examination by a physician. All medical procedures, including administration of medical disease questionnaires, shall be performed by or under the supervision of a licensed physician and shall be provided without cost to the employee, without loss of pay, and at a reasonable time and place. § 1910.1048 (3) Medical disease questionnaire. The employer shall make the following medical surveillance available to employees prior to assignment to a job where formaldehyde exposure is at or above the action level or above the STEL and annually thereafter. The employer shall also make the following medical surveillance available promptly upon determining that an employee is experiencing signs and symptoms indicative of possible overexposure to formaldehyde. (i) Administration of a medical disease questionnaire, such as in appendix D, which is designed to elicit information on work history, smoking history, any evidence of eye, nose, or throat irritation; chronic airway problems or hyperreactive airway disease: allergic skin conditions or dermatitis; and upper or lower respiratory problems. (ii) A determination by the physician, based on evaluation of the medical disease questionnaire, of whether a medical examination is necessary for employees not required to wear respirators to reduce exposure to formaldehyde. (4) Medical examinations. Medical examinations shall be given to any employee who the physician feels, based on information in the medical disease questionnaire, may be at increased risk from exposure to formaldehyde and at the time of initial assignment and at least annually thereafter to all employees required to wear a respirator to reduce exposure to formaldehyde. The medical examination shall include: (i) A physical examination with emphasis on evidence of irritation or sensitization of the skin and respiratory system, shortness of breath, or irritation of the eyes. (ii) Laboratory examinations for respirator wearers consisting of baseline and annual pulmonary function tests. As a minimum, these tests shall consist of forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and forced expiratory flow (FEF). (iii) Any other test which the examining physician deems necessary to complete the written opinion. 361 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00371 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& erowe on DSK5CLS3C1PROD with CFR § 1910.1048 29 CFR Ch. XVII (7–1–09 Edition) (iv) Counseling of employees having medical conditions that would be directly or indirectly aggravated by exposure to formaldehyde on the increased risk of impairment of their health. (5) Examinations for employees exposed in an emergency. The employer shall make medical examinations available as soon as possible to all employees who have been exposed to formaldehyde in an emergency. (i) The examination shall include a medical and work history with emphasis on any evidence of upper or lower respiratory problems, allergic conditions, skin reaction or hypersensitivity, and any evidence of eye, nose, or throat irritation. (ii) Other examinations shall consist of those elements considered appropriate by the examining physician. (6) Information provided to the physician. The employer shall provide the following information to the examining physician: (i) A copy of this standard and appendix A, C, D, and E; (ii) A description of the affected employee’s job duties as they relate to the employee’s exposure to formaldehyde; (iii) The representative exposure level for the employee’s job assignment; (iv) Information concerning any personal protective equipment and respiratory protection used or to be used by the employee; and (v) Information from previous medical examinations of the affected employee within the control of the employer. (vi) In the event of a nonroutine examination because of an emergency, the employer shall provide to the physician as soon as possible: A description of how the emergency occurred and the exposure the victim may have received. (7) Physician’s written opinion. (i) For each examination required under this standard, the employer shall obtain a written opinion from the examining physician. This written opinion shall contain the results of the medical examination except that it shall not reveal specific findings or diagnoses unrelated to occupational exposure to formaldehyde. The written opinion shall include: (A) The physician’s opinion as to whether the employee has any medical condition that would place the employee at an increased risk of material impairment of health from exposure to formaldehyde; (B) Any recommended limitations on the employee’s exposure or changes in the use of personal protective equipment, including respirators; (C) A statement that the employee has been informed by the physician of any medical conditions which would be aggravated by exposure to formaldehyde, whether these conditions may have resulted from past formaldehyde exposure or from exposure in an emergency, and whether there is a need for further examination or treatment. (ii) The employer shall provide for retention of the results of the medical examination and tests conducted by the physician. (iii) The employer shall provide a copy of the physician’s written opinion to the affected employee within 15 days of its receipt. (8) Medical removal. (i) The provisions of paragraph (l)(8) apply when an employee reports significant irritation of the mucosa of the eyes or the upper airways, respiratory sensitization, dermal irritation, or dermal sensitization attributed to workplace formaldehyde exposure. Medical removal provisions do not apply in the case of dermal irritation or dermal sensitization when the product suspected of causing the dermal condition contains less than 0.05% formaldehyde. (ii) An employee’s report of signs or symptoms of possible overexposure to formaldehyde shall be evaluated by a physician selected by the employer pursuant to paragraph (l)(3). If the physician determines that a medical examination is not necessary under paragraph (l)(3)(ii), there shall be a twoweek evaluation and remediation period to permit the employer to ascertain whether the signs or symptoms subside untreated or with the use of creams, gloves, first aid treatment or personal protective equipment. Industrial hygiene measures that limit the employee’s exposure to formaldehyde may also be implemented during this 362 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00372 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& erowe on DSK5CLS3C1PROD with CFR Occupational Safety and Health Admin., Labor period. The employee shall be referred immediately to a physician prior to expiration of the two-week period if the signs or symptoms worsen. Earnings, seniority and benefits may not be altered during the two-week period by virtue of the report. (iii) If the signs or symptoms have not subsided or been remedied by the end of the two-week period, or earlier if signs or symptoms warrant, the employee shall be examined by a physician selected by the employer. The physician shall presume, absent contrary evidence, that observed dermal irritation or dermal sensitization are not attributable to formaldehyde when products to which the affected employee is exposed contain less than 0.1% formaldehyde. (iv) Medical examinations shall be conducted in compliance with the requirements of paragraph (l)(5) (i) and (ii). Additional guidelines for conducting medical exams are contained in appendix C. (v) If the physician finds that significant irritation of the mucosa of the eyes or of the upper airways, respiratory sensitization, dermal irritation, or dermal sensitization result from workplace formaldehyde exposure and recommends restrictions or removal, the employer shall promptly comply with the restrictions or recommendation of removal. In the event of a recommendation of removal, the employer shall remove the effected employee from the current formaldehyde exposure and if possible, transfer the employee to work having no or significantly less exposure to formaldehyde. (vi) When an employee is removed pursuant to paragraph (l)(8)(v), the employer shall transfer the employee to comparable work for which the employee is qualified or can be trained in a short period (up to 6 months), where the formaldehyde exposures are as low as possible, but not higher than the action level. The employeer shall maintain the employee’s current earnings, seniority, and other benefits. If there is no such work available, the employer shall maintain the employee’s current earnings, seniority and other benefits until such work becomes available, until the employee is determined to be unable to return to workplace form- § 1910.1048 aldehyde exposure, until the employee is determined to be able to return to the original job status, or for six months, whichever comes first. (vii) The employer shall arrange for a follow-up medical examination to take place within six months after the employee is removed pursuant to this paragraph. This examination shall determine if the employee can return to the original job status, or if the removal is to be permanent. The physician shall make a decision within six months of the date the employee was removed as to whether the employee can be returned to the original job status, or if the removal is to be permanent. (viii) An employer’s obligation to provide earnings, seniority and other benefits to a removed employee may be reduced to the extent that the employee receives compensation for earnings lost during the period of removal either from a publicly or employerfunded compensation program or from employment with another employer made possible by virtue of the employee’s removal. (ix) In making determinations of the formaldehyde content of materials under this paragraph the employer may rely on objective data. (9) Multiple physician review. (i) After the employer selects the initial physician who conducts any medical examination or consultation to determine whether medical removal or restriction is appropriate, the employee may designate a second physician to review any findings, determinations or recommendations of the initial physician and to conduct such examinations, consultations, and laboratory tests as the second physician deems necessary and appropriate to evaluate the effects of formaldehyde exposure and to facilitate this review. (ii) The employer shall promptly notify an employee of the right to seek a second medical opinion after each occasion that an initial physician conducts a medical examination or consultation for the purpose of medical removal or restriction. (iii) The employer may condition its participation in, and payment for, the multiple physician review mechanism upon the employee doing the following 363 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00373 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& erowe on DSK5CLS3C1PROD with CFR § 1910.1048 29 CFR Ch. XVII (7–1–09 Edition) within fifteen (15) days after receipt of the notification of the right to seek a second medical opinion, or receipt of the initial physician’s written opinion, whichever is later; (A) The employee informs the employer of the intention to seek a second medical opinion, and (B) The employee initiates steps to make an appointment with a second physician. (iv) If the findings, determinations or recommendations of the second physician differ from those of the initial physician, then the employer and the employee shall assure that efforts are made for the two physicians to resolve the disagreement. If the two physicians are unable to quickly resolve their disagreement, then the employer and the employee through their respective physicians shall designate a third physician who shall be a specialist in the field at issue: (A) To review the findings, determinations or recommendations of the prior physicians; and (B) To conduct such examinations, consultations, laboratory tests and discussions with the prior physicians as the third physician deems necessary to resolve the disagreement of the prior physicians. (v) In the alternative, the employer and the employee or authorized employee representative may jointly designate such third physician. (vi) The employer shall act consistent with the findings, determinations and recommendations of the third physician, unless the employer and the employee reach an agreement which is otherwise consistent with the recommendations of at least one of the three physicians. (m) Hazard communication—(1) General. Communication of the hazards associated with formaldehyde in the workplace shall be governed by the requirements of paragraph (m). The definitions of 29 CFR 1910.1200(c) shall apply under this paragraph. (i) The following shall be subject to the hazard communication requirements of this paragraph: Formaldehyde gas, all mixtures or solutions composed of greater than 0.1 percent formaldehyde, and materials capable of releasing formaldehyde into the air, under reasonably foreseeable conditions of use, at concentrations reaching or exceeding 0.1 ppm. (ii) As a minimum, specific health hazards that the employer shall address are: Cancer, irritation and sensitization of the skin and respiratory system, eye and throat irritation, and acute toxicity. (2) Manufacturers and importers who produce or import formaldehyde or formaldehyde-containing products shall provide downstream employers using or handling these products with an objective determination through the required labels and MSDSs if these items may constitute a health hazard within the meaning of 29 CFR 1910.1200(d) under normal conditions of use. (3) Labels. (i) The employer shall assure that hazard warning labels complying with the requirements of 29 CFR 1910.1200(f) are affixed to all containers of materials listed in paragraph (m)(1)(i), except to the extent that 29 CFR 1910.1200(f) is inconsistent with this paragraph. (ii) Information on labels. As a minimum, for all materials listed in paragraph (m)(1)(i) capable of releasing formaldehyde at levels of 0.1 ppm to 0.5 ppm, labels shall identify that the product contains formaldehyde; list the name and address of the responsible party; and state that physical and health hazard information is readily available from the employer and from material safety data sheets. (iii) For materials listed in paragraph (m)(1)(i) capable of releasing formaldehyde at levels above 0.5 ppm, labels shall appropriately address all hazards as defined in 29 CFR 1910.1200(d) and 29 CFR 1910.1200 appendices A and B, including respiratory sensitization, and shall contain the words ‘‘Potential Cancer Hazard.’’ (iv) In making the determinations of anticipated levels of formaldehyde release, the employer may rely on objective data indicating the extent of potential formaldehyde release under reasonably foreseeable conditions of use. (v) Substitute warning labels. The employer may use warning labels required 364 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00374 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& erowe on DSK5CLS3C1PROD with CFR Occupational Safety and Health Admin., Labor by other statutes, regulations, or ordinances which impart the same information as the warning statements required by this paragraph. (4) Material safety data sheets. (i) Any employer who uses formaldehyde-containing materials listed in paragraph (m)(1)(i) shall comply with the requirements of 29 CFR 1910.1200(g) with regard to the development and updating of material safety data sheets. (ii) Manufacturers, importers, and distributors of formaldehyde-containing materials listed in paragraph (m)(1)(i) shall assure that material safety data sheets and updated information are provided to all employers purchasing such materials at the time of the initial shipment and at the time of the first shipment after a material safety data sheet is updated. (5) Written hazard communication program. The employer shall develop, implement, and maintain at the workplace, a written hazard communication program for formaldehyde exposures in the workplace, which at a minimum describes how the requirements specified in this paragraph for labels and other forms of warning and material safety data sheets, and paragraph (n) for employee information and training, will be met. Employers in multi-employer workplaces shall comply with the requirements of 29 CFR 1910.1200(e)(2). (n) Employee information and training—(1) Participation. The employer shall assure that all employees who are assigned to workplaces where there is exposure to formaldehyde participate in a training program, except that where the employer can show, using objective data, that employees are not exposed to formaldehyde at or above 0.1 ppm, the employer is not required to provide training. (2) Frequency. Employers shall provide such information and training to employees at the time of initial assignment, and whenever a new exposure to formaldehyde is introduced into the work area. The training shall be repeated at least annually. (3) Training program. The training program shall be conducted in a manner which the employee is able to understand and shall include: § 1910.1048 (i) A discussion of the contents of this regulation and the contents of the Material Safety Data Sheet. (ii) The purpose for and a description of the medical surveillance program required by this standard, including: (A) A description of the potential health hazards associated with exposure to formaldehyde and a description of the signs and symptoms of exposure to formaldehyde. (B) Instructions to immediately report to the employer the development of any adverse signs or symptoms that the employee suspects is attributable to formaldehyde exposure. (iii) Description of operations in the work area where formaldehyde is present and an explanation of the safe work practices appropriate for limiting exposure to formaldehyde in each job; (iv) The purpose for, proper use of, and limitations of personal protective clothing and equipment; (v) Instructions for the handling of spills, emergencies, and clean-up procedures; (vi) An explanation of the importance of engineering and work practice controls for employee protection and any necessary instruction in the use of these controls; and (vii) A review of emergency procedures including the specific duties or assignments of each employee in the event of an emergency. (4) Access to training materials. (i) The employer shall inform all affected employees of the location of written training materials and shall make these materials readily available, without cost, to the affected employees. (ii) The employer shall provide, upon request, all training materials relating to the employee training program to the Assistant Secretary and the Director. (o) Recordkeeping—(1) Exposure measurements. The employer shall establish and maintain an accurate record of all measurements taken to monitor employee exposure to formaldehyde. This record shall include: (i) The date of measurement; (ii) The operation being monitored; (iii) The methods of sampling and analysis and evidence of their accuracy and precision; 365 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00375 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& erowe on DSK5CLS3C1PROD with CFR § 1910.1048 29 CFR Ch. XVII (7–1–09 Edition) (iv) The number, durations, time, and results of samples taken; (v) The types of protective devices worn; and (vi) The names, job classifications, social security numbers, and exposure estimates of the employees whose exposures are represented by the actual monitoring results. (2) Exposure determinations. Where the employer has determined that no monitoring is required under this standard, the employer shall maintain a record of the objective data relied upon to support the determination that no employee is exposed to formaldehyde at or above the action level. (3) Medical surveillance. The employer shall establish and maintain an accurate record for each employee subject to medical surveillance under this standard. This record shall include: (i) The name and social security number of the employee; (ii) The physician’s written opinion; (iii) A list of any employee health complaints that may be related to exposure to formaldehyde; and (iv) A copy of the medical examination results, including medical disease questionnaires and results of any medical tests required by the standard or mandated by the examining physician. (4) Respirator fit testing. (i) The employer shall establish and maintain accurate records for employees subject to negative pressure respirator fit testing required by this standard. (ii) This record shall include: (A) A copy of the protocol selected for respirator fit testing. (B) A copy of the results of any fit testing performed. (C) The size and manufacturer of the types of respirators available for selection. (D) The date of the most recent fit testing, the name and social security number of each tested employee, and the respirator type and facepiece selected. (5) Record retention. The employer shall retain records required by this standard for at least the following periods: (i) Exposure records and determinations shall be kept for at least 30 years. (ii) Medical records shall be kept for the duration of employment plus 30 years. (iii) Respirator fit testing records shall be kept until replaced by a more recent record. (6) Availability of records. (i) Upon request, the employer shall make all records maintained as a requirement of this standard available for examination and copying to the Assistant Secretary and the Director. (ii) The employer shall make employee exposure records, including estimates made from representative monitoring and available upon request for examination, and copying to the subject employee, or former employee, and employee representatives in accordance with 29 CFR 1910.1020 (a)–(e) and (g)–(i). (iii) Employee medical records required by this standard shall be provided upon request for examination and coying, to the subject employee or former employee or to anyone having the specific written consent of the subject employee or former employee in accordance with 29 CFR 1910.1020 (a)–(e) and (g)–(i). APPENDIX A TO § 1910.1048—SUBSTANCE TECHNICAL GUIDELINES FOR FORMALIN The following Substance Technical Guideline for Formalin provides information on uninhibited formalin solution (37% formaldehyde, no methanol stabilizer). It is designed to inform employees at the production level of their rights and duties under the formaldehyde standard whether their job title defines them as workers or supervisors. Much of the information provided is general; however, some information is specific for formalin. When employee exposure to formaldehyde is from resins capable of releasing formaldehyde, the resin itself and other impurities or decomposition products may also be toxic, and employers should include this information as well when informing employees of the hazards associated with the materials they handle. The precise hazards associated with exposure to formaldehyde depend both on the form (solid, liquid, or gas) of the material and the concentration of formaldehyde present. For example, 37–50 percent solutions of formaldehyde present a much greater hazard to the skin and eyes from spills or splashes than solutions containing less than 1 percent formaldehyde. Individual Substance Technical Guidelines used by the employer for training employees should be modified to properly give information on the material actually being used. 366 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00376 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& Occupational Safety and Health Admin., Labor Substance Identification Chemical Name: Formaldehyde Chemical Family: Aldehyde Chemical Formula: HCHO Molecular Weight: 30.03 Chemical Abstracts Service Number (CAS Number): 50–00–0 Synonyms: Formalin; Formic Aldehyde; Paraform; Formol; Formalin (Methanolfree); Fyde; Formalith; Methanal; Methyl Aldehyde; Methylene Glycol; Methylene Oxide; Tetraoxymethalene; Oxomethane; Oxymethylene Components and Contaminants Percent: 37.0 Formaldehyde Percent: 63.0 Water (Note—Inhibited solutions anol.) contain meth- National Fire Protection Association Section 325M Designation: Health: 2—Materials hazardous to health, but areas may be entered with full-faced mask self-contained breathing apparatus which provides eye protection. Flammability: 2—Materials which must be moderately heated before ignition will occur. Water spray may be used to extinguish the fire because the material can be cooled below its flash point. Reactivity: D—Materials which (in themselves) are normally stable even under fire exposure conditions and which are not reactive with water. Normal fire fighting procedures may be used. Reactivity Description: Colorless liquid, pungent odor Boiling point: 214 °F (101 °C) Specific Gravity: 1.08 (H2 O=1 @ 20 °C) pH: 2.8–4.0 Solubility in Water: Miscible Solvent Solubility: Soluble in alcohol and acetone Vapor Density: 1.04 (Air=1 @ 20 °C) Odor Threshold: 0.8–1 ppm Stability: Formaldehyde solutions may selfpolymerize to form paraformaldehyde which precipitates. Incompatibility (Materials to Avoid): Strong oxidizing agents, caustics, strong alkalies, isocyanates, anhydrides, oxides, and inorganic acids. Formaldehyde reacts with hydrochloric acid to form the potent carcinogen, bis-chloromethyl ether. Formaldehyde reacts with nitrogen dioxide, nitromethane, perchloric acid and aniline, or peroxyformic acid to yield explosive compounds. A violent reaction occurs when formaldehyde is mixed with strong oxidizers. Hazardous Combustion or Decomposition Products: Oxygen from the air can oxidize formaldehyde to formic acid, especially when heated. Formic acid is corrosive. Fire and Explosion Hazard Health Hazard Data Moderate fire and explosion hazard when exposed to heat or flame. The flash point of 37% formaldehyde solutions is above normal room temperature, but the explosion range is very wide, from 7 to 73% by volume in air. Reaction of formaldehyde with nitrogen dioxide, nitromethane, perchloric acid and aniline, or peroxyformic acid yields explosive compounds. Flash Point: 185 °F (85 °C) closed cup Lower Explosion Limit: 7% Upper Explosion Limit: 73% Autoignition Temperature: 806 °F (430 °C) Flammability Class (OSHA): III A Extinguishing Media: Use dry chemical, ‘‘alcohol foam’’, carbon dioxide, or water in flooding amounts as fog. Solid streams may not be effective. Cool fire-exposed containers with water from side until well after fire is out. Use of water spray to flush spills can also dilute the spill to produce nonflammable mixtures. Water runoff, however, should be contained for treatment. Ingestion (Swallowing): Liquids containing 10 to 40% formaldehyde cause severe irritation and inflammation of the mouth, throat, and stomach. Severe stomach pains will follow ingestion with possible loss of consciousness and death. Ingestion of dilute formaldehyde solutions (0.03–0.04%) may cause discomfort in the stomach and pharynx. Inhalation (Breathing): Formaldehyde is highly irritating to the upper respiratory tract and eyes. Concentrations of 0.5 to 2.0 ppm may irritate the eyes, nose, and throat of some individuals. Concentrations of 3 to 5 ppm also cause tearing of the eyes and are intolerable to some persons. Concentrations of 10 to 20 ppm cause difficulty in breathing, burning of the nose and throat, cough, and heavy tearing of the eyes, and 25 to 30 ppm causes severe respiratory tract injury leading to pulmonary edema and pneumonitis. A concentration of 100 ppm is immediately dangerous to life and health. Deaths from accidental exposure to high concentrations of formaldehyde have been reported. Other Contaminants: Formic acid (alcohol free) Exposure Limits: OSHA TWA—0.75 ppm OSHA STEL—2 ppm Physical Data erowe on DSK5CLS3C1PROD with CFR § 1910.1048 Acute Effects of Exposure 367 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00377 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& § 1910.1048 29 CFR Ch. XVII (7–1–09 Edition) Skin (Dermal): Formalin is a severe skin irritant and a sensitizer. Contact with formalin causes white discoloration, smarting, drying, cracking, and scaling. Prolonged and repeated contact can cause numbness and a hardening or tanning of the skin. Previously exposed persons may react to future exposure with an allergic eczematous dermatitis or hives. Eye Contact: Formaldehyde solutions splashed in the eye can cause injuries ranging from transient discomfort to severe, permanent corneal clouding and loss of vision. The severity of the effect depends on the concentration of formaldehyde in the solution and whether or not the eyes are flushed with water immediately after the accident. NOTE. The perception of formaldehyde by odor and eye irritation becomes less sensitive with time as one adapts to formaldehyde. This can lead to overexposure if a worker is relying on formaldehyde’s warning properties to alert him or her to the potential for exposure. Acute Animal Toxicity: Oral, rats: LD50=800 mg/kg Oral, mouse: LD50=42 mg/kg Inhalation, rats: LCLo=250 mg/kg Inhalation, mouse: LCLo=900 mg/kg Inhalation, rats: LC50=590 mg/kg Chronic Effects of Exposure Carcinogenicity: Formaldehyde has the potential to cause cancer in humans. Repeated and prolonged exposure increases the risk. Various animal experiments have conclusively shown formaldehyde to be a carcinogen in rats. In humans, formaldehyde exposure has been associated with cancers of the lung, nasopharynx and oropharynx, and nasal passages. Mutagenicity: Formaldehyde is genotoxic in several in vitro test systems showing properties of both an initiator and a promoter. Toxicity: Prolonged or repeated exposure to formaldehyde may result in respiratory impairment. Rats exposed to formaldehyde at 2 ppm developed benign nasal tumors and changes of the cell structure in the nose as well as inflamed mucous membranes of the nose. Structural changes in the epithelial cells in the human nose have also been observed. Some persons have developed asthma or bronchitis following exposure to formaldehyde, most often as the result of an accidental spill involving a single exposure to a high concentration of formaldehyde. erowe on DSK5CLS3C1PROD with CFR Emergency and First Aid Procedures Ingestion (Swallowing): If the victim is conscious, dilute, inactivate, or absorb the ingested formaldehyde by giving milk, activated charcoal, or water. Any organic material will inactivate formaldehyde. Keep affected person warm and at rest. Get medical attention immediately. If vomiting occurs, keep head lower than hips. Inhalation (Breathing): Remove the victim from the exposure area to fresh air immediately. Where the formaldehyde concentration may be very high, each rescuer must put on a self-contained breathing apparatus before attempting to remove the victim, and medical personnel should be informed of the formaldehyde exposure immediately. If breathing has stopped, give artificial respiration. Keep the affected person warm and at rest. Qualified first-aid or medical personnel should administer oxygen, if available, and maintain the patient’s airways and blood pressure until the victim can be transported to a medical facility. If exposure results in a highly irritated upper respiratory tract and coughing continues for more than 10 minutes, the worker should be hospitalized for observation and treatment. Skin Contact: Remove contaminated clothing (including shoes) immediately. Wash the affected area of your body with soap or mild detergent and large amounts of water until no evidence of the chemical remains (at least 15 to 20 minutes). If there are chemical burns, get first aid to cover the area with sterile, dry dressing, and bandages. Get medical attention if you experience appreciable eye or respiratory irritation. Eye Contact: Wash the eyes immediately with large amounts of water occasionally lifting lower and upper lids, until no evidence of chemical remains (at least 15 to 20 minutes). In case of burns, apply sterile bandages loosely without medication. Get medical attention immediately. If you have experienced appreciable eye irritation from a splash or excessive exposure, you should be referred promptly to an opthamologist for evaluation. Emergency Procedures Emergencies: If you work in an area where a large amount of formaldehyde could be released in an accident or from equipment failure, your employer must develop procedures to be followed in event of an emergency. You should be trained in your specific duties in the event of an emergency, and it is important that you clearly understand these duties. Emergency equipment must be accessible and you should be trained to use any equipment that you might need. Formaldehyde contaminated equipment must be cleaned before reuse. If a spill of appreciable quantity occurs, leave the area quickly unless you have specific emergency duties. Do not touch spilled material. Designated persons may stop the leak and shut off ignition sources if these procedures can be done without risk. Designated persons should isolate the hazard area and deny entry except for necessary people protected by suitable protective 368 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00378 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& Occupational Safety and Health Admin., Labor clothing and respirators adequate for the exposure. Use water spray to reduce vapors. Do not smoke, and prohibit all flames or flares in the hazard area. Special Firefighting Procedures: Learn procedures and responsibilities in the event of a fire in your workplace. Become familiar with the appropriate equipment and supplies and their location. In firefighting, withdraw immediately in case of rising sound from venting safety device or any discoloration of storage tank due to fire. Spill, Leak, and Disposal Procedures Occupational Spill: For small containers, place the leaking container in a well ventilated area. Take up small spills with absorbent material and place the waste into properly labeled containers for later disposal. For larger spills, dike the spill to minimize contamination and facilitate salvage or disposal. You may be able to neutralize the spill with sodium hydroxide or sodium sulfite. Your employer must comply with EPA rules regarding the clean-up of toxic waste and notify state and local authorities, if required. If the spill is greater than 1,000 lb/day, it is reportable under EPA’s Superfund legislation. Waste Disposal: Your employer must dispose of waste containing formaldehyde in accordance with applicable local, state, and Federal law and in a manner that minimizes exposure of employees at the site and of the clean-up crew. erowe on DSK5CLS3C1PROD with CFR Monitoring and Measurement Procedures Monitoring Requirements: If your exposure to formaldehyde exceeds the 0.5 ppm action level or the 2 ppm STEL, your employer must monitor your exposure. Your employer need not measure every exposure if a ‘‘high exposure’’ employee can be identified. This person usually spends the greatest amount of time nearest the process equipment. If you are a ‘‘representative employee’’, you will be asked to wear a sampling device to collect formaldehyde. This device may be a passive badge, a sorbent tube attached to a pump, or an impinger containing liquid. You should perform your work as usual, but inform the person who is conducting the monitoring of any difficulties you are having wearing the device. Evaluation of 8-hour Exposure: Measurements taken for the purpose of determining time-weighted average (TWA) exposures are best taken with samples covering the full shift. Samples collected must be taken from the employee’s breathing zone air. Short-term Exposure Evaluation: If there are tasks that involve brief but intense exposure to formaldehyde, employee exposure must be measured to assure compliance with the STEL. Sample collections are for brief peri- § 1910.1048 ods, only 15 minutes, but several samples may be needed to identify the peak exposure. Monitoring Techniques: OSHA’s only requirement for selecting a method for sampling and analysis is that the methods used accurately evaluate the concentration of formaldehyde in employees’ breathing zones. Sampling and analysis may be performed by collection of formaldehyde on liquid or solid sorbents with subsequent chemical analysis. Sampling and analysis may also be performed by passive diffusion monitors and short-term exposure may be measured by instruments such as real-time continuous monitoring systems and portable direct reading instruments. Notification of Results: Your employer must inform you of the results of exposure monitoring representative of your job. You may be informed in writing, but posting the results where you have ready access to them constitutes compliance with the standard. Protective Equipment and Clothing [Material impervious to formaldehyde is needed if the employee handles formaldehyde solutions of 1% or more. Other employees may also require protective clothing or equipment to prevent dermatitis.] Respiratory Protection: Use NIOSH-approved full facepiece negative pressure respirators equipped with approved cartridges or canisters within the use limitations of these devices. (Present restrictions on cartridges and canisters do not permit them to be used for a full workshift.) In all other situations, use positive pressure respirators such as the positive-pressure air purifying respirator or the self-contained breathing apparatus (SCBA). If you use a negative pressure respirator, your employer must provide you with fit testing of the respirator at least once a year. Protective Gloves: Wear protective (impervious) gloves provided by your employer, at no cost, to prevent contact with formalin. Your employer should select these gloves based on the results of permeation testing and in accordance with the ACGIH Guidelines for Selection of Chemical Protective Clothing. Eye Protection: If you might be splashed in the eyes with formalin, it is essential that you wear goggles or some other type of complete protection for the eye. You may also need a face shield if your face is likely to be splashed with formalin, but you must not substitute face shields for eye protection. (This section pertains to formaldehyde solutions of 1% or more.) Other Protective Equipment: You must wear protective (impervious) clothing and equipment provided by your employer at no cost to prevent repeated or prolonged contact with formaldehyde liquids. If you are required to change into whole-body chemical 369 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00379 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& § 1910.1048 29 CFR Ch. XVII (7–1–09 Edition) protective clothing, your employer must provide a change room for your privacy and for storage of your normal clothing. If you are splashed with formaldehyde, use the emergency showers and eyewash fountains provided by your employer immediately to prevent serious injury. Report the incident to your supervisor and obtain necessary medical support. ENTRY INTO AN IDLH ATMOSPHERE Enter areas where the formaldehyde concentration might be 100 ppm or more only with complete body protection including a self-contained breathing apparatus with a full facepiece operated in a positive pressure mode or a supplied air respirator with full facepiece and operated in a positive pressure mode. This equipment is essential to protect your life and health under such extreme conditions. Engineering Controls Ventilation is the most widely applied engineering control method for reducing the concentration of airborne substances in the breathing zones of workers. There are two distinct types of ventilation. Local Exhaust: Local exhaust ventilation is designed to capture airborne contaminants as near to the point of generation as possible. To protect you, the direction of contaminant flow must always be toward the local exhaust system inlet and away from you. General (Mechanical): General dilution ventilation involves continuous introduction of fresh air into the workroom to mix with the contaminated air and lower your breathing zone concentration of formaldehyde. Effectiveness depends on the number of air changes per hour. Where devices emitting formaldehyde are spread out over a large area, general dilution ventilation may be the only practical method of control. Work Practices: Work practices and administrative procedures are an important part of a control system. If you are asked to perform a task in a certain manner to limit your exposure to formaldehyde, it is extremely important that you follow these procedures. erowe on DSK5CLS3C1PROD with CFR Medical Surveillance Medical surveillance helps to protect employees’ health. You are encouraged strongly to participate in the medical surveillance program. Your employer must make a medical surveillance program available at no expense to you and at a reasonable time and place if you are exposed to formaldehyde at concentrations above 0.5 ppm as an 8-hour average or 2 ppm over any 15-minute period. You will be offered medical surveillance at the time of your initial assignment and once a year afterward as long as your exposure is at least 0.5 ppm (TWA) or 2 ppm (STEL). Even if your exposure is below these levels, you should inform your employer if you have signs and symptoms that you suspect, through your training, are related to your formaldehyde exposure because you may need medical surveillance to determine if your health is being impaired by your exposure. The surveillance plan includes: (a) A medical disease questionnaire. (b) A physical examination if the physician determines this is necessary. If you are required to wear a respirator, your employer must offer you a physical examination and a pulmonary function test every year. The physician must collect all information needed to determine if you are at increased risk from your exposure to formaldehyde. At the physician’s discretion, the medical examination may include other tests, such as a chest x-ray, to make this determination. After a medical examination the physician will provide your employer with a written opinion which includes any special protective measures recommended and any restrictions on your exposure. The physician must inform you of any medical conditions you have which would be aggravated by exposure to formaldehyde. All records from your medical examinations, including disease surveys, must be retained at your employer’s expense. EMERGENCIES If you are exposed to formaldehyde in an emergency and develop signs or symptoms associated with acute toxicity from formaldehyde exposure, your employer must provide you with a medical examination as soon as possible. This medical examination will include all steps necessary to stabilize your health. You may be kept in the hospital for observation if your symptoms are severe to ensure that any delayed effects are recognized and treated. APPENDIX B TO § 1910.1048—SAMPLING STRATEGY AND ANALYTICAL METHODS FOR FORMALDEHYDE To protect the health of employees, exposure measurements must be unbiased and representative of employee exposure. The proper measurement of employee exposure requires more than a token commitment on the part of the employer. OSHA’s mandatory requirements establish a baseline; under the best of circumstances all questions regarding employee exposure will be answered. Many employers, however, will wish to conduct more extensive monitoring before undertaking expensive commitments, such as engineering controls, to assure that the modifications are truly necessary. The following sampling strategy, which was developed at 370 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00380 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& Occupational Safety and Health Admin., Labor NIOSH by Nelson A. Leidel, Kenneth A. Busch, and Jeremiah R. Lynch and described in NIOSH publication No. 77–173 (Occupational Exposure Sampling Strategy Manual) will assist the employer in developing a strategy for determining the exposure of his or her employees. There is no one correct way to determine employee exposure. Obviously, measuring the exposure of every employee exposed to formaldehyde will provide the most information on any given day. Where few employees are exposed, this may be a practical solution. For most employers, however, use of the following strategy will give just as much information at less cost. Exposure data collected on a single day will not automatically guarantee the employer that his or her workplace is always in compliance with the formaldehyde standard. This does not imply, however, that it is impossible for an employer to be sure that his or her worksite is in compliance with the standard. Indeed, a properly designed sampling strategy showing that all employees are exposed below the PELs, at least with a 95 percent certainty, is compelling evidence that the exposure limits are being achieved provided that measurements are conducted using valid sampling strategy and approved analytical methods. There are two PELs, the TWA concentration and the STEL. Most employers will find that one of these two limits is more critical in the control of their operations, and OSHA expects that the employer will concentrate monitoring efforts on the critical component. If the more difficult exposure is controlled, this information, along with calculations to support the assumptions, should be adequate to show that the other exposure limit is also being achieved. Sampling Strategy erowe on DSK5CLS3C1PROD with CFR Determination of the Need for Exposure Measurements The employer must determine whether employees may be exposed to concentrations in excess of the action level. This determination becomes the first step in an employee exposure monitoring program that minimizes employer sampling burdens while providing adequate employee protection. If employees may be exposed above the action level, the employer must measure exposure. Otherwise, an objective determination that employee exposure is low provides adequate evidence that exposure potential has been examined. The employer should examine all available relevant information, eg. insurance company and trade association data and information from suppliers or exposure data collected from similar operations. The employer may also use previously-conducted sampling including area monitoring. The employer must § 1910.1048 make a determination relevant to each operation although this need not be on a separate piece of paper. If the employer can demonstrate conclusively that no employee is exposed above the action level or the STEL through the use of objective data, the employer need proceed no further on employee exposure monitoring until such time that conditions have changed and the determination is no longer valid. If the employer cannot determine that employee exposure is less than the action level and the STEL, employee exposure monitoring will have to be conducted. Workplace Material Survey The primary purpose of a survey of raw material is to determine if formaldehyde is being used in the work environment and if so, the conditions under which formaldehyde is being used. The first step is to tabulate all situations where formaldehyde is used in a manner such that it may be released into the workplace atmosphere or contaminate the skin. This information should be available through analysis of company records and information on the MSDSs available through provisions of this standard and the Hazard Communication standard. If there is an indication from materials handling records and accompanying MSDSs that formaldehyde is being used in the following types of processes or work operations, there may be a potential for releasing formaldehyde into the workplace atmosphere: (1) Any operation that involves grinding, sanding, sawing, cutting, crushing, screening, sieving, or any other manipulation of material that generates formaldehyde-bearing dust (2) Any processes where there have been employee complaints or symptoms indicative of exposure to formaldehyde (3) Any liquid or spray process involving formaldehyde (4) Any process that uses formaldehyde in preserved tissue (5) Any process that involves the heating of a formaldehyde-bearing resin. Processes and work operations that use formaldehyde in these manners will probably require further investigation at the worksite to determine the extent of employee monitoring that should be conducted. Workplace Observations To this point, the only intention has been to provide an indication as to the existence of potentially exposed employees. With this information, a visit to the workplace is needed to observe work operations, to identify potential health hazards, and to determine whether any employees may be exposed to hazardous concentrations of formaldehyde. 371 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00381 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& § 1910.1048 29 CFR Ch. XVII (7–1–09 Edition) In many circumstances, sources of formaldehyde can be identified through the sense of smell. However, this method of detection should be used with caution because of olfactory fatigue. Employee location in relation to source of formaldehyde is important in determining if an employee may be significantly exposed to formaldehyde. In most instances, the closer a worker is to the source, the higher the probability that a significant exposure will occur. Other characteristics should be considered. Certain high temperature operations give rise to higher evaporation rates. Locations of open doors and windows provide natural ventilation that tend to dilute formaldehyde emissions. General room ventilation also provides a measure of control. Calculation of Potential Exposure Concentrations By knowing the ventilation rate in a workplace and the quantity of formaldehyde generated, the employer may be able to determine by calculation if the PELs might be exceeded. To account for poor mixing of formaldehyde into the entire room, locations of fans and proximity of employees to the work operation, the employer must include a safety factor. If an employee is relatively close to a source, particularly if he or she is located downwind, a safety factor of 100 may be necessary. For other situations, a factor of 10 may be acceptable. If the employer can demonstrate through such calculations that employee exposure does not exceed the action level or the STEL, the employer may use this information as objective data to demonstrate compliance with the standard. erowe on DSK5CLS3C1PROD with CFR Sampling Strategy Once the employer determines that there is a possibility of substantial employee exposure to formaldehyde, the employer is obligated to measure employee exposure. The next step is selection of a maximum risk employee. When there are different processes where employees may be exposed to formaldehyde, a maximum risk employee should be selected for each work operation. Selection of the maximum risk employee requires professional judgment. The best procedure for selecting the maximum risk employee is to observe employees and select the person closest to the source of formaldehyde. Employee mobility may affect this selection; eg. if the closest employee is mobile in his tasks, he may not be the maximum risk employee. Air movement patterns and differences in work habits will also affect selection of the maximum risk employee. When many employees perform essentially the same task, a maximum risk employee cannot be selected. In this circumstance, it is necessary to resort to random sampling of the group of workers. The objective is to select a subgroup of adequate size so that there is a high probability that the random sample will contain at least one worker with high exposure if one exists. The number of persons in the group influences the number that need to be sampled to ensure that at least one individual from the highest 10 percent exposure group is contained in the sample. For example, to have 90 percent confidence in the results, if the group size is 10, nine should be sampled; for 50, only 18 need to be sampled. If measurement shows exposure to formaldehyde at or above the action level or the STEL, the employer needs to identify all other employees who may be exposed at or above the action level or STEL and measure or otherwise accurately characterize the exposure of these employees. Whether representative monitoring or random sampling are conducted, the purpose remains the same—to determine if the exposure of any employee is above the action level. If the exposure of the most exposed employee is less than the action level and the STEL, regardless of how the employee is identified, then it is reasonable to assume that measurements of exposure of the other employees in that operation would be below the action level and the STEL. Exposure Measurements There is no ‘‘best’’ measurement strategy for all situations. Some elements to consider in developing a strategy are: (1) Availability and cost of sampling equipment (2) Availability and cost of analytic facilities (3) Availability and cost of personnel to take samples (4) Location of employees and work operations (5) Intraday and interday variations in the process (6) Precision and accuracy of sampling and analytic methods, and (7) Number of samples needed. Samples taken for determining compliance with the STEL differ from those that measure the TWA concentration in important ways. STEL samples are best taken in a nonrandom fashion using all available knowledge relating to the area, the individual, and the process to obtain samples during periods of maximum expected concentrations. At least three measurements on a shift are generally needed to spot gross errors or mistakes; however, only the highest value represents the STEL. If an operation remains constant throughout the workshift, a much greater number of samples would need to be taken over the 32 discrete nonoverlapping periods in an 8-hour workshift to verify compliance with a STEL. If employee exposure is truly uniform 372 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00382 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& Occupational Safety and Health Admin., Labor throughout the workshift, however, an employer in compliance with the l ppm TWA would be in compliance with the 2 ppm STEL, and this determination can probably be made using objective data. erowe on DSK5CLS3C1PROD with CFR Need To Repeat the Monitoring Strategy Interday and intraday fluctuations in employee exposure are mostly influenced by the physical processes that generate formaldehyde and the work habits of the employee. Hence, in-plant process variations influence the employer’s determination of whether or not additional controls need to be imposed. Measurements that employee exposure is low on a day that is not representative of worst conditions may not provide sufficient information to determine whether or not additional engineering controls should be installed to achieve the PELs. The person responsible for conducting sampling must be aware of systematic changes which will negate the validity of the sampling results. Systematic changes in formaldehyde exposure concentration for an employee can occur due to: (1) The employee changing patterns of movement in the workplace (2) Closing of plant doors and windows (3) Changes in ventilation from season to season (4) Decreases in ventilation efficiency or abrupt failure of engineering control equipment (5) Changes in the production process or work habits of the employee. Any of these changes, if they may result in additional exposure that reaches the next level of action (i.e. 0.5 or 1.0 ppm as an 8-hr average or 2 ppm over 15 minutes) require the employer to perform additional monitoring to reassess employee exposure. A number of methods are suitable for measuring employee exposure to formaldehyde or for characterizing emissions within the worksite. The preamble to this standard describes some methods that have been widely used or subjected to validation testing. A detailed analytical procedure derived from the OSHA Method 52 for acrolein and formaldehyde is presented below for informational purposes. Inclusion of OSHA’s method in this appendix in no way implies that it is the only acceptable way to measure employee exposure to formaldehyde. Other methods that are free from significant interferences and that can determine formaldehyde at the permissible exposure limits within ±25 percent of the ‘‘true’’ value at the 95 percent confidence level are also acceptable. Where applicable, the method shou1d a1so be capab1e of measuring formaldehyde at the action level to ±35 percent of the ‘‘true’’ value with a 95 percent confidence level. OSHA encourages emp1oyers to choose methods that will be § 1910.1048 best for their individual needs. The employer must exercise caution, however, in choosing an appropriate method since some techniques suffer from interferences that are likely to be present in workplaces of certain industry sectors where formaldehyde is used. OSHA’s Analytical Laboratory Method Method No: 52 Matrix: Air Target Concentration: 1 ppm (1.2 mg/m3) Procedures: Air samples are collected by drawing known volumes of air through sampling tubes containing XAD–2 adsorbent which have been coated with 2(hydroxymethyl) piperidine. The samples are desorbed with toluene and then analyzed by gas chromatography using a nitrogen selective detector. Recommended Sampling Rate and Air Volumes: 0.1 L/min and 24 L Reliable Quantitation Limit:16 ppb (20 µg/m3) Standard Error of Estimate at the Target Concentration: 7.3% Status of the Method: A sampling and analytical method that has been subjected to the established evaluation procedures of the Organic Methods Evaluation Branch. Date: March 1985 1. General Discussion 1.1 Background: The current OSHA method for collecting acrolein vapor recommends the use of activated 13X molecular sieves. The samples must be stored in an ice bath during and after sampling and also they must be analyzed within 48 hours of collection. The current OSHA method for collecting formaldehyde vapor recommends the use of bubblers containing 10% methanol in water as the trapping solution. This work was undertaken to resolve the sample stability problems associated with acrolein and also to eliminate the need to use bubb1ers to sample formaldehyde. A goal of this work was to develop and/or to evaluate a common sampling and analytical procedure for acrolein and formaldehyde. NIOSH has developed independent methodologies for acrolein and formaldehyde which recommend the use of reagent-coated adsorbent tubes to collect the aldehydes as stable derivatives. The formaldehyde sampling tubes contain Chromosorb 102 adsorbent coated with N-benzylethanolamine (BEA) which reacts with formaldehyde vapor to form a stable oxazolidine compound. The acrolein sampling tubes contain XAD–2 adsorbent coated with 2(hydroxymethyl)piperidine (2–HMP) which reacts with acrolein vapor to form a different, stable oxazolidine derivative. Acrolein does not appear to react with BEA to give a suitable reaction product. Therefore, the formaldehyde procedure cannot provide a 373 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00383 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& erowe on DSK5CLS3C1PROD with CFR § 1910.1048 29 CFR Ch. XVII (7–1–09 Edition) common method for both aldehydes. However, formaldehyde does react with 2–HMP to form a very suitable reaction product. It is the quantitative reaction of acrolein and formaldehyde with 2–HMP that provides the basis for this evaluation. This sampling and analytical procedure is very similar to the method recommended by NIOSH for acrolein. Some changes in the NIOSH methodology were necessary to permit the simultaneous determination of both aldehydes and also to accommodate OSHA laboratory equipment and analytical techniques. 1.2 Limit-defining parameters: The analyte air concentrations reported in this method are based on the recommended air volume for each analyte collected separately and a desorption volume of 1 mL. The amounts are presented as acrolein and/or formaldehyde, even though the derivatives are the actual species analyzed. 1.2.1 Detection limits of the analytical procedure: The detection limit of the analytical procedure was 386 pg per injection for formaldehyde. This was the amount of analyte which gave a peak whose height was about five times the height of the peak given by the residual formaldehyde derivative in a typical blank front section of the recommended sampling tube. 1.2.2 Detection limits of the overall procedure: The detection limits of the overall procedure were 482 ng per sample (16 ppb or 20 µg/m3 for formaldehyde). This was the amount of analyte spiked on the sampling device which allowed recoveries approximately equal to the detection limit of the analytical procedure. 1.2.3 Reliable quantitation limits: The reliable quantitation limit was 482 ng per sample (16 ppb or 20 µg/m3) for formaldehyde. These were the smallest amounts of analyte which could be quantitated within the limits of a recovery of at least 75% and a precision (±1.96 SD) of ±25% or better. llllllllllllllllllllllll The reliable quantitation limit and detection limits reported in the method are based upon optimization of the instrument for the smallest possible amount of analyte. When the target concentration of an analyte is exceptionally higher than these limits, they may not be attainable at the routine operating parameters. llllllllllllllllllllllll 1.2.4 Sensitivity: The sensitivity of the analytical procedure over concentration ranges representing 0.4 to 2 times the target concentration, based on the recommended air volumes, was 7,589 area units per µg/mL for formaldehyde. This value was determined from the slope of the calibration curve. The sensitivity may vary with the particular instrument used in the analysis. 1.2.5 Recovery: The recovery of formaldehyde from samples used in an 18-day storage test remained above 92% when the samples were stored at ambient temperature. These values were determined from regression lines which were calculated from the storage data. The recovery of the analyte from the collection device must be at least 75% following storage. 1.2.6 Precision (analytical method only): The pooled coefficient of variation obtained from replicate determinations of analytical standards over the range of 0.4 to 2 times the target concentration was 0.0052 for formaldehyde (Section 4.3). 1.2.7 Precision (overall procedure): The precision at the 95% confidence level for the ambient temperature storage tests was ±14.3% for formaldehyde. These values each include an additional ±5% for sampling error. The overall procedure must provide results at the target concentrations that are ±25% at the 95% confidence level. 1.2.8 Reproducibility: Samples collected from controlled test atmospheres and a draft copy of this procedure were given to a chemist unassociated with this evaluation. The formaldehyde samples were analyzed following 15 days storage. The average recovery was 96.3% and the standard deviation was 1.7%. 1.3 Advantages: 1.3.1 The sampling and analytical procedures permit the simultaneous determination of acrolein and formaldehyde. 1.3.2 Samples are stable following storage at ambient temperature for at least 18 days. 1.4 Disadvantages: None. 2. Sampling Procedure 2.1 Apparatus: 2.1.1 Samples are collected by use of a personal sampling pump that can be calibrated to within ±5% of the recommended 0.1 L/min sampling rate with the sampling tube in line. 2.1.2 Samples are collected with laboratory prepared sampling tubes. The sampling tube is constructed of silane treated glass and is about 8-cm long. The ID is 4 mm and the OD is 6 mm. One end of the tube is tapered so that a glass wool end plug will hold the contents of the tube in place during sampling. The other end of the sampling tube is open to its full 4-mm ID to facilitate packing of the tube. Both ends of the tube are firepolished for safety. The tube is packed with a 75-mg backup section, located nearest the tapered end and a 150-mg sampling section of pretreated XAD–2 adsorbent which has been coated with 2–HMP. The two sections of coated adsorbent are separated and retained with small plugs of silanized glass wool. Following packing, the sampling tubes are sealed with two 7⁄32 inch OD plastic end caps. Instructions for the pretreatment and the coating of XAD–2 adsorbent are presented in Section 4 of this method. 374 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00384 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& erowe on DSK5CLS3C1PROD with CFR Occupational Safety and Health Admin., Labor 2.1.3 Sampling tubes, similar to those recommended in this method, are marketed by Supelco, Inc. These tubes were not available when this work was initiated; therefore, they were not evaluated. 2.2 Reagents: None required. 2.3 Technique: 2.3.1 Properly label the sampling tube before sampling and then remove the plastic end caps. 2.3.2 Attach the sampling tube to the pump using a section of flexible plastic tubing such that the large, front section of the sampling tube is exposed directly to the atmosphere. Do not place any tubing ahead of the sampling tube. The sampling tube should be attached in the worker’s breathing zone in a vertical manner such that it does not impede work performance. 2.3.3 After sampling for the appropriate time, remove the sampling tube from the pump and then seal the tube with plastic end caps. 2.3.4 Include at least one blank for each sampling set. The blank should be handled in the same manner as the samples with the exception that air is not drawn through it. 2.3.5 List any potential interferences on the sample data sheet. 2.4 Breakthrough: 2.4.1 Breakthrough was defined as the relative amount of analyte found on a backup sample in relation to the total amount of analyte collected on the sampling train. 2.4.2 For formaldehyde collected from test atmospheres containing 6 times the PEL, the average 5% breakthrough air volume was 41 L. The sampling rate was 0.1 L/min and the average mass of formaldehyde collected was 250 µg. 2.5 Desorption Efficiency: No desorption efficiency corrections are necessary to compute air sample results because analytical standards are prepared using coated adsorbent. Desorption efficiencies were determined, however, to investigate the recoveries of the analytes from the sampling device. The average recovery over the range of 0.4 to 2 times the target concentration, based on the recommended air volumes, was 96.2% for formaldehyde. Desorption efficiencies were essentially constant over the ranges studied. 2.6 Recommended Air Volume and Sampling Rate: 2.6.1 The recommended air volume for formaldehyde is 24 L. 2.6.2 The recommended sampling rate is 0.1 L/min. 2.7 Interferences: 2.7.1 Any collected substance that is capable of reacting 2-HMP and thereby depleting the derivatizing agent is a potential interference. Chemicals which contain a carbonyl group, such as acetone, may be capable or reacting with 2-HMP. 2.7.2 There are no other known interferences to the sampling method. § 1910.1048 2.8 Safety Precautions: 2.8.1 Attach the sampling equipment to the worker in such a manner that it well not interfere with work performance or safety. 2.8.2 Follow all safety practices that apply to the work area being sampled. 3. Analytical Procedure 3.1 Apparatus: 3.1.1 A gas chromatograph (GC), equipped with a nitrogen selective detector. A Hewlett-Packard Model 5840A GC fitted with a nitrogen-phosphorus flame ionization detector (NPD) was used for this evaluation. Injections were performed using a HewlettPackard Model 7671A automatic sampler. 3.1.2 A GC column capable of resolving the analytes from any interference. A 6 ft × 1⁄4 in OD (2mm ID) glass GC column containing 10% UCON 50–HB–5100 + 2% KOH on 80/100 mesh Chromosorb W-AW was used for the evaluation. Injections were performed on-column. 3.1.3 Vials, glass 2-mL with Teflon-lined caps. 3.1.4 Volumetric flasks, pipets, and syringes for preparing standards, making dilutions, and performing injections. 3.2 Reagents: 3.2.1 Toluene and dimethylformamide. Burdick and Jackson solvents were used in this evaluation. 3.2.2 Helium, hydrogen, and air, GC grade. 3.2.3 Formaldehyde, 37%, by weight, in water. Aldrich Chemical, ACS Reagent Grade formaldehyde was used in this evaluation. 3.2.4 Amberlite XAD–2 adsorbent coated with 2-(hydroxymethyl—piperidine (2-HMP), 10% by weight (Section 4). 3.2.5 Desorbing solution with internal standard. This solution was prepared by adding 20 µL of dimethylformamide to 100 mL of toluene. 3.3 Standard preparation: 3.3.1 Formaldehyde: Prepare stock standards by diluting known volumes of 37% formaldehyde solution with methanol. A procedure to determine the formaldehyde content of these standards is presented in Section 4. A standard containing 7.7 mg/mL formaldehyde was prepared by diluting 1 mL of the 37% reagent to 50 mL with methanol. 3.3.2 It is recommended that analytical standards be prepared about 16 hours before the air samples are to be analyzed in order to ensure the complete reaction of the analytes with 2–HMP. However, rate studies have shown the reaction to be greater than 95% complete after 4 hours. Therefore, one or two standards can be analyzed after this reduced time if sample results are outside the concentration range of the prepared standards. 3.3.3 Place 150-mg portions of coated XAD–2 adsorbent, from the same lot number as used to collect the air samples, into each of several glass 2-mL vials. Seal each vial with a Teflon-lined cap. 375 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00385 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& erowe on DSK5CLS3C1PROD with CFR § 1910.1048 29 CFR Ch. XVII (7–1–09 Edition) 3.3.4 Prepare fresh analytical standards each day by injecting appropriate amounts of the diluted analyte directly onto 150-mg portions of coated adsorbent. It is permissible to inject both acrolein and formaldehyde on the same adsorbent portion. Allow the standards to stand at room temperature. A standard, approximately the target levels, was prepared by injecting 11 µL of the acrolein and 12 µL of the formaldehyde stock standards onto a single coated XAD–2 adsorbent portion. 3.3.5 Prepare a sufficient number of standards to generate the calibration curves. Analytical standard concentrations should bracket sample concentrations. Thus, if samples are not in the concentration range of the prepared standards, additional standards must be prepared to determine detector response. 3.3.7 Desorb the standards in the same manner as the samples following the 16-hour reaction time. 3.4 Sample preparation: 3.4.1 Transfer the 150-mg section of the sampling tube to a 2-mL vial. Place the 75mg section in a separate vial. If the glass wool plugs contain a significant number of adsorbent beads, place them with the appropriate sampling tube section. Discard the glass wool plugs if they do not contain a significant number of adsorbent beads. 3.4.2 Add 1 mL of desorbing solution to each vial. 3.4.3 Seal the vials with Teflon-lined caps and then allow them to desorb for one hour. Shake the vials by hand with vigorous force several times during the desorption time. 3.4.4 Save the used sampling tubes to be cleaned and recycled. 3.5 Analysis: 3.5.1 GC Conditions Column Temperature: Bi-level temperature program—First level: 100 to 140 °C at 4 °C/min following completion of the first level. Second level: 140 to 180 °C at 20 °C/min following completion of the first level. Isothermal period: Hold column at 180 °C until the recorder pen returns to baseline (usually about 25 min after injection). Injector temperature: 180 °C Helium flow rate: 30 mL/min (detector response will be reduced if nitrogen is substituted for helium carrier gas). Injection volume: 0.8 µL GC column: Six-ft × 1⁄4-in OD (2 mm ID) glass GC column containing 10% UCON 50–HB– 5100+2% KOH on 80/100 Chromosorb W-AW. NPD conditions: Hydrogen flow rate: 3 mL/min Air flow rate: 50 mL/min Detector temperature: 275 °C 3.5.2 Chromatogram: For an example of a typical chromatogram, see Figure 4.11 in OSHA Method 52. 3.5.3 Use a suitable method, such as electronic integration, to measure detector response. 3.5.4 Use an internal standard method to prepare the calibration curve with several standard solutions of different concentrations. Prepare the calibration curve daily. Program the integrator to report results in µg/mL. 3.5.5 Bracket sample concentrations with standards. 3.6 Interferences (Analytical) 3.6.1 Any compound with the same general retention time as the analytes and which also gives a detector response is a potential interference. Possible interferences should be reported to the laboratory with submitted samples by the industrial hygienist. 3.6.2 GC parameters (temperature, column, etc.) may be changed to circumvent interferences. 3.6.3 A useful means of structure designation is GC/MS. It is recommended this procedure be used to confirm samples whenever possible. 3.6.4 The coated adsorbent usually contains a very small amount of residual formaldehyde derivative (Section 4.8). 3.7 Calculations: 3.7.1 Results are obtained by use of calibration curves. Calibration curves are prepared by plotting detector response against concentration for each standard. The best line through the data points is determined by curve fitting. 3.7.2 The concentration, in µg/mL, for a particular sample is determined by comparing its detector response to the calibration curve. If either of the analytes is found on the backup section, it is added to the amount found on the front section. Blank corrections should be performed before adding the results together. 3.7.3 The acrolein and/or formaldehyde air concentration can be expressed using the following equation: mg/m3=(A)(B)/C where A=µg/mL from 3.7.2, B=desorption volume, and C=L of air sampled. No desorption efficiency corrections are required. 3.7.4 The following equation can be used to convert results in mg/m3 to ppm. ppm=(mg/m3)(24.45)/MW where mg/m3=result from 3.7.3, 24.45=molar volume of an ideal gas at 760 mm Hg and 25 °C, MW=molecular weight (30.0). 4. Backup Data 4.1 Backup data on detection limits, reliable quantitation limits, sensitivity and precision of the analytical method, breakthrough, desorption efficiency, storage, reproducibility, and generation of test 376 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00386 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& Occupational Safety and Health Admin., Labor atmospheres are available in OSHA Method 52, developed by the Organics Methods Evaluation Branch, OSHA Analytical Laboratory, Salt Lake City, Utah. 4.2 Procedure to Coat XAD–2 Adsorbent with 2–HMP: 4.2.1 Apparatus: Soxhlet extraction apparatus, rotary evaporation apparatus, vacuum dessicator, 1–L vacuum flask, 1–L round-bottomed evaporative flask, 1–L Erlenmeyer flask, 250-mL Buchner funnel with a coarse fritted disc, etc. 4.2.2 Reagents: 4.2.2.1 Methanol, isooctane, and toluene. 4.2.2.2 2-(Hydroxymethyl)piperidine. 4.2.2.3 Amberlite XAD–2 non-ionic polymeric adsorbent, 20 to 60 mesh, Aldrich Chemical XAD–2 was used in this evaluation. 4.2.3 Procedure: Weigh 125 g of crude XAD– 2 adsorbent into a 1–L Erlenmeyer flask. Add about 200 mL of water to the flask and then swirl the mixture to wash the adsorbent. Discard any adsorbent that floats to the top of the water and then filter the mixture using a fritted Buchner funnel. Air dry the adsorbent for 2 minutes. Transfer the adsorbent back to the Erlenmeyer flask and then add about 200 mL of methanol to the flask. Swirl and then filter the mixture as before. Transfer the washed adsorbent back to the Erlenmeyer flask and then add about 200 mL of methanol to the flask. Swirl and then filter the mixture as before. Transfer the washed adsorbent to a 1–L round-bottomed evaporative flask, add 13 g of 2–HMP and then 200 mL of methanol, swirl the mixture and then allow it to stand for one hour. Remove the methanol at about 40 °C and reduced pressure using a rotary evaporation apparatus. Transfer the coated adsorbent to a suitable container and store it in a vacuum desiccator at room temperature overnight. Transfer the coated adsorbent to a Soxhlet extractor and then extract the material with toluene for about 24 hours. Discard the contaminated toluene, add methanol in its place and then continue the Soxhlet extraction for an additional 4 hours. Transfer the adsorbent to a weighted 1–L round-bottom evaporative flask and remove the methanol using the ro- tary evaporation apparatus. Determine the weight of the adsorbent and then add an amount of 2-HMP, which is 10% by weight of the adsorbent. Add 200 mL of methanol and then swirl the mixture. Allow the mixture to stand for one hour. Remove the methanol by rotary evaporation. Transfer the coated adsorbent to a suitable container and store it in a vacuum desiccator until all traces of solvents are gone. Typically, this will take 2–3 days. The coated adsorbent should be protected from contamination. XAD–2 adsorbent treated in this manner will probably not contain residual acrolein derivative. However, this adsorbent will often contain residual formaldehyde derivative levels of about 0.1 µg per 150 mg of adsorbent. If the blank values for a batch of coated adsorbent are too high, then the batch should be returned to the Soxhlet extractor, extracted with toluene again and then recoated. This process can be repeated until the desired blank levels are attained. The coated adsorbent is now ready to be packed into sampling tubes. The sampling tubes should be stored in a sealed container to prevent contamination. Sampling tubes should be stored in the dark at room temperature. The sampling tubes should be segregated by coated adsorbent lot number. A sufficient amount of each lot number of coated adsorbent should be retained to prepare analytical standards for use with air samples from that lot number. 4.3 A Procedure to Determine Formaldehyde by Acid Titration: Standardize the 0.1 N HCl solution using sodium carbonate and methyl orange indicator. Place 50 mL of 0.1 M sodium sulfite and three drops of thymophthalein indicator into a 250-mL Erlenmeyer flask. Titrate the contents of the flask to a colorless endpoint with 0.1 N HCl (usually one or two drops is sufficient). Transfer 10 mL of the formaldehyde/methanol solution (prepared in 3.3.1) into the same flask and titrate the mixture with 0.1 N HCl, again, to a colorless endpoint. The formaldehyde concentration of the standard may be calculated by the following equation: acid titer × acid normality × 30.0 mL of sample This method is based on the quantitative liberation of sodium hydroxide when formaldehyde reacts with sodium sulfite to form the formaldehyde-bisulfite addition product. The volume of sample may be varied depending on the formaldehyde content but the solution to be titrated must contain excess sodium sulfite. Formaldehyde solutions con- taining substantial amounts of acid or base must be neutralized before analysis. 377 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00387 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& EC15NO91.041</MATH> erowe on DSK5CLS3C1PROD with CFR Formaldehyde, mg/mL = § 1910.1048 § 1910.1048 29 CFR Ch. XVII (7–1–09 Edition) APPENDIX C TO § 1910.1048—MEDICAL SURVEILLANCE—FORMALDEHYDE I. Health Hazards The occupational health hazards of formaldehyde are primarily due to its toxic effects after inhalation, after direct contact with the skin or eyes by formaldehyde in liquid or vapor form, and after ingestion. II. Toxicology erowe on DSK5CLS3C1PROD with CFR A. Acute Effects of Exposure 1. Inhalation (breathing): Formaldehyde is highly irritating to the upper airways. The concentration of formaldehyde that is immediately dangerous to life and health is 100 ppm. Concentrations above 50 ppm can cause severe pulmonary reactions within minutes. These include pulmonary edema, pneumonia, and bronchial irritation which can result in death. Concentrations above 5 ppm readily cause lower airway irritation characterized by cough, chest tightness and wheezing. There is some controversy regarding whether formaldehyde gas is a pulmonary sensitizer which can cause occupational asthma in a previously normal individual. Formaldehyde can produce symptoms of bronchial asthma in humans. The mechanism may be either sensitization of the individual by exposure to formaldehyde or direct irritation by formaldehyde in persons with pre-existing asthma. Upper airway irritation is the most common respiratory effect reported by workers and can occur over a wide range of concentrations, most frequently above 1 ppm. However, airway irritation has occurred in some workers with exposures to formaldehyde as low as 0.1 ppm. Symptoms of upper airway irritation include dry or sore throat, itching and burning sensations of the nose, and nasal congestion. Tolerance to this level of exposure may develop within 1–2 hours. This tolerance can permit workers remaining in an environment of gradually increasing formaldehyde concentrations to be unaware of their increasingly hazardous exposure. 2. Eye contact: Concentrations of formaldehyde between 0.05 ppm and 0.5 ppm produce a sensation of irritation in the eyes with burning, itching, redness, and tearing. Increased rate of blinking and eye closure generally protects the eye from damage at these low levels, but these protective mechanisms may interfere with some workers’ work abilities. Tolerance can occur in workers continuously exposed to concentrations of formaldehyde in this range. Accidental splash injuries of human eyes to aqueous solutions of formaldehyde (formalin) have resulted in a wide range of ocular injuries including corneal opacities and blindness. The severity of the reactions have been directly dependent on the concentration of formaldehyde in solu- tion and the amount of time lapsed before emergency and medical intervention. 3. Skin contact: Exposure to formaldehyde solutions can cause irritation of the skin and allergic contact dermatitis. These skin diseases and disorders can occur at levels well below those encountered by many formaldehyde workers. Symptoms include erythema, edema, and vesiculation or hives. Exposure to liquid formalin or formaldehyde vapor can provoke skin reactions in sensitized individuals even when airborne concentrations of formaldehyde are well below 1 ppm. 4. Ingestion: Ingestion of as little as 30 ml of a 37 percent solution of formaldehyde (formalin) can result in death. Gastrointestinal toxicity after ingestion is most severe in the stomach and results in symptoms which can include nausea, vomiting, and servere abdominal pain. Diverse damage to other organ systems including the liver, kidney, spleen, pancreas, brain, and central nervous systems can occur from the acute response to ingestion of formaldehyde. B. Chronic Effects of Exposure Long term exposure to formaldehyde has been shown to be associated with an increased risk of cancer of the nose and accessory sinuses, nasopharyngeal and oropharyngeal cancer, and lung cancer in humans. Animal experiments provide conclusive evidence of a causal relationship between nasal cancer in rats and formaldehyde exposure. Concordant evidence of carcinogenicity includes DNA binding, genotoxicity in short-term tests, and cytotoxic changes in the cells of the target organ suggesting both preneoplastic changes and a dose-rate effect. Formaldehyde is a complete carcinogen and appears to exert an effect on at least two stages of the carcinogenic process. III. Surveillance considerations A. History 1. Medical and occupational history: Along with its acute irritative effects, formaldehyde can cause allergic sensitization and cancer. One of the goals of the work history should be to elicit information on any prior or additional exposure to formaldehyde in either the occupational or the non-occupational setting. 2. Respiratory history: As noted above, formaldehyde has recognized properties as an airway irritant and has been reported by some authors as a cause of occupational asthma. In addition, formaldehyde has been associated with cancer of the entire respiratory system of humans. For these reasons, it is appropriate to include a comprehensive review of the respiratory system in the medical history. Components of this history might include questions regarding dyspnea 378 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00388 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& Occupational Safety and Health Admin., Labor on exertion, shortness of breath, chronic airway complaints, hyperreactive airway disease, rhinitis, bronchitis, bronchiolitis, asthma, emphysema, respiratory allergic reaction, or other preexisting pulmonary disease. In addition, generalized airway hypersensitivity can result from exposures to a single sensitizing agent. The examiner should, therefore, elicit any prior history of exposure to pulmonary irritants, and any short- or long-term effects of that exposure. Smoking is known to decrease mucociliary clearance of materials deposited during respiration in the nose and upper airways. This may increase a worker’s exposure to inhaled materials such as formaldehyde vapor. In addition, smoking is a potential confounding factor in the investigation of any chronic respiratory disease, including cancer. For these reasons, a complete smoking history should be obtained. 3. Skin Disorders: Because of the dermal irritant and sensitizing effects of formaldehyde, a history of skin disorders should be obtained. Such a history might include the existence of skin irritation, previously documented skin sensitivity, and other dermatologic disorders. Previous exposure to formaldehyde and other dermal sensitizers should be recorded. 4. History of atopic or allergic diseases: Since formaldehyde can cause allergic sensitization of the skin and airways, it might be useful to identify individuals with prior allergen sensitization. A history of atopic disease and allergies to formaldehyde or any other substances should also be obtained. It is not definitely known at this time whether atopic diseases and allergies to formaldehyde or any other substances should also be obtained. Also it is not definitely known at this time whether atopic individuals have a greater propensity to develop formaldehyde sensitivity than the general population, but identification of these individuals may be useful for ongoing surveillance. 5. Use of disease questionnaires: Comparison of the results from previous years with present results provides the best method for detecting a general deterioration in health when toxic signs and symptoms are measured subjectively. In this way recall bias does not affect the results of the analysis. Consequently, OSHA has determined that the findings of the medical and work histories should be kept in a standardized form for comparison of the year-to-year results. erowe on DSK5CLS3C1PROD with CFR B. Physical Examination 1. Mucosa of eyes and airways: Because of the irritant effects of formaldehyde, the examining physician should be alert to evidence of this irritation. A speculum examination of the nasal mucosa may be helpful in assessing possible irritation and cytotoxic changes, as may be indirect inspection of the posterior pharynx by mirror. § 1910.1048 2. Pulmonary system: A conventional respiratory examination, including inspection of the thorax and auscultation and percussion of the lung fields should be performed as part of the periodic medical examination. Although routine pulmonary function testing is only required by the standard once every year for persons who are exposed over the TWA concentration limit, these tests have an obvious value in investigating possible respiratory dysfunction and should be used wherever deemed appropriate by the physician. In cases of alleged formaldehyde-induced airway disease, other possible causes of pulmonary disfunction (including exposures to other substances) should be ruled out. A chest radiograph may be useful in these circumstances. In cases of suspected airway hypersensitivity or allergy, it may be appropriate to use bronchial challenge testing with formaldehyde or methacholine to determine the nature of the disorder. Such testing should be performed by or under the supervision of a physician experienced in the procedures involved. 3. Skin: The physician should be alert to evidence of dermal irritation of sensitization, including reddening and inflammation, urticaria, blistering, scaling, formation of skin fissures, or other symptoms. Since the integrity of the skin barrier is compromised by other dermal diseases, the presence of such disease should be noted. Skin sensitivity testing carries with it some risk of inducing sensitivity, and therefore, skin testing for formaldehyde sensitivity should not be used as a routine screening test. Sensitivity testing may be indicated in the investigation of a suspected existing sensitivity. Guidelines for such testing have been prepared by the North American Contact Dermatitis Group. C. Additional Examinations or Tests The physician may deem it necessary to perform other medical examinations or tests as indicated. The standard provides a mechanism whereby these additional investigations are covered under the standard for occupational exposure to formaldehyde. D. Emergencies The examination of workers exposed in an emergency should be directed at the organ systems most likely to be affected. Much of the content of the examination will be similar to the periodic examination unless the patient has received a severe acute exposure requiring immediate attention to prevent serious consequences. If a severe overexposure requiring medical intervention or hospitalization has occurred, the physician must be alert to the possibility of delayed symptoms. Followup nonroutine examinations may be necessary to assure the patient’s well-being. 379 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00389 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& § 1910.1048 29 CFR Ch. XVII (7–1–09 Edition) E. Employer Obligations The employer is required to provide the physician with the following information: A copy of this standard and appendices A, C, D, and E; a description of the affected employee’s duties as they relate to his or her exposure concentration; an estimate of the employee’s exposure including duration (e.g. 15 hr/wk, three 8-hour shifts, full-time); a description of any personal protective equipment, including respirators, used by the employee; and the results of any previous medical determinations for the affected employee related to formaldehyde exposure to the extent that this information is within the employer’s control. F. Physician’s Obligations The standard requires the employer to obtain a written statement from the physician. This statement must contain the physician’s opinion as to whether the employee has any medical condition which would place him or her at increased risk of impaired health from exposure to formaldehyde or use of respirators, as appropriate. The physician must also state his opinion regarding any restrictions that should be placed on the employee’s exposure to formaldehyde or upon the use of protective clothing or equipment such as respirators. If the employee wears a respirator as a result of his or her exposure to formaldehyde, the physician’s opinion must also contain a statement regarding the suitability of the employee to wear the type of respirator assigned. Finally, the physician must inform the employer that the employee has been told the results of the medical examination and of any medical conditions which require further explanation or treatment. This written opinion is not to contain any information on specific findings or diagnoses unrelated to occupational exposure to formaldehyde. The purpose in requiring the examining physician to supply the employer with a written opinion is to provide the employer with a medical basis to assist the employer in placing employees initially, in assuring that their health is not being inpaired by formaldehyde, and to assess the employee’s ability to use any required protective equipment. APPENDIX D TO § 1910.1048—NONMANDATORY MEDICAL DISEASE QUESTIONNAIRE erowe on DSK5CLS3C1PROD with CFR A. Identification Plant Name lllllllllllllllll Date lllllllllllllllllllll Employee Name lllllllllllllll S.S. # llllllllllllllllllll Job Title llllllllllllllllll Birthdate: llllllllllllllllll Age: lllllllllllllllllllll Sex: lllllllllllllllllllll Height: lllllllllllllllllll Weight: lllllllllllllllllll B. Medical History 1. Have you ever been in the hospital as a patient? Yes b No b If yes, what kind of problem were you having? llllllllllllllllllll llllllllllllllllllllllll 2. Have you ever had any kind of operation? Yes b No b If yes, what kind? llllllllllllll llllllllllllllllllllllll 3. Do you take any kind of medicine regularly? Yes b No b If yes, what kind? llllllllllllll llllllllllllllllllllllll 4. Are you allergic to any drugs, foods, or chemicals? Yes b No b If yes, what kind of allergy is it? llllll llllllllllllllllllllllll What causes the allergy? llllllllll llllllllllllllllllllllll 5. Have you ever been told that you have asthma, hayfever, or sinusitis? Yes b No b 6. Have you ever been told that you have emphysema, bronchitis, or any other respiratory problems? Yes b No b 7. Have you ever been told you had hepatitis? Yes b No b 8. Have you ever been told that you had cirrhosis? Yes b No b 9. Have you ever been told that you had cancer? Yes b No b 10. Have you ever had arthritis or joint pain? Yes b No b 11. Have you ever been told that you had high blood pressure? Yes b No b 12. Have you ever had a heart attack or heart trouble? Yes b No b B–1. Medical History Update 1. Have you been in the hospital as a patient any time within the past year? Yes b No b If so, for what condition? llllllllll llllllllllllllllllllllll 2. Have you been under the care of a physician during the past year? Yes b No b If so, for what condition? llllllllll llllllllllllllllllllllll 3. Is there any change in your breathing since last year? 380 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00390 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& Occupational Safety and Health Admin., Labor Yes b No b Better? lllllllllllllllllll Worse? lllllllllllllllllll No change? lllllllllllllllll If change, do you know why? llllllll llllllllllllllllllllllll 4. Is your general health different this year from last year? Yes b No b If different, in what way? llllllllll llllllllllllllllllllllll 5. Have you in the past year or are you now taking any medication on a regular basis? Yes b No b Name Rx llllllllllllllllll Condition being treated lllllllllll erowe on DSK5CLS3C1PROD with CFR C. Occupational History 1. How long have you worked for your present employer? llllllllllllllllllllllll 2. What jobs have you held with this employer? Include job title and length of time in each job. llllllllllllllllllllllll llllllllllllllllllllllll llllllllllllllllllllllll llllllllllllllllllllllll 3. In each of these jobs, how many hours a day were you exposed to chemicals? llllllllllllllllllllllll 4. What chemicals have you worked with most of the time? llllllllllllllllllllllll 5. Have you ever noticed any type of skin rash you feel was related to your work? Yes b No b 6. Have you ever noticed that any kind of chemical makes you cough? Yes b No b Wheeze? Yes b No b Become short of breath or cause your chest to become tight? Yes b No b 7. Are you exposed to any dust or chemicals at home? Yes b No b If yes, explain: lllllllllllllll llllllllllllllllllllllll 8. In other jobs, have you ever had exposure to: Wood dust? Yes b No b Nickel or chromium? Yes b No b Silica (foundry, sand blasting)? Yes b No b Arsenic or asbestos? Yes b No b Organic solvents? Yes b No b Urethane foams? Yes b No b § 1910.1048 C–1. Occupational History Update 1. Are you working on the same job this year as you were last year? Yes b No b If not, how has your job changed? lllll llllllllllllllllllllllll 2. What chemicals are you exposed to on your job? llllllllllllllllllllllll 3. How many hours a day are you exposed to chemicals? llllllllllllllllllllllll 4. Have you noticed any skin rash within the past year you feel was related to your work? Yes b No b If so, explain circumstances: llllllll llllllllllllllllllllllll 5. Have you noticed that any chemical makes you cough, be short of breath, or wheeze? Yes b No b If so, can you identify it? llllllllll llllllllllllllllllllllll D. Miscellaneous 1. Do you smoke? Yes b No b If so, how much and for how long? lllll llllllllllllllllllllllll Pipe lllllllllllllllllllll Cigars llllllllllllllllllll Cigarettes llllllllllllllllll 2. Do you drink alcohol in any form? Yes b No b If so, how much, how long, and how often? llllllllllllllllllllllll 3. Do you wear glasses or contact lenses? Yes b No b 4. Do you get any physical exercise other than that required to do your job? Yes b No b If so, explain: llllllllllllllll llllllllllllllllllllllll 5. Do you have any hobbies or ‘‘side jobs’’ that require you to use chemicals, such as furniture stripping, sand blasting, insulation or manufacture of urethane foam, furniture, etc? Yes b No b If so, please describe, giving type of business or hobby, chemicals used and length of exposures. llllllllllllllllllllllll E. Symptoms Questionnaire 1. Do you ever have any shortness of breath? Yes b No b If yes, do you have to rest after climbing several flights of stairs? Yes b No b If yes, if you walk on the level with people your own age, do you walk slower than they do? Yes b No b 381 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00391 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& erowe on DSK5CLS3C1PROD with CFR § 1910.1048 29 CFR Ch. XVII (7–1–09 Edition) If yes, if you walk slower than a normal pace, do you have to limit the distance that you walk? Yes b No b If yes, do you have to stop and rest while bathing or dressing? Yes b No b 2. Do you cough as much as three months out of the year? Yes b No b If yes, have you had this cough for more than two years? Yes b No b If yes, do you ever cough anything up from chest? Yes b No b 3. Do you ever have a feeling of smothering, unable to take a deep breath, or tightness in your chest? Yes b No b If yes, do you notice that this on any particular day of the week? Yes b No b If yes, what day or the week? Yes b No b If yes, do you notice that this occurs at any particular place? Yes b No b If yes, do you notice that this is worse after you have returned to work after being off for several days? Yes b No b 4. Have you ever noticed any wheezing in your chest? Yes b No b If yes, is this only with colds or other infections? Yes b No b Is this caused by exposure to any kind of dust or other material? Yes b No b If yes, what kind? llllllllllllll 5. Have you noticed any burning, tearing, or redness of your eyes when you are at work? Yes b No b If so, explain circumstances: llllllll llllllllllllllllllllllll 6. Have you noticed any sore or burning throat or itchy or burning nose when you are at work? Yes b No b If so, explain circumstances: llllllll llllllllllllllllllllllll 7. Have you noticed any stuffiness or dryness of your nose? Yes b No b 8. Do you ever have swelling of the eyelids or face? Yes b No b 9. Have you ever been jaundiced? Yes b No b If yes, was this accompanied by any pain? Yes b No b 10. Have you ever had a tendency to bruise easily or bleed excessively? Yes b No b 11. Do you have frequent headaches that are not relieved by aspirin or tylenol? Yes b No b If yes, do they occur at any particular time of the day or week? Yes b No b If yes, when do they occur? lllllllll llllllllllllllllllllllll 12. Do you have frequent episodes of nervousness or irritability? Yes b No b 13. Do you tend to have trouble concentrating or remembering? Yes b No b 14. Do you ever feel dizzy, light-headed, excessively drowsy or like you have been drugged? Yes b No b 15. Does your vision ever become blurred? Yes b No b 16. Do you have numbness or tingling of the hands or feet or other parts of your body? Yes b No b 17. Have you ever had chronic weakness or fatigue? Yes b No b 18. Have you ever had any swelling of your feet or ankles to the point where you could not wear your shoes? Yes b No b 19. Are you bothered by heartburn or indigestion? Yes b No b 20. Do you ever have itching, dryness, or peeling and scaling of the hands? Yes b No b 21. Do you ever have a burning sensation in the hands, or reddening of the skin? Yes b No b 22. Do you ever have cracking or bleeding of the skin on your hands? Yes b No b 23. Are you under a physician’s care? Yes b No b If yes, for what are you being treated? lll llllllllllllllllllllllll 24. Do you have any physical complaints today? Yes b No b If yes, explain? lllllllllllllll llllllllllllllllllllllll 25. Do you have other health conditions not covered by these questions? Yes b No b If yes, explain: lllllllllllllll llllllllllllllllllllllll [57 FR 22310, May 27, 1992; 57 FR 27161, June 18, 1992; 61 FR 5508, Feb. 13, 1996; 63 FR 1292, Jan. 8, 1998; 63 FR 20099, Apr. 23, 1998; 70 FR 1143, Jan. 5, 2005; 71 FR 16672, 16673, Apr. 3, 2006; 71 FR 50190, Aug. 24, 2006; 73 FR 75586, Dec. 12, 2008] 382 VerDate Nov<24>2008 09:15 Aug 28, 2009 Jkt 217114 PO 00000 Frm 00392 Fmt 8010 Sfmt 8010 Y:\SGML\217114.XXX 217114 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[& General Information Appendix D: General Industry Standard on Emergency Action Plans $ WR = ,QGH[ _ (Q HVSDx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eneral Information Appendix E: OSHA Fact Sheet – Formaldehyde FactSheet Formaldehyde Formaldehyde is a colorless, strong-smelling gas often found in aqueous (waterbased) solutions. Commonly used as a preservative in medical laboratories and mortuaries, formaldehyde is also found in many products such as chemicals, particle board, household products, glues, permanent press fabrics, paper product coatings, fiberboard, and plywood. It is also widely used as an industrial fungicide, germicide and disinfectant. Although the term formaldehyde describes various mixtures of formaldehyde, water, and alcohol, the term “formalin” is used to describe a saturated solution of formaldehyde dissolved in water, typically with another agent, most commonly methanol, added to stabilize the solution. Formalin is typically 37% formaldehyde by weight (40% by volume) and 6-13% methanol by volume in water. The formaldehyde component provides the disinfectant effects of formalin. exposure is highly irritating to the eyes, nose, and throat and can make anyone exposed cough and wheeze. Subsequent exposure may cause severe allergic reactions of the skin, eyes and respiratory tract. Ingestion of formaldehyde can be fatal, and long-term exposure to low levels in the air or on the skin can cause asthma-like respiratory problems and skin irritation such as dermatitis and itching. Concentrations of 100 ppm are immediately dangerous to life and health (IDLH). What Employers Should Know Note: The National Institute for Occupational Safety and Health (NIOSH) considers 20 ppm of formaldehyde to be IDLH. The OSHA Formaldehyde standard (29 CFR 1910.1048) and equivalent regulations in states with OSHA-approved state plans protects workers exposed to formaldehyde and apply to all occupational exposures to formaldehyde from formaldehyde gas, its solutions, and materials that release formaldehyde. • The permissible exposure limit (PEL) for formaldehyde in the workplace is 0.75 parts formaldehyde per million parts of air (0.75 ppm) measured as an 8-hour time-weighted average (TWA). • The standard includes a second PEL in the form of a short-term exposure limit (STEL) of 2 ppm which is the maximum exposure allowed during a 15-minute period. • The action level – which is the standard’s trig- ger for increased industrial hygiene monitoring and initiation of worker medical surveillance – is 0.5 ppm when calculated as an 8-hour TWA. Harmful Effects on Workers Formaldehyde is a sensitizing agent that can cause an immune system response upon initial exposure. It is also a cancer hazard. Acute Routes of Exposure Workers can inhale formaldehyde as a gas or vapor or absorb it through the skin as a liquid. They can be exposed during the treatment of textiles and the production of resins. In addition to healthcare professionals and medical lab technicians, groups at potentially high risk include mortuary workers as well as teachers and students who handle biological specimens preserved with formaldehyde or formalin. How Employers Can Protect Workers Airborne concentrations of formaldehyde above 0.1 ppm can cause irritation of the respiratory tract. The severity of irritation intensifies as concentrations increase. Provisions of the OSHA standard require employers to do the following: • Identify all workers who may be exposed to formaldehyde at or above the action level or STEL through initial monitoring and determine their exposure. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[( • Reassign workers who suffer significant adverse effects from formaldehyde exposure to jobs with significantly less or no exposure until their condition improves. Reassignment may continue for up to 6 months until the worker is determined to be able to return to the original job or to be unable to return to work – whichever comes first. • Implement feasible engineering and work practice controls to reduce and maintain worker exposure to formaldehyde at or below the 8hour TWA and the STEL. If these controls cannot reduce exposure to or below the PELs, employers must provide workers with respirators. • Label all mixtures or solutions composed of greater than 0.1 percent formaldehyde and materials capable of releasing formaldehyde into the air at concentrations reaching or exceeding 0.1 ppm. For all materials capable of releasing formaldehyde at levels above 0.5 ppm during normal use, the label must contain the words “potential cancer hazard.” • Train all workers exposed to formaldehyde concentrations of 0.1 ppm or greater at the time of initial job assignment and whenever a new exposure to formaldehyde is introduced into the work area. Repeat training annually. gloves, aprons, and chemical splash goggles to prevent skin and eye contact with formaldehyde. • Provide showers and eyewash stations if splashing is likely. • Provide medical surveillance for all workers exposed to formaldehyde at concentrations at or above the action level or exceeding the STEL, for those who develop signs and symptoms of overexposure, and for all workers exposed to formaldehyde in emergencies. Recordkeeping Requirements Employers are required to do the following regarding worker exposure records: • Retain exposure records for 30 years. • Retain medical records for 30 years after employment ends. • Allow access to medical and exposure records to current and former workers or their designated representatives upon request. Additional Information For more information on this, and other healthrelated issues affecting workers, visit OSHA’s web site at www.osha.gov. • Select, provide and maintain appropriate per- sonal protective equipment (PPE). Ensure that workers use PPE such as impervious clothing, This is one in a series of informational fact sheets highlighting OSHA programs, policies or standards. It does not impose any new compliance requirements. For a comprehensive list of compliance requirements of OSHA standards or regulations, refer to Title 29 of the Code of Federal Regulations. This information will be made available to sensory-impaired individuals upon request. The voice phone is (202) 693-1999; the teletypewriter (TTY) number is (877) 889-5627. For assistance, contact us. We can help. It’s confidential. Occupational Safety and Health Administration www.osha.gov 1-800-321-6742 DSG 4/2011 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[( General Information Appendix F: OSHA Plans per State State Occupational Safety and Health Plans | Directory of States with Approved Occupational Safety and Health Plans - Text Version OSHA A to Z Index | En Español | Contact Us | FAQs | About OSHA Newsletter RSS Feeds Occupational Safety & Health Administration We Can Help Home Training Workers Publications Regulations Newsroom Enforcement Small Business Data & Statistics Search Search Anti-Retaliation Was this page helpful? What's New | Offices Back to Previous /Directory of States with Approved Occupational Safety and Health Plans Directory of States with Approved Occupational Safety and Health Plans (Text Version) Alaska Department of Labor and Workforce Development P.O. Box 111149 1111 W. 8th Street, Room 304 Juneau, Alaska 99811-1149 Dianne Blumer, Commissioner (907) 465-2700 Fax: (907) 465-2784 Grey Mitchell, Director (907) 465-4855 Fax: (907) 465-6012 Industrial Commission of Arizona 800 W. Washington Phoenix, Arizona 85007-2922 Laura L. McGrory, Director, ICA (602) 542-4411 Fax: (602) 542-7889 Bill Warren, Program Director (602) 542-5795 Fax: (602) 542-1614 California Department of Industrial Relations 1515 Clay Street, 17th Floor Oakland, California 94612 Christine Baker, Director (510) 622-3965 Fax: (510) 286-7037 Juliann Sum, Acting Chief, Cal/OSHA (510) 286-7000 Fax: (510) 286-7037 Cora Gherga, Acting Deputy Chief, Enforcement, Cal/OSHA (510) 286-7000 Fax: (510) 286-7037 Deborah Gold, Deputy Chief, Health and Engineering Services, Cal/OSHA (510) 286-7000 Fax: (510) 286-7037 Connecticut Department of Labor https://www.osha.gov/dcsp/osp/states_text.html[11/20/2014 2:27:59 PM] BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[) State Occupational Safety and Health Plans | Directory of States with Approved Occupational Safety and Health Plans - Text Version 200 Folly Brook Boulevard Wethersfield, Connecticut 06109 Sharon Palmer, Commissioner (860) 263-6505 Fax: (860) 263-6529 CONN-OSHA 38 Wolcott Hill Road Wethersfield, Connecticut 06109 Kenneth Tucker, Director (860) 263-6900 Fax: (860) 263-6940 Hawaii Department of Labor and Industrial Relations 830 Punchbowl Street Honolulu, Hawaii 96813 Dwight Takamine, Director (808) 586-8844 Fax: (808) 586-9099 Diantha Goo, HIOSH Administrator (808) 586-9116 Fax: (808) 586-9104 Illinois Department of Labor 900 South Spring Street Springfield, IL 62702 Joe Costigan, Director (217) 782-6206 Fax: (217) 782-0596 Cheryl Neff, Manager (217) 782-1442 Indiana Department of Labor State Office Building 402 West Washington Street, Room W195 Indianapolis, Indiana 46204-2751 Rick J. Ruble, Commissioner of Labor (317) 232-2693 Fax: (317) 233-3790 Tim Maley, Deputy Commissioner, IOSHA (317) 233-3605 Fax: (317) 233-3790 Iowa Division of Labor Services 1000 E. Grand Avenue Des Moines, Iowa 50319-0209 Michael A. Mauro, Labor Commissioner (515) 281-3447 Fax: (515) 281-5631 Stephen Slater, Deputy Labor Commissioner/IOSH Administrator (515) 281-3469 Fax: (515) 281-7995 Kentucky Labor Cabinet 1047 US HWY 127 South, Suite 4 Frankfort KY 40601 Larry L. Roberts, Secretary (502) 564-0684, FAX: 502-564-5387 Rocky Comito, Deputy Secretary (502) 564-0684, FAX: 502-564-5387 Anthony Russell, Commissioner, Department of Workplace Standards (502) 564-3070, FAX: (502) 564-5387 Chuck Stribling, CSP, OSH Federal-State Coordinator, Department of Workplace Standards (502) 564-3070 Maryland Division of Labor and Industry https://www.osha.gov/dcsp/osp/states_text.html[11/20/2014 2:27:59 PM] BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[) State Occupational Safety and Health Plans | Directory of States with Approved Occupational Safety and Health Plans - Text Version Department of Labor, Licensing and Regulation Division of Labor and Industry 1100 North Eutaw Street, Room 606 Baltimore, Maryland 21201-2206 Ron DeJuliis, Commissioner (410) 767-2241 Fax: (410) 767-2986 Craig Lowry, Deputy Commissioner (410) 767-2929 Fax: (410) 767-7909 Maryland Occupational Safety and Health (MOSH) 10946 Golden West Drive, Suite 160 Hunt Valley, MD 21031 Eric Uttenreither, Assistant Commissioner (410) 527-4499 Fax: (410) 527-4481 Michigan Department of Licensing and Regulatory Affairs Mike Zimmer, Acting Director (517) 241-7124 Fax: (517) 373-2129 Michigan Occupational Safety and Health Administration P.O. Box 30643 Lansing, MI 48909-8143 Martha Yoder, Director, MIOSHA, (517) 322-1817 Fax: (517) 322-1775 Minnesota Department of Labor and Industry 443 Lafayette Road St. Paul, Minnesota 55155 Ken Peterson, Commissioner (651) 284-5010 Fax: (651) 284-5721 Cindy Valentine, Workplace Safety Manager (651) 284-5602 Fax: (651) 284-5724 James Krueger, Compliance Director, MNOSHA Compliance (651) 284-5110 Fax: (651) 284-5741 Nevada Division of Industrial Relations Department of Business & Industry 400 West King Street, Suite 400 Carson City, Nevada 89703 Steve George, Administrator (775) 684-7262, Fax: (775)-684-7086 Occupational Safety and Health Administration 1301 N. Green Valley Parkway, Suite 200 Henderson, Nevada 89074 John Wanamaker, Chief Administrative Officer (702) 486-9020 Fax: (702) 990-0365 New Jersey Department of Labor and Workforce Development Office of Public Employees' Occupational Safety & Health (PEOSH) 1 John Fitch Plaza P.O. Box 386 Trenton, NJ 08625-0386 Harold J. Wirths, Commissioner (609) 292-2975 Fax: (609) 292-3749 John Monahan, Assistant Commissioner (609) 292-2313 Fax: (609) 695-1314 Howard Black, Director, PEOSH (609) 292-0501 Fax: (609) 292-4409 Joe Eldridge, Director, Consumer, Environmental and Occupational Health Service, NJ Dept. of Health and Senior Services https://www.osha.gov/dcsp/osp/states_text.html[11/20/2014 2:27:59 PM] BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[) State Occupational Safety and Health Plans | Directory of States with Approved Occupational Safety and Health Plans - Text Version (609) 826-4920 Fax: (609) 984-2779 New Mexico Environment Department 525 Camino de los Marquez, Suite 3 P.O. Box 5469 Santa Fe, New Mexico 87502 Ryan Flynn, Secretary-Designate (505) 827-2855 Fax: (505) 827-2836 Robert Genoway, Bureau Chief (505) 476-8700 Fax: (505) 476-8734 New York Department of Labor New York Public Employee Safety and Health Bureau (PESH) State Office Campus Building 12, Room 158 Albany, New York 12240 Peter Rivera, Commissioner (518) 457-2746 Fax: (518) 457-5545 Eileen Franko, Acting Director, Division of Safety and Health (DOSH) (518) 457-3518 Fax: (518) 457-5545 Normand Labbe, Public Employee Safety and Health Program Manager (518) 457-1263 Fax: (518) 457-5545 North Carolina Department of Labor 1101 Mail Service Center Raleigh, North Carolina 27699-1101 Cherie Berry, Commissioner (919) 733-0359 Fax: (919) 733-6197 Allen McNeely, Deputy Commissioner, OSH Director (919) 807-2861 Fax: (919) 807-2855 Kevin Beauregard, OSH Assistant Director (919) 807-2863 Fax: (919) 807-2856 Oregon Occupational Safety and Health Division Department of Consumer and Business Services 350 Winter Street, NE, Room 430 P.O. Box 14480 Salem, Oregon 97309-0405 Michael Wood, Administrator (503) 378-3272 Fax: (503) 947-7461 Joan Fraser, Deputy Administrator (503) 378-3272 Fax: (503) 947-7461 Puerto Rico Department of Labor and Human Resources Puerto Rico Department of Labor and Human Resources Prudencio Rivera Martinez Building 21st Floor 505 Muñoz Rivera Avenue Hato Rey, Puerto Rico 00918 Vance Thomas Rider, Secretary of Labor (787) 754-2119 Fax: (787) 753-9550 Jose Israel Droz Alvarado, Assistant Secretary of Labor (787) 754-2172 Fax: (787) 767-6051 South Carolina Department of Labor, Licensing, and Regulation Synergy Business Park, Kingstree Building 110 Centerview Drive P.O. Box 11329 https://www.osha.gov/dcsp/osp/states_text.html[11/20/2014 2:27:59 PM] BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[) State Occupational Safety and Health Plans | Directory of States with Approved Occupational Safety and Health Plans - Text Version Columbia, South Carolina 29211 Holly Pisarik, Director (803) 896-4300 Fax: (803) 896-4393 Dottie Ison, Administrator (803) 896-7686 Fax: (803) 896-7670 Office of Voluntary Programs (803) 896-7787 Fax: (803) 896-7750 Tennessee Department of Labor and Workforce Development 220 French Landing Drive Nashville, Tennessee 37243 Burns Phillips, Commissioner (615) 741-2582 Fax: (615) 741-5078 Steve Hawkins, TOSHA Administrator (615) 741-2793 Fax: (615) 741-3325 Utah Labor Commission 160 East 300 South, 3rd Floor P.O. Box 146600 Salt Lake City, Utah 84114-6600 Sherrie M. Hayashi, Commissioner (801) 530-6848 Fax: (801) 530-6390 Christopher Hill, Director, Utah Occupational Safety and Health (801) 530-6901 Fax: (801) 530-7606 Vermont Department of Labor 5 Green Mountain Drive P.O. Box 488 Montpelier, Vermont 05601-0488 Annie Noonan, Commissioner (802) 828-4000 Fax: (802) 888-4022 Daniel Whipple, VOSHA Program Manager (802) 828-5084 Fax: (802) 828-0408 Virgin Islands Division of Occupational Safety and Health (VIDOSH) 4401 Sion Farm Christiansted, St. Croix, VI 00820 Albert Bryan, Jr., Commissioner, Virgin Islands Department of Labor (VIDOL) (340) 773-1994 Fax: (340) 773-1858 Dean R. Andrews, Director (340) 773-1994 X-2161 Fax: (340) 773-0094 Virginia Department of Labor and Industry Main Street Centre 600 East Main Street Richmond, VA 23219 C. Ray Davenport, Commissioner (804) 786-2377 Fax: (804) 371-6524 William Burge, Assistant Commissioner (804) 371-2327 Fax: (804) 371-6524 Ronald L. Graham, VOSH Health Director (804) 786-0574 Fax: (804) 371-6524 Paul B. Schilinski, VOSH Safety Director (703) 392-0900 or (804) 786-7776 Fax: (703) 392-0308 Jay Withrow, Director, Division of Legal Support (804) 371-2327 Fax: (804) 371-6524 Washington Department of Labor and Industries General Administration Building PO Box 44001 https://www.osha.gov/dcsp/osp/states_text.html[11/20/2014 2:27:59 PM] BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[) State Occupational Safety and Health Plans | Directory of States with Approved Occupational Safety and Health Plans - Text Version Olympia, Washington 98504-4001 7273 Linderson Way SW Tumwater, WA 98501-5414 Judy Schurke, Director (360) 902-4200 Fax: (360) 902-4202 Division of Occupational Safety and Health Anne Soiza, Assistant Director, DOSH, (360) 902-4805 Fax: (360) 902-5619 Dave Puente, Deputy Assistant Director, DOSH Wyoming Department of Workforce Services Workers' Safety and Compensation Division 1510 East Pershing Boulevard - West Wing Cheyenne, Wyoming 82002 John Ysebaert, Administrator Standards & Compliance (307) 777-7672 Fax: (307) 777-5805 Mike Todd, OSHA Division Manager (307) 777-3581 Fax: (307) 777-3646 Freedom of Information Act | Privacy & Security Statement | Disclaimers | Contact Us Important Web Site Notices | International | U.S. Department of Labor | Occupational Safety & Health Administration | 200 Constitution Ave., NW, Washington, DC 20210 Telephone: 800-321-OSHA (6742) | TTY www.OSHA.gov https://www.osha.gov/dcsp/osp/states_text.html[11/20/2014 2:27:59 PM] BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[) ______________________________________________________________________________________ General Information Appendix G: Glossary Glossary of terms and abbreviations used in the Compliance Manual____________________________ ACGIH- American Conference of Governmental Industrial Hygienists ADA- American Dental Association AIDS- Acquired Immune Deficiency Syndrome Bloodborne pathogens- pathogenic microorganisms that are present in human blood and can cause disease in humans. These include, but are not limited to, HBV and HIV. CDC- Centers for Disease Control and Prevention Compliance Manager- the person designated as the coordinator of the program who will bring the dental office into compliance with OSHA regulations. Contaminated laundry- laundry that has been soiled with blood or other potentially infectious materials or that may contain sharps. Contaminated- the presence or the reasonably anticipated presence of blood or other potentially infectious material on an item or surface. CPR- cardiopulmonary resuscitation Decontamination- the use of physical or chemical means to remove, inactivate or destroy pathogens. Disinfectant- an agent that eliminates virtually all recognized pathogenic microorganisms but not necessarily all microbial forms (bacterial endospores) on inanimate objects. DOT- Department of Transportation EPA- Environmental Protection Agency Exposure incident- a specific eye, mouth, other mucous membrane, nonintact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee’s duties. FDA- Food and Drug Administration, an agency of the United States Public Health Service. Formal complaint- any complaint that is in writing, alleges that an imminent danger or a violation threatening physical harm exists, sets forth with reasonable particularity the grounds on which the complaint is based, and is signed by at least one current employee or the employee’s authorized representative (former employees can only submit nonformal complaints). HBV- Hepatitis B virus BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[* ______________________________________________________________________________________ HCP- healthcare professional HCV Hepatitis C virus HIV Human immunodeficiency virus, the etiologic agent for AIDS. HIV+ term used to describe someone who tests positive for HIV antibody. HIV antibody positive- phrase used to describe someone who tests positive for HIV antibody. Infectious waste (OSHA definition)- see Regulated waste Infectious waste (EPA definition)- contaminated sharps, teeth, pathologic waste, and blood soaked items, when applied to dentistry. MMWR-Morbidity and Mortality Weekly Report, a weekly publication of the CDC. MWTA- Medical Waste Tracking Act, enacted by Congress in 1988. NIOSH- National Institute for Occupational Safety and Health Nonformal complaint- any complaint that does not meet the requirements of a formal complaint, e.g., unsigned or oral complaints by current employees, written and oral complaints by non-employees or former employees. Occupational exposure- skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee’s duties. OSHA- Occupational Safety and Health Administration, a part of the U.S. Department of Labor. Other potentially infectious materials (OPIM)- 1) body fluids including semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures; and any body fluid that is visibly contaminated by blood; and all body fluids in situations where differentiating between body fluids is difficult or impossible; 2) any unfixed tissue or organ from a human (living or dead); and 3) HIVcontaining cell or tissue cultures, organ cultures; HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV. Parenteral- piercing mucous membranes or the skin barrier through needlesticks, human bites, cuts and abrasions. PEL- OSHA-permissible exposure limit PEP- postexposure prophylaxis Percutaneous- pierced through the skin Personal protective equipment (PPE)- clothing or equipment worn for protection against a hazard. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[* ______________________________________________________________________________________ Regulated Waste (OSHA definition)- liquid or semiliquid blood or other potentially infectious materials, items that would release blood or other potentially infectious materials if compressed, items that are caked with dried blood and could release it during handling, contaminated sharps, extracted teeth and pathological waste (tissue). REL- recommended exposure limit Safety Data Sheet (SDS)- a sheet of information that lists the chemical, physical, and biological properties of a product and the precautions to be used when handling the product. Seropositive- term used to describe someone who tests positive for HIV antibody. Sharps- any object that can penetrate the skin, such as needles, scalpels, broken glass and exposed ends of dental wires. Federal EPA and state waste disposal regulations may also regulate unused or uncontaminated sharps. Source individual- any individual whose blood or other potentially infectious materials may be a source of occupational exposure to the dental team. Standard- the term applied to a final regulation of OSHA, in this Manual, the Standard on Bloodborne Pathogens and the Hazard Communication Standard. Such standards have the force of law. Standard precautions- an approach to infection control that integrates and expands the elements of universal precautions, and in which human blood or any other body fluid, excretion, or secretion (except sweat) is treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens. Sterilize- the use of a physical or chemical procedure to destroy all microbial life, including highly resistant endospores. TLV- ACGIH threshold limit value Universal precautions- an approach to infection control in which all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens. USPHS- U.S. Public Health Service ZDV- zidovudine BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[* Does the plan identify how or where personal information on employees can be obtained in an emergency? Does the plan address the types of actions expected of different employees for the various types of potential emergencies? Does the plan designate who, if anyone, will stay to shut down critical operations during an evacuation? Does the plan outline specific evacuation routes and exits and are these posted in the workplace where they are easily accessible to all employees? Does the plan address procedures for assisting people during evacuations, particularly those with disabilities or who do not speak English? Does the plan identify the conditions under which an evacuation would be necessary? Does the plan identify a clear chain of command and designate a person authorized to order an evacuation or shutdown of operations? Evacuation Policy and Procedure Does the plan address how medical assistance will be provided? Does the plan consider all potential natural or man-made emergencies that could disrupt your workplace? Does the plan consider all potential internal sources of emergencies that could disrupt your workplace? Does the plan consider the impact of these internal and external emergencies on the workplace’s operations and is the response tailored to the workplace? Does the plan contain a list of key personnel with contact information as well as contact information for local emergency responders, agencies and contractors? Does the plan contain the names, titles, departments, and telephone numbers of individuals to contact for additional information or an explanation of duties and responsibilities under the plan? Does the plan address how rescue operations will be performed? General Issues The plan should identify the different types of situations that will require an evacuation of the workplace. This might include a fire, earthquake, or chemical spill. The extent of evacuation may be different for different types of hazards. It is common practice to select a responsible individual to lead and coordinate your emergency plan and evacuation. It is critical that employees know who the coordinator is and understand that this person has the authority to make decisions during emergencies. The coordinator should be responsible for assessing the situation to determine whether an emergency exists requiring activation of the emergency procedures, overseeing emergency procedures, notifying and coordinating with outside emergency services, and directing shutdown of utilities or plant operations if necessary. The plan may specify different actions for employees depending on the emergency. For example, employers may want to have employees assemble in one area of the workplace if it is threatened by a tornado or earthquake but evacuate to an exterior location during a fire. You may want to include in your plan locations where utilities (such as electrical and gas utilities) can be shut down for all or part of the facility. All individuals remaining behind to shut down critical systems or utilities must be capable of recognizing when to abandon the operation or task and evacuate themselves. Most employers create maps from floor diagrams with arrows that designate the exit route assignments. These maps should include locations of exits, assembly points and equipment (such as fire extinguishers, first aid kits, spill kits) that may be needed in an emergency. Exit routes should be clearly marked and well lit, wide enough to accommodate the number of evacuating personnel, unobstructed and clear of debris at all times, and unlikely to expose evacuating personnel to additional hazards. Many employers designate individuals as evacuation wardens to help move employees from danger to safe areas during an emergency. Generally, one warden for every 20 employees should be adequate, and the appropriate number of wardens should be available at all times during working hours. Wardens may be responsible for checking offices and Unless you are a large employer handling hazardous materials and processes or have employees regularly working in hazardous situations, you will probably choose to rely on local public resources, such as the fire department, who are trained, equipped, and certified to conduct rescues. Make sure any external department or agency identified in your plan is prepared to respond as outlined in your plan. Untrained individuals may endanger themselves and those they are trying to rescue. Most small employers do not have a formal internal medical program and make arrangements with medical clinics or facilities close by to handle emergency cases and provide medical and first-aid services to their employees. If an infirmary, clinic, or hospital is not close to your workplace, ensure that onsite person(s) have adequate training in first aid. The American Red Cross, some insurance providers, local safety councils, fire departments, or other resources may be able to provide this training. Treatment of a serious injury should begin within 3 to 4 minutes of the accident. Consult with a physician to order appropriate first-aid supplies for emergencies. Establish a relationship with a local ambulance service so transportation is readily available for emergencies. In the event of an emergency, it could be important to have ready access to important personal information about your employees. This includes their home telephone numbers, the names and telephone numbers of their next of kin, and medical information. Common sources of emergencies identified in emergency action plans include - fires, explosions, floods, hurricanes, tornadoes, toxic material releases, radiological and biological accidents, civil disturbances and workplace violence. Conduct a hazard assessment of the workplace to identify any physical or chemical hazards that may exist and could cause an emergency. Brainstorm worst case scenarios asking yourself what you would do and what would be the likely impact on your operation and device appropriate responses. Keep your list of key contacts current and make provisions for an emergency communications system such as a cellular phone, a portable radio unit, or other means so that contact with local law enforcement, the fire department, and others can be swift. List names and contact information for individuals responsible for implementation of the plan. Emergency Action Plan Checklist General Information Appendix H: Emergency Action Plan Checklist Available at: www.osha.gove/SLTC/etools/evaluation/implementation.html BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[+ BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH *HQHUDO,QIRUPDWLRQ$SSHQGL[+ Does the plan address how visitors will be assisted in evacuation and accounted for? Does the plan describe the method to be used to alert employees, including disabled workers, to evacuate or take other action? Does the plan identify a preferred method for reporting fires and other emergencies? Training should be offered employees when you develop your initial plan and when new employees are hired. Employees should be retrained when your plan changes due to a change in the layout or design of the facility, when new equipment, hazardous materials, or processes are introduced that affect evacuation routes, or when new types of hazards are introduced that require special actions. General training for your employees should address the following: x Individual roles and responsibilities; x Threats, hazards, and protective actions; x Notification, warning, and communications procedures; x Emergency response procedures; x Evacuation, shelter, and accountability procedures; x Location and use of common emergency equipment; and x Emergency shutdown procedures. You may also need to provide additional training to your employees (i.e. first-aid procedures, portable fire extinguisher use, etc.) depending on the responsibilities allocated employees in your plan. If training is not reinforced it will be forgotten. Consider retaining employees annually. Once you have reviewed your emergency action plan with your employees and everyone has had the proper training, it is a good idea to hold practice drills as often as necessary to keep employees prepared. Include outside resources such as fire and police departments when possible. After each drill, gather management and employees to evaluate the effectiveness of the drill. Identify the strengths and weaknesses of your plan and work to improve it. Does the plan identify how and when employees will be trained so that they understand the types of emergencies that may occur, their responsibilities and actions as outlined in the plan? Does the plan address how and when retraining will be conducted? Does the plan address if and how often drills will be conducted? Dialing 911 is a common method for reporting emergencies if external responders are utilized. Internal numbers may be used. Internal numbers are sometimes connected to intercom systems so that coded announcements may be made. In some cases employees are requested to activate manual pull stations or other alarm systems. Make sure alarms are distinctive and recognized by all employees as a signal to evacuate the work area or perform other actions identified in your plan. Sequences of horn blows or different types of alarms (bells, horns, etc.) can be used to signal different responses or actions from employees. Consider making available an emergency communications system, such as a public address system, for broadcasting emergency information to employees. Ideally alarms will be able to be heard, seen, or otherwise perceived by everyone in the workplace including those that may be blind or deaf. Otherwise floor wardens or others must be tasked with ensuring all employees are notified. You might want to consider providing an auxiliary power supply in the event of an electrical failure. Employee Training and Drills Reporting Emergencies and Alerting Employees in an Emergency Does the plan identify one or more assembly areas (as necessary for different types of emergencies) where employees will gather and a method for accounting for all employees? bathrooms before being the last person to exit an area as well as ensuring that fire doors are closed when exiting. Employees designated to assist in emergency evacuation procedures should be trained in the complete workplace layout and various alternative escape routes. Employees designated to assist in emergencies should be made aware of employees with special needs (who may require extra assistance during an evacuation), how to use the buddy system, and any hazardous areas to avoid during an emergency evacuation. Accounting for all employees following an evacuation is critical. Confusion in the assembly areas can lead to delays in rescuing anyone trapped in the building, or unnecessary and dangerous search-and-rescue operations. To ensure the fastest, most accurate accounting of your employees, consider taking a head count after the evacuation. The names and last known locations of anyone not accounted for should be passed on to the official in charge. Some employers have all visitors and contractors sign in when entering the workplace. The hosts and/or area wardens, if established, are often tasked with assisting these individuals evacuate safely. General Information Appendix I: Sample Emergency Action Plan Adapted from the Centers for Disease Control and Prevention’s Emergency Action Plan (Template), which is available at www.cdc.gov/niosh/docs/2004-101/emrgact/emrgact1.html. 01/2015 49 General Information Appendix I EMERGENCY ACTION PLAN For Facility Name: ___________________________________________________________ Facility Address: _________________________________________________________ DATE PREPARED: _______/_______/_______ 01/2015 50 General Information Appendix I EMERGENCY PERSONNEL NAMES AND PHONE NUMBERS DESIGNATED RESPONSIBLE OFFICIAL: Name: _______________________________________ Phone: ( ________ ) ________________ EMERGENCY COORDINATOR: Name: _______________________________________ Phone: ( ________ ) ________________ AREA/FLOOR MONITORS (If applicable): Area/Floor: _____________________________________________________________________ Name: _______________________________________ Phone: ( ________ ) ________________ Area/Floor: _____________________________________________________________________ Name: _______________________________________ Phone: ( ________ ) ________________ ASSISTANTS TO PHYSICALLY CHALLENGED (If applicable): Name: _______________________________________ Phone: ( ________ ) ________________ Name: _______________________________________ Phone: ( ________ ) ________________ Date: _______/_______/_______ 01/2015 51 General Information Appendix I EVACUATION ROUTES Evacuation route maps have been posted in each work area. The following information is marked on evacuation maps: 1. Emergency exits 2. Primary and secondary evacuation routes 3. Locations of fire extinguishers 4. Fire alarm pull stations’ location 5. Assembly points Site personnel should know at least two evacuation routes. 01/2015 52 General Information Appendix I EMERGENCY PHONE NUMBERS FIRE DEPARTMENT: ____________________________________________________ PARAMEDICS: ___________________________________________________________ AMBULANCE: ___________________________________________________________ POLICE: ________________________________________________________________ FEDERAL PROTECTIVE SERVICE: ______________________________________ SECURITY (If applicable): ________________________________________________ BUILDING MANAGER (If applicable): _____________________________________ Date: _______/_______/_______ 01/2015 53 General Information Appendix I UTILITY COMPANY EMERGENCY CONTACTS (Specify name of the company, phone number and point of contact) ELECTRIC: ______________________________________________________________ __________________________________________________________________________ WATER: _________________________________________________________________ __________________________________________________________________________ GAS (if applicable): ______________________________________________________ __________________________________________________________________________ TELEPHONE COMPANY: ________________________________________________ __________________________________________________________________________ Date: _______/_______/_______ 01/2015 54 General Information Appendix I EMERGENCY REPORTING AND EVACUATION PROCEDURES Types of emergencies to be reported by site personnel are: • MEDICAL • FIRE • SEVERE WEATHER • BOMB THREAT • CHEMICAL SPILL • STRUCTURE CLIMBING/DESCENDING • EXTENDED POWER LOSS • OTHER (specify): ______________________________________________________ (e.g., terrorist attack/hostage taking) Date: _______/_______/_______ 01/2015 55 General Information Appendix I MEDICAL EMERGENCY Call medical emergency phone number (check applicable): Paramedics Ambulance Fire Department Other Provide the following information: a. Nature of medical emergency b. Location of the emergency (address, building, room number) c. Your name and phone number from which you are calling Do not move victim unless absolutely necessary. Call the following personnel trained in CPR and First Aid to provide the required assistance prior to the arrival of the professional medical help: Name: _____________________________________ Phone: ( ________ ) ________________ Name: _____________________________________ Phone: ( ________ ) ________________ If personnel trained in First Aid are not available, as a minimum, attempt to provide the following assistance: 1. Stop the bleeding with firm pressure on the wounds (note: avoid contact with blood or other bodily fluids). 2. Clear the air passages using the Heimlich Maneuver in case of choking. In case of rendering assistance to personnel exposed to hazardous materials, consult the Safety Data Sheet (SDS) and wear the appropriate personal protective equipment. Attempt first aid ONLY if trained and qualified. Date: _______/_______/_______ 01/2015 56 General Information Appendix I FIRE EMERGENCY When fire is discovered: • Activate the nearest fire alarm (if installed) • Notify the local Fire Department by calling • If the fire alarm is not available, notify the site personnel about the fire emergency by the following means (check applicable): Voice Communication Phone Paging Radio Other (specify) Fight the fire ONLY if: • The Fire Department has been notified • The fire is small and is not spreading to other areas • Escaping the area is possible by backing up to the nearest exit • The fire extinguisher is in working condition and personnel are trained to use it Upon being notified about the fire emergency, occupants must: • Leave the building using the designated escape routes • Assemble in the designated area (specify location): • Remain outside until the competent authority (designated official or designee) announces that it is safe to reenter. Designated official, emergency coordinator or supervisors must (underline one): • Disconnect utilities and equipment unless doing so jeopardizes his/her safety • Coordinate an orderly evacuation of personnel • Perform an accurate head count of personnel reported to the designated area • Determine a rescue method to locate missing personnel • Provide the Fire Department personnel with the necessary information about the facility • Perform assessment and coordinate weather forecast office emergency closing procedures Area/Floor Monitors must: • Ensure that all employees have evacuated the area/floor • Report any problems to the emergency coordinator at the assembly area Assistants to physically challenged should: • Assist all physically challenged employees in emergency evacuation. Date: _______/_______/_______ 01/2015 57 General Information Appendix I EXTENDED POWER LOSS In the event of extended power loss to a facility certain precautionary measures should be taken depending on the geographical location and environment of the facility: • Unnecessary electrical equipment and appliances should be turned off in the event that power restoration would surge causing damage to electronics and affecting sensitive equipment • Facilities with freezing temperatures should turn off and drain the following lines in the event of a long term power loss o Fire sprinkler system o Standpipes o Potable water lines o Toilets • Add propylene-glycol to drains to prevent traps from freezing • Equipment that contain fluids that may freeze due to long term exposure to freezing temperatures should be moved to heated areas, drained of liquids, or provided with auxiliary heat sources Upon restoration of heat and power: • Electronic equipment should be brought up to ambient temperatures before energizing to prevent condensate from forming on circuitry • Fire and potable water piping should be checked for leaks from freeze damage after the heat has been restored to the facility and water turned back on Date: _______/_______/_______ 01/2015 58 General Information Appendix I CHEMICAL SPILL The following are the locations of: Spill Containment and Security Equipment: ________________________________ Personal Protective Equipment (PPE): _____________________________________ Safety Data Sheets (SDS): ________________________________________________ When a large chemical spill has occurred: • Immediately notify the designated official and emergency coordinator • Contain the spill with available equipment (e.g., pads, booms, absorbent powder, etc.) • Secure the area and alert other site personnel • Do not attempt to clean the spill unless trained to do so • Attend to injured personnel and call the medical emergency number, if required • Call a local spill cleanup company or the Fire Department (if arrangement has been made) to perform a large chemical (e.g., mercury) spill cleanup Name of Spill Cleanup Company: _______________________________________ Phone Number: ________________________________________________________ • Evacuate building as necessary When a small chemical spill has occurred: • Notify the emergency coordinator and/or supervisor (select one) • If toxic fumes are present, secure the area (with caution tapes or cones) to prevent other personnel from entering • Deal with the spill in accordance with the instructions described in the SDS • Small spills must be handled in a safe manner, while wearing the proper PPE • Review the general spill cleanup procedures Date: _______/_______/_______ 01/2015 59 General Information Appendix I STRUCTURE CLIMBING/DESCENDING EMERGENCIES List structures maintained by site personnel (tower, river gauge, etc.): No. Structure Type Location (address, if applicable) Emergency Response Organization* (if available within 30-minute response time) Name: ________________________________ Phone: ( ________ ) ________________ Name: ________________________________ Phone: ( ________ ) ________________ (Attach Emergency Response Agreement if available) * N/A. If no Emergency Response Organization available within 30-minute response time, additional personnel trained in rescue operations and equipped with rescue kit must accompany the climber(s). 01/2015 60 General Information Appendix I TELEPHONE BOMB THREAT CHECKLIST INSTRUCTIONS: BE CALM, BE COURTEOUS. LISTEN. DO NOT INTERRUPT THE CALLER. YOUR NAME: _________________________________________________________________ TIME: _________________________________ DATE:_________________________________ CALLER’S IDENTITY SEX: Male ____ Female____ Adult ___ Juvenile ___ APPROX. AGE: ___ ORIGIN OF CALL: Local ____ Long Distance ____ Telephone Booth ____ VOICE CHARACTERISTICS /RXG +LJK3LWFK 5DVS\ ,QWR[LFDWHG 6RIW 'HHS 3OHDVDQW 2WKHU 5DFH 1RW/RFDO 5HJLRQ MANNER &DOP 5DWLRQDO &RKHUHQW 'HOLEHUDWH 5LJKWHRXV $QJU\ ,UUDWLRQDO ,QFRKHUHQW (PRWLRQDO /DXJKLQJ SPEECH )DVW 'LVWLQFW 6WXWWHU 6OXUUHG 6ORZ 'LVWRUWHG 1DVDO 2WKHU BACKGROUND NOISES )DFWRU\ 0DFKLQHV 0XVLF 2IILFH 0DFKLQHV 6WUHHW 7UDIILF 7UDLQV LANGUAGE ([FHOOHQW )DLU )RXO *RRG 3RRU 2WKHU ACCENT /RFDO )RUHLJQ 01/2015 61 $QLPDOV 4XLHW 9RLFHV $LUSODQHV 3DUW\ $WPRVSKHUH General Information Appendix I BOMB FACTS • Pretend to have difficulty hearing. • Keep the caller talking. • If the caller seems agreeable to further conversation, ask questions like: o When will it go off? Certain Hour ______ Time Remaining_______________________ o Where is it located? Building _______________________________________________ Area _________________________________________________________________ o What kind of bomb? _______________________________________________________ o What kind of package? ____________________________________________________ o How do you know so much about the bomb? _________________________________ o What is your name and address? ___________________________________________ • If building is occupied, inform caller that detonation could cause injury or death. • Call Security at _____________________________ and relay information about call. • Did the caller appear familiar with plant or building (by his/her description of the bomb location)? • Write out the message in its entirety and any other comments on a separate sheet of paper and attach to this checklist. • Notify your supervisor immediately. 01/2015 62 General Information Appendix I SEVERE WEATHER AND NATURAL DISASTERS Tornado • When a warning is issued by sirens or other means, seek inside shelter. Consider the following: o Small interior rooms on the lowest floor and without windows o Hallways on the lowest floor away from doors and windows o Rooms constructed with reinforced concrete, brick, or block with no windows • Stay away from outside walls and windows • Use arms to protect head and neck • Remain sheltered until the tornado threat is announced to be over Earthquake • Stay calm and await instructions from the emergency coordinator or the designated official • Keep away from overhead fixtures, windows, filing cabinets, and electrical power. • Assist people with disabilities in finding a safe place. • Evacuate as instructed by the emergency coordinator and/or the designated official. Flood If indoors: • Be ready to evacuate as directed by the emergency coordinator and/or the designated official. • Follow the recommended primary or secondary evacuation routes. If outdoors: • Climb to high ground and stay there. • Avoid walking or driving through flood water. • If car stalls, abandon it immediately and climb to a higher ground. Hurricane • The nature of a hurricane provides for more warning than other natural and weather disasters. A hurricane watch issued when a hurricane becomes a threat to a coastal area. A hurricane warning is issued when hurricane winds of 74 mph or higher, or a combination of dangerously high water and rough seas, are expected in the area within 24 hours. Once a hurricane watch has been issued: • • • • Stay calm and await instructions from the emergency coordinator or the designated official. Moor any boats securely, or move to a safe place if time allows. Continue to monitor local TV and radio stations for instructions. Move early out of low-lying areas or from the coast, at the request of officials. 01/2015 63 General Information Appendix I • If you are on high ground, away from the coast and plan to stay, secure the building, moving all loose items indoors and boarding up windows and openings. • Collect drinking water in appropriate containers. Once a hurricane warning has been issued: • Be ready to evacuate as directed by the emergency coordinator and/or the designated official. • Leave areas that might be affected by storm tide or stream flooding. During a hurricane: • Remain indoors and consider the following: o Small interior rooms on the lowest floor and without windows, o Hallways on the lowest floor away from doors and windows, and o Rooms constructed with reinforced concrete, brick, or block with no windows. Blizzard If indoors: • Stay calm and await instructions from the emergency coordinator or the designated official. • Stay indoors! • If there is no heat: o Close off unneeded rooms or areas. o Stuff towels or rags in cracks under doors. o Cover windows at night. • Eat and drink. Food provides the body with energy and heat. Fluids prevent dehydration. • Wear layers of loose-fitting, light-weight, warm clothing, if available. If outdoors: • Find a dry shelter. Cover all exposed parts of the body. • If shelter is not available: o Prepare a lean-to, wind break, or snow cave for protection from the wind. o Build a fire for heat and to attract attention. Place rocks around the fire to absorb and reflect heat. o Do not eat snow. It will lower your body temperature. Melt it first. If stranded in a car or truck: • Stay in the vehicle! • Run the motor about ten minutes each hour. Open the windows a little for fresh air to avoid carbon monoxide poisoning. Make sure the exhaust pipe is not blocked. • Make yourself visible to rescuers. o Turn on the dome light at night when running the engine. o Tie a colored cloth to your antenna or door. o Raise the hood after the snow stops falling. • Exercise to keep blood circulating and to keep warm. 01/2015 64 General Information Appendix I CRITICAL OPERATIONS During some emergency situations, it will be necessary for some specially assigned personnel to remain at the work areas to perform critical operations. Assignments: Work Area Name Job Title Description of Assignment • Personnel involved in critical operations may remain on the site upon the permission of the site designated official or emergency coordinator. • In case emergency situation will not permit any of the personnel to remain at the facility, the designated official or other assigned personnel shall notify the appropriate _____________________ offices to initiate backups. This information can be obtained from the Emergency Evacuation Procedures included in the ______________________________ Manual. The following offices should be contacted: Name/Location: _____________________________________________________________ Telephone Number: _________________________________________________________ Name/Location: _____________________________________________________________ Telephone Number: _________________________________________________________ Name/Location: _____________________________________________________________ Telephone Number: _________________________________________________________ 01/2015 65 General Information Appendix I TRAINING The following personnel have been trained to ensure a safe and orderly emergency evacuation of other employees: Facility: Name 01/2015 Title Responsibility 66 Date General Information Appendix I General Policy Austin Community College, Department of Dental Hygiene (known as ACC-DH) is committed to providing a safe and healthful workplace for all employees through compliance with applicable OSHA standards. This written exposure control plan has been developed to comply with OSHA’s Bloodborne Pathogens Standard. The standard is designed to protect employees from occupational exposure to HIV, HBV and other bloodborne pathogens. The exposure control plan is accessible to all employees and will be reviewed at least annually and updated as often as changes in positions, tasks or procedures require. The exposure control plan is filed under the tab marked “Exposure control plan” in the Bloodborne Pathogens section of the ACC-DH Regulatory Compliance Manual. The manual is kept: in the computer study area of the Dental Hygiene Clinic, Room #8142, Eastview Campus. Kate Goin, RDH, Clinic Manager has been designated the OSHA compliance manager for this office and is responsible for implementing the exposure control plan. The compliance manager will provide employees with a copy of the plan upon request. Exposure Determination The Bloodborne Pathogens Standard describes how to determine which employees have occupational exposure to bloodborne pathogens. The standard defines occupational exposure as reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee’s duties. Other potentially infectious materials defined in the standard include saliva in dental procedures and unfixed tissue. Occupational exposure must be determined without regard to the use of personal protective equipment. The standard requires each employer who has one or more employees with occupational exposure to prepare an exposure determination that includes the following: • A list of job classifications in which all employees in the job classification have occupational exposure. “Dentist,” “dental hygienist,” and “dental assistant” are examples of job classifications that would typically be on this list. All employees with these jobs probably have occupational exposure. It is not necessary to list the specific tasks and procedures that give rise to the exposure. • A list of job classifications in which some employees in the job classification have occupational exposure. For each job classification on this list the employer must list the tasks and procedures that give rise to the occupational exposure. 01/2008 1 Bloodborne Pathogens An example of a job classification on this list might be “receptionist.” Receptionists in some offices have chairside or cleanup duties involving occupational exposure to blood or other potentially infectious materials. If some receptionists in your office have occupational exposure, (e.g., have chairside duties) the job classification belongs on the second list with a list of tasks and procedures that give rise to the exposure, e.g., “dental assisting procedures.” If all receptionists in your office have occupational exposure, the job classification belongs on the first list. If no receptionist in your office has occupational exposure, the job classification does not need to be listed. You do not need to list the names of the individuals in these job classifications, but if you choose to do so, remember to update the exposure determination whenever the names change. Treat the dentist as an employee of an incorporated practice. The following exposure determination has been prepared for this office: All employees in the following job classifications have occupational exposure (write “none,” if none): Job Classification Name (optional) Dentists Faculty Dental Hygienists Faculty Dental Hygiene Students Students Dental Assisting Students Students Advanced Degree/Independent Study Students Students Some employees in the following job classifications have occupational exposure, and the tasks/procedures that give rise to the exposure are listed (write “none,” if none): Job Classification Name (optional) Task or Procedure none 01/2008 2 Bloodborne Pathogens Schedule and Methods of Implementation The exposure control plan must include the schedule and methods for implementing each section of the standard. The information that follows complies with this requirement. DATES This office implemented all sections of the Bloodborne Pathogens Standard by the dates shown below: Provision Implemented by Standard precautions 09/01/03 Exposure control plan 09/01/03 Information and training 09/01/03 Recordkeeping 09/01/03 Engineering/work practice controls 09/01/03 Personal protective equipment 09/01/03 Housekeeping 09/01/03 HBV vaccination/post-exposure evaluation and follow-up procedures 09/01/03 Labels and signs 09/01/03 Standard Precautions The OSHA Bloodborne Pathogens Standard adopted an approach to infection control called universal precautions that treats all human blood and other potentially infectious materials as if they were infectious for HIV and HBV or other bloodborne pathogens. The CDC1 recommends implementation of standard precautions, which expands coverage to include all body fluids and substances (except sweat). No operational difference exists in clinical dental practice when implementing universal or standard precautions, because saliva has always been considered a potentially infectious material in dental infection control. Engineering controls isolate or remove a hazard from the workplace. Examples of engineering controls that might be used in a dental office are sharps containers, rubber dams, needleless or shielded needle devices, and high volume evacuators. 1 Centers for Disease Control and Prevention. Guidelines for Infection Control in Dental Health-Care Settings – 2003 MMWR 2003;52(No.RR-17). 01/2008 3 Bloodborne Pathogens NEW ENGINEERING CONTROLS EVALUATION RECORD In this office, the following engineering controls have been evaluated and/or implemented for appropriate usage in a dental setting: Engineering Control Sharps containers Date Evaluated Person Evaluated 05/20/2015 Results of Evaluation (i.e. implemented or not appropriate) K. Goin Implemented High volume evacuation 01/05/2015 K. Goin/R. Cornett Implemented Rubber dams S. Pearce Implemented K. Goin Implemented 09/01/2011 Dedicated housekeeping 01/05/2015 procedures Input has been solicited from non-managerial employees responsible for direct patient care in the identification, evaluation and selection of effective engineering and work practice controls, using the following processes: Weekly faculty meetings; clinical testing The following non-managerial employees were involved in this process, by name and/or position: Departmental faculty The following process was used to consider safer needle devices and, where necessary, to implement them: Changes in instrument cassettes to design with syringe cap holders Input for the above process was sought from the following non-managerial employees: Departmental faculty Engineering controls must be examined routinely and maintained or replaced as needed to ensure their effectiveness (e.g., inspecting sharps containers daily to make sure they are not overfilled.) 01/2008 4 Bloodborne Pathogens CURRENT ENGINEERING CONTROLS MAINTENANCE SCHEDULE In this office, engineering controls are inspected and maintained or replaced as follows: Engineering Control Inspection/Maintenance Schedule Who is responsible Sharps containers Daily Clinic Manager Housekeeping Daily Clinic Manager High volume suction Annually Clinic Manager HANDWASHING Handwashing facilities are readily accessible to employees in the following locations: operatories, darkroom, sterilization room, dental laboratory, and restrooms. • Employees and students must wash their hands immediately or as soon as feasible after removing gloves or other personal protective equipment. • Employees and students must wash their hands and any other skin with soap and water, and flush mucous membranes (eyes, nose, mouth) with water immediately or as soon as possible after contact with blood or other potentially infectious materials. • Employees and students will be provided with antiseptic hand cleaner and towels if handwashing facilities are not feasible. HANDLING CONTAMINATED NEEDLES AND OTHER SHARPS The standard defines contaminated sharps to mean any contaminated object that can penetrate the skin including, but not limited to needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires. Contaminated sharps are handled as follows to minimize employee exposure: • In general, contaminated sharps must not be bent, recapped or removed. • Recapping/removal is permitted for the procedures listed below because there is no feasible alternative or recapping/removal is required by the specific dental procedure (e.g., administering multiple doses of an anesthetic to the same patient). • In cases where recapping/removal of contaminated sharps is permitted, employees must use a mechanical device or one-handed technique. 01/2008 5 Bloodborne Pathogens In this office, recapping/removal of contaminated sharps is only permitted for the following procedures using the mechanical device or one-handed technique indicated: Procedure Device or technique Administering multiple doses of anesthetic to the One-handed technique same patient • Recapping is also permitted in the following circumstances because it is not feasible to immediately discard the used needles into a sharps container. (NOTE: used sharps must always be discarded in an appropriate sharps container if it is feasible to do so). Circumstances: N/A • Shearing or breaking of contaminated sharps is never permitted. Immediately or as soon as possible after use, contaminated reusable sharps (such as scaler or explorer) must be placed in appropriate containers until they are processed. Containers provided for this purpose are puncture resistant, marked with the biohazard label or colorcoded red, leakproof on the sides and bottom and handled in a manner that does not require employees to reach by hand into the containers. Below is a brief description of the procedures used in this office to ensure that employees do not reach by hand into containers of contaminated, reusable sharps: The instruments are placed in cassettes or strainer-type baskets for soaking. The cassettes are then transferred into the Miele disinfector for decontamination. Contents in strainer-type baskets are removed with forceps and/or the container is turned on its side and the contents are carefully emptied onto a towel on the countertop. EATING AND DRINKING • Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses is prohibited in the following work areas where there is a reasonable likelihood of occupational exposure: Dental operatories, sterilization room, and darkroom • Food and drink may not be stored in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present. In this office, food and drink may be stored in the following locations: Dental hygiene conference room #8145.1 01/2008 7 Bloodborne Pathogens TECHNIQUES TO MINIMIZE SPLASHING AND SPRAYING • Procedures involving blood or other potentially infectious materials are performed in a manner to minimize splashing, spraying, spattering and generating droplets of these substances. Methods that may be used to accomplish this goal include: high volume evacuation, use of the dental dam SPECIMENS Check the one that applies: No specimens of blood or other potentially infectious materials are handled in this office. Specimens of blood or other potentially infectious materials are handled in this office as follows: • Specimens are placed in a container that prevents leakage during collection, handling, processing, storing, transporting, or shipping. • Containers provided for this purpose are marked with the biohazard label or colorcoded red and are closed before they are stored, transported, or shipped. • If outside contamination of the primary container occurs, it must be placed inside a secondary container that prevents leakage. Any specimen that could puncture the primary container must be placed in a secondary container that is puncture resistant. The secondary container must also be marked with the biohazard label or be colorcoded red. CONTAMINATED EQUIPMENT • Equipment that becomes contaminated with blood or other potentially infectious materials must be examined before servicing or shipping and decontaminated as necessary, unless decontamination is not feasible. • Equipment that cannot be completely decontaminated before servicing or shipping must be marked with a biohazard label that states which parts are still contaminated. This information must be conveyed to employees, service people, and others who handle the contaminated equipment. 01/2008 7 Bloodborne Pathogens Personal Protective Equipment (PPE) The standard defines personal protective equipment (PPE) as specialized clothing or equipment worn by an employee to protect against a hazard. General work clothes that are not intended to function as protection against a hazard are not regarded as PPE. • Employees and students are provided with appropriate PPE at no cost to them. Examples of PPE that might be used in a dental office are gloves; gowns; laboratory coats or clinical jackets; face shields or masks and eye protection; and resuscitation bags and mouthpieces. • The specific PPE used will depend on the task and degree of exposure anticipated. In general, PPE is appropriate if it prevents blood or other potentially infectious materials from passing through or reaching employees’ undergarments, clothing, skin, eyes, mouth, or other mucous membranes under normal conditions of use. USE OF PPE • Employees and students must use appropriate PPE whenever there is occupational exposure. This is an OSHA requirement. • The only exception is in rare and extraordinary circumstances where, in the employee’s or student’s judgment, using the PPE would: 1) expose the employee or student to greater hazard or 2) prevent the employee or student from delivering patient care. • Generally, this exception would only apply in cases of extreme emergency. When an employee or student makes this judgment, the circumstances will be investigated and documented to determine whether changes can be made to prevent such occurrences in the future. GLOVES • Gloves must be worn whenever hand contact with blood or other potentially infectious materials, mucous membranes, or nonintact skin can reasonably be anticipated. Gloves must also be worn when touching contaminated items or surfaces. • Disposable (single-use) gloves, such as surgical or examination gloves, must be replaced as soon as practical when they become contaminated (e.g., between patients) or as soon as feasible if they are torn or punctured or their ability to function as a barrier is compromised. • Disposable (single-use) gloves should never be reused. • Utility gloves may be decontaminated for reuse as long as the integrity of the gloves is not compromised. However, they must be discarded if they become cracked or torn or show any other sign that their ability to function as a barrier is compromised. MASKS, PROTECTIVE EYEWEAR AND FACE SHIELDS • A surgical mask that covers the nose and mouth in combination with protective eyewear (such as goggles or glasses with solid side shields) must be worn whenever splashes, spray, spatter, or droplets of blood or other potentially infectious materials may be generated and eye, nose, or mouth contamination can reasonably be anticipated. When using a face shield, a mask should also be worn. 01/2008 8 Bloodborne Pathogens GOWNS AND OTHER PROTECTIVE CLOTHING • Gowns, lab coats, clinic jackets, or some other form of protective clothing must be worn whenever the employee’s or student’s skin, street clothing or underwear is subject to occupational exposure. The fabric and style selected depend on the task and degree of exposure anticipated. OSHA considers the standard cotton, cotton/poly clinic jacket, or lab coat to be appropriate for most routine dental procedures. An ordinary shirt or blouse may also be appropriate, depending on the task and degree of exposure anticipated. Additional personal protective clothing, such as surgical caps or boots, may be required when gross contamination can reasonably be anticipated. In this office, employees and students must use the PPE indicated when performing the following tasks and procedures: Task/Procedure Type of PPE Required Decontaminating equipment/surfaces Overgown, gloves, mask, protective eyewear Providing routine patient care Overgown, gloves, mask, protective eyewear Providing advanced patient care (i.e., ultrasonic Overgown, gloves, mask, protective eyewear, scaling, air abrasive polishing) bonnet Transporting contaminated items Gloves Processing contaminated items Overgown, gloves, mask, protective eyewear Employees should contact: Clinic Manager or Department Chair if additional PPE is required by unusual circumstances involving large quantities of blood or other potentially infectious materials. ACCESSIBILITY • PPE in appropriate sizes is made readily available in the following locations: Type of PPE Location Gloves Operatories, darkroom, sterilization room, laboratory Overgowns Operatories, sterilization room Masks Operatories, sterilization room Protective eyewear Operatories, sterilization room, laboratory Bonnets Operatories • Glove liners, powderless gloves, or other similar alternatives will be made readily available to employees who are allergic to the gloves normally provided. 01/2008 9 Bloodborne Pathogens CLEANING, DISPOSAL, REPAIR AND REPLACEMENT • PPE will be cleaned, laundered, repaired, replaced and disposed of at no cost to employees or students. • PPE must be removed immediately or as soon as feasible after blood or other potentially infectious materials penetrate it. • All PPE must be removed before employees or students leave the work area. • After PPE is removed, it must be placed in the designated area or container for storage, washing, decontamination, or disposal. The following areas/containers have been designated in this office for PPE after it is removed: Type of PPE Area/Container Overgowns Operatories, sterilization room trash receptacles Masks Operatories, sterilization room trash receptacles Gloves Operatories, sterilization room trash receptacles Bonnets Operatories, sterilization room trash receptacles Protective eyewear After decontamination, in operatory cabinet Face shield After decontamination, in computer study area LAUNDRY The standard defines contaminated laundry as laundry that has become soiled with blood or other potentially infectious materials or may contain sharps. OSHA interprets the standard as prohibiting employees or students from taking contaminated laundry home to clean. However, employees and students are permitted to take uniforms or clothing they wear under PPE home to clean, as long as clothing has not become contaminated. The following work rules apply in this office to contaminated laundry: • Handle as little as possible • Remove where used and place in the bag or container provided • Store or transport in bags/containers that are marked with the biohazard label or color-coded red • Never sort or rinse laundry where it is used • Handle laundry with gloves, overgown, mask, and protective eyewear In this office, contaminated laundry is cleaned in the following manner: Washer and dryer on-site, according to manufacturer’s recommendations for the garment 01/2008 11 Bloodborne Pathogens Housekeeping The following work rules apply in this office to housekeeping tasks: • All equipment and environmental and work surfaces must be cleaned and decontaminated after contact with blood or other potentially infectious materials. • Contaminated work surfaces must be decontaminated with an appropriate disinfectant after completion of procedures, immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials, and at the end of the workday if the surface may have become contaminated since the last cleaning. • Contaminated work surfaces should be cleaned with appropriate disinfectants. Appropriate disinfectants include a diluted bleach solution and EPA-registered tuberculocides, sterilants or products registered against HIV/HBV. Lists of these EPA-registered products are available from the EPA website at www.epa.gov/opppmsd1/PPISdata/index.html • If they are used, protective coverings such as plastic wrap, aluminum foil, or imperviously backed absorbent paper must be removed and replaced whenever they become overtly contaminated and at the end of the workday. • All bins, pails, cans and similar receptacles intended for reuse that have a reasonable likelihood for becoming contaminated with blood or other potentially infectious materials must be inspected and decontaminated on a regular basis and cleaned and decontaminated immediately or as soon as feasible upon visible contamination. • Spills of blood or other potentially infectious materials must be wiped up immediately or as soon as feasible, and the area decontaminated using an appropriate disinfectant. See Appendix C for specific sterilization/disinfection information. • Employees and students must wear utility gloves when cleaning contaminated equipment and surfaces. • Employees and students must use mechanical means (e.g., brush and dustpan or forceps) to pick up broken glassware that may be contaminated. Broken contaminated glassware may never be picked up by hand, even if gloves are used. The dental setting is cleaned and decontaminated according to the following schedule: Area or Receptacle Schedule (e.g., between patients, daily) Method and Cleaning Solution/Disinfectant Used Operatories Between patients Wipe-discard-wipe with Birex Sterilization Room Daily Wipe-discard-wipe with Birex Darkroom and Laboratory As needed Wipe-discard-wipe with Birex Operatory and Sterilization trash receptacles Twice daily Biohazard trash As needed Emptied by janitorial staff and disinfected as required with Birex Disposed of in biohazard room in building 8000 Use of disinfectant and dedicated cleaning equipment Floors – Clinic and Sterilization Daily 01/2008 11 Bloodborne Pathogens Regulated Waste The Standard defines regulated waste as: • Liquid or semi-liquid blood or other potentially infectious materials • Contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed • Items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling • Contaminated sharps (including dental wires) • Pathological and microbiological wastes containing blood or other potentially infectious materials (including extracted teeth) CONTAMINATED DISPOSABLE SHARPS Immediately, or as soon as feasible after use, contaminated sharps must be disposed of in sharps containers. Containers provided for this purpose are closable, puncture resistant, leakproof on the sides and bottom and marked with the biohazard label or color-coded red. Sharps containers are located as close as feasible to the immediate area of use, which in the office is: in each operatory and the sterilization room. Containers for contaminated sharps must be kept upright while in use. They must be replaced routinely to prevent overfilling. If the sharps container has an unwinder to separate needles from reusable syringes, the device must be used in a safe, one-handed manner. Containers of contaminated sharps must be closed before they are moved to prevent spills. If leakage is possible, the first container must be placed in a second container with the same characteristics as the first. Reusable sharps containers may not be opened, emptied, or cleaned manually or in any other manner that would expose employees to the risk of percutaneous injury. OTHER REGULATED WASTE Other regulated waste must be placed in containers that are: • Closable • Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport, or shipping • Marked with the biohazard label or color-coded red • Closed before removal to prevent the contents from spilling or protruding from the container during handling, storage, transport, or shipping. If outside contamination of the regulated waste container occurs, the container must be placed in a second container with the same characteristics as the first. 01/2008 12 Bloodborne Pathogens Containers for other regulated waste in this office are located: in the sterilization room. All regulated waste is disposed of according to applicable local, state and federal laws. OSHA does not require waste to be labeled after it is decontaminated. However, state and local waste laws may have different requirements. NOTE: This standard does not prohibit giving an extracted tooth to the patient, but the tooth should be handled with precautions. Hepatitis B Vaccination Hepatitis B vaccination will be provided free of charge to all employees identified as having occupational exposure, unless: • The employee previously received and responded to the complete vaccination series • Testing reveals the employee is already immune • The vaccine is contraindicated for medical reasons • The employee chose not to be vaccinated No employee will be required to participate in a prescreening program as a condition of receiving hepatitis B vaccination. An employee is entitled to refuse vaccination, but the employee must sign a form declining vaccination using the exact language in OSHA’s Appendix A of the Bloodborne Pathogens Standard. This is an OSHA requirement. A blank declination form is found under “Recordkeeping” in the Bloodborne Pathogens section of the manual. An employee who initially declines to be vaccinated may elect to be vaccinated later at no cost to the employee. The first dose of vaccine will be administered within 10 working days of the employee’s assignment to a job involving occupational exposure. Before the vaccine is made available, the employee will receive training about the efficacy, safety, method of administration and benefits of vaccination. The employee will also be told that vaccination is provided free of charge. The licensed healthcare professional selected to administer the vaccine will be provided with a copy of the Bloodborne Pathogens Standard. The employer will obtain from the healthcare professional within 15 days after the evaluation is completed a written opinion stating: 1) whether Hepatitis B vaccination was indicated for the employee and 2) whether the vaccine was administered. The employee will be given a copy of the opinion and the original will be kept in the employee’s confidential medical record. 3) Post vaccination testing for antibody to HBV surface antigen response is indicated. Knowledge of antibody response aids in determining appropriate exposure prophylaxis. Employers are not currently required to make available routine booster doses of hepatitis B vaccine. If in the future the U.S. Public Health Service recommends this service, the employer will provide it at no cost to employees. Students enroll in the program meeting vaccination requirements. 01/2008 13 Bloodborne Pathogens Postexposure Evaluation and Follow-Up The standard defines an exposure incident as a specific eye, mouth, or other mucous membrane, non-intact skin or parenteral contact with blood or other potentially infectious materials that results from performance of an employee’s duties. Any employee or student who suffers an exposure incident must immediately report the incident to: the Clinic Coordinator on duty and/or the Department Chair. Employees or students who experience an exposure incident will be offered postexposure evaluation and follow-up at no cost to the employee or student, as follows: • A report of the incident will be made documenting the route of exposure and circumstances in which the exposure occurred. The report should be sufficiently detailed to permit review of the exposure incident, including information about the engineering controls in use at the time, work practice controls followed, a description of any devices involved in the exposure e.g., syringe), PPE in use at the time, where the exposure occurred, the procedure being performed and any relevant information about the exposed employee’s or student’s training. The source patient will be identified, if possible. The report will note if the source patient is unknown or if it would be a violation of state or local law to disclose the source patient’s identity. • The employer will attempt to have source patient’s blood tested as soon as feasible to determine HBV, HCV, and HIV infectivity. The employer will determine if the source patient’s consent to testing is required by law. If consent is required and cannot be obtained, the employer will document that fact in the incident report. If consent is not required and the source patient’s blood is available, it will be tested. Testing is not required if the source patient is known to be infected. • Results of the source patient’s blood tests will be made available to the exposed employee or student, if the patient consents to disclosure or if the law permits disclosure without the patient’s consent. The exposed employee or student will be notified of any applicable law governing further disclosure of the test results. • The employee’s or student’s blood will be collected, with the employee’s or student’s consent, for baseline testing for HBV, HCV and HIV. If the employee or student consents to have blood collected but not tested, the blood will be kept for 90 days after the exposure incident to allow the employee or student to change his or her mind. • The exposed employee or student will be offered any medically indicated prophylaxis recommended by the U.S. Public Health Service. Counseling and evaluation of any reported illness will also be provided. See the “HBV vaccination/post-exposure procedures” in this section and Appendix D for further information. • The licensed healthcare professional who provides post-exposure evaluation and follow-up services will be given a copy of the Bloodborne Pathogens Standard, a description of the exposed employee’s or student’s relevant job duties, a copy of the incident report, results of the source patient’s blood testing (if available) and any relevant medical records in the employer’s possession. 01/2008 14 Bloodborne Pathogens • The employer will obtain from the healthcare professional within 15 days after the evaluation is completed a written opinion stating that the employee or student has been informed of the results of the evaluation and any medical conditions that may require further evaluation and treatment. The employee or student will be given a copy of the opinion, and the original will be kept in the employee’s or student’s confidential medical record. • The circumstances of the exposure incident will be reviewed to determine if procedures, protocols, and/or training need to be revised to prevent the incident from happening again. Labels In this office, potentially biohazardous materials are color-coded red or identified with the following biohazard symbol and the word “biohazard” in contrasting color on a fluorescent orange or orange-red label: BIOHAZARD SYMBOL Medical Records A confidential medical record is maintained for each employee or student with occupational exposure. The medical record includes: • The employee’s or student’s name and social security number • A copy of the employee’s or student’s hepatitis B immunization status and any of the following that apply: o Exposure incident report o Written opinion of health care professional o Form refusing hepatitis B vaccination o Form refusing postexposure evaluation and follow-up (not required by OSHA, but highly recommended) Employee and student medical records for this office are maintained: in the Department Chair’s office, Room 8155 and in the office of the Executive Dean of Health Sciences in building 8000, Eastview Campus, Austin Community College 01/2008 15 Bloodborne Pathogens Employee and student medical records are kept confidential and will not be disclosed without the employee’s or student’s consent or as required by law. Employee and student medical records are retained for the length of employment plus 30 years. Medical records of employees or students who have worked for less than one year need not be retained beyond the term of employment or student’s enrollment in the program if the records are provided to the employee or student upon termination of employment or withdrawal from the dental hygiene program. Employees or students should contact: the Dental Hygiene Department Chair to inspect their medical records or to obtain a copy. OSHA standard 1910.1020 gives employees the right of access to their own medical and exposure records. For further information, see the copy of standard 1910.1020 located under the “Appendices” tab in the section of the manual entitled “General Information for the DentistEmployer.” To ensure that you are reviewing the most current version of the standard, check OSHA’s website, www.osha.gov. Training All employees and students will be provided with initial training before they begin work involving occupational exposure. Thereafter, refresher training will be provided at least annually and whenever changes in tasks or procedures require. Someone who is familiar with the standard will provide training during work hours at no cost to the employee or student as it relates to the dental office. Employees and students will have the opportunity for interactive questions and answers with the person conducting the training. Initial training will cover: • An explanation of the Bloodborne Pathogens Standard and where a copy of the standard is filed (e.g., in the Bloodborne Pathogens section of the Manual) • General information about the epidemiology and symptoms of bloodborne diseases • Modes of transmission of bloodborne pathogens • An explanation of this office’s exposure control plan and how to obtain a copy • How to recognize tasks involving occupational exposure • The use and limits of engineering controls, work practice controls and personal protective equipment • Where PPE is located and how to use, remove, handle, decontaminate, and dispose of it • How to select appropriate PPE • The effectiveness, safety, benefits, and method of administering hepatitis B vaccine and that vaccination will be provided free of charge • What to do if there is an emergency spill of blood or other potentially infectious material • What to do if an exposure incident occurs 01/2008 16 Bloodborne Pathogens • Postexposure evaluation and follow-up that will be made available to employees or students in case of an exposure incident • The system of labels and color-coding used in this office to warn employees of biohazards • An opportunity for interactive questions and answers Refresher training will cover the same subjects, to the extent needed, and will emphasize new information and procedures, including but not limited to training in the effective use of engineering controls in this office. A model initial training program for employees and students is provided under “Training” in the Bloodborne Pathogens section of the Manual. The employer will maintain a record of all training sessions. The training record will include: • Date of training • Contents of training (a summary or list of subjects is sufficient) • Name and qualification of trainer • Name and job title of each person attending Training records for this office are kept: in the office of the OSHA compliance manager. Training records are retained for 3 years following the training session. Employees may inspect training records or obtain a copy by contacting: the OSHA compliance manager. If this dental hygiene program is transferred, employee and student records will be transferred to the new institution. If the practice is closed, employee and student records will be offered to the National Institute for Occupational Safety and Health (NIOSH). Any employee or student who has a question about this exposure control plan or how it is implemented in this office is encouraged to contact: Kate Goin, the OSHA compliance manager for more information. 01/2008 17 Bloodborne Pathogens Hepatitis B Vaccination/Postexposure Procedures Introduction The OSHA Standard on Bloodborne Pathogens defines the responsibilities of the employer for providing hepatitis B vaccination to employees who have occupational exposure to bloodborne pathogens and postexposure evaluation and follow-up to employees who have had an exposure incident. (See Glossary in General Information for definition of terms.) OSHA considers part-time, temporary, and probationary workers as employees. Newly hired employees are permitted to participate in patient care during the two- to six-month period it takes to complete the series of vaccine injections, but the vaccination series must be made available to them within 10 days of their initial assignment to a job with occupational exposure. NOTE: All ACC-DH procedures are also performed in accordance with the procedures set forth by the ACC Office of Environmental Health and Safety. Hepatitis B Vaccination • Hepatitis B vaccination must be made available at no cost to all employees who have occupational exposure. • Vaccination shall be made available after the employee has received the training described under the heading “Training” and within 10 working days of initial assignment. • This requirement is waived if the employee has previously received the complete HBV vaccination series (three vaccines, or in the case of a nonresponder, six) if antibody testing reveals that the employee is immune, or if the vaccine is contraindicated for medical reasons. • The employer may not require pre-screening for antibody to HBV prior to vaccination. • If the employee initially declines to be vaccinated but at a later date, while still covered under the Standard, decides to accept vaccination, the employer must make it available at no cost. • Employees who refuse to be vaccinated must sign the Hepatitis B Vaccine Declination form, included in this section of the manual. • Employees not responding or completing the primary vaccination series should be revaccinated with a second three-dose vaccine. Revaccinated persons should be tested for anti-HBV antibodies on completion of second vaccine series. • While current U.S. Public Health Service guidelines do not recommend booster doses, if they should in the future, the employer must provide these at no cost. • The employer must provide a copy of the Standard to the healthcare professional who will evaluate the employee and/or administer the vaccine, if the healthcare professional does not have one already. • If the employee wishes to be evaluated before vaccination, the employer must obtain the healthcare professional’s written opinion (see Healthcare Professional’s Written Opinion form on page 28) and give it to the employee within 15 days of its completion. The report should state whether HBV Vaccination is indicated and if vaccination has been received. 01/2008 18 Bloodborne Pathogens • This report should be filed in the employee’s Medical Record; findings and diagnoses not pertaining to HBV must remain confidential and cannot be included in the written report. • Post-vaccination testing for antibody to HBV surface antigen is indicated. Knowledge of antibody response aids in determining appropriate postexposure prophylaxis. • Although OSHA does not require it, you may wish to request new employees who have already been vaccinated to provide proof of their vaccination (e.g., a written statement from their physician to place in your files.) Postexposure evaluation and follow-up (Management of occupational exposures to bloodborne pathogens) – Immediately following an exposure incident (see Glossary in General Information), the employer must make available to the employee a confidential medical evaluation and follow-up. OSHA’s requirements are based on recommendations of the United States Public Health Service, Centers for Disease Control and Prevention (CDC) and may change from time to time with changes in the CDC’s recommendations. In June of 2001, the CDC published new recommendations for the management of occupational exposures to bloodborne pathogens and recommendations for postexposure prophylaxis (MMWR 2001:50, 1-52; available online at http://www.cdc.gov/mmwr/PDF/rr/rr5011. pdf.) It updates and consolidates all previous CDC recommendations for the management of health-care personnel (HCP) who have occupational exposure to blood and other bodily fluids that might contain hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV). (See Table 1, “Recommended postexposure prophylaxis for exposure to hepatitis B virus.”) The portion of these 2001 Guidelines pertaining to HIV Recommendations has been superseded by the Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Post- Exposure Prophylaxis - 2005 (see Appendix F). A poster summarizing postexposure procedures for both HBV and HIV is available on the CDC’s web site at www.cdc.gov and is included here in Appendix I. One of the most important things a dentist can do to prepare is to select the health care professional before an exposure incident occurs. This person should be familiar with the CDCrecommended evaluation and treatment protocols. They should be readily available in the event of an exposure incident during work hours and have access to postexposure prophylaxis as necessary. Postexposure prophylaxis, if indicated, is most likely to be effective if administered as soon after the exposure as possible. According to OSHA (and based on the CDC’s latest recommendations) if an exposure occurs, the following must be done: • Provide immediate care to the exposure site (e.g., wash wounds and skin with soap and water, flush mucous membranes with water). • Document the route(s) of exposure and how it occurred, including determining the risk associated with exposure by type of fluid (e.g., blood, visibly bloody fluid, other potentially infectious fluid or tissue) and type of exposure (i.e., percutaneous injury, mucous membrane or nonintact skin exposure, and bites resulting in blood exposure). 01/2008 19 Bloodborne Pathogens • Identify and document the source individual, unless prohibited by state or local law or not feasible. • Obtain consent of the source individual and make arrangements to have him/her tested for HBV, HCV and/or HIV as soon as possible. Document that the source individual’s test results were conveyed to the employee’s HCP. If the source individual is already known to be positive for any of the viruses, then no additional testing for that specific virus is necessary. • Ensure that the exposed employee is provided with the source individual’s test results. • Ensure that the exposed employee is informed about laws protecting confidentiality, such as applicable disclosure laws and regulations concerning the identity and infectious status of the source individual. • Evaluate the exposed employee by assessing immune status for HBV infection. • Test exposed employee’s blood for HBV, and obtain history of hepatitis B vaccination and vaccine response (see table 1), and HIV serological status as soon as feasible after exposure incident. Obtain consent prior to collecting blood. • If the employee does not consent to HIV testing at baseline, preserve the baseline blood sample for at least 90 days. If at any time the exposed employee then elects to have the baseline blood sample tested, do so as soon as it is feasible. Exposures through a percutaneous injury (i.e., needlestick or other penetrating sharpsrelated event) or through contact with a mucous membrane are situations that pose a risk for bloodborne virus transmission and require further evaluation. For skin exposure, follow-up is indicated only if it involves exposure to a type of body fluid that poses a risk and evidence exists of compromised skin integrity (e.g., dermatitis, abrasion, or open wound). If a bite results in bloody exposure to either person involved, postexposure follow-up should be provided. Occupational Exposure Report (information required by evaluating healthcare professional [HCP]) – The HCP should be provided with an occupational exposure report that includes the items listed in Box 1. It should also include the following: • A copy of the Bloodborne Pathogens Standard, if the HCP does not have one already. • A description of the exposed employee’s responsibilities as they relate to the exposure incident. • All medical records relevant to the treatment of the employee, which are the employee’s responsibility to maintain. 01/2008 20 Bloodborne Pathogens Recommendations for the Contents of the Occupational Exposure Report • Date and time of the exposure; • Details of the procedure being performed, includes where and how the exposure occurred; if related to a sharp device, the type and brand of device and how and when in the course of handling the device the exposure occurred; • Details of the exposure, including the type and amount of fluid or material and the severity of the exposure (e.g., for a percutaneous exposure, depth of injury and whether fluid was injected; for a skin and mucous membrane exposure, the estimated volume of material and condition of the skin [e.g., chapped, abraded, intact]); • Details about the exposure source (e.g.. whether the source material contained HBV, HCV, or HIV; if the source is HIV infected, the stage of disease, history of antiretroviral therapy, viral load, and antiretroviral resistance information, if known); • Details about the exposed person (e.g. hepatitis B vaccination and vaccine-response status); and Details about counseling, postexposure management, and follow-up. Healthcare Professional’s Written Opinion The written opinion of the evaluating HCP should be made available to the employee within 15 days of completion of the evaluation. All findings and diagnoses unrelated to the exposure incident are to remain confidential and are not to be included in the written report. It must be limited to the following: That the employee has been informed about any medical conditions resulting from the exposure to blood or other potentially infectious materials, that require further evaluation or treatment. That the employee has been informed of the results of the evaluation. Postexposure Recommendations The OSHA standard does not provide specific recommendations on PEP. Instead, the recommendation of the evaluating HCP regarding the use of PEP is to be based on current CDC recommendations. These are summarized in table form below for HBV and appear in Appendix F for HIV. 01/2008 21 Bloodborne Pathogens Table 1. Recommended Postexposure Prophylaxis for Exposure to Hepatitis B Virus Treatment Vaccination and antibody response status of exposed workers* Source Source HBsAg• positive HBsAg• negative Source unknown or not available for testing HBIG x 1 and initiate HB vaccine series Initiate HB vaccine series Initiate HB vaccine series Known responder** No treatment No treatment No treatment Known HBIG x 1 and initiate revaccination or HBIG x2 No treatment If known high risk source, treat as if source were HBsAg positive Test exposed person for anti-HBs No treatment Test exposed person for anti-HBs Unvaccinated Previously vaccinated nonresponder •• Antibody response Unknown 1. If adequate,** no treatment is necessary 1. If adequate, no treatment is necessary 2. If inadequate,•• administer HBIG x 1 and vaccine booster 2. If inadequate, administer vaccine booster and recheck titer in 1-2 months * Persons who have previously been infected with HBV are immune to reinfection and do not require postexposure prophylaxis. • Hepatitis B surface antigen. Hepatitis B immune globulin; dose is 0.06 mL/kg intramuscularly. Hepatitis B vaccine. ** A responder is a person with adequate levels of serum antibody to HBsAg (i.e., serum anti- HBs<10 mIU/mL). •• A nonresponder is a person with inadequate response to vaccination (i.e. anti- HBs<10 mIU/mL.) The option of giving one dose of HBIG and reinitiating the vaccine series is preferred for nonresponders who have not completed a second 3-dose vaccine series. For persons who previously completed a second vaccine series but failed to respond, two doses of HBIG are preferred. Antibody to HBsAg. 01/2008 22 Bloodborne Pathogens Confidential Note to employer: This form should be signed by the healthcare professional twice: after the first vaccination and again when the series is completed. If vaccination is not indicated, only one signature is necessary. Maintain this record for the duration of employment plus 30 years. Provide a copy to the employee within 15 days of the initial evaluation. Hepatitis B Vaccination Healthcare Professional’s Written Opinion for (Name of employee) To the healthcare professional: OSHA requires the healthcare professional who evaluates an employee for hepatitis B vaccination to provide a written opinion in the form provided below. Please complete this form and return it to the employee at the time services are rendered. Thank you for your cooperation. ----------------------------------------------------------------------------------------------------------------I hereby certify that on (date): I evaluated the employee whose name appears above and determined that hepatitis B vaccination: Is indicated for this employee In addition, the employee: Did Is not indicated for this employee. Did not receive the first hepatitis B vaccination. Signed: Date: (Healthcare professional) The employee: Did Did not receive the entire series of 3 hepatitis B vaccinations. Signed: Date: (Healthcare professional) 01/2008 23 Bloodborne Pathogens Confidential Note to employer: Maintain this record for duration of employment plus 30 years. Provide a copy to the employee within 15 days after the evaluation is completed. Postexposure Evaluation and Follow-Up Healthcare Professional’s Written Opinion for (Name of employee) To the healthcare professional: OSHA requires the healthcare professional who provides postexposure evaluation and follow-up services to an employee to provide a written opinion in the form provided below. Please complete this form and return it to the employee at the time services are rendered. Thank you for your cooperation. ----------------------------------------------------------------------------------------------------------------I hereby certify that on (date): I evaluated the employee whose name appears above and informed the employee of: The results of the evaluation; and any medical conditions resulting from exposure to blood or other potentially infectious materials which require further evaluation or treatment. NOTE: ALL OTHER FINDINGS OR DIAGNOSES ARE CONFIDENTIAL AND SHOULD NOT BE INCLUDED IN THIS WRITTEN REPORT. Signed: Date: (Healthcare professional) 01/2008 24 Bloodborne Pathogens Labeling Introduction The OSHA standard has a section entitled “Communication of hazards to employees,” which includes requirements for labels and information and training of those employees with occupational exposure. Labels • The required label is the biohazard symbol and the legend “Biohazard” (shown below) which should be fluorescent orange or orange-red with lettering or symbols in a contrasting color. • Labels are affixed or attached as closely as possible to the container, so that there is no possibility of loss. Alternatively, labels can be imprinted on the container or bag. • Red bags or red containers may be substituted for labels. • Regulated waste that has been decontaminated need not be labeled or placed in red bags. For example, autoclaved waste would not be labeled. • Biohazard labels are placed on containers of regulated waste, e.g., sharps containers. Laundry contaminated with blood or other potentially infectious materials is also labeled or color-coded. BIOHAZARD SYMBOL 01/2008 25 Bloodborne Pathogens Training Introduction The OSHA Standard includes requirements for providing information and training of those employees with occupational exposure. Manner of Presentation Information and training will be provided: • At the time of initial assignments to duties that may result in occupational exposure. • At least annually or as soon as possible when there are changes in procedures or in job assignments. • In a manner and language that can be understood by all employees and students. • In an interactive style that encourages questions and answers. • By a person knowledgeable in the subject matter specified by the Standard. • During working hours. • Office specific. Contents of the Training Program The training program contains the following elements. OSHA STANDARD An accessible copy of this standard (under “Appendices” tab in this section) and an explanation of its contents is part of the training program. EPIDEMIOLOGY, MODES OF TRANSMISSION, AND SYMPTOMS OF BLOODBORNE DISEASES • Hepatitis B Epidemiology. Numerous studies document that workers occupationally exposed to blood have a prevalence of serum HBV markers, which indicates previous infection, several times that of the general population or workers not exposed to blood. Prevalence of serum HBV markers is related to the number of exposures to blood and/or needles but not patient contacts per se. High-risk groups for hepatitis B include, among others, operating room staff, phlebotomists, surgeons, dental professionals, and blood bank technicians. Modes of Transmission. Blood and body fluids contaminated with blood contain the highest quantities of virus and are the most likely vectors of HBV transmission. Certain other body fluids such as saliva and semen contain infectious virus but at one-thousandth of the concentration found in blood. Other body fluids such as urine and feces contain only small quantities of virus unless they are visibly contaminated with blood. Lesions on the hands from injuries incurred at the workplace or at home or from dermatitis may provide a route of entry for the virus. In addition, transfer of contaminated blood via inanimate objects or environmental surfaces has been shown to cause infection in healthcare workers. 01/2008 26 Bloodborne Pathogens Symptoms. About one third of infected individuals have no symptoms when infected with the virus, one third have a relatively mild clinical course of a flu-like illness that is usually not diagnosed as hepatitis, and the remaining third have a much more severe clinical course of jaundice, dark urine, extreme fatigue, anorexia, nausea, abdominal pain, and sometimes joint pain, rash and fever. The annual number of occupational infections has decreased 95% since the hepatitis B vaccine became available in 1982, from over 10,000 in 1983 to less than 400 in 2001 (CDC, unpublished data). • Human immunodeficiency virus infection Epidemiology. As of December 2001, CDC reported 57 documented cases and 138 possible cases of occupationally acquired HIV infection among healthcare personnel in the United States since reporting began in 1985. The average risk of infection resulting from exposure to HIV-infected blood through a needlestick or cut is 0.3%, the eye, nose or mouth is 0.1%, and non-intact skin is less than 0.1%. There are no documented cases of HIV transmission due to an exposure involving a small amount of blood on intact skin (a few drops of blood on skin for a short period of time) (Centers for Disease Control and Prevention National Center for Infectious Diseases Division of Healthcare Quality Promotion and Division of Viral Hepatitis. Exposure to Blood: What Healthcare Personnel Need to Know. July 2003). Modes of transmission. HIV has been isolated from human blood, semen, breast milk, vaginal secretions, saliva, tears, urine, cerebrospinal fluid, and amniotic fluid. However, epidemiologic evidence implicates only blood, semen, vaginal secretions, and possibly breast milk in the transmission of the virus. Documented modes of HIV transmission include: engaging in sexual intercourse with an HIV-infected person; using needles contaminated with the virus; having parenteral, mucous membrane, or nonintact skin contact with HIVinfected blood, blood components, or blood products; receiving transplants of HIV-infected organs and tissues, including bone; receiving transfusions of HIV-infected blood; and perinatal transmission (from mother to child around the time of birth). The actual amount of virus may be very important in the likelihood of transmission since it appears that there is a greater probability of infection from HIVcontaminated blood transfusions (890 infections per 1,000 persons receiving such transfusions) than from accidental needlesticks with needles that have been contaminated with HIV (approximately three infections per 1,000 persons injured with contaminated needles.) Symptoms. Within a month after exposure, an individual may experience acute retroviral syndrome, the first clinical evidence of HIV infection. This is a flu-like illness with signs and symptoms that can include fever, lymphadenopathy, myalgias, arthralgias, diarrhea, fatigue and rash. This syndrome is usually self-limiting and is followed or accompanied by the development of antibodies. Following this acute illness, HIV infection leads to a continuum of events in which the patient is initially asymptomatic and apparently healthy and then, after an indeterminate time, sometimes longer than 10 years, may develop symptoms uniquely associated with a later stage of HIV infection that is classified as acquired immune deficiency syndrome, or AIDS. Some of the signs and symptoms of HIV infection are persistent generalized lymphadenopathy, fever for more than one month, significant weight loss, persistent diarrhea, or a combination of these. An individual with HIV infection is considered to have AIDS when one or more so-called “indicator” diseases has been diagnosed. The most common of these indicator diseases are pneumocystis carninii pneumonia, esophogeal 01/2008 27 Bloodborne Pathogens candidiasis, neurological disorders or dementia, and cancers such as Kaposi’s sarcoma and non-Hodgkin’s lymphoma. An HIV infected person is also considered to have AIDS if he or she has less than 200 CD4+ lymphocytes/mm³ of blood. The CD4+, or T-helper lymphocyte, is the primary target cell for HIV infection and a decrease in number of these cells correlates with the risk and severity of HIVrelated illness. • Hepatitis C Epidemiology. HCV, like all bloodborne pathogens, can be transmitted through occupational exposure to infectious body fluids. The number of healthcare personnel occupationally infected with HCV is unknown. Studies indicate, however, that about 1% of hospital healthcare personnel have evidence of HCV infection, while about 3% of the U.S. population has evidence of infection. The average risk of HCV infection after a needlestick or cut exposure to HCV-infected blood is approximately 1.8%. HCV infection resulting from an infected blood splash to the eye has been reported, as well as a possible infection from exposure to nonintact skin (Centers for Disease Control and Prevention National Center for Infectious Diseases Division of Healthcare Quality Promotion and Division of Viral Hepatitis. Exposure to Blood: What Healthcare Personnel Need to Know. July 2003). Modes of Transmission. HCV has been isolated from human blood and bodily fluids and is transmitted primarily through large or repeated direct percutaneous exposures to blood, e.g., intravenous drug use and blood transfusions. In other countries, different kinds of percutaneous injuries such as tattooing and body piercing have been associated with HCV infection; however, case studies in the U.S. have not shown this association. Although inconsistencies exist among studies, data indicate overall that sexual transmission of HCV does occur, but at a relatively low rate. Symptoms. Only approximately 30% of individuals with newly acquired HCV infections develop clinical symptoms such as jaundice, fatigue, abdominal pain, and loss of appetite. The average time period from exposure to symptom onset is 6-7 weeks while the average time period for seroconversion is 8-9 weeks. HCV does have a high rate of chronic infection due to its genetic diversity that enables the virus to elude the host’s immune system. EXPOSURE CONTROL PLAN The written exposure control plan, which is included in this manual under the “Exposure Control” tab, will be explained to all employees and students by either the DHDC or compliance manager. A copy of the plan is available upon request. The plan will be updated annually or when alterations in procedures create new occupational exposure. RECOGNITION OF TASKS AND ACTIVITIES THAT MAY INVOLVE EXPOSURE Tasks that involve contacts with blood or other potentially infectious materials and mucous membranes may result in exposure to bloodborne pathogens. Items contaminated with blood or other potentially infectious materials, such as soiled instruments, laundry, and equipment can also result in occupational exposure. METHODS TO REDUCE EXPOSURE The use and limitations of methods that will prevent or reduce exposure, including appropriate engineering controls, work practices, and personal protective equipment (see “Methods of Compliance”), will be explained. 01/2008 28 Bloodborne Pathogens TYPES, PROPER USE, LOCATION, REMOVAL, HANDLING, DECONTAMINATION, AND/OR DISPOSAL OF PPE Various kinds of gloves can be used in the dental office: vinyl, latex, rubber or nitrile, and plastic film. Latex, nitrile or vinyl gloves are used for most treatment procedures. When surgical procedures are performed, sterile surgical latex or vinyl gloves are required. Nonsterile latex or vinyl treatment gloves are adequate for most procedures. Rubber utility or nitrile puncture-resistant gloves are used for housekeeping procedures such as cleaning instruments prior to sterilization or surface disinfection. Plastic film gloves may be used temporarily over a latex treatment glove when it is necessary to prevent contamination of an object such as a drawer handle or chart. Gloves must be changed between patients, whether they are worn for treatment or examination. They should not be washed for reuse. Disinfecting agents may cause deterioration of glove material, and minute tears or punctures in gloves may occur during treatment, resulting in contamination of hands. If tears or punctures do appear, gloves must be removed and replaced. Hands should then be washed before regloving. Utility gloves can be washed and reused. They should be replaced when they become cracked or worn. According to the CDC, using gloves in health care settings reduces hand contamination by 70 to 80%, prevents cross- contamination and protects patients and health care personnel from infection; but does not eliminate the need for hand hygiene (Centers for Disease Control and Prevention. Guideline for Hand Hygiene in Health-Care Settings. MMWR 2002;51(No.RR-17):1-44). A mask is used to protect mucous membranes of the mouth and nose from exposure to blood and saliva. The mask should be adjusted so that it fits snugly against the face so as not to allow spatter to enter around its edges. Beards and mustaches should be groomed so that the mask fits well. The mask should be changed between patients or if it gets wet. It should be removed as soon as treatment is over. It should not be dangled around the neck or left in place after leaving the operatory. When removing the mask, handle it only by the elastic or cloth tie string. The mask itself should not be touched. OSHA does not consider masks and gloves to be regulated waste. However, you must dispose of masks and gloves according to state or local regulations, if they exist. Protective eyewear must be worn when projectiles and splashes, spray, or spatter of blood or other potentially infectious materials may be generated and eye, nose, or mouth contamination can be reasonably anticipated. Protective eyewear may include conventional glasses with solid side shields, safety glasses, or goggles. As an alternative, a face shield with a mask may be worn. Gowns, lab coats, clinic jackets, or similar outer garments must be worn when there is a likelihood of occupational exposure to blood or other potentially infectious material. The type and characteristics of protective clothing depends upon the task and degree of exposure anticipated. The garment must be removed immediately or as soon as possible when penetrated by blood or other potentially infectious materials and before leaving the work area. Place contaminated gowns in designated, labeled laundry bags. 01/2008 29 Bloodborne Pathogens The location of PPE in our office is as follows: Personal Protective Gloves, nonsterile Gloves, sterile Location Disposal Operatories, Darkroom, Operatory/Sterilization Room Sterilization Room, Laboratory trash receptacles Operatory/Sterilization Room Sterilization Room trash receptacles Gloves, utility Operatories, Sterilization Room Washed and autoclaved Masks, face shields Operatories, Sterilization Room Protective eyewear Operatories, Sterilization Room Disinfect with Birex Protective clothing (lab coats, overgowns) Operatories, Sterilization Room Operatory/Sterilization Room trash receptacles Resuscitation equipment pocket masks Emergency cart in computer study area Operatory/Sterilization Room trash receptacles Operatory/Sterilization Room trash receptacles Contact: Kate Goin, compliance manager if you need additional information on the location and use of these items. SELECTION OF PPE Selection of PPE will depend on the degree of anticipated exposure and the procedure to be performed. For example, an oral examination may simply require gloves, whereas procedures in which exposure to blood or other potentially infectious materials may be reasonably anticipated will require gloves, mask, protective eyewear, and a lab coat, clinic jacket, or gown. HEPATITIS B VACCINES Currently there are two licensed hepatitis B vaccines. Recombivax HB and Engerix-B prepared from recombinant yeast cultures. These two vaccines are given in three intramuscular injections (deltoid muscle of the arm) over a six-month period, at zero, one and six months. Engerix-B, however, can also be administered at an accelerated schedule of zero, one, two, and 12 months for more rapid induction of immunity or for postexposure prophylaxis. Recombivax HB and Engerix-B should not be given to individuals known to be hypersensitive to yeast or yeast products. An earlier plasmaderived vaccine, Heptavax-B, is limitedly available for these specific individuals. In 2001, a combined Hepatitis A (Havrix) and B (Engerix-B) vaccine became available called Twinrix. Hepatitis B vaccines induce protective antibody levels in most healthy adults, depending on age. Protection against infection and development of the carrier state both last at least five to seven years after immunization. Even when the antibody titers have dropped below detectable levels, vaccinated individuals develop a rapid immunologic memory response and do not become clinically ill or infected with HBV. Booster inoculation is not officially 01/2008 30 Bloodborne Pathogens recommended by the Centers for Disease Control and Prevention at this time. For individuals who did not develop hepatitis antibodies following the primary series, revaccination results in 15-25% developing antibodies after one injection and up to 50% developing antibodies after a complete second-series administration of the vaccine. ACTIONS TO TAKE AND PERSONS TO CONTACT IN AN EMERGENCY In cases of an emergency that may pose the potential for exposure to blood or other potentially infectious materials, be certain to use appropriate PPE. For example, if a blood spill occurs, don utility gloves, mask, lab coat, clinical jacket or gown, and protective eyewear before proceeding with cleanup. Continue to wear protective equipment when decontaminating the area with an appropriate disinfectant. If you are unsure of the appropriate action to take in an emergency, contact the compliance manager or the DHDC. Compliance manager DHDC Name: Kate Goin, BA, RDH Name: Renee Cornett, RDH, MBA Telephone number: 512-223-5708 Telephone number: 512-223-5711 Occasionally, emergency situations may arise in which the use of PPE may not be possible. OSHA defines these emergency situations as extraordinary, unexpected events that threaten the life or safety of a patient or fellow worker. It may be judged that the time required to don personal protective equipment is critical to saving the person’s life. However, the use of the exemption is meant to be limited in extent and time. Those practices associated with standard precautions that can be used without jeopardizing the victim’s life are to be implemented whenever possible. Moreover, as soon as the situation changes as, for example, the patient’s condition stabilizes, the employee is expected to implement use of full standard precautions. The decision not to utilize personal protective equipment in such situations rests with the employee, not the employer. Employees must exercise their professional judgment in making such a decision, but they should be aware that they may be asked to explain the reasons for their course of action. Although saliva has not been implicated in HIV transmission, OSHA considers it to be a potentially infectious material in the dental setting. To minimize the need for emergency, mouthto-mouth resuscitation, mouthpieces, resuscitation bags, or other ventilation devices must be kept in the office. In case of an emergency, each employee must be aware of his or her responsibility. One of the responsibilities is to contact the local hospital or rescue squad. The telephone number in case of an emergency is: Campus Emergencies, 222 (from campus phone) or 512-223-7999 (off campus phone) 01/2008 31 Bloodborne Pathogens POSTEXPOSURE PROCEDURES The procedure to follow if an exposure incident occurs, including the method of reporting the incident and the medical evaluation and follow-up that will be made available (see information under “HBV vaccination/postexposure procedures”) will be explained. LABELING AND COLOR CODING The signs and labels and/or color coding required by the OSHA Standard (see information under “Labeling”) will be explained. TRAINING SESSIONS The DHDC or the compliance manager will conduct training sessions that are interactive and allow the opportunity for questions and answers. 01/2008 32 Bloodborne Pathogens Recordkeeping This section of the manual contains record forms either mandated by the OSHA Standard or that are recommended by the ADA. Employee Medical Record • This record is required by OSHA for each employee with occupational exposure. • It must be confidential, separate from other personnel records, and may be maintained on site or by the healthcare professional who provides services to dental healthcare employees. The medical record must be retained for the duration of the employee’s employment plus 30 years. Medical records of employees who have worked for less than one year need not be retained beyond the term of employment if the records are provided to the employee upon the termination of employment. • It must include the name and social security number of the employee. • It must include the employee’s Hepatitis B vaccination status, including dates received, and any medical records relative to the employee’s ability to receive the vaccination. • If an occupational exposure incident occurs, copies of all results of examinations, medical testing, and follow-up procedures, as well as the written opinion of the health care professional, must be attached to the medical record. • It must include copies of the information provided to the healthcare professional regarding hepatitis B vaccination and/or exposure incidents, as appropriate. Employee Training Record Training records document each training session and must be retained by the employer for three years. They should be made available upon request to employees or OSHA representatives. Training records must include: • Dates of training • Summary of the contents of training • Names and qualifications of the person(s) conducting the training • Names and job titles of all persons attending the training Hepatitis B Vaccine Declination Statement The OSHA Standard requires that an employee who declines to accept hepatitis B vaccination offered by the employer sign the Hepatitis B Vaccine Declination provided with the record forms. This form must be retained for the duration of employment plus 30 years, except for employees who have worked less than one year (see above). 01/2008 33 Bloodborne Pathogens Informed Refusal by Employee of Postexposure Medical Evaluation and Follow-up There is no requirement that an employee who refuses postexposure medical evaluation and follow-up sign a statement to that effect. However, it is suggested that employers may want to use the form in this section to document such employee refusal. 01/2008 34 Bloodborne Pathogens EMPLOYEE MEDICAL RECORD CONFIDENTIAL Employee Medical Record Employee name: Employee address: Employee social security Employee starting number: date: Employee termination date (if any): History of HBV vaccination (date received, or, if not received, a brief explanation of why not): History of exposure incident(s) (dates, brief explanation, attachments): Results of medical exams and follow-up procedures regarding exposure incident or hepatitis B immunity, including written opinion of healthcare professional (dates, brief explanation, attachments): Information provided to the healthcare professional regarding hepatitis B vaccination and/or exposure incident(s) (dates, brief explanation, attachments): Note: Maintain this record for duration of employment plus 30 years. Medical records of employees who have worked for less than one year need not be retained beyond the term of employment if the records are provided to the employee upon termination of their employment. 01/2008 35 Bloodborne Pathogens HEPATITIS B VACCINE DECLINATION CONFIDENTIAL Hepatitis B Vaccine Declination I understand that due to my occupational exposure to blood or other potentially infectious materials, I may be at risk of acquiring hepatitis B virus (HBV) infection. I have been given the opportunity to be vaccinated with the hepatitis B vaccine, at no charge to myself. However, I decline hepatitis B vaccination at this time. I understand that by declining this vaccine, I continue to be at risk of acquiring hepatitis B, a serious disease. If in the future I continue to have occupational exposure to blood or other potentially infectious materials and I want to be vaccinated with the hepatitis B vaccine, I can receive the vaccination series at no charge to me. Witness Signature Name Address City, State, Zip Code Date Note: Maintain this record for duration of employment plus 30 years. Medical records of employees who have worked for less than one year need not be retained beyond the term of employment if the records are provided to the employee upon the termination of their employment. 01/2008 36 Bloodborne Pathogens INFORMED REFUSAL OF POSTEXPOSURE MEDICAL EVALUATION CONFIDENTIAL Informed Refusal of Postexposure Medical Evaluation I, , am employed by as a dentist/dental assistant/hygienist/lab technician. My employer has provided training to me regarding exposure control for bloodborne pathogens and the risk of disease transmission in the dental office. On , 20 , I was involved in an exposure incident when I (describe details of needlestick, etc.). My employer has offered to provide post exposure medical evaluation and follow-up for me in order to assure that I have full knowledge of whether I have been exposed to or contracted an infectious disease from this incident. However, I, of my own free will and volition, and despite my employer’s offer, have elected not to have a medical evaluation. I have personal reasons for making this decision. Witness Signature Name Address City, State, Zip Code Date Note: Maintain this record for duration of employment plus 30 years. Medical records of employees who have worked for less than one year need not be retained beyond the term of employment if the records are provided to the employee upon the termination of their employment. 01/2008 37 Bloodborne Pathogens This Page Intentionally Left Blank 01/2008 38 Bloodborne Pathogens EMPLOYEE T R AI NING REC ORD Employee Training Record Name of office Austin Community College – Department of Dental Hygiene Address of office 3401 Webberville Rd, Austin, TX 78702 Date of training session 09/01/2016 Name(s) and qualifications of person conducting training session Kate Goin, BA, RDH, OSHA Compliance Manager and ADA OSHA Training for Dental Professionals Video Contents/Summary of training session General Safety Standards and OSHA overview; Bloodborne Pathogens Standard; Hazard Communications Standard Names and job titles of all persons attending training session: Name Job Title Renee Cornett, RDH Full Time Faculty, Department Chair Michelle Landrum, RDH Full Time Faculty, Clinic Coordinator Tina Stein, RDH Full Time Faculty, Clinic Coordinator Joe Wright, DDS Full Time Faculty Kellie Hicks, RDH Adjunct Faculty Sima Sohrabi, RDH Adjunct Faculty Kimberly McDougall, RDH Adjunct Faculty David Reeves, DMD Adjunct Faculty Note: Maintain this record for duration of employment plus 30 years. Medical records of employees who have worked for less than one year need not be retained beyond the term of employment if the records are provided to the employee upon the termination of their employment. 01/2008 39 Bloodborne Pathogens Name Job Title Debra Segen, RDH Adjunct Faculty Rita Snodell, RDH Adjunct Faculty Prema Strecker, RDH Adjunct Faculty Veronica Ledesma, RDH Adjunct Faculty Teri Frank, CDA Administrative Assistant 01/2008 40 Bloodborne Pathogens EMPLOYEE T R AI NING REC ORD Employee Training Record Name of office Austin Community College – Department of Dental Hygiene Address of office 3401 Webberville Rd, Austin, TX 78702 Date of training session 09/12/2016 Name(s) and qualifications of person conducting training session Kate Goin, BA, RDH, OSHA Compliance Manager and ADA OSHA Training for Dental Professionals Video Contents/Summary of training session General Safety Standards and OSHA overview; Bloodborne Pathogens Standard; Hazard Communications Standard Names and job titles of all persons attending training session: Name Job Title Monique Alarcon Dental Hygiene Student Rachel Dickens Dental Hygiene Student Sunena Gagneja Dental Hygiene Student Lacie Herrin Dental Hygiene Student Dylon Hopper Dental Hygiene Student Cydnie Johnson Dental Hygiene Student Julia Levitt Dental Hygiene Student Stephanie Liu Dental Hygiene Student Note: Maintain this record for duration of employment plus 30 years. Medical records of employees who have worked for less than one year need not be retained beyond the term of employment if the records are provided to the employee upon the termination of their employment. 01/2008 41 Bloodborne Pathogens Name Job Title Kristi Madrid Dental Hygiene Student Katie Natale Dental Hygiene Student Aneesa Patel Dental Hygiene Student Lee Pepe Dental Hygiene Student Jennifer Rice Dental Hygiene Student Shaunda Talamantez Dental Hygiene Student Yula Voznesenskaya Dental Hygiene Student Jeremiah Wallace Dental Hygiene Student Allyson Walter Dental Hygiene Student 01/2008 42 Bloodborne Pathogens EMPLOYEE T R AI NING REC ORD Employee Training Record Name of office Austin Community College – Department of Dental Hygiene Address of office 3401 Webberville Rd, Austin, TX 78702 Date of training session 08/30/2016 Name(s) and qualifications of person conducting training session Kate Goin, BA, RDH, OSHA Compliance Manager and ADA OSHA Training for Dental Professionals Video Contents/Summary of training session General Safety Standards and OSHA overview; Bloodborne Pathogens Standard; Hazard Communications Standard Names and job titles of all persons attending training session: Name Job Title Jason Blunck Dental Hygiene Student Wendy Bushman Dental Hygiene Student Josette Chen Dental Hygiene Student Amy Deng Dental Hygiene Student Becca Eiserer Dental Hygiene Student Zainab Jabr Dental Hygiene Student Laura Jaimes Dental Hygiene Student Whitney Jones Dental Hygiene Student Note: Maintain this record for duration of employment plus 30 years. Medical records of employees who have worked for less than one year need not be retained beyond the term of employment if the records are provided to the employee upon the termination of their employment. 01/2008 43 Bloodborne Pathogens Name Job Title Molly Keith Dental Hygiene Student Shari Langerhans Dental Hygiene Student Jessica Lee Dental Hygiene Student Jess Ross Dental Hygiene Student Azadeh Samani Dental Hygiene Student Elya Singler Dental Hygiene Student 01/2008 44 Bloodborne Pathogens Bloodborne Pathogens Appendix A U.S. Department of Labor Occupational Safety & Health Administration www.osha.gov [skip navigational links] Search Advanced Search | A-Z Ind Regulations (Standards - 29 CFR) Bloodborne pathogens. - 1910.1030 Regulations (Standards - 29 CFR) - Table of Contents • • • • • • • Part Number: Part Title: Subpart: Subpart Title: Standard Number: Title: Appendix: 1910 Occupational Safety and Health Standards Z Toxic and Hazardous Substances 1910.1030 Bloodborne pathogens. A 1910.1030(a) Scope and Application. This section applies to all occupational exposure to blood or other potentially infectious materials as defined by paragraph (b) of this section. 1910.1030(b) Definitions. For purposes of this section, the following shall apply: Assistant Secretary means the Assistant Secretary of Labor for Occupational Safety and Health, or designated representative. Blood means human blood, human blood components, and products made from human blood. Bloodborne Pathogens means pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV) and human immunodeficiency virus (HIV). Clinical Laboratory means a workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials. Contaminated means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface. Contaminated Laundry means laundry which has been soiled with blood or other potentially infectious materials or may contain sharps. Contaminated Sharps means any contaminated object that can penetrate the skin including, but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires. Decontamination means the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ Director means the Director of the National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designated representative. Engineering Controls means controls (e.g., sharps disposal containers, selfsheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace. Exposure Incident means a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee's duties. Handwashing Facilities means a facility providing an adequate supply of running potable water, soap and single use towels or hot air drying machines. Licensed Healthcare Professional is a person whose legally permitted scope of practice allows him or her to independently perform the activities required by paragraph (f) Hepatitis B Vaccination and Post-exposure Evaluation and Followup. HBV means hepatitis B virus. HIV means human immunodeficiency virus. Needleless systems means a device that does not use needles for: (1) The collection of bodily fluids or withdrawal of body fluids after initial venous or arterial access is established; (2) The administration of medication or fluids; or (3) Any other procedure involving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps. Occupational Exposure means reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties. Other Potentially Infectious Materials means (1) The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids; (2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and (3) HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV. Parenteral means piercing mucous membranes or the skin barrier through such events as needlesticks, human bites, cuts, and abrasions. Personal Protective Equipment is specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment. Production Facility means a facility engaged in industrial-scale, large-volume or high concentration production of HIV or HBV. Regulated Waste means liquid or semi-liquid blood or other potentially BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials. Research Laboratory means a laboratory producing or using researchlaboratory-scale amounts of HIV or HBV. Research laboratories may produce high concentrations of HIV or HBV but not in the volume found in production facilities. Sharps with engineered sharps injury protections means a nonneedle sharp or a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids, with a built-in safety feature or mechanism that effectively reduces the risk of an exposure incident. Source Individual means any individual, living or dead, whose blood or other potentially infectious materials may be a source of occupational exposure to the employee. Examples include, but are not limited to, hospital and clinic patients; clients in institutions for the developmentally disabled; trauma victims; clients of drug and alcohol treatment facilities; residents of hospices and nursing homes; human remains; and individuals who donate or sell blood or blood components. Sterilize means the use of a physical or chemical procedure to destroy all microbial life including highly resistant bacterial endospores. Universal Precautions is an approach to infection control. According to the concept of Universal Precautions, all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens. Work Practice Controls means controls that reduce the likelihood of exposure by altering the manner in which a task is performed (e.g., prohibiting recapping of needles by a two-handed technique). 1910.1030(c) Exposure Control -1910.1030(c)(1) Exposure Control Plan. 1910.1030(c)(1)(i) Each employer having an employee(s) with occupational exposure as defined by paragraph (b) of this section shall establish a written Exposure Control Plan designed to eliminate or minimize employee exposure. 1910.1030(c)(1)(ii) The Exposure Control Plan shall contain at least the following elements: 1910.1030(c)(1)(ii)(A) The exposure determination required by paragraph (c)(2), BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ 1910.1030(c)(1)(ii)(B) The schedule and method of implementation for paragraphs (d) Methods of Compliance, (e) HIV and HBV Research Laboratories and Production Facilities, (f) Hepatitis B Vaccination and Post-Exposure Evaluation and Follow-up, (g) Communication of Hazards to Employees, and (h) Recordkeeping, of this standard, and 1910.1030(c)(1)(ii)(C) The procedure for the evaluation of circumstances surrounding exposure incidents as required by paragraph (f)(3)(i) of this standard. 1910.1030(c)(1)(iii) Each employer shall ensure that a copy of the Exposure Control Plan is accessible to employees in accordance with 29 CFR 1910.1020(e). 1910.1030(c)(1)(iv) The Exposure Control Plan shall be reviewed and updated at least annually and whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure and to reflect new or revised employee positions with occupational exposure. The review and update of such plans shall also: 1910.1030(c)(1)(iv)(A) Reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens; and 1910.1030(c)(1)(iv)(B) Document annually consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure. 1910.1030(c)(1)(v) An employer, who is required to establish an Exposure Control Plan shall solicit input from non-managerial employees responsible for direct patient care who are potentially exposed to injuries from contaminated sharps in the identification, evaluation, and selection of effective engineering and work practice controls and shall document the solicitation in the Exposure Control Plan. 1910.1030(c)(1)(vi) The Exposure Control Plan shall be made available to the Assistant Secretary and the Director upon request for examination and copying. 1910.1030(c)(2) Exposure Determination. 1910.1030(c)(2)(i) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ Each employer who has an employee(s) with occupational exposure as defined by paragraph (b) of this section shall prepare an exposure determination. This exposure determination shall contain the following: 1910.1030(c)(2)(i)(A) A list of all job classifications in which all employees in those job classifications have occupational exposure; 1910.1030(c)(2)(i)(B) A list of job classifications in which some employees have occupational exposure, and 1910.1030(c)(2)(i)(C) A list of all tasks and procedures or groups of closely related task and procedures in which occupational exposure occurs and that are performed by employees in job classifications listed in accordance with the provisions of paragraph (c)(2)(i)(B) of this standard. 1910.1030(c)(2)(ii) This exposure determination shall be made without regard to the use of personal protective equipment. 1910.1030(d) Methods of Compliance -1910.1030(d)(1) General. Universal precautions shall be observed to prevent contact with blood or other potentially infectious materials. Under circumstances in which differentiation between body fluid types is difficult or impossible, all body fluids shall be considered potentially infectious materials. 1910.1030(d)(2) Engineering and Work Practice Controls. 1910.1030(d)(2)(i) Engineering and work practice controls shall be used to eliminate or minimize employee exposure. Where occupational exposure remains after institution of these controls, personal protective equipment shall also be used. 1910.1030(d)(2)(ii) Engineering controls shall be examined and maintained or replaced on a regular schedule to ensure their effectiveness. 1910.1030(d)(2)(iii) Employers shall provide handwashing facilities which are readily accessible to employees. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ 1910.1030(d)(2)(iv) When provision of handwashing facilities is not feasible, the employer shall provide either an appropriate antiseptic hand cleanser in conjunction with clean cloth/paper towels or antiseptic towelettes. When antiseptic hand cleansers or towelettes are used, hands shall be washed with soap and running water as soon as feasible. 1910.1030(d)(2)(v) Employers shall ensure that employees wash their hands immediately or as soon as feasible after removal of gloves or other personal protective equipment. 1910.1030(d)(2)(vi) Employers shall ensure that employees wash hands and any other skin with soap and water, or flush mucous membranes with water immediately or as soon as feasible following contact of such body areas with blood or other potentially infectious materials. 1910.1030(d)(2)(vii) Contaminated needles and other contaminated sharps shall not be bent, recapped, or removed except as noted in paragraphs (d)(2)(vii)(A) and (d)(2) (vii)(B) below. Shearing or breaking of contaminated needles is prohibited. 1910.1030(d)(2)(vii)(A) Contaminated needles and other contaminated sharps shall not be bent, recapped or removed unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical or dental procedure. 1910.1030(d)(2)(vii)(B) Such bending, recapping or needle removal must be accomplished through the use of a mechanical device or a one-handed technique. 1910.1030(d)(2)(viii) Immediately or as soon as possible after use, contaminated reusable sharps shall be placed in appropriate containers until properly reprocessed. These containers shall be: 1910.1030(d)(2)(viii)(A) Puncture resistant; 1910.1030(d)(2)(viii)(B) Labeled or color-coded in accordance with this standard; 1910.1030(d)(2)(viii)(C) Leakproof on the sides and bottom; and BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ 1910.1030(d)(2)(viii)(D) In accordance with the requirements set forth in paragraph (d)(4)(ii)(E) for reusable sharps. 1910.1030(d)(2)(ix) Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure. 1910.1030(d)(2)(x) Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present. 1910.1030(d)(2)(xi) All procedures involving blood or other potentially infectious materials shall be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances. 1910.1030(d)(2)(xii) Mouth pipetting/suctioning of blood or other potentially infectious materials is prohibited. 1910.1030(d)(2)(xiii) Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping. 1910.1030(d)(2)(xiii)(A) The container for storage, transport, or shipping shall be labeled or color-coded according to paragraph (g)(1)(i) and closed prior to being stored, transported, or shipped. When a facility utilizes Universal Precautions in the handling of all specimens, the labeling/color-coding of specimens is not necessary provided containers are recognizable as containing specimens. This exemption only applies while such specimens/containers remain within the facility. Labeling or color-coding in accordance with paragraph (g)(1)(i) is required when such specimens/containers leave the facility. 1910.1030(d)(2)(xiii)(B) If outside contamination of the primary container occurs, the primary container shall be placed within a second container which prevents leakage during handling, processing, storage, transport, or shipping and is labeled or colorcoded according to the requirements of this standard. 1910.1030(d)(2)(xiii)(C) If the specimen could puncture the primary container, the primary container shall be placed within a secondary container which is puncture-resistant in BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ addition to the above characteristics. 1910.1030(d)(2)(xiv) Equipment which may become contaminated with blood or other potentially infectious materials shall be examined prior to servicing or shipping and shall be decontaminated as necessary, unless the employer can demonstrate that decontamination of such equipment or portions of such equipment is not feasible. 1910.1030(d)(2)(xiv)(A) A readily observable label in accordance with paragraph (g)(1)(i)(H) shall be attached to the equipment stating which portions remain contaminated. 1910.1030(d)(2)(xiv)(B) The employer shall ensure that this information is conveyed to all affected employees, the servicing representative, and/or the manufacturer, as appropriate, prior to handling, servicing, or shipping so that appropriate precautions will be taken. 1910.1030(d)(3) Personal Protective Equipment -1910.1030(d)(3)(i) Provision. When there is occupational exposure, the employer shall provide, at no cost to the employee, appropriate personal protective equipment such as, but not limited to, gloves, gowns, laboratory coats, face shields or masks and eye protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices. Personal protective equipment will be considered "appropriate" only if it does not permit blood or other potentially infectious materials to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used. 1910.1030(d)(3)(ii) Use. The employer shall ensure that the employee uses appropriate personal protective equipment unless the employer shows that the employee temporarily and briefly declined to use personal protective equipment when, under rare and extraordinary circumstances, it was the employee's professional judgment that in the specific instance its use would have prevented the delivery of health care or public safety services or would have posed an increased hazard to the safety of the worker or co-worker. When the employee makes this judgement, the circumstances shall be investigated and documented in order to determine whether changes can be instituted to prevent such occurrences in the future. 1910.1030(d)(3)(iii) Accessibility. The employer shall ensure that appropriate personal protective equipment in the appropriate sizes is readily accessible at the worksite or is issued to employees. Hypoallergenic gloves, glove liners, powderless gloves, or other similar alternatives shall be readily accessible to those employees who are BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ allergic to the gloves normally provided. 1910.1030(d)(3)(iv) Cleaning, Laundering, and Disposal. The employer shall clean, launder, and dispose of personal protective equipment required by paragraphs (d) and (e) of this standard, at no cost to the employee. 1910.1030(d)(3)(v) Repair and Replacement. The employer shall repair or replace personal protective equipment as needed to maintain its effectiveness, at no cost to the employee. 1910.1030(d)(3)(vi) If a garment(s) is penetrated by blood or other potentially infectious materials, the garment(s) shall be removed immediately or as soon as feasible. 1910.1030(d)(3)(vii) All personal protective equipment shall be removed prior to leaving the work area. 1910.1030(d)(3)(viii) When personal protective equipment is removed it shall be placed in an appropriately designated area or container for storage, washing, decontamination or disposal. 1910.1030(d)(3)(ix) Gloves. Gloves shall be worn when it can be reasonably anticipated that the employee may have hand contact with blood, other potentially infectious materials, mucous membranes, and non-intact skin; when performing vascular access procedures except as specified in paragraph (d)(3)(ix)(D); and when handling or touching contaminated items or surfaces. 1910.1030(d)(3)(ix)(A) Disposable (single use) gloves such as surgical or examination gloves, shall be replaced as soon as practical when contaminated or as soon as feasible if they are torn, punctured, or when their ability to function as a barrier is compromised. 1910.1030(d)(3)(ix)(B) Disposable (single use) gloves shall not be washed or decontaminated for reuse. 1910.1030(d)(3)(ix)(C) Utility gloves may be decontaminated for re-use if the integrity of the glove is not compromised. However, they must be discarded if they are cracked, peeling, torn, punctured, or exhibit other signs of deterioration or when their ability to function as a barrier is compromised. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ 1910.1030(d)(3)(ix)(D) If an employer in a volunteer blood donation center judges that routine gloving for all phlebotomies is not necessary then the employer shall: 1910.1030(d)(3)(ix)(D)(1) Periodically reevaluate this policy; 1910.1030(d)(3)(ix)(D)(2) Make gloves available to all employees who wish to use them for phlebotomy; 1910.1030(d)(3)(ix)(D)(3) Not discourage the use of gloves for phlebotomy; and 1910.1030(d)(3)(ix)(D)(4) Require that gloves be used for phlebotomy in the following circumstances: 1910.1030(d)(3)(ix)(D)(4)(i) When the employee has cuts, scratches, or other breaks in his or her skin; 1910.1030(d)(3)(ix)(D)(4)(ii) When the employee judges that hand contamination with blood may occur, for example, when performing phlebotomy on an uncooperative source individual; and 1910.1030(d)(3)(ix)(D)(4)(iii) When the employee is receiving training in phlebotomy. 1910.1030(d)(3)(x) Masks, Eye Protection, and Face Shields. Masks in combination with eye protection devices, such as goggles or glasses with solid side shields, or chinlength face shields, shall be worn whenever splashes, spray, spatter, or droplets of blood or other potentially infectious materials may be generated and eye, nose, or mouth contamination can be reasonably anticipated. 1910.1030(d)(3)(xi) Gowns, Aprons, and Other Protective Body Clothing. Appropriate protective clothing such as, but not limited to, gowns, aprons, lab coats, clinic jackets, or similar outer garments shall be worn in occupational exposure situations. The type and characteristics will depend upon the task and degree of exposure anticipated. 1910.1030(d)(3)(xii) Surgical caps or hoods and/or shoe covers or boots shall be worn in instances when gross contamination can reasonably be anticipated (e.g., autopsies, BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ orthopaedic surgery). 1910.1030(d)(4) Housekeeping -1910.1030(d)(4)(i) General. Employers shall ensure that the worksite is maintained in a clean and sanitary condition. The employer shall determine and implement an appropriate written schedule for cleaning and method of decontamination based upon the location within the facility, type of surface to be cleaned, type of soil present, and tasks or procedures being performed in the area. 1910.1030(d)(4)(ii) All equipment and environmental and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials. 1910.1030(d)(4)(ii)(A) Contaminated work surfaces shall be decontaminated with an appropriate disinfectant after completion of procedures; immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials; and at the end of the work shift if the surface may have become contaminated since the last cleaning. 1910.1030(d)(4)(ii)(B) Protective coverings, such as plastic wrap, aluminum foil, or imperviouslybacked absorbent paper used to cover equipment and environmental surfaces, shall be removed and replaced as soon as feasible when they become overtly contaminated or at the end of the workshift if they may have become contaminated during the shift. 1910.1030(d)(4)(ii)(C) All bins, pails, cans, and similar receptacles intended for reuse which have a reasonable likelihood for becoming contaminated with blood or other potentially infectious materials shall be inspected and decontaminated on a regularly scheduled basis and cleaned and decontaminated immediately or as soon as feasible upon visible contamination. 1910.1030(d)(4)(ii)(D) Broken glassware which may be contaminated shall not be picked up directly with the hands. It shall be cleaned up using mechanical means, such as a brush and dust pan, tongs, or forceps. 1910.1030(d)(4)(ii)(E) Reusable sharps that are contaminated with blood or other potentially infectious materials shall not be stored or processed in a manner that requires employees to reach by hand into the containers where these sharps have been placed. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ 1910.1030(d)(4)(iii) Regulated Waste -1910.1030(d)(4)(iii)(A) Contaminated Sharps Discarding and Containment. 1910.1030(d)(4)(iii)(A) (1) Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are: 1910.1030(d)(4)(iii)(A)(1)(i) Closable; 1910.1030(d)(4)(iii)(A)(1)(ii) Puncture resistant; 1910.1030(d)(4)(iii)(A)(1)(iii) Leakproof on sides and bottom; and 1910.1030(d)(4)(iii)(A)(1)(iv) Labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard. 1910.1030(d)(4)(iii)(A)(2) During use, containers for contaminated sharps shall be: 1910.1030(d)(4)(iii)(A) (2)(i) Easily accessible to personnel and located as close as is feasible to the immediate area where sharps are used or can be reasonably anticipated to be found (e.g., laundries); 1910.1030(d)(4)(iii)(A)(2)(ii) Maintained upright throughout use; and 1910.1030(d)(4)(iii)(A)(2)(iii) Replaced routinely and not be allowed to overfill. 1910.1030(d)(4)(iii)(A)(3) When moving containers of contaminated sharps from the area of use, the containers shall be: 1910.1030(d)(4)(iii)(A) (3)(i) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ Closed immediately prior to removal or replacement to prevent spillage or protrusion of contents during handling, storage, transport, or shipping; 1910.1030(d)(4)(iii)(A)(3)(ii) Placed in a secondary container if leakage is possible. The second container shall be: 1910.1030(d)(4)(iii)(A)(3)(ii)(A) Closable; 1910.1030(d)(4)(iii)(A)(3)(ii)(B) Constructed to contain all contents and prevent leakage during handling, storage, transport, or shipping; and 1910.1030(d)(4)(iii)(A)(3)(ii)(C) Labeled or color-coded according to paragraph (g)(1)(i) of this standard. 1910.1030(d)(4)(iii)(A)(4) Reusable containers shall not be opened, emptied, or cleaned manually or in any other manner which would expose employees to the risk of percutaneous injury. 1910.1030(d)(4)(iii)(B) Other Regulated Waste Containment -1910.1030(d)(4)(iii)(B)(1) Regulated waste shall be placed in containers which are: 1910.1030(d)(4)(iii)(B)(1)(i) Closable; 1910.1030(d)(4)(iii)(B)(1)(ii) Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport or shipping; 1910.1030(d)(4)(iii)(B)(1)(iii) Labeled or color-coded in accordance with paragraph (g)(1)(i) this standard; and 1910.1030(d)(4)(iii)(B)(1)(iv) Closed prior to removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping. 1910.1030(d)(4)(iii)(B)(2) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ If outside contamination of the regulated waste container occurs, it shall be placed in a second container. The second container shall be: 1910.1030(d)(4)(iii)(B)(2)(i) Closable; 1910.1030(d)(4)(iii)(B)(2)(ii) Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport or shipping; 1910.1030(d)(4)(iii)(B)(2)(iii) Labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard; and 1910.1030(d)(4)(iii)(B)(2)(iv) Closed prior to removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping. 1910.1030(d)(4)(iii)(C) Disposal of all regulated waste shall be in accordance with applicable regulations of the United States, States and Territories, and political subdivisions of States and Territories. 1910.1030(d)(4)(iv) Laundry. 1910.1030(d)(4)(iv)(A) Contaminated laundry shall be handled as little as possible with a minimum of agitation. 1910.1030(d)(4)(iv)(A)(1) Contaminated laundry shall be bagged or containerized at the location where it was used and shall not be sorted or rinsed in the location of use. 1910.1030(d)(4)(iv)(A)(2) Contaminated laundry shall be placed and transported in bags or containers labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard. When a facility utilizes Universal Precautions in the handling of all soiled laundry, alternative labeling or color-coding is sufficient if it permits all employees to recognize the containers as requiring compliance with Universal Precautions. 1910.1030(d)(4)(iv)(A)(3) Whenever contaminated laundry is wet and presents a reasonable likelihood of soak-through of or leakage from the bag or container, the laundry shall be placed and transported in bags or containers which prevent soak-through BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ and/or leakage of fluids to the exterior. 1910.1030(d)(4)(iv)(B) The employer shall ensure that employees who have contact with contaminated laundry wear protective gloves and other appropriate personal protective equipment. 1910.1030(d)(4)(iv)(C) When a facility ships contaminated laundry off-site to a second facility which does not utilize Universal Precautions in the handling of all laundry, the facility generating the contaminated laundry must place such laundry in bags or containers which are labeled or color-coded in accordance with paragraph (g)(1) (i). 1910.1030(e) HIV and HBV Research Laboratories and Production Facilities. 1910.1030(e)(1) This paragraph applies to research laboratories and production facilities engaged in the culture, production, concentration, experimentation, and manipulation of HIV and HBV. It does not apply to clinical or diagnostic laboratories engaged solely in the analysis of blood, tissues, or organs. These requirements apply in addition to the other requirements of the standard. 1910.1030(e)(2) Research laboratories and production facilities shall meet the following criteria: 1910.1030(e)(2)(i) Standard Microbiological Practices. All regulated waste shall either be incinerated or decontaminated by a method such as autoclaving known to effectively destroy bloodborne pathogens. 1910.1030(e)(2)(ii) Special Practices. 1910.1030(e)(2)(ii)(A) Laboratory doors shall be kept closed when work involving HIV or HBV is in progress. 1910.1030(e)(2)(ii)(B) Contaminated materials that are to be decontaminated at a site away from the work area shall be placed in a durable, leakproof, labeled or color-coded container that is closed before being removed from the work area. 1910.1030(e)(2)(ii)(C) Access to the work area shall be limited to authorized persons. Written policies BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ and procedures shall be established whereby only persons who have been advised of the potential biohazard, who meet any specific entry requirements, and who comply with all entry and exit procedures shall be allowed to enter the work areas and animal rooms. 1910.1030(e)(2)(ii)(D) When other potentially infectious materials or infected animals are present in the work area or containment module, a hazard warning sign incorporating the universal biohazard symbol shall be posted on all access doors. The hazard warning sign shall comply with paragraph (g)(1)(ii) of this standard. 1910.1030(e)(2)(ii)(E) All activities involving other potentially infectious materials shall be conducted in biological safety cabinets or other physical-containment devices within the containment module. No work with these other potentially infectious materials shall be conducted on the open bench. 1910.1030(e)(2)(ii)(F) Laboratory coats, gowns, smocks, uniforms, or other appropriate protective clothing shall be used in the work area and animal rooms. Protective clothing shall not be worn outside of the work area and shall be decontaminated before being laundered. 1910.1030(e)(2)(ii)(G) Special care shall be taken to avoid skin contact with other potentially infectious materials. Gloves shall be worn when handling infected animals and when making hand contact with other potentially infectious materials is unavoidable. 1910.1030(e)(2)(ii)(H) Before disposal all waste from work areas and from animal rooms shall either be incinerated or decontaminated by a method such as autoclaving known to effectively destroy bloodborne pathogens. 1910.1030(e)(2)(ii)(I) Vacuum lines shall be protected with liquid disinfectant traps and high-efficiency particulate air (HEPA) filters or filters of equivalent or superior efficiency and which are checked routinely and maintained or replaced as necessary. 1910.1030(e)(2)(ii)(J) Hypodermic needles and syringes shall be used only for parenteral injection and aspiration of fluids from laboratory animals and diaphragm bottles. Only needlelocking syringes or disposable syringe-needle units (i.e., the needle is integral to the syringe) shall be used for the injection or aspiration of other potentially infectious materials. Extreme caution shall be used when handling needles and syringes. A needle shall not be bent, sheared, replaced in the sheath or guard, or removed from the syringe following use. The needle and syringe shall be promptly placed in a puncture-resistant container and autoclaved or decontaminated before reuse or disposal. 1910.1030(e)(2)(ii)(K) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ All spills shall be immediately contained and cleaned up by appropriate professional staff or others properly trained and equipped to work with potentially concentrated infectious materials. 1910.1030(e)(2)(ii)(L) A spill or accident that results in an exposure incident shall be immediately reported to the laboratory director or other responsible person. 1910.1030(e)(2)(ii)(M) A biosafety manual shall be prepared or adopted and periodically reviewed and updated at least annually or more often if necessary. Personnel shall be advised of potential hazards, shall be required to read instructions on practices and procedures, and shall be required to follow them. 1910.1030(e)(2)(iii) Containment Equipment. 1910.1030(e)(2)(iii)(A) Certified biological safety cabinets (Class I, II, or III) or other appropriate combinations of personal protection or physical containment devices, such as special protective clothing, respirators, centrifuge safety cups, sealed centrifuge rotors, and containment caging for animals, shall be used for all activities with other potentially infectious materials that pose a threat of exposure to droplets, splashes, spills, or aerosols. 1910.1030(e)(2)(iii)(B) Biological safety cabinets shall be certified when installed, whenever they are moved and at least annually. 1910.1030(e)(3) HIV and HBV research laboratories shall meet the following criteria: 1910.1030(e)(3)(i) Each laboratory shall contain a facility for hand washing and an eye wash facility which is readily available within the work area. 1910.1030(e)(3)(ii) An autoclave for decontamination of regulated waste shall be available. 1910.1030(e)(4) HIV and HBV production facilities shall meet the following criteria: 1910.1030(e)(4)(i) The work areas shall be separated from areas that are open to unrestricted traffic flow within the building. Passage through two sets of doors shall be the basic requirement for entry into the work area from access corridors or other BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ contiguous areas. Physical separation of the high-containment work area from access corridors or other areas or activities may also be provided by a doubledoored clothes-change room (showers may be included), airlock, or other access facility that requires passing through two sets of doors before entering the work area. 1910.1030(e)(4)(ii) The surfaces of doors, walls, floors and ceilings in the work area shall be water resistant so that they can be easily cleaned. Penetrations in these surfaces shall be sealed or capable of being sealed to facilitate decontamination. 1910.1030(e)(4)(iii) Each work area shall contain a sink for washing hands and a readily available eye wash facility. The sink shall be foot, elbow, or automatically operated and shall be located near the exit door of the work area. 1910.1030(e)(4)(iv) Access doors to the work area or containment module shall be self-closing. 1910.1030(e)(4)(v) An autoclave for decontamination of regulated waste shall be available within or as near as possible to the work area. 1910.1030(e)(4)(vi) A ducted exhaust-air ventilation system shall be provided. This system shall create directional airflow that draws air into the work area through the entry area. The exhaust air shall not be recirculated to any other area of the building, shall be discharged to the outside, and shall be dispersed away from occupied areas and air intakes. The proper direction of the airflow shall be verified (i.e., into the work area). 1910.1030(e)(5) Training Requirements. Additional training requirements for employees in HIV and HBV research laboratories and HIV and HBV production facilities are specified in paragraph (g)(2)(ix). 1910.1030(f) Hepatitis B Vaccination and Post-exposure Evaluation and Follow-up -1910.1030(f)(1) General. 1910.1030(f)(1)(i) The employer shall make available the hepatitis B vaccine and vaccination series to all employees who have occupational exposure, and post-exposure evaluation and follow-up to all employees who have had an exposure incident. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ 1910.1030(f)(1)(ii) The employer shall ensure that all medical evaluations and procedures including the hepatitis B vaccine and vaccination series and post-exposure evaluation and follow-up, including prophylaxis, are: 1910.1030(f)(1)(ii)(A) Made available at no cost to the employee; 1910.1030(f)(1)(ii)(B) Made available to the employee at a reasonable time and place; 1910.1030(f)(1)(ii)(C) Performed by or under the supervision of a licensed physician or by or under the supervision of another licensed healthcare professional; and 1910.1030(f)(1)(ii)(D) Provided according to recommendations of the U.S. Public Health Service current at the time these evaluations and procedures take place, except as specified by this paragraph (f). 1910.1030(f)(1)(iii) The employer shall ensure that all laboratory tests are conducted by an accredited laboratory at no cost to the employee. 1910.1030(f)(2) Hepatitis B Vaccination. 1910.1030(f)(2)(i) Hepatitis B vaccination shall be made available after the employee has received the training required in paragraph (g)(2)(vii)(I) and within 10 working days of initial assignment to all employees who have occupational exposure unless the employee has previously received the complete hepatitis B vaccination series, antibody testing has revealed that the employee is immune, or the vaccine is contraindicated for medical reasons. 1910.1030(f)(2)(ii) The employer shall not make participation in a prescreening program a prerequisite for receiving hepatitis B vaccination. 1910.1030(f)(2)(iii) If the employee initially declines hepatitis B vaccination but at a later date while still covered under the standard decides to accept the vaccination, the employer shall make available hepatitis B vaccination at that time. 1910.1030(f)(2)(iv) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ The employer shall assure that employees who decline to accept hepatitis B vaccination offered by the employer sign the statement in Appendix A. 1910.1030(f)(2)(v) If a routine booster dose(s) of hepatitis B vaccine is recommended by the U.S. Public Health Service at a future date, such booster dose(s) shall be made available in accordance with section (f)(1)(ii). 1910.1030(f)(3) Post-exposure Evaluation and Follow-up. Following a report of an exposure incident, the employer shall make immediately available to the exposed employee a confidential medical evaluation and follow-up, including at least the following elements: 1910.1030(f)(3)(i) Documentation of the route(s) of exposure, and the circumstances under which the exposure incident occurred; 1910.1030(f)(3)(ii) Identification and documentation of the source individual, unless the employer can establish that identification is infeasible or prohibited by state or local law; 1910.1030(f)(3)(ii)(A) The source individual's blood shall be tested as soon as feasible and after consent is obtained in order to determine HBV and HIV infectivity. If consent is not obtained, the employer shall establish that legally required consent cannot be obtained. When the source individual's consent is not required by law, the source individual's blood, if available, shall be tested and the results documented. 1910.1030(f)(3)(ii)(B) When the source individual is already known to be infected with HBV or HIV, testing for the source individual's known HBV or HIV status need not be repeated. 1910.1030(f)(3)(ii)(C) Results of the source individual's testing shall be made available to the exposed employee, and the employee shall be informed of applicable laws and regulations concerning disclosure of the identity and infectious status of the source individual. 1910.1030(f)(3)(iii) Collection and testing of blood for HBV and HIV serological status; 1910.1030(f)(3)(iii)(A) The exposed employee's blood shall be collected as soon as feasible and tested after consent is obtained. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ 1910.1030(f)(3)(iii)(B) If the employee consents to baseline blood collection, but does not give consent at that time for HIV serologic testing, the sample shall be preserved for at least 90 days. If, within 90 days of the exposure incident, the employee elects to have the baseline sample tested, such testing shall be done as soon as feasible. 1910.1030(f)(3)(iv) Post-exposure prophylaxis, when medically indicated, as recommended by the U.S. Public Health Service; 1910.1030(f)(3)(v) Counseling; and 1910.1030(f)(3)(vi) Evaluation of reported illnesses. 1910.1030(f)(4) Information Provided to the Healthcare Professional. 1910.1030(f)(4)(i) The employer shall ensure that the healthcare professional responsible for the employee's Hepatitis B vaccination is provided a copy of this regulation. 1910.1030(f)(4)(ii) The employer shall ensure that the healthcare professional evaluating an employee after an exposure incident is provided the following information: 1910.1030(f)(4)(ii)(A) A copy of this regulation; 1910.1030(f)(4)(ii)(B) A description of the exposed employee's duties as they relate to the exposure incident; 1910.1030(f)(4)(ii)(C) Documentation of the route(s) of exposure and circumstances under which exposure occurred; 1910.1030(f)(4)(ii)(D) Results of the source individual's blood testing, if available; and 1910.1030(f)(4)(ii)(E) All medical records relevant to the appropriate treatment of the employee BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ including vaccination status which are the employer's responsibility to maintain. 1910.1030(f)(5) Healthcare Professional's Written Opinion. The employer shall obtain and provide the employee with a copy of the evaluating healthcare professional's written opinion within 15 days of the completion of the evaluation. 1910.1030(f)(5)(i) The healthcare professional's written opinion for Hepatitis B vaccination shall be limited to whether Hepatitis B vaccination is indicated for an employee, and if the employee has received such vaccination. 1910.1030(f)(5)(ii) The healthcare professional's written opinion for post-exposure evaluation and follow-up shall be limited to the following information: 1910.1030(f)(5)(ii)(A) That the employee has been informed of the results of the evaluation; and 1910.1030(f)(5)(ii)(B) That the employee has been told about any medical conditions resulting from exposure to blood or other potentially infectious materials which require further evaluation or treatment. 1910.1030(f)(5)(iii) All other findings or diagnoses shall remain confidential and shall not be included in the written report. 1910.1030(f)(6) Medical Recordkeeping. Medical records required by this standard shall be maintained in accordance with paragraph (h)(1) of this section. 1910.1030(g) Communication of Hazards to Employees -1910.1030(g)(1) Labels and Signs -1910.1030(g)(1)(i) Labels. 1910.1030(g)(1)(i)(A) Warning labels shall be affixed to containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material; and other BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ containers used to store, transport or ship blood or other potentially infectious materials, except as provided in paragraph (g)(1)(i)(E), (F) and (G). 1910.1030(g)(1)(i)(B) Labels required by this section shall include the following legend: 1910.1030(g)(1)(i)(C) These labels shall be fluorescent orange or orange-red or predominantly so, with lettering and symbols in a contrasting color. 1910.1030(g)(1)(i)(D) Labels shall be affixed as close as feasible to the container by string, wire, adhesive, or other method that prevents their loss or unintentional removal. 1910.1030(g)(1)(i)(E) Red bags or red containers may be substituted for labels. 1910.1030(g)(1)(i)(F) Containers of blood, blood components, or blood products that are labeled as to their contents and have been released for transfusion or other clinical use are exempted from the labeling requirements of paragraph (g). 1910.1030(g)(1)(i)(G) Individual containers of blood or other potentially infectious materials that are placed in a labeled container during storage, transport, shipment or disposal are exempted from the labeling requirement. 1910.1030(g)(1)(i)(H) Labels required for contaminated equipment shall be in accordance with this paragraph and shall also state which portions of the equipment remain contaminated. 1910.1030(g)(1)(i)(I) Regulated waste that has been decontaminated need not be labeled or colorcoded. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ 1910.1030(g)(1)(ii) Signs. 1910.1030(g)(1)(ii)(A) The employer shall post signs at the entrance to work areas specified in paragraph (e), HIV and HBV Research Laboratory and Production Facilities, which shall bear the following legend: (Name of the Infectious Agent) (Special requirements for entering the area) (Name, telephone number of the laboratory director or other responsible person.) 1910.1030(g)(1)(ii)(B) These signs shall be fluorescent orange-red or predominantly so, with lettering and symbols in a contrasting color. 1910.1030(g)(2) Information and Training. 1910.1030(g)(2)(i) Employers shall ensure that all employees with occupational exposure participate in a training program which must be provided at no cost to the employee and during working hours. 1910.1030(g)(2)(ii) Training shall be provided as follows: 1910.1030(g)(2)(ii)(A) At the time of initial assignment to tasks where occupational exposure may take place; 1910.1030(g)(2)(ii)(B) At least annually thereafter. 1910.1030(g)(2)(iii) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ [Reserved] 1910.1030(g)(2)(iv) Annual training for all employees shall be provided within one year of their previous training. 1910.1030(g)(2)(v) Employers shall provide additional training when changes such as modification of tasks or procedures or institution of new tasks or procedures affect the employee's occupational exposure. The additional training may be limited to addressing the new exposures created. 1910.1030(g)(2)(vi) Material appropriate in content and vocabulary to educational level, literacy, and language of employees shall be used. 1910.1030(g)(2)(vii) The training program shall contain at a minimum the following elements: 1910.1030(g)(2)(vii)(A) An accessible copy of the regulatory text of this standard and an explanation of its contents; 1910.1030(g)(2)(vii)(B) A general explanation of the epidemiology and symptoms of bloodborne diseases; 1910.1030(g)(2)(vii)(C) An explanation of the modes of transmission of bloodborne pathogens; 1910.1030(g)(2)(vii)(D) An explanation of the employer's exposure control plan and the means by which the employee can obtain a copy of the written plan; 1910.1030(g)(2)(vii)(E) An explanation of the appropriate methods for recognizing tasks and other activities that may involve exposure to blood and other potentially infectious materials; 1910.1030(g)(2)(vii)(F) An explanation of the use and limitations of methods that will prevent or reduce exposure including appropriate engineering controls, work practices, and personal protective equipment; 1910.1030(g)(2)(vii)(G) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ Information on the types, proper use, location, removal, handling, decontamination and disposal of personal protective equipment; 1910.1030(g)(2)(vii)(H) An explanation of the basis for selection of personal protective equipment; 1910.1030(g)(2)(vii)(I) Information on the hepatitis B vaccine, including information on its efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccine and vaccination will be offered free of charge; 1910.1030(g)(2)(vii)(J) Information on the appropriate actions to take and persons to contact in an emergency involving blood or other potentially infectious materials; 1910.1030(g)(2)(vii)(K) An explanation of the procedure to follow if an exposure incident occurs, including the method of reporting the incident and the medical follow-up that will be made available; 1910.1030(g)(2)(vii)(L) Information on the post-exposure evaluation and follow-up that the employer is required to provide for the employee following an exposure incident; 1910.1030(g)(2)(vii)(M) An explanation of the signs and labels and/or color coding required by paragraph (g)(1); and 1910.1030(g)(2)(vii)(N) An opportunity for interactive questions and answers with the person conducting the training session. 1910.1030(g)(2)(viii) The person conducting the training shall be knowledgeable in the subject matter covered by the elements contained in the training program as it relates to the workplace that the training will address. 1910.1030(g)(2)(ix) Additional Initial Training for Employees in HIV and HBV Laboratories and Production Facilities. Employees in HIV or HBV research laboratories and HIV or HBV production facilities shall receive the following initial training in addition to the above training requirements. 1910.1030(g)(2)(ix)(A) The employer shall assure that employees demonstrate proficiency in standard microbiological practices and techniques and in the practices and operations BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ specific to the facility before being allowed to work with HIV or HBV. 1910.1030(g)(2)(ix)(B) The employer shall assure that employees have prior experience in the handling of human pathogens or tissue cultures before working with HIV or HBV. 1910.1030(g)(2)(ix)(C) The employer shall provide a training program to employees who have no prior experience in handling human pathogens. Initial work activities shall not include the handling of infectious agents. A progression of work activities shall be assigned as techniques are learned and proficiency is developed. The employer shall assure that employees participate in work activities involving infectious agents only after proficiency has been demonstrated. 1910.1030(h) Recordkeeping -1910.1030(h)(1) Medical Records. 1910.1030(h)(1)(i) The employer shall establish and maintain an accurate record for each employee with occupational exposure, in accordance with 29 CFR 1910.1020. 1910.1030(h)(1)(ii) This record shall include: 1910.1030(h)(1)(ii)(A) The name and social security number of the employee; 1910.1030(h)(1)(ii)(B) A copy of the employee's hepatitis B vaccination status including the dates of all the hepatitis B vaccinations and any medical records relative to the employee's ability to receive vaccination as required by paragraph (f)(2); 1910.1030(h)(1)(ii)(C) A copy of all results of examinations, medical testing, and follow-up procedures as required by paragraph (f)(3); 1910.1030(h)(1)(ii)(D) The employer's copy of the healthcare professional's written opinion as required by paragraph (f)(5); and 1910.1030(h)(1)(ii)(E) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ A copy of the information provided to the healthcare professional as required by paragraphs (f)(4)(ii)(B)(C) and (D). 1910.1030(h)(1)(iii) Confidentiality. The employer shall ensure that employee medical records required by paragraph (h)(1) are: 1910.1030(h)(1)(iii)(A) Kept confidential; and 1910.1030(h)(1)(iii)(B) Not disclosed or reported without the employee's express written consent to any person within or outside the workplace except as required by this section or as may be required by law. 1910.1030(h)(1)(iv) The employer shall maintain the records required by paragraph (h) for at least the duration of employment plus 30 years in accordance with 29 CFR 1910.1020. 1910.1030(h)(2) Training Records. 1910.1030(h)(2)(i) Training records shall include the following information: 1910.1030(h)(2)(i)(A) The dates of the training sessions; 1910.1030(h)(2)(i)(B) The contents or a summary of the training sessions; 1910.1030(h)(2)(i)(C) The names and qualifications of persons conducting the training; and 1910.1030(h)(2)(i)(D) The names and job titles of all persons attending the training sessions. 1910.1030(h)(2)(ii) Training records shall be maintained for 3 years from the date on which the training occurred. 1910.1030(h)(3) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ Availability. 1910.1030(h)(3)(i) The employer shall ensure that all records required to be maintained by this section shall be made available upon request to the Assistant Secretary and the Director for examination and copying. 1910.1030(h)(3)(ii) Employee training records required by this paragraph shall be provided upon request for examination and copying to employees, to employee representatives, to the Director, and to the Assistant Secretary. 1910.1030(h)(3)(iii) Employee medical records required by this paragraph shall be provided upon request for examination and copying to the subject employee, to anyone having written consent of the subject employee, to the Director, and to the Assistant Secretary in accordance with 29 CFR 1910.1020. 1910.1030(h)(4) Transfer of Records. 1910.1030(h)(4)(i) The employer shall comply with the requirements involving transfer of records set forth in 29 CFR 1910.1020(h). 1910.1030(h)(4)(ii) If the employer ceases to do business and there is no successor employer to receive and retain the records for the prescribed period, the employer shall notify the Director, at least three months prior to their disposal and transmit them to the Director, if required by the Director to do so, within that three month period. 1910.1030(h)(5) Sharps injury log. 1910.1030(h)(5)(i) The employer shall establish and maintain a sharps injury log for the recording of percutaneous injuries from contaminated sharps. The information in the sharps injury log shall be recorded and maintained in such manner as to protect the confidentiality of the injured employee. The sharps injury log shall contain, at a minimum: 1910.1030(h)(5)(i)(A) The type and brand of device involved in the incident, 1910.1030(h)(5)(i)(B) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ The department or work area where the exposure incident occurred, and 1910.1030(h)(5)(i)(C) An explanation of how the incident occurred. 1910.1030(h)(5)(ii) The requirement to establish and maintain a sharps injury log shall apply to any employer who is required to maintain a log of occupational injuries and illnesses under 29 CFR 1904. 1910.1030(h)(5)(iii) The sharps injury log shall be maintained for the period required by 29 CFR 1904.6. 1910.1030(i) Dates -1910.1030(i)(1) Effective Date. The standard shall become effective on March 6, 1992. 1910.1030(i)(2) The Exposure Control Plan required by paragraph (c) of this section shall be completed on or before May 5, 1992. 1910.1030(i)(3) Paragraph (g)(2) Information and Training and (h) Recordkeeping shall take effect on or before June 4, 1992. 1910.1030(i)(4) Paragraphs (d)(2) Engineering and Work Practice Controls, (d)(3) Personal Protective Equipment, (d)(4) Housekeeping, (e) HIV and HBV Research Laboratories and Production Facilities, (f) Hepatitis B Vaccination and PostExposure Evaluation and Follow-up, and (g)(1) Labels and Signs, shall take effect July 6, 1992. [56 FR 64004, Dec. 06, 1991, as amended at 57 FR 12717, April 13, 1992; 57 FR 29206, July 1, 1992; 61 FR 5507, Feb. 13, 1996; 66 FR 5325 Jan., 18, 2001; 71 FR 16672 and 16673, April 3, 2006] Next Standard (1910.1030 App A) Regulations (Standards - 29 CFR) - Table of Contents Back to Top www.osha.gov BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[$ Bloodborne Pathogens Appendix B Summary of CDC’s Guidelines for Infection Control in Dental Health-Care Settings - 2003 New CDC Guidelines for Infection Control in Dental Health-Care Settings - 2003 were released on December 19, 2003. These recommendations incorporate into a single document advances in infection control knowledge and technology acquired since 1993. Furthermore, pertinent recommendations found in regulatory documents from other agencies are also included. The CDC endeavored to base recommendations upon sound scientific data, theoretical rationale and applicability to dentistry. Recommendations were categorized by the quality of the supporting data. Guidance is provided for infection control issues when insufficient evidence is available to make a recommendation. Several research studies conducted by the ADA contributed to the formulation of these recommendations. The following summary focuses on recommendations and guidances that are new or modified from 1993 infection control recommendations. NEW: Issue not addressed in the 1993 recommendations or substantially modified since 1993. UPDATED: Issue previously addressed but updated with new information. Standard Precautions. UPDATED. Standard precautions now supercede the use of universal precautions. In 1996, CDC replaced universal precautions with Standard Precautions. Standard precautions integrate and expand the elements of universal precautions into a standard of care designed to protect health care providers and patients from pathogens that may be spread by blood or any other body fluid, excretion, or secretion. Standard precautions apply to contact with 1) blood; 2) all body fluids, secretions, and excretions except sweat, regardless of whether they contain blood; 3) nonintact skin; and 4) mucous membranes. Airborne pathogen transmission cannot be adequately prevented by standard precautions. Oral Surgical Procedures. NEW. The oral cavity is colonized with numerous microorganisms. Oral surgical procedures present an opportunity for entry of microorganisms (i.e., exogenous and endogenous) into the vascular system and other normally sterile areas of the oral cavity (e.g., bone, subcutaneous tissue) and an increased potential for localized or systemic infection. Oral surgical procedures involve the incision, excision, or reflection of tissue that exposes the normally sterile areas of the oral cavity. Examples include biopsy, periodontal surgery, apical surgery, implant surgery, and surgical extractions of teeth (e.g., removal of erupted or nonerupted tooth, requiring elevation of mucoperiosteal flap, removal of bone and/or section of tooth, and suturing if needed). Sterile gloves and sterile water are recommended for all oral surgical procedures. Furthermore, either plain soap and water or an antimicrobial soap and water followed by an alcohol-based hand rub with persistent activity should be used before any oral surgical procedure. Persistent activity refers to prolonged or extended activity that prevents or inhibits the proliferation or survival of microorganisms after application of the product. After application of an alcoholbased product, hands and forearms should dry thoroughly before immediately donning sterile gloves and other personal protective equipment (e.g., surgical mask, protective eyewear, protective clothing). 31 Bloodborne Pathogens Appendix B Dental Unit Water Quality. NEW. Dentists need to assure that the quality of water emanating from their dental units does not exceed 500 colony-forming units per milliliter (CFU/mL). This means that dental units directly plumbed to municipal water sources likely need to be retrofitted with a self-contained water supply as soon as possible. Furthermore, all closed-circuit water supply systems in dental units would require implementation of a regular schedule of water line cleaning or disinfection to control biofilm proliferation. This schedule includes periodic microbial enumeration to assure effluent below 500 CFU/mL. 500 CFU/mL is a realistic, achievable microbial level for dental unit water, and is the EPA standard level for potable drinking water. The previous recommendation to flush waterlines at the beginning of each clinic day has been eliminated. If dental unit water treatments are successful in meeting the requirement for 500 CFU/mL, then there is no reason to continue initial flushing. The recommendation remains for flushing the high-speed handpiece for 20-30 seconds between patients to expel any patient material. Environmental Surface Disinfection. UPDATED. A tuberculocidal claim is no longer required for environmental surface disinfectants. Disinfectants carrying a virucidal claim for HBV and HIV are now permitted; giving dentists a greater choice of available disinfectants, which may be less corrosive to equipment, have a more pleasant odor or lower toxic potential than some tuberculocidal products. Many surrogate tests for HBV or HCV virucidal activity have been recently developed and have been accepted by the EPA as predictive of virucidal activity. As a result many more disinfectants now carry a label claim of efficacy against HBV, HCV, HIV as well as a host of pathogenic bacteria and fungi. This recommendation is consistent with the OSHA bloodborne pathogens standard recommendations. Furthermore, disinfectants that carry a TB kill claim can continue to be used as surface disinfectants, but do not use glutaraldehyde based products for surface disinfection. Immunization. UPDATED. Immunization of DHCP (dental health care providers) before they are placed at risk remains the most efficient and effective use of vaccines in health-care settings. Detailed recommendations and immunization schedule are provided for immunization of dental health care providers against several pathogenic organisms for which vaccines are available. Earliest possible hepatitis B vaccination continues to be recommended, along with post vaccination testing for surface antibody within 1 to 2 months following the final inoculation. Booster inoculation for individuals who have lost surface antibody titers continues not to be recommended. Work restrictions for health care personnel occupationally exposed to or infected with infectious diseases. NEW. The use of standard precautions is effective in preventing transmission of an infectious agent from provider to patient. Under certain circumstances, however, health care facilities may need to implement additional measures to prevent further transmission of infection that warrant exclusion of personnel from work or patient contact. Decisions on work restrictions are based on the mode of transmission and the epidemiology of the disease. Exclusion policies should be written, include a statement of authority defining who may exclude personnel (e.g., personal physician), and be clearly communicated to personnel through education and training. Policies also need to be designed to encourage personnel to report their illnesses or exposures and not to penalize them with loss of wages, benefits or job status. 32 Bloodborne Pathogens Appendix B Management of occupational exposures to bloodborne pathogens, including postexposure prophylaxis (PEP). NEW. Follow current CDC recommendations for postexposure management and prophylaxis after percutaneous, mucous membrane, or nonintact skin exposure to blood or blood-contaminated saliva. Many effective antiviral therapies were discovered over the past decade resulting in modified approaches to PEP. The US Public Health Service (USPHS) published several guidelines for the management of exposures to HBV, HCV, or HIV that included considerations for PEP and management. The USPHS consolidated into one set of guidelines (MMWR June 29, 2001/ Vol. 50/ No. RR11) all previous USPHS recommendations. Current guidelines reflect the availability of new antiretroviral agents, new information about the use and safety of HIV PEP, and considerations about employing HIV PEP when resistance of the source patient’s virus to antiretroviral agents is known or suspected. In addition, the 2001 document provides guidance to clinicians and exposed HCP on deciding when to consider HIV PEP and recommendations for PEP regimens. Selection and use of devices with features engineered to prevent sharps injury. NEW. Improved safety devices continue to emerge for the prevention of percutaneous injuries, and DHCPs are encouraged to use and evaluate these new devices as they become available (e.g., safer anesthetic syringes, blunt suture needle, retractable scalpel, needleless IV system). Hand hygiene. UPDATED. Reduction of the bioburden on the skin of hands is one of the most important methods of reducing microbial transmission in a health care setting. When hands are visibly dirty or contaminated with proteinaceous material or are visibly soiled with blood or other body fluids, perform hand hygiene with either a non-antimicrobial soap and water or an antimicrobial soap and water. If hands are not visibly soiled, a nonantimicrobial soap, an antimicrobial soap or an alcohol-based hand rub may be used. Contact dermatitis and latex hypersensitivity. NEW. Dental health care providers must familiarize themselves about the signs, symptoms, and diagnoses of skin reactions associated with frequent hand hygiene and glove use. Immediate and delayed hypersensitivities have been associated with natural rubber latex (NRL) proteins and processing chemicals used in the manufacture of NRL gloves. Lotions should be used to prevent skin dryness associated with hand washing at the end of the workday. Lotions must be compatible with antiseptic products and must not compromise the integrity of gloves. Petroleum-based lotions will degrade NRL gloves. Flash sterilization. NEW. Patient care items routinely should not be sterilized unwrapped. Use must be limited to emergency situations where time does not permit wrapped, full cycle heat sterilization. Boil-water advisories. NEW. While a boil-water advisory is in effect do not deliver water from the public water system to the patient through the dental operative unit, ultrasonic scaler, or other dental equipment that uses the public water system. Do not use water from the public water system for dental treatment, patient rinsing or hand washing. Use antimicrobialcontaining products for hand washing that does not require water for use such as alcoholbased hand rubs. If hands are visibly soiled, use bottled water and soap for hand washing or a detergent-containing towelette. When the boil-water advisory is cancelled follow guidance given by the local water utility on proper flushing of waterlines. If no guidance is provided, flush dental waterlines and faucets for 1 to 5 minutes before using for patient care. Disinfect dental waterlines as recommended by the dental unit manufacturer. 33 Bloodborne Pathogens Appendix B Aseptic technique for parenteral medications. NEW. Medication from a single-dose syringe must not be administered to multiple patients even if the needle on the syringe is changed. Use single-dose vials for parenteral additives or medications when possible. Do not combine the leftover content of single-use vials for later use. If multiple dose vials are used, cleanse the access diaphragm of multiple dose vials with 70% alcohol before inserting a device into the vial. Use a sterile device to access a multiple dose vial and avoid touch contamination of the device before penetrating the access diaphragm. Refrigerate multiple dose vials after they are opened if recommended by the manufacturer. Discard a multiple dose vial if sterility is compromised. All fluid infusion and administration sets (IV tubing and connections) are single patient use. Pre-procedural mouth rinsing for patients. NEW. To date, no scientific evidence indicates that pre-procedural mouth rinsing prevents clinical infections among DHCP or patients. Therefore, only guidance is provided without recommendation. However, studies have shown that a pre-procedural rinse with a long-lasting antimicrobial (e.g., chlorhexidine gluconate, essential oils, povidone-iodine) can reduce the level of oral microorganisms generated during routine dental procedures with rotary instruments (e.g., dental handpieces, ultrasonic scalers). Pre-procedural mouth rinses may be most beneficial before a procedure using a prophylaxis cup or ultrasonic scaler because rubber dams cannot be used to minimize aerosol and spatter generation; unless the provider has an assistant, high-volume evacuation is not commonly used. Transmissible spongiform encephalopathies (TSEs). NEW. There is no evidence to indicate that TSEs are transmissible in a dental setting. Nevertheless, guidances but not recommendations are provided for preventing the transmission of prionic protein from an infected patient requiring dental care. The use of disposable items is encouraged along with chemical pretreatment followed by prolonged steam sterilization for non-disposable items. Handling of Extracted Teeth. UPDATED. Extracted teeth containing amalgam should not be disposed of in regulated medical waste intended for incineration. Incineration will vaporize mercury. Program evaluation. NEW. Dental facilities should establish an infection control program evaluation, based on evaluation of performance indicators at an established frequency. The primary goal of an infection control program is to prevent errors and provide a safe working environment that will reduce the risk of health-care-associated infections among patients and occupational exposures among DHCP. Medical errors are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent them. Effective program evaluation is a systematic way to improve and account for safe public health actions by involving procedures that are useful, feasible, ethical, and accurate. 34 Bloodborne Pathogens Appendix B Bloodborne Pathogens Appendix C 66 MMWR December 19, 2003 Appendix C Methods for Sterilizing and Disinfecting Patient-Care Items and Environmental Surfaces* Health-care application Process Sterilization Result Destroys all microorganisms, including bacterial spores. Method Heat-automated High temperature Examples Type of patient-care item Environmental surfaces Not applicable Steam, dry heat, unsaturated chemical vapor Heat-tolerant critical and semicritical Ethylene oxide gas, plasma sterilization Heat-sensitive critical and semicritical Liquid immersion† Chemical sterilants. Glutaraldehyde, glutaraldehydes with phenol, hydrogen peroxide, hydrogen peroxide with peracetic acid, peracetic acid Heat-sensitive critical and semicritical Destroys all microorganisms, but not necessarily high numbers of bacterial spores. Heat-automated Washer-disinfector Heat-sensitive semicritical Not applicable Liquid immersion† Chemical sterilants/high-level disinfectants. Glutaraldehyde, glutaraldehyde with phenol, hydrogen peroxide, hydrogen peroxide with peracetic acid, ortho-phthalaldehyde Intermediatelevel disinfection Destroys vegetative bacteria and the majority of fungi and viruses. Inactivates Mycobacterium bovis.§ Not necessarily capable of killing bacterial spores. Liquid contact U.S. Environmental Protection Agency (EPA)registered hospital disinfectant with label claim of tuberculocidal activity (e.g., chlorinecontaining products, quaternary ammonium compounds with alcohol, phenolics, iodophors, EPA-registered chlorine-based product¶) Noncritical with visible blood Clinical contact surfaces; blood spills on housekeeping surfaces Low-level disinfection Destroys the majority of vegetative bacteria, certain fungi, and viruses. Does not inactivate Mycobacterium bovis .§ Liquid contact EPA-registered hospital disinfectant with no label claim regarding tuberculocidal activity.** The Occupational Safety and Health Administration also requires label claims of human immunodeficiency virus (HIV) and hepatitis B virus (HBV) potency for clinical contact surfaces (e.g., quaternary ammonium compounds, some phenolics, some iodophors) Noncritical without visible blood Clinical contact surfaces; housekeeping surfaces Low temperature High-level disinfection * EPA and the Food and Drug Administration (FDA) regulate chemical germicides used in health-care settings. FDA regulates chemical sterilants used on critical and semicritical medical devices, and the EPA regulates gaseous sterilants and liquid chemical disinfectants used on noncritical surfaces. FDA also regulates medical devices, including sterilizers. More information is available at 1) http://www.epa.gov/oppad001/chemregindex.htm, 2) http://www.fda.gov/cdrh/index.html, and 3) http://www.fda.gov/cdrh/ode/ germlab.html. † Contact time is the single critical variable distinguishing the sterilization process from high-level disinfection with FDA-cleared liquid chemical sterilants. FDA defines a high-level disinfectant as a sterilant used under the same contact conditions as sterilization except for a shorter immersion time (C-1). § The tuberculocidal claim is used as a benchmark to measure germicidal potency. Tuberculosis (TB) is transmitted via the airborne route rather than by environmental surfaces and, accordingly, use of such products on environmental surfaces plays no role in preventing the spread of TB. Because mycobacteria have among the highest intrinsic levels of resistance among vegetative bacteria, viruses, and fungi, any germicide with a tuberculocidal claim on the label (i.e., an intermediate-level disinfectant) is considered capable of inactivating a broad spectrum of pathogens, including much less resistant organisms, including bloodborne pathogens (e.g., HBV, hepatitis C virus [HCV], and HIV). It is this broad-spectrum capability, rather than the product’s specific potency against mycobacteria, that is the basis for protocols and regulations dictating use of tuberculocidal chemicals for surface disinfection. ¶ Chlorine-based products that are EPA-registered as intermediate-level disinfectants are available commercially. In the absence of an EPA-registered chlorine-based product, a fresh solution of sodium hypochlorite (e.g., household bleach) is an inexpensive and effective intermediate-level germicide. Concentrations ranging from 500 ppm to 800 ppm of chlorine (1:100 dilution of 5.25% bleach and tap water, or approximately ¼ cup of 5.25% bleach to 1 gallon of water) are effective on environmental surfaces that have been cleaned of visible contamination. Appropriate personal protective equipment (e.g., gloves and goggles) should be worn when preparing hypochlorite solutions (C-2,C-3). Caution should be exercised, because chlorine solutions are corrosive to metals, especially aluminum. ** Germicides labeled as “hospital disinfectant” without a tuberculocidal claim pass potency tests for activity against three representative microorganisms: Pseudomonas aeruginosa, Staphylococcus aureus, and Salmonella choleraesuis. References C-1. Food and Drug Administration. Guidance for industry and FDA reviewers: content and format of premarket notification [510(k)] submissions for liquid chemical sterilants/high level disinfectants. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, 2000. Available at http://www.fda.gov/cdrh/ode/ 397.pdf. C-2. US Department of Labor, Occupational Safety and Health Administration. 29 CFR Part 1910.1030. Occupational exposure to bloodborne pathogens; needlesticks and other sharps injuries; final rule. Federal Register 2001;66:5317–25. As amended from and includes 29 CFR Part 1910.1030. Occupational exposure to bloodborne pathogens; final rule. Federal Register 1991;56:64174–82. Available at http://www. osha.gov/SLTC/dentistry/index.html. C-3. CDC. Guidelines for environmental infection control in health-care facilities: recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). MMWR 2003;52(No. RR-10). BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[& Bloodborne Pathogens Appendix D Morbidity and Mortality Weekly Report Recommendations and Reports December 19, 2003 / Vol. 52 / No. RR-17 Guidelines for Infection Control in Dental Health-Care Settings — 2003 INSIDE: Continuing Education Examination depar tment of health and human ser vices department services Centers for Disease Control and Prevention BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' MMWR CONTENTS The MMWR series of publications is published by the Epidemiology Program Office, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, Atlanta, GA 30333. SUGGESTED CITATION Centers for Disease Control and Prevention. Guidelines for Infection Control in Dental Health-Care Settings — 2003. MMWR 2003;52(No. RR-17):[inclusive page numbers]. Centers for Disease Control and Prevention Julie L. Gerberding, M.D., M.P.H. Director Dixie E. Snider, Jr., M.D., M.P.H. (Acting) Deputy Director for Public Health Science Susan Y. Chu, Ph.D., M.S.P.H. (Acting) Associate Director for Science Epidemiology Program Office Stephen B. Thacker, M.D., M.Sc. Director Office of Scientific and Health Communications John W. Ward, M.D. Director Editor, MMWR Series Suzanne M. Hewitt, M.P.A. Managing Editor, MMWR Series C. Kay Smith-Akin, M.Ed. Lead Technical Writer/Editor C. Kay Smith-Akin, M.Ed. Douglas W. Weatherwax Project Editors Beverly J. Holland Lead Visual Information Specialist Malbea A. LaPete Visual Information Specialist Kim L. Bright, M.B.A. Quang M. Doan, M.B.A. Erica R. Shaver Information Technology Specialists Introduction ......................................................................... 1 Background ......................................................................... 2 Previous Recommendations .............................................. 3 Selected Definitions .......................................................... 4 Review of Science Related to Dental Infection Control ......... 6 Personnel Health Elements of an Infection-Control Program .......................................................................... 6 Preventing Transmission of Bloodborne Pathogens ................................................ 10 Hand Hygiene ................................................................ 14 Personal Protective Equipment ........................................ 16 Contact Dermatitis and Latex Hypersensitivity ................. 19 Sterilization and Disinfection of Patient-Care Items ......... 20 Environmental Infection Control ..................................... 25 Dental Unit Waterlines, Biofilm, and Water Quality ......... 28 Special Considerations ...................................................... 30 Dental Handpieces and Other Devices Attached to Air and Waterlines .................................................... 30 Saliva Ejectors ................................................................ 31 Dental Radiology ............................................................ 31 Aseptic Technique for Parenteral Medications ................. 31 Single-Use or Disposable Devices ................................... 32 Preprocedural Mouth Rinses ........................................... 32 Oral Surgical Procedures ................................................ 32 Handling of Biopsy Specimens ........................................ 33 Handling of Extracted Teeth ............................................ 33 Dental Laboratory ........................................................... 33 Laser/Electrosurgery Plumes or Surgical Smoke .............. 34 M. tuberculosis ................................................................. 35 Creutzfeldt-Jakob Disease and Other Prion Diseases ...... 36 Program Evaluation ........................................................ 37 Infection-Control Research Considerations ..................... 38 Recommendations ............................................................. 39 Infection-Control Internet Resources ................................. 48 Acknowledgement ............................................................. 48 References ......................................................................... 48 Appendix A ....................................................................... 62 Appendix B ........................................................................ 65 Appendix C ....................................................................... 66 Continuing Education Activity* ....................................... CE-1 * For Continuing Dental Education (CDE), see http://www.ada.org. To request additional copies of this report, contact CDC's Division of Oral Health by e-mail: [email protected]; telephone: 770-4886054; or fax: 770-488-6080. Disclosure of Relationship Our subject matter experts wish to disclose they have no financial interests or other relationships with the manufacture of commercial products, providers of commercial services, or commercial supporters. This report does not include any discussion of the unlabeled use of commercial products or products for investigational use. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports 1 Guidelines for Infection Control in Dental Health-Care Settings — 2003 Prepared by William G. Kohn, D.D.S.1 Amy S. Collins, M.P.H.1 Jennifer L. Cleveland, D.D.S.1 Jennifer A. Harte, D.D.S.2 Kathy J. Eklund, M.H.P.3 Dolores M. Malvitz, Dr.P.H.1 1 Division of Oral Health National Center for Chronic Disease Prevention and Health Promotion, CDC 2 United States Air Force Dental Investigation Service Great Lakes, Illinois 3 The Forsyth Institute Boston, Massachusetts Summary This report consolidates previous recommendations and adds new ones for infection control in dental settings. Recommendations are provided regarding 1) educating and protecting dental health-care personnel; 2) preventing transmission of bloodborne pathogens; 3) hand hygiene; 4) personal protective equipment; 5) contact dermatitis and latex hypersensitivity; 6) sterilization and disinfection of patient-care items; 7) environmental infection control; 8) dental unit waterlines, biofilm, and water quality; and 9) special considerations (e.g., dental handpieces and other devices, radiology, parenteral medications, oral surgical procedures, and dental laboratories). These recommendations were developed in collaboration with and after review by authorities on infection control from CDC and other public agencies, academia, and private and professional organizations. Introduction This report consolidates recommendations for preventing and controlling infectious diseases and managing personnel health and safety concerns related to infection control in dental settings. This report 1) updates and revises previous CDC recommendations regarding infection control in dental settings (1,2); 2) incorporates relevant infection-control measures from other CDC guidelines; and 3) discusses concerns not addressed in previous recommendations for dentistry. These updates and additional topics include the following: • application of standard precautions rather than universal precautions; • work restrictions for health-care personnel (HCP) infected with or occupationally exposed to infectious diseases; • management of occupational exposures to bloodborne pathogens, including postexposure prophylaxis (PEP) for work exposures to hepatitis B virus (HBV), hepatitis C virus (HCV); and human immunodeficiency virus (HIV); • selection and use of devices with features designed to prevent sharps injury; The material in this report originated in the National Center for Chronic Disease Prevention and Health Promotion, James S. Marks, M.D., M.P.H., Director; and the Division of Oral Health, William R. Maas, D.D.S., M.P.H., Director. • • • • hand-hygiene products and surgical hand antisepsis; contact dermatitis and latex hypersensitivity; sterilization of unwrapped instruments; dental water-quality concerns (e.g., dental unit waterline biofilms; delivery of water of acceptable biological quality for patient care; usefulness of flushing waterlines; use of sterile irrigating solutions for oral surgical procedures; handling of community boil-water advisories); • dental radiology; • aseptic technique for parenteral medications; • preprocedural mouth rinsing for patients; • oral surgical procedures; • laser/electrosurgery plumes; • tuberculosis (TB); • Creutzfeldt-Jakob disease (CJD) and other prion-related diseases; • infection-control program evaluation; and • research considerations. These guidelines were developed by CDC staff members in collaboration with other authorities on infection control. Draft documents were reviewed by other federal agencies and professional organizations from the fields of dental health care, public health, and hospital epidemiology and infection control. A Federal Register notice elicited public comments that were considered in the decision-making process. Existing guidelines and published research pertinent to dental infection-control prin- BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 2 MMWR ciples and practices were reviewed. Wherever possible, recommendations are based on data from well-designed scientific studies. However, only a limited number of studies have characterized risk factors and the effectiveness of prevention measures for infections associated with dental health-care practices. Some infection-control practices routinely used by healthcare practitioners cannot be rigorously examined for ethical or logistical reasons. In the absence of scientific evidence for such practices, certain recommendations are based on strong theoretical rationale, suggestive evidence, or opinions of respected authorities based on clinical experience, descriptive studies, or committee reports. In addition, some recommendations are derived from federal regulations. No recommendations are offered for practices for which insufficient scientific evidence or lack of consensus supporting their effectiveness exists. Background In the United States, an estimated 9 million persons work in health-care professions, including approximately 168,000 dentists, 112,000 registered dental hygienists, 218,000 dental assistants (3), and 53,000 dental laboratory technicians (4). In this report, dental health-care personnel (DHCP) refers to all paid and unpaid personnel in the dental health-care setting who might be occupationally exposed to infectious materials, including body substances and contaminated supplies, equipment, environmental surfaces, water, or air. DHCP include dentists, dental hygienists, dental assistants, dental laboratory technicians (in-office and commercial), students and trainees, contractual personnel, and other persons not directly involved in patient care but potentially exposed to infectious agents (e.g., administrative, clerical, housekeeping, maintenance, or volunteer personnel). Recommendations in this report are designed to prevent or reduce potential for disease transmission from patient to DHCP, from DHCP to patient, and from patient to patient. Although these guidelines focus mainly on outpatient, ambulatory dental health-care settings, the recommended infection-control practices are applicable to all settings in which dental treatment is provided. Dental patients and DHCP can be exposed to pathogenic microorganisms including cytomegalovirus (CMV), HBV, HCV, herpes simplex virus types 1 and 2, HIV, Mycobacterium tuberculosis, staphylococci, streptococci, and other viruses and bacteria that colonize or infect the oral cavity and respiratory tract. These organisms can be transmitted in dental settings through 1) direct contact with blood, oral fluids, or other patient materials; 2) indirect contact with contaminated objects (e.g., instruments, equipment, or environmental surfaces); 3) contact of conjunctival, nasal, or oral mucosa with December 19, 2003 droplets (e.g., spatter) containing microorganisms generated from an infected person and propelled a short distance (e.g., by coughing, sneezing, or talking); and 4) inhalation of airborne microorganisms that can remain suspended in the air for long periods (5). Infection through any of these routes requires that all of the following conditions be present: • a pathogenic organism of sufficient virulence and in adequate numbers to cause disease; • a reservoir or source that allows the pathogen to survive and multiply (e.g., blood); • a mode of transmission from the source to the host; • a portal of entry through which the pathogen can enter the host; and • a susceptible host (i.e., one who is not immune). Occurrence of these events provides the chain of infection (6). Effective infection-control strategies prevent disease transmission by interrupting one or more links in the chain. Previous CDC recommendations regarding infection control for dentistry focused primarily on the risk of transmission of bloodborne pathogens among DHCP and patients and use of universal precautions to reduce that risk (1,2,7,8). Universal precautions were based on the concept that all blood and body fluids that might be contaminated with blood should be treated as infectious because patients with bloodborne infections can be asymptomatic or unaware they are infected (9,10). Preventive practices used to reduce blood exposures, particularly percutaneous exposures, include 1) careful handling of sharp instruments, 2) use of rubber dams to minimize blood spattering; 3) handwashing; and 4) use of protective barriers (e.g., gloves, masks, protective eyewear, and gowns). The relevance of universal precautions to other aspects of disease transmission was recognized, and in 1996, CDC expanded the concept and changed the term to standard precautions. Standard precautions integrate and expand the elements of universal precautions into a standard of care designed to protect HCP and patients from pathogens that can be spread by blood or any other body fluid, excretion, or secretion (11). Standard precautions apply to contact with 1) blood; 2) all body fluids, secretions, and excretions (except sweat), regardless of whether they contain blood; 3) nonintact skin; and 4) mucous membranes. Saliva has always been considered a potentially infectious material in dental infection control; thus, no operational difference exists in clinical dental practice between universal precautions and standard precautions. In addition to standard precautions, other measures (e.g., expanded or transmission-based precautions) might be necessary to prevent potential spread of certain diseases (e.g., TB, influenza, and varicella) that are transmitted through airborne, BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports droplet, or contact transmission (e.g., sneezing, coughing, and contact with skin) (11). When acutely ill with these diseases, patients do not usually seek routine dental outpatient care. Nonetheless, a general understanding of precautions for diseases transmitted by all routes is critical because 1) some DHCP are hospital-based or work part-time in hospital settings; 2) patients infected with these diseases might seek urgent treatment at outpatient dental offices; and 3) DHCP might become infected with these diseases. Necessary transmissionbased precautions might include patient placement (e.g., isolation), adequate room ventilation, respiratory protection (e.g., N-95 masks) for DHCP, or postponement of nonemergency dental procedures. DHCP should be familiar also with the hierarchy of controls that categorizes and prioritizes prevention strategies (12). For bloodborne pathogens, engineering controls that eliminate or isolate the hazard (e.g., puncture-resistant sharps containers or needle-retraction devices) are the primary strategies for protecting DHCP and patients. Where engineering controls are not available or appropriate, work-practice controls that result in safer behaviors (e.g., one-hand needle recapping or not using fingers for cheek retraction while using sharp instruments or suturing), and use of personal protective equipment (PPE) (e.g., protective eyewear, gloves, and mask) can prevent exposure (13). In addition, administrative controls (e.g., policies, procedures, and enforcement measures targeted at reducing the risk of exposure to infectious persons) are a priority for certain pathogens (e.g., M. tuberculosis), particularly those spread by airborne or droplet routes. Dental practices should develop a written infection-control program to prevent or reduce the risk of disease transmission. Such a program should include establishment and implementation of policies, procedures, and practices (in conjunction with selection and use of technologies and products) to prevent work-related injuries and illnesses among DHCP as well as health-care–associated infections among patients. The program should embody principles of infection control and occupational health, reflect current science, and adhere to relevant federal, state, and local regulations and statutes. An infection-control coordinator (e.g., dentist or other DHCP) knowledgeable or willing to be trained should be assigned responsibility for coordinating the program. The effectiveness of the infection-control program should be evaluated on a dayto-day basis and over time to help ensure that policies, procedures, and practices are useful, efficient, and successful (see Program Evaluation). Although the infection-control coordinator remains responsible for overall management of the program, creating and maintaining a safe work environment ultimately requires the 3 commitment and accountability of all DHCP. This report is designed to provide guidance to DHCP for preventing disease transmission in dental health-care settings, for promoting a safe working environment, and for assisting dental practices in developing and implementing infection-control programs. These programs should be followed in addition to practices and procedures for worker protection required by the Occupational Safety and Health Administration’s (OSHA) standards for occupational exposure to bloodborne pathogens (13), including instituting controls to protect employees from exposure to blood or other potentially infectious materials (OPIM), and requiring implementation of a written exposurecontrol plan, annual employee training, HBV vaccinations, and postexposure follow-up (13). Interpretations and enforcement procedures are available to help DHCP apply this OSHA standard in practice (14). Also, manufacturer’s Material Safety Data Sheets (MSDS) should be consulted regarding correct procedures for handling or working with hazardous chemicals (15). Previous Recommendations This report includes relevant infection-control measures from the following previously published CDC guidelines and recommendations: • CDC. Guideline for disinfection and sterilization in health-care facilities: recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). MMWR (in press). • CDC. Guidelines for environmental infection control in health-care facilities: recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). MMWR 2003;52(No. RR-10). • CDC. Guidelines for the prevention of intravascular catheter-related infections. MMWR 2002;51(No. RR-10). • CDC. Guideline for hand hygiene in health-care settings: recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/ APIC/IDSA Hand Hygiene Task Force. MMWR 2002;51 (No. RR-16). • CDC. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis. MMWR 2001;50(No. RR-11). • Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR, Hospital Infection Control Practices Advisory Committee. Guideline for prevention of surgical site infection, 1999. Infect Control Hosp Epidemiol 1999;20:250–78. • Bolyard EA, Tablan OC, Williams WW, Pearson ML, Shapiro CN, Deitchman SD, Hospital Infection Control Practices Advisory Committee. Guideline for infection BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 4 MMWR • • • • • • • • control in health care personnel, 1998. Am J Infect Control 1998;26:289–354. CDC. Immunization of health-care workers: recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC). MMWR 1997;46(No. RR-18). Rutala WA, Association for Professionals in Infection Control and Epidemiology, Inc. APIC guideline for selection and use of disinfectants. Am J Infect Control 1996;24:313–42. Garner JS, Hospital Infection Control Practices Advisory Committee. Guideline for isolation precautions in hospitals. Infect Control Hosp Epidemiol 1996;17:53–80. Larson EL, 1992, 1993, and 1994 Guidelines Committee. APIC guideline for handwashing and hand antisepsis in health-care settings. Am J Infect Control 1995;23:251–69. CDC. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care facilities, 1994. MMWR 1994;43(No. RR-13). CDC. Recommendations for preventing transmission of human immunodeficiency virus and hepatitis B virus to patients during exposure-prone invasive procedures. MMWR 1991;40(No. RR-8). Garner JS. CDC guideline for prevention of surgical wound infections, 1985. Supersedes guideline for prevention of surgical wound infections published in 1982. (Originally published in November 1985). Revised. Infect Control 1986;7:193–200. Garner JS, Favero MS. CDC guideline for handwashing and hospital environmental control, 1985. Infect Control 1986;7:231–43. Selected Definitions Alcohol-based hand rub: An alcohol-containing preparation designed for reducing the number of viable microorganisms on the hands. Antimicrobial soap: A detergent containing an antiseptic agent. Antiseptic: A germicide used on skin or living tissue for the purpose of inhibiting or destroying microorganisms (e.g., alcohols, chlorhexidine, chlorine, hexachlorophene, iodine, chloroxylenol [PCMX], quaternary ammonium compounds, and triclosan). Bead sterilizer: A device using glass beads 1.2–1.5 mm diameter and temperatures 217ºC–232ºC for brief exposures (e.g., 45 seconds) to inactivate microorganisms. (This term is actually a misnomer because it has not been cleared by the Food and Drug Administration [FDA] as a sterilizer). December 19, 2003 Bioburden: Microbiological load (i.e., number of viable organisms in or on an object or surface) or organic material on a surface or object before decontamination, or sterilization. Also known as bioload or microbial load. Colony-forming unit (CFU): The minimum number (i.e., tens of millions) of separable cells on the surface of or in semisolid agar medium that give rise to a visible colony of progeny. CFUs can consist of pairs, chains, clusters, or as single cells and are often expressed as colony-forming units per milliliter (CFUs/mL). Decontamination: Use of physical or chemical means to remove, inactivate, or destroy pathogens on a surface or item so that they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal. Dental treatment water: Nonsterile water used during dental treatment, including irrigation of nonsurgical operative sites and cooling of high-speed rotary and ultrasonic instruments. Disinfectant: A chemical agent used on inanimate objects (e.g., floors, walls, or sinks) to destroy virtually all recognized pathogenic microorganisms, but not necessarily all microbial forms (e.g., bacterial endospores). The U.S. Environmental Protection Agency (EPA) groups disinfectants on the basis of whether the product label claims limited, general, or hospital disinfectant capabilities. Disinfection: Destruction of pathogenic and other kinds of microorganisms by physical or chemical means. Disinfection is less lethal than sterilization, because it destroys the majority of recognized pathogenic microorganisms, but not necessarily all microbial forms (e.g., bacterial spores). Disinfection does not ensure the degree of safety associated with sterilization processes. Droplet nuclei: Particles <5 µm in diameter formed by dehydration of airborne droplets containing microorganisms that can remain suspended in the air for long periods of time. Droplets: Small particles of moisture (e.g., spatter) generated when a person coughs or sneezes, or when water is converted to a fine mist by an aerator or shower head. These particles, intermediate in size between drops and droplet nuclei, can contain infectious microorganisms and tend to quickly settle from the air such that risk of disease transmission is usually limited to persons in close proximity to the droplet source. Endotoxin: The lipopolysaccharide of gram-negative bacteria, the toxic character of which resides in the lipid protein. Endotoxins can produce pyrogenic reactions in persons exposed to their bacterial component. Germicide: An agent that destroys microorganisms, especially pathogenic organisms. Terms with the same suffix (e.g., virucide, fungicide, bactericide, tuberculocide, and sporicide) indi- BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports cate agents that destroy the specific microorganism identified by the prefix. Germicides can be used to inactivate microorganisms in or on living tissue (i.e., antiseptics) or on environmental surfaces (i.e., disinfectants). Hand hygiene: General term that applies to handwashing, antiseptic handwash, antiseptic hand rub, or surgical hand antisepsis. Health-care–associated infection: Any infection associated with a medical or surgical intervention. The term health-care– associated replaces nosocomial, which is limited to adverse infectious outcomes occurring in hospitals. Hepatitis B immune globulin (HBIG): Product used for prophylaxis against HBV infection. HBIG is prepared from plasma containing high titers of hepatitis B surface antibody (antiHBs) and provides protection for 3–6 mos. Hepatitis B surface antigen (HBsAg): Serologic marker on the surface of HBV detected in high levels during acute or chronic hepatitis. The body normally produces antibodies to surface antigen as a normal immune response to infection. Hepatitis B e antigen (HBeAg): Secreted product of the nucleocapsid gene of HBV found in serum during acute and chronic HBV infection. Its presence indicates that the virus is replicating and serves as a marker of increased infectivity. Hepatitis B surface antibody (anti-HBs): Protective antibody against HBsAg. Presence in the blood can indicate past infection with, and immunity to, HBV, or immune response from hepatitis B vaccine. Heterotrophic bacteria: Those bacteria requiring an organic carbon source for growth (i.e., deriving energy and carbon from organic compounds). High-level disinfection: Disinfection process that inactivates vegetative bacteria, mycobacteria, fungi, and viruses but not necessarily high numbers of bacterial spores. FDA further defines a high-level disinfectant as a sterilant used for a shorter contact time. Hospital disinfectant: Germicide registered by EPA for use on inanimate objects in hospitals, clinics, dental offices, and other medical-related facilities. Efficacy is demonstrated against Salmonella choleraesuis, Staphylococcus aureus, and Pseudomonas aeruginosa. Iatrogenic: Induced inadvertently by HCP, medical (including dental) treatment, or diagnostic procedures. Used particularly in reference to an infectious disease or other complication of treatment. Immunization: Process by which a person becomes immune, or protected against a disease. Vaccination is defined as the process of administering a killed or weakened infectious organism or a toxoid; however, vaccination does not always result in immunity. 5 Implantable device: Device placed into a surgically or naturally formed cavity of the human body and intended to remain there for >30 days. Independent water reservoir: Container used to hold water or other solutions and supply it to handpieces and air and water syringes attached to a dental unit. The independent reservoir, which isolates the unit from the public water system, can be provided as original equipment or as a retrofitted device. Intermediate-level disinfection: Disinfection process that inactivates vegetative bacteria, the majority of fungi, mycobacteria, and the majority of viruses (particularly enveloped viruses) but not bacterial spores. Intermediate-level disinfectant: Liquid chemical germicide registered with EPA as a hospital disinfectant and with a label claim of potency as tuberculocidal (Appendix A). Latex: Milky white fluid extracted from the rubber tree Hevea brasiliensis that contains the rubber material cis-1,4 polyisoprene. Low-level disinfection: Process that inactivates the majority of vegetative bacteria, certain fungi, and certain viruses, but cannot be relied on to inactivate resistant microorganisms (e.g., mycobacteria or bacterial spores). Low-level disinfectant: Liquid chemical germicide registered with EPA as a hospital disinfectant. OSHA requires low-level hospital disinfectants also to have a label claim for potency against HIV and HBV if used for disinfecting clinical contact surfaces (Appendix A). Microfilter: Membrane filter used to trap microorganisms suspended in water. Filters are usually installed on dental unit waterlines as a retrofit device. Microfiltration commonly occurs at a filter pore size of 0.03–10 µm. Sediment filters commonly found in dental unit water regulators have pore sizes of 20–90 µm and do not function as microbiological filters. Nosocomial: Infection acquired in a hospital as a result of medical care. Occupational exposure: Reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or OPIM that can result from the performance of an employee’s duties. OPIM: Other potentially infectious materials. OPIM is an OSHA term that refers to 1) body fluids including semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures; any body fluid visibly contaminated with blood; and all body fluids in situations where differentiating between body fluids is difficult or impossible; 2) any unfixed tissue or organ (other than intact skin) from a human (living or dead); and 3) HIV-containing cell or tissue cultures, organ BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 6 MMWR cultures; HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV. Parenteral: Means of piercing mucous membranes or skin barrier through such events as needlesticks, human bites, cuts, and abrasions. Persistent activity: Prolonged or extended activity that prevents or inhibits proliferation or survival of microorganisms after application of a product. This activity can be demonstrated by sampling a site minutes or hours after application and demonstrating bacterial antimicrobial effectiveness when compared with a baseline level. Previously, this property was sometimes termed residual activity. Prion: Protein particle lacking nucleic acid that has been implicated as the cause of certain neurodegenerative diseases (e.g., scrapie, CJD, and bovine spongiform encephalopathy [BSE]). Retraction: Entry of oral fluids and microorganisms into waterlines through negative water pressure. Seroconversion: The change of a serological test from negative to positive indicating the development of antibodies in response to infection or immunization. Sterile: Free from all living microorganisms; usually described as a probability (e.g., the probability of a surviving microorganism being 1 in 1 million). Sterilization: Use of a physical or chemical procedure to destroy all microorganisms including substantial numbers of resistant bacterial spores. Surfactants: Surface-active agents that reduce surface tension and help cleaning by loosening, emulsifying, and holding soil in suspension, to be more readily rinsed away. Ultrasonic cleaner: Device that removes debris by a process called cavitation, in which waves of acoustic energy are propagated in aqueous solutions to disrupt the bonds that hold particulate matter to surfaces. Vaccination: See immunization. Vaccine: Product that induces immunity, therefore protecting the body from the disease. Vaccines are administered through needle injections, by mouth, and by aerosol. Washer-disinfector: Automatic unit that cleans and thermally disinfects instruments, by using a high-temperature cycle rather than a chemical bath. Wicking: Absorption of a liquid by capillary action along a thread or through the material (e.g., penetration of liquids through undetected holes in a glove). December 19, 2003 Review of Science Related to Dental Infection Control Personnel Health Elements of an Infection-Control Program A protective health component for DHCP is an integral part of a dental practice infection-control program. The objectives are to educate DHCP regarding the principles of infection control, identify work-related infection risks, institute preventive measures, and ensure prompt exposure management and medical follow-up. Coordination between the dental practice’s infection-control coordinator and other qualified health-care professionals is necessary to provide DHCP with appropriate services. Dental programs in institutional settings, (e.g., hospitals, health centers, and educational institutions) can coordinate with departments that provide personnel health services. However, the majority of dental practices are in ambulatory, private settings that do not have licensed medical staff and facilities to provide complete on-site health service programs. In such settings, the infection-control coordinator should establish programs that arrange for site-specific infectioncontrol services from external health-care facilities and providers before DHCP are placed at risk for exposure. Referral arrangements can be made with qualified health-care professionals in an occupational health program of a hospital, with educational institutions, or with health-care facilities that offer personnel health services. Education and Training Personnel are more likely to comply with an infectioncontrol program and exposure-control plan if they understand its rationale (5,13,16). Clearly written policies, procedures, and guidelines can help ensure consistency, efficiency, and effective coordination of activities. Personnel subject to occupational exposure should receive infection-control training on initial assignment, when new tasks or procedures affect their occupational exposure, and at a minimum, annually (13). Education and training should be appropriate to the assigned duties of specific DHCP (e.g., techniques to prevent crosscontamination or instrument sterilization). For DHCP who perform tasks or procedures likely to result in occupational exposure to infectious agents, training should include 1) a description of their exposure risks; 2) review of prevention strategies and infection-control policies and procedures; 3) discussion regarding how to manage work-related illness and injuries, including PEP; and 4) review of work restrictions for the exposure or infection. Inclusion of DHCP with minimal exposure risks (e.g., administrative employees) in education and training programs might enhance facilitywide understand- BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports ing of infection-control principles and the importance of the program. Educational materials should be appropriate in content and vocabulary for each person’s educational level, literacy, and language, as well as be consistent with existing federal, state, and local regulations (5,13). Immunization Programs DHCP are at risk for exposure to, and possible infection with, infectious organisms. Immunizations substantially reduce both the number of DHCP susceptible to these diseases and the potential for disease transmission to other DHCP and patients (5,17). Thus, immunizations are an essential part of prevention and infection-control programs for DHCP, and a comprehensive immunization policy should be implemented for all dental health-care facilities (17,18). The Advisory Committee on Immunization Practices (ACIP) provides national guidelines for immunization of HCP, which includes DHCP (17). Dental practice immunization policies should incorporate current state and federal regulations as well as recommendations from the U.S. Public Health Service and professional organizations (17) (Appendix B). On the basis of documented health-care–associated transmission, HCP are considered to be at substantial risk for acquiring or transmitting hepatitis B, influenza, measles, mumps, rubella, and varicella. All of these diseases are vaccine-preventable. ACIP recommends that all HCP be vaccinated or have documented immunity to these diseases (5,17). ACIP does not recommend routine immunization of HCP against TB (i.e., inoculation with bacille Calmette-Guérin vaccine) or hepatitis A (17). No vaccine exists for HCV. ACIP guidelines also provide recommendations regarding immunization of HCP with special conditions (e.g., pregnancy, HIV infection, or diabetes) (5,17). Immunization of DHCP before they are placed at risk for exposure remains the most efficient and effective use of vaccines in health-care settings. Some educational institutions and infection-control programs provide immunization schedules for students and DHCP. OSHA requires that employers make hepatitis B vaccination available to all employees who have potential contact with blood or OPIM. Employers are also required to follow CDC recommendations for vaccinations, evaluation, and follow-up procedures (13). Nonpatient-care staff (e.g., administrative or housekeeping) might be included, depending on their potential risk of coming into contact with blood or OPIM. Employers are also required to ensure that employees who decline to accept hepatitis B vaccination sign an appropriate declination statement (13). DHCP unable or unwilling to be vaccinated as required or recommended should be educated regarding their exposure risks, infection-control policies and procedures for the facility, and the management 7 of work-related illness and work restrictions (if appropriate) for exposed or infected DHCP. Exposure Prevention and Postexposure Management Avoiding exposure to blood and OPIM, as well as protection by immunization, remain primary strategies for reducing occupationally acquired infections, but occupational exposures can still occur (19). A combination of standard precautions, engineering, work practice, and administrative controls is the best means to minimize occupational exposures. Written policies and procedures to facilitate prompt reporting, evaluation, counseling, treatment, and medical follow-up of all occupational exposures should be available to all DHCP. Written policies and procedures should be consistent with federal, state, and local requirements addressing education and training, postexposure management, and exposure reporting (see Preventing Transmission of Bloodborne Pathogens). DHCP who have contact with patients can also be exposed to persons with infectious TB, and should have a baseline tuberculin skin test (TST), preferably by using a two-step test, at the beginning of employment (20). Thus, if an unprotected occupational exposure occurs, TST conversions can be distinguished from positive TST results caused by previous exposures (20,21). The facility’s level of TB risk will determine the need for routine follow-up TSTs (see Special Considerations). Medical Conditions, Work-Related Illness, and Work Restrictions DHCP are responsible for monitoring their own health status. DHCP who have acute or chronic medical conditions that render them susceptible to opportunistic infection should discuss with their personal physicians or other qualified authority whether the condition might affect their ability to safely perform their duties. However, under certain circumstances, health-care facility managers might need to exclude DHCP from work or patient contact to prevent further transmission of infection (22). Decisions concerning work restrictions are based on the mode of transmission and the period of infectivity of the disease (5) (Table 1). Exclusion policies should 1) be written, 2) include a statement of authority that defines who can exclude DHCP (e.g., personal physicians), and 3) be clearly communicated through education and training. Policies should also encourage DHCP to report illnesses or exposures without jeopardizing wages, benefits, or job status. With increasing concerns regarding bloodborne pathogens and introduction of universal precautions, use of latex gloves among HCP has increased markedly (7,23). Increased use of these gloves has been accompanied by increased reports of allergic reactions to natural rubber latex among HCP, DHCP, and patients BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 8 MMWR December 19, 2003 TABLE 1. Suggested work restrictions for health-care personnel infected with or exposed to major infectious diseases in healthcare settings, in the absence of state and local regulations* Disease/problem Duration Work restriction Conjunctivitis Restrict from patient contact and contact with patient’s environment. Cytomegalovirus infection No restriction Until discharge ceases Diarrheal disease Acute stage (diarrhea with other symptoms) Restrict from patient contact, contact with patient’s environment, and food-handling. Until symptoms resolve Convalescent stage, Salmonella species Restrict from care of patients at high risk. Until symptoms resolve; consult with local and state health authorities regarding need for negative stool cultures Enteroviral infection Restrict from care of infants, neonates, and immunocompromised patients and their environments. Until symptoms resolve Hepatitis A Restrict from patient contact, contact with patient’s environment, and food-handing. Until 7 days after onset of jaundice Hepatitis B Personnel with acute or chronic hepatitis B surface antigenemia who do not perform exposure-prone procedures No restriction†; refer to state regulations. Standard precautions should always be followed. Personnel with acute or chronic hepatitis B e antigenemia who perform exposure-prone procedures Do not perform exposure-prone invasive procedures until counsel from a review panel has been sought; panel should review and recommend procedures that personnel can perform, taking into account specific procedures as well as skill and technique. Standard precautions should always be observed. Refer to state and local regulations or recommendations. Until hepatitis B e antigen is negative No restrictions on professional activity.† HCV-positive health-care personnel should follow aseptic technique and standard precautions. Hepatitis C Herpes simplex Genital No restriction Hands (herpetic whitlow) Restrict from patient contact and contact with patient’s environment. Orofacial Evaluate need to restrict from care of patients at high risk. Human immunodeficiency virus; personnel who perform exposure-prone procedures Until lesions heal Do not perform exposure-prone invasive procedures until counsel from an expert review panel has been sought; panel should review and recommend procedures that personnel can perform, taking into account specific procedures as well as skill and technique. Standard precautions should always be observed. Refer to state and local regulations or recommendations. Measles Active Exclude from duty Until 7 days after the rash appears Postexposure (susceptible personnel) Exclude from duty From fifth day after first exposure through twenty-first day after last exposure, or 4 days after rash appears Exclude from duty Until 24 hours after start of effective therapy Active Exclude from duty Until 9 days after onset of parotitis Postexposure (susceptible personnel) Exclude from duty From twelfth day after first exposure through twenty-sixth day after last exposure, or until 9 days after onset of parotitis Meningococcal infection Mumps Source: Adapted from Bolyard EA, Hospital Infection Control Practices Advisory Committee. Guidelines for infection control in health care personnel, 1998. Am J Infect Control 1998;26:289–354. * Modified from recommendations of the Advisory Committee on Immunization Practices (ACIP). † Unless epidemiologically linked to transmission of infection. § Those susceptible to varicella and who are at increased risk of complications of varicella (e.g., neonates and immunocompromised persons of any age). ¶ Patients at high risk as defined by ACIP for complications of influenza. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports 9 TABLE 1. (Continued) Suggested work restrictions for health-care personnel infected with or exposed to major infectious diseases in health-care settings, in the absence of state and local regulations* Disease/problem Pediculosis Work restriction Duration Restrict from patient contact Until treated and observed to be free of adult and immature lice Active Exclude from duty From beginning of catarrhal stage through third week after onset of paroxysms, or until 5 days after start of effective antibiotic therapy Postexposure (asymptomatic personnel) No restriction, prophylaxis recommended Postexposure (symptomatic personnel) Exclude from duty Until 5 days after start of effective antibiotic therapy Active Exclude from duty Until 5 days after rash appears Postexposure (susceptible personnel) Exclude from duty From seventh day after first exposure through twenty-first day after last exposure Active, draining skin lesions Restrict from contact with patients and patient’s environment or food handling. Until lesions have resolved Carrier state No restriction unless personnel are epidemiologically linked to transmission of the organism Pertussis Rubella Staphylococcus aureus infection Restrict from patient care, contact with patient’s environment, and food-handling. Until 24 hours after adequate treatment started Active disease Exclude from duty Until proved noninfectious PPD converter No restriction Streptococcal infection, group A Tuberculosis Varicella (chicken pox) Active Exclude from duty Until all lesions dry and crust Postexposure (susceptible personnel) Exclude from duty From tenth day after first exposure through twenty-first day (twenty-eighth day if varicella-zoster immune globulin [VZIG] administered) after last exposure. Localized, in healthy person Cover lesions, restrict from care of patients§ at high risk Until all lesions dry and crust Generalized or localized in immunosuppressed person Restrict from patient contact Until all lesions dry and crust Postexposure (susceptible personnel) Restrict from patient contact From tenth day after first exposure through twenty-first day (twenty-eighth day if VZIG administered) after last exposure; or, if varicella occurs, when lesions crust and dry Consider excluding from the care of patients at high risk¶ or contact with such patients’ environments during community outbreak of respiratory syncytial virus and influenza Until acute symptoms resolve Zoster (shingles) Viral respiratory infection, acute febrile Source: Adapted from Bolyard EA, Hospital Infection Control Practices Advisory Committee. Guidelines for infection control in health care personnel, 1998. Am J Infect Control 1998;26:289–354. * Modified from recommendations of the Advisory Committee on Immunization Practices (ACIP). † Unless epidemiologically linked to transmission of infection. § Those susceptible to varicella and who are at increased risk of complications of varicella (e.g., neonates and immunocompromised persons of any age). ¶ Patients at high risk as defined by ACIP for complications of influenza. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 10 MMWR (24–30), as well as increased reports of irritant and allergic contact dermatitis from frequent and repeated use of hand-hygiene products, exposure to chemicals, and glove use. DHCP should be familiar with the signs and symptoms of latex sensitivity (5,31–33). A physician should evaluate DHCP exhibiting symptoms of latex allergy, because further exposure could result in a serious allergic reaction. A diagnosis is made through medical history, physical examination, and diagnostic tests. Procedures should be in place for minimizing latexrelated health problems among DHCP and patients while protecting them from infectious materials. These procedures should include 1) reducing exposures to latex-containing materials by using appropriate work practices, 2) training and educating DHCP, 3) monitoring symptoms, and 4) substituting nonlatex products where appropriate (32) (see Contact Dermatitis and Latex Hypersensitivity). Maintenance of Records, Data Management, and Confidentiality The health status of DHCP can be monitored by maintaining records of work-related medical evaluations, screening tests, immunizations, exposures, and postexposure management. Such records must be kept in accordance with all applicable state and federal laws. Examples of laws that might apply include the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, 45 CFR 160 and 164, and the OSHA Occupational Exposure to Bloodborne Pathogens; Final Rule 29 CFR 1910.1030(h)(1)(i–iv) (34,13). The HIPAA Privacy Rule applies to covered entities, including certain defined health providers, health-care clearinghouses, and health plans. OSHA requires employers to ensure that certain information contained in employee medical records is 1) kept confidential; 2) not disclosed or reported without the employee’s express written consent to any person within or outside the workplace except as required by the OSHA standard; and 3) maintained by the employer for at least the duration of employment plus 30 years. Dental practices that coordinate their infection-control program with off-site providers might consult OSHA’s Bloodborne Pathogen standard and employee Access to Medical and Exposure Records standard, as well as other applicable local, state, and federal laws, to determine a location for storing health records (13,35). Preventing Transmission of Bloodborne Pathogens Although transmission of bloodborne pathogens (e.g., HBV, HCV, and HIV) in dental health-care settings can have serious consequences, such transmission is rare. Exposure to December 19, 2003 infected blood can result in transmission from patient to DHCP, from DHCP to patient, and from one patient to another. The opportunity for transmission is greatest from patient to DHCP, who frequently encounter patient blood and blood-contaminated saliva during dental procedures. Since 1992, no HIV transmission from DHCP to patients has been reported, and the last HBV transmission from DHCP to patients was reported in 1987. HCV transmission from DHCP to patients has not been reported. The majority of DHCP infected with a bloodborne virus do not pose a risk to patients because they do not perform activities meeting the necessary conditions for transmission. For DHCP to pose a risk for bloodborne virus transmission to patients, DHCP must 1) be viremic (i.e., have infectious virus circulating in the bloodstream); 2) be injured or have a condition (e.g., weeping dermatitis) that allows direct exposure to their blood or other infectious body fluids; and 3) enable their blood or infectious body fluid to gain direct access to a patient’s wound, traumatized tissue, mucous membranes, or similar portal of entry. Although an infected DHCP might be viremic, unless the second and third conditions are also met, transmission cannot occur. The risk of occupational exposure to bloodborne viruses is largely determined by their prevalence in the patient population and the nature and frequency of contact with blood and body fluids through percutaneous or permucosal routes of exposure. The risk of infection after exposure to a bloodborne virus is influenced by inoculum size, route of exposure, and susceptibility of the exposed HCP (12). The majority of attention has been placed on the bloodborne pathogens HBV, HCV, and HIV, and these pathogens present different levels of risk to DHCP. Hepatitis B Virus HBV is a well-recognized occupational risk for HCP (36,37). HBV is transmitted by percutaneous or mucosal exposure to blood or body fluids of a person with either acute or chronic HBV infection. Persons infected with HBV can transmit the virus for as long as they are HBsAg-positive. The risk of HBV transmission is highly related to the HBeAg status of the source person. In studies of HCP who sustained injuries from needles contaminated with blood containing HBV, the risk of developing clinical hepatitis if the blood was positive for both HBsAg and HBeAg was 22%–31%; the risk of developing serologic evidence of HBV infection was 37%–62% (19). By comparison, the risk of developing clinical hepatitis from a needle contaminated with HBsAg-positive, HBeAg-negative blood was 1%–6%, and the risk of developing serologic evidence of HBV infection, 23%–37% (38). BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports Blood contains the greatest proportion of HBV infectious particle titers of all body fluids and is the most critical vehicle of transmission in the health-care setting. HBsAg is also found in multiple other body fluids, including breast milk, bile, cerebrospinal fluid, feces, nasopharyngeal washings, saliva, semen, sweat, and synovial fluid. However, the majority of body fluids are not efficient vehicles for transmission because they contain low quantities of infectious HBV, despite the presence of HBsAg (19). The concentration of HBsAg in body fluids can be 100–1,000-fold greater than the concentration of infectious HBV particles (39). Although percutaneous injuries are among the most efficient modes of HBV transmission, these exposures probably account for only a minority of HBV infections among HCP. In multiple investigations of nosocomial hepatitis B outbreaks, the majority of infected HCP could not recall an overt percutaneous injury (40,41), although in certain studies, approximately one third of infected HCP recalled caring for a patient who was HBsAg-positive (42,43). In addition, HBV has been demonstrated to survive in dried blood at room temperature on environmental surfaces for <1 week (44). Thus, HBV infections that occur in HCP with no history of nonoccupational exposure or occupational percutaneous injury might have resulted from direct or indirect blood or body fluid exposures that inoculated HBV into cutaneous scratches, abrasions, burns, other lesions, or on mucosal surfaces (45–47). The potential for HBV transmission through contact with environmental surfaces has been demonstrated in investigations of HBV outbreaks among patients and HCP in hemodialysis units (48–50). Since the early 1980s, occupational infections among HCP have declined because of vaccine use and adherence to universal precautions (51). Among U.S. dentists, >90% have been vaccinated, and serologic evidence of past HBV infection decreased from prevaccine levels of 14% in 1972 to approximately 9% in 1992 (52). During 1993–2001, levels remained relatively unchanged (Chakwan Siew, Ph.D., American Dental Association, Chicago, Illinois, personal communication, June 2003). Infection rates can be expected to decline further as vaccination rates remain high among young dentists and as older dentists with lower vaccination rates and higher rates of infection retire. Although the potential for transmission of bloodborne infections from DHCP to patients is considered limited (53–55), precise risks have not been quantified by carefully designed epidemiologic studies (53,56,57). Reports published during 1970–1987 describe nine clusters in which patients were thought to be infected with HBV through treatment by an infected DHCP (58–67). However, transmission of HBV 11 from dentist to patient has not been reported since 1987, possibly reflecting such factors as 1) adoption of universal precautions, 2) routine glove use, 3) increased levels of immunity as a result of hepatitis B vaccination of DHCP, 4) implementation of the 1991 OSHA bloodborne pathogen standard (68), and 5) incomplete ascertainment and reporting. Only one case of patient-to-patient transmission of HBV in the dental setting has been documented (CDC, unpublished data, 2003). In this case, appropriate office infection-control procedures were being followed, and the exact mechanism of transmission was undetermined. Because of the high risk of HBV infection among HCP, DHCP who perform tasks that might involve contact with blood, blood-contaminated body substances, other body fluids, or sharps should be vaccinated (2,13,17,19,69). Vaccination can protect both DHCP and patients from HBV infection and, whenever possible, should be completed when dentists or other DHCP are in training and before they have contact with blood. Prevaccination serological testing for previous infection is not indicated, although it can be cost-effective where prevalence of infection is expected to be high in a group of potential vacinees (e.g., persons who have emigrated from areas with high rates of HBV infection). DHCP should be tested for antiHBs 1–2 months after completion of the 3-dose vaccination series (17). DHCP who do not develop an adequate antibody response (i.e., anti-HBs <10 mIU/mL) to the primary vaccine series should complete a second 3-dose vaccine series or be evaluated to determine if they are HBsAg-positive (17). Revaccinated persons should be retested for anti-HBs at the completion of the second vaccine series. Approximately half of nonresponders to the primary series will respond to a second 3-dose series. If no antibody response occurs after the second series, testing for HBsAg should be performed (17). Persons who prove to be HBsAg-positive should be counseled regarding how to prevent HBV transmission to others and regarding the need for medical evaluation. Nonresponders to vaccination who are HBsAg-negative should be considered susceptible to HBV infection and should be counseled regarding precautions to prevent HBV infection and the need to obtain HBIG prophylaxis for any known or probable parenteral exposure to HBsAg-positive blood. Vaccine-induced antibodies decline gradually over time, and 60% of persons who initially respond to vaccination will lose detectable antibodies over 12 years. Even so, immunity continues to prevent clinical disease or detectable viral infection (17). Booster doses of vaccine and periodic serologic testing to monitor antibody concentrations after completion of the vaccine series are not necessary for vaccine responders (17). BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 12 MMWR Hepatitis D Virus An estimated 4% of persons with acute HBV infection are also infected with hepatitis Delta virus (HDV). Discovered in 1977, HDV is a defective bloodborne virus requiring the presence of HBV to replicate. Patients coinfected with HBV and HDV have substantially higher mortality rates than those infected with HBV alone. Because HDV infection is dependent on HBV for replication, immunization to prevent HBV infection, through either pre- or postexposure prophylaxis, can also prevent HDV infection (70). Hepatitis C Virus Hepatitis C virus appears not to be transmitted efficiently through occupational exposures to blood. Follow-up studies of HCP exposed to HCV-infected blood through percutaneous or other sharps injuries have determined a low incidence of seroconversion (mean: 1.8%; range, 0%–7%) (71–74). One study determined transmission occurred from hollow-bore needles but not other sharps (72). Although these studies have not documented seroconversion associated with mucous membrane or nonintact skin exposure, at least two cases of HCV transmission from a blood splash to the conjunctiva (75,76) and one case of simultaneous transmission of HCV and HIV after nonintact skin exposure have been reported (77). Data are insufficient to estimate the occupational risk of HCV infection among HCP, but the majority of studies indicate the prevalence of HCV infection among dentists, surgeons, and hospital-based HCP is similar to that among the general population, approximately 1%–2% (78–86). In a study that evaluated risk factors for infection, a history of unintentional needlesticks was the only occupational risk factor independently associated with HCV infection (80). No studies of transmission from HCV-infected DHCP to patients have been reported, and the risk for such transmission appears limited. Multiple reports have been published describing transmission from HCV-infected surgeons, which apparently occurred during performance of invasive procedures; the overall risk for infection averaged 0.17% (87–90). Human Immunodeficiency Virus In the United States, the risk of HIV transmission in dental settings is extremely low. As of December 2001, a total of 57 cases of HIV seroconversion had been documented among HCP, but none among DHCP, after occupational exposure to a known HIV-infected source (91). Transmission of HIV to six patients of a single dentist with AIDS has been reported, but the mode of transmission could not be determined (2,92,93). As of September 30, 1993, CDC had information regarding test results of >22,000 patients of 63 HIV-infected December 19, 2003 HCP, including 33 dentists or dental students (55,93). No additional cases of transmission were documented. Prospective studies worldwide indicate the average risk of HIV infection after a single percutaneous exposure to HIV-infected blood is 0.3% (range: 0.2%–0.5%) (94). After an exposure of mucous membranes in the eye, nose, or mouth, the risk is approximately 0.1% (76). The precise risk of transmission after skin exposure remains unknown but is believed to be even smaller than that for mucous membrane exposure. Certain factors affect the risk of HIV transmission after an occupational exposure. Laboratory studies have determined if needles that pass through latex gloves are solid rather than hollow-bore, or are of small gauge (e.g., anesthetic needles commonly used in dentistry), they transfer less blood (36). In a retrospective case-control study of HCP, an increased risk for HIV infection was associated with exposure to a relatively large volume of blood, as indicated by a deep injury with a device that was visibly contaminated with the patient’s blood, or a procedure that involved a needle placed in a vein or artery (95). The risk was also increased if the exposure was to blood from patients with terminal illnesses, possibly reflecting the higher titer of HIV in late-stage AIDS. Exposure Prevention Methods Avoiding occupational exposures to blood is the primary way to prevent transmission of HBV, HCV, and HIV, to HCP in health-care settings (19,96,97). Exposures occur through percutaneous injury (e.g., a needlestick or cut with a sharp object), as well as through contact between potentially infectious blood, tissues, or other body fluids and mucous membranes of the eye, nose, mouth, or nonintact skin (e.g., exposed skin that is chapped, abraded, or shows signs of dermatitis). Observational studies and surveys indicate that percutaneous injuries among general dentists and oral surgeons occur less frequently than among general and orthopedic surgeons and have decreased in frequency since the mid-1980s (98–102). This decline has been attributed to safer work practices, safer instrumentation or design, and continued DHCP education (103,104). Percutaneous injuries among DHCP usually 1) occur outside the patient’s mouth, thereby posing less risk for recontact with patient tissues; 2) involve limited amounts of blood; and 3) are caused by burs, syringe needles, laboratory knives, and other sharp instruments (99–102,105,106). Injuries among oral surgeons might occur more frequently during fracture reductions using wires (104,107). Experience, as measured by years in practice, does not appear to affect the risk of injury among general dentists or oral surgeons (100,104,107). BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports The majority of exposures in dentistry are preventable, and methods to reduce the risk of blood contacts have included use of standard precautions, use of devices with features engineered to prevent sharp injuries, and modifications of work practices. These approaches might have contributed to the decrease in percutaneous injuries among dentists during recent years (98–100,103). However, needlesticks and other blood contacts continue to occur, which is a concern because percutaneous injuries pose the greatest risk of transmission. Standard precautions include use of PPE (e.g., gloves, masks, protective eyewear or face shield, and gowns) intended to prevent skin and mucous membrane exposures. Other protective equipment (e.g., finger guards while suturing) might also reduce injuries during dental procedures (104). Engineering controls are the primary method to reduce exposures to blood and OPIM from sharp instruments and needles. These controls are frequently technology-based and often incorporate safer designs of instruments and devices (e.g., self-sheathing anesthetic needles and dental units designed to shield burs in handpieces) to reduce percutaneous injuries (101,103,108). Work-practice controls establish practices to protect DHCP whose responsibilities include handling, using, assembling, or processing sharp devices (e.g., needles, scalers, laboratory utility knives, burs, explorers, and endodontic files) or sharps disposal containers. Work-practice controls can include removing burs before disassembling the handpiece from the dental unit, restricting use of fingers in tissue retraction or palpation during suturing and administration of anesthesia, and minimizing potentially uncontrolled movements of such instruments as scalers or laboratory knives (101,105). As indicated, needles are a substantial source of percutaneous injury in dental practice, and engineering and workpractice controls for needle handling are of particular importance. In 2001, revisions to OSHA’s bloodborne pathogens standard as mandated by the Needlestick Safety and Prevention Act of 2000 became effective. These revisions clarify the need for employers to consider safer needle devices as they become available and to involve employees directly responsible for patient care (e.g., dentists, hygienists, and dental assistants) in identifying and choosing such devices (109). Safer versions of sharp devices used in hospital settings have become available (e.g., blunt suture needles, phlebotomy devices, and butterfly needles), and their impact on reducing injuries has been documented (110–112). Aspirating anesthetic syringes that incorporate safety features have been developed for dental procedures, but the low injury rates in dentistry limit assessment of their effect on reducing injuries among DHCP. 13 Work-practice controls for needles and other sharps include placing used disposable syringes and needles, scalpel blades, and other sharp items in appropriate puncture-resistant containers located as close as feasible to where the items were used (2,7,13,113–115). In addition, used needles should never be recapped or otherwise manipulated by using both hands, or any other technique that involves directing the point of a needle toward any part of the body (2,7,13,97,113,114). A onehanded scoop technique, a mechanical device designed for holding the needle cap to facilitate one-handed recapping, or an engineered sharps injury protection device (e.g., needles with resheathing mechanisms) should be employed for recapping needles between uses and before disposal (2,7,13,113,114). DHCP should never bend or break needles before disposal because this practice requires unnecessary manipulation. Before attempting to remove needles from nondisposable aspirating syringes, DHCP should recap them to prevent injuries. For procedures involving multiple injections with a single needle, the practitioner should recap the needle between injections by using a one-handed technique or use a device with a needle-resheathing mechanism. Passing a syringe with an unsheathed needle should be avoided because of the potential for injury. Additional information for developing a safety program and for identifying and evaluating safer dental devices is available at • http://www.cdc.gov/OralHealth/infectioncontrol/ forms.htm (forms for screening and evaluating safer dental devices), and • http://www.cdc.gov/niosh/topics/bbp (state legislation on needlestick safety). Postexposure Management and Prophylaxis Postexposure management is an integral component of a complete program to prevent infection after an occupational exposure to blood. During dental procedures, saliva is predictably contaminated with blood (7,114). Even when blood is not visible, it can still be present in limited quantities and therefore is considered a potentially infectious material by OSHA (13,19). A qualified health-care professional should evaluate any occupational exposure incident to blood or OPIM, including saliva, regardless of whether blood is visible, in dental settings (13). Dental practices and laboratories should establish written, comprehensive programs that include hepatitis B vaccination and postexposure management protocols that 1) describe the types of contact with blood or OPIM that can place DHCP at risk for infection; 2) describe procedures for promptly reporting and evaluating such exposures; and 3) identify a health- The portion of these 2003 Guidelines pertaining to HIV Recommendations has been superseded by the Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Post-Exposure Prophylaxis – 2005 (see Bloodborne Pathogens Appendix F, page 95). The 2005 Guidelines only update the Recommendations for HIV, not for Hepatitis B and C. Bloodborne Pathogens Appendix D - Page 51 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 14 MMWR care professional who is qualified to provide counseling and perform all medical evaluations and procedures in accordance with current recommendations of the U.S. Public Health Service (PHS), including PEP with chemotherapeutic drugs when indicated. DHCP, including students, who might reasonably be considered at risk for occupational exposure to blood or OPIM should be taught strategies to prevent contact with blood or OPIM and the principles of postexposure management, including PEP options, as part of their job orientation and training. Educational programs for DHCP and students should emphasize reporting all exposures to blood or OPIM as soon as possible, because certain interventions have to be initiated promptly to be effective. Policies should be consistent with the practices and procedures for worker protection required by OSHA and with current PHS recommendations for managing occupational exposures to blood (13,19). After an occupational blood exposure, first aid should be administered as necessary. Puncture wounds and other injuries to the skin should be washed with soap and water; mucous membranes should be flushed with water. No evidence exists that using antiseptics for wound care or expressing fluid by squeezing the wound further reduces the risk of bloodborne pathogen transmission; however, use of antiseptics is not contraindicated. The application of caustic agents (e.g., bleach) or the injection of antiseptics or disinfectants into the wound is not recommended (19). Exposed DHCP should immediately report the exposure to the infection-control coordinator or other designated person, who should initiate referral to the qualified health-care professional and complete necessary reports. Because multiple factors contribute to the risk of infection after an occupational exposure to blood, the following information should be included in the exposure report, recorded in the exposed person’s confidential medical record, and provided to the qualified health-care professional: • Date and time of exposure. • Details of the procedure being performed, including where and how the exposure occurred and whether the exposure involved a sharp device, the type and brand of device, and how and when during its handling the exposure occurred. • Details of the exposure, including its severity and the type and amount of fluid or material. For a percutaneous injury, severity might be measured by the depth of the wound, gauge of the needle, and whether fluid was injected; for a skin or mucous membrane exposure, the estimated volume of material, duration of contact, and the condition of the skin (e.g., chapped, abraded, or intact) should be noted. • Details regarding whether the source material was known to contain HIV or other bloodborne pathogens, and, if December 19, 2003 the source was infected with HIV, the stage of disease, history of antiretroviral therapy, and viral load, if known. • Details regarding the exposed person (e.g., hepatitis B vaccination and vaccine-response status). • Details regarding counseling, postexposure management, and follow-up. Each occupational exposure should be evaluated individually for its potential to transmit HBV, HCV, and HIV, based on the following: • The type and amount of body substance involved. • The type of exposure (e.g., percutaneous injury, mucous membrane or nonintact skin exposure, or bites resulting in blood exposure to either person involved). • The infection status of the source. • The susceptibility of the exposed person (19). All of these factors should be considered in assessing the risk for infection and the need for further follow-up (e.g., PEP). During 1990–1998, PHS published guidelines for PEP and other management of health-care worker exposures to HBV, HCV, or HIV (69,116–119). In 2001, these recommendations were updated and consolidated into one set of PHS guidelines (19). The new guidelines reflect the availability of new antiretroviral agents, new information regarding the use and safety of HIV PEP, and considerations regarding employing HIV PEP when resistance of the source patient’s virus to antiretroviral agents is known or suspected. In addition, the 2001 guidelines provide guidance to clinicians and exposed HCP regarding when to consider HIV PEP and recommendations for PEP regimens (19). Hand Hygiene Hand hygiene (e.g., handwashing, hand antisepsis, or surgical hand antisepsis) substantially reduces potential pathogens on the hands and is considered the single most critical measure for reducing the risk of transmitting organisms to patients and HCP (120–123). Hospital-based studies have demonstrated that noncompliance with hand hygiene practices is associated with health-care–associated infections and the spread of multiresistant organisms. Noncompliance also has been a major contributor to outbreaks (123). The prevalence of health-care–associated infections decreases as adherence of HCP to recommended hand hygiene measures improves (124–126). The microbial flora of the skin, first described in 1938, consist of transient and resident microorganisms (127). Transient flora, which colonize the superficial layers of the skin, are easier to remove by routine handwashing. They are often acquired by HCP during direct contact with patients or contaminated environmental surfaces; these organisms are most frequently Bloodborne Pathogens Appendix D - Page 52 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports associated with health-care–associated infections. Resident flora attached to deeper layers of the skin are more resistant to removal and less likely to be associated with such infections. The preferred method for hand hygiene depends on the type of procedure, the degree of contamination, and the desired persistence of antimicrobial action on the skin (Table 2). For routine dental examinations and nonsurgical procedures, handwashing and hand antisepsis is achieved by using either a plain or antimicrobial soap and water. If the hands are not visibly soiled, an alcohol-based hand rub is adequate. The purpose of surgical hand antisepsis is to eliminate transient flora and reduce resident flora for the duration of a procedure to prevent introduction of organisms in the operative wound, if gloves become punctured or torn. Skin bacteria can rapidly multiply under surgical gloves if hands are washed with soap that is not antimicrobial (127,128). Thus, an antimicrobial soap or alcohol hand rub with persistent activity should be used before surgical procedures (129–131). Agents used for surgical hand antisepsis should substantially reduce microorganisms on intact skin, contain a nonirritating antimicrobial preparation, have a broad spectrum of activity, be fast-acting, and have a persistent effect (121,132–135). Persistence (i.e., extended antimicrobial activity that prevents or inhibits survival of microorganisms after the product is 15 applied) is critical because microorganisms can colonize on hands in the moist environment underneath gloves (122). Alcohol hand rubs are rapidly germicidal when applied to the skin but should include such antiseptics as chlorhexidine, quaternary ammonium compounds, octenidine, or triclosan to achieve persistent activity (130). Factors that can influence the effectiveness of the surgical hand antisepsis in addition to the choice of antiseptic agent include duration and technique of scrubbing, as well as condition of the hands, and techniques used for drying and gloving. CDC’s 2002 guideline on hand hygiene in health-care settings provides more complete information (123). Selection of Antiseptic Agents Selecting the most appropriate antiseptic agent for hand hygiene requires consideration of multiple factors. Essential performance characteristics of a product (e.g., the spectrum and persistence of activity and whether or not the agent is fastacting) should be determined before selecting a product. Delivery system, cost per use, reliable vendor support and supply are also considerations. Because HCP acceptance is a major factor regarding compliance with recommended hand hygiene protocols (122,123,147,148), considering DHCP needs is critical and should include possible chemical allergies, TABLE 2. Hand-hygiene methods and indications Method Agent Purpose Duration (minimum) seconds§ Routine handwash Water and nonantimicrobial soap (e.g., plain soap†) Remove soil and transient microorganisms 15 Antiseptic handwash Water and antimicrobial soap (e.g., chlorhexidine, iodine and iodophors, chloroxylenol [PCMX], triclosan) Remove or destroy transient microorganisms and reduce resident flora 15 seconds§ Antiseptic hand rub Alcohol-based hand rub¶ Remove or destroy transient microorganisms and reduce resident flora Rub hands until the agent is dry¶ Surgical antisepsis Water and antimicrobial soap (e.g., chlorhexidine, iodine and iodophors, chloroxylenol [PCMX], triclosan) Remove or destroy transient microorganisms and reduce resident flora (persistent effect) 2–6 minutes Water and non-antimicrobial soap (e.g., plain soap†) followed by an alcohol-based surgical hand-scrub product with persistent activity Indication* Before and after treating each patient (e.g., before glove placement and after glove removal). After barehanded touching of inanimate objects likely to be contaminated by blood or saliva. Before leaving the dental operatory or the dental laboratory. When visibly soiled.¶ Before regloving after removing gloves that are torn, cut, or punctured. Before donning sterile surgeon’s gloves for surgical procedures†† Follow manufacturer instructions for surgical hand-scrub product with persistent activity¶** * (7,9,11,13,113,120–123,125,126,136–138). Pathogenic organisms have been found on or around bar soap during and after use (139). Use of liquid soap with hands-free dispensing controls is preferable. § Time reported as effective in removing most transient flora from the skin. For most procedures, a vigorous rubbing together of all surfaces of premoistened lathered hands and fingers for >15 seconds, followed by rinsing under a stream of cool or tepid water is recommended (9,120,123,140,141). Hands should always be dried thoroughly before donning gloves. ¶ Alcohol-based hand rubs should contain 60%–95% ethanol or isopropanol and should not be used in the presence of visible soil or organic material. If using an alcohol-based hand rub, apply adequate amount to palm of one hand and rub hands together, covering all surfaces of the hands and fingers, until hands are dry. Follow manufacturer’s recommendations regarding the volume of product to use. If hands feel dry after rubbing them together for 10–15 seconds, an insufficient volume of product likely was applied. The drying effect of alcohol can be reduced or eliminated by adding 1%–3% glycerol or other skin-conditioning agents (123). ** After application of alcohol-based surgical hand-scrub product with persistent activity as recommended, allow hands and forearms to dry thoroughly and immediately don sterile surgeon’s gloves (144,145). Follow manufacturer instructions (122,123,137,146). †† Before beginning surgical hand scrub, remove all arm jewelry and any hand jewelry that may make donning gloves more difficult, cause gloves to tear more readily (142,143), or interfere with glove usage (e.g., ability to wear the correct-sized glove or altered glove integrity). † BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 16 MMWR skin integrity after repeated use, compatibility with lotions used, and offensive agent ingredients (e.g., scent). Discussing specific preparations or ingredients used for hand antisepsis is beyond the scope of this report. DHCP should choose from commercially available HCP handwashes when selecting agents for hand antisepsis or surgical hand antisepsis. Storage and Dispensing of Hand Care Products Handwashing products, including plain (i.e., nonantimicrobial) soap and antiseptic products, can become contaminated or support the growth of microorganisms (122). Liquid products should be stored in closed containers and dispensed from either disposable containers or containers that are washed and dried thoroughly before refilling. Soap should not be added to a partially empty dispenser, because this practice of topping off might lead to bacterial contamination (149,150). Store and dispense products according to manufacturers’ directions. Lotions The primary defense against infection and transmission of pathogens is healthy, unbroken skin. Frequent handwashing with soaps and antiseptic agents can cause chronic irritant contact dermatitis among DHCP. Damage to the skin changes skin flora, resulting in more frequent colonization by staphylococci and gram-negative bacteria (151,152). The potential of detergents to cause skin irritation varies considerably, but can be reduced by adding emollients. Lotions are often recommended to ease the dryness resulting from frequent handwashing and to prevent dermatitis from glove use (153,154). However, petroleum-based lotion formulations can weaken latex gloves and increase permeability. For that reason, lotions that contain petroleum or other oil emollients should only be used at the end of the work day (122,155). Dental practitioners should obtain information from lotion manufacturers regarding interaction between lotions, gloves, dental materials, and antimicrobial products. Fingernails and Artificial Nails Although the relationship between fingernail length and wound infection is unknown, keeping nails short is considered key because the majority of flora on the hands are found under and around the fingernails (156). Fingernails should be short enough to allow DHCP to thoroughly clean underneath them and prevent glove tears (122). Sharp nail edges or broken nails are also likely to increase glove failure. Long artificial or natural nails can make donning gloves more difficult and can cause gloves to tear more readily. Hand carriage of gramnegative organisms has been determined to be greater among December 19, 2003 wearers of artificial nails than among nonwearers, both before and after handwashing (157–160). In addition, artificial fingernails or extenders have been epidemiologically implicated in multiple outbreaks involving fungal and bacterial infections in hospital intensive-care units and operating rooms (161– 164). Freshly applied nail polish on natural nails does not increase the microbial load from periungual skin if fingernails are short; however, chipped nail polish can harbor added bacteria (165,166). Jewelry Studies have demonstrated that skin underneath rings is more heavily colonized than comparable areas of skin on fingers without rings (167–170). In a study of intensive-care nurses, multivariable analysis determined rings were the only substantial risk factor for carriage of gram-negative bacilli and Staphylococcus aureus, and the concentration of organisms correlated with the number of rings worn (170). However, two other studies demonstrated that mean bacterial colony counts on hands after handwashing were similar among persons wearing rings and those not wearing rings (169,171). Whether wearing rings increases the likelihood of transmitting a pathogen is unknown; further studies are needed to establish whether rings result in higher transmission of pathogens in health-care settings. However, rings and decorative nail jewelry can make donning gloves more difficult and cause gloves to tear more readily (142,143). Thus, jewelry should not interfere with glove use (e.g., impair ability to wear the correct-sized glove or alter glove integrity). Personal Protective Equipment PPE is designed to protect the skin and the mucous membranes of the eyes, nose, and mouth of DHCP from exposure to blood or OPIM. Use of rotary dental and surgical instruments (e.g., handpieces or ultrasonic scalers) and air-water syringes creates a visible spray that contains primarily largeparticle droplets of water, saliva, blood, microorganisms, and other debris. This spatter travels only a short distance and settles out quickly, landing on the floor, nearby operatory surfaces, DHCP, or the patient. The spray also might contain certain aerosols (i.e., particles of respirable size, <10 µm). Aerosols can remain airborne for extended periods and can be inhaled. However, they should not be confused with the large-particle spatter that makes up the bulk of the spray from handpieces and ultrasonic scalers. Appropriate work practices, including use of dental dams (172) and high-velocity air evacuation, should minimize dissemination of droplets, spatter, and aerosols (2). Primary PPE used in oral health-care settings includes gloves, surgical masks, protective eyewear, face shields, and protective BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports clothing (e.g., gowns and jackets). All PPE should be removed before DHCP leave patient-care areas (13). Reusable PPE (e.g., clinician or patient protective eyewear and face shields) should be cleaned with soap and water, and when visibly soiled, disinfected between patients, according to the manufacturer’s directions (2,13). Wearing gloves, surgical masks, protective eyewear, and protective clothing in specified circumstances to reduce the risk of exposures to bloodborne pathogens is mandated by OSHA (13). General work clothes (e.g., uniforms, scrubs, pants, and shirts) are neither intended to protect against a hazard nor considered PPE. Masks, Protective Eyewear, Face Shields A surgical mask that covers both the nose and mouth and protective eyewear with solid side shields or a face shield should be worn by DHCP during procedures and patient-care activities likely to generate splashes or sprays of blood or body fluids. Protective eyewear for patients shields their eyes from spatter or debris generated during dental procedures. A surgical mask protects against microorganisms generated by the wearer, with >95% bacterial filtration efficiency, and also protects DHCP from large-particle droplet spatter that might contain bloodborne pathogens or other infectious microorganisms (173). The mask’s outer surface can become contaminated with infectious droplets from spray of oral fluids or from touching the mask with contaminated fingers. Also, when a mask becomes wet from exhaled moist air, the resistance to airflow through the mask increases, causing more airflow to pass around edges of the mask. If the mask becomes wet, it should be changed between patients or even during patient treatment, when possible (2,174). When airborne infection isolation precautions (expanded or transmission-based) are necessary (e.g., for TB patients), a National Institute for Occupational Safety and Health (NIOSH)-certified particulate-filter respirator (e.g., N95, N99, or N100) should be used (20). N95 refers to the ability to filter 1-µm particles in the unloaded state with a filter efficiency of >95% (i.e., filter leakage <5%), given flow rates of <50 L/min (i.e., approximate maximum airflow rate of HCP during breathing). Available data indicate infectious droplet nuclei measure 1–5 µm; therefore, respirators used in healthcare settings should be able to efficiently filter the smallest particles in this range. The majority of surgical masks are not NIOSH-certified as respirators, do not protect the user adequately from exposure to TB, and do not satisfy OSHA requirements for respiratory protection (174,175). However, certain surgical masks (i.e., surgical N95 respirator) do meet the requirements and are certified by NIOSH as respirators. The level of protection a respirator provides is determined by the efficiency of the filter 17 material for incoming air and how well the face piece fits or seals to the face (e.g., qualitatively or quantitatively tested in a reliable way to obtain a face-seal leakage of <10% and to fit the different facial sizes and characteristics of HCP). When respirators are used while treating patients with diseases requiring airborne-transmission precautions (e.g., TB), they should be used in the context of a complete respiratory protection program (175). This program should include training and fit testing to ensure an adequate seal between the edges of the respirator and the wearer’s face. Detailed information regarding respirator programs, including fit-test procedures are available at http://www.cdc.gov/niosh/99-143.html (174,176). Protective Clothing Protective clothing and equipment (e.g., gowns, lab coats, gloves, masks, and protective eyewear or face shield) should be worn to prevent contamination of street clothing and to protect the skin of DHCP from exposures to blood and body substances (2,7,10,11,13,137). OSHA bloodborne pathogens standard requires sleeves to be long enough to protect the forearms when the gown is worn as PPE (i.e., when spatter and spray of blood, saliva, or OPIM to the forearms is anticipated) (13,14). DHCP should change protective clothing when it becomes visibly soiled and as soon as feasible if penetrated by blood or other potentially infectious fluids (2,13,14,137). All protective clothing should be removed before leaving the work area (13). Gloves and Gloving DHCP wear gloves to prevent contamination of their hands when touching mucous membranes, blood, saliva, or OPIM, and also to reduce the likelihood that microorganisms present on the hands of DHCP will be transmitted to patients during surgical or other patient-care procedures (1,2,7,10). Medical gloves, both patient examination and surgeon’s gloves, are manufactured as single-use disposable items that should be used for only one patient, then discarded. Gloves should be changed between patients and when torn or punctured. Wearing gloves does not eliminate the need for handwashing. Hand hygiene should be performed immediately before donning gloves. Gloves can have small, unapparent defects or can be torn during use, and hands can become contaminated during glove removal (122,177–187). These circumstances increase the risk of operative wound contamination and exposure of the DHCP’s hands to microorganisms from patients. In addition, bacteria can multiply rapidly in the moist environments underneath gloves, and thus, the hands should be dried thoroughly before donning gloves and washed again immediately after glove removal. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 18 MMWR Types of Gloves Because gloves are task-specific, their selection should be based on the type of procedure to be performed (e.g., surgery or patient examination) (Table 3). Sterile surgeon’s gloves must meet standards for sterility assurance established by FDA and are less likely than patient examination gloves to harbor pathogens that could contaminate an operative wound (188). Appropriate gloves in the correct size should be readily accessible (13). Glove Integrity Limited studies of the penetrability of different glove materials under conditions of use have been conducted in the dental environment. Consistent with observations in clinical medicine, leakage rates vary by glove material (e.g., latex, vinyl, and nitrile), duration of use, and type of procedure performed (182,184,186,189–191), as well as by manufacturer (192– 194). The frequency of perforations in surgeon’s gloves used during outpatient oral surgical procedures has been determined to range from 6% to 16% (181,185,195,196). Studies have demonstrated that HCP and DHCP are frequently unaware of minute tears in gloves that occur during use (186,190,191,197). These studies determined that gloves developed defects in 30 minutes–3 hours, depending on type of glove and procedure. Investigators did not determine an optimal time for changing gloves during procedures. During dental procedures, patient examination and surgeon’s gloves commonly contact multiple types of chemicals and materials (e.g., disinfectants and antiseptics, composite resins, and bonding agents) that can compromise the integrity of latex as well as vinyl, nitrile, and other synthetic glove materials (198–206). In addition, latex gloves can interfere with the setting of vinyl polysiloxane impression materials (207–209), although the setting is apparently not adversely affected by synthetic vinyl gloves (207,208). Given the diverse selection of dental materials on the market, dental practitioners should consult glove manufacturers regarding the chemical compatibility of glove materials. If the integrity of a glove is compromised (e.g., punctured), it should be changed as soon as possible (13,210,211). Washing latex gloves with plain soap, chlorhexidine, or alcohol can lead to the formation of glove micropunctures (177,212,213) and subsequent hand contamination (138). Because this condition, known as wicking, can allow penetration of liquids through undetected holes, washing gloves is not recommended. After a hand rub with alcohol, the hands should be thoroughly TABLE 3. Glove types and indications Glove Commercially available glove materials* Indication Comment Patient examination gloves§ Patient care, examinations, other nonsurgical procedures involving contact with mucous membranes, and laboratory procedures Medical device regulated by the Food and Drug Administration (FDA). Surgeon’s gloves§ Surgical procedures Medical device regulated by the FDA. Nonmedical gloves Housekeeping procedures (e.g., cleaning and disinfection) Nonsterile and sterile single-use disposable. Use for one patient and discard appropriately. Sterile and single-use disposable. Use for one patient and discard appropriately. Handling contaminated sharps or chemicals Not for use during patient care December 19, 2003 Not a medical device regulated by the FDA. Commonly referred to as utility, industrial, or general purpose gloves. Should be puncture- or chemical-resistant, depending on the task. Latex gloves do not provide adequate chemical protection. Material Attributes† Natural-rubber latex (NRL) Nitrile Nitrile and chloroprene (neoprene) blends Nitrile & NRL blends Butadiene methyl methacrylate Polyvinyl chloride (PVC, vinyl) Polyurethane Styrene-based copolymer 1, 2 2, 3 2, 3 1, 2, 3 2, 3 4 4 4, 5 NRL Nitrile Chloroprene (neoprene) NRL and nitrile or chloroprene blends Synthetic polyisoprene Styrene-based copolymer Polyurethane 1, 2 2, 3 2, 3 2, 3 2 4, 5 4 NRL and nitrile or chloroprene blends Chloroprene (neoprene) Nitrile Butyl rubber Fluoroelastomer Polyethylene and ethylene vinyl alcohol copolymer 2, 3 2, 3 2, 3 2, 3 3, 4, 6 3, 4, 6 Sanitize after use. * Physical properties can vary by material, manufacturer, and protein and chemical composition. † 1 contains allergenic NRL proteins. 2 vulcanized rubber, contains allergenic rubber processing chemicals. 3 likely to have enhanced chemical or puncture resistance. 4 nonvulcanized and does not contain rubber processing chemicals. 5 inappropriate for use with methacrylates. 6 resistant to most methacrylates. § Medical or dental gloves include patient-examination gloves and surgeon’s (i.e., surgical) gloves and are medical devices regulated by the FDA. Only FDA-cleared medical or dental patient-examination gloves and surgical gloves can be used for patient care. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports dried before gloving, because hands still wet with an alcoholbased hand hygiene product can increase the risk of glove perforation (192). FDA regulates the medical glove industry, which includes gloves marketed as sterile surgeon’s and sterile or nonsterile patient examination gloves. General-purpose utility gloves are also used in dental health-care settings but are not regulated by FDA because they are not promoted for medical use. More rigorous standards are applied to surgeon’s than to examination gloves. FDA has identified acceptable quality levels (e.g., maximum defects allowed) for glove manufacturers (214), but even intact gloves eventually fail with exposure to mechanical (e.g., sharps, fingernails, or jewelry) and chemical (e.g., dimethyacrylates) hazards and over time. These variables can be controlled, ultimately optimizing glove performance, by 1) maintaining short fingernails, 2) minimizing or eliminating hand jewelry, and 3) using engineering and work-practice controls to avoid injuries with sharps. Sterile Surgeon’s Gloves and Double-Gloving During Oral Surgical Procedures Certain limited studies have determined no difference in postoperative infection rates after routine tooth extractions when surgeons wore either sterile or nonsterile gloves (215,216). However, wearing sterile surgeon’s gloves during surgical procedures is supported by a strong theoretical rationale (2,7,137). Sterile gloves minimize transmission of microorganisms from the hands of surgical DHCP to patients and prevent contamination of the hands of surgical DHCP with the patient’s blood and body fluids (137). In addition, sterile surgeon’s gloves are more rigorously regulated by FDA and therefore might provide an increased level of protection for the provider if exposure to blood is likely. Although the effectiveness of wearing two pairs of gloves in preventing disease transmission has not been demonstrated, the majority of studies among HCP and DHCP have demonstrated a lower frequency of inner glove perforation and visible blood on the surgeon’s hands when double gloves are worn (181,185,195,196,198,217–219). In one study evaluating double gloves during oral surgical and dental hygiene procedures, the perforation of outer latex gloves was greater during longer procedures (i.e., >45 minutes), with the highest rate (10%) of perforation occurring during oral surgery procedures (196). Based on these studies, double gloving might provide additional protection from occupational blood contact (220). Double gloving does not appear to substantially reduce either manual dexterity or tactile sensitivity (221–223). Additional protection might also be provided by specialty products (e.g., orthopedic surgical gloves and glove liners) (224). 19 Contact Dermatitis and Latex Hypersensitivity Occupationally related contact dermatitis can develop from frequent and repeated use of hand hygiene products, exposure to chemicals, and glove use. Contact dermatitis is classified as either irritant or allergic. Irritant contact dermatitis is common, nonallergic, and develops as dry, itchy, irritated areas on the skin around the area of contact. By comparison, allergic contact dermatitis (type IV hypersensitivity) can result from exposure to accelerators and other chemicals used in the manufacture of rubber gloves (e.g., natural rubber latex, nitrile, and neoprene), as well as from other chemicals found in the dental practice setting (e.g., methacrylates and glutaraldehyde). Allergic contact dermatitis often manifests as a rash beginning hours after contact and, similar to irritant dermatitis, is usually confined to the area of contact. Latex allergy (type I hypersensitivity to latex proteins) can be a more serious systemic allergic reaction, usually beginning within minutes of exposure but sometimes occurring hours later and producing varied symptoms. More common reactions include runny nose, sneezing, itchy eyes, scratchy throat, hives, and itchy burning skin sensations. More severe symptoms include asthma marked by difficult breathing, coughing spells, and wheezing; cardiovascular and gastrointestinal ailments; and in rare cases, anaphylaxis and death (32,225). The American Dental Association (ADA) began investigating the prevalence of type I latex hypersensitivity among DHCP at the ADA annual meeting in 1994. In 1994 and 1995, approximately 2,000 dentists, hygienists, and assistants volunteered for skin-prick testing. Data demonstrated that 6.2% of those tested were positive for type I latex hypersensitivity (226). Data from the subsequent 5 years of this ongoing crosssectional study indicated a decline in prevalence from 8.5% to 4.3% (227). This downward trend is similar to that reported by other studies and might be related to use of latex gloves with lower allergen content (228–230). Natural rubber latex proteins responsible for latex allergy are attached to glove powder. When powdered latex gloves are worn, more latex protein reaches the skin. In addition, when powdered latex gloves are donned or removed, latex protein/ powder particles become aerosolized and can be inhaled, contacting mucous membranes (231). As a result, allergic patients and DHCP can experience cutaneous, respiratory, and conjunctival symptoms related to latex protein exposure. DHCP can become sensitized to latex protein with repeated exposure (232–236). Work areas where only powder-free, low-allergen latex gloves are used demonstrate low or undetectable amounts of latex allergy-causing proteins (237–239) and fewer symptoms among HCP related to natural rubber latex allergy. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 20 MMWR Because of the role of glove powder in exposure to latex protein, NIOSH recommends that if latex gloves are chosen, HCP should be provided with reduced protein, powder-free gloves (32). Nonlatex (e.g., nitrile or vinyl) powder-free and lowprotein gloves are also available (31,240). Although rare, potentially life-threatening anaphylactic reactions to latex can occur; dental practices should be appropriately equipped and have procedures in place to respond to such emergencies. DHCP and dental patients with latex allergy should not have direct contact with latex-containing materials and should be in a latex-safe environment with all latex-containing products removed from their vicinity (31). Dental patients with histories of latex allergy can be at risk from dental products (e.g., prophylaxis cups, rubber dams, orthodontic elastics, and medication vials) (241). Any latex-containing devices that cannot be removed from the treatment environment should be adequately covered or isolated. Persons might also be allergic to chemicals used in the manufacture of natural rubber latex and synthetic rubber gloves as well as metals, plastics, or other materials used in dental care. Taking thorough health histories for both patients and DHCP, followed by avoidance of contact with potential allergens can minimize the possibility of adverse reactions. Certain common predisposing conditions for latex allergy include previous history of allergies, a history of spina bifida, urogenital anomalies, or allergies to avocados, kiwis, nuts, or bananas. The following precautions should be considered to ensure safe treatment for patients who have possible or documented latex allergy: • Be aware that latent allergens in the ambient air can cause respiratory or anaphylactic symptoms among persons with latex hypersensitivity. Patients with latex allergy can be scheduled for the first appointment of the day to minimize their inadvertent exposure to airborne latex particles. • Communicate with other DHCP regarding patients with latex allergy (e.g., by oral instructions, written protocols, and posted signage) to prevent them from bringing latexcontaining materials into the treatment area. • Frequently clean all working areas contaminated with latex powder or dust. December 19, 2003 • Have emergency treatment kits with latex-free products available at all times. • If latex-related complications occur during or after a procedure, manage the reaction and seek emergency assistance as indicated. Follow current medical emergency response recommendations for management of anaphylaxis (32). Sterilization and Disinfection of Patient-Care Items Patient-care items (dental instruments, devices, and equipment) are categorized as critical, semicritical, or noncritical, depending on the potential risk for infection associated with their intended use (Table 4) (242). Critical items used to penetrate soft tissue or bone have the greatest risk of transmitting infection and should be sterilized by heat. Semicritical items touch mucous membranes or nonintact skin and have a lower risk of transmission; because the majority of semicritical items in dentistry are heat-tolerant, they also should be sterilized by using heat. If a semicritical item is heat-sensitive, it should, at a minimum, be processed with high-level disinfection (2). Noncritical patient-care items pose the least risk of transmission of infection, contacting only intact skin, which can serve as an effective barrier to microorganisms. In the majority of cases, cleaning, or if visibly soiled, cleaning followed by disinfection with an EPA-registered hospital disinfectant is adequate. When the item is visibly contaminated with blood or OPIM, an EPA-registered hospital disinfectant with a tuberculocidal claim (i.e., intermediate-level disinfectant) should be used (2,243,244). Cleaning or disinfection of certain noncritical patient-care items can be difficult or damage the surfaces; therefore, use of disposable barrier protection of these surfaces might be a preferred alternative. FDA-cleared sterilant/high-level disinfectants and EPAregistered disinfectants must have clear label claims for intended use, and manufacturer instructions for use must be followed (245). A more complete description of the regulatory framework in the United States by which liquid chemical germicides are evaluated and regulated is included (Appendix A). TABLE 4. Infection-control categories of patient-care instruments Category Definition Dental instrument or item Critical Penetrates soft tissue, contacts bone, enters into or contacts the bloodstream or other normally sterile tissue. Surgical instruments, periodontal scalers, scalpel blades, surgical dental burs Semicritical Contacts mucous membranes or nonintact skin; will not penetrate soft tissue, contact bone, enter into or contact the bloodstream or other normally sterile tissue. Dental mouth mirror, amalgam condenser, reusable dental impression trays, dental handpieces* Noncritical Contacts intact skin. Radiograph head/cone, blood pressure cuff, facebow, pulse oximeter * Although dental handpieces are considered a semicritical item, they should always be heat-sterilized between uses and not high-level disinfected (246). See Dental Handpieces and Other Devices Attached to Air or Waterlines for detailed information. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports Three levels of disinfection, high, intermediate, and low, are used for patient-care devices that do not require sterility and two levels, intermediate and low, for environmental surfaces (242). The intended use of the patient-care item should determine the recommended level of disinfection. Dental practices should follow the product manufacturer’s directions regarding concentrations and exposure time for disinfectant activity relative to the surface to be disinfected (245). A summary of sterilization and disinfection methods is included (Appendix C). Transporting and Processing Contaminated Critical and Semicritical Patient-Care Items DHCP can be exposed to microorganisms on contaminated instruments and devices through percutaneous injury, contact with nonintact skin on the hands, or contact with mucous membranes of the eyes, nose, or mouth. Contaminated instruments should be handled carefully to prevent exposure to sharp instruments that can cause a percutaneous injury. Instruments should be placed in an appropriate container at the point of use to prevent percutaneous injuries during transport to the instrument processing area (13). Instrument processing requires multiple steps to achieve sterilization or high-level disinfection. Sterilization is a complex process requiring specialized equipment, adequate space, qualified DHCP who are provided with ongoing training, and regular monitoring for quality assurance (247). Correct cleaning, packaging, sterilizer loading procedures, sterilization methods, or high-level disinfection methods should be followed to ensure that an instrument is adequately processed and safe for reuse on patients. Instrument Processing Area DHCP should process all instruments in a designated central processing area to more easily control quality and ensure safety (248). The central processing area should be divided into sections for 1) receiving, cleaning, and decontamination; 2) preparation and packaging; 3) sterilization; and 4) storage. Ideally, walls or partitions should separate the sections to control traffic flow and contain contaminants generated during processing. When physical separation of these sections cannot be achieved, adequate spatial separation might be satisfactory if the DHCP who process instruments are trained in work practices to prevent contamination of clean areas (248). Space should be adequate for the volume of work anticipated and the items to be stored (248). Receiving, Cleaning, and Decontamination Reusable instruments, supplies, and equipment should be received, sorted, cleaned, and decontaminated in one section of the processing area. Cleaning should precede all disinfection 21 and sterilization processes; it should involve removal of debris as well as organic and inorganic contamination. Removal of debris and contamination is achieved either by scrubbing with a surfactant, detergent, and water, or by an automated process (e.g., ultrasonic cleaner or washer-disinfector) using chemical agents. If visible debris, whether inorganic or organic matter, is not removed, it will interfere with microbial inactivation and can compromise the disinfection or sterilization process (244,249–252). After cleaning, instruments should be rinsed with water to remove chemical or detergent residue. Splashing should be minimized during cleaning and rinsing (13). Before final disinfection or sterilization, instruments should be handled as though contaminated. Considerations in selecting cleaning methods and equipment include 1) efficacy of the method, process, and equipment; 2) compatibility with items to be cleaned; and 3) occupational health and exposure risks. Use of automated cleaning equipment (e.g., ultrasonic cleaner or washer-disinfector) does not require presoaking or scrubbing of instruments and can increase productivity, improve cleaning effectiveness, and decrease worker exposure to blood and body fluids. Thus, using automated equipment can be safer and more efficient than manually cleaning contaminated instruments (253). If manual cleaning is not performed immediately, placing instruments in a puncture-resistant container and soaking them with detergent, a disinfectant/detergent, or an enzymatic cleaner will prevent drying of patient material and make cleaning easier and less time-consuming. Use of a liquid chemical sterilant/high-level disinfectant (e.g., glutaraldehyde) as a holding solution is not recommended (244). Using work-practice controls (e.g., long-handled brush) to keep the scrubbing hand away from sharp instruments is recommended (14). To avoid injury from sharp instruments, DHCP should wear punctureresistant, heavy-duty utility gloves when handling or manually cleaning contaminated instruments and devices (6). Employees should not reach into trays or containers holding sharp instruments that cannot be seen (e.g., sinks filled with soapy water in which sharp instruments have been placed). Work-practice controls should include use of a strainer-type basket to hold instruments and forceps to remove the items. Because splashing is likely to occur, a mask, protective eyewear or face shield, and gown or jacket should be worn (13). Preparation and Packaging In another section of the processing area, cleaned instruments and other dental supplies should be inspected, assembled into sets or trays, and wrapped, packaged, or placed into container systems for sterilization. Hinged instruments should be processed open and unlocked. An internal chemical indicator should be placed in every package. In addition, an external BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 22 MMWR chemical indicator (e.g., chemical indicator tape) should be used when the internal indicator cannot be seen from outside the package. For unwrapped loads, at a minimum, an internal chemical indicator should be placed in the tray or cassette with items to be sterilized (254) (see Sterilization of Unwrapped Instruments). Dental practices should refer to the manufacturer’s instructions regarding use and correct placement of chemical indicators (see Sterilization Monitoring). Critical and semicritical instruments that will be stored should be wrapped or placed in containers (e.g., cassettes or organizing trays) designed to maintain sterility during storage (2,247,255–257). Packaging materials (e.g., wraps or container systems) allow penetration of the sterilization agent and maintain sterility of the processed item after sterilization. Materials for maintaining sterility of instruments during transport and storage include wrapped perforated instrument cassettes, peel pouches of plastic or paper, and sterilization wraps (i.e., woven and nonwoven). Packaging materials should be designed for the type of sterilization process being used (256–259). Sterilization The sterilization section of the processing area should include the sterilizers and related supplies, with adequate space for loading, unloading, and cool down. The area can also include incubators for analyzing spore tests and enclosed storage for sterile items and disposable (single-use) items (260). Manufacturer and local building code specifications will determine placement and room ventilation requirements. Sterilization Procedures. Heat-tolerant dental instruments usually are sterilized by 1) steam under pressure (autoclaving), 2) dry heat, or 3) unsaturated chemical vapor. All sterilization should be performed by using medical sterilization equipment cleared by FDA. The sterilization times, temperatures, and other operating parameters recommended by the manufacturer of the equipment used, as well as instructions for correct use of containers, wraps, and chemical or biological indicators, should always be followed (243,247). Items to be sterilized should be arranged to permit free circulation of the sterilizing agent (e.g., steam, chemical vapor, or dry heat); manufacturer’s instructions for loading the sterilizer should be followed (248,260). Instrument packs should be allowed to dry inside the sterilizer chamber before removing and handling. Packs should not be touched until they are cool and dry because hot packs act as wicks, absorbing moisture, and hence, bacteria from hands (247). The ability of equipment to attain physical parameters required to achieve sterilization should be monitored by mechanical, chemical, and biological indicators. Sterilizers vary in their types of indicators and their ability to provide readings on the mechani- December 19, 2003 cal or physical parameters of the sterilization process (e.g., time, temperature, and pressure). Consult with the sterilizer manufacturer regarding selection and use of indicators. Steam Sterilization. Among sterilization methods, steam sterilization, which is dependable and economical, is the most widely used for wrapped and unwrapped critical and semicritical items that are not sensitive to heat and moisture (260). Steam sterilization requires exposure of each item to direct steam contact at a required temperature and pressure for a specified time needed to kill microorganisms. Two basic types of steam sterilizers are the gravity displacement and the high-speed prevacuum sterilizer. The majority of tabletop sterilizers used in a dental practice are gravity displacement sterilizers, although prevacuum sterilizers are becoming more widely available. In gravity displacement sterilizers, steam is admitted through steam lines, a steam generator, or self-generation of steam within the chamber. Unsaturated air is forced out of the chamber through a vent in the chamber wall. Trapping of air is a concern when using saturated steam under gravity displacement; errors in packaging items or overloading the sterilizer chamber can result in cool air pockets and items not being sterilized. Prevacuum sterilizers are fitted with a pump to create a vacuum in the chamber and ensure air removal from the sterilizing chamber before the chamber is pressurized with steam. Relative to gravity displacement, this procedure allows faster and more positive steam penetration throughout the entire load. Prevacuum sterilizers should be tested periodically for adequate air removal, as recommended by the manufacturer. Air not removed from the chamber will interfere with steam contact. If a sterilizer fails the air removal test, it should not be used until inspected by sterilizer maintenance personnel and it passes the test (243,247). Manufacturer’s instructions, with specific details regarding operation and user maintenance information, should be followed. Unsaturated Chemical-Vapor Sterilization. Unsaturated chemical-vapor sterilization involves heating a chemical solution of primarily alcohol with 0.23% formaldehyde in a closed pressurized chamber. Unsaturated chemical vapor sterilization of carbon steel instruments (e.g., dental burs) causes less corrosion than steam sterilization because of the low level of water present during the cycle. Instruments should be dry before sterilizing. State and local authorities should be consulted for hazardous waste disposal requirements for the sterilizing solution. Dry-Heat Sterilization. Dry heat is used to sterilize materials that might be damaged by moist heat (e.g., burs and certain orthodontic instruments). Although dry heat has the advantages of low operating cost and being noncorrosive, it is BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports a prolonged process and the high temperatures required are not suitable for certain patient-care items and devices (261). Dry-heat sterilizers used in dentistry include static-air and forced-air types. • The static-air type is commonly called an oven-type sterilizer. Heating coils in the bottom or sides of the unit cause hot air to rise inside the chamber through natural convection. • The forced-air type is also known as a rapid heat-transfer sterilizer. Heated air is circulated throughout the chamber at a high velocity, permitting more rapid transfer of energy from the air to the instruments, thereby reducing the time needed for sterilization. Sterilization of Unwrapped Instruments. An unwrapped cycle (sometimes called flash sterilization) is a method for sterilizing unwrapped patient-care items for immediate use. The time required for unwrapped sterilization cycles depends on the type of sterilizer and the type of item (i.e., porous or nonporous) to be sterilized (243). The unwrapped cycle in tabletop sterilizers is preprogrammed by the manufacturer to a specific time and temperature setting and can include a drying phase at the end to produce a dry instrument with much of the heat dissipated. If the drying phase requirements are unclear, the operation manual or manufacturer of the sterilizer should be consulted. If the unwrapped sterilization cycle in a steam sterilizer does not include a drying phase, or has only a minimal drying phase, items retrieved from the sterilizer will be hot and wet, making aseptic transport to the point of use more difficult. For dry-heat and chemical-vapor sterilizers, a drying phase is not required. Unwrapped sterilization should be used only under certain conditions: 1) thorough cleaning and drying of instruments precedes the unwrapped sterilization cycle; 2) mechanical monitors are checked and chemical indicators used for each cycle; 3) care is taken to avoid thermal injury to DHCP or patients; and 4) items are transported aseptically to the point of use to maintain sterility (134,258,262). Because all implantable devices should be quarantined after sterilization until the results of biological monitoring are known, unwrapped or flash sterilization of implantable items is not recommended (134). Critical instruments sterilized unwrapped should be transferred immediately by using aseptic technique, from the sterilizer to the actual point of use. Critical instruments should not be stored unwrapped (260). Semicritical instruments that are sterilized unwrapped on a tray or in a container system should be used immediately or within a short time. When sterile items are open to the air, they will eventually become contaminated. Storage, even temporary, of unwrapped semicritical instruments is discouraged because it permits exposure to dust, airborne organisms, and other unnecessary contamination before use on a patient (260). A carefully written protocol for minimiz- 23 ing the risk of contaminating unwrapped instruments should be prepared and followed (260). Other Sterilization Methods. Heat-sensitive critical and semicritical instruments and devices can be sterilized by immersing them in liquid chemical germicides registered by FDA as sterilants. When using a liquid chemical germicide for sterilization, certain poststerilization procedures are essential. Items need to be 1) rinsed with sterile water after removal to remove toxic or irritating residues; 2) handled using sterile gloves and dried with sterile towels; and 3) delivered to the point of use in an aseptic manner. If stored before use, the instrument should not be considered sterile and should be sterilized again just before use. In addition, the sterilization process with liquid chemical sterilants cannot be verified with biological indicators (263). Because of these limitations and because liquid chemical sterilants can require approximately 12 hours of complete immersion, they are almost never used to sterilize instruments. Rather, these chemicals are more often used for high-level disinfection (249). Shorter immersion times (12–90 minutes) are used to achieve high-level disinfection of semicritical instruments or items. These powerful, sporicidal chemicals (e.g., glutaraldehyde, peracetic acid, and hydrogen peroxide) are highly toxic (244,264,265). Manufacturer instructions (e.g., regarding dilution, immersion time, and temperature) and safety precautions for using chemical sterilants/high-level disinfectants must be followed precisely (15,245). These chemicals should not be used for applications other than those indicated in their label instructions. Misapplications include use as an environmental surface disinfectant or instrument-holding solution. When using appropriate precautions (e.g., closed containers to limit vapor release, chemically resistant gloves and aprons, goggles, and face shields), glutaraldehyde-based products can be used without tissue irritation or adverse health effects. However, dermatologic, eye irritation, respiratory effects, and skin sensitization have been reported (266–268). Because of their lack of chemical resistance to glutaraldehydes, medical gloves are not an effective barrier (200,269,270). Other factors might apply (e.g., room exhaust ventilation or 10 air exchanges/hour) to ensure DHCP safety (266,271). For all of these reasons, using heat-sensitive semicritical items that must be processed with liquid chemical germicides is discouraged; heat-tolerant or disposable alternatives are available for the majority of such items. Low-temperature sterilization with ethylene oxide gas (ETO) has been used extensively in larger health-care facilities. Its primary advantage is the ability to sterilize heat- and moisture-sensitive patient-care items with reduced deleterious effects. However, extended sterilization times of 10–48 hours BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 24 MMWR and potential hazards to patients and DHCP requiring stringent health and safety requirements (272–274) make this method impractical for private-practice settings. Handpieces cannot be effectively sterilized with this method because of decreased penetration of ETO gas flow through a small lumen (250,275). Other types of low-temperature sterilization (e.g., hydrogen peroxide gas plasma) exist but are not yet practical for dental offices. Bead sterilizers have been used in dentistry to sterilize small metallic instruments (e.g., endodontic files). FDA has determined that a risk of infection exists with these devices because of their potential failure to sterilize dental instruments and has required their commercial distribution cease unless the manufacturer files a premarket approval application. If a bead sterilizer is employed, DHCP assume the risk of employing a dental device FDA has deemed neither safe nor effective (276). Sterilization Monitoring. Monitoring of sterilization procedures should include a combination of process parameters, including mechanical, chemical, and biological (247,248,277). These parameters evaluate both the sterilizing conditions and the procedure’s effectiveness. Mechanical techniques for monitoring sterilization include assessing cycle time, temperature, and pressure by observing the gauges or displays on the sterilizer and noting these parameters for each load (243,248). Some tabletop sterilizers have recording devices that print out these parameters. Correct readings do not ensure sterilization, but incorrect readings can be the first indication of a problem with the sterilization cycle. Chemical indicators, internal and external, use sensitive chemicals to assess physical conditions (e.g., time and temperature) during the sterilization process. Although chemical indicators do not prove sterilization has been achieved, they allow detection of certain equipment malfunctions, and they can help identify procedural errors. External indicators applied to the outside of a package (e.g., chemical indicator tape or special markings) change color rapidly when a specific parameter is reached, and they verify that the package has been exposed to the sterilization process. Internal chemical indicators should be used inside each package to ensure the sterilizing agent has penetrated the packaging material and actually reached the instruments inside. A single-parameter internal chemical indicator provides information regarding only one sterilization parameter (e.g., time or temperature). Multiparameter internal chemical indicators are designed to react to >2 parameters (e.g., time and temperature; or time, temperature, and the presence of steam) and can provide a more reliable indication that sterilization conditions have been met (254). Multiparameter internal indicators are available only for steam sterilizers (i.e., autoclaves). December 19, 2003 Because chemical indicator test results are received when the sterilization cycle is complete, they can provide an early indication of a problem and where in the process the problem might exist. If either mechanical indicators or internal or external chemical indicators indicate inadequate processing, items in the load should not be used until reprocessed (134). Biological indicators (BIs) (i.e., spore tests) are the most accepted method for monitoring the sterilization process (278,279) because they assess it directly by killing known highly resistant microorganisms (e.g., Geobacillus or Bacillus species), rather than merely testing the physical and chemical conditions necessary for sterilization (243). Because spores used in BIs are more resistant and present in greater numbers than the common microbial contaminants found on patient-care equipment, an inactivated BI indicates other potential pathogens in the load have been killed (280). Correct functioning of sterilization cycles should be verified for each sterilizer by the periodic use (at least weekly) of BIs (2,9,134,243,278,279). Every load containing implantable devices should be monitored with such indicators (248), and the items quarantined until BI results are known. However, in an emergency, placing implantable items in quarantine until spore tests are known to be negative might be impossible. Manufacturer’s directions should determine the placement and location of BI in the sterilizer. A control BI, from the same lot as the test indicator and not processed through the sterilizer, should be incubated with the test BI; the control BI should yield positive results for bacterial growth. In-office biological monitoring is available; mail-in sterilization monitoring services (e.g., from private companies or dental schools) can also be used to test both the BI and the control. Although some DHCP have expressed concern that delays caused by mailing specimens might cause false-negatives, studies have determined that mail delays have no substantial effect on final test results (281,282). Procedures to follow in the event of a positive spore test have been developed (243,247). If the mechanical (e.g., time, temperature, and pressure) and chemical (i.e., internal or external) indicators demonstrate that the sterilizer is functioning correctly, a single positive spore test probably does not indicate sterilizer malfunction. Items other than implantable devices do not necessarily need to be recalled; however the spore test should be repeated immediately after correctly loading the sterilizer and using the same cycle that produced the failure. The sterilizer should be removed from service, and all records reviewed of chemical and mechanical monitoring since the last negative BI test. Also, sterilizer operating procedures should be reviewed, including packaging, loading, and spore testing, with all persons who work with the sterilizer to determine whether operator error could be responsible (9,243,247). BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports Overloading, failure to provide adequate package separation, and incorrect or excessive packaging material are all common reasons for a positive BI in the absence of mechanical failure of the sterilizer unit (260). A second monitored sterilizer in the office can be used, or a loaner from a sales or repair company obtained, to minimize office disruption while waiting for the repeat BI. If the repeat test is negative and chemical and mechanical monitoring indicate adequate processing, the sterilizer can be put back into service. If the repeat BI test is positive, and packaging, loading, and operating procedures have been confirmed as performing correctly, the sterilizer should remain out of service until it has been inspected, repaired, and rechallenged with BI tests in three consecutive empty chamber sterilization cycles (9,243). When possible, items from suspect loads dating back to the last negative BI should be recalled, rewrapped, and resterilized (9,283). A more conservative approach has been recommended (247) in which any positive spore test is assumed to represent sterilizer malfunction and requires that all materials processed in that sterilizer, dating from the sterilization cycle having the last negative biologic indicator to the next cycle indicating satisfactory biologic indicator results, should be considered nonsterile and retrieved, if possible, and reprocessed or held in quarantine until the results of the repeat BI are known. This approach is considered conservative because the margin of safety in steam sterilization is sufficient enough that infection risk, associated with items in a load indicating spore growth, is minimal, particularly if the item was properly cleaned and the temperature was achieved (e.g., as demonstrated by acceptable chemical indicator or temperature chart) (243). Published studies are not available that document disease transmission through a nonretrieved surgical instrument after a steam sterilization cycle with a positive biological indicator (243). This more conservative approach should always be used for sterilization methods other than steam (e.g., dry heat, unsaturated chemical vapor, ETO, or hydrogen peroxide gas plasma) (243). Results of biological monitoring should be recorded and sterilization monitoring records (i.e., mechanical, chemical, and biological) retained long enough to comply with state and local regulations. Such records are a component of an overall dental infection-control program (see Program Evaluation). Storage of Sterilized Items and Clean Dental Supplies The storage area should contain enclosed storage for sterile items and disposable (single-use) items (173). Storage practices for wrapped sterilized instruments can be either date- or event-related. Packages containing sterile supplies should be inspected before use to verify barrier integrity and dryness. 25 Although some health-care facilities continue to date every sterilized package and use shelf-life practices, other facilities have switched to event-related practices (243). This approach recognizes that the product should remain sterile indefinitely, unless an event causes it to become contaminated (e.g., torn or wet packaging) (284). Even for event-related packaging, minimally, the date of sterilization should be placed on the package, and if multiple sterilizers are used in the facility, the sterilizer used should be indicated on the outside of the packaging material to facilitate the retrieval of processed items in the event of a sterilization failure (247). If packaging is compromised, the instruments should be recleaned, packaged in new wrap, and sterilized again. Clean supplies and instruments should be stored in closed or covered cabinets, if possible (285). Dental supplies and instruments should not be stored under sinks or in other locations where they might become wet. Environmental Infection Control In the dental operatory, environmental surfaces (i.e., a surface or equipment that does not contact patients directly) can become contaminated during patient care. Certain surfaces, especially ones touched frequently (e.g., light handles, unit switches, and drawer knobs) can serve as reservoirs of microbial contamination, although they have not been associated directly with transmission of infection to either DHCP or patients. Transfer of microorganisms from contaminated environmental surfaces to patients occurs primarily through DHCP hand contact (286,287). When these surfaces are touched, microbial agents can be transferred to instruments, other environmental surfaces, or to the nose, mouth, or eyes of workers or patients. Although hand hygiene is key to minimizing this transferal, barrier protection or cleaning and disinfecting of environmental surfaces also protects against health-care–associated infections. Environmental surfaces can be divided into clinical contact surfaces and housekeeping surfaces (249). Because housekeeping surfaces (e.g., floors, walls, and sinks) have limited risk of disease transmission, they can be decontaminated with less rigorous methods than those used on dental patient-care items and clinical contact surfaces (244). Strategies for cleaning and disinfecting surfaces in patient-care areas should consider the 1) potential for direct patient contact; 2) degree and frequency of hand contact; and 3) potential contamination of the surface with body substances or environmental sources of microorganisms (e.g., soil, dust, or water). Cleaning is the necessary first step of any disinfection process. Cleaning is a form of decontamination that renders the environmental surface safe by removing organic matter, salts, BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 26 MMWR and visible soils, all of which interfere with microbial inactivation. The physical action of scrubbing with detergents and surfactants and rinsing with water removes substantial numbers of microorganisms. If a surface is not cleaned first, the success of the disinfection process can be compromised. Removal of all visible blood and inorganic and organic matter can be as critical as the germicidal activity of the disinfecting agent (249). When a surface cannot be cleaned adequately, it should be protected with barriers (2). Clinical Contact Surfaces Clinical contact surfaces can be directly contaminated from patient materials either by direct spray or spatter generated during dental procedures or by contact with DHCP’s gloved hands. These surfaces can subsequently contaminate other instruments, devices, hands, or gloves. Examples of such surfaces include • light handles, • switches, • dental radiograph equipment, • dental chairside computers, • reusable containers of dental materials, • drawer handles, • faucet handles, • countertops, • pens, • telephones, and • doorknobs. Barrier protection of surfaces and equipment can prevent contamination of clinical contact surfaces, but is particularly effective for those that are difficult to clean. Barriers include clear plastic wrap, bags, sheets, tubing, and plastic-backed paper or other materials impervious to moisture (260,288). Because such coverings can become contaminated, they should be removed and discarded between patients, while DHCP are still gloved. After removing the barrier, examine the surface to make sure it did not become soiled inadvertently. The surface needs to be cleaned and disinfected only if contamination is evident. Otherwise, after removing gloves and performing hand hygiene, DHCP should place clean barriers on these surfaces before the next patient (1,2,288). If barriers are not used, surfaces should be cleaned and disinfected between patients by using an EPA-registered hospital disinfectant with an HIV, HBV claim (i.e., low-level disinfectant) or a tuberculocidal claim (i.e., intermediate-level disinfectant). Intermediate-level disinfectant should be used when the surface is visibly contaminated with blood or OPIM (2,244). Also, general cleaning and disinfection are recommended for clinical contact surfaces, dental unit surfaces, and countertops at the end of daily work activities and are required December 19, 2003 if surfaces have become contaminated since their last cleaning (13). To facilitate daily cleaning, treatment areas should be kept free of unnecessary equipment and supplies. Manufacturers of dental devices and equipment should provide information regarding material compatibility with liquid chemical germicides, whether equipment can be safely immersed for cleaning, and how it should be decontaminated if servicing is required (289). Because of the risks associated with exposure to chemical disinfectants and contaminated surfaces, DHCP who perform environmental cleaning and disinfection should wear gloves and other PPE to prevent occupational exposure to infectious agents and hazardous chemicals. Chemical- and puncture-resistant utility gloves offer more protection than patient examination gloves when using hazardous chemicals. Housekeeping Surfaces Evidence does not support that housekeeping surfaces (e.g., floors, walls, and sinks) pose a risk for disease transmission in dental health-care settings. Actual, physical removal of microorganisms and soil by wiping or scrubbing is probably as critical, if not more so, than any antimicrobial effect provided by the agent used (244,290). The majority of housekeeping surfaces need to be cleaned only with a detergent and water or an EPA-registered hospital disinfectant/detergent, depending on the nature of the surface and the type and degree of contamination. Schedules and methods vary according to the area (e.g., dental operatory, laboratory, bathrooms, or reception rooms), surface, and amount and type of contamination. Floors should be cleaned regularly, and spills should be cleaned up promptly. An EPA-registered hospital disinfectant/ detergent designed for general housekeeping purposes should be used in patient-care areas if uncertainty exists regarding the nature of the soil on the surface (e.g., blood or body fluid contamination versus routine dust or dirt). Unless contamination is reasonably anticipated or apparent, cleaning or disinfecting walls, window drapes, and other vertical surfaces is unnecessary. However, when housekeeping surfaces are visibly contaminated by blood or OPIM, prompt removal and surface disinfection is appropriate infection-control practice and required by OSHA (13). Part of the cleaning strategy is to minimize contamination of cleaning solutions and cleaning tools (e.g., mop heads or cleaning cloths). Mops and cloths should be cleaned after use and allowed to dry before reuse, or single-use, disposable mop heads and cloths should be used to avoid spreading contamination. Cost, safety, product-surface compatibility, and acceptability by housekeepers can be key criteria for selecting a cleaning agent or an EPA-registered hospital disinfectant/ BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports detergent. PPE used during cleaning and housekeeping procedures followed should be appropriate to the task. In the cleaning process, another reservoir for microorganisms can be dilute solutions of detergents or disinfectants, especially if prepared in dirty containers, stored for long periods of time, or prepared incorrectly (244). Manufacturers’ instructions for preparation and use should be followed. Making fresh cleaning solution each day, discarding any remaining solution, and allowing the container to dry will minimize bacterial contamination. Preferred cleaning methods produce minimal mists and aerosols or dispersion of dust in patientcare areas. Cleaning and Disinfection Strategies for Blood Spills The majority of blood contamination events in dentistry result from spatter during dental procedures using rotary or ultrasonic instrumentation. Although no evidence supports that HBV, HCV, or HIV have been transmitted from a housekeeping surface, prompt removal and surface disinfection of an area contaminated by either blood or OPIM are appropriate infection-control practices and required by OSHA (13,291). Strategies for decontaminating spills of blood and other body fluids differ by setting and volume of the spill (113,244). Blood spills on either clinical contact or housekeeping surfaces should be contained and managed as quickly as possible to reduce the risk of contact by patients and DHCP (244,292). The person assigned to clean the spill should wear gloves and other PPE as needed. Visible organic material should be removed with absorbent material (e.g., disposable paper towels discarded in a leak-proof, appropriately labeled container). Nonporous surfaces should be cleaned and then decontaminated with either an EPA-registered hospital disinfectant effective against HBV and HIV or an EPA-registered hospital disinfectant with a tuberculocidal claim (i.e., intermediate-level disinfectant). If sodium hypochlorite is chosen, an EPA-registered sodium hypochlorite product is preferred. However, if such products are unavailable, a 1:100 dilution of sodium hypochlorite (e.g., approximately ¼ cup of 5.25% household chlorine bleach to 1 gallon of water) is an inexpensive and effective disinfecting agent (113). Carpeting and Cloth Furnishings Carpeting is more difficult to clean than nonporous hardsurface flooring, and it cannot be reliably disinfected, especially after spills of blood and body substances. Studies have documented the presence of diverse microbial populations, primarily bacteria and fungi, in carpeting (293–295). Cloth furnishings pose similar contamination risks in areas of direct patient care and places where contaminated materials are man- 27 aged (e.g., dental operatory, laboratory, or instrument processing areas). For these reasons, use of carpeted flooring and fabric-upholstered furnishings in these areas should be avoided. Nonregulated and Regulated Medical Waste Studies have compared microbial load and diversity of microorganisms in residential waste with waste from multiple health-care settings. General waste from hospitals or other health-care facilities (e.g., dental practices or clinical/research laboratories) is no more infective than residential waste (296,297). The majority of soiled items in dental offices are general medical waste and thus can be disposed of with ordinary waste. Examples include used gloves, masks, gowns, lightly soiled gauze or cotton rolls, and environmental barriers (e.g., plastic sheets or bags) used to cover equipment during treatment (298). Although any item that has had contact with blood, exudates, or secretions might be infective, treating all such waste as infective is neither necessary nor practical (244). Infectious waste that carries a substantial risk of causing infection during handling and disposal is regulated medical waste. A complete definition of regulated waste is included in OSHA’s bloodborne pathogens standard (13). Regulated medical waste is only a limited subset of waste: 9%–15% of total waste in hospitals and 1%–2% of total waste in dental offices (298,299). Regulated medical waste requires special storage, handling, neutralization, and disposal and is covered by federal, state, and local rules and regulations (6,297,300,301). Examples of regulated waste found in dental-practice settings are solid waste soaked or saturated with blood or saliva (e.g., gauze saturated with blood after surgery), extracted teeth, surgically removed hard and soft tissues, and contaminated sharp items (e.g., needles, scalpel blades, and wires) (13). Regulated medical waste requires careful containment for treatment or disposal. A single leak-resistant biohazard bag is usually adequate for containment of nonsharp regulated medical waste, provided the bag is sturdy and the waste can be discarded without contaminating the bag’s exterior. Exterior contamination or puncturing of the bag requires placement in a second biohazard bag. All bags should be securely closed for disposal. Puncture-resistant containers with a biohazard label, located at the point of use (i.e., sharps containers), are used as containment for scalpel blades, needles, syringes, and unused sterile sharps (13). Dental health-care facilities should dispose of medical waste regularly to avoid accumulation. Any facility generating regulated medical waste should have a plan for its management that complies with federal, state, and local regulations to ensure health and environmental safety. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 28 MMWR Discharging Blood or Other Body Fluids to Sanitary Sewers or Septic Tanks All containers with blood or saliva (e.g., suctioned fluids) can be inactivated in accordance with state-approved treatment technologies, or the contents can be carefully poured down a utility sink, drain, or toilet (6). Appropriate PPE (e.g., gloves, gown, mask, and protective eyewear) should be worn when performing this task (13). No evidence exists that bloodborne diseases have been transmitted from contact with raw or treated sewage. Multiple bloodborne pathogens, particularly viruses, are not stable in the environment for long periods (302), and the discharge of limited quantities of blood and other body fluids into the sanitary sewer is considered a safe method for disposing of these waste materials (6). State and local regulations vary and dictate whether blood or other body fluids require pretreatment or if they can be discharged into the sanitary sewer and in what volume. Dental Unit Waterlines, Biofilm, and Water Quality Studies have demonstrated that dental unit waterlines (i.e., narrow-bore plastic tubing that carries water to the high-speed handpiece, air/water syringe, and ultrasonic scaler) can become colonized with microorganisms, including bacteria, fungi, and protozoa (303–309). Protected by a polysaccharide slime layer known as a glycocalyx, these microorganisms colonize and replicate on the interior surfaces of the waterline tubing and form a biofilm, which serves as a reservoir that can amplify the number of free-floating (i.e., planktonic) microorganisms in water used for dental treatment. Although oral flora (303,310,311) and human pathogens (e.g., Pseudomonas aeruginosa [303,305,312,313], Legionella species [303,306,313], and nontuberculous Mycobacterium species [303,304]), have been isolated from dental water systems, the majority of organisms recovered from dental waterlines are common heterotrophic water bacteria (305,314,315). These exhibit limited pathogenic potential for immunocompetent persons. Clinical Implications Certain reports associate waterborne infections with dental water systems, and scientific evidence verifies the potential for transmission of waterborne infections and disease in hospital settings and in the community (306,312,316). Infection or colonization caused by Pseudomonas species or nontuberculous mycobacteria can occur among susceptible patients through direct contact with water (317–320) or after exposure to residual waterborne contamination of inadequately reprocessed medical instruments (321–323). Nontuberculous mycobacteria can also be transmitted to patients from tap water aero- December 19, 2003 sols (324). Health-care–associated transmission of pathogenic agents (e.g., Legionella species) occurs primarily through inhalation of infectious aerosols generated from potable water sources or through use of tap water in respiratory therapy equipment (325–327). Disease outbreaks in the community have also been reported from diverse environmental aerosolproducing sources, including whirlpool spas (328), swimming pools (329), and a grocery store mist machine (330). Although the majority of these outbreaks are associated with species of Legionella and Pseudomonas (329), the fungus Cladosporium (331) has also been implicated. Researchers have not demonstrated a measurable risk of adverse health effects among DHCP or patients from exposure to dental water. Certain studies determined DHCP had altered nasal flora (332) or substantially greater titers of Legionella antibodies in comparisons with control populations; however, no cases of legionellosis were identified among exposed DHCP (333,334). Contaminated dental water might have been the source for localized Pseudomonas aeruginosa infections in two immunocompromised patients (312). Although transient carriage of P. aeruginosa was observed in 78 healthy patients treated with contaminated dental treatment water, no illness was reported among the group. In this same study, a retrospective review of dental records also failed to identify infections (312). Concentrations of bacterial endotoxin <1,000 endotoxin units/mL from gram-negative water bacteria have been detected in water from colonized dental units (335). No standards exist for an acceptable level of endotoxin in drinking water, but the maximum level permissible in United States Pharmacopeia (USP) sterile water for irrigation is only 0.25 endotoxin units/ mL (336). Although the consequences of acute and chronic exposure to aerosolized endotoxin in dental health-care settings have not been investigated, endotoxin has been associated with exacerbation of asthma and onset of hypersensitivity pneumonitis in other occupational settings (329,337). Dental Unit Water Quality Research has demonstrated that microbial counts can reach <200,000 colony-forming units (CFU)/mL within 5 days after installation of new dental unit waterlines (305), and levels of microbial contamination <106 CFU/mL of dental unit water have been documented (309,338). These counts can occur because dental unit waterline factors (e.g., system design, flow rates, and materials) promote both bacterial growth and development of biofilm. Although no epidemiologic evidence indicates a public health problem, the presence of substantial numbers of pathogens in dental unit waterlines generates concern. Exposing patients or DHCP to water of uncertain microbiological quality, despite BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports the lack of documented adverse health effects, is inconsistent with accepted infection-control principles. Thus in 1995, ADA addressed the dental water concern by asking manufacturers to provide equipment with the ability to deliver treatment water with <200 CFU/mL of unfiltered output from waterlines (339). This threshold was based on the quality assurance standard established for dialysate fluid, to ensure that fluid delivery systems in hemodialysis units have not been colonized by indigenous waterborne organisms (340). Standards also exist for safe drinking water quality as established by EPA, the American Public Health Association (APHA), and the American Water Works Association (AWWA); they have set limits for heterotrophic bacteria of <500 CFU/mL of drinking water (341,342). Thus, the number of bacteria in water used as a coolant/irrigant for nonsurgical dental procedures should be as low as reasonably achievable and, at a minimum, <500 CFU/mL, the regulatory standard for safe drinking water established by EPA and APHA/ AWWA. Strategies To Improve Dental Unit Water Quality In 1993, CDC recommended that dental waterlines be flushed at the beginning of the clinic day to reduce the microbial load (2). However, studies have demonstrated this practice does not affect biofilm in the waterlines or reliably improve the quality of water used during dental treatment (315,338,343). Because the recommended value of <500 CFU/ mL cannot be achieved by using this method, other strategies should be employed. Dental unit water that remains untreated or unfiltered is unlikely to meet drinking water standards (303– 309). Commercial devices and procedures designed to improve the quality of water used in dental treatment are available (316); methods demonstrated to be effective include self-contained water systems combined with chemical treatment, in-line microfilters, and combinations of these treatments. Simply using source water containing <500 CFU/mL of bacteria (e.g., tap, distilled, or sterile water) in a self-contained water system will not eliminate bacterial contamination in treatment water if biofilms in the water system are not controlled. Removal or inactivation of dental waterline biofilms requires use of chemical germicides. Patient material (e.g., oral microorganisms, blood, and saliva) can enter the dental water system during patient treatment (311,344). Dental devices that are connected to the dental water system and that enter the patient’s mouth (e.g., handpieces, ultrasonic scalers, or air/water syringes) should be operated to discharge water and air for a minimum of 20–30 seconds after each patient (2). This procedure is intended to physically flush out patient material that might have entered 29 the turbine, air, or waterlines. The majority of recently manufactured dental units are engineered to prevent retraction of oral fluids, but some older dental units are equipped with antiretraction valves that require periodic maintenance. Users should consult the owner’s manual or contact the manufacturer to determine whether testing or maintenance of antiretraction valves or other devices is required. Even with antiretraction valves, flushing devices for a minimum of 20– 30 seconds after each patient is recommended. Maintenance and Monitoring of Dental Unit Water DHCP should be trained regarding water quality, biofilm formation, water treatment methods, and appropriate maintenance protocols for water delivery systems. Water treatment and monitoring products require strict adherence to maintenance protocols, and noncompliance with treatment regimens has been associated with persistence of microbial contamination in treated systems (345). Clinical monitoring of water quality can ensure that procedures are correctly performed and that devices are working in accordance with the manufacturer’s previously validated protocol. Dentists should consult with the manufacturer of their dental unit or water delivery system to determine the best method for maintaining acceptable water quality (i.e., <500 CFU/mL) and the recommended frequency of monitoring. Monitoring of dental water quality can be performed by using commercial selfcontained test kits or commercial water-testing laboratories. Because methods used to treat dental water systems target the entire biofilm, no rationale exists for routine testing for such specific organisms as Legionella or Pseudomonas, except when investigating a suspected waterborne disease outbreak (244). Delivery of Sterile Surgical Irrigation Sterile solutions (e.g., sterile saline or sterile water) should be used as a coolant/irrigation in the performance of oral surgical procedures where a greater opportunity exists for entry of microorganisms, exogenous and endogenous, into the vascular system and other normally sterile areas that support the oral cavity (e.g., bone or subcutaneous tissue) and increased potential exists for localized or systemic infection (see Oral Surgical Procedures). Conventional dental units cannot reliably deliver sterile water even when equipped with independent water reservoirs because the water-bearing pathway cannot be reliably sterilized. Delivery devices (e.g., bulb syringe or sterile, singleuse disposable products) should be used to deliver sterile water (2,121). Oral surgery and implant handpieces, as well as ultrasonic scalers, are commercially available that bypass the dental unit to deliver sterile water or other solutions by using singleuse disposable or sterilizable tubing (316). BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 30 MMWR Boil-Water Advisories A boil-water advisory is a public health announcement that the public should boil tap water before drinking it. When issued, the public should assume the water is unsafe to drink. Advisories can be issued after 1) failure of or substantial interruption in water treatment processes that result in increased turbidity levels or particle counts and mechanical or equipment failure; 2) positive test results for pathogens (e.g., Cryptosporidium, Giardia, or Shigella) in water; 3) violations of the total coliform rule or the turbidity standard of the surface water treatment rule; 4) circumstances that compromise the distribution system (e.g., watermain break) coupled with an indication of a health hazard; or 5) a natural disaster (e.g., flood, hurricane, or earthquake) (346). In recent years, increased numbers of boil-water advisories have resulted from contamination of public drinking water systems with waterborne pathogens. Most notable was the outbreak of cryptosporidiosis in Milwaukee, Wisconsin, where the municipal water system was contaminated with the protozoan parasite Cryptosporidium parvum. An estimated 403,000 persons became ill (347,348). During a boil-water advisory, water should not be delivered to patients through the dental unit, ultrasonic scaler, or other dental equipment that uses the public water system. This restriction does not apply if the water source is isolated from the municipal water system (e.g., a separate water reservoir or other water treatment device cleared for marketing by FDA). Patients should rinse with bottled or distilled water until the boil-water advisory has been cancelled. During these advisory periods, tap water should not be used to dilute germicides or for hand hygiene unless the water has been brought to a rolling boil for >1 minute and cooled before use (346,349–351). For hand hygiene, antimicrobial products that do not require water (e.g., alcohol-based hand rubs) can be used until the boil-water notice is cancelled. If hands are visibly contaminated, bottled water and soap should be used for handwashing; if bottled water is not immediately available, an antiseptic towelette should be used (13,122). When the advisory is cancelled, the local water utility should provide guidance for flushing of waterlines to reduce residual microbial contamination. All incoming waterlines from the public water system inside the dental office (e.g., faucets, waterlines, and dental equipment) should be flushed. No consensus exists regarding the optimal duration for flushing procedures after cancellation of the advisory; recommendations range from 1 to 5 minutes (244,346,351,352). The length of time needed can vary with the type and length of the plumbing system leading to the office. After the incoming public water system lines are flushed, dental unit waterlines should be disinfected according to the manufacturer’s instructions (346). December 19, 2003 Special Considerations Dental Handpieces and Other Devices Attached to Air and Waterlines Multiple semicritical dental devices that touch mucous membranes are attached to the air or waterlines of the dental unit. Among these devices are high- and low-speed handpieces, prophylaxis angles, ultrasonic and sonic scaling tips, air abrasion devices, and air and water syringe tips. Although no epidemiologic evidence implicates these instruments in disease transmission (353), studies of high-speed handpieces using dye expulsion have confirmed the potential for retracting oral fluids into internal compartments of the device (354–358). This determination indicates that retained patient material can be expelled intraorally during subsequent uses. Studies using laboratory models also indicate the possibility for retention of viral DNA and viable virus inside both high-speed handpieces and prophylaxis angles (356,357,359). The potential for contamination of the internal surfaces of other devices (e.g., low-speed handpieces and ultrasonic scalers), has not been studied, but restricted physical access limits their cleaning. Accordingly, any dental device connected to the dental air/water system that enters the patient’s mouth should be run to discharge water, air, or a combination for a minimum of 20–30 seconds after each patient (2). This procedure is intended to help physically flush out patient material that might have entered the turbine and air and waterlines (2,356,357). Heat methods can sterilize dental handpieces and other intraoral devices attached to air or waterlines (246,275,356, 357,360). For processing any dental device that can be removed from the dental unit air or waterlines, neither surface disinfection nor immersion in chemical germicides is an acceptable method. Ethylene oxide gas cannot adequately sterilize internal components of handpieces (250,275). In clinical evaluations of high-speed handpieces, cleaning and lubrication were the most critical factors in determining performance and durability (361–363). Manufacturer’s instructions for cleaning, lubrication, and sterilization should be followed closely to ensure both the effectiveness of the process and the longevity of handpieces. Some components of dental instruments are permanently attached to dental unit waterlines and although they do not enter the patient’s oral cavity, they are likely to become contaminated with oral fluids during treatment procedures. Such components (e.g., handles or dental unit attachments of saliva ejectors, high-speed air evacuators, and air/water syringes) should be covered with impervious barriers that are changed after each use. If the item becomes visibly contaminated during use, DHCP should clean and disinfect with an EPA- BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports registered hospital disinfectant (intermediate-level) before use on the next patient. Saliva Ejectors Backflow from low-volume saliva ejectors occurs when the pressure in the patient’s mouth is less than that in the evacuator. Studies have reported that backflow in low-volume suction lines can occur and microorganisms be present in the lines retracted into the patient’s mouth when a seal around the saliva ejector is created (e.g., by a patient closing lips around the tip of the ejector, creating a partial vacuum) (364–366). This backflow can be a potential source of cross-contamination; occurrence is variable because the quality of the seal formed varies between patients. Furthermore, studies have demonstrated that gravity pulls fluid back toward the patient’s mouth whenever a length of the suction tubing holding the tip is positioned above the patient’s mouth, or during simultaneous use of other evacuation (high-volume) equipment (364– 366). Although no adverse health effects associated with the saliva ejector have been reported, practitioners should be aware that in certain situations, backflow could occur when using a saliva ejector. Dental Radiology When taking radiographs, the potential to cross-contaminate equipment and environmental surfaces with blood or saliva is high if aseptic technique is not practiced. Gloves should be worn when taking radiographs and handling contaminated film packets. Other PPE (e.g., mask, protective eyewear, and gowns) should be used if spattering of blood or other body fluids is likely (11,13,367). Heat-tolerant versions of intraoral radiograph accessories are available and these semicritical items (e.g., film-holding and positioning devices) should be heatsterilized before patient use. After exposure of the radiograph and before glove removal, the film should be dried with disposable gauze or a paper towel to remove blood or excess saliva and placed in a container (e.g., disposable cup) for transport to the developing area. Alternatively, if FDA-cleared film barrier pouches are used, the film packets should be carefully removed from the pouch to avoid contamination of the outside film packet and placed in the clean container for transport to the developing area. Various methods have been recommended for aseptic transport of exposed films to the developing area, and for removing the outer film packet before exposing and developing the film. Other information regarding dental radiography infection control is available (260,367,368). However, care should be taken to avoid contamination of the developing equipment. Protective barriers should be used, or any surfaces that 31 become contaminated should be cleaned and disinfected with an EPA-registered hospital disinfectant of low- (i.e., HIV and HBV claim) to intermediate-level (i.e., tuberculocidal claim) activity. Radiography equipment (e.g., radiograph tubehead and control panel) should be protected with surface barriers that are changed after each patient. If barriers are not used, equipment that has come into contact with DHCP’s gloved hands or contaminated film packets should be cleaned and then disinfected after each patient use. Digital radiography sensors and other high-technology instruments (e.g., intraoral camera, electronic periodontal probe, occlusal analyzers, and lasers) come into contact with mucous membranes and are considered semicritical devices. They should be cleaned and ideally heat-sterilized or highlevel disinfected between patients. However, these items vary by manufacturer or type of device in their ability to be sterilized or high-level disinfected. Semicritical items that cannot be reprocessed by heat sterilization or high-level disinfection should, at a minimum, be barrier protected by using an FDAcleared barrier to reduce gross contamination during use. Use of a barrier does not always protect from contamination (369– 374). One study determined that a brand of commercially available plastic barriers used to protect dental digital radiography sensors failed at a substantial rate (44%). This rate dropped to 6% when latex finger cots were used in conjunction with the plastic barrier (375). To minimize the potential for device-associated infections, after removing the barrier, the device should be cleaned and disinfected with an EPAregistered hospital disinfectant (intermediate-level) after each patient. Manufacturers should be consulted regarding appropriate barrier and disinfection/sterilization procedures for digital radiography sensors, other high-technology intraoral devices, and computer components. Aseptic Technique for Parenteral Medications Safe handling of parenteral medications and fluid infusion systems is required to prevent health-care–associated infections among patients undergoing conscious sedation. Parenteral medications can be packaged in single-dose ampules, vials or prefilled syringes, usually without bacteriostatic/preservative agents, and intended for use on a single patient. Multidose vials, used for more than one patient, can have a preservative, but both types of containers of medication should be handled with aseptic techniques to prevent contamination. Single-dose vials should be used for parenteral medications whenever possible (376,377). Single-dose vials might pose a risk for contamination if they are punctured repeatedly. The leftover contents of a single-dose vial should be discarded and BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 32 MMWR never combined with medications for use on another patient (376,377). Medication from a single-dose syringe should not be administered to multiple patients, even if the needle on the syringe is changed (378). The overall risk for extrinsic contamination of multidose vials is probably minimal, although the consequences of contamination might result in life-threatening infection (379). If necessary to use a multidose vial, its access diaphragm should be cleansed with 70% alcohol before inserting a sterile device into the vial (380,381). A multidose vial should be discarded if sterility is compromised (380,381). Medication vials, syringes, or supplies should not be carried in uniform or clothing pockets. If trays are used to deliver medications to individual patients, they should be cleaned between patients. To further reduce the chance of contamination, all medication vials should be restricted to a centralized medication preparation area separate from the treatment area (382). All fluid infusion and administration sets (e.g., IV bags, tubing, and connections) are single-patient use because sterility cannot be guaranteed when an infusion or administration set is used on multiple patients. Aseptic technique should be used when preparing IV infusion and administration sets, and entry into or breaks in the tubing should be minimized (378). Single-Use or Disposable Devices A single-use device, also called a disposable device, is designed to be used on one patient and then discarded, not reprocessed for use on another patient (e.g., cleaned, disinfected, or sterilized) (383). Single-use devices in dentistry are usually not heat-tolerant and cannot be reliably cleaned. Examples include syringe needles, prophylaxis cups and brushes, and plastic orthodontic brackets. Certain items (e.g., prophylaxis angles, saliva ejectors, high-volume evacuator tips, and air/water syringe tips) are commonly available in a disposable form and should be disposed of appropriately after each use. Single-use devices and items (e.g., cotton rolls, gauze, and irrigating syringes) for use during oral surgical procedures should be sterile at the time of use. Because of the physical construction of certain devices (e.g., burs, endodontic files, and broaches) cleaning can be difficult. In addition, deterioration can occur on the cutting surfaces of some carbide/diamond burs and endodontic files during processing (384) and after repeated processing cycles, leading to potential breakage during patient treatment (385–388). These factors, coupled with the knowledge that burs and endodontic instruments exhibit signs of wear during normal use, might make it practical to consider them as single-use devices. December 19, 2003 Preprocedural Mouth Rinses Antimicrobial mouth rinses used by patients before a dental procedure are intended to reduce the number of microorganisms the patient might release in the form of aerosols or spatter that subsequently can contaminate DHCP and equipment operatory surfaces. In addition, preprocedural rinsing can decrease the number of microorganisms introduced in the patient’s bloodstream during invasive dental procedures (389,390). No scientific evidence indicates that preprocedural mouth rinsing prevents clinical infections among DHCP or patients, but studies have demonstrated that a preprocedural rinse with an antimicrobial product (e.g., chlorhexidine gluconate, essential oils, or povidone-iodine) can reduce the level of oral microorganisms in aerosols and spatter generated during routine dental procedures with rotary instruments (e.g., dental handpieces or ultrasonic scalers) (391–399). Preprocedural mouth rinses can be most beneficial before a procedure that requires using a prophylaxis cup or ultrasonic scaler because rubber dams cannot be used to minimize aerosol and spatter generation and, unless the provider has an assistant, highvolume evacuation is not commonly used (173). The science is unclear concerning the incidence and nature of bacteremias from oral procedures, the relationship of these bacteremias to disease, and the preventive benefit of antimicrobial rinses. In limited studies, no substantial benefit has been demonstrated for mouth rinsing in terms of reducing oral microorganisms in dental-induced bacteremias (400,401). However, the American Heart Association’s recommendations regarding preventing bacterial endocarditis during dental procedures (402) provide limited support concerning preprocedural mouth rinsing with an antimicrobial as an adjunct for patients at risk for bacterial endocarditis. Insufficient data exist to recommend preprocedural mouth rinses to prevent clinical infections among patients or DHCP. Oral Surgical Procedures The oral cavity is colonized with numerous microorganisms. Oral surgical procedures present an opportunity for entry of microorganisms (i.e., exogenous and endogenous) into the vascular system and other normally sterile areas of the oral cavity (e.g., bone or subcutaneous tissue); therefore, an increased potential exists for localized or systemic infection. Oral surgical procedures involve the incision, excision, or reflection of tissue that exposes the normally sterile areas of the oral cavity. Examples include biopsy, periodontal surgery, apical surgery, implant surgery, and surgical extractions of teeth (e.g., removal of erupted or nonerupted tooth requiring elevation of mucoperiosteal flap, removal of bone or section of tooth, BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports and suturing if needed) (see Hand Hygiene, PPE, Single Use or Disposable Devices, and Dental Unit Water Quality). Handling of Biopsy Specimens To protect persons handling and transporting biopsy specimens, each specimen must be placed in a sturdy, leakproof container with a secure lid for transportation (13). Care should be taken when collecting the specimen to avoid contaminating the outside of the container. If the outside of the container becomes visibly contaminated, it should be cleaned and disinfected or placed in an impervious bag (2,13). The container must be labeled with the biohazard symbol during storage, transport, shipment, and disposal (13,14). Handling of Extracted Teeth Disposal Extracted teeth that are being discarded are subject to the containerization and labeling provisions outlined by OSHA’s bloodborne pathogens standard (13). OSHA considers extracted teeth to be potentially infectious material that should be disposed in medical waste containers. Extracted teeth sent to a dental laboratory for shade or size comparisons should be cleaned, surface-disinfected with an EPA-registered hospital disinfectant with intermediate-level activity (i.e., tuberculocidal claim), and transported in a manner consistent with OSHA regulations. However, extracted teeth can be returned to patients on request, at which time provisions of the standard no longer apply (14). Extracted teeth containing dental amalgam should not be placed in a medical waste container that uses incineration for final disposal. Commercial metalrecycling companies also might accept extracted teeth with metal restorations, including amalgam. State and local regulations should be consulted regarding disposal of the amalgam. Educational Settings Extracted teeth are occasionally collected for use in preclinical educational training. These teeth should be cleaned of visible blood and gross debris and maintained in a hydrated state in a well-constructed closed container during transport. The container should be labeled with the biohazard symbol (13,14). Because these teeth will be autoclaved before clinical exercises or study, use of the most economical storage solution (e.g., water or saline) might be practical. Liquid chemical germicides can also be used but do not reliably disinfect both external surface and interior pulp tissue (403,404). Before being used in an educational setting, the teeth should be heat-sterilized to allow safe handling. Microbial growth can be eliminated by using an autoclave cycle for 40 minutes (405), 33 but because preclinical educational exercises simulate clinical experiences, students enrolled in dental programs should still follow standard precautions. Autoclaving teeth for preclinical laboratory exercises does not appear to alter their physical properties sufficiently to compromise the learning experience (405,406). However, whether autoclave sterilization of extracted teeth affects dentinal structure to the point that the chemical and microchemical relationship between dental materials and the dentin would be affected for research purposes on dental materials is unknown (406). Use of teeth that do not contain amalgam is preferred in educational settings because they can be safely autoclaved (403,405). Extracted teeth containing amalgam restorations should not be heat-sterilized because of the potential health hazard from mercury vaporization and exposure. If extracted teeth containing amalgam restorations are to be used, immersion in 10% formalin solution for 2 weeks should be effective in disinfecting both the internal and external structures of the teeth (403). If using formalin, manufacturer MSDS should be reviewed for occupational safety and health concerns and to ensure compliance with OSHA regulations (15). Dental Laboratory Dental prostheses, appliances, and items used in their fabrication (e.g., impressions, occlusal rims, and bite registrations) are potential sources for cross-contamination and should be handled in a manner that prevents exposure of DHCP, patients, or the office environment to infectious agents. Effective communication and coordination between the laboratory and dental practice will ensure that appropriate cleaning and disinfection procedures are performed in the dental office or laboratory, materials are not damaged or distorted because of disinfectant overexposure, and effective disinfection procedures are not unnecessarily duplicated (407,408). When a laboratory case is sent off-site, DHCP should provide written information regarding the methods (e.g., type of disinfectant and exposure time) used to clean and disinfect the material (e.g., impression, stone model, or appliance) (2,407,409). Clinical materials that are not decontaminated are subject to OSHA and U.S. Department of Transportation regulations regarding transportation and shipping of infectious materials (13,410). Appliances and prostheses delivered to the patient should be free of contamination. Communication between the laboratory and the dental practice is also key at this stage to determine which one is responsible for the final disinfection process. If the dental laboratory staff provides the disinfection, an EPAregistered hospital disinfectant (low to intermediate) should be used, written documentation of the disinfection method BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 34 MMWR provided, and the item placed in a tamper-evident container before returning it to the dental office. If such documentation is not provided, the dental office is responsible for final disinfection procedures. Dental prostheses or impressions brought into the laboratory can be contaminated with bacteria, viruses, and fungi (411,412). Dental prostheses, impressions, orthodontic appliances, and other prosthodontic materials (e.g., occlusal rims, temporary prostheses, bite registrations, or extracted teeth) should be thoroughly cleaned (i.e., blood and bioburden removed), disinfected with an EPA-registered hospital disinfectant with a tuberculocidal claim, and thoroughly rinsed before being handled in the in-office laboratory or sent to an off-site laboratory (2,244,249,407). The best time to clean and disinfect impressions, prostheses, or appliances is as soon as possible after removal from the patient’s mouth before drying of blood or other bioburden can occur. Specific guidance regarding cleaning and disinfecting techniques for various materials is available (260,413–416). DHCP are advised to consult with manufacturers regarding the stability of specific materials during disinfection. In the laboratory, a separate receiving and disinfecting area should be established to reduce contamination in the production area. Bringing untreated items into the laboratory increases chances for cross infection (260). If no communication has been received regarding prior cleaning and disinfection of a material, the dental laboratory staff should perform cleaning and disinfection procedures before handling. If during manipulation of a material or appliance a previously undetected area of blood or bioburden becomes apparent, cleaning and disinfection procedures should be repeated. Transfer of oral microorganisms into and onto impressions has been documented (417–419). Movement of these organisms onto dental casts has also been demonstrated (420). Certain microbes have been demonstrated to remain viable within gypsum cast materials for <7 days (421). Incorrect handling of contaminated impressions, prostheses, or appliances, therefore, offers an opportunity for transmission of microorganisms (260). Whether in the office or laboratory, PPE should be worn until disinfection is completed (1,2,7,10,13). If laboratory items (e.g., burs, polishing points, rag wheels, or laboratory knives) are used on contaminated or potentially contaminated appliances, prostheses, or other material, they should be heat-sterilized, disinfected between patients, or discarded (i.e., disposable items should be used) (260,407). Heat-tolerant items used in the mouth (e.g., metal impression tray or face bow fork) should be heat-sterilized before being used on another patient (2,407). Items that do not normally contact the patient, prosthetic device, or appliance but frequently become contaminated and cannot withstand heat-sterilization (e.g., articulators, case December 19, 2003 pans, or lathes) should be cleaned and disinfected between patients and according to the manufacturer’s instructions. Pressure pots and water baths are particularly susceptible to contamination with microorganisms and should be cleaned and disinfected between patients (422). In the majority of instances, these items can be cleaned and disinfected with an EPAregistered hospital disinfectant. Environmental surfaces should be barrier-protected or cleaned and disinfected in the same manner as in the dental treatment area. Unless waste generated in the dental laboratory (e.g., disposable trays or impression materials) falls under the category of regulated medical waste, it can be discarded with general waste. Personnel should dispose of sharp items (e.g., burs, disposable blades, and orthodontic wires) in puncture-resistant containers. Laser/Electrosurgery Plumes or Surgical Smoke During surgical procedures that use a laser or electrosurgical unit, the thermal destruction of tissue creates a smoke byproduct. Laser plumes or surgical smoke represent another potential risk for DHCP (423–425). Lasers transfer electromagnetic energy into tissues, resulting in the release of a heated plume that includes particles, gases (e.g., hydrogen cyanide, benzene, and formaldehyde), tissue debris, viruses, and offensive odors. One concern is that aerosolized infectious material in the laser plume might reach the nasal mucosa of the laser operator and adjacent DHCP. Although certain viruses (e.g., varicella-zoster virus and herpes simplex virus) appear not to aerosolize efficiently (426,427), other viruses and various bacteria (e.g., human papilloma virus, HIV, coagulase-negative Staphylococcus, Corynebacterium species, and Neisseria species) have been detected in laser plumes (428–434). However, the presence of an infectious agent in a laser plume might not be sufficient to cause disease from airborne exposure, especially if the agent’s normal mode of transmission is not airborne. No evidence indicates that HIV or HBV have been transmitted through aerosolization and inhalation (435). Although continuing studies are needed to evaluate the risk for DHCP of laser plumes and electrosurgery smoke, following NIOSH recommendations (425) and practices developed by the Association of periOperative Registered Nurses (AORN) might be practical (436). These practices include using 1) standard precautions (e.g., high-filtration surgical masks and possibly full face shields) (437); 2) central room suction units with in-line filters to collect particulate matter from minimal plumes; and 3) dedicated mechanical smoke exhaust systems with a highefficiency filter to remove substantial amounts of laser plume particles. Local smoke evacuation systems have been recom- BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports mended by consensus organizations, and these systems can improve the quality of the operating field. Employers should be aware of this emerging problem and advise employees of the potential hazards of laser smoke (438). However, this concern remains unresolved in dental practice and no recommendation is provided here. M. tuberculosis Patients infected with M. tuberculosis occasionally seek urgent dental treatment at outpatient dental settings. Understanding the pathogenesis of the development of TB will help DHCP determine how to manage such patients. M. tuberculosis is a bacterium carried in airborne infective droplet nuclei that can be generated when persons with pulmonary or laryngeal TB sneeze, cough, speak, or sing (439). These small particles (1–5 µm) can stay suspended in the air for hours (440). Infection occurs when a susceptible person inhales droplet nuclei containing M. tuberculosis, which then travel to the alveoli of the lungs. Usually within 2–12 weeks after initial infection with M. tuberculosis, immune response prevents further spread of the TB bacteria, although they can remain alive in the lungs for years, a condition termed latent TB infection. Persons with latent TB infection usually exhibit a reactive tuberculin skin test (TST), have no symptoms of active disease, and are not infectious. However, they can develop active disease later in life if they do not receive treatment for their latent infection. Approximately 5% of persons who have been recently infected and not treated for latent TB infection will progress from infection to active disease during the first 1–2 years after infection; another 5% will develop active disease later in life. Thus, approximately 90% of U.S. persons with latent TB infection do not progress to active TB disease. Although both latent TB infection and active TB disease are described as TB, only the person with active disease is contagious and presents a risk of transmission. Symptoms of active TB disease include a productive cough, night sweats, fatigue, malaise, fever, and unexplained weight loss. Certain immunocompromising medical conditions (e.g., HIV) increase the risk that TB infection will progress to active disease at a faster rate (441). Overall, the risk borne by DHCP for exposure to a patient with active TB disease is probably low (20,21). Only one report exists of TB transmission in a dental office (442), and TST conversions among DHCP are also low (443,444). However, in certain cases, DHCP or the community served by the dental facility might be at relatively high risk for exposure to TB. Surgical masks do not prevent inhalation of M. tuberculosis droplet nuclei, and therefore, standard precautions are not sufficient to prevent transmission of this organism. Recom- 35 mendations for expanded precautions to prevent transmission of M. tuberculosis and other organisms that can be spread by airborne, droplet, or contact routes have been detailed in other guidelines (5,11,20). TB transmission is controlled through a hierarchy of measures, including administrative controls, environmental controls, and personal respiratory protection. The main administrative goals of a TB infection-control program are early detection of a person with active TB disease and prompt isolation from susceptible persons to reduce the risk of transmission. Although DHCP are not responsible for diagnosis and treatment of TB, they should be trained to recognize signs and symptoms to help with prompt detection. Because potential for transmission of M. tuberculosis exists in outpatient settings, dental practices should develop a TB control program appropriate for their level of risk (20,21). • A community risk assessment should be conducted periodically, and TB infection-control policies for each dental setting should be based on the risk assessment. The policies should include provisions for detection and referral of patients who might have undiagnosed active TB; management of patients with active TB who require urgent dental care; and DHCP education, counseling, and TST screening. • DHCP who have contact with patients should have a baseline TST, preferably by using a two-step test at the beginning of employment. The facility’s level of TB risk will determine the need for routine follow-up TST. • While taking patients’ initial medical histories and at periodic updates, dental DHCP should routinely ask all patients whether they have a history of TB disease or symptoms indicative of TB. • Patients with a medical history or symptoms indicative of undiagnosed active TB should be referred promptly for medical evaluation to determine possible infectiousness. Such patients should not remain in the dental-care facility any longer than required to evaluate their dental condition and arrange a referral. While in the dental health-care facility, the patient should be isolated from other patients and DHCP, wear a surgical mask when not being evaluated, or be instructed to cover their mouth and nose when coughing or sneezing. • Elective dental treatment should be deferred until a physician confirms that a patient does not have infectious TB, or if the patient is diagnosed with active TB disease, until confirmed the patient is no longer infectious. • If urgent dental care is provided for a patient who has, or is suspected of having active TB disease, the care should be provided in a facility (e.g., hospital) that provides airborne infection isolation (i.e., using such engineering con- BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 36 MMWR trols as TB isolation rooms, negatively pressured relative to the corridors, with air either exhausted to the outside or HEPA-filtered if recirculation is necessary). Standard surgical face masks do not protect against TB transmission; DHCP should use respiratory protection (e.g., fittested, disposable N-95 respirators). • Settings that do not require use of respiratory protection because they do not treat active TB patients and do not perform cough-inducing procedures on potential active TB patients do not need to develop a written respiratory protection program. • Any DHCP with a persistent cough (i.e., lasting >3 weeks), especially in the presence of other signs or symptoms compatible with active TB (e.g., weight loss, night sweats, fatigue, bloody sputum, anorexia, or fever), should be evaluated promptly. The DHCP should not return to the workplace until a diagnosis of TB has been excluded or the DHCP is on therapy and a physician has determined that the DHCP is noninfectious. Creutzfeldt-Jakob Disease and Other Prion Diseases Creutzfeldt-Jakob disease (CJD) belongs to a group of rapidly progressive, invariably fatal, degenerative neurological disorders, transmissible spongiform encephalopathies (TSEs) that affect both humans and animals and are thought to be caused by infection with an unusual pathogen called a prion. Prions are isoforms of a normal protein, capable of self-propagation although they lack nucleic acid. Prion diseases have an incubation period of years and are usually fatal within 1 year of diagnosis. Among humans, TSEs include CJD, Gerstmann-StrausslerScheinker syndrome, fatal familial insomnia, kuru, and variant CJD (vCJD). Occurring in sporadic, familial, and acquired (i.e., iatrogenic) forms, CJD has an annual incidence in the United States and other countries of approximately 1 case/ million population (445–448). In approximately 85% of affected patients, CJD occurs as a sporadic disease with no recognizable pattern of transmission. A smaller proportion of patients (5%–15%) experience familial CJD because of inherited mutations of the prion protein gene (448). vCJD is distinguishable clinically and neuropathologically from classic CJD, and strong epidemiologic and laboratory evidence indicates a causal relationship with bovine spongiform encephalopathy (BSE), a progressive neurological disorder of cattle commonly known as mad cow disease (449–451). vCJD, was reported first in the United Kingdom in 1996 (449) and subsequently in other European countries (452). Only one case of vCJD has been reported in the United States, in an December 19, 2003 immigrant from the United Kingdom (453). Compared with CJD patients, those with vCJD are younger (28 years versus 68 years median age at death), and have a longer duration of illness (13 months versus 4.5 months). Also, vCJD patients characteristically exhibit sensory and psychiatric symptoms that are uncommon with CJD. Another difference includes the ease with which the presence of prions is consistently demonstrated in lymphoreticular tissues (e.g., tonsil) in vCJD patients by immunohistochemistry (454). CJD and vCJD are transmissible diseases, but not through the air or casual contact. All known cases of iatrogenic CJD have resulted from exposure to infected central nervous tissue (e.g., brain and dura mater), pituitary, or eye tissue. Studies in experimental animals have determined that other tissues have low or no detectable infectivity (243,455,456). Limited experimental studies have demonstrated that scrapie (a TSE in sheep) can be transmitted to healthy hamsters and mice by exposing oral tissues to infectious homogenate (457,458). These animal models and experimental designs might not be directly applicable to human transmission and clinical dentistry, but they indicate a theoretical risk of transmitting prion diseases through perioral exposures. According to published reports, iatrogenic transmission of CJD has occurred in humans under three circumstances: after use of contaminated electroencephalography depth electrodes and neurosurgical equipment (459); after use of extracted pituitary hormones (460,461); and after implant of contaminated corneal (462) and dura mater grafts (463,464) from humans. The equipment-related cases occurred before the routine implementation of sterilization procedures used in healthcare facilities. Case-control studies have found no evidence that dental procedures increase the risk of iatrogenic transmission of TSEs among humans. In these studies, CJD transmission was not associated with dental procedures (e.g., root canals or extractions), with convincing evidence of prion detection in human blood, saliva, or oral tissues, or with DHCP becoming occupationally infected with CJD (465–467). In 2000, prions were not found in the dental pulps of eight patients with neuropathologically confirmed sporadic CJD by using electrophoresis and a Western blot technique (468). Prions exhibit unusual resistance to conventional chemical and physical decontamination procedures. Considering this resistance and the invariably fatal outcome of CJD, procedures for disinfecting and sterilizing instruments potentially contaminated with the CJD prion have been controversial for years. Scientific data indicate the risk, if any, of sporadic CJD transmission during dental and oral surgical procedures is low to nil. Until additional information exists regarding the transmissibility of CJD or vCJD, special precautions in addition to BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports standard precautions might be indicated when treating known CJD or vCJD patients; the following list of precautions is provided for consideration without recommendation (243,249,277,469): • Use single-use disposable items and equipment whenever possible. • Consider items difficult to clean (e.g., endodontic files, broaches, and carbide and diamond burs) as single-use disposables and discard after one use. • To minimize drying of tissues and body fluids on a device, keep the instrument moist until cleaned and decontaminated. • Clean instruments thoroughly and steam-autoclave at 134ºC for 18 minutes. This is the least stringent of sterilization methods offered by the World Health Organization. The complete list (469) is available at http://www.who.int/emcdocuments/tse/whocdscsraph2003c.html. • Do not use flash sterilization for processing instruments or devices. Potential infectivity of oral tissues in CJD or vCJD patients is an unresolved concern. CDC maintains an active surveillance program on CJD. Additional information and resources are available at http://www.cdc.gov/ncidod/diseases/cjd/cjd.htm. Program Evaluation The goal of a dental infection-control program is to provide a safe working environment that will reduce the risk of health- 37 care–associated infections among patients and occupational exposures among DHCP. Medical errors are caused by faulty systems, processes, and conditions that lead persons to make mistakes or fail to prevent errors being made by others (470). Effective program evaluation is a systematic way to ensure procedures are useful, feasible, ethical, and accurate. Program evaluation is an essential organizational practice; however, such evaluation is not practiced consistently across program areas, nor is it sufficiently well-integrated into the day-to-day management of the majority of programs (471). A successful infection-control program depends on developing standard operating procedures, evaluating practices, routinely documenting adverse outcomes (e.g., occupational exposures to blood) and work-related illnesses in DHCP, and monitoring health-care–associated infections in patients. Strategies and tools to evaluate the infection-control program can include periodic observational assessments, checklists to document procedures, and routine review of occupational exposures to bloodborne pathogens. Evaluation offers an opportunity to improve the effectiveness of both the infection-control program and dentalpractice protocols. If deficiencies or problems in the implementation of infection-control procedures are identified, further evaluation is needed to eliminate the problems. Examples of infection-control program evaluation activities are provided (Table 5). TABLE 5. Examples of methods for evaluating infection-control programs Program element Evaluation activity Appropriate immunization of dental health-care personnel (DHCP). Conduct annual review of personnel records to ensure up-to-date immunizations. Assessment of occupational exposures to infectious agents. Report occupational exposures to infectious agents. Document the steps that occurred around the exposure and plan how such exposure can be prevented in the future. Comprehensive postexposure management plan and medical follow-up program after occupational exposures to infectious agents. Ensure the postexposure management plan is clear, complete, and available at all times to all DHCP. All staff should understand the plan, which should include tollfree phone numbers for access to additional information. Adherence to hand hygiene before and after patient care. Observe and document circumstances of appropriate or inappropriate handwashing. Review findings in a staff meeting. Proper use of personal protective equipment to prevent occupational exposures to infectious agents. Observe and document the use of barrier precautions and careful handling of sharps. Review findings in a staff meeting. Routine and appropriate sterilization of instruments using a biologic monitoring system. Monitor paper log of steam cycle and temperature strip with each sterilization load, and examine results of weekly biologic monitoring. Take appropriate action when failure of sterilization process is noted. Evaluation and implementation of safer medical devices. Conduct an annual review of the exposure control plan and consider new developments in safer medical devices. Compliance of water in routine dental procedures with current drinking U.S. Environmental Protection Agency water standards (fewer than 500 CFU of heterotrophic water bacteria). Monitor dental water quality as recommended by the equipment manufacturer, using commercial self-contained test kits, or commercial water-testing laboratories. Proper handling and disposal of medical waste. Observe the safe disposal of regulated and nonregulated medical waste and take preventive measures if hazardous situations occur. Health-care–associated infections. Assess the unscheduled return of patients after procedures and evaluate them for an infectious process. A trend might require formal evaluation. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 38 MMWR Infection-Control Research Considerations Although the number of published studies concerning dental infection control has increased in recent years, questions regarding infection-control practices and their effectiveness remain unanswered. Multiple concerns were identified by the working group for this report, as well as by others during the December 19, 2003 public comment period (Box). This list is not exhaustive and does not represent a CDC research agenda, but rather is an effort to identify certain concerns, stimulate discussion, and provide direction for determining future action by clinical, basic science, and epidemiologic investigators, as well as health and professional organizations, clinicians, and policy makers. BOX. Dental infection-control research considerations Education and promotion • Design strategies to communicate, to the public and providers, the risk of disease transmission in dentistry. • Promote use of protocols for recommended postexposure management and follow-up. • Educate and train dental health-care personnel (DHCP) to screen and evaluate safer dental devices by using tested design and performance criteria. Laboratory-based research • Develop animal models to determine the risk of transmitting organisms through inhalation of contaminated aerosols (e.g., influenza) produced from rotary dental instruments. • Conduct studies to determine the effectiveness of gloves (i.e., material compatibility and duration of use). • Develop devices with passive safety features to prevent percutaneous injuries. • Study the effect of alcohol-based hand-hygiene products on retention of latex proteins and other dental allergens (e.g., methylmethacrylate, glutaraldehyde, thiurams) on the hands of DHCP after latex glove use. • Investigate the applicability of other types of sterilization procedures (e.g., hydrogen peroxide gas plasma) in dentistry. • Encourage manufacturers to determine optimal methods and frequency for testing dental-unit waterlines and maintaining dental-unit water-quality standards. • Determine the potential for internal contamination of low-speed handpieces, including the motor, and other devices connected to dental air and water supplies, as well as more efficient ways to clean, lubricate, and sterilize handpieces and other devices attached to air or waterlines. • Investigate the infectivity of oral tissues in Creutzfeldt-Jakob disease (CJD) or variant CJD patients. • Determine the most effective methods to disinfect dental impression materials. • Investigate the viability of pathogenic organisms on dental materials (e.g., impression materials, acrylic resin, or gypsum materials) and dental laboratory equipment. • Determine the most effective methods for sterilization or disinfection of digital radiology equipment. • Evaluate the effects of repetitive reprocessing cycles on burs and endodontic files. • Investigate the potential infectivity of vapors generated from the various lasers used for oral procedures. Clinical and population-based epidemiologic research and development • Continue to characterize the epidemiology of blood contacts, particularly percutaneous injuries, and the effectiveness of prevention measures. • Further assess the effectiveness of double gloving in preventing blood contact during routine and surgical dental procedures. • Continue to assess the stress placed on gloves during dental procedures and the potential for developing defects during different procedures. • Develop methods for evaluating the effectiveness and cost-effectiveness of infection-control interventions. • Determine how infection-control guidelines affect the knowledge, attitudes, and practices of DHCP. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports Recommendations Each recommendation is categorized on the basis of existing scientific data, theoretical rationale, and applicability. Rankings are based on the system used by CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC) to categorize recommendations: Category IA. Strongly recommended for implementation and strongly supported by well-designed experimental, clinical, or epidemiologic studies. Category IB. Strongly recommended for implementation and supported by experimental, clinical, or epidemiologic studies and a strong theoretical rationale. Category IC. Required for implementation as mandated by federal or state regulation or standard. When IC is used, a second rating can be included to provide the basis of existing scientific data, theoretical rationale, and applicability. Because of state differences, the reader should not assume that the absence of a IC implies the absence of state regulations. Category II. Suggested for implementation and supported by suggestive clinical or epidemiologic studies or a theoretical rationale. Unresolved issue. No recommendation. Insufficient evidence or no consensus regarding efficacy exists. I. Personnel Health Elements of an Infection-Control Program A. General Recommendations 1. Develop a written health program for DHCP that includes policies, procedures, and guidelines for education and training; immunizations; exposure prevention and postexposure management; medical conditions, work-related illness, and associated work restrictions; contact dermatitis and latex hypersensitivity; and maintenance of records, data management, and confidentiality (IB) (5,16–18,22). 2. Establish referral arrangements with qualified health-care professionals to ensure prompt and appropriate provision of preventive services, occupationally related medical services, and postexposure management with medical followup (IB, IC) (5,13,19,22). B. Education and Training 1. Provide DHCP 1) on initial employment, 2) when new tasks or procedures affect the employee’s occupational exposure, and 3) at a minimum, annually, with education and training regarding occupational exposure to potentially infectious agents and infection-control procedures/protocols appropriate for and spe- 39 cific to their assigned duties (IB, IC) (5,11,13, 14,16,19,22). 2. Provide educational information appropriate in content and vocabulary to the educational level, literacy, and language of DHCP (IB, IC) (5,13). C. Immunization Programs 1. Develop a written comprehensive policy regarding immunizing DHCP, including a list of all required and recommended immunizations (IB) (5,17,18). 2. Refer DHCP to a prearranged qualified healthcare professional or to their own health-care professional to receive all appropriate immunizations based on the latest recommendations as well as their medical history and risk for occupational exposure (IB) (5,17). D. Exposure Prevention and Postexposure Management 1. Develop a comprehensive postexposure management and medical follow-up program (IB, IC) (5,13,14,19). a. Include policies and procedures for prompt reporting, evaluation, counseling, treatment, and medical follow-up of occupational exposures. b. Establish mechanisms for referral to a qualified health-care professional for medical evaluation and follow-up. c. Conduct a baseline TST, preferably by using a two-step test, for all DHCP who might have contact with persons with suspected or confirmed infectious TB, regardless of the risk classification of the setting (IB) (20). E. Medical Conditions, Work-Related Illness, and Work Restrictions 1. Develop and have readily available to all DHCP comprehensive written policies regarding work restriction and exclusion that include a statement of authority defining who can implement such policies (IB) (5,22). 2. Develop policies for work restriction and exclusion that encourage DHCP to seek appropriate preventive and curative care and report their illnesses, medical conditions, or treatments that can render them more susceptible to opportunistic infection or exposures; do not penalize DHCP with loss of wages, benefits, or job status (IB) (5,22). BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 40 MMWR 3. Develop policies and procedures for evaluation, diagnosis, and management of DHCP with suspected or known occupational contact dermatitis (IB) (32). 4. Seek definitive diagnosis by a qualified healthcare professional for any DHCP with suspected latex allergy to carefully determine its specific etiology and appropriate treatment as well as work restrictions and accommodations (IB) (32). F. Records Maintenance, Data Management, and Confidentiality 1. Establish and maintain confidential medical records (e.g., immunization records and documentation of tests received as a result of occupational exposure) for all DHCP (IB, IC) (5,13). 2. Ensure that the practice complies with all applicable federal, state, and local laws regarding medical recordkeeping and confidentiality (IC) (13,34). II. Preventing Transmission of Bloodborne Pathogens A. HBV Vaccination 1. Offer the HBV vaccination series to all DHCP with potential occupational exposure to blood or other potentially infectious material (IA, IC) (2,13,14,19). 2. Always follow U.S. Public Health Service/CDC recommendations for hepatitis B vaccination, serologic testing, follow-up, and booster dosing (IA, IC) (13,14,19). 3. Test DHCP for anti-HBs 1–2 months after completion of the 3-dose vaccination series (IA, IC) (14,19). 4. DHCP should complete a second 3-dose vaccine series or be evaluated to determine if they are HBsAg-positive if no antibody response occurs to the primary vaccine series (IA, IC) (14,19). 5. Retest for anti-HBs at the completion of the second vaccine series. If no response to the second 3-dose series occurs, nonresponders should be tested for HBsAg (IC) (14,19). 6. Counsel nonresponders to vaccination who are HBsAg-negative regarding their susceptibility to HBV infection and precautions to take (IA, IC) (14,19). 7. Provide employees appropriate education regarding the risks of HBV transmission and the availability of the vaccine. Employees who decline December 19, 2003 the vaccination should sign a declination form to be kept on file with the employer (IC) (13). B. Preventing Exposures to Blood and OPIM 1. General recommendations a. Use standard precautions (OSHA’s bloodborne pathogen standard retains the term universal precautions) for all patient encounters (IA, IC) (11,13,19,53). b. Consider sharp items (e.g., needles, scalers, burs, lab knives, and wires) that are contaminated with patient blood and saliva as potentially infective and establish engineering controls and work practices to prevent injuries (IB, IC) (6,13,113). c. Implement a written, comprehensive program designed to minimize and manage DHCP exposures to blood and body fluids (IB, IC). (13,14,19,97). 2. Engineering and work-practice controls a. Identify, evaluate, and select devices with engineered safety features at least annually and as they become available on the market (e.g., safer anesthetic syringes, blunt suture needle, retractable scalpel, or needleless IV systems) (IC) (13,97,110–112). b. Place used disposable syringes and needles, scalpel blades, and other sharp items in appropriate puncture-resistant containers located as close as feasible to the area in which the items are used (IA, IC) (2,7,13,19,113, 115). c. Do not recap used needles by using both hands or any other technique that involves directing the point of a needle toward any part of the body. Do not bend, break, or remove needles before disposal (IA, IC) (2,7,8,13,97,113). d. Use either a one-handed scoop technique or a mechanical device designed for holding the needle cap when recapping needles (e.g., between multiple injections and before removing from a nondisposable aspirating syringe) (IA, IC) (2,7,8,13,14,113). 3. Postexposure management and prophylaxis a. Follow CDC recommendations after percutaneous, mucous membrane, or nonintact skin exposure to blood or other potentially infectious material (IA, IC) (13,14,19). BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports III. Hand Hygiene A. General Considerations 1. Perform hand hygiene with either a nonantimicrobial or antimicrobial soap and water when hands are visibly dirty or contaminated with blood or other potentially infectious material. If hands are not visibly soiled, an alcohol-based hand rub can also be used. Follow the manufacturer’s instructions (IA) (123). 2. Indications for hand hygiene include a. when hands are visibly soiled (IA, IC); b. after barehanded touching of inanimate objects likely to be contaminated by blood, saliva, or respiratory secretions (IA, IC); c. before and after treating each patient (IB); d. before donning gloves (IB); and e. immediately after removing gloves (IB, IC) (7–9,11,13,113,120–123,125,126,138). 3. For oral surgical procedures, perform surgical hand antisepsis before donning sterile surgeon’s gloves. Follow the manufacturer’s instructions by using either an antimicrobial soap and water, or soap and water followed by drying hands and application of an alcohol-based surgical handscrub product with persistent activity (IB) (121– 123,127–133,144,145). 4. Store liquid hand-care products in either disposable closed containers or closed containers that can be washed and dried before refilling. Do not add soap or lotion to (i.e., top off ) a partially empty dispenser (IA) (9,120,122,149,150). B. Special Considerations for Hand Hygiene and Glove Use 1. Use hand lotions to prevent skin dryness associated with handwashing (IA) (153,154). 2. Consider the compatibility of lotion and antiseptic products and the effect of petroleum or other oil emollients on the integrity of gloves during product selection and glove use (IB) (2,14,122,155). 3. Keep fingernails short with smooth, filed edges to allow thorough cleaning and prevent glove tears (II) (122,123,156). 4. Do not wear artificial fingernails or extenders when having direct contact with patients at high risk (e.g., those in intensive care units or operating rooms) (IA) (123,157–160). 5. Use of artificial fingernails is usually not recommended (II) (157–160). 41 6. Do not wear hand or nail jewelry if it makes donning gloves more difficult or compromises the fit and integrity of the glove (II) (123,142, 143). IV. PPE A. Masks, Protective Eyewear, and Face Shields 1. Wear a surgical mask and eye protection with solid side shields or a face shield to protect mucous membranes of the eyes, nose, and mouth during procedures likely to generate splashing or spattering of blood or other body fluids (IB, IC) (1,2,7,8,11,13,137). 2. Change masks between patients or during patient treatment if the mask becomes wet (IB) (2). 3. Clean with soap and water, or if visibly soiled, clean and disinfect reusable facial protective equipment (e.g., clinician and patient protective eyewear or face shields) between patients (II) (2). B. Protective Clothing 1. Wear protective clothing (e.g., reusable or disposable gown, laboratory coat, or uniform) that covers personal clothing and skin (e.g., forearms) likely to be soiled with blood, saliva, or OPIM (IB, IC) (7,8,11,13,137). 2. Change protective clothing if visibly soiled (134); change immediately or as soon as feasible if penetrated by blood or other potentially infectious fluids (IB, IC) (13). 3. Remove barrier protection, including gloves, mask, eyewear, and gown before departing work area (e.g., dental patient care, instrument processing, or laboratory areas) (IC) (13). C. Gloves 1. Wear medical gloves when a potential exists for contacting blood, saliva, OPIM, or mucous membranes (IB, IC) (1,2,7,8,13). 2. Wear a new pair of medical gloves for each patient, remove them promptly after use, and wash hands immediately to avoid transfer of microorganisms to other patients or environments (IB) (1,7,8,123). 3. Remove gloves that are torn, cut, or punctured as soon as feasible and wash hands before regloving (IB, IC) (13,210,211). 4. Do not wash surgeon’s or patient examination gloves before use or wash, disinfect, or sterilize gloves for reuse (IB, IC) (13,138,177,212,213). BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 42 MMWR 5. Ensure that appropriate gloves in the correct size are readily accessible (IC) (13). 6. Use appropriate gloves (e.g., puncture- and chemical-resistant utility gloves) when cleaning instruments and performing housekeeping tasks involving contact with blood or OPIM (IB, IC) (7,13,15). 7. Consult with glove manufacturers regarding the chemical compatibility of glove material and dental materials used (II). D. Sterile Surgeon’s Gloves and Double Gloving During Oral Surgical Procedures 1. Wear sterile surgeon’s gloves when performing oral surgical procedures (IB) (2,8,137). 2. No recommendation is offered regarding the effectiveness of wearing two pairs of gloves to prevent disease transmission during oral surgical procedures. The majority of studies among HCP and DHCP have demonstrated a lower frequency of inner glove perforation and visible blood on the surgeon’s hands when double gloves are worn; however, the effectiveness of wearing two pairs of gloves in preventing disease transmission has not been demonstrated (Unresolved issue). V. Contact Dermatitis and Latex Hypersensitivity A. General Recommendations 1. Educate DHCP regarding the signs, symptoms, and diagnoses of skin reactions associated with frequent hand hygiene and glove use (IB) (5,31,32). 2. Screen all patients for latex allergy (e.g., take health history and refer for medical consultation when latex allergy is suspected) (IB) (32). 3. Ensure a latex-safe environment for patients and DHCP with latex allergy (IB) (32). 4. Have emergency treatment kits with latex-free products available at all times (II) (32). VI. Sterilization and Disinfection of Patient-Care Items A. General Recommendations 1. Use only FDA-cleared medical devices for sterilization and follow the manufacturer’s instructions for correct use (IB) (248). 2. Clean and heat-sterilize critical dental instruments before each use (IA) (2,137,243,244, 246,249,407). 3. Clean and heat-sterilize semicritical items before each use (IB) (2,249,260,407). 4. Allow packages to dry in the sterilizer before they are handled to avoid contamination (IB) (247). December 19, 2003 5. Use of heat-stable semicritical alternatives is encouraged (IB) (2). 6. Reprocess heat-sensitive critical and semi-critical instruments by using FDA-cleared sterilant/ high-level disinfectants or an FDA-cleared lowtemperature sterilization method (e.g., ethylene oxide). Follow manufacturer’s instructions for use of chemical sterilants/high-level disinfectants (IB) (243). 7. Single-use disposable instruments are acceptable alternatives if they are used only once and disposed of correctly (IB, IC) (243,383). 8. Do not use liquid chemical sterilants/high-level disinfectants for environmental surface disinfection or as holding solutions (IB, IC) (243,245). 9. Ensure that noncritical patient-care items are barrier-protected or cleaned, or if visibly soiled, cleaned and disinfected after each use with an EPA-registered hospital disinfectant. If visibly contaminated with blood, use an EPA-registered hospital disinfectant with a tuberculocidal claim (i.e., intermediate level) (IB) (2,243,244). 10. Inform DHCP of all OSHA guidelines for exposure to chemical agents used for disinfection and sterilization. Using this report, identify areas and tasks that have potential for exposure (IC) (15). B. Instrument Processing Area 1. Designate a central processing area. Divide the instrument processing area, physically or, at a minimum, spatially, into distinct areas for 1) receiving, cleaning, and decontamination; 2) preparation and packaging; 3) sterilization; and 4) storage. Do not store instruments in an area where contaminated instruments are held or cleaned (II) (173,247,248). 2. Train DHCP to employ work practices that prevent contamination of clean areas (II). C. Receiving, Cleaning, and Decontamination Work Area 1. Minimize handling of loose contaminated instruments during transport to the instrument processing area. Use work-practice controls (e.g., carry instruments in a covered container) to minimize exposure potential (II). Clean all visible blood and other contamination from dental instruments and devices before sterilization or disinfection procedures (IA) (243,249–252). 2. Use automated cleaning equipment (e.g., ultrasonic cleaner or washer-disinfector) to remove BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports debris to improve cleaning effectiveness and decrease worker exposure to blood (IB) (2,253). 3. Use work-practice controls that minimize contact with sharp instruments if manual cleaning is necessary (e.g., long-handled brush) (IC) (14). 4. Wear puncture- and chemical-resistant/heavyduty utility gloves for instrument cleaning and decontamination procedures (IB) (7). 5. Wear appropriate PPE (e.g., mask, protective eyewear, and gown) when splashing or spraying is anticipated during cleaning (IC) (13). D. Preparation and Packaging 1. Use an internal chemical indicator in each package. If the internal indicator cannot be seen from outside the package, also use an external indicator (II) (243,254,257). 2. Use a container system or wrapping compatible with the type of sterilization process used and that has received FDA clearance (IB) (243,247, 256). 3. Before sterilization of critical and semicritical instruments, inspect instruments for cleanliness, then wrap or place them in containers designed to maintain sterility during storage (e.g., cassettes and organizing trays) (IA) (2,247,255,256). E. Sterilization of Unwrapped Instruments 1. Clean and dry instruments before the unwrapped sterilization cycle (IB) (248). 2. Use mechanical and chemical indicators for each unwrapped sterilization cycle (i.e., place an internal chemical indicator among the instruments or items to be sterilized) (IB) (243,258). 3. Allow unwrapped instruments to dry and cool in the sterilizer before they are handled to avoid contamination and thermal injury (II) (260). 4. Semicritical instruments that will be used immediately or within a short time can be sterilized unwrapped on a tray or in a container system, provided that the instruments are handled aseptically during removal from the sterilizer and transport to the point of use (II). 5. Critical instruments intended for immediate reuse can be sterilized unwrapped if the instruments are maintained sterile during removal from the sterilizer and transport to the point of use (e.g., transported in a sterile covered container) (IB) (258). 6. Do not sterilize implantable devices unwrapped (IB) (243,247). 43 7. Do not store critical instruments unwrapped (IB) (248). F. Sterilization Monitoring 1. Use mechanical, chemical, and biological monitors according to the manufacturer’s instructions to ensure the effectiveness of the sterilization process (IB) (248,278,279). 2. Monitor each load with mechanical (e.g., time, temperature, and pressure) and chemical indicators (II) (243,248). 3. Place a chemical indicator on the inside of each package. If the internal indicator is not visible from the outside, also place an exterior chemical indicator on the package (II) (243,254,257). 4. Place items/packages correctly and loosely into the sterilizer so as not to impede penetration of the sterilant (IB) (243). 5. Do not use instrument packs if mechanical or chemical indicators indicate inadequate processing (IB) (243,247,248). 6. Monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e., biological indicator and control from same lot number) (IB) (2,9,243,247,278,279). 7. Use a biological indicator for every sterilizer load that contains an implantable device. Verify results before using the implantable device, whenever possible (IB) (243,248). 8. The following are recommended in the case of a positive spore test: a. Remove the sterilizer from service and review sterilization procedures (e.g., work practices and use of mechanical and chemical indicators) to determine whether operator error could be responsible (II) (8). b. Retest the sterilizer by using biological, mechanical, and chemical indicators after correcting any identified procedural problems (II). c. If the repeat spore test is negative, and mechanical and chemical indicators are within normal limits, put the sterilizer back in service (II) (9,243). 9. The following are recommended if the repeat spore test is positive: a. Do not use the sterilizer until it has been inspected or repaired or the exact reason for the positive test has been determined (II) (9,243). BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 44 MMWR b. Recall, to the extent possible, and reprocess all items processed since the last negative spore test (II) (9,243,283). c. Before placing the sterilizer back in service, rechallenge the sterilizer with biological indicator tests in three consecutive empty chamber sterilization cycles after the cause of the sterilizer failure has been determined and corrected (II) (9,243,283). 10. Maintain sterilization records (i.e., mechanical, chemical, and biological) in compliance with state and local regulations (IB) (243). G. Storage Area for Sterilized Items and Clean Dental Supplies 1. Implement practices on the basis of date- or event-related shelf-life for storage of wrapped, sterilized instruments and devices (IB) (243, 284). 2. Even for event-related packaging, at a minimum, place the date of sterilization, and if multiple sterilizers are used in the facility, the sterilizer used, on the outside of the packaging material to facilitate the retrieval of processed items in the event of a sterilization failure (IB) (243,247). 3. Examine wrapped packages of sterilized instruments before opening them to ensure the barrier wrap has not been compromised during storage (II) (243,284). 4. Reclean, repack, and resterilize any instrument package that has been compromised (II). 5. Store sterile items and dental supplies in covered or closed cabinets, if possible (II) (285). VII. Environmental Infection Control A. General Recommendations 1. Follow the manufacturers’ instructions for correct use of cleaning and EPA-registered hospital disinfecting products (IB, IC) (243–245). 2. Do not use liquid chemical sterilants/high-level disinfectants for disinfection of environmental surfaces (clinical contact or housekeeping) (IB, IC) (243–245). 3. Use PPE, as appropriate, when cleaning and disinfecting environmental surfaces. Such equipment might include gloves (e.g., puncture- and chemical-resistant utility), protective clothing (e.g., gown, jacket, or lab coat), and protective eyewear/face shield, and mask (IC) (13,15). B. Clinical Contact Surfaces 1. Use surface barriers to protect clinical contact surfaces, particularly those that are difficult to December 19, 2003 C. D. E. F. clean (e.g., switches on dental chairs) and change surface barriers between patients (II) (1,2,260, 288). 2. Clean and disinfect clinical contact surfaces that are not barrier-protected, by using an EPAregistered hospital disinfectant with a low- (i.e., HIV and HBV label claims) to intermediate-level (i.e., tuberculocidal claim) activity after each patient. Use an intermediate-level disinfectant if visibly contaminated with blood (IB) (2,243,244). Housekeeping Surfaces 1. Clean housekeeping surfaces (e.g., floors, walls, and sinks) with a detergent and water or an EPAregistered hospital disinfectant/detergent on a routine basis, depending on the nature of the surface and type and degree of contamination, and as appropriate, based on the location in the facility, and when visibly soiled (IB) (243,244). 2. Clean mops and cloths after use and allow to dry before reuse; or use single-use, disposable mop heads or cloths (II) (243,244). 3. Prepare fresh cleaning or EPA-registered disinfecting solutions daily and as instructed by the manufacturer. (II) (243,244). 4. Clean walls, blinds, and window curtains in patient-care areas when they are visibly dusty or soiled (II) (9,244). Spills of Blood and Body Substances 1. Clean spills of blood or OPIM and decontaminate surface with an EPA-registered hospital disinfectant with low- (i.e., HBV and HIV label claims) to intermediate-level (i.e., tuberculocidal claim) activity, depending on size of spill and surface porosity (IB, IC) (13,113). Carpet and Cloth Furnishings 1. Avoid using carpeting and cloth-upholstered furnishings in dental operatories, laboratories, and instrument processing areas (II) (9,293– 295). Regulated Medical Waste 1. General Recommendations a. Develop a medical waste management program. Disposal of regulated medical waste must follow federal, state, and local regulations (IC) (13,301). b. Ensure that DHCP who handle and dispose of regulated medical waste are trained in appropriate handling and disposal methods BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports and informed of the possible health and safety hazards (IC) (13). 2. Management of Regulated Medical Waste in Dental Health-Care Facilities a. Use a color-coded or labeled container that prevents leakage (e.g., biohazard bag) to contain nonsharp regulated medical waste (IC) (13). b. Place sharp items (e.g., needles, scalpel blades, orthodontic bands, broken metal instruments, and burs) in an appropriate sharps container (e.g., puncture resistant, color-coded, and leakproof). Close container immediately before removal or replacement to prevent spillage or protrusion of contents during handling, storage, transport, or shipping (IC) (2,8,13,113,115). c. Pour blood, suctioned fluids or other liquid waste carefully into a drain connected to a sanitary sewer system, if local sewage discharge requirements are met and the state has declared this an acceptable method of disposal. Wear appropriate PPE while performing this task (IC) (7,9,13). VIII. Dental Unit Waterlines, Biofilm, and Water Quality A. General Recommendations 1. Use water that meets EPA regulatory standards for drinking water (i.e., <500 CFU/mL of heterotrophic water bacteria) for routine dental treatment output water (IB, IC) (341,342). 2. Consult with the dental unit manufacturer for appropriate methods and equipment to maintain the recommended quality of dental water (II) (339). 3. Follow recommendations for monitoring water quality provided by the manufacturer of the unit or waterline treatment product (II). 4. Discharge water and air for a minimum of 20– 30 seconds after each patient, from any device connected to the dental water system that enters the patient’s mouth (e.g., handpieces, ultrasonic scalers, and air/water syringes) (II) (2,311,344). 5. Consult with the dental unit manufacturer on the need for periodic maintenance of antiretraction mechanisms (IB) (2,311). B. Boil-Water Advisories 1. The following apply while a boil-water advisory is in effect: a. Do not deliver water from the public water system to the patient through the dental 45 operative unit, ultrasonic scaler, or other dental equipment that uses the public water system (IB, IC) (341,342,346,349,350). b. Do not use water from the public water system for dental treatment, patient rinsing, or handwashing (IB, IC) (341,342,346,349, 350). c. For handwashing, use antimicrobialcontaining products that do not require water for use (e.g., alcohol-based hand rubs). If hands are visibly contaminated, use bottled water, if available, and soap for handwashing or an antiseptic towelette (IB, IC) (13,122). 2. The following apply when the boil-water advisory is cancelled: a. Follow guidance given by the local water utility regarding adequate flushing of waterlines. If no guidance is provided, flush dental waterlines and faucets for 1–5 minutes before using for patient care (IC) (244,346, 351,352). b. Disinfect dental waterlines as recommended by the dental unit manufacturer (II). IX. Special Considerations A. Dental Handpieces and Other Devices Attached to Air and Waterlines 1. Clean and heat-sterilize handpieces and other intraoral instruments that can be removed from the air and waterlines of dental units between patients (IB, IC) (2,246,275,356,357,360,407). 2. Follow the manufacturer’s instructions for cleaning, lubrication, and sterilization of handpieces and other intraoral instruments that can be removed from the air and waterlines of dental units (IB) (361–363). 3. Do not surface-disinfect, use liquid chemical sterilants, or ethylene oxide on handpieces and other intraoral instruments that can be removed from the air and waterlines of dental units (IC) (2,246,250,275). 4. Do not advise patients to close their lips tightly around the tip of the saliva ejector to evacuate oral fluids (II) (364–366). B. Dental Radiology 1. Wear gloves when exposing radiographs and handling contaminated film packets. Use other PPE (e.g., protective eyewear, mask, and gown) as appropriate if spattering of blood or other body fluids is likely (IA, IC) (11,13). BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 46 MMWR 2. Use heat-tolerant or disposable intraoral devices whenever possible (e.g., film-holding and positioning devices). Clean and heat-sterilize heattolerant devices between patients. At a minimum, high-level disinfect semicritical heatsensitive devices, according to manufacturer’s instructions (IB) (243). 3. Transport and handle exposed radiographs in an aseptic manner to prevent contamination of developing equipment (II). 4. The following apply for digital radiography sensors: a. Use FDA-cleared barriers (IB) (243). b. Clean and heat-sterilize, or high-level disinfect, between patients, barrier-protected semicritical items. If the item cannot tolerate these procedures then, at a minimum, protect with an FDA-cleared barrier and clean and disinfect with an EPA-registered hospital disinfectant with intermediate-level (i.e., tuberculocidal claim) activity, between patients. Consult with the manufacturer for methods of disinfection and sterilization of digital radiology sensors and for protection of associated computer hardware (IB) (243). C. Aseptic Technique for Parenteral Medications 1. Do not administer medication from a syringe to multiple patients, even if the needle on the syringe is changed (IA) (378). 2. Use single-dose vials for parenteral medications when possible (II) (376,377). 3. Do not combine the leftover contents of singleuse vials for later use (IA) (376,377). 4. The following apply if multidose vials are used: a. Cleanse the access diaphragm with 70% alcohol before inserting a device into the vial (IA) (380,381). b. Use a sterile device to access a multiple-dose vial and avoid touching the access diaphragm. Both the needle and syringe used to access the multidose vial should be sterile. Do not reuse a syringe even if the needle is changed (IA) (380,381). c. Keep multidose vials away from the immediate patient treatment area to prevent inadvertent contamination by spray or spatter (II). d. Discard the multidose vial if sterility is compromised (IA) (380,381). December 19, 2003 D. E. F. G. 5. Use fluid infusion and administration sets (i.e., IV bags, tubings and connections) for one patient only and dispose of appropriately (IB) (378). Single-Use (Disposable) Devices 1. Use single-use devices for one patient only and dispose of them appropriately (IC) (383). Preprocedural Mouth Rinses 1. No recommendation is offered regarding use of preprocedural antimicrobial mouth rinses to prevent clinical infections among DHCP or patients. Although studies have demonstrated that a preprocedural antimicrobial rinse (e.g., chlorhexidine gluconate, essential oils, or povidone-iodine) can reduce the level of oral microorganisms in aerosols and spatter generated during routine dental procedures and can decrease the number of microorganisms introduced in the patient’s bloodstream during invasive dental procedures (391–399), the scientific evidence is inconclusive that using these rinses prevents clinical infections among DHCP or patients (see discussion, Preprocedural Mouth Rinses) (Unresolved issue). Oral Surgical Procedures 1. The following apply when performing oral surgical procedures: a. Perform surgical hand antisepsis by using an antimicrobial product (e.g., antimicrobial soap and water, or soap and water followed by alcohol-based hand scrub with persistent activity) before donning sterile surgeon’s gloves (IB) (127–132,137). b. Use sterile surgeon’s gloves (IB) (2,7,121, 123,137). c. Use sterile saline or sterile water as a coolant/irrigatant when performing oral surgical procedures. Use devices specifically designed for delivering sterile irrigating fluids (e.g., bulb syringe, single-use disposable products, and sterilizable tubing) (IB) (2,121). Handling of Biopsy Specimens 1. During transport, place biopsy specimens in a sturdy, leakproof container labeled with the biohazard symbol (IC) (2,13,14). 2. If a biopsy specimen container is visibly contaminated, clean and disinfect the outside of a BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports container or place it in an impervious bag labeled with the biohazard symbol, (IC) (2,13). H. Handling of Extracted Teeth 1. Dispose of extracted teeth as regulated medical waste unless returned to the patient (IC) (13,14). 2. Do not dispose of extracted teeth containing amalgam in regulated medical waste intended for incineration (II). 3. Clean and place extracted teeth in a leakproof container, labeled with a biohazard symbol, and maintain hydration for transport to educational institutions or a dental laboratory (IC) (13,14). 4. Heat-sterilize teeth that do not contain amalgam before they are used for educational purposes (IB) (403,405,406). I. Dental Laboratory 1. Use PPE when handling items received in the laboratory until they have been decontaminated (IA, IC) (2,7,11,13,113). 2. Before they are handled in the laboratory, clean, disinfect, and rinse all dental prostheses and prosthodontic materials (e.g., impressions, bite registrations, occlusal rims, and extracted teeth) by using an EPA-registered hospital disinfectant having at least an intermediate-level (i.e., tuberculocidal claim) activity (IB) (2,249,252,407). 3. Consult with manufacturers regarding the stability of specific materials (e.g., impression materials) relative to disinfection procedures (II). 4. Include specific information regarding disinfection techniques used (e.g., solution used and duration), when laboratory cases are sent offsite and on their return (II) (2,407,409). 5. Clean and heat-sterilize heat-tolerant items used in the mouth (e.g., metal impression trays and face-bow forks) (IB) (2,407). 6. Follow manufacturers’ instructions for cleaning and sterilizing or disinfecting items that become contaminated but do not normally contact the patient (e.g., burs, polishing points, rag wheels, articulators, case pans, and lathes). If manufacturer instructions are unavailable, clean and heatsterilize heat-tolerant items or clean and disinfect with an EPA-registered hospital disinfectant with low- (HIV, HBV effectiveness claim) to intermediate-level (tuberculocidal claim) activity, depending on the degree of contamination (II). J. Laser/Electrosurgery Plumes/Surgical Smoke 47 1. No recommendation is offered regarding practices to reduce DHCP exposure to laser plumes/ surgical smoke when using lasers in dental practice. Practices to reduce HCP exposure to laser plumes/surgical smoke have been suggested, including use of a) standard precautions (e.g., high-filtration surgical masks and possibly full face shields) (437); b) central room suction units with in-line filters to collect particulate matter from minimal plumes; and c) dedicated mechanical smoke exhaust systems with a highefficiency filter to remove substantial amounts of laser-plume particles. The effect of the exposure (e.g., disease transmission or adverse respiratory effects) on DHCP from dental applications of lasers has not been adequately evaluated (see previous discussion, Laser/ Electrosurgery Plumes or Surgical Smoke) (Unresolved issue). K. Mycobacterium tuberculosis 1. General Recommendations a. Educate all DHCP regarding the recognition of signs, symptoms, and transmission of TB (IB) (20,21). b. Conduct a baseline TST, preferably by using a two-step test, for all DHCP who might have contact with persons with suspected or confirmed active TB, regardless of the risk classification of the setting (IB) (20). c. Assess each patient for a history of TB as well as symptoms indicative of TB and document on the medical history form (IB) (20,21). d. Follow CDC recommendations for 1) developing, maintaining, and implementing a written TB infection-control plan; 2) managing a patient with suspected or active TB; 3) completing a community risk-assessment to guide employee TSTs and follow-up; and 4) managing DHCP with TB disease (IB) (2,21). 2. The following apply for patients known or suspected to have active TB: a. Evaluate the patient away from other patients and DHCP. When not being evaluated, the patient should wear a surgical mask or be instructed to cover mouth and nose when coughing or sneezing (IB) (20,21). b. Defer elective dental treatment until the patient is noninfectious (IB) (20,21). BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 48 MMWR c. Refer patients requiring urgent dental treatment to a previously identified facility with TB engineering controls and a respiratory protection program (IB) (20,21). L. Creutzfeldt-Jakob Disease (CJD) and Other Prion Diseases 1. No recommendation is offered regarding use of special precautions in addition to standard precautions when treating known CJD or vCJD patients. Potential infectivity of oral tissues in CJD or vCJD patients is an unresolved issue. Scientific data indicate the risk, if any, of sporadic CJD transmission during dental and oral surgical procedures is low to nil. Until additional information exists regarding the transmissibility of CJD or vCJD during dental procedures, special precautions in addition to standard precautions might be indicated when treating known CJD or vCJD patients; a list of such precautions is provided for consideration without recommendation (see Creutzfeldt-Jakob Disease and Other Prion Diseases) (Unresolved issue). M. Program Evaluation 1. Establish routine evaluation of the infectioncontrol program, including evaluation of performance indicators, at an established frequency (II) (470-471). Infection-Control Internet Resources Advisory Committee on Immunization Practices http://www.cdc.gov/nip/ACIP/default.htm American Dental Association http://www.ada.org American Institute of Architects Academy of Architecture for Health http://www.aahaia.org American Society of Heating, Refrigeration, Air-conditioning Engineers http://www.ashrae.org Association for Professionals in Infection Control and Epidemiology, Inc. http://www.apic.org/resc/guidlist.cfm CDC, Division of Healthcare Quality Promotion http://www.cdc.gov/ncidod/hip CDC, Division of Oral Health, Infection Control http://www.cdc.gov/OralHealth/infectioncontrol/index.htm CDC, Morbidity and Mortality Weekly Report http://www.cdc.gov/mmwr December 19, 2003 CDC, NIOSH http://www.cdc.gov/niosh/homepage.html CDC Recommends, Prevention Guidelines System http://www.phppo.cdc.gov/cdcRecommends/AdvSearchV.asp EPA, Antimicrobial Chemicals http://www.epa.gov/oppad001/chemregindex.htm FDA http://www.fda.gov Immunization Action Coalition http://www.immunize.org/acip Infectious Diseases Society of America http://www.idsociety.org/PG/toc.htm OSHA, Dentistry, Bloodborne Pathogens http://www.osha.gov/SLTC/dentistry/index.html http://www.osha.gov/SLTC/bloodbornepathogens/index.html Organization for Safety and Asepsis Procedures http://www.osap.org Society for Healthcare Epidemiology of America, Inc., Position Papers http://www.shea-online.org/PositionPapers.html Acknowledgement The Division of Oral Health thanks the working group as well as CDC and other federal and external reviewers for their efforts in developing and reviewing drafts of this report and acknowledges that all opinions of the reviewers might not be reflected in all of the recommendations. References 1. CDC. Recommended infection-control practices for dentistry. MMWR 1986;35:237–42. 2. CDC. Recommended infection-control practices for dentistry, 1993. MMWR 1993;42(No. RR-8). 3. US Census Bureau. Statistical Abstract of the United States: 2001. Washington, DC: US Census Bureau, 2001. Available at http://www. census.gov/prod/www/statistical-abstract-02.html. 4. Health Resources and Services Administration, Bureau of Health Professions. United States health workforce personnel factbook. Rockville, MD: US Department of Health and Human Services, Health Resources and Services Administration, 2000. 5. Bolyard EA, Tablan OC, Williams WW, Pearson ML, Shapiro CN, Deitchman SD, Hospital Infection Control Practices Advisory Committee. Guideline for infection control in health care personnel, 1998. Am J Infect Control 1998;26:289–354. 6. Greene VW. Microbiological contamination control in hospitals. 1. Perspectives. Hospitals 1969;43:78–88. 7. CDC. Perspectives in disease prevention and health promotion update: universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus, and other bloodborne pathogens in health-care settings. MMWR 1988;38:377–382, 387–8. The list of references for this article is several pages long. For the complete list, please see the MMWR article online at www.cdc.gov/mmwr/PDF/RR/RR5217.pdf BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 62 MMWR December 19, 2003 Appendix A Regulatory Framework for Disinfectants and Sterilants When using the guidance provided in this report regarding use of liquid chemical disinfectants and sterilants, dental health-care personnel (DHCP) should be aware of federal laws and regulations that govern the sale, distribution, and use of these products. In particular, DHCPs should know what requirements pertain to them when such products are used. Finally, DHCP should understand the relative roles of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA) and CDC. The choice of specific cleaning or disinfecting agents is largely a matter of judgment, guided by product label claims and instructions and government regulations. A single liquid chemical germicide might not satisfy all disinfection requirements in a given dental practice or facility. Realistic use of liquid chemical germicides depends on consideration of multiple factors, including the degree of microbial killing required; the nature and composition of the surface, item, or device to be treated; and the cost, safety, and ease of use of the available agents. Selecting one appropriate product with a higher degree of potency to cover all situations might be more convenient. In the United States, liquid chemical germicides (disinfectants) are regulated by EPA and FDA (A-1–A-3). In healthcare settings, EPA regulates disinfectants that are used on environmental surfaces (housekeeping and clinical contact surfaces), and FDA regulates liquid chemical sterilants/ high-level disinfectants (e.g., glutaraldehyde, hydrogen peroxide, and peracetic acid) used on critical and semicritical patientcare devices. Disinfectants intended for use on clinical contact surfaces (e.g., light handles, radiographic-ray heads, or drawer knobs) or housekeeping surfaces (e.g., floors, walls, or sinks) are regulated in interstate commerce by the Antimicrobials Division, Office of Pesticide Programs, EPA, under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of 1947, as amended in 1996 (A-4). Under FIFRA, any substance or mixture of substances intended to prevent, destroy, repel, or mitigate any pest, including microorganisms but excluding those in or on living man or animals, must be registered before sale or distribution. To obtain a registration, a manufacturer must submit specific data regarding the safety and the effectiveness of each product. EPA requires manufacturers to test formulations by using accepted methods for microbicidal activity, stability, and toxicity to animals and humans. Manufacturers submit these data to EPA with proposed labeling. If EPA concludes a product may be used without causing unreasonable adverse effects, the product and its labeling are given an EPA registration number, and the manufacturer may then sell and distribute the product in the United States. FIFRA requires users of products to follow the labeling directions on each product explicitly. The following statement appears on all EPA-registered product labels under the Directions for Use heading: “It is a violation of federal law to use this product inconsistent with its labeling.” This means that DHCP must follow the safety precautions and use directions on the labeling of each registered product. Not following the specified dilution, contact time, method of application, or any other condition of use is considered misuse of the product. FDA, under the authority of the 1976 Medical Devices Amendment to the Food, Drug, and Cosmetic Act, regulates chemical germicides if they are advertised and marketed for use on specific medical devices (e.g., dental unit waterline or flexible endoscope). A liquid chemical germicide marketed for use on a specific device is considered, for regulatory purposes, a medical device itself when used to disinfect that specific medical device. Also, this FDA regulatory authority over a particular instrument or device dictates that the manufacturer is obligated to provide the user with adequate instructions for the safe and effective use of that device. These instructions must include methods to clean and disinfect or sterilize the item if it is to be marketed as a reusable medical device. OSHA develops workplace standards to help ensure safe and healthful working conditions in places of employment. OSHA is authorized under Pub. L. 95-251, and as amended, to enforce these workplace standards. In 1991, OSHA published Occupational Exposure to Bloodborne Pathogens; final rule [29 CFR Part 1910.1030] (A-5). This standard is designed to help prevent occupational exposures to blood or other potentially infectious substances. Under this standard, OSHA has interpreted that, to decontaminate contaminated work surfaces, either an EPA-registered hospital tuberculocidal disinfectant or an EPA-registered hospital disinfectant labeled as effective against human immunodeficiency virus (HIV) and hepatitis B virus (HBV) is appropriate. Hospital disinfectants with such HIV and HBV claims can be used, provided surfaces are not contaminated with agents or concentration of agents for which higher level (i.e., intermediate-level) disinfection is recommended. In addition, as with all disinfectants, effectiveness is governed by strict adherence to the label instructions for intended use of the product. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports CDC is not a regulatory agency and does not test, evaluate, or otherwise recommend specific brand-name products of chemical germicides. This report is intended to provide overall guidance for providers to select general classifications of products based on certain infection-control principles. In this report, CDC provides guidance to practitioners regarding appropriate application of EPA- and FDA-registered liquid chemical disinfectants and sterilants in dental health-care settings. CDC recommends disinfecting environmental surfaces or sterilizing or disinfecting medical equipment, and DHCP should use products approved by EPA and FDA unless no such products are available for use against certain microorganisms or sites. However, if no registered or approved products are available for a specific pathogen or use situation, DHCP are advised to follow the specific guidance regarding unregistered or unapproved (e.g., off-label) uses for various chemical germicides. For example, no antimicrobial products are registered for use specifically against certain emerging pathogens (e.g., Norwalk virus), potential terrorism agents (e.g., variola major or Yersinia pestis), or Creutzfeldt-Jakob disease agents. One point of clarification is the difference in how EPA and FDA classify disinfectants. FDA adopted the same basic terminology and classification scheme as CDC to categorize medical devices (i.e., critical, semicritical, and noncritical) and to define antimicrobial potency for processing surfaces (i.e., sterilization, and high-, intermediate- and low-level disinfection) (A-6). EPA registers environmental surface disinfectants based on the manufacturer’s microbiological activity claims when registering its disinfectant. This difference has led to confusion on the part of users because the EPA does not use the terms intermediate- and low-level disinfectants as used in CDC guidelines. CDC designates any EPA-registered hospital disinfectant without a tuberculocidal claim as a low-level disinfectant and any EPA-registered hospital disinfectant with a tuberculocidal claim as an intermediate-level disinfectant. To understand this comparison, one needs to know how EPA registers disinfectants. First, to be labeled as an EPA hospital disinfectant, the product must pass Association of Official Analytical Chemists (AOAC) effectiveness tests against three target organisms: Salmonella choleraesuis for effectiveness against gram-negative bacteria; Staphylococcus aureus for effectiveness against grampositive bacteria; and Pseudomonas aeruginosa for effectiveness 63 against a primarily nosocomial pathogen. Substantiated label claims of effectiveness of a disinfectant against specific microorganisms other than the test microorganisms are permitted, but not required, provided that the test microorganisms are likely to be present in or on the recommended use areas and surfaces. Therefore, manufacturers might also test specifically against organisms of known concern in health-care practices (e.g., HIV, HBV, hepatitis C virus [HCV], and herpes) although it is considered likely that any product satisfying AOAC tests for hospital disinfectant designation will also be effective against these relatively fragile organisms when the product is used as directed by the manufacturer. Potency against Mycobacterium tuberculosis has been recognized as a substantial benchmark. However, the tuberculocidal claim is used only as a benchmark to measure germicidal potency. Tuberculosis is not transmitted via environmental surfaces but rather by the airborne route. Accordingly, use of such products on environmental surfaces plays no role in preventing the spread of tuberculosis. However, because mycobacteria have among the highest intrinsic levels of resistance among the vegetative bacteria, viruses, and fungi, any germicide with a tuberculocidal claim on the label is considered capable of inactivating a broad spectrum of pathogens, including such less-resistant organisms as bloodborne pathogens (e.g., HBV, HCV, and HIV). It is this broad-spectrum capability, rather than the product’s specific potency against mycobacteria, that is the basis for protocols and regulations dictating use of tuberculocidal chemicals for surface disinfection. EPA also lists disinfectant products according to their labeled use against these organisms of interest as follows: • List B. Tuberculocide products effective against Mycobacterium species. • List C. Products effective against human HIV-1 virus. • List D. Products effective against human HIV-1 virus and HBV. • List E. Products effective against Mycobacterium species, human HIV-1 virus, and HBV. • List F. Products effective against HCV. Microorganisms vary in their resistance to disinfection and sterilization, enabling CDC’s designation of disinfectants as high-, intermediate-, and low-level, when compared with EPA’s designated organism spectrum (Figure). However, exceptions to this general guide exist, and manufacturer’s label claims and instructions should always be followed. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 64 MMWR December 19, 2003 FIGURE. Decreasing order of resistance of microorganisms to germicidal chemicals Organism Processing Level Required Sterilization Bacterial spores Geobacillus stearothermophilus Bacillus atrophaeus Mycobacteria Mycobacterium tuberculosis Nonlipid or small viruses Polio virus Coxsackle virus Rhinovirus Fungi Aspergillus Candida Vegetative bacteria Staphylococcus species Pseudomonus species Salmonella species Lipid or medium-sized viruses Human immunodeficiency virus Herpes simplex virus Hepatitis B and hepatitis C Coronavirus FDA sterilant/high-level disinfectant (= CDC sterilant/high-level disinfectant) EPA hospital disinfectant with tuberculocidal claim (= CDC intermediate-level disinfectant) EPA hospital disinfectant (= CDC low-level disinfectant) Source: Adapted from Bond WW, Ott BJ, Franke K, McCracken JE. Effective use of liquid chemical germicides on medical devices; instrument design problems. In: Block SS, ed. Disinfection, sterilization and preservation. 4 th ed. Philadelphia, PA: Lea & Gebiger, 1991:1100. References A-1. Food and Drug Administration (FDA) and US Environmental Protection Agency (EPA). Memorandum of understanding between the FDA and EPA: notice regarding matters of mutual responsibility— regulation of liquid chemical germicides intended for use on medical devices. Rockville, MD: US Department of Health and Human Services, Public Health Service, Food and Drug Administration, US Environmental Protection Agency, 1993. A-2. Food and Drug Administration (FDA). Interim measures for registration of antimicrobial products/liquid chemical germicides with medical device use claims under the memorandum of understanding between EPA and FDA. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, 1994. A-3. Food and Drug Administration. Guidance for industry and FDA reviewers: content and format of premarket notification [510(k)] submissions for liquid chemical sterilants/high level disinfectants. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, 2000. Available at http://www.fda.gov/cdrh/ode/ 397.pdf. A-4. US Environmental Protection Agency. 40 CFR Parts 152, 156, and 158. Exemption of certain pesticide substances from federal insecticide, fungicide, and rodenticide act requirements. Amended 1996. Federal Register 1996;61:8876–9. A-5. US Department of Labor, Occupational Safety and Health Administration. 29 CFR Part 1910.1030. Occupational exposure to bloodborne pathogens; needlesticks and other sharps injuries; final rule. Federal Register 2001;66:5317–25. As amended from and includes 29 CFR Part 1910.1030. Occupational exposure to bloodborne pathogens; final rule. Federal Register 1991;56:64174–82. Available at http://www. osha.gov/SLTC/dentistry/index.html. A-6. Spaulding EH. Role of chemical disinfection in preventing nosocomial infections. In: Proceedings of the International Conference on Nosocomial Infections, 1970. Brachman PS, Eickhoff TC, eds. Chicago, IL: American Hospital Association, 1971:247–54. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' Vol. 52 / RR-17 Recommendations and Reports 65 Appendix B Immunizations Strongly Recommended for Health-Care Personnel (HCP) Vaccine Dose schedule Indications Major precautions and contraindications Special considerations Hepatitis B recombinant vaccine* Three-dose schedule Health-care personnel (HCP) administered intramuscularly at risk for exposure to blood (IM) in the deltoid; 0,1,6 and body fluids. second dose administered 1 month after first dose; third dose administered 4 months after second. Booster doses are not necessary for persons who have developed adequate antibodies to hepatitis B surface antigen (anti-HBs). History of anaphylactic reaction to common baker’s yeast. Pregnancy is not a contraindication. No therapeutic or adverse effects on hepatitis B virus (HBV)-infected persons; costeffectiveness of prevaccination screening for susceptibility to HBV depends on costs of vaccination and antibody testing and prevalence of immunity in the group of potential vaccinees; health-care personnel who have ongoing contact with patients or blood should be tested 1–2 months after completing the vaccination series to determine serologic response. If vaccination does not induce adequate anti-HBs (>10 mIU/mL), a second vaccine series should be administered. Influenza vaccine (inactivated)¶ Annual single-dose vaccination IM with current vaccine. HCP who have contact with patients at high risk or who work in chronic-care facilities; HCP aged >50 years or who have high-risk medical conditions. History of anaphylactic hypersensitivity to eggs or to other components of the vaccine. Recommended for women who will be in the second or third trimesters of pregnancy during the influenza season and women in any stage of pregnancy who have chronic medical conditions that are associated with an increased risk of influenza.§ Measles livevirus vaccine One dose administered subcutaneously (SC); second dose >4 weeks later. HCP who were born during or after 1957 without documentation of 1) receipt of 2 doses of live vaccine on or after their first birthday, 2) physician-diagnosed measles, or 3) laboratory evidence of immunity. Vaccine should also be considered for all HCP who have no proof of immunity, including those born before 1957. Pregnancy; immunocompromised† state (including human immunodeficiency virus [HIV]-infected persons with severe immunosuppression); history of anaphylactic reactions after gelatin ingestion or receipt of neomycin; or recent receipt of antibody-containing blood products. Measles, mumps, rubella (MMR) is the recommended vaccine, if recipients are also likely to be susceptible to rubella or mumps; persons vaccinated during 1963–1967 with 1) measles killed-virus vaccine alone, 2) killed-virus vaccine followed by live-virus vaccine, or 3) a vaccine of unknown type, should be revaccinated with two doses of live-virus measles vaccine. Mumps livevirus vaccine One dose SC; no booster. HCP believed susceptible can be vaccinated; adults born before 1957 can be considered immune. Pregnancy; immunocompromised† state; history of anaphylactic reaction after gelatin ingestion or receipt of neomycin. MMR is the recommended vaccine. Rubella livevirus vaccine One dose SC; no booster. HCP, both male and female, who lack documentation of receipt of live vaccine on or after their first birthday, or lack of laboratory evidence of immunity can be vaccinated. Adults born before 1957 can be considered immune, except women of childbearing age. Pregnancy; immunocompromised† state; history of anaphylactic reaction after receipt of neomycin. Women pregnant when vaccinated or who become pregnant within 4 weeks of vaccination should be counseled regarding theoretic risks to the fetus; however, the risk of rubella vaccine-associated malformations among these women is negligible. MMR is the recommended vaccine. Varicella-zoster live-virus vaccine Two 0.5 mL doses SC 4–8 weeks apart if aged >13 years. HCP without reliable history of varicella or laboratory evidence of varicella immunity. Pregnancy; immunocompromised† state; history of anaphylactic reaction after receipt of neomycin or gelatin; recent receipt of antibody-containing blood products; salicylate use should be avoided for 6 weeks after vaccination. Because 71%–93% of U.S.-born persons without a history of varicella are immune, serologic testing before vaccination might be cost-effective. Sources: Adapted from Bolyard EA, Hospital Infection Control Practices Advisory Committee. Guidelines for infection control in health care personnel, 1998. Am J Infect Control 1998;26:289–354. CDC. Immunization of health-care workers: recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC). MMWR 1997;46(No. RR-18). CDC. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2003;52:1-34. CDC. Using live, attenuated influenza vaccine for prevention and control of influenza: supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2003;52(No. RR-13). * A federal standard issued in December 1991 under the Occupational Safety and Health Act mandates that hepatitis B vaccine be made available at the employer’s expense to all HCP occupationally exposed to blood or other potentially infectious materials. The Occupational Safety and Health Administration requires that employers make available hepatitis B vaccinations, evaluations, and follow-up procedures in accordance with current CDC recommendations. † Persons immunocompromised because of immune deficiencies, HIV infection, leukemia, lymphoma, generalized malignancy; or persons receiving immunosuppressive therapy with corticosteroids, alkylating drugs, antimetabolites; or persons receiving radiation. § Vaccination of pregnant women after the first trimester might be preferred to avoid coincidental association with spontaneous abortions, which are most common during the first trimester. However, no adverse fetal effects have been associated with influenza vaccination. ¶ A live attenuated influenza vaccine (LAIV) is FDA-approved for healthy persons aged 5-49 years. Because of the possibility of transmission of vaccine viruses from recipients of LAIV to other persons and in the absence of data on the risk of illness and among immunocompromised persons infected with LAIV viruses, the inactivated influenza vaccine is preferred for HCP who have close contact with immunocompromised persons. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' 66 MMWR December 19, 2003 Appendix C Methods for Sterilizing and Disinfecting Patient-Care Items and Environmental Surfaces* Health-care application Process Sterilization Result Destroys all microorganisms, including bacterial spores. Method Heat-automated High temperature Examples Type of patient-care item Environmental surfaces Not applicable Steam, dry heat, unsaturated chemical vapor Heat-tolerant critical and semicritical Ethylene oxide gas, plasma sterilization Heat-sensitive critical and semicritical Liquid immersion† Chemical sterilants. Glutaraldehyde, glutaraldehydes with phenol, hydrogen peroxide, hydrogen peroxide with peracetic acid, peracetic acid Heat-sensitive critical and semicritical Destroys all microorganisms, but not necessarily high numbers of bacterial spores. Heat-automated Washer-disinfector Heat-sensitive semicritical Not applicable Liquid immersion† Chemical sterilants/high-level disinfectants. Glutaraldehyde, glutaraldehyde with phenol, hydrogen peroxide, hydrogen peroxide with peracetic acid, ortho-phthalaldehyde Intermediatelevel disinfection Destroys vegetative bacteria and the majority of fungi and viruses. Inactivates Mycobacterium bovis.§ Not necessarily capable of killing bacterial spores. Liquid contact U.S. Environmental Protection Agency (EPA)registered hospital disinfectant with label claim of tuberculocidal activity (e.g., chlorinecontaining products, quaternary ammonium compounds with alcohol, phenolics, iodophors, EPA-registered chlorine-based product¶) Noncritical with visible blood Clinical contact surfaces; blood spills on housekeeping surfaces Low-level disinfection Destroys the majority of vegetative bacteria, certain fungi, and viruses. Does not inactivate Mycobacterium bovis .§ Liquid contact EPA-registered hospital disinfectant with no label claim regarding tuberculocidal activity.** The Occupational Safety and Health Administration also requires label claims of human immunodeficiency virus (HIV) and hepatitis B virus (HBV) potency for clinical contact surfaces (e.g., quaternary ammonium compounds, some phenolics, some iodophors) Noncritical without visible blood Clinical contact surfaces; housekeeping surfaces Low temperature High-level disinfection * EPA and the Food and Drug Administration (FDA) regulate chemical germicides used in health-care settings. FDA regulates chemical sterilants used on critical and semicritical medical devices, and the EPA regulates gaseous sterilants and liquid chemical disinfectants used on noncritical surfaces. FDA also regulates medical devices, including sterilizers. More information is available at 1) http://www.epa.gov/oppad001/chemregindex.htm, 2) http://www.fda.gov/cdrh/index.html, and 3) http://www.fda.gov/cdrh/ode/ germlab.html. † Contact time is the single critical variable distinguishing the sterilization process from high-level disinfection with FDA-cleared liquid chemical sterilants. FDA defines a high-level disinfectant as a sterilant used under the same contact conditions as sterilization except for a shorter immersion time (C-1). § The tuberculocidal claim is used as a benchmark to measure germicidal potency. Tuberculosis (TB) is transmitted via the airborne route rather than by environmental surfaces and, accordingly, use of such products on environmental surfaces plays no role in preventing the spread of TB. Because mycobacteria have among the highest intrinsic levels of resistance among vegetative bacteria, viruses, and fungi, any germicide with a tuberculocidal claim on the label (i.e., an intermediate-level disinfectant) is considered capable of inactivating a broad spectrum of pathogens, including much less resistant organisms, including bloodborne pathogens (e.g., HBV, hepatitis C virus [HCV], and HIV). It is this broad-spectrum capability, rather than the product’s specific potency against mycobacteria, that is the basis for protocols and regulations dictating use of tuberculocidal chemicals for surface disinfection. ¶ Chlorine-based products that are EPA-registered as intermediate-level disinfectants are available commercially. In the absence of an EPA-registered chlorine-based product, a fresh solution of sodium hypochlorite (e.g., household bleach) is an inexpensive and effective intermediate-level germicide. Concentrations ranging from 500 ppm to 800 ppm of chlorine (1:100 dilution of 5.25% bleach and tap water, or approximately ¼ cup of 5.25% bleach to 1 gallon of water) are effective on environmental surfaces that have been cleaned of visible contamination. Appropriate personal protective equipment (e.g., gloves and goggles) should be worn when preparing hypochlorite solutions (C-2,C-3). Caution should be exercised, because chlorine solutions are corrosive to metals, especially aluminum. ** Germicides labeled as “hospital disinfectant” without a tuberculocidal claim pass potency tests for activity against three representative microorganisms: Pseudomonas aeruginosa, Staphylococcus aureus, and Salmonella choleraesuis. References C-1. Food and Drug Administration. Guidance for industry and FDA reviewers: content and format of premarket notification [510(k)] submissions for liquid chemical sterilants/high level disinfectants. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, 2000. Available at http://www.fda.gov/cdrh/ode/ 397.pdf. C-2. US Department of Labor, Occupational Safety and Health Administration. 29 CFR Part 1910.1030. Occupational exposure to bloodborne pathogens; needlesticks and other sharps injuries; final rule. Federal Register 2001;66:5317–25. As amended from and includes 29 CFR Part 1910.1030. Occupational exposure to bloodborne pathogens; final rule. Federal Register 1991;56:64174–82. Available at http://www. osha.gov/SLTC/dentistry/index.html. C-3. CDC. Guidelines for environmental infection control in health-care facilities: recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). MMWR 2003;52(No. RR-10). BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' MMWR The Morbidity and Mortality Weekly Report (MMWR) Series is prepared by the Centers for Disease Control and Prevention (CDC) and is available free of charge in electronic format and on a paid subscription basis for paper copy. To receive an electronic copy each week, send an e-mail message to [email protected]. The body content should read SUBscribe mmwr-toc. Electronic copy also is available from CDC’s World-Wide Web server at http://www.cdc.gov/mmwr or from CDC’s file transfer protocol server at ftp://ftp.cdc.gov/pub/publications/mmwr. To subscribe for paper copy, contact Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402; telephone 202-512-1800. Data in the weekly MMWR are provisional, based on weekly reports to CDC by state health departments. The reporting week concludes at close of business on Friday; compiled data on a national basis are officially released to the public on the following Friday. Address inquiries about the MMWR Series, including material to be considered for publication, to Editor, MMWR Series, Mailstop C-08, CDC, 1600 Clifton Rd., N.E., Atlanta, GA 30333; telephone 888-232-3228. All material in the MMWR Series is in the public domain and may be used and reprinted without permission; citation as to source, however, is appreciated. All MMWR references are available on the Internet at http://www.cdc.gov/mmwr. Use the search function to find specific articles. Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services. References to non-CDC sites on the Internet are provided as a service to MMWR readers and do not constitute or imply endorsement of these organizations or their programs by CDC or the U.S. Department of Health and Human Services. CDC is not responsible for the content of these sites. URL addresses listed in MMWR were current as of the date of publication. ✩U.S. Government Printing Office: 2004-633-140/4-00056 Region IV ISSN: 1057-5987 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[' ADA.org: ADA Statement on Infection Control in Dentistry Page 1 of 1 Bloodborne Pathogens Appendix E Licensure | Catalog | Member Directory | Contact Us | ADA POSITIONS & STATEMENTS ADA STATEMENT ON INFECTION CONTROL IN DENTISTRY Twenty-five years ago the ADA Foundation's Health Screening Program helped identify HBV as an occupational hazard in dentistry. The ADA responded by being the first to recommend that dentists follow standard infection control procedures. The ADA subsequently worked with the Centers for Disease Control and Prevention (CDC) to develop CDC's own infection control recommendations for dentistry, which were issued in 1993. Since then, both the ADA and CDC have updated and supplemented their recommendations from time to time to reflect new scientific knowledge and growing understanding of the principles of infection control. ADA LIBRARY ADA PUBLICATIONS DENTAL CAREERS AND JOB LISTINGS EVIDENCE BASED DENTISTRY PODCASTS ADA POLICIES & POSITIONS ADA Current Policies ADA Positions & Statements Research Agenda STANDARDS In December 2003, the CDC published a major consolidation and update of its infection control recommendations for dentistry.1 Although the procedures recommended in the 2003 document are for the most part unchanged, the new document does incorporate relevant recommendations that were previously scattered throughout several other CDC publications and contains an extensive review of the science related to dental infection control. The 2003 CDC Guidelines are a comprehensive and evidence-based source for infection control practices relevant to the dental office that have been developed for the protection of dental care workers and their patients. The ADA urges all practicing dentists, dental auxiliaries and dental laboratories to employ appropriate infection control procedures as described in the 2003 CDC Guidelines, and to keep up-to-date as scientific information leads to improvements in infection control, risk assessment and disease management in oral health care. The ADA has long advocated the use of infection control procedures in dental practice and provided dentists with resources to help them understand and implement them. In addition to the online resources available at ADA.org, the Association has a number of publications that provide detailed information about infection control and treatment of patients with infectious diseases. These include Dental Management of the HIV-Infected Patient and ADA Catalog products, including the Effective Infection Control training DVD (P692), the ADA Regulatory Compliance Manual and the OSHA Training for Dental Professionals DVD (P889). Centers for Disease Control and Prevention. Guidelines for Infection Control in Dental HealthCare Settings – 2003. MMWR 2003;52(No. RR-17) Adopted March 2004 Return to Top For more topics related to the needs of patients, see: Oral Health Topics A-Z Copyright 1995-2008 American Dental Association. Reproduction or republication strictly prohibited without prior written permission. See Privacy Policy (Updated 03/14/05) and Terms of Use for further legal information. Link opens in separate window. Pop-up Blocker may need to be disabled. Member only content. from http://www.ada.org/prof/resources/positions/statements/infectionconrol.asp BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[( http://www.ada.org/prof/resources/positions/statements/infectionconrol.asp 1/7/2008 Bloodborne Pathogens Appendix F ___________________________________________ Updated US Public Health Service Guidelines for the Management of Occupational Exposures to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis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http://www.jstor.org/stable/10.1086/672271 . $FFHVVHG Your use of the JSTOR archive indicates your acceptance of the Terms & Conditions of Use, available at . http://www.jstor.org/page/info/about/policies/terms.jsp . 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The University of Chicago Press and The Society for Healthcare Epidemiology of America are collaborating with JSTOR to digitize, preserve and extend access to Infection Control and Hospital Epidemiology. http://www.jstor.org BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) infection control and hospital epidemiology september 2013, vol. 34, no. 9 u s p u b l i c h e a l t h s e rv i c e g u i d e l i n e Updated US Public Health Service Guidelines for the Management of Occupational Exposures to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis David T. Kuhar, MD;1 David K. Henderson, MD;2 Kimberly A. Struble, PharmD;3 Walid Heneine, PhD;4 Vasavi Thomas, RPh, MPH;4 Laura W. Cheever, MD, ScM;5 Ahmed Gomaa, MD, ScD, MSPH;6 Adelisa L. Panlilio, MD;1 for the US Public Health Service Working Group This report updates US Public Health Service recommendations for the management of healthcare personnel (HCP) who experience occupational exposure to blood and/or other body fluids that might contain human immunodeficiency virus (HIV). Although the principles of exposure management remain unchanged, recommended HIV postexposure prophylaxis (PEP) regimens and the duration of HIV followup testing for exposed personnel have been updated. This report emphasizes the importance of primary prevention strategies, the prompt reporting and management of occupational exposures, adherence to recommended HIV PEP regimens when indicated for an exposure, expert consultation in management of exposures, follow-up of exposed HCP to improve adherence to PEP, and careful monitoring for adverse events related to treatment, as well as for virologic, immunologic, and serologic signs of infection. To ensure timely postexposure management and administration of HIV PEP, clinicians should consider occupational exposures as urgent medical concerns, and institutions should take steps to ensure that staff are aware of both the importance of and the institutional mechanisms available for reporting and seeking care for such exposures. The following is a summary of recommendations: (1) PEP is recommended when occupational exposures to HIV occur; (2) the HIV status of the exposure source patient should be determined, if possible, to guide need for HIV PEP; (3) PEP medication regimens should be started as soon as possible after occupational exposure to HIV, and they should be continued for a 4-week duration; (4) new recommendation—PEP medication regimens should contain 3 (or more) antiretroviral drugs (listed in Appendix A) for all occupational exposures to HIV; (5) expert consultation is recommended for any occupational exposures to HIV and at a minimum for situations described in Box 1; (6) close follow-up for exposed personnel (Box 2) should be provided that includes counseling, baseline and follow-up HIV testing, and monitoring for drug toxicity; follow-up appointments should begin within 72 hours of an HIV exposure; and (7) new recommendation—if a newer fourth-generation combination HIV p24 antigen–HIV antibody test is utilized for follow-up HIV testing of exposed HCP, HIV testing may be concluded 4 months after exposure (Box 2); if a newer testing platform is not available, follow-up HIV testing is typically concluded 6 months after an HIV exposure. Infect Control Hosp Epidemiol 2013;34(9):875-892 Preventing exposures to blood and body fluids (ie, primary prevention) is the most important strategy for preventing occupationally acquired human immunodeficiency virus (HIV) infection. Both individual healthcare providers and the institutions that employ them should work to ensure adherence to the principles of Standard Precautions,1 including ensuring access to and consistent use of appropriate work practices, work practice controls, and personal protective equipment. For instances in which an occupational exposure has occurred, appropriate postexposure management is an important element of workplace safety. This document provides updated recommendations concerning the management of occupational exposures to HIV. The use of antiretrovirals as postexposure prophylaxis (PEP) for occupational exposures to HIV was first considered in guidelines issued by the Centers for Disease Control and Prevention (CDC) in 1990.2 In 1996, the first US Public Health Service (PHS) recommendations advocating the use of PEP after occupational exposure to HIV were published; these recommendations have been updated 3 times.3-6 Since Affiliations: 1. Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; 2. Office of the Deputy Director for Clinical Care, Clinical Center, National Institutes of Health, Bethesda, Maryland; 3. Division of Antiviral Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland; 4. Division of HIV/ AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia; 5. HIV/AIDS Bureau, Health Resources and Services Administration, Rockville, Maryland; 6. Division of Surveillance, Hazard Evaluation, and Health Studies, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Cincinnati, Ohio. Received June 27, 2013; accepted June 27, 2013; electronically published August 6, 2013. This article is in the public domain, and no copyright is claimed. 0899-823X/2013/3409-0001. DOI: 10.1086/672271 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) 876 infection control and hospital epidemiology september 2013, vol. 34, no. 9 publication of the most recent guidelines in 2005, several new antiretroviral agents have been approved by the Food and Drug Administration (FDA), and additional information has become available regarding both the use and the safety of agents previously recommended for administration for HIV PEP. As a direct result of 7 years’ experience with the 2005 guidelines, several challenges in the interpretation and implementation of those guidelines have been identified. These challenges include difficulties in determining levels of risk of HIV transmission for individual exposure incidents, problems determining the appropriate use of 2 versus 3 (or more) drugs in PEP regimens, the high frequency of side effects and toxicities associated with administration of previously recommended drugs, and the initial management of healthcare personnel (HCP) with exposures to a source patient whose HIV infection status was unknown. The PHS working group has attempted to address both the new information that has been developed and the challenges associated with the practical implementation of the 2005 guidelines in this update. This report encourages using HIV PEP regimens that are optimally tolerated, eliminates the recommendation to assess the level of risk associated with individual exposures to determine the number of drugs recommended for PEP, modifies and expands the list of antiretroviral medications that can be considered for use as PEP, and offers an option for concluding HIV follow-up testing of exposed personnel earlier than 6 months after exposure. This report also continues to emphasize the following: (1) primary prevention of occupational exposures; (2) prompt management of occupational exposures and, if indicated, initiation of PEP as soon as possible after exposure; (3) selection of PEP regimens that have the fewest side effects and that are best tolerated by prophylaxis recipients; (4) anticipating and preemptively treating side effects commonly associated with taking antiretroviral drugs; (5) attention to potential interactions involving both drugs that could be included in HIV PEP regimens and other medications that PEP recipients might be taking; (6) consultation with experts on postexposure management strategies (especially determining whether an exposure has actually occurred and selecting HIV PEP regimens, particularly when the source patient is antiretroviral treatment experienced); (7) HIV testing of source patients (without delaying PEP initiation in the exposed provider) using methods that produce rapid results; and (8) counseling and follow-up of exposed HCP. Recommendations concerning the management of occupational exposures to hepatitis B virus and/or hepatitis C virus (HCV) have been published previously 5,7 and are not included in this report. Recommendations for nonoccupational (eg, sexual, pediatric, and perinatal) HIV exposures also have been published previously.8-10 methods In 2011, the CDC reconvened the interagency PHS working group to plan and prepare an update to the 2005 Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis.6 The PHS working group was comprised of members from the CDC, the FDA, the Health Resources and Services Administration, and the National Institutes of Health. Names, credentials, and affiliations of the PHS working group members are listed as the byline of this guideline. The working group met twice a month to monthly to create a plan for the update as well as draft the guideline. A systematic review of new literature that may have become available since 2005 was not conducted; however, an initial informal literature search did not reveal human randomized trials demonstrating superiority of 2-drug antiretroviral medication regimens versus those with 3 (or more) drugs as PEP or an optimal PEP regimen for occupational exposures to HIV. Because of the low risk of transmission associated with occupational exposures (ie, approximately 0.3% per exposure when all parenteral exposures are considered together),11 neither the conduct of a randomized trial assessing efficacy nor the conduct of trials assessing the comparative efficacy of 2versus 3-drug regimens for PEP is practical. In light of the absence of such randomized trials, the CDC convened a meeting of the interagency PHS working group and an expert panel of consultants in July 2011 to discuss the use of HIV PEP and develop the recommendations for this update. The expert panel consisted of professionals in academic medicine considered to be experts in the treatment of HIV-infected individuals, the use of antiretroviral medications, and PEP. Names, credentials, and affiliations of the expert panel of consultants are listed in “Expert Panel Consultants” at the end of this guideline. Prior to the July 2011 meeting, the meeting participants were provided an electronic copy of the 2005 guidelines and asked to review them and consider the following topics for discussion at the upcoming meeting: (1) the challenges associated with the implementation of the 2005 guidelines, (2) the role of ongoing risk stratification in determining the use of 2-drug PEP regimens versus those with 3 or more drugs, (3) updated drug choices for PEP, (4) the safety and tolerability of antiretroviral agents for the general population and for pregnant or lactating HCP, and (5) any other topics in the 2005 guideline that needed to be updated. At the July 2011 meeting, a CDC representative presented a review of the 2005 guideline recommendations, surveillance data on occupational exposures from the National Surveillance System for Healthcare Workers,12 and data from the National Clinicians’ Post-Exposure Prophylaxis Hotline (PEPline) on the number of occupational exposures to HIV managed annually, PEP regimens recommended, and challenges experienced with implementation of the 2005 guidelines. An FDA representative presented a review of the new medications that have become available since 2005 for the treatment of HIV-infected individuals, information about medication tolerability and toxicity, and the use of these medications during pregnancy. These presentations were followed by a discussion of the topics listed above. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) phs guidelines for occupational exposures to hiv Among the challenges discussed regarding implementation of the 2005 guidelines were the difficulties in determining level of risk of HIV transmission for individual exposure incidents, which in turn determined the number of drugs recommended for HIV PEP. The consensus of the meeting participants was to no longer recommend exposure risk stratification (discussed in detail in “Recommendations for the Selection of Drugs for HIV PEP” below). To update the drug choices for PEP, all drugs available for the treatment of HIVinfected individuals were discussed with regard to tolerability, side effects, toxicity, safety in pregnancy and lactation, pill burden, and frequency of dosing. A hierarchy of recommended drugs/regimens was developed at the meeting and utilized in creating the PEP regimen recommendations (Appendixes A and B) in these guidelines. Among other topics identified as needing an update were the acceptable HIV testing platforms available for source patient and follow-up testing of exposed HCP; the timing of such testing, depending on the platform used; and the potential utility of source patient drug-resistance information/testing in PEP regimens. After the expert consultation, the expert panelists received draft copies of these guidelines as they were updated and provided insights, information, suggestions, and edits and participated in subsequent teleconferences with the PHS working group, to assist in developing these recommendations. Proposed recommendation updates were presented to the Healthcare Infection Control Practices Advisory Committee in November 201113 and June 201214 during public meetings. The PHS working group considered all available information, expert opinion, and feedback in finalizing the recommendations in this update. definition of hcp and exposure The definitions of HCP and occupational exposures are unchanged from those used in 2001 and 2005.5,6 The term HCP refers to all paid and unpaid persons working in healthcare settings who have the potential for exposure to infectious materials, including body substances (eg, blood, tissue, and specific body fluids), contaminated medical supplies and equipment, and contaminated environmental surfaces. HCP might include but are not limited to emergency medical service personnel, dental personnel, laboratory personnel, autopsy personnel, nurses, nursing assistants, physicians, technicians, therapists, pharmacists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care but potentially exposed to blood and body fluids (eg, clerical, dietary, housekeeping, security, maintenance, and volunteer personnel). The same principles of exposure management could be applied to other workers with potential for occupational exposure to blood and body fluids in other settings. An exposure that might place HCP at risk for HIV infection is defined as a percutaneous injury (eg, a needlestick or cut with a sharp object) or contact of mucous membrane or nonintact skin (eg, exposed skin that is chapped, abraded, or af- 877 flicted with dermatitis) with blood, tissue, or other body fluids that are potentially infectious. In addition to blood and visibly bloody body fluids, semen and vaginal secretions are also considered potentially infectious. Although semen and vaginal secretions have been implicated in the sexual transmission of HIV, they have not been implicated in occupational transmission from patients to HCP. The following fluids are also considered potentially infectious: cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, and amniotic fluid. The risk for transmission of HIV infection from these fluids is unknown; the potential risk to HCP from occupational exposures has not been assessed by epidemiologic studies in healthcare settings. Feces, nasal secretions, saliva, sputum, sweat, tears, urine, and vomitus are not considered potentially infectious unless they are visibly bloody.11 Any direct contact (ie, contact without barrier protection) to concentrated virus in a research laboratory or production facility requires clinical evaluation. For human bites, clinical evaluation must include the possibility that both the person bitten and the person who inflicted the bite were exposed to bloodborne pathogens. Transmission of HIV infection by this route has been reported rarely, but not after an occupational exposure.15-20 risk for occupational transmission of hiv Factors associated with risk for occupational transmission of HIV have been described; risks vary with the type and severity of exposure.4,5,11 In prospective studies of HCP, the average risk for HIV transmission after a percutaneous exposure to HIV-infected blood has been estimated to be approximately 0.3% (95% confidence interval [CI], 0.2%–0.5%)11 and that after a mucous membrane exposure to be approximately 0.09% (95% CI, 0.006%–0.5%).21 Although episodes of HIV transmission after nonintact skin exposure have been documented, the average risk for transmission by this route has not been precisely quantified but is estimated to be less than the risk for mucous membrane exposures. The risk for transmission after exposure to fluids or tissues other than HIVinfected blood also has not been quantified but is probably considerably lower than that for blood exposures. Epidemiologic and laboratory studies suggest that multiple factors might affect the risk of HIV transmission after an occupational exposure.22 In a retrospective case-control study of HCP who had percutaneous exposure to HIV, increased risk for HIV infection was associated with exposure to a larger quantity of blood from the source person as indicated by (1) a device (eg, a needle) visibly contaminated with the patient’s blood, (2) a procedure that involved a needle being placed directly in a vein or artery, or (3) a deep injury. The risk also was increased for exposure to blood from source persons with terminal illness, likely reflecting the higher titer of HIV in blood late in the course of acquired immunodeficiency syndrome (AIDS). Taken together, these factors suggest a direct inoculum effect (ie, the larger the viral inoculum, the higher BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) 878 infection control and hospital epidemiology september 2013, vol. 34, no. 9 the risk for infection). One laboratory study that demonstrated that more blood is transferred by deeper injuries and hollow-bore needles lends further credence to the observed variation in risk related to inoculum size.23 Exposure to a source patient with an undetectable serum viral load does not eliminate the possibility of HIV transmission or the need for PEP and follow-up testing. While the risk of transmission from an occupational exposure to a source patient with an undetectable serum viral load is thought to be very low, PEP should still be offered. Plasma viral load (eg, HIV RNA) reflects only the level of cell-free virus in the peripheral blood; persistence of HIV in latently infected cells, despite patient treatment with antiretroviral drugs, has been demonstrated,24,25 and such cells might transmit infection even in the absence of viremia. HIV transmission from exposure to a source person who had an undetectable viral load has been described in cases of sexual and mother-to-child transmissions.26,27 antiretroviral agents for pep Antiretroviral agents from 6 classes of drugs are currently available to treat HIV infection.28 These include the nucleoside and nucleotide reverse-transcriptase inhibitors (NRTIs), nonnucleoside reverse-transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), a fusion inhibitor (FI), an integrase strand transfer inhibitor (INSTI), and a chemokine (C-C motif) receptor 5 (CCR5) antagonist. Only antiretroviral agents approved by the FDA for treatment of HIV infection are included in these guidelines, although none of these agents has an FDA-approved indication for administration as PEP. The rationale for offering antiretroviral medications as HIV PEP is based on our current understanding of the pathogenesis of HIV infection and the plausibility of pharmacologic intervention in this process, studies of the efficacy of antiretroviral chemoprophylaxis in animal models,29,30 and epidemiologic data from HIV-exposed HCP.22,31 The recommendations in this report provide guidance for PEP regimens comprised of 3 (or, when appropriate, more) antiretrovirals, consonant with currently recommended treatment guidelines for HIV-infected individuals.28 toxicity and drug interactions of antiretroviral agents Persons receiving PEP should complete a full 4-week regimen.5 However, previous results show that a substantial proportion of HCP taking an earlier generation of antiretroviral agents as PEP frequently reported side effects,12,32-40 and many were unable to complete a full 4-week course of HIV PEP due to these effects and toxicities.32-37 Because all antiretroviral agents have been associated with side effects (Appendix B),28 the toxicity profile of these agents, including the frequency, severity, duration, and reversibility of side effects, is a critical consideration in selection of an HIV PEP regimen. The majority of data concerning adverse events has been reported primarily for persons with established HIV infection receiving prolonged antiretroviral therapy and therefore might not reflect the experience of uninfected persons who take PEP. In fact, anecdotal evidence from clinicians knowledgeable about HIV treatment indicates that antiretroviral agents are tolerated more poorly by HCP taking HIV PEP than by HIVinfected patients on antiretroviral medications. As side effects have been cited as a major reason for not completing PEP regimens as prescribed, the selection of regimens should be heavily influenced toward those that are best tolerated by HCP receiving PEP. Potential side effects of antiretroviral agents should be discussed with the PEP recipient, and, when anticipated, preemptive prescribing of agents for ameliorating side effects (eg, antiemetics and antispasmodics) may improve PEP regimen adherence. In addition, the majority of approved antiretroviral agents might have potentially serious drug interactions when used with certain other drugs, thereby requiring careful evaluation of concomitant medications, including over-the-counter medications and supplements (eg, herbals), used by an exposed person before prescribing PEP and close monitoring for toxicity of anyone receiving these drugs.28 PIs and NNRTIs have the greatest potential for interactions with other drugs. Information regarding potential drug interactions has been published, and up-to-date information can be found in the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.28 Additional information is included in manufacturers’ package inserts. Consultation with a pharmacist or physician who is an expert in HIV PEP and antiretroviral medication drug interactions is strongly encouraged. selection of hiv pep regimens Guidelines for treating HIV infection, a condition typically involving a high total body burden of HIV, recommend the use of 3 or more drugs. Although the applicability of these recommendations to PEP is unknown, newer antiretroviral agents are better tolerated and have preferable toxicity profiles than agents previously used for PEP.28 As less toxic and bettertolerated medications for the treatment of HIV infection are now available, minimizing the risk of PEP noncompletion, and the optimal number of medications needed for HIV PEP remains unknown, the PHS working group recommends prescribing 3 (or more) tolerable drugs as PEP for all occupational exposures to HIV. Medications included in an HIV PEP regimen should be selected to optimize side effect and toxicity profiles and a convenient dosing schedule to encourage HCP completion of the PEP regimen. resistance to antiretroviral agents Known or suspected resistance of the source virus to antiretroviral agents, particularly to 1 or more of those that might be included in a PEP regimen, raises concerns about reduced PEP efficacy.41 Drug resistance to all available antiretroviral agents has been reported, and cross-resistance within drug BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) phs guidelines for occupational exposures to hiv classes occurs frequently.42 Occupational transmission of drug-resistant HIV strains, despite PEP with combination drug regimens, has been reported.43-45 If a source patient is known to harbor drug-resistant HIV, expert consultation is recommended for selection of an optimal PEP regimen. However, awaiting expert consultation should not delay the initiation of HIV PEP. In instances of an occupational exposure to drug-resistant HIV, administration of antiretroviral agents to which the source patient’s virus is unlikely to be resistant is recommended for PEP. Information on whether a source patient harbors drugresistant HIV may be unclear or unavailable at the time of an occupational exposure. Resistance should be suspected in a source patient who experiences clinical progression of disease, a persistently increasing viral load, or a decline in CD4! T cell count despite therapy and in instances in which a virologic response to therapy fails to occur. However, resistance testing of the source virus at the time of an exposure is impractical because the results will not be available in time to influence the choice of the initial PEP regimen. If source patient HIV drug resistance is suspected in the management of an occupational exposure to HIV, consultation with an expert in HIV management is recommended so that antiretroviral agents to which the source patient’s virus is unlikely to be resistant may be identified and prescribed. However, awaiting expert consultation should, again, not delay initiation of HIV PEP. If drug resistance information becomes available later in a course of PEP, this information should be discussed with the expert consultant for possible modification of the PEP regimen. antiretroviral drugs during pregnancy and lactation The decision to offer HIV PEP to a pregnant or breast-feeding healthcare provider should be based on the same considerations that apply to any provider who sustains an occupational exposure to HIV. The risk of HIV transmission poses a threat not only to the mother but also to the fetus and infant, as the risk of mother-to-child HIV transmission is markedly increased during acute HIV infection during pregnancy and breast-feeding.46 However, unique considerations are associated with the administration of antiretroviral agents to pregnant HCP, and the decision to use antiretroviral drugs during pregnancy should involve both counseling and discussion between the pregnant woman and her healthcare provider(s) regarding the potential risks and benefits of PEP for both the healthcare provider and her fetus. The potential risks associated with antiretroviral drug exposure for pregnant women, fetuses, and infants depend on the duration of exposure as well as the number and type of drugs. Information about the use of newer antiretroviral agents, administered as PEP to HIV-uninfected pregnant women, is limited. For reasons including the complexities associated with appropriate counseling about the risks and 879 benefits of PEP as well as the selection of antiretroviral drugs in pregnant women, expert consultation should be sought in all cases in which antiretroviral medications are prescribed to pregnant HCP for PEP. In general, antiretroviral drug toxicity has not been shown to be increased during pregnancy. Conflicting data have been published concerning the risk of preterm delivery in pregnant women receiving antiretroviral drugs, particularly PIs;47 in studies that have reported a positive association, the increase in risk was primarily observed in women who were receiving antiretroviral drug regimens at the time of conception and continued during pregnancy. Fatal48 and nonfatal49 lactic acidosis has been reported in pregnant women treated throughout gestation with a combination of stavudine and didanosine. Prescribing this drug combination for PEP is not recommended. Physiologic changes that occur during pregnancy may alter antiretroviral drug metabolism and, therefore, optimal drug dosing. The clinical significance of these changes is not clear, particularly when used for PEP in HIVuninfected women. For details on antiretroviral drug choice and dosing in pregnancy, see Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States.10 Prospective data from the Antiretroviral Pregnancy Registry do not demonstrate an increase in overall birth defects associated with first-trimester antiretroviral drug use. In this population, the birth defect prevalence is 2.9 per 100 live births, similar to the prevalence in the general population in the CDC’s birth defect surveillance system (ie, 2.7 per 100 live births).50 Central nervous system defects were observed in fetal primates that experienced in utero efavirenz (EFV) exposure and that had drug levels similar to those representing human therapeutic exposure; however, the relevance of in vitro laboratory and animal data to humans is unknown.10 While human data are reassuring,51 1 case of meningomyelocele has been reported among the Antiretroviral Pregnancy Registry prospective cases, and data are insufficient to conclude that there is no increase in a rare outcome, such as neural tube defect, with first-trimester EFV exposure.50 For these reasons, we recommend that pregnant women not use EFV during the first trimester.10 If EFV-based PEP is used in women, a pregnancy test should be done to rule out early pregnancy, and nonpregnant women who are receiving EFVbased PEP should be counseled to avoid pregnancy until after PEP is completed. HCP who care for women who receive antiretroviral drugs during pregnancy are strongly advised to report instances of prenatal exposure to the Antiretroviral Pregnancy Registry (http://www.APRegistry.com/). The currently available literature contains only limited data describing the long-term effects (eg, neoplasia and mitochondrial toxicity) of in utero antiretroviral drug exposure. For this reason, long-term follow-up is recommended for all children who experience in utero exposures.10,52,53 Antiretroviral drug levels in breast milk vary among drugs, BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) 880 infection control and hospital epidemiology september 2013, vol. 34, no. 9 with administration of some drugs resulting in high levels (eg, lamivudine), while other drugs, such as PIs and tenofovir (TDF), are associated with only limited penetration into milk.54,55 Administration of antiretroviral triple-drug regimens to breast-feeding HIV-infected women has been shown to decrease the risk of transmission to their infants and infant toxicity has been minimal. Prolonged maternal antiretroviral drug use during breast-feeding may be associated with increased infant hematologic toxicity,56,57 but limited drug exposure during 4 weeks of PEP may also limit the risk of drug toxicity to the breast-feeding infant. Breast-feeding should not be a contraindication to use of PEP when needed, given the high risk of mother-to-infant transmission with acute HIV infection during breast-feeding.46 The lactating healthcare provider should be counseled regarding the high risk of HIV transmission through breast milk should acute HIV infection occur (in a study in Zimbabwe, the risk of breast milk HIV transmission during the 3 months after seroconversion was 77.6 infections per 100 child-years).58 To completely eliminate any risk of HIV transmission to her infant, the provider may want to consider stopping breast-feeding. Ultimately, lactating women with occupational exposures to HIV who will take antiretroviral medications as PEP must be counseled to weigh the risks and benefits of continued breast-feeding both while taking PEP and while being monitored for HIV seroconversion. management of occupational exposure by emergency physicians Many HCP exposures to HIV occur outside of occupational health clinic hours of operation and at sites at which occupational health services are unavailable, and initial exposure management is often overseen by emergency physicians or other providers who are not experts in the treatment of HIV infection or the use of antiretroviral medications. These providers may not be familiar with either the PHS guidelines for the management of occupational exposures to HIV or the available antiretroviral agents and their relative risks and benefits. Previous focus groups conducted among emergency department physicians who had managed occupational exposures to blood and body fluids in 200259 identified 3 challenges in occupational exposure management: evaluation of an unknown source patient or a source patient who refused testing, inexperience in managing occupational HIV exposures, and counseling of exposed workers in busy emergency departments. For these reasons, the PHS working group recommends that institutions develop clear protocols for the management of occupational exposures to HIV, indicating a formal expert consultation mechanism (eg, the in-house infectious diseases consultant or PEPline), appropriate initial source patient and exposed provider laboratory testing, procedures for counseling the exposed provider, identifying and having an initial HIV PEP regimen available, and a mechanism for outpatient HCP follow-up. In addition, these pro- tocols must be distributed appropriately and must be readily available (eg, posted on signs in the emergency department, posted on a website, or disseminated to staff on pocket-sized cards) to emergency physicians and any other providers who may be called on to manage these exposure incidents. recommendations for the management of hcp potentially exposed to hiv Exposure prevention remains the primary strategy for reducing occupational bloodborne pathogen infections. However, when occupational exposures do occur, PEP remains an important element of exposure management. HIV PEP The recommendations provided in this report apply to situations in which a healthcare provider has been exposed to a source person who has HIV infection or for whom there is reasonable suspicion of HIV infection. These recommendations reflect expert opinion and are based on limited data regarding safety, tolerability, efficacy, and toxicity of PEP. If PEP is offered and taken and the source is later determined to be HIV negative, PEP should be discontinued, and no further HIV follow-up testing is indicated for the exposed provider. Because the great majority of occupational HIV exposures do not result in transmission of HIV, the potential benefits and risks of PEP (including the potential for severe toxicity and drug interactions, such as may occur with oral contraceptives, H2-receptor antagonists, and proton pump inhibitors, among many other agents) must be considered carefully when prescribing PEP. HIV PEP medication regimen recommendations are listed in Appendix A, and more detailed information on individual antiretroviral medications is provided in Appendix B. Because of the complexity of selecting HIV PEP regimens, these recommendations should, whenever possible, be implemented in consultation with persons who have expertise in the administration of antiretroviral therapy and who are knowledgeable about HIV transmission. Reevaluation of exposed HCP is recommended within 72 hours after exposure, especially as additional information about the exposure or source person becomes available. Source Patient HIV Testing Whenever possible, the HIV status of the exposure source patient should be determined to guide appropriate use of HIV PEP. Although concerns have been expressed about HIVnegative sources who might be in the so-called window period before seroconversion (ie, the period of time between initial HIV infection and the development of detectable HIV antibodies), no such instances of occupational transmission have been detected in the United States to date. Hence, investigation of whether a source patient might be in the window period is unnecessary for determining whether HIV PEP is BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) phs guidelines for occupational exposures to hiv indicated unless acute retroviral syndrome is clinically suspected. Rapid HIV testing of source patients facilitates timely decision making regarding the need for administration of HIV PEP after occupational exposures to sources whose HIV status is unknown. FDA-approved rapid tests can produce HIV test results within 30 minutes, with sensitivities and specificities similar to those of first- and second-generation enzyme immunoassays (EIAs).60 Third-generation chemiluminescent immunoassays, run on automated platforms, can detect HIVspecific antibodies 2 weeks sooner than conventional EIAs60 and generate test results in an hour or less.61 Fourth-generation combination p24 antigen–HIV antibody (Ag/Ab) tests produce both rapid and accurate results, and their p24 antigen detection allows identification of most infections during the window period.62 Rapid determination of source patient HIV status provides essential information about the need to initiate and/or continue PEP. Regardless of which type of HIV testing is employed, all of the above tests are acceptable for determination of source patient HIV status. Administration of PEP should not be delayed while waiting for test results. If the source patient is determined to be HIV negative, PEP should be discontinued, and no follow-up HIV testing for the exposed provider is indicated. Timing and Duration of PEP Animal studies have suggested that PEP is most effective when begun as soon as possible after the exposure and that PEP becomes less effective as time from the exposure increases.29,30 PEP should be initiated as soon as possible, preferably within hours of exposure. Occupational exposures to HIV should be considered urgent medical concerns and treated immediately. For example, a surgeon who sustains an occupational exposure to HIV while performing a surgical procedure should promptly scrub out of the surgical case, if possible, and seek immediate medical evaluation for the injury and PEP. Additionally, if the HIV status of a source patient for whom the practitioner has a reasonable suspicion of HIV infection is unknown and the practitioner anticipates that hours or days may be required to resolve this issue, antiretroviral medications should be started immediately rather than delayed. Although animal studies demonstrate that PEP is likely to be less effective when started more than 72 hours after exposure,30,63 the interval after which no benefit is gained from PEP for humans is undefined. If initiation of PEP is delayed, the likelihood increases that benefits might not outweigh the risks inherent in taking antiretroviral medications. Initiating therapy after a longer interval (eg, 1 week) might still be considered for exposures that represent an extremely high risk of transmission. The optimal duration of PEP is unknown; however, duration of treatment has been shown to influence success of PEP in animal models.30 Because 4 weeks of PEP appeared protective in in vitro, animal,29,30,63,64 and occupational22 studies, PEP should be administered for 4 weeks, if tolerated. 881 Recommendations for the Selection of Drugs for HIV PEP The PHS no longer recommends that the severity of exposure be used to determine the number of drugs to be offered in an HIV PEP regimen, and a regimen containing 3 (or more) antiretroviral drugs is now recommended routinely for all occupational exposures to HIV. Examples of recommended PEP regimens include those consisting of a dual NRTI backbone plus an INSTI, a PI (boosted with ritonavir), or a NNRTI. Other antiretroviral drug combinations may be indicated for specific cases (eg, exposure to a source patient harboring drugresistant HIV) but should be prescribed only after consultation with an expert in the use of antiretroviral agents. No new definitive data exist to demonstrate increased efficacy of 3-drug HIV PEP regimens compared with the previously recommended 2-drug HIV PEP regimens for occupational HIV exposures associated with a lower level of transmission risk. The recommendation for consistent use of 3-drug HIV PEP regimens reflects (1) studies demonstrating superior effectiveness of 3 drugs in reducing viral burden in HIV-infected persons compared with 2 agents,28,65,66 (2) concerns about source patient drug resistance to agents commonly used for PEP,67,68 (3) the safety and tolerability of new HIV drugs, and (4) the potential for improved PEP regimen adherence due to newer medications that are likely to have fewer side effects. Clinicians facing challenges such as antiretroviral medication availability, potential adherence and toxicity issues, and others associated with a 3-drug PEP regimen might still consider a 2-drug PEP regimen in consultation with an expert. The drug regimen selected for HIV PEP should have a favorable side effect profile as well as a convenient dosing schedule to facilitate both adherence to the regimen and completion of 4 weeks of PEP. Because the agents administered for PEP still can be associated with severe side effects, PEP is not justified for exposures that pose a negligible risk for transmission. Expert consultation could be helpful in determining whether an exposure constitutes a risk that would warrant PEP. The preferred HIV PEP regimen recommended in this guideline should be reevaluated and modified whenever additional information is obtained concerning the source of the occupational exposure (eg, possible treatment history or antiretroviral drug resistance) or if expert consultants recommend the modification. Given the complexity of choosing and administering HIV PEP, consultation with an infectious diseases specialist or another physician who is an expert in the administration of antiretroviral agents is recommended whenever possible. Such consultation should not, however, delay timely initiation of PEP. The PHS now recommends emtricitabine (FTC) plus TDF (these 2 agents may be dispensed as Truvada, a fixed-dose combination tablet) plus raltegravir (RAL) as HIV PEP for occupational exposures to HIV. This regimen is tolerable, potent, and conveniently administered, and it has been associated with minimal drug interactions. Additionally, al- BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) 882 infection control and hospital epidemiology september 2013, vol. 34, no. 9 Box 1: Situations for Which Expert Consultation for Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) Is Recommended Delayed (ie, later than 72 hours) exposure report • Interval after which benefits from PEP are undefined Unknown source (eg, needle in sharps disposal container or laundry) • Use of PEP to be decided on a case-by-case basis • Consider severity of exposure and epidemiologic likelihood of HIV exposure • Do not test needles or other sharp instruments for HIV Known or suspected pregnancy in the exposed person • Provision of PEP should not be delayed while awaiting expert consultation Breast-feeding in the exposed person • Provision of PEP should not be delayed while awaiting expert consultation Known or suspected resistance of the source virus to antiretroviral agents • If source person’s virus is known or suspected to be resistant to 1 or more of the drugs considered for PEP, selection of drugs to which the source person’s virus is unlikely to be resistant is recommended • Do not delay initiation of PEP while awaiting any results of resistance testing of the source person’s virus Toxicity of the initial PEP regimen • Symptoms (eg, gastrointestinal symptoms and others) are often manageable without changing PEP regimen by prescribing antimotility or antiemetic agents • Counseling and support for management of side effects is very important, as symptoms are often exacerbated by anxiety Serious medical illness in the exposed person • Significant underlying illness (eg, renal disease) or an exposed provider already taking multiple medications may increase the risk of drug toxicity and drug-drug interactions Expert consultation can be made with local experts or by calling the National Clinicians’ Post-Exposure Prophylaxis Hotline (PEPline) at 888-448-4911. though we have only limited data on the safety of RAL during pregnancy, this regimen could be administered to pregnant HCP as PEP (see the discussion above). Preparation of this PEP regimen in single-dose “starter packets,” which are kept on hand at sites expected to manage occupational exposures to HIV, may facilitate timely initiation of PEP. Several drugs may be used as alternatives to FTC plus TDF plus RAL. TDF has been associated with renal toxicity,69 and an alternative should be sought for HCP who have underlying renal disease. Zidovudine could be used as an alternative to TDF and could be conveniently prescribed in combination with lamivudine, to replace both TDF and FTC, as Combivir. Alternatives to RAL include darunavir plus ritonavir (RTV), etravirine, rilpivirine, atazanavir plus RTV, and lopinivir plus RTV. When a more cost-efficient alternative to RAL is required, saquinivir plus RTV could be considered. A list of preferred alternative PEP regimens is provided in Appendix A. Some antiretroviral drugs are contraindicated as HIV PEP or should be used for PEP only under the guidance of expert consultants (Appendixes A and B). Among these drugs are nevirapine, which should not be used and is contraindicated as PEP because of serious reported toxicities, including hepatotoxicity (with 1 instance of fulminant liver failure requiring liver transplantation), rhabdomyolysis, and hypersensitivity syndrome.70-72 Antiretroviral drugs not routinely recommended for use as PEP because of the higher risk for potentially serious or life-threatening adverse events include di- danosine and tipranavir. The combination of didanosine and stavudine should not be prescribed as PEP due to increased risk of toxicity (eg, peripheral neuropathy, pancreatitis, and lactic acidosis). Additionally, abacavir should be used as HIV PEP only in the setting of expert consultation, due to the need for prior HLA B57-01 testing to identify individuals at higher risk for a potentially fatal hypersensitivity reaction.28 The FI enfuvirtide (Fuzeon, T20) is also not generally recommended as PEP, unless its use is deemed necessary during expert consultation, due to its subcutaneous route of administration, significant side effects, and potential for development of anti-T20 antibodies that may cause false-positive HIV antibody tests among uninfected patients. When the source patient’s virus is known or suspected to be resistant to 1 or more of the drugs considered for the PEP regimen, the selection of drugs to which the source person’s virus is unlikely to be resistant is recommended; again, expert consultation is strongly advised. If this information is not immediately available, the initiation of PEP, if indicated, should not be delayed; the regimen can be modified after PEP has been initiated whenever such modifications are deemed appropriate. For HCP who initiate PEP, reevaluation of the exposed person should occur within 72 hours after exposure, especially if additional information about the exposure or source person becomes available. Regular consultation with experts in antiretroviral therapy and HIV transmission is strongly recommended. Preferably, BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) phs guidelines for occupational exposures to hiv 883 Box 2: Follow-Up of Healthcare Personnel (HCP) Exposed to Known or Suspected Human Immunodeficiency Virus (HIV)–Positive Sources Counseling (at the time of exposure and at follow-up appointments). Exposed HCP should be advised to use precautions (eg, use of barrier contraception and avoidance of blood or tissue donations, pregnancy, and, if possible, breast-feeding) to prevent secondary transmission, especially during the first 6–12 weeks after exposure. For exposures for which postexposure prophylaxis (PEP) is prescribed, HCP should be informed regarding the following: • Possible drug toxicities (eg, rash and hypersensitivity reactions that could imitate acute HIV seroconversion and the need for monitoring) • Possible drug interactions • The need for adherence to PEP regimens Early reevaluation after exposure. Regardless of whether a healthcare provider is taking PEP, reevaluation of exposed HCP within 72 hours after exposure is strongly recommended, as additional information about the exposure or source person may be available. Follow-up testing and appointments. Follow-up testing at a minimum should include the following: • HIV testing at baseline and at 6 weeks, 12 weeks, and 6 months after exposure; alternatively, if the clinician is certain that a fourth-generation combination HIV p24 antigen–HIV antibody test is being utilized, then HIV testing could be performed at baseline, 6 weeks after exposure, and 4 months after exposure • Complete blood counts and renal and hepatic function tests (at baseline and 2 weeks after exposure; further testing may be indicated if abnormalities are detected) HIV testing results should preferably be given to the exposed healthcare provider at face-to-face appointments. a process for involvement of an expert consultant should be formalized in advance of an exposure incident. Certain institutions have required consultation with a hospital epidemiologist or infectious diseases consultant when HIV PEP use is under consideration. At a minimum, expert consultation is recommended for the situations described in Box 1. Resources for consultation are available from the following sources: • PEPline at http://www.nccc.ucsf.edu/about_nccc/pepline/; telephone: 888-448-4911. • Antiretroviral Pregnancy Registry at http://www .apregistry.com/index.htm; address: Research Park, 1011 Ashes Drive, Wilmington, NC 28405; telephone: 800-2584263; fax: 800-800-1052; e-mail: [email protected]. • FDA (for reporting unusual or severe toxicity to antiretroviral agents) at http://www.fda.gov/medwatch/; telephone: 800332-1088; address: MedWatch, The FDA Safety Information and Adverse Event Reporting Program, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852. • The CDC’s Cases of Public Health Importance (COPHI) coordinator (for reporting HIV infections in HCP and failures of PEP) at telephone number 404-639-2050. • HIV/AIDS Treatment Information Service at http:// aidsinfo.nih.gov/. follow-up of exposed hcp Importance of Follow-Up Appointments HCP who have experienced occupational exposure to HIV should receive follow-up counseling, postexposure testing, and medical evaluation regardless of whether they take PEP. Greater emphasis is placed on the importance of follow-up of HCP on HIV PEP within 72 hours of exposure and im- proving follow-up care provided to exposed HCP (Box 2). Careful attention to follow-up evaluation within 72 hours of exposure can (1) provide another (and perhaps less anxietyridden) opportunity to allow the exposed HCP to ask questions and for the counselor to make certain that the exposed HCP has a clear understanding of the risks for infection and the risks and benefits of PEP, (2) ensure that continued treatment with PEP is indicated, (3) increase adherence to HIV PEP regimens, (4) manage associated symptoms and side effects more effectively, (5) provide an early opportunity for ancillary medications or regimen changes, (6) improve detection of serious adverse effects, and (7) improve the likelihood of follow-up serologic testing for a larger proportion of exposed personnel to detect infection. Closer follow-up should in turn reassure HCP who become anxious after these events.73,74 The psychological impact of needlesticks or exposure to blood or body fluid should not be underestimated for HCP. Exposed personnel should be advised to use precautions (eg, use of barrier contraception and avoidance of blood or tissue donations, pregnancy, and, if possible, breastfeeding) to prevent secondary transmission, especially during the first 6–12 weeks after exposure. Providing HCP with psychological counseling should be an essential component of the management and care of exposed HCP. Postexposure Testing HIV testing should be used to monitor HCP for seroconversion after occupational HIV exposure. After baseline testing at the time of exposure, follow-up testing should be performed at 6 weeks, 12 weeks, and 6 months after exposure. Use of fourth-generation HIV Ag/Ab combination immunoassays allow for earlier detection of HIV infection.60,62,75 If a provider is certain that a fourth-generation combination BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) 884 infection control and hospital epidemiology september 2013, vol. 34, no. 9 HIV Ag/Ab test is used, HIV follow-up testing could be concluded earlier than 6 months after exposure. In this instance, an alternative follow-up testing schedule could be used (eg, testing at baseline and 6 weeks after exposure, then concluding testing at 4 months after exposure). Extended HIV followup (eg, for 12 months) is recommended for HCP who become infected with HCV after exposure to a source who is coinfected with HIV and HCV. Whether extended follow-up is indicated in other circumstances (eg, for exposure to a source coinfected with HIV and HCV in the absence of HCV seroconversion or for exposed persons with a medical history suggesting an impaired ability to mount an antibody response to acute infection) is unknown. Although rare instances of delayed HIV seroconversion have been reported,76,77 adding to an exposed person’s anxiety by routinely extending the duration of postexposure follow-up is not warranted. However, decisions to extend follow-up in a particular situation should be based on the clinical judgment of the exposed person’s healthcare provider and should not be precluded because of HCP anxiety. HIV tests should also be performed for any exposed person who has an illness compatible with an acute retroviral syndrome, regardless of the interval since exposure. A person in whom HIV infection is identified should be referred to a specialist who has expertise in HIV treatment and counseling for medical management. Healthcare providers caring for persons who have occupationally acquired HIV infection should report these cases to their state health departments and to the CDC’s COPHI coordinator at telephone number 404-639-2050. Monitoring and Management of PEP Toxicity If PEP is used, HCP should be monitored for drug toxicity by testing at baseline and again 2 weeks after starting PEP. In addition, HCP taking antiretrovirals should be evaluated if any acute symptoms develop while receiving therapy. The scope of testing should be based on medical conditions in the exposed person and the known and anticipated toxicities of the drugs included in the PEP regimen. Minimally, laboratory monitoring for toxicity should include a complete blood count and renal and hepatic function tests. If toxicities are identified, modification of the regimen should be considered after expert consultation. In addition, depending on the clinical situation, further diagnostic studies may be indicated (eg, monitoring for hyperglycemia in a diabetic whose regimen includes a PI). Exposed HCP who choose to take PEP should be advised of the importance of completing the prescribed regimen. Information should be provided about potential drug interactions and prescription/nonprescription drugs and nutritional supplements that should not be taken with PEP or require dose or administration adjustments, side effects of prescribed drugs, measures (including pharmacologic interventions) that may assist in minimizing side effects, and methods of clinical monitoring for toxicity during the follow- up period. HCP should be advised that evaluation of certain symptoms (eg, rash, fever, back or abdominal pain, pain on urination or blood in the urine, dark urine, yellowing of the skin or whites of the eyes, or symptoms of hyperglycemia [eg, increased thirst or frequent urination]) should not be delayed. Serious adverse events should be reported to the FDA’s MedWatch program. reevaluation and updating of hiv pep guidelines As new antiretroviral agents for treatment of HIV infection and additional information concerning early HIV infection and prevention of HIV transmission become available, the interagency PHS working group will assess the need to update these guidelines. Updates will be published periodically as appropriate. expert panel consultants Judith Aberg, MD, FIDSA, FACP, New York University; Joseph Eron, MD, University of North Carolina, Chapel Hill; Ronald Goldschmidt, MD, University of California, San Francisco; Mark Russi, MD, MPH, Yale University; Michael S. Saag, MD, University of Alabama, Birmingham; and Michael L. Tapper, MD, Lennox Hill Hospital. acknowledgments We thank Lynne M. Mofenson, MD (National Institutes of Health), for providing expert assistance with drafting the section of the guideline titled “Antiretroviral Drugs during Pregnancy and Lactation” as well as S. Michele Owen, PhD (Centers for Disease Control and Prevention [CDC]), and Bernard M. Branson, MD (CDC), for providing expert assistance with drafting the sections titled “Source Patient HIV Testing” and “Postexposure Testing.” We also acknowledge contributions from John T. Brooks, MD (CDC), Kenneth Dominguez, MD, MPH (CDC), and David Kim, MD (CDC). Potential conflicts of interest. The expert panel consultants report the following competing interests: J.A. has a board membership with and has received funding from Bristol-Myers Squibb, Janssen, Merck, and ViiV; J.E. has consulted for Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Janssen, Merck, and ViiV and has received grant funding from Bristol-Myers Squibb, GlaxoSmithKline, Merck, and ViiV; M.S.S. has consulted for Bristol-Myers Squibb, Gilead, Janssen, Merck, and ViiV and has received grant funding from Bristol-Myers Squibb, Gilead, Merck, and ViiV; M.L.T. owns Merck stock. All other authors report no conflicts of interest relevant to this article. Address correspondence to David T. Kuhar, MD, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS A-31, Atlanta, GA 30333 ([email protected]). The material in this report originated in the Division of Healthcare Quality Promotion (Denise M. Cardo, MD, director), National Center for Emerging and Zoonotic Infectious Diseases (Beth Bell, MD, director). Information included in these recommendations might not represent US Food and Drug Administration (FDA) approval or approved labeling for the particular product or indications in question. Specifically, the terms “safe” and “effective” might not be synonymous with the FDA-defined legal standard for product approval. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) phs guidelines for occupational exposures to hiv 885 appendix a table a1. Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) Regimens Preferred HIV PEP Regimen Raltegravir (Isentress; RAL) 400 mg PO twice daily Plus Truvada, 1 PO once daily (Tenofovir DF [Viread; TDF] 300 mg ! emtricitabine [Emtriva; FTC] 200 mg) Alternative Regimens (May combine 1 drug or drug pair from the left column with 1 pair of nucleoside/nucleotide reverse-transcriptase inhibitors from the right column; prescribers unfamiliar with these agents/regimens should consult physicians familiar with the agents and their toxicities) a,b Tenofovir DF (Viread; TDF) ! emtricitabine (Emtriva; FTC); Raltegravir (Isentress; RAL) available as Truvada Darunavir (Prezista; DRV) ! ritonavir (Norvir; RTV) Tenofovir DF (Viread; TDF) ! lamivudine (Epivir; 3TC) Etravirine (Intelence; ETR) Zidovudine (Retrovir; ZDV; AZT) ! lamivudine (Epivir; 3TC); Rilpivirine (Edurant; RPV) available as Combivir Atazanavir (Reyataz; ATV) ! ritonavir (Norvir; RTV) Zidovudine (Retrovir; ZDV; AZT) ! emtricitabine (Emtriva; FTC) Lopinavir/ritonavir (Kaletra; LPV/RTV) The following alternative is a complete fixed-dose combination regimen, and no additional antiretrovirals are needed: Stribild (elvitegravir, cobicistat, tenofovir DF, emtricitabine) Alternative Antiretroviral Agents for Use as PEP Only with Expert Consultationb Abacavir (Ziagen; ABC) Efavirenz (Sustiva; EFV) Enfuvirtide (Fuzeon; T20) Fosamprenavir (Lexiva; FOSAPV) Maraviroc (Selzentry; MVC) Saquinavir (Invirase; SQV) Stavudine (Zerit; d4T) Antiretroviral Agents Generally Not Recommended for Use as PEP Didanosine (Videx EC; ddI) Nelfinavir (Viracept; NFV) Tipranavir (Aptivus; TPV) Antiretroviral Agents Contraindicated as PEP Nevirapine (Viramune; NVP) note. For consultation or assistance with HIV PEP, contact the National Clinicians’ Post-Exposure Prophylaxis Hotline at telephone number 888-448-4911 or visit its website at http://www.nccc.ucsf.edu/about_nccc/pepline/. DF, disoproxil fumarate; PO, per os. a The alternatives regimens are listed in order of preference; however, other alternatives may be reasonable based on patient and clinician preference. b For drug dosing information, see Appendix B. appendix b table b1. Information on Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) Medications Drug name Abacavir (Ziagen; ABC) Drug class Dosing (dosage form) Nucleoside reversetranscriptase inhibitor (NRTI) ABC: 300 mg daily; available as 300-mg tablet Also available as component of fixed-dose combination Epzicom, dosed daily (300 mg of 3TC ! 600 mg of ABC) Trizivir, dosed twice daily (150 mg of 3TC ! 300 mg of ABC ! 300 mg of AZT) Advantages Take without regard for food Disadvantages Potential for life-threatening ABC hypersensitivity reaction (rash, fever, nausea, vomiting, diarrhea, abdominal pain, malaise, respiratory symptoms) in patients with HLA-B*5701; requires patient testing prior to use, which may not be available or practical prior to initiating PEP BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) 886 infection control and hospital epidemiology september 2013, vol. 34, no. 9 table b1 (Continued) Drug name Drug class Dosing (dosage form) Atazanavir (Reyataz; ATV) Protease inhibitor (PI) ATV: 300 mg ! RTV: 100 mg once daily (preferred dosing for PEPa) ATV: 400 mg once daily without RTV (alternative dosing—may not be used in combination with TDF) Available as 100-, 150-, 200-, and 300-mg capsules Well tolerated Darunavir (Prezista; DRV) PI Well tolerated Efavirenz (Sustiva; EFV) Nonnucleoside reverse-transcriptase inhibitor (NNRTI) DRV: 800 mg once daily ! RTV: 100 mg once daily (preferred dosing for PEPa) DRV: 600 mg twice daily ! RTV: 100 mg twice daily (alternative dosing) Available as 75-, 150-, 400-, and 600-mg tablets EFV: 600 mg daily; available as 50- and 200-mg capsules and 600-mg tablets Also available as component of fixed-dose combination Atripla, dosed daily (200 mg of FTC ! 300 mg of TDF ! 600 mg of EFV) Elvitegravir (EVG) Integrase strand transfer inhibitor (INSTI) Available as a component of fixed-dose combination Stribild, dosed daily (150 mg of EVG ! 150 mg of cobicistat ! 300 mg of TDF ! 200 mg of FTC) Advantages Available as a complete regimen dosed once per day Well tolerated Available as a complete regimen dosed once per day Disadvantages Indirect hyperbilirubinemia and jaundice common Rash Nephrolithiasis Potential for serious or life-threatening drug interactions that may affect dosing Absorption depends on low pH; caution when coadministered with H2 antagonists, antacids, and proton pump inhibitors PR interval prolongation Caution in patients with underlying conduction defects or on concomitant medications that can cause PR prolongation Must be given with food Rash (DRV has sulfonamide moiety) Diarrhea, nausea, headache Hepatotoxicity Potential for serious or life-threatening drug interactions that may affect dosing Must be given with food and with RTV Rash Neuropsychiatric side effects (eg, dizziness, somnolence, insomnia, abnormal dreaming) common; severe psychiatric symptoms possible (dosing before bedtime might minimize these side effects); use with caution in shift workers Do not use during pregnancy; teratogen in nonhuman primates Potential for serious or life-threatening drug interactions that may affect dosing May cause false-positive results with some cannabinoid and benzodiazepine screening assays Take on an empty stomach Diarrhea, nausea, headache Nephrotoxicity; should not be administered to individuals with acute or chronic kidney injury or those with eGFR !70 Cobicistat is a pharmacokinetic enhancer to increase EVG exposures and has no antiviral activity but is a potent CYP3A inhibitor Potential for serious or life-threatening drug interactions Must be given with food BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) phs guidelines for occupational exposures to hiv 887 table b1 (Continued) Drug name Drug class Emtricitabine (Emtriva; FTC) NRTI Enfuvirtide (Fuzeon; T20) Fusion inhibitor (FI) Etravirine (Intelence; ETR) Dosing (dosage form) Advantages 200 mg once daily; available as 200-mg capsule Also available as component of fixed-dose combination Atripla, dosed daily (200 mg of FTC ! 300 mg of TDF ! 600 mg of EFV) Complera, dosed daily (25 mg of RPV ! 300 mg of TDF ! 200 mg of FTC) Stribild, dosed daily (150 mg of EVG ! 150 mg of cobicistat ! 300 mg of TDF ! 200 mg of FTC) Truvada, dosed daily (200 mg of FTC ! 300 mg of TDF) T20: 90 mg (1 mL) twice daily by subcutaneous injection; available as single-dose vial, reconstituted to 90 mg/mL Well tolerated Minimal toxicity Minimal drug interactions Take without regard for food NNRTI 200 mg twice daily; available as 100- and 200-mg tablets Well tolerated and has not had the same frequency of CNS side effects reported as EFV Fosamprenavir (Lexiva; FOSAPV) PI FOSAPV: 1,400 mg daily ! RTV: 100 mg once daily (preferred dosing for PEP) FOSAPV: 1,400 mg twice daily without RTV (alternative dosing) Available as 700-mg tablet Well tolerated Lamivudine (Epivir; 3TC) NRTI 3TC: 300 mg once daily (preferred dosing for PEP) 3TC: 150 mg twice daily (alternative dosing) Available as 150- and 300-mg tablets Also available as component of fixed-dose combination generic lamivudine/zidovudine, dosed twice daily (150 mg of 3TC ! 300 mg of AZT) Combivir, dosed twice daily (150 mg of 3TC ! 300 mg of AZT) Epzicom, dosed daily (300 mg of 3TC ! 600 mg of ABC) Trizivir, dosed twice daily (150 mg of 3TC ! 300 mg of ABC ! 300 mg of AZT) Well tolerated Minimal toxicity Minimal drug interactions Take without regard for food ... Disadvantages Rash perhaps more frequent than with 3TC Hyperpigmentation/skin discoloration If the PEP recipient has chronic hepatitis B, withdrawal of this drug may cause an acute hepatitis exacerbation Local injection-site reactions occur in almost 100% of patients Never studied among antiretroviralnaive or HIV-negative patients False-positive EIA HIV antibody tests might result from formation of anti-T20 antibodies that crossreact with anti-gp41 antibodies Twice-daily injection Rash (including SJS) and hypersensitivity (sometimes with organ dysfunction, including hepatic failure) Nausea Potential for serious or life-threatening drug interactions that may affect dosing Must be given with food Diarrhea, nausea, vomiting, headache, rash (FOSAPV has sulfonamide moiety) Potential for serious or life-threatening drug interactions that may affect dosing Oral contraceptives decrease FOSAPV concentrations Take with food if given with RTV If the PEP recipient has chronic hepatitis B, withdrawal of this drug may cause an acute hepatitis exacerbation BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) 888 infection control and hospital epidemiology september 2013, vol. 34, no. 9 table b1 (Continued) Drug name Drug class Dosing (dosage form) Advantages Lopinavir/ritonavir (Kaletra; LPV/RTV) PI Kaletra: 400/100 mg p 2 tablets twice daily (preferred dosing for PEP) Kaletra: 800/200 mg p 4 tablets once daily (alternative dosing) Available as 200/50-mg tablets Take without regard for food Maraviroc (Selzentry; MVC) CCR5 coreceptor antagonist MVC: 300 mg twice daily (if on concomitant CYP3A inducers, dose may need adjustment by expert consultant); available as 150- and 300-mg tablets Well tolerated Raltegravir (Isentress; RAL) INSTI 400 mg twice daily; available as 400-mg tablet Rilpivirine (Edurant; RPV) NNRTI 25 mg once daily; available as 25mg tablet Also available as component of fixed-dose combination Complera, dosed daily (25 mg of RPV ! 300 mg of TDF ! 300 mg of FTC) Well tolerated Minimal drug interactions Take without regard for food Well tolerated and fewer rashes and discontinuations for CNS adverse effects compared with EFV Available as a complete regimen dosed once per day Saquinavir (Invirase; SQV) PI SQV: 1,000 mg ! RTV: 100 mg twice daily (preferred dosing for PEP); available as 500 mg tablet Well tolerated, although GI events common Disadvantages GI intolerance, nausea, vomiting, diarrhea are common PR and QT interval prolongation have been reported; use with caution in patients at risk of cardiac conduction abnormalities or receiving other drugs with similar effect Potential for serious or life-threatening drug interactions that may affect dosing Abdominal pain, cough, dizziness, musculoskeletal symptoms, pyrexia, rash, orthostatic hypotension Hepatotoxicity that may present with an allergic reaction, including rash Requires HIV tropism testing of source virus before treatment to ensure CCR5-tropic virus and efficacy, which may not be available or practical prior to initiating PEP Potential for serious or life-threatening drug interactions that may affect dosing Dose adjustments for MVC required when given with potent CYP3A inhibitors or inducers Insomnia, nausea, fatigue, headache, and severe skin and hypersensitivity reactions have been reported Depression, insomnia, rash, hypersensitivity, headache Potential for serious or life-threatening drug interactions that may affect dosing Caution when coadministered with H2 antagonists and antacids Coadministration with proton pump inhibitors is contraindicated Use RPV with caution when coadministered with a drug having a known risk of torsades de pointes Must be given with food GI intolerance, nausea, diarrhea, headache Pretreatment ECG recommended SQV/r is not recommended for patients with any of the following: (1) congenital or acquired QT prolongation, (2) pretreatment ECG 1450 msec, (3) receiving concomitant therapy with other drugs that prolong QT interval, (4) complete AV block without implanted pacemakers, and (5) risk of complete AV block PR and QT interval prolongations, torsades de pointes has been reported Potential for serious or life-threatening drug interactions that may affect dosing Must be given with food BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) phs guidelines for occupational exposures to hiv 889 table b1 (Continued) Drug name Drug class Stavudine (Zerit; d4T) NRTI Tenofovir DF (Viread; TDF) NRTI Zidovudine (Retrovir; ZDV; AZT) NRTI Dosing (dosage form) Advantages d4T: 40 mg twice daily if body weight is 160 kg d4T: 30 mg twice daily if body weight is !60 kg Available as 15-, 20-, 30-, and 40-mg tablets 300 mg once daily; available as 300-mg tablet Also available as component of fixed-dose combination Atripla, dosed daily (200 mg of FTC ! 300 mg of TDF ! 600 mg of EFV) Complera, dosed daily (25 mg of RPV ! 300 mg of TDF ! 200 mg of FTC) Stribild, dosed daily (150 mg of EVG ! 150 mg of cobicistat ! 300 mg of TDF ! 200 mg of FTC) Truvada, dosed daily (200 mg of FTC ! 300 mg of TDF) AZT: 300 mg twice daily; available as 100-mg capsule or 300mg tablet Also available as component of fixed-dose combination generic lamivudine/zidovudine, dosed twice daily (150 mg of 3TC ! 300 mg of AZT) Combivir, dosed twice daily (150 mg of 3TC ! 300 mg of AZT) Trizivir, dosed twice daily (150 mg of 3TC ! 300 mg of ABC ! 300 mg of AZT) Disadvantages Take without regard for food GI side effects include diarrhea and nausea Hepatotoxicity, neurologic symptoms (eg, peripheral neuropathy), pancreatitis Well tolerated Take without regard for food Asthenia, headache, diarrhea, nausea, vomiting Nephrotoxicity; should not be administered to individuals with acute or chronic kidney injury or those with eGFR !60 If the PEP recipient has chronic hepatitis B, withdrawal of this drug may cause an acute hepatitis exacerbation Drug interactions Take without regard for food Side effects (especially nausea, vomiting, headache, insomnia, and fatigue) common and might result in low adherence Anemia and neutropenia note. This appendix does not provide comprehensive information on each individual drug. For detailed information, please refer to individual drug package inserts. AV, atrioventricular; CNS, central nervous system; ECG, electrocardiogram; eGFR, estimated glomerular filtration rate; EIA, enzyme immunoassay; GI, gastrointestinal; SJS, Stevens-Johnson syndrome. a Certain antiretroviral agents, such as PIs, have the option of once- or twice-daily dosing depending on treatment history and use with ritonavir. For PEP, the selection of dosing and schedule is to optimize adherence while minimizing side effects where possible. This table includes the preferred dosing schedule for each agent, and in all cases with the exception of Kaletra the once-daily regimen option is preferred for PEP. Twice-daily administration of Kaletra is better tolerated with respect to GI toxicities compared with the once-daily regimen. 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Association of tenofovir ex- BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) 892 70. 71. 72. 73. 74. infection control and hospital epidemiology september 2013, vol. 34, no. 9 posure with kidney disease risk in HIV infection. AIDS 2012; 26(7):867–875. Cattelan AM, Erne E, Salatino A, et al. Severe hepatic failure related to nevirapine treatment. Clin Infect Dis 1999;29(2):455– 456. Johnson S, Baraboutis JG. Adverse effects associated with use of nevirapine in HIV postexposure prophylaxis for 2 health care workers. JAMA 2000;284(21):2722–2723. Centers for Disease Control and Prevention. Serious adverse events attributed to nevirapine regimens for postexposure prophylaxis after HIV exposures—worldwide, 1997–2000. MMWR Morb Mortal Wkly Rep 2001;49(51–52):1153–1156. Armstrong K, Gorden R, Santorella G. 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Duration of time between exposure and seroconversion in healthcare workers with occupationally acquired infection with human immunodeficiency virus. Am J Med 1997;102(5B):115–116. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) infection control and hospital epidemiology november 2013, vol. 34, no. 11 erratum In the September 2013 issue of the journal, in the article by Kuhar et al (Kuhar DT, Henderson DK, Struble KA, Heneine W, Thomas V, Cheever LW, Gomaa A, Panlilio AL, US Public Health Service Working Group. Updated US Public Health Service guidelines for the management of occupational exposures to human immunodeficiency virus and recommendations for postexposure prophylaxis. Infect Control Hosp Epidemiol 2013;34(9):875–892), there are 3 errors. In Appendix Table B1, row 1 (“Abacavir”), column 3 (“Dosing (dosage form)”), “300 mg daily” is incorrect; the correct dosing is 600 mg daily. Also in Appendix Table B1, row 17 (“Tenofovir DF”), column 5 (“Disadvantages”), the text immediately following “Nephrotoxicity” (“should not be administered to individuals with acute or chronic kidney injury or those with eGFR !60”) should be deleted. Finally, the correct affiliation for author Ahmed Gomaa is Division of Surveillance, Hazard Evaluation, and Field [not “Health”] Studies, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Cincinnati, Ohio. The authors regret these errors. ! 2013 by The Society for Healthcare Epidemiology of America. All rights reserved. 0899-823X/2013/3411-0023$15.00. DOI: 10.1086/673726 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[) Bloodborne Pathogens Appendix G U.S. Department of Labor Occupational Safety & Health Administration www.osha.gov [skip navigational links] Search Advanced Search | A-Z Inde Frequently Asked Questions 1. What is the Needlestick Safety and Prevention Act? The Needlestick Safety and Prevention Act (the Act) (Pub. L. 106-430) was signed into law on November 6, 2000. Because occupational exposure to bloodborne pathogens from accidental sharps injuries in healthcare and other occupational settings continues to be a serious problem, Congress felt that a modification to OSHA's Bloodborne Pathogens Standard was appropriate (29 CFR 1910.1030) to set forth in greater detail (and make more specific) OSHA's requirement for employers to identify, evaluate, and implement safer medical devices. The Act also mandated additional requirements for maintaining a sharps injury log and for the involvement of non-managerial healthcare workers in evaluating and choosing devices. 2. How does the "Needlestick Act" apply to OSHA's Bloodborne Pathogens Standard? The Act directed OSHA to revise its Bloodborne Pathogens Standard (29 CFR 1910.1030). OSHA published the revised standard in the Federal Register on January 18, 2001; it took effect on April 18, 2001. The agency implemented a 90-day outreach and education effort for both OSHA staff and the regulated public before beginning enforcement of the new requirements. Accordingly, OSHA will not enforce the new provisions of the standard (requiring employers to maintain a sharps injury log and to involve non-managerial employees in selecting safer needle devices) until July 17, 2001. (The requirement to implement the use of engineering controls, which includes safer medical devices, has been in effect since 1992). 3. How does the revision affect states that operate their own federally-approved occupational safety and health programs? States and territories that operate their own OSHA-approved state programs must adopt the revisions to the bloodborne pathogens standard, or adopt a more stringent amendment to their existing standard, by Oct. 18, 2001. (NOTE: The original adoption date for state plan states was July 18, 2001 (or six months from the date the standard was published in the Federal Register). However, an additional three months was added which coincides with the Federal 90-day education campaign). 4. Does the standard apply to public sector (State and local government) employees? Federal OSHA standards do not apply to public sector employees, but the 24 states and two territories that operate OSHA-approved state plans are required to enforce an "at least as effective" standard in the public sector. 5. Does the "Needlestick Act" apply to me? OSHA's Bloodborne Pathogens Standard, including its 2001 revisions, applies to all employers who have employees with reasonably anticipated occupational exposure to blood or other potentially infectious materials (OPIM). These employers must implement the applicable requirements set forth in the standard. Some of the new and clarified provisions in the standard apply only to healthcare activities, but some of the provisions, particularly the requirements to update the Exposure Control Plan and to keep a sharps injury log, will apply to non-healthcare as well as healthcare activities. 6. By what date do we have to implement safer medical devices? The requirement to implement safer medical devices is not new. However, the revised standard further clarifies what is meant by "engineering controls" in the original 1991 Bloodborne Pathogens standard by BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[* f adding language to the definition section of the standard that reflects the development and availability o new safer medical devices over the last decade. The 1991 standard states, "engineering and work practice controls shall be used to eliminate or minimize employee exposure." The revision defines Engineering Controls as "controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace." Consequently, you should already have safer devices in place. If you have not already evaluated and implemented appropriate and available engineering controls, you must do so now. Also, employees with occupational exposure to blood and OPIM must be trained regarding the proper use of all engineering and work practice controls. 7. What if I've never had an employee experience a needlestick, do I still need to use safer devices? Yes. OSHA standards are intended to be implemented as a means to prevent occupational injuries and illnesses. In order to most effectively avoid percutaneous injuries from contaminated sharps, employees must use engineering controls, including safer medical devices. 8. How many non-managerial employees do I need to include in the process of choosing safer medical devices? Small medical offices may want to seek input from all employees when making their decisions. Larger facilities are not required to request input from all exposed employees; however, the employees selected should represent the range of exposure situations encountered in the workplace (e.g., pediatrics, emergency department, etc.). The solicitation of employees who have been involved in the input and evaluation process must be documented in the Exposure Control Plan. 9. Does OSHA have a list of available safer medical devices? No. OSHA does not approve or endorse any product. It is your responsibility as an employer to determine which engineering controls are appropriate for specific hazards, based on what is appropriate to the specific medical procedures being conducted, what is feasible, and what is commercially available. 10. What if a safer option is not available for the medical device that I use? A key element in choosing a safer medical device, other than its appropriateness to the procedure and effectiveness, is its availability on the market. If there is no safer option for a particular medical device used where there is exposure to blood or OPIM, you are not required to use something other than the device that is normally used. During your annual review of devices, you must inquire about new or prospective safer options and document this fact in your written Exposure Control Plan. With increasing medical technology, more devices are becoming available for different procedures. If no engineering control is available, work practice controls shall be used and, if occupational exposure still remains, personal protective equipment must also be used. 11. What if the safer device that I choose is on back order? Safety equipment must be available at all times. If for some reason an engineering control is not available (due to supply shortages, back orders, shipping delays, etc.), this must be documented in your Exposure Control Plan. You would then be responsible to implement the chosen control(s) as soon as it becomes available and adjust your exposure control plan to illustrate such. In the meantime, work practice controls must be used and, if occupational exposure still remains, personal protective equipment must also be used. 12. Do I have to keep a sharps injury log? Does it have to be confidential? If, as an employer, you are required to maintain a log of occupational injuries and illnesses under 29 CFR 1904, you must also establish and maintain a sharps injury log for recording percutaneous injuries from contaminated sharps. The Sharps Log must contain, at a minimum, information about the injury, BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[* the type and brand of device involved in the injury (if known), the department or work area where the exposure occurred, and an explanation of how the incident occurred. The log must be recorded and maintained in such a manner so as to protect the confidentiality of the injured employee (e.g., removal of personal identifiers). 13. Does the revised Bloodborne Pathogens Standard apply to medical or dental offices that have fewer than 10 employees? OSHA's Bloodborne Pathogens Standard applies to all employers with employees who have occupational exposure to blood or other potentially infectious materials (OPIM), regardless of how many workers are employed. However, workplaces with 10 or fewer employees are exempt from OSHA recordkeeping requirements and are also exempt from recording and maintaining a Sharps Injury Log. (See 29 CFR 1904 for applicability of recordkeeping requirements). All other applicable provisions of the Bloodborne Pathogens Standard still apply. 14. What new information do I need to include in my written Exposure Control Plan? How often to I need to update it? In addition to what is already required by the 1991 standard, the revised standard requires the documentation of (1) annual consideration and implementation of appropriate engineering controls, and (2) solicitation of non-managerial healthcare workers in evaluating and choosing devices. The plan must be reviewed and updated at least annually. 15. Where can I get information about what is expected of me? There are several resources available for employers and employees with regard to occupational exposures to blood and OPIM. First, of course, is the OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030). Also available are "CPL 2-2.69 (November 2001). Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, and many other related documents. You may access this information, as well as information from OSHA's Consultation and State Plan State Offices, via OSHA's website at http://www.osha.gov or by phone at 1-800-321-OSHA. The National Institute for Occupational Safety and Health (NIOSH) and the Centers for Disease Control and Prevention (CDC) also have several documents related to the prevention of occupational exposure to blood and OPIM. ### Back to Top www.osha.gov www Contact Us | Freedom of Information Act | Customer Survey Privacy and Security Statement | Disclaimers Occupational Safety & Health Administration 200 Constitution Avenue, NW Washington, DC 20210 Page last updated: 08/0 Page last updated: 08/05/2005 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[* Bloodborne Pathogens Appendix H U.S. Department of Labor Occupational Safety & Health Administration www.osha.gov [skip navigational links] Search Advanced Sea Regulations (Standards - 29 CFR) Access to employee exposure and medical records. - 1910.1020 Regulations (Standards - 29 CFR) - Table of Contents • • • • • • • Part Number: Part Title: Subpart: Subpart Title: Standard Number: Title: Appendix: 1910 Occupational Safety and Health Standards Z Toxic and Hazardous Substances 1910.1020 Access to employee exposure and medical records. A, B 1910.1020(a) "Purpose." The purpose of this section is to provide employees and their designated representatives a right of access to relevant exposure and medical records; and to provide representatives of the Assistant Secretary a right of access to these records in order to fulfill responsibilities under the Occupational Safety and Health Act. Access by employees, their representatives, and the Assistant Secretary is necessary to yield both direct and indirect improvements in the detection, treatment, and prevention of occupational disease. Each employer is responsible for assuring compliance with this section, but the activities involved in complying with the access to medical records provisions can be carried out, on behalf of the employer, by the physician or other health care personnel in charge of employee medical records. Except as expressly provided, nothing in this section is intended to affect existing legal and ethical obligations concerning the maintenance and confidentiality of employee medical information, the duty to disclose information to a patient/employee or any other aspect of the medical-care relationship, or affect existing legal obligations concerning the protection of trade secret information. 1910.1020(b) "Scope and application." 1910.1020(b)(1) This section applies to each general industry, maritime, and construction employer who makes, maintains, contracts for, or has access to employee exposure or medical records, or analyses thereof, pertaining to employees exposed to toxic substances or harmful physical agents. 1910.1020(b)(2) This section applies to all employee exposure and medical records, and analyses thereof, of such employees, whether or not the records are mandated by specific occupational safety and health standards. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ 1910.1020(b)(3) This section applies to all employee exposure and medical records, and analyses thereof, made or maintained in any manner, including on an in-house or contractual (e.g., fee-for-service) basis. Each employer shall assure that the preservation and access requirements of this section are complied with regardless of the manner in which records are made or maintained. 1910.1020(c) "Definitions." 1910.1020(c)(1) "Access" means the right and opportunity to examine and copy. 1910.1020(c)(2) "Analysis using exposure or medical records" means any compilation of data or any statistical study based at least in part on information collected from individual employee exposure or medical records or information collected from health insurance claims records, provided that either the analysis has been reported to the employer or no further work is currently being done by the person responsible for preparing the analysis. 1910.1020(c)(3) "Designated representative" means any individual or organization to whom an employee gives written authorization to exercise a right of access. For the purposes of access to employee exposure records and analyses using exposure or medical records, a recognized or certified collective bargaining agent shall be treated automatically as a designated representative without regard to written employee authorization. 1910.1020(c)(4) "Employee" means a current employee, a former employee, or an employee being assigned or transferred to work where there will be exposure to toxic substances or harmful physical agents. In the case of a deceased or legally incapacitated employee, the employee's legal representative may directly exercise all the employee's rights under this section. 1910.1020(c)(5) "Employee exposure record" means a record containing any of the following kinds of information: 1910.1020(c)(5)(i) Environmental (workplace) monitoring or measuring of a toxic substance or harmful physical agent, including personal, area, grab, wipe, or other form of sampling, as well as related collection and analytical methodologies, calculations, and other background data relevant to interpretation of the results obtained; BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ 1910.1020(c)(5)(ii) Biological monitoring results which directly assess the absorption of a toxic substance or harmful physical agent by body systems (e.g., the level of a chemical in the blood, urine, breath, hair, fingernails, etc.) but not including results which assess the biological effect of a substance or agent or which assess an employee's use of alcohol or drugs; 1910.1020(c)(5)(iii) Material safety data sheets indicating that the material may pose a hazard to human health; or 1910.1020(c)(5)(iv) In the absence of the above, a chemical inventory or any other record which reveals where and when used and the identity (e.g., chemical, common, or trade name) of a toxic substance or harmful physical agent. 1910.1020(c)(6) 1910.1020(c)(6)(i) "Employee medical record" means a record concerning the health status of an employee which is made or maintained by a physician, nurse, or other health care personnel, or technician, including: 1910.1020(c)(6)(i)(A) Medical and employment questionnaires or histories (including job description and occupational exposures), 1910.1020(c)(6)(i)(B) The results of medical examinations (pre-employment, pre-assignment, periodic, or episodic) and laboratory tests (including chest and other X-ray examinations taken for the purpose of establishing a base-line or detecting occupational illnesses and all biological monitoring not defined as an "employee exposure record"), 1910.1020(c)(6)(i)(C) Medical opinions, diagnoses, progress notes, and recommendations, 1910.1020(c)(6)(i)(D) First aid records, 1910.1020(c)(6)(i)(E) Descriptions of treatments and prescriptions, and 1910.1020(c)(6)(i)(F) Employee medical complaints. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ 1910.1020(c)(6)(ii) "Employee medical record" does not include medical information in the form of: 1910.1020(c)(6)(ii)(A) Physical specimens (e.g., blood or urine samples) which are routinely discarded as a part of normal medical practice, or 1910.1020(c)(6)(ii)(B) Records concerning health insurance claims if maintained separately from the employer's medical program and its records, and not accessible to the employer by employee name or other direct personal identifier (e.g., social security number, payroll number, etc.), or 1910.1020(c)(6)(ii)(C) Records created solely in preparation for litigation which are privileged from discovery under the applicable rules of procedure or evidence; or 1910.1020(c)(6)(ii)(D) Records concerning voluntary employee assistance programs (alcohol, drug abuse, or personal counseling programs) if maintained separately from the employer's medical program and its records. 1910.1020(c)(7) "Employer" means a current employer, a former employer, or a successor employer. 1910.1020(c)(8) "Exposure" or "exposed" means that an employee is subjected to a toxic substance or harmful physical agent in the course of employment through any route of entry (inhalation, ingestion, skin contact or absorption, etc.), and includes past exposure and potential (e.g., accidental or possible) exposure, but does not include situations where the employer can demonstrate that the toxic substance or harmful physical agent is not used, handled, stored, generated, or present in the workplace in any manner different from typical non-occupational situations. 1910.1020(c)(9) " Health Professional" means a physician, occupational health nurse, industrial hygienist, toxicologist, or epidemiologist, providing medical or other occupational health services to exposed employees. 1910.1020(c)(10) "Record" means any item, collection, or grouping of information regardless of the form or process by which it is maintained (e.g., paper document, microfiche, microfilm, X-ray film, or automated data processing). BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ 1910.1020(c)(11) "Specific chemical identity" means a chemical name, Chemical Abstracts Service (CAS) Registry Number, or any other information that reveals the precise chemical designation of the substance. 1910.1020(c)(12) 1910.1020(c)(12)(i) "Specific written consent" means a written authorization containing the following: 1910.1020(c)(12)(i)(A) The name and signature of the employee authorizing the release of medical information, 1910.1020(c)(12)(i)(B) The date of the written authorization, 1910.1020(c)(12)(i)(C) The name of the individual or organization that is authorized to release the medical information, 1910.1020(c)(12)(i)(D) The name of the designated representative (individual or organization) that is authorized to receive the released information, 1910.1020(c)(12)(i)(E) A general description of the medical information that is authorized to be released, 1910.1020(c)(12)(i)(F) A general description of the purpose for the release of the medical information, and 1910.1020(c)(12)(i)(G) A date or condition upon which the written authorization will expire (if less than one year). 1910.1020(c)(12)(ii) A written authorization does not operate to authorize the release of medical information not in existence on the date of written authorization, unless the release of future information is expressly authorized, and does not operate for more than one year from the date of written authorization. 1910.1020(c)(12)(iii) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ A written authorization may be revoked in writing prospectively at any time. 1910.1020(c)(13) "Toxic substance or harmful physical agent" means any chemical substance, biological agent (bacteria, virus, fungus, etc.), or physical stress (noise, heat, cold, vibration, repetitive motion, ionizing and non-ionizing radiation, hypo - or hyperbaric pressure, etc.) which: 1910.1020(c)(13)(i) Is listed in the latest printed edition of the National Institute for Occupational Safety and Health (NIOSH) Registry of Toxic Effects of Chemical Substances (RTECS) which is incorporated by reference as specified in Sec. 1910.6; or 1910.1020(c)(13)(ii) Has yielded positive evidence of an acute or chronic health hazard in testing conducted by, or known to, the employer; or 1910.1020(c)(13)(iii) Is the subject of a material safety data sheet kept by or known to the employer indicating that the material may pose a hazard to human health. 1910.1020(c)(14) "Trade secret" means any confidential formula, pattern, process, device, or information or compilation of information that is used in an employer's business and that gives the employer an opportunity to obtain an advantage over competitors who do not know or use it. 1910.1020(d) "Preservation of records." 1910.1020(d)(1) Unless a specific occupational safety and health standard provides a different period of time, each employer shall assure the preservation and retention of records as follows: 1910.1020(d)(1)(i) "Employee medical records." The medical record for each employee shall be preserved and maintained for at least the duration of employment plus thirty (30) years, except that the following types of records need not be retained for any specified period: 1910.1020(d)(1)(i)(A) Health insurance claims records maintained separately from the employer's medical program and its records, BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ 1910.1020(d)(1)(i)(B) First aid records (not including medical histories) of one-time treatment and subsequent observation of minor scratches, cuts, burns, splinters, and the like which do not involve medical treatment, loss of consciousness, restriction of work or motion, or transfer to another job, if made on-site by a non-physician and if maintained separately from the employer's medical program and its records, and 1910.1020(d)(1)(i)(C) The medical records of employees who have worked for less than (1) year for the employer need not be retained beyond the term of employment if they are provided to the employee upon the termination of employment. 1910.1020(d)(1)(ii) "Employee exposure records." Each employee exposure record shall be preserved and maintained for at least thirty (30) years, except that: 1910.1020(d)(1)(ii)(A) Background data to environmental (workplace) monitoring or measuring, such as laboratory reports and worksheets, need only be retained for one (1) year so long as the sampling results, the collection methodology (sampling plan), a description of the analytical and mathematical methods used, and a summary of other background data relevant to interpretation of the results obtained, are retained for at least thirty (30) years; and 1910.1020(d)(1)(ii)(B) Material safety data sheets and paragraph (c)(5)(iv) records concerning the identity of a substance or agent need not be retained for any specified period as long as some record of the identity (chemical name if known) of the substance or agent, where it was used, and when it was used is retained for at least thirty (30) years(1); and __________ Footnote(1) Material safety data sheets must be kept for those chemicals currently in use that are effected by the Hazard Communication Standard in accordance with 29 CFR 1910.1200(g). 1910.1020(d)(1)(ii)(C) Biological monitoring results designated as exposure records by specific occupational safety and health standards shall be preserved and maintained as required by the specific standard. 1910.1020(d)(1)(iii) "Analyses using exposure or medical records." Each analysis using exposure or medical records shall be preserved and maintained for at least thirty (30) years. 1910.1020(d)(2) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ Nothing in this section is intended to mandate the form, manner, or process by which an employer preserves a record so long as the information contained in the record is preserved and retrievable, except that chest X-ray films shall be preserved in their original state. 1910.1020(e) "Access to records" 1910.1020(e)(1) "General." 1910.1020(e)(1)(i) Whenever an employee or designated representative requests access to a record, the employer shall assure that access is provided in a reasonable time, place, and manner. If the employer cannot reasonably provide access to the record within fifteen (15) working days, the employer shall within the fifteen (15) working days apprise the employee or designated representative requesting the record of the reason for the delay and the earliest date when the record can be made available. 1910.1020(e)(1)(ii) The employer may require of the requester only such information as should be readily known to the requester and which may be necessary to locate or identify the records being requested (e.g. dates and locations where the employee worked during the time period in question). 1910.1020(e)(1)(iii) Whenever an employee or designated representative requests a copy of a record, the employer shall assure that either: 1910.1020(e)(1)(iii)(A) A copy of the record is provided without cost to the employee or representative, 1910.1020(e)(1)(iii)(B) The necessary mechanical copying facilities (e.g., photocopying) are made available without cost to the employee or representative for copying the record, or 1910.1020(e)(1)(iii)(C) The record is loaned to the employee or representative for a reasonable time to enable a copy to be made. 1910.1020(e)(1)(iv) In the case of an original X-ray, the employer may restrict access to on-site examination or make other suitable arrangements for the temporary loan of the BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ X-ray. 1910.1020(e)(1)(v) Whenever a record has been previously provided without cost to an employee or designated representative, the employer may charge reasonable, nondiscriminatory administrative costs (i.e., search and copying expenses but not including overhead expenses) for a request by the employee or designated representative for additional copies of the record, except that 1910.1020(e)(1)(v)(A) An employer shall not charge for an initial request for a copy of new information that has been added to a record which was previously provided; and 1910.1020(e)(1)(v)(B) An employer shall not charge for an initial request by a recognized or certified collective bargaining agent for a copy of an employee exposure record or an analysis using exposure or medical records. 1910.1020(e)(1)(vi) Nothing in this section is intended to preclude employees and collective bargaining agents from collectively bargaining to obtain access to information in addition to that available under this section. 1910.1020(e)(2) "Employee and designated representative access" 1910.1020(e)(2)(i) "Employee exposure records." 1910.1020(e)(2)(i)(A) Except as limited by paragraph (f) of this section, each employer shall, upon request, assure the access to each employee and designated representative to employee exposure records relevant to the employee. For the purpose of this section, an exposure record relevant to the employee consists of: 1910.1020(e)(2)(i)(A)(1) A record which measures or monitors the amount of a toxic substance or harmful physical agent to which the employee is or has been exposed; 1910.1020(e)(2)(i)(A)(2) In the absence of such directly relevant records, such records of other employees with past or present job duties or working conditions related to or similar to those of the employee to the extent necessary to reasonably indicate the amount and nature of the toxic substances or harmful physical agents to which the employee is or has been subjected, and BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ 1910.1020(e)(2)(i)(A)(3) Exposure records to the extent necessary to reasonably indicate the amount and nature of the toxic substances or harmful physical agents at workplaces or under working conditions to which the employee is being assigned or transferred. 1910.1020(e)(2)(i)(B) Requests by designated representatives for unconsented access to employee exposure records shall be in writing and shall specify with reasonable particularity: 1910.1020(e)(2)(i)(B)(1) The record requested to be disclosed; and 1910.1020(e)(2)(i)(B)(2) The occupational health need for gaining access to these records. 1910.1020(e)(2)(ii) "Employee medical records." 1910.1020(e)(2)(ii)(A) Each employer shall, upon request, assure the access of each employee to employee medical records of which the employee is the subject, except as provided in paragraph (e)(2)(ii)(D) of this section. 1910.1020(e)(2)(ii)(B) Each employer shall, upon request, assure the access of each designated representative to the employee medical records of any employee who has given the designated representative specific written consent. Appendix A to this section contains a sample form which may be used to establish specific written consent for access to employee medical records. 1910.1020(e)(2)(ii)(C) Whenever access to employee medical records is requested, a physician representing the employer may recommend that the employee or designated representative: 1910.1020(e)(2)(ii)(C)(1) Consult with the physician for the purposes of reviewing and discussing the records requested, 1910.1020(e)(2)(ii)(C)(2) Accept a summary of material facts and opinions in lieu of the records requested, or BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ 1910.1020(e)(2)(ii)(C)(3) Accept release of the requested records only to a physician or other designated representative. 1910.1020(e)(2)(ii)(D) Whenever an employee requests access to his or her employee medical records, and a physician representing the employer believes that direct employee access to information contained in the records regarding a specific diagnosis of a terminal illness or a psychiatric condition could be detrimental to the employee's health, the employer may inform the employee that access will only be provided to a designated representative of the employee having specific written consent, and deny the employee's request for direct access to this information only. Where a designated representative with specific written consent requests access to information so withheld, the employer shall assure the access of the designated representative to this information, even when it is known that the designated representative will give the information to the employee. 1910.1020(e)(2)(ii)(E) A physician, nurse, or other responsible health care personnel maintaining employee medical records may delete from requested medical records the identity of a family member, personal friend, or fellow employee who has provided confidential information concerning an employee's health status. 1910.1020(e)(2)(iii) Analyses using exposure or medical records. 1910.1020(e)(2)(iii)(A) Each employer shall, upon request, assure the access of each employee and designated representative to each analysis using exposure or medical records concerning the employee's working conditions or workplace. 1910.1020(e)(2)(iii)(B) Whenever access is requested to an analysis which reports the contents of employee medical records by either direct identifier (name, address, social security number, payroll number, etc.) or by information which could reasonably be used under the circumstances indirectly to identify specific employees (exact age, height, weight, race, sex, date of initial employment, job title, etc.), the employer shall assure that personal identifiers are removed before access is provided. If the employer can demonstrate that removal of personal identifiers from an analysis is not feasible, access to the personally identifiable portions of the analysis need not be provided. 1910.1020(e)(3) "OSHA access." 1910.1020(e)(3)(i) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ Each employer shall, upon request, and without derogation of any rights under the Constitution or the Occupational Safety and Health Act of 1970, 29 U.S.C. 651 "et seq.," that the employer chooses to exercise, assure the prompt access of representatives of the Assistant Secretary of Labor for Occupational Safety and Health to employee exposure and medical records and to analyses using exposure or medical records. Rules of agency practice and procedure governing OSHA access to employee medical records are contained in 29 CFR 1913.10. 1910.1020(e)(3)(ii) Whenever OSHA seeks access to personally identifiable employee medical information by presenting to the employer a written access order pursuant to 29 CFR 1913.10(d), the employer shall prominently post a copy of the written access order and its accompanying cover letter for at least fifteen (15) working days. 1910.1020(f) "Trade secrets." 1910.1020(f)(1) Except as provided in paragraph (f)(2) of this section, nothing in this section precludes an employer from deleting from records requested by a health professional, employee, or designated representative any trade secret data which discloses manufacturing processes, or discloses the percentage of a chemical substance in mixture, as long as the health professional, employee, or designated representative is notified that information has been deleted. Whenever deletion of trade secret information substantially impairs evaluation of the place where or the time when exposure to a toxic substance or harmful physical agent occurred, the employer shall provide alternative information which is sufficient to permit the requesting party to identify where and when exposure occurred. 1910.1020(f)(2) The employer may withhold the specific chemical identity, including the chemical name and other specific identification of a toxic substance from a disclosable record provided that: 1910.1020(f)(2)(i) The claim that the information withheld is a trade secret can be supported; 1910.1020(f)(2)(ii) All other available information on the properties and effects of the toxic substance is disclosed; 1910.1020(f)(2)(iii) The employer informs the requesting party that the specific chemical identity is being withheld as a trade secret; and 1910.1020(f)(2)(iv) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ The specific chemical identity is made available to health professionals, employees and designated representatives in accordance with the specific applicable provisions of this paragraph. 1910.1020(f)(3) Where a treating physician or nurse determines that a medical emergency exists and the specific chemical identity of a toxic substance is necessary for emergency or first-aid treatment, the employer shall immediately disclose the specific chemical identity of a trade secret chemical to the treating physician or nurse, regardless of the existence of a written statement of need or a confidentiality agreement. The employer may require a written statement of need and confidentiality agreement, in accordance with the provisions of paragraphs (f)(4) and (f)(5), as soon as circumstances permit. 1910.1020(f)(4) In non-emergency situations, an employer shall, upon request, disclose a specific chemical identity, otherwise permitted to be withheld under paragraph (f)(2) of this section, to a health professional, employee, or designated representative if: 1910.1020(f)(4)(i) The request is in writing; 1910.1020(f)(4)(ii) The request describes with reasonable detail one or more of the following occupational health needs for the information: 1910.1020(f)(4)(ii)(A) To assess the hazards of the chemicals to which employees will be exposed; 1910.1020(f)(4)(ii)(B) To conduct or assess sampling of the workplace atmosphere to determine employee exposure levels; 1910.1020(f)(4)(ii)(C) To conduct pre-assignment or periodic medical surveillance of exposed employees; 1910.1020(f)(4)(ii)(D) To provide medical treatment to exposed employees; 1910.1020(f)(4)(ii)(E) To select or assess appropriate personal protective equipment for exposed employees; BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ 1910.1020(f)(4)(ii)(F) To design or assess engineering controls or other protective measures for exposed employees; and 1910.1020(f)(4)(ii)(G) To conduct studies to determine the health effects of exposure. 1910.1020(f)(4)(iii) The request explains in detail why the disclosure of the specific chemical identity is essential and that, in lieu thereof, the disclosure of the following information would not enable the health professional, employee or designated representative to provide the occupational health services described in paragraph (f)(4)(ii) of this section; 1910.1020(f)(4)(iii)(A) The properties and effects of the chemical; 1910.1020(f)(4)(iii)(B) Measures for controlling workers' exposure to the chemical; 1910.1020(f)(4)(iii)(C) Methods of monitoring and analyzing worker exposure to the chemical; and 1910.1020(f)(4)(iii)(D) Methods of diagnosing and treating harmful exposures to the chemical; 1910.1020(f)(4)(iv) The request includes a description of the procedures to be used to maintain the confidentiality of the disclosed information; and 1910.1020(f)(4)(v) The health professional, employee, or designated representative and the employer or contractor of the services of the health professional or designated representative agree in a written confidentiality agreement that the health professional, employee or designated representative will not use the trade secret information for any purpose other than the health need(s) asserted and agree not to release the information under any circumstances other than to OSHA, as provided in paragraph (f)(7) of this section, except as authorized by the terms of the agreement or by the employer. 1910.1020(f)(5) The confidentiality agreement authorized by paragraph (f)(4)(iv) of this section: 1910.1020(f)(5)(i) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ May restrict the use of the information to the health purposes indicated in the written statement of need; 1910.1020(f)(5)(ii) May provide for appropriate legal remedies in the event of a breach of the agreement, including stipulation of a reasonable pre-estimate of likely damages; and, 1910.1020(f)(5)(iii) May not include requirements for the posting of a penalty bond. 1910.1020(f)(6) Nothing in this section is meant to preclude the parties from pursuing noncontractual remedies to the extent permitted by law. 1910.1020(f)(7) If the health professional, employee or designated representative receiving the trade secret information decides that there is a need to disclose it to OSHA, the employer who provided the information shall be informed by the health professional prior to, or at the same time as, such disclosure. 1910.1020(f)(8) If the employer denies a written request for disclosure of a specific chemical identity, the denial must: 1910.1020(f)(8)(i) Be provided to the health professional, employee or designated representative within thirty days of the request; 1910.1020(f)(8)(ii) Be in writing; 1910.1020(f)(8)(iii) Include evidence to support the claim that the specific chemical identity is a trade secret; 1910.1020(f)(8)(iv) State the specific reasons why the request is being denied; and, 1910.1020(f)(8)(v) Explain in detail how alternative information may satisfy the specific medical or occupational health need without revealing the specific chemical identity. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ 1910.1020(f)(9) The health professional, employee, or designated representative whose request for information is denied under paragraph (f)(4) of this section may refer the request and the written denial of the request to OSHA for consideration. 1910.1020(f)(10) When a health professional, employee, or designated representative refers a denial to OSHA under paragraph (f)(9) of this section, OSHA shall consider the evidence to determine if: 1910.1020(f)(10)(i) The employer has supported the claim that the specific chemical identity is a trade secret; 1910.1020(f)(10)(ii) The health professional employee, or designated representative has supported the claim that there is a medical or occupational health need for the information; and 1910.1020(f)(10)(iii) The health professional, employee or designated representative has demonstrated adequate means to protect the confidentiality. 1910.1020(f)(11) 1910.1020(f)(11)(i) If OSHA determines that the specific chemical identity requested under paragraph (f)(4) of this section is not a "bona fide" trade secret, or that it is a trade secret but the requesting health professional, employee or designated representatives has a legitimate medical or occupational health need for the information, has executed a written confidentiality agreement, and has shown adequate means for complying with the terms of such agreement, the employer will be subject to citation by OSHA. 1910.1020(f)(11)(ii) If an employer demonstrates to OSHA that the execution of a confidentiality agreement would not provide sufficient protection against the potential harm from the unauthorized disclosure of a trade secret specific chemical identity, the Assistant Secretary may issue such orders or impose such additional limitations or conditions upon the disclosure of the requested chemical information as may be appropriate to assure that the occupational health needs are met without an undue risk of harm to the employer. 1910.1020(f)(12) Notwithstanding the existence of a trade secret claim, an employer shall, upon request, disclose to the Assistant Secretary any information which this section requires the employer to make available. Where there is a trade secret claim, such claim shall be made no later than at the time the information is provided to the Assistant Secretary so that suitable determinations of trade secret status BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ can be made and the necessary protections can be implemented. 1910.1020(f)(13) Nothing in this paragraph shall be construed as requiring the disclosure under any circumstances of process or percentage of mixture information which is a trade secret. 1910.1020(g) "Employee information." 1910.1020(g)(1) Upon an employee's first entering into employment, and at least annually thereafter, each employer shall inform current employees covered by this section of the following: 1910.1020(g)(1)(i) The existence, location, and availability of any records covered by this section; 1910.1020(g)(1)(ii) The person responsible for maintaining and providing access to records; and 1910.1020(g)(1)(iii) Each employee's rights of access to these records. 1910.1020(g)(2) Each employer shall keep a copy of this section and its appendices, and make copies readily available, upon request, to employees. The employer shall also distribute to current employees any informational materials concerning this section which are made available to the employer by the Assistant Secretary of Labor for Occupational Safety and Health. 1910.1020(h) "Transfer of records." 1910.1020(h)(1) Whenever an employer is ceasing to do business, the employer shall transfer all records subject to this section to the successor employer. The successor employer shall receive and maintain these records. 1910.1020(h)(2) Whenever an employer is ceasing to do business and there is no successor employer to receive and maintain the records subject to this standard, the employer shall notify affected current employees of their rights of access to records at least three (3) months prior to the cessation of the employer's BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ business. 1910.1020(h)(3) Whenever an employer either is ceasing to do business and there is no successor employer to receive and maintain the records, or intends to dispose of any records required to be preserved for at least thirty (30) years, the employer shall: 1910.1020(h)(3)(i) Transfer the records to the Director of the National Institute for Occupational Safety and Health (NIOSH) if so required by a specific occupational safety and health standard; or 1910.1020(h)(3)(ii) Notify the Director of NIOSH in writing of the impending disposal of records at least three (3) months prior to the disposal of the records. 1910.1020(h)(4) Where an employer regularly disposes of records required to be preserved for at least thirty (30) years, the employer may, with at least (3) months notice, notify the Director of NIOSH on an annual basis of the records intended to be disposed of in the coming year. 1910.1020(i) "Appendices." The information contained in appendices A and B to this section is not intended, by itself, to create any additional obligations not otherwise imposed by this section nor detract from any existing obligation. [61 FR 5507, Feb. 13, 1996; 61 FR 9227, March 7, 1996; 61 FR 31427, June 20, 1996; 71 FR 16673, April 3, 2006] Next Standard (1910.1020 App A) Regulations (Standards - 29 CFR) - Table of Contents www.osha.gov Back to Top Contact Us | Freedom of Information Act | Customer Survey Privacy and Security Statement | Disclaimers Occupational Safety & Health Administration 200 Constitution Avenue, NW Washington, DC 20210 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH %ORRGERUQH3DWKRJHQV$SSHQGL[+ Hazard Communication Program for Austin Community College, Department of Dental Hygiene (known as ACC-DH) General Policy The purpose of this notice is to inform you that the office of: Austin Community College – Department of Dental Hygiene, located at: Eastview Campus, Building 8000, 3401 Webberville Road, Austin, TX 78702, is complying with OSHA Hazard Communication Standard, Title 29 Code of Federal Regulations 1910.1200 by compiling a hazardous chemicals list, by using Safety Data Sheets (SDS), by ensuring that containers are labeled, and by providing you with training. The program applies to all work operations in this office where you may be exposed to hazardous chemicals under normal working conditions or during an emergency situation. The program coordinator is: Renee Cornett, RDH, MBA – Department Chair. Renee Cornett, RDH, MBA – Department Chair, has overall responsibility for the program, which will be reviewed and updated, as necessary, by Kate Goin, BA, RDH – Clinic Manager. Copies of the written program may be obtained from Kate Goin, BA, RDH – Clinic Manager. 01/2013 1 Hazard Communications List of Hazardous Chemicals The program coordinator will make a list of all products that contain hazardous chemicals (except those that the OSHA Standard excludes. See “Exemptions,” below) used in the facility and will update the list as necessary. Our list of chemicals contains the names of the chemicals used in this office. It also indicates examples of materials that may contain these chemicals. For specific hazardous chemicals in a product, refer to the SDS for that product. Safety Data Sheets An SDS is a government-approved form or equivalent that provides specific information on the chemicals in products you use. It was formerly called a Material Safety Data Sheet (MSDS). The program coordinator will maintain a file of SDS on products for which the manufacturers or suppliers consider SDS to be necessary. The program coordinator is responsible for acquiring, filing, and substituting updated SDS, as well as for contacting manufacturers, suppliers, or dealers if additional information is needed or if an SDS has not been provided with the initial shipment of a product and the dental office has reason to believe that an SDS should have been provided. A master list of SDS is available from the program coordinator; the file of SDS is accessible to all employees. Labels and Other Forms of Warning The program coordinator will ensure that all hazardous chemicals are properly labeled and that labeling is updated, as necessary. Labels should list, at least, the chemical identity of the material, appropriate hazard warnings, and the name and address of the manufacturer or other responsible party. Containers labeled by the manufacturers do not require additional labels. The manufacturer is responsible for properly labeling the original container. When the chemicals are transferred to other containers (secondary containers) to be used at a later time or by employees other than one who is going to use the product immediately, these containers need to be labeled. Examples are containers of alcohol, bleach, disinfectant, and radiographic chemicals such as developer and fixer solutions that are transferred from the original containers. Copies of the original labels can be used to label these containers. If you transfer chemicals from a labeled container to another container that is intended only for your immediate use, no labels are required on the second container. Professional products that are regulated by the Food and Drug Administration (FDA) are exempt from the labeling requirement of the Hazard Communication Standard (see the list provided at the end of this section). Examples of such materials are impression materials and composite resins, the labeling of which is approved by the FDA. These labels must not be removed from the containers. Drugs that are in solid form for direct administration to the patient are also exempt from the labeling requirement. Nonroutine Tasks When you are required to perform nonroutine tasks that involve hazardous chemicals, a special training session will be conducted to provide information about the chemicals to which you may be exposed and the precautions you must take to reduce or avoid exposure. 01/2013 2 Hazard Communications Exemptions This regulation does not cover finished articles that do not, under normal use, release a hazardous chemical (e.g., dental chairs, hand instruments, pencils, and photocopy machines). Preparing Labels for Secondary Containers The Hazard Communication Standard requires that hazardous chemicals be labeled if they are transferred from their original container to an unlabeled secondary container under the applicable conditions as described above. List of Hazardous Chemicals Description Principal responsibility for determining whether a chemical is hazardous or a product contains hazardous chemicals lies with the manufacturer or supplier. As a user you should rely on the information on the label and/or the SDS. If there is any question about whether or not a chemical or product is potentially hazardous, it should be included in the hazard program. In order to be in compliance with the Hazard Communication Standard, it is recommended that you take the following steps: • Check the products you use in your office against the list of dental products that contain hazardous chemicals. This list follows and it is titled, “Some Hazardous Chemicals and the Dental Products in Which They May Be Found.” • For each product that you have in your office and that is on the list “Some Hazardous Chemicals and the Dental Products in Which They May Be Found” determine if you have an SDS. If you do not, request one from the manufacturer without delay. • OSHA requires that you develop your own list of the hazardous chemicals used in your office. The information needed for your own list should be taken from the SDS in your files. A sample of a completed list of hazardous chemicals and a form you may use to make your list follow. OSHA requires, at a minimum, that the list include the name of the chemical and that an SDS for that product be on file. • For products that may contain hazardous chemicals, enter their names on the list of hazardous chemicals and record the date on which a letter requesting an SDS was sent. If the manufacturer replies that an SDS is not necessary, indicate that on the form. • Add additional hazardous chemicals to your list as new SDS are received. 01/2013 3 Hazard Communications Some Hazardous Chemicals and the Dental Products in Which They May Be Found The following is a list of chemical substances identified by OSHA as hazardous that the American Dental Association believes may be found in the dental office. This list is not all inclusive. It is based on two sources mentioned in the OSHA regulation: the OSHA Safety and Health Standards 29 CFR 1910 Subpart Z1 and the Threshold Limit Values for Chemical Substances and Physical Agents in the Work Environment, American Conference of Governmental Industrial Hygienists (ACGIH). Chemical Name May be found in Acetic Acid photographic solutions Acetone solvents Aluminum oxide polishing disks Aluminum soluble salts astringent agents Asbestos some cast ring liners Benzoyl peroxide resin systems, denture resins Beryllium nickel-based casting alloys Calcium carbonate polishing agents Carbon tetrachloride solvents Chloroform solvents Chromium casting alloys Cobalt casting alloys Copper amalgam, casting alloys Cresol, all isomers endodontic materials Cyanide as CN plating solutions Dibutylphthalate impression materials Ethyl acetate solvents Ethyl acrylate resins Ethyl alcohol solvents, sterilizing agents Ethyl chloride solvents, topical refrigerants Ethyl silicate silicate investments, impression materials (condensation silicones) Ethylene oxide sterilizing agents Fluorides (as F) fluoride-containing composites Formaldehyde sterilizing agents Glutaraldehyde sterilizing agents Hydrochloric acid pickling solutions, bleaching agents Hydrogen fluoride etching agents for porcelain Hydroquinone methacrylate and denture base resins, photographic solutions Iodine iodophor disinfectants and antimicrobial hand cleansers Isopropyl alcohol solvents, wiping agents Lead/inorganic lead compounds impression materials (some polysulfides) 01/2013 4 Hazard Communications LPG (liquid petroleum gas) burners Mercury amalgam Mercury, organic topical antiseptics Methyl acetate solvents Methyl alcohol denatured alcohol Methyl methacrylate denture base resins Methylene chloride solvents Molybdenum, insoluble compounds casting alloys (chromium-cobalt alloys stainless steel Nickel, metal and soluble compounds nickel-based casting alloys, stainless steel orthodontic appliances pickling solutions, some bleaching solutions nitrous oxide handpiece lubricants Disinfection devices solvents, waxes, jellies disinfectants etching agents, phosphate cements resins pickling agents impression materials (addition silicones) casting alloys burners polishing agent composite resins, materials Nitric acid Nitrous oxide Oil mist, mineral Ozone Petroleum distillates Phenol Phosphoric acid Phthalic anhydride Picric acid Platinum soluble salts Platinum Propane Rouge Silica, amorphous including Natural diatomaceous earth Silica, crystalline (quartz) Silicon carbide Silver (metal and soluble Compounds) composite resins, materials polishing disks, cutting wheels amalgam, endodontic points, casting alloys, photographic solutions etchant for alloys, copper plating solutions gloves nickel-chromium-cobalt alloys amalgam, polishing pastes impression materials (condensation silicones) porcelain, impression materials solvents solvents porcelain maxillofacial plastics, mouth guard trays solvents porcelain, polishing pastes Sulfuric acid Talc, nonasbestos form Tantalum Tin, inorganic compounds Tin, inorganic compounds Titanium dioxide Toluene Trichloroethane Uranium, insoluble compounds Vinyl chloride Xylene Zirconium compounds 01/2013 5 Hazard Communications Sample List of Hazardous Chemicals for this Office List of Hazardous Chemicals for this Office Chemical Product (Trade Name) Company Generic Area SDS on File? (y/n) Silver Dispersalloy Johnson & Johnson (J&J) Amalgam Yes Tin Dispersalloy J&J Amalgam Yes Copper Dispersalloy J&J Amalgam Yes Zinc Dispersalloy J&J Amalgam Yes Mercury Dispersalloy J&J Amalgam Yes Beryllium Rexillium III Jeneric Casting alloy Yes Nickel Rexillium III Jeneric Casting alloy Yes Chromium Rexillium III Jeneric Casting alloy Yes Molybdenum Rexillium III Jeneric Casting alloy Yes Nickel Harmony Line Extra hard Williams Casting alloy Yes Copper Harmony Line Extra Hard Williams Casting alloy Yes Platinum Harmony Line Extra Hard Williams Casting alloy Yes Indium Harmony Line Extra Hard Williams Casting alloy Yes Vinyl polysiloxane Imprint 3M Impression material Yes Quartz silica Imprint 3M Impression material Yes Cobalt pigment Imprint 3M Impression material Yes Silane copolymer Imprint 3M Impression material Yes Hydrophilic agent Imprint 3M Impression Material Yes Phosphoric acid Modern Tenacin Cement Liquid L.D. Caulk Cement Yes Zinc oxide Modern Tenacin Cement Powder L.D. Caulk Cement Yes Glutaraldehyde Cidex Plus Surgikos Disinfectant/sterilant Yes Glass powder Occlusin Coe Lab Composite Yes Methacrylate ether Occlusin Coe Lab Composite Yes Methyl Methacrylate monomers Formatray liquid Kerr Tray material Yes Hydroquinone Kodax GBX Developer Eastman Kodak Film developer Yes 01/2013 6 Hazard Communications List of Hazardous Chemicals for this Dental Setting The hazardous chemicals can be found in the table on the pages following Hazard Communication Training Record. 01/2013 7 Hazard Communications Sample Letter to Request Safety Data Sheets January, 20XX Acme Distribution Company 29 Acme Drive Deerfield, WI 38050 Dear Sir or Madam: I purchased (amount/size) of (name of product) on (date) from your company. I took delivery of the product on (date) but I did not receive a Safety Data Sheet (SDS) with my order. Please send me the appropriate SDS immediately as required by OSHA. Thank you for your cooperation, John L. Smith, D.D.S. 1234 Maple Tree Lane Scranton, WI 23456 01/2013 8 Hazard Communications Hazard Communication Training Program Introduction OSHA enforces a regulation on the rights of employees to know the potential dangers associated with chemicals (defined by OSHA as hazardous) that they may encounter in products used on the job. This regulation preempts existing state and local right-to-know laws, except in those states that have OSHA-approved right-to-know programs. OSHA rules require employers, including dentist employers, to inform all employees of the dangers of hazardous chemicals present in products used in the workplace and to train them on how to handle these substances safely. The purpose of the regulation is to help employees understand and deal with chemical hazards to which they may be exposed during the course of their employment. This hazard communication training program is for your use in training your employees as required by OSHA. After the training session, have the employees sign the training record and fill out the comment forms. Retain the records and forms on file. Components of the Program The Hazard Communication Standard requires five basic actions. 1. Labeling All products that contain hazardous chemicals are to be properly labeled. Ensure that labels are affixed to all containers of products that contain hazardous chemicals. Containers properly labeled by the manufacturer or supplier do not need additional labels. Notify the manufacturer or supplier immediately if it appears that a label is missing or incomplete. Employees should know the identity of the chemicals in products they are handling. The information should be on the product labels. Professional products that are regulated by the Food and Drug Administration (FDA) do not require additional labels, because the labeling of these products is regulated and approved by that agency. These labels should not be removed. No additional label needs to be placed on products regulated by the FDA, assuming the original label is not missing. Drugs that are in solid final form for direct administration to the patient, (e.g., pills or tablets) are also exempted from the labeling requirement. OSHA has recently updated the labeling requirements of hazardous chemicals, which includes the development of pictograms to warn users of chemical hazards. As of June 1, 2015, all labels should contain: • • • • • Pictograms Signal words Hazard and precautionary statements The product identifier Supplier identification 01/2013 9 Hazard Communications The following two OSHA Quick Cards illustrate: 1. The new system of pictograms 2. The new label requirements 01/2013 10 Hazard Communications 01/2013 Hazard Communications 01/2013 Hazard Communications Products containing hazardous chemicals that are transferred by an employee to another container for immediate use need not be labeled in the new container. However, if an employee transfers the product to a new container for later use by another employee (e.g., a large bottle of surface disinfecting solution is transferred to a smaller spray bottle for each operatory), the new container must be properly labeled with hazard information. This rule can be particularly important for two common areas in the dental office: X-ray tanks and sterilization/disinfection trays. X-ray tanks should be labeled with the information contained on the manufacturer’s containers of fixer and developer. Sterilization/disinfection trays should be labeled similarly if the solution is not immediately used and discarded. 2. Safety Data Sheet Obtain SDS from suppliers. • Manufacturers and dental suppliers are required to provide an SDS for a product if it contains a hazardous chemical. If an SDS is not supplied, the employer is obligated to request it from the manufacturer or supplier. • If the label indicates a hazard, employers may rely on that representation and should ensure that a current SDS is on file for that product. If you are unsure about any given product, contact the manufacturer or supplier immediately. As of June 1, 2015, the Hazard Communication Standard will require new SDS to be in a uniform format. The following OSHA Quick Card shows the SDS new format and explains the various sections of the form: 01/2013 13 Hazard Communications OSHA · Hazard Communication Safety Data Sheets The Hazard Communication Standard (HCS) requires chemical manufacturers, distributors, or importers to provide Safety Data Sheets (SDSs) (formerly known as Material Safety Data Sheets or MSDSs) to communicate the hazards of hazardous chemical products. As of June 1,2015, the HCS will require new SDSs to be in a uniform format, and include the section numbers, the headings, and associated information under the headings below: Section 1,Identification includes product identifier; manufacturer or distributor name, address, phone number; emergency phone number; recommended use; restrictions on use. Section 2, Hazard(s) identification includes all hazards regarding the chemical; required label elements. Section 3, Composition/information on ingredients includes information on chemical ingredients; trade secret claims. Section 4, First-aid measures includes important symptoms/ effects, acute, delayed; required treatment. Section S, Fire-fighting measures lists suitable extinguishing techniques, equipment; chemical hazards from fire. Section 6, Accidental release measures lists emergency procedures; protective equipment; proper methods of containment and cleanup. Section 7, Handling and storage lists precautions for safe handling and storage, including incompatibilities . Section 8, Exposure controls/personal protection lists OSHA's Permissible Exposure Limits (PEL.s); Threshold Limit Values (TLVs); appropriate engineering controls; personal protective equipment (PPE). Section 9, Physical and chemical properties lists the chemical's characteristics. Section 10, Stability and reactivity lists chemical stability and possibility of hazardous reactions. Section 11, Toxicological information includes routes of exposure; related symptoms, acute and chronic effects; numerical measures of toxicity. Section 12, Ecological information* Section 13, Disposal considerations * Section 14, Transport information* Section 15, Regulatory information* Section 16, Other information, includes the date of preparation or last revision. *Note: Since other Agencies regulate this information, OSHA will not be enforcing Sections 12 through 15(29 CFR 1910.1200(g)(2)) . Employers must ensure that SDSs are readily accessible to employees. See Appendix D of 1910.1200 for a detailed description of SOS contents. For more information : www .osha .gov l 01/2013 SHA (800) 321-0SHA (6742) U.S. Department of Labor J 14 Hazard Communications 3. File Maintain a file of all SDS. • SDS should be maintained in a file available to all employees. The file should be kept up to date. • Employers should maintain a file of requests for SDS to document a good faith attempt to comply with the OSHA standard. 4. Training Dentists must provide training for employees at the time of their initial assignment, whenever a new hazardous material is introduced into the workplace, and whenever procedures for safe handling and emergencies are modified. • Giving an employee an SDS to read does not satisfy the intent of this regulation. The training should make clear to employees the hazards of the chemicals and their handling, the procedures that involve hazardous chemicals, the location and availability of the written hazard communication program including the list of chemicals, measures to prevent exposure, and explanation of the labeling and SDS requirements, and an explanation of the OSHA rule. • This can be accomplished through continuing education, staff meetings and discussions, and/or audiovisual materials. Training sessions should always include an opportunity for employees to ask questions to ensure that they understand the information presented. 5. Recordkeeping At the end of each training session, each employee should sign a form indicating participation. Maintain a record of training sessions. 01/2013 15 Hazard Communications Employee Notification The Hazard Communication Program for this office can be found: on page 1 of this manual The program coordinator for this dental office is: Kate Goin, BA, RDH Your work in this dental office involves one or more products that may contain hazardous chemicals. A list of hazardous chemicals in products used in this office is available from the program coordinator. It is necessary to know the hazardous chemicals in your workplace. Information on hazardous chemicals in a specific product can be found in the SDS for that product. An SDS file for these products is located in: the Sterilization Room #8143 It is necessary to know the hazards, methods of controlling exposure, and precautions on handling of products containing hazardous chemicals. 01/2013 16 Hazard Communications Dental Office Safety The following general descriptions deal with several groups of chemicals that may be found in products handled in the dental office. The hazard potential is dependent on the amount of exposure and individual variability. In most dental offices the amounts of chemicals are small and therefore risks should be small as well. The risks can be further minimized if recommended procedures and precautions are followed. For information on specific products, always refer to the SDS. If any of the information here varies from that on an SDS, always rely on the SDS first and foremost. GENERAL PRECAUTIONS • Handle chemicals properly in accordance with manufacturer’s or supplier’s instructions. • Avoid skin contact with chemicals. • Minimize chemical vapor in the air. • Do not leave chemical bottles open. • Do not use a flame near flammable chemicals. • Do not eat or smoke in areas where chemicals are used. • When appropriate, wear protective eyewear and masks. • Know proper cleanup procedures. • Dispose of all hazardous chemicals in accordance with SDS instructions and applicable local, state, and federal regulations. ACID ETCH SOLUTIONS AND GELS Examples Solutions and gels for acid etch techniques associated with placement of composites, sealants, and orthodontic brackets usually contain phosphoric acid Hazards Acid burns with possible sloughing of tissue, eye damage Do: • Handle acid-soaked material with forceps or gloves. • Clean spills with a commercial acid spill cleanup kit. • Avoid skin or soft tissue contact. • Rinse with a large amount of running water in case of eye or skin contact. 01/2013 17 Hazard Communications FLAMMABLE GASES Examples Nitrous oxide and oxygen, liquefied petroleum gas Hazards Fire Do: • Test periodically for leaks. • Avoid contact between compressed oxygen gas and lubricants or grease. • Avoid having sparks or flames near flammable gases. FLAMMABLE LIQUIDS Examples Solvents such as acetone or alcohol Hazards Fire or explosion Do: • Store flammable liquids in tightly covered containers. • Provide adequate ventilation. • Have fire extinguishers available at locations where these liquids are used. • Avoid sparks or flames in areas where flammable liquids are used. BERYLLIUM Examples Beryllium dust and fumes arise from the melting, grinding, and milling of some base-metal alloys Hazards Contact dermatitis, corneal burns, and inflammation and scarring of respiratory tissues Do: • Wear gloves, eye protection, and a NIOSH-approved mask when casting, polishing, or grinding these alloys. • Provide adequate local exhaust ventilation for all operations in casting areas. • Use power suction methods rather than air hoses to remove dust from clothing and to clean machinery. • Dispose of wastes, storage materials, or contaminated clothing in sealed bags. 01/2013 18 Hazard Communications MERCURY Examples Bulk mercury, precapsulated alloy, scrap amalgam Hazards Nausea, loss of appetite, diarrhea; fine tremors, depression, fatigue, increased irritability, headache, insomnia; allergic manifestations, contact dermatitis, pneumonitis, nephritis; dark pigmentation of marginal gingiva, loosening of teeth Do: • Work in well-ventilated spaces. • Avoid direct skin contact with mercury. • Store mercury in unbreakable, tightly sealed containers away from any source of heat. • Salvage amalgam scrap; store under photographic fixer solution in a closed container. • Clean up spilled mercury using appropriate procedures and equipment; do not use a household vacuum cleaner. • Place contaminated disposable materials in polyethylene bags and seal. Please note: The ADA’s Best Management Practices call for use of encapsulated mercury only. NICKEL Examples Nickel-containing dental alloys, gold alloys, solders; particles released during fabrication and grinding of nickel-containing alloys Hazards Allergic manifestations, irritation to eyes and respiratory system Do: • Wear protective eyewear and a NIOSH-approved mask when grinding nickel-containing alloys. • Use high-velocity evacuation systems. OTHER METALS Examples Casting alloys may contain cobalt and chromium; alloys for amalgam contain silver, tin, and copper Hazards Metal dust and fumes may irritate eyes and respiratory systems; contact dermatitis Do: • Wear protective eyewear and a NIOSH-approved mask while grinding metal prostheses. 01/2013 19 Hazard Communications NITROUS OXIDE (N2O) Hazards Based on laboratory animal studies and several published reports of N2O abuse, high exposure may cause adverse health effects, especially neuropathies. Do: • Take steps to minimize the concentration of nitrous oxide in the dental suite. • Use a scavenging system. • Check nitrous oxide machines, lines, hoses, and masks for leakage. • Maintain adequate ventilation ORGANIC CHEMICALS Examples Alcohols, ketones, esters, solvents, and monomers such as methyl methacrylate and dimethacrylates. The halogen-containing organic liquids used in dental offices primarily include chloroform and carbon tetrachloride and some solvents and cleaners. Hazards Fire; allergic manifestations, contact dermatitis; possible mutagenesis; irritation to mucous membranes; respiratory problems; nausea, liver and kidney damage; central nervous system depression, headache, drowsiness, loss of consciousness Do: • Avoid skin contact. • Avoid excessive inhalation of vapors. • Work in well-ventilated areas. • Use forceps or gloves when handling contaminated gauze or brushes. • Keep containers tightly closed when not in use. • Store containers on flat sturdy surfaces. • Clean outside surfaces of containers after use to prevent residual material from contacting the next user. • Use a commercially available flammable solvent cleanup kit in case of spills. 01/2013 20 Hazard Communications PHOTOGRAPHIC CHEMICALS Hazards Contact dermatitis; irritation of eyes, nose, throat, and respiratory system from vapors and fine particulates of chemicals Do: • Use protective eyewear. • Minimize exposure to dry powder during mixing of solution. • Avoid skin contact with photographic chemicals and solutions by wearing heavy-duty rubber gloves. • Work in well-ventilated areas. • Clean up spilled chemicals immediately. • Wash off chemicals with large amounts of water and a pH-balanced soap if contact occurs. • Regularly launder clothing that comes in contact with photographic solutions. • Store photographic solutions and chemicals in tightly covered containers. PICKLING SOLUTIONS Examples Strongly acidic solutions containing metal ions after use. The components may be volatile. Hazards Burning of skin, irritation of skin and mucous membranes, damage to eyes, irritation to respiratory system Do: • Wear safety goggles for eye protection. • Use forceps to hold the object being pickled. • Avoid skin contact by wearing heavy-duty rubber gloves. • Use pickling solutions in well-ventilated areas. • Minimize the formation of airborne droplets. • Avoid splattering of solution and putting hot objects into the solution. • Store pickling solutions in covered glass containers. • Keep soda lime or a commercial acid spill cleanup kit available in case of spills. • Rinse with a large amount of running water in case of eye or skin contact. Seek medical attention as necessary. 01/2013 21 Hazard Communications PLASTER AND OTHER GYPSUM PRODUCTS Examples Gypsum products contain silica and calcium sulfate Hazards Irritation and impairment of respiratory system, silicosis, irritation of the eyes Do: • Use plaster and other gypsum products in areas equipped with an exhaust system. • Wear protective eyewear and a NIOSH-approved mask while handling powders or trimming models. • Minimize exposure to powder during handling. 01/2013 22 Hazard Communications Hazard Communication Training Record This office has conducted a training session for employees incorporating the OSHA Hazard Communication Standard, including new regulations in 2012 SDS requirements and labeling requirements. Date 09/02/15 Conducted by ADA OSHA Training for Dental Professionals video and Kate Goin, BA, RDH Signature Attended by Tina Stein Signature Attended by Renee Cornett Signature Attended by Michelle Landrum Signature Attended by Kimberly McDougall Signature Attended by Kellie Murphree Signature Attended by David Reeves Signature 01/2015 23 Hazard Communications Hazard Communication Training Record This office has conducted a training session for employees incorporating the OSHA Hazard Communication Standard, including new regulations in 2012 SDS requirements and labeling requirements. Date 09/02/15 Conducted by ADA OSHA Training for Dental Professionals video and Kate Goin, BA, RDH Signature Attended by Deb Segen Signature Attended by Rita Snodell Signature Attended by Prema Strecker Signature Attended by Joe Wright Signature Attended by Sima Sohrabi Signature Attended by Andrea Kovarik Signature 01/2015 24 Hazard Communications Hazard Communication Training Record This office has conducted a training session for employees incorporating the OSHA Hazard Communication Standard, including new regulations in 2012 SDS requirements and labeling requirements. Date 09/12/16 Conducted by ADA OSHA Training for Dental Professionals video and Kate Goin, BA, RDH Signature Attended by Veronica Ledesma Signature Attended by Teri Frank Signature Attended by Signature Attended by Signature Attended by Signature Attended by Signature 01/2015 25 Hazard Communications This page intentionally left blank 01/2015 26 Hazard Communications Hazard Communication Training Record This office has conducted a training session for employees incorporating the OSHA Hazard Communication Standard, including new regulations in 2012 SDS requirements and labeling requirements. Date 09/12/16 Conducted by ADA OSHA Training for Dental Professionals video and Kate Goin, BA, RDH Signature Attended by Monique Alarcon Signature Attended by Rachel Dickens Signature Attended by Sunena Gagneja Signature Attended by Lacie Herrin Signature Attended by Dylon Hopper Signature Attended by Cydnie Johnson Signature 01/2015 27 Hazard Communications Hazard Communication Training Record This office has conducted a training session for employees incorporating the OSHA Hazard Communication Standard, including new regulations in 2012 SDS requirements and labeling requirements. Date 09/12/16 Conducted by ADA OSHA Training for Dental Professionals video and Kate Goin, BA, RDH Signature Attended by Julia Levitt Signature Attended by Stephanie Liu Signature Attended by Kristi Madrid Signature Attended by Katie Natale Signature Attended by Aneesa Patel Signature Attended by Lee Pepe Signature 01/2015 28 Hazard Communications Hazard Communication Training Record This office has conducted a training session for employees incorporating the OSHA Hazard Communication Standard, including new regulations in 2012 SDS requirements and labeling requirements. Date 09/12/16 Conducted by ADA OSHA Training for Dental Professionals video and Kate Goin, BA, RDH Signature Attended by Jennifer Rice Signature Attended by Shaunda Talamantez Signature Attended by Yulia Voznesenskaya Signature Attended by Jeremiah Wallace Signature Attended by Allyson Walter Signature Attended by Signature 01/2015 29 Hazard Communications This page intentionally left blank 01/2015 30 Hazard Communications Hazard Communication Training Record This office has conducted a training session for employees incorporating the OSHA Hazard Communication Standard, including new regulations in 2012 SDS requirements and labeling requirements. Date 09/02/15 Conducted by ADA OSHA Training for Dental Professionals video and Kate Goin, BA, RDH Signature Attended by Jason Blunck Signature Attended by Wendy Bushman Signature Attended by Josette Chen Signature Attended by Amy Deng Signature Attended by Becca Eiserer Signature Attended by Zainab Jabr Signature 01/2015 31 Hazard Communications Hazard Communication Training Record This office has conducted a training session for employees incorporating the OSHA Hazard Communication Standard, including new regulations in 2012 SDS requirements and labeling requirements. Date 09/02/15 Conducted by ADA OSHA Training for Dental Professionals video and Kate Goin, BA, RDH Signature Attended by Laura Jaimes Signature Attended by Whitney Jones Signature Attended by Molly Keith Signature Attended by Shari Langerhans Signature Attended by Jessica Lee Signature Attended by Carrie Nunnally Signature 01/2015 30 Hazard Communications Hazard Communication Training Record This office has conducted a training session for employees incorporating the OSHA Hazard Communication Standard, including new regulations in 2012 SDS requirements and labeling requirements. Date 09/02/15 Conducted by ADA OSHA Training for Dental Professionals video and Kate Goin, BA, RDH Signature Attended by Jess Ross Signature Attended by Azadeh Samani Signature Attended by Elya Singler Signature Attended by Allyson Walter Signature Attended by Stacy Weiner Signature Attended by Jason Whittley Signature 01/2015 31 Hazard Communications Hazard Communication Appendix A BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[$ Hazard Communication Appendix A BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[$ Hazard Communication Appendix B QUICK CARD TM Hazard Communication Standard Pictogram As of June 1, 2015, the Hazard Communication Standard (HCS) will require pictograms on labels to alert users of the chemical hazards to which they may be exposed. Each pictogram consists of a symbol on a white background framed within a red border and represents a distinct hazard(s). The pictogram on the label is determined by the chemical hazard classification. -Ê*VÌ}À>ÃÊ>`Ê>â>À`à i>Ì Ê>â>À`ÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊ>iÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÝV>>ÌÊÊ>À UÊ >ÀV}i UÊÕÌ>}iVÌÞ UÊ,i«À`ÕVÌÛiÊ/ÝVÌÞ UÊ,iëÀ>ÌÀÞÊ-iÃÌâiÀ UÊ/>À}iÌÊ"À}>Ê/ÝVÌÞ UÊëÀ>ÌÊ/ÝVÌÞÊ UÊ>>LiÃÊ UÊ*ÞÀ« ÀVà UÊ-ivi>Ì} UÊÌÃÊ>>LiÊ>à UÊ-iv,i>VÌÛià UÊ"À}>VÊ*iÀÝ`ià UÊÀÀÌ>ÌÊÃÊ>`ÊiÞi® UÊ-Ê-iÃÌâiÀ UÊVÕÌiÊ/ÝVÌÞÊ >ÀvÕ® UÊ >ÀVÌVÊvviVÌà UÊ,iëÀ>ÌÀÞÊ/À>VÌÊ ÊÊÊÀÀÌ>Ì UÊ>â>À`ÕÃÊÌÊ"âiÊ ÊÊÊÊ>ÞiÀÊ >`>ÌÀÞ® >ÃÊ Þ`iÀÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊ ÀÀÃÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÝ«`}ÊL UÊ>ÃiÃÊ1`iÀÊ*ÀiÃÃÕÀi UÊ-Ê ÀÀÃÉÊ ÊÊÊÕÀà UÊÞiÊ>>}i UÊ ÀÀÃÛiÊÌÊiÌ>à UÊÝ«ÃÛià UÊ-iv,i>VÌÛià UÊ"À}>VÊ*iÀÝ`ià >iÊ"ÛiÀÊ ÀViÊÊÊÊÊÊÊÊÊÊÛÀiÌÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊ-ÕÊÊ ÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊ >`>ÌÀÞ®ÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊ>`Ê ÀÃÃLià UʵÕ>ÌVÊ/ÝVÌÞ UÊVÕÌiÊ/ÝVÌÞÊ ÊÊÊv>Ì>ÊÀÊÌÝV® For more information: U.S. Department of Labor www.osha.gov (800) 321-OSHA (6742) OSHA 3491-02 2012 UÊ"Ý`âiÀà BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[% Hazard Communication Appendix C } Product Identifier SAMPLE LABEL CODE _______________________________ Product Name________________________ Supplier Identification Hazard Statements Hazard Pictograms Signal Word Danger } Fill weight:____________ Lot Number:___________ Gross weight:__________ Fill Date:______________ Expiration Date:________ Directions for Use __________________________________ __________________________________ __________________________________ Supplemental Information Highly flammable liquid and vapor. May cause liver and kidney damage. Precautionary Statements } Keep container tightly closed. Store in a cool, well-ventilated place that is locked. Keep away from heat/sparks/open flame. No smoking. Only use non-sparking tools. Use explosion-proof electrical equipment. Take precautionary measures against static discharge. Ground and bond container and receiving equipment. Do not breathe vapors. Wear protective gloves. Do not eat, drink or smoke when using this product. Wash hands thoroughly after handling. Dispose of in accordance with local, regional, national, international regulations as specified. } Company Name_______________________ Street Address________________________ City_______________________ State_____ Postal Code______________Country_____ Emergency Phone Number_____________ OSHA has updated the requirements for labeling of hazardous chemicals under its Hazard Communication Standard (HCS). As of June 1, 2015, all labels will be required to have pictograms, a signal word, hazard and precautionary statements, the product identifier, and supplier identification. A sample revised HCS label, identifying the required label elements, is shown on the right. Supplemental information can also be provided >â>À`Ê ÕV>ÌÊ-Ì>`>À`Ê>Lià on the label as needed. First Aid If exposed call Poison Center. If on skin (or hair): Take off immediately any contaminated clothing. Rinse skin with water. In Case of Fire: use dry chemical (BC) or Carbon Dioxide (CO2) fire extinguisher to extinguish. ÀÊÀiÊvÀ>Ì\ (800) 321-OSHA (6742) www.osha.gov OSHA 3492-02 2012 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[& Hazard Communication Appendix D QUICK CARD TM Hazard Communication Safety Data Sheets The Hazard Communication Standard (HCS) requires chemical manufacturers, distributors, or importers to provide Safety Data Sheets (SDSs) (formerly known as Material Safety Data Sheets or MSDSs) to communicate the hazards of hazardous chemical products. As of June 1, 2015, the HCS will require new SDSs to be in a uniform format, and include the section numbers, the headings, and associated information under the headings below: Section 1, Identification includes product identifier; manufacturer or distributor name, address, phone number; emergency phone number; recommended use; restrictions on use. Section 2, Hazard(s) identification includes all hazards regarding the chemical; required label elements. Section 3, Composition/information on ingredients includes information on chemical ingredients; trade secret claims. Section 4, First-aid measures includes important symptoms/effects, acute, delayed; required treatment. Section 5, Fire-fighting measures lists suitable extinguishing techniques, equipment; chemical hazards from fire. Section 6, Accidental release measures lists emergency procedures; protective equipment; proper methods of containment and cleanup. Section 7, Handling and storage lists precautions for safe handling and storage, including incompatibilities. For more information: U.S. Department of Labor OSHA 3493-02 2012 (Continued on other side) www.osha.gov (800) 321-OSHA (6742) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[' Hazard Communication Appendix D QUICK CARD TM Hazard Communication Safety Data Sheets Section 8, Exposure controls/personal protection lists OSHA’s Permissible Exposure Limits (PELs); Threshold Limit Values (TLVs); appropriate engineering controls; personal protective equipment (PPE). Section 9, Physical and chemical properties lists the chemical’s characteristics. Section 10, Stability and reactivity lists chemical stability and possibility of hazardous reactions. Section 11, Toxicological information includes routes of exposure; related symptoms, acute and chronic effects; numerical measures of toxicity. Section 12, Ecological information* Section 13, Disposal considerations* Section 14, Transport information* Section 15, Regulatory information* Section 16, Other information, includes the date of preparation or last revision. *Note: Since other Agencies regulate this information, OSHA will not be enforcing Sections 12 through 15 (29 CFR 1910.1200(g)(2)). For more information: U.S. Department of Labor OSHA 3493-02-2012 Employers must ensure that SDSs are readily accessible to employees. See Appendix D of 29 CFR 1910.1200 for a detailed description of SDS contents. www.osha.gov (800) 321-OSHA (6742) BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[' Hazard Communication Appendix E BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[( Hazard Communication Appendix E BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[( Hazard Communication Appendix E BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[( Hazard Communication Appendix E BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[( Hazard Communication Appendix E BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[( Hazard Communication Appendix E BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[( BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[( Hazard Communication Appendix E BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[( Hazard Communication Appendix E BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[( Hazard Communication Appendix E BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[( Hazard Communication Appendix E BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[( Hazard Communication Appendix E BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[( Hazard Communication Appendix E BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[( Hazard Communication Appendix E BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH +D]DUG&RPPXQLFDWLRQV$SSHQGL[( Guidelines/Procedures SUBJECT: ACC Hazardous Waste Management Program ACC Management Safety Statement Guideline/Procedure for AR#: 3.03.006 Date Effective: PLACEHOLDER TABLE OF CONTENTS These Table of Contents divisions will be set up on the EHS web site as hyperlinks to the specific sections of the I. Introduction – Value Statement II. Hazardous Waste Management Regulations III. Duties and Responsibilities IV. Hazardous Waste Management Program A. EHS & Insurance Duties as Administrator of the Hazardous Waste Management Program B. Hazardous Waste Training C. Hazardous Waste Determination D. Disposal of Non-hazardous Waste E. Determining Your Generator Status F. Classification and Segregation of Hazardous Waste G. Containment and Storage of Hazardous Waste H. Satellite Accumulation Area and 180-day Accumulation Storage Areas I. Hazardous Waste Labels and Labeling J. Hazardous Waste Disposal & Tracking K. SQG Emergency Preparedness and Contingency Planning L. Hazardous Waste Management Recordkeeping & Reporting V. Other Regulated Waste A. B. C. D. E. F. G. H. Used Dry Solid Materials Used Oil, Used Oil Filters and Used Antifreeze Gas Cylinders Photographic Processing Waste Unknown Chemical Waste Universal Waste Biohazard Waste Contractor Waste VI. Source Reduction and Hazardous Waste Minimization VII. Emergency Procedures Appendix A Definitions Appendix B Identification of Hazardous Waste (EPA’s “P”, “U”, “F” and “K” listed hazardous waste) Appendix C Container Storage Inspection Sheets Appendix D Spill Prevention and Control Measures – Place Holder Appendix E Source Reduction and Waste Minimization Plan – Place Holder 2 AUSTIN COMMUNITY COLLEGE HAZARDOUS WASTE MANAGEMENT PROGRAM I. II. Value The purpose of this document is to inform faculty, staff, employees, and students at Austin Community College (ACC), regarding Federal and State hazardous waste disposal regulations and to define the ACC Hazardous Waste Management Program (Program). The Program pertains to hazardous waste and does not include procedures for the management of radioactive, infectious, and biological waste. The ACC Environmental Health Safety and Insurance Office (herein referred to as EHS & Insurance) administers the Hazardous Waste Management Program at ACC. Compliance with the program is critical and requires full cooperation by all College entities. Hazardous Waste Management Regulations The U. S. Environmental Protection Agency (EPA) administers the Resource Conservation and Recovery Act (RCRA). Under this Act, the EPA has the responsibility for regulating hazardous chemical wastes. RCRA established a "cradle to grave" hazardous waste management requirement to protect public health and the environment from improper disposal of hazardous waste. The law went into effect in November 1980. The Texas Commission on Environmental Quality (TCEQ) administers an equivalent to RCRA for the State of Texas under Industrial Solid Waste and Municipal Hazardous Waste Regulations of the Texas Administrative Code (TAC) (Title 30, Part I, Chapter 335). Appendix A provides definitions for commonly used RCRA words. Any business or industrial facilities, including academic institutions that generate hazardous waste are required to comply with EPA and TCEQ hazardous waste regulations. These regulations, contained in Title 40 Code of Federal Regulations (CFR) Parts 260-279 and Title 30 TAC Chapter 335 respectively, can be very difficult to understand. The intent of the following guidelines are to provide basic assistance in identifying wastes, in determining if these wastes are considered hazardous and identifying techniques to safely and correctly manage and dispose of these wastes. It is vital that generators work closely with EHS and Insurance Office to establish compliant procedures for the individual areas that generator hazardous waste. Since Federal and State regulations govern hazardous waste disposal at ACC, failure to comply with any hazardous waste regulation may result in substantial fines and penalties for the College; individual generators (e.g., principal investigators, employees) causing the violation may be 3 personally liable. It is ultimately the responsibility of the generator to determine whether their wastes are considered hazardous or not. EPA and TCEQ regulations stipulate that each individual who generates hazardous waste is personally liable and is responsible for assuring compliance with regulations and proper hazardous waste management. A waste generator never totally loses liability for environmental damage; therefore, the selection of a reliable disposal facility is very important. Violations may range from failure to properly label a container of hazardous waste to intentionally disposing of hazardous waste into the air, down the drain, or in the garbage. In Texas, penalties for non-compliance may be civil, criminal, or administrative violations with penalties ranging from fines of up to $25,000 per day to a 15-year prison term for individuals. ACC has applied for and received an identification number from the EPA and a Texas solid waste registration number from the TCEQ identifying ACC as a hazardous waste generator, as defined by RCRA. Some ACC campuses generate between 100 and 1,000 kg of hazardous waste per month and are subject to regulations applicable to non-industrial Small Quantity Generators, including hazardous waste storage up to 180 days. ACC has made the decision to internally manage all campus locations’ hazardous waste in compliance with the regulatory requirements for a Small Quantity Generator (SQG). This will enable the College to use one consistent set of guidelines for hazardous waste management. III. Duties and Responsibilities The ACC President is the College Official ultimately responsible for ACC’s compliance with environmental health and safety regulations. In addition, responsibility and liability for the Hazardous Waste Management Program extends to the ACC Board of Trustees. The ACC College President and Board of Trustees shall show visible support for safety as a value at ACC, through funding and appropriate staffing in support of the Program. The ACC Executive Team / Administrators are responsible for insuring implementation of the Hazardous Waste Management Program in their areas of responsibility, showing visible support for the program and for ensuring the health and safety of the College’s employees and students. The Dean, Unit Director, Department Chair will have ultimate responsibility for implementation and compliance with the ACC Hazardous Waste Management Program within their disciplines / areas / units. Various duties associated with this program may be delegated to personnel within the department/ unit. This designation of duties does not reduce ultimate responsibility of Unit Heads or Supervisory Personnel for compliance to the Program. 4 EHS & Insurance Office Duties as Administrator of the Hazardous Waste Management Program The EHS & Insurance Office coordinates the Hazardous Waste Management Program for ACC and designated ACC facilities. Duties of the EHS & Insurance Office include: 1. Assist areas/units with the implementation of and compliance with this Program, including but not limited to, training, hazardous waste stream determinations and classifications, oversight of hazardous waste disposal, establishing/coordinating area compliance audits and assisting with corrective actions. 2. Provide annual and refresher hazardous waste training to all required personnel as defined by RCRA. 3. Compile and maintain a list of all the College’s hazardous waste generators so that RCRA training can be documented. 4. Maintain manifest master file. Manifests are required to be maintained for a minimum of three years however, ACC will maintain them indefinitely. 5. Maintain liaison with the appropriate regulatory authorities (TCEQ, EPA, etc.). a) Submit required Notice of Registrations to the TCEQ when necessary. b) Submit annual waste summaries to the TCEQ for all facilities generating more than 220 pounds of hazardous waste in any one calendar month. 6. Ensure that a contract with a qualified, properly licensed hazardous waste disposal contractor is in place at all times. EHS and I Office will do, at a minimum, annual inspections of hazardous waste disposal contractors and associated facilities to ensure compliance with Federal and State regulations. 7. Coordinate a schedule with ACC’s designated hazardous waste disposal contractor for hazardous waste pick-ups at all facilities and to be present for all pick ups. The EHS & Insurance Coordinator (or the EHS & Insurance Director as backup) will sign all manifests for all regulated waste shipments. The Department of Transportation regulates the transportation of hazardous waste and EHS and I will ensure that EHS and I personnel are trained and certified as required by D.O.T. 5 8. Coordinate with generators on each campus to prepare for the scheduled hazardous waste pick-ups. 9. Coordinate with ACC’s designated environmental contractor whenever hazardous waste testing is needed at a facility. 10. Provide supportive technical consultation to ACC’s hazardous waste generators. IV. Hazardous Waste Management Program A. Introduction The Hazardous Waste Management Program for Austin Community College shall be administered by the EHS & Insurance Office, whose line of administrative authority is through the Vice President of Business Services. Generators are responsible for following the ACC disposal procedures, for ensuring that their employees are trained in proper disposal procedures, and for properly identifying the hazardous waste generated. Each academic, vocational or support department including instructional laboratory facilities which produces hazardous waste in any way, must, also, ensure that personnel who generate hazardous waste have received documented training in the use of the ACC hazardous waste handling system and are complying with ACC procedures in regards to hazardous waste. The Dean / Director of each group has ultimate responsibility for insuring compliance. A. Procedures The following procedures are intended to assure compliance with applicable EPA and TCEQ regulations for the proper management of hazardous chemical waste and to reduce adverse effects to human health and the environment. B. Hazardous Waste Training RCRA requires that employees of SQGs who manage or handle hazardous waste be trained. Initial training must be provided prior to an employee participating in any hazardous waste related activities. Annual refresher training must be completed within 13 months of the previous training. Training will be approved / provided by the EHS & Insurance Office. This training shall include: 6 1. 2. 3. 4. 5. 6. Overview of the both EPA and TCEQ regulations Generators’ responsibilities Hazardous waste determination Waste classification, labeling, segregation, and storage Spill cleanup procedures Disposal procedures Although SQGs are not required to maintain training records, ACC has opted to do so. The EHS & Insurance Office will maintain a master file of all ACC employees’ RCRA training records. C. Hazardous Chemical Waste Determination A material becomes "waste" when the individual generator determines that it is no longer useful and should be discarded. If the material is to be discarded, the EHS & Insurance Office must make a determination whether the waste is non-hazardous or hazardous for each waste stream generated by ACC. Because the primary source for waste determination is the generator's process knowledge, the EHS & Insurance Office utilizes a Chemical Inventory and Waste Stream Identification spreadsheet that the generator completes and returns to the EHS & Insurance Office within one day of a material being declared a waste. Certified Laboratories or licensed/certified waste vendors will perform chemical analyses to be used for the identification/characterization of unknown or improperly labeled wastes. ALL WASTE STREAMS MUST BE CLASSIFIED AS HAZARDOUS OR NONHAZARDOUS. CONTACT THE EHS & INSURANCE OFFICE CONCERNING NEW OR EXISTING WASTE STREAMS THAT ARE UNCLASSIFIED. Personnel classifying waste streams must be RCRA certified through appropriate and current RCRA training as specified in 40CFR Parts 260-279. All RCRA training must be approved through the Director of EHS and I. A material is "non-hazardous waste" if it does not meet the definition of “hazardous waste". “Hazardous waste” is any waste that is defined as being hazardous in 40 CFR Section 261.3 and 30 TAC Chapter 335, rule 335.504. A material is "hazardous waste" if it meets one or more of the following: 1. It is a chemical listed on one of the Chemical Tables in Appendix B (that provides EPA’s four hazardous waste lists with respective waste codes: “P”, “U”, “F” and “K”) By definition, EPA determined that some specific wastes are hazardous. These wastes 7 are incorporated into lists published by the Agency. These lists are organized into three categories: 2. 3. • The F-list (non-specific source wastes). This list identifies wastes from common manufacturing and industrial processes, such as solvents that have been used in cleaning or degreasing operations. Because the processes producing these wastes can occur in different sectors of industry, the F-listed wastes are known as wastes from non-specific sources. Wastes included on the F-list can be found in the regulations at 40 CFR §261.31 (click for hyperlink). • The K-list (source-specific wastes). This list includes certain wastes from specific industries, such as petroleum refining or pesticide manufacturing. Certain sludges and wastewaters from treatment and production processes in these industries are examples of source-specific wastes. Wastes included on the K-list can be found in the regulations at 40 CFR §261.32 (click for hyperlink). • The P-list and the U-list (discarded commercial chemical products). These lists include specific commercial chemical products in an unused form. Some pesticides and some pharmaceutical products become hazardous waste when discarded. Wastes included on the P- and U-lists can be found in the regulations at 40 CFR §261.33 (click for hyperlink). It is a mixture or solution containing a listed chemical) and a non-hazardous chemical. It meets the definition of one of the following for Characteristic Waste: Waste that does not meet any of the listings explained above may still be considered a hazardous waste if exhibits one of the four characteristics defined in 40 CFR Part 261 Subpart C — ignitability (D001), corrosivity (D002), reactivity (D003), and toxicity (D004 - D043). a) Ignitability (flashpoint <60o C (140o F) or supports combustion 1) 8 Ignitability – Ignitable wastes can create fires under certain conditions, are spontaneously combustible, or have a flash point less than 60 °C (140 °F). Examples include waste oils and used solvents. For more details, see 40 CFR §261.21 (click for hyperlink). Test methods that may be used to determine ignitability include the Pensky-Martens Closed-Cup Method for Determining Ignitability (Method 1010a) (PDF, 1 pp., 19 KB), the Setaflash Closed-Cup Method for Determining Ignitability (Method 1020b) (PDF, 1 pp., 17 KB), and the Ignitability of Solids (Method 1030) (PDF, 13 pp., 116 KB). (b) Corrosivity (pH ≤2 or≥12.5); Corrosivity – Corrosive wastes are acids or bases (pH less than or equal to 2, or greater than or equal to 12.5) that are capable of corroding metal containers, such as storage tanks, drums, and barrels. Battery acid is an example. For more details, see 40 CFR §261.22 (click for hyperlink). The test method that may be used to determine corrosivity is the Corrosivity Towards Steel (Method 1110a) (PDF, 6 pp., 37 KB). (c) Reactivity (e.g., responds violently to air or water, cyanides, explosives, unstable chemicals Reactivity – Reactive wastes are unstable under "normal" conditions. They can cause explosions, toxic fumes, gases, or vapors when heated, compressed, or mixed with water. Examples include lithium-sulfur batteries and explosives. For more details, see 40 CFR §261.23 (click for hyperlink) There are currently no test methods available. (d) Toxicity (e.g., pesticides, heavy metals, poisons); Toxicity – Toxic wastes are harmful or fatal when ingested or absorbed (e.g., containing mercury, lead, etc.). When toxic wastes are land disposed, contaminated liquid may leach from the waste and pollute ground water. Toxicity is defined through a laboratory procedure called the Toxicity Characteristic Leaching Procedure (TCLP) (Method 1311) (PDF, 35 pp., 288 KB). The TCLP helps identify wastes likely to leach concentrations of contaminants that may be harmful to human health or the environment. For more details, see 40 CFR §261.24. (click for hyperlink) 4. 5. It is a Universal Waste per 30 TAC 335.261; or Material is not excluded from the regulations It is critical that generators classify any waste they generate as either non-hazardous or hazardous 9 so that they will know how the proper disposal method. For example, it is illegal to dispose of hazardous waste in any of the following ways: 1. 2. 3. 4. Disposal through the sanitary drain such as sink drain, floor drain or urinal or toilets. Intentional evaporation in or outside a fume hood. Disposal in the regular trash. Disposal through storm drain, on paved surface or on the ground. However, non-hazardous waste may be disposed using the sanitary sewer or regular trash, with prior approval of the EHS & Insurance Office. Additional information about non-hazardous waste disposal can be obtained below or from the EHS & Insurance Office. D. Disposal of Non-hazardous Waste An area must have documented approval from the EHS & Insurance Office stating that the waste is non-hazardous prior to disposal as a non-hazardous waste. Not all chemical wastes are hazardous and so should not be entered into the ACC Hazardous Waste Management Program. The following guidelines for determining which non-hazardous wastes are suitable for disposal through normal waste channels were developed after careful review of TCEQ regulations. No waste that is defined as hazardous by the TCEQ or EPA may be placed in the regular trash. “Regular trash” is referring to placing material into dumpsters outside of a building or any trash can inside a building. Custodial services will not pick up any type of chemical placed in trashcans inside a building. Liquid waste (i.e., bottles of unused or partially used solutions) may never be disposed of in dumpsters because liquid wastes are not permitted at municipal landfills. Empty containers of waste commercial products or chemicals are acceptable if: • No freestanding liquids remain in the container and all disposal requirements noted on the label are complied with. • Empty chemical containers should be placed in a dumpster for disposal with other nonhazardous trash when the following requirements are satisfied: 10 o EPA regulations stipulate that an empty chemical container must: 1. Shall not contain free liquid or solid residue; 2. Pesticide containers or containers which contained acutely hazardous materials must be triple rinsed and the rinse water collected for disposal as hazardous waste 3. Have the label removed or defaced; 4. Have the lid or cap removed; and 5. Have a hole punched in the bottom (for metal or plastic containers). Certain solid, non-hazardous chemicals are suitable for disposal in the sanitary landfills.) Solid, non-hazardous waste must be placed directly in the dumpsters outside the building and not into the trashcans inside a building. The following types of solid waste, which are generally considered non-hazardous or of low toxicity can be put directly into dumpsters outside the building. 1. Organic chemicals: a. Sugars and starches b. Naturally occurring amino acids and salts c. Citric acid and its Na, K, Mg, Ca, NH4 salts d. Lactic acid and it’s Na, K, Mg, Ca, NH4 salts 2. Inorganic chemicals: a. Sulfates: Na, K, Mg, Ca, Sr, NH4 b. Phosphates: Na, K, Mg, Ca, Sr, NH4 c. Carbonates: Na, K, Mg, Ca, Sr, NH4 d. Oxides: B, Na, Ca, Sr, Al, Si, Ti, Mn, Fe, Cu, Zn e. Chlorides: Na, K, Mg f. Borates: Na, K, Mg, Ca g. Fluorides: Ca Note: As noted above, liquid solutions of such wastes should not be put into the dumpsters. Contact the EHS & Insurance Office prior to sewer disposal of such liquid solutions. 11 3. Laboratory materials not contaminated with hazardous chemicals: a. Chromatographic absorbents b. Filter papers, filter aids, and glassware c. Rubber and plastic protective clothing If there is any question as to whether a waste is acceptable for land filling, please contact the EHS & Insurance Office. E. Determining Generator Status There are three categories of hazardous waste generators: • Conditionally Exempt Small Quantity Generator (CESQG); • Small Quantity Generator (SQG); and • Large Quantity Generator (LQG). Typically, the more hazardous waste generated, the more stringent the regulations. The EHS & Insurance Office must know how much hazardous waste each ACC campus generates each month. This is necessary for three reasons: 1) to know what regulatory requirements apply to the campus; 2) to know the monthly amount when applying for the EPA identification number or when submitting modifications; and 3) to submit annual waste summary reports to the TCEQ. In order for the EHS & Insurance Office to determine the generator category for each campus, each generating area on a campus must count (track) the amount of hazardous waste and acutely hazardous waste that is generated each calendar month. The total weight of hazardous waste for the month determines the generator category. One acceptable counting method is to use a hazardous waste tracking log. The generator may create a log sheet that should have at minimum the date, type of chemical waste and amount. To facilitate the counting of hazardous waste, the tracking log can be kept on a clipboard and hung near the Satellite Accumulation Area storage containers. At the end of each semester, each generating area should provide a copy of their tracking log to the EHS&I Coordinator (or sooner if requested by the EHS & Insurance Office). If a campus falls into different generator categories from month to month, the campus should choose the more stringent requirements to ensure compliance. This last statement should not occur, but if 12 it does, then EHS&I should make determination and ensure compliance. F. Classification and Segregation of Hazardous Waste Hazardous chemical waste is categorized into the following hazard classes: 1. 2. 3. 4. 5. 6. 7. 8. Halogenated solvents Non-halogenated solvents Acids (inorganic or organic) Bases (inorganic or organic) Heavy metals (silver, cadmium, lead, mercury, etc.) Poisons (inorganic or organic) Reactives, water-reactive chemicals Flammables Different classes of hazardous chemical waste must not to be commingled in the same waste container. For example, do not combine inorganic heavy metal compounds with organic acidic waste solvents. In addition, do not combine non-hazardous waste (e.g., mixture of water, dilute acetic acid, and sodium bicarbonate) with hazardous chemical waste. Areas should contact EHS and I for assistance with these determinations. G. Containment and Storage of Hazardous Waste An integral part of any hazardous waste management program is the container storage areas. These areas are used to hold the waste prior to shipment to a permitted Treatment Storage and Disposal (TSD) facility. Individual hazardous waste generators shall maintain custody and control of their container storage areas. Generators should do the following regarding hazardous waste container storage: 1. Ensure the waste containers are accessible to the EHS & Insurance Office. 2. Accumulate their waste in safe, transportable containers that are properly labeled and stored to prevent human exposure to, or environmental release of, the hazardous waste materials. 3. Ensure that hazardous waste containers are compatible with the hazardous chemical waste contents (e.g., do not use metal containers for corrosive waste or plastic 13 containers for organic solvent). Currently, ACC’s hazardous waste disposal vendor supplies each campus with containers. 4. Use containers that are in good condition and do not leak. All containers must have suitable screw caps or other means of secure closure. Also true of universal wastes, e.g., batteries? 5. When waste containers) are required, contact the EHS & Insurance Office for assistance on selection and placement of appropriate container type and size. Never overfill hazardous waste containers. Expansion and excess weight can lead to spills, explosions, and extensive environmental exposure. The following guidelines will help prevent overfill of containers. 1. Containers of solids must not be filled beyond their weight and volume capacity. 2. Jugs and bottles should not be filled above the shoulder of the container. 3. Closed-head cans (5 gallons or less) should have at least two inches of headspace between the liquid level and the head of the container. 4. Closed-head drums (larger than 5 gallons) should have at least four inches of headspace. Containers must be closed or sealed to prevent leakage. All waste collection containers must be kept closed except when adding or removing material. H. Satellite Accumulation Area and 180-Day Accumulation Storage Areas Hazardous waste that is generated at or near the point of generation is accumulated in a Satellite Accumulation Area (SAA). Once the waste leaves the SAA, it can be stored in 180-Day Accumulation Storage Area. As stated above in Section II, ACC has opted to store hazardous waste in compliance with the SQG regulatory requirements, which allows for 180-Day Accumulation Storage Area. Each accumulation area has specific requirements set forth in the regulations. The following requirements pertain to Satellite Accumulation Areas: 1. 14 The area is secured from “Unauthorized Entry”. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. Warning signs (specify) and emergency contacts are posted. These signs are available from EHS and I. Hazardous waste is stored in a designated and marked area. Storage containers are properly labeled with the words “hazardous waste” or with other words that identify the contents of the containers. Storage containers are in good condition. If container begins to leak, the generator must transfer the hazardous waste from the leaking container to a container in good condition. Storage containers must be compatible with the hazardous waste being stored (i.e. made of or lined with materials which will not react with the hazardous waste). Storage containers must be closed except when adding waste. Full storage containers are properly labeled as indicated above and marked with an accumulation start date (reflects the date of the day that the container becomes full). Once an accumulation start date is assigned, no more materials can be added to the container. Areas must be accessible to EHS & Insurance personnel. Hazardous waste containers are separated from non-waste chemicals. Less than 55 gallons of any one hazard class of waste or one quart of acutely hazardous waste is being stored. Full containers labeled and marked with an accumulation start date are not stored for more than three days. The generator must transfer full containers to the 180Day Accumulation Storage Area within three days. Appropriate spill Control Equipment is available. Weekly inspection of the Satellite Accumulation Area must be completed, using the form in Appendix C The following requirements pertain to 180-day Accumulation Storage Areas: 1. 2. 3. 15 The area is secured from “Unauthorized Entry". Warning signs (specify) and emergency contacts are posted. EHS & Insurance is the RCRA designated Emergency Coordinator. These signs are available from EHS and Insurance Office. Hazardous waste containers and drums stored in the container storage must adhere to the following guidelines. a. Containers are properly labeled with the words “hazardous waste” and marked with an accumulation start date. Once an accumulation start date is assigned, no more materials can be added to the container. b. Drums are marked with a completed RCRA sticker. ACC’s hazardous waste disposal vendor will apply appropriate Department of Transportation (DOT) labeling prior to shipment. c. Containers are closed except when adding or removing waste. d. Containers are in good condition and not leaking. e. Containers are properly segregated according to hazard class and separated from non-hazardous waste chemicals. f. Containers are stored to maintain aisle space to allow the unobstructed movement of personnel so that they can be inspected. g. Containers have not been stored for more than 180 days (or 270 days if TSD facility is greater than 200 miles away. 4. Area is inspected weekly (Appendix C provides a copy of the Container Storage Area Inspection Sheet). Monthly inspection records are to be submitted to the EHS & Insurance Office by the 5th day of the following month. Inspection records are to be maintained for 1 year. 6. Appropriate spill prevention and control measures are established (see Appendix D). I. Hazardous Waste Labels and Labeling 1. 2. 3. 16 The original chemical label on containers used for waste accumulation must be destroyed or defaced. EPA regulations require that hazardous waste containers be labeled with the words "Hazardous Waste" when the hazardous waste is first added to the container. Containers at ACC can be labeled in one of two methods: a. For small containers (less than 5-gallons), attach a completed Hazardous Waste Disposal Tag (available from the EHS & Insurance Office) with string to each new waste container when the chemical is first added. Print the information on the tag legibly. Do not fill in the accumulation start date. • Alternate means of identifying waste constituents, dates and quantities may be used with the prior approval of EHS & I Office. These may be in the form of spreadsheets or tabulation documents that are supplied to EHS & I Office at the time a chemical waste pickup is requested. b. For containers larger than 5-gallons, a Hazardous Waste Label (available from the EHS & Insurance Office) can be used. These labels have an adhesive back and are placed on the container when the chemical is first added. Hazardous waste labels for printing out are available through this hyperlink Hazardous Waste Labels. Identify the hazardous waste on the label but do not fill in the accumulation start date. Follow the example below to properly complete your hazardous waste disposal tag: Fill in the Accumulation Start Date and attach a completed waste disposal tag when the waste container is full and /or ready for pickup. HAZARDOUS WASTE ACCUMULATION START DATE CONTENTS acetone, chloroform, hexane oil, water HANDLE WITH CARE! CONTAINS HAZARDOUS OR TOXIC WASTE 17 (ATTACH TAG TO CONTAINER WITH STRING) HAZARDOUS WASTE DISPOSAL TAG -----------------------------------------------------------------------2 REQUESTOR : DEPT/PART: John Doe Chemistry PHONE: 5-3140 CHEMICAL (S)3: Methylene Chloride, Toluene Attach An Individual Hazardous Waste Disposal Tag To Each Waste Container Both upper and lower sections of the tag must be filled out completely and legibly except for the accumulation date when chemical is first added to a waste container. (This information is essential for record keeping). 1 Fill in the Accumulation Start Date when the waste container is full and/or ready for pickup. HAZARDOUS WASTE DISPOSAL TAG ACCUMULATION START DATE1: 5/22/96 Secure the top part of the tag with a string that encircles the top of the container - rubber bands, tape, and wire are not acceptable. 2 The "REQUESTOR" is the Principal Investigator or person in charge of the lab that generated the waste. REQUESTOR2: John Doe DEPT/PART: Chemistry BLDG.NAME & NO: Chemistry - 376 ROOM NO. 2002 PHONE: 53140 CHEMICAL (S)3: Methylene Chloride, Toluene PHYSICAL PROPERTY: Solid ____ Gas ___Other 18 _____Liquid ____ 3 Chemical name/Common name. Chemical formulas or abbreviations are not acceptable. List all chemical components in a waste container (including water). Lists may be continued on the back of the tag. Tags for containers of potentially explosive materials such as picric acid, silanes, nitro compounds, and ethers must indicate the percent concentration of these chemicals. Place any additional Hazard Information about container contents in REMARKS. 19 J. Hazardous Waste Disposal & Tracking The EHS & Insurance Office will supply ACC generators a Chemical Waste Request for Disposal form, coordinate disposal requirements with generators, maintain records of disposal services, and provide reports as appropriate to Federal or State agencies. TCEQ and EPA regulations require “cradle to grave” tracking of hazardous waste shipments in order to ensure proper disposal. Two main forms are required: the Texas Uniform Hazardous Waste Manifest (Form TNRCC-0311) and land ban documentation. The manifest has four (carbon) copies: green, yellow, pink, and white. ACC’s hazardous waste disposal vendor prepares all manifests on behalf of the College prior to pick up. The EHS & Insurance Office is responsible for signing all manifests by hand. Individuals signing manifests must be certified through appropriate and current training under 49 CFR – U. S. Department of Transportation (DOT) regulations. At the time of pick up, the initial transporter of the hazardous waste (ACC’s hazardous waste disposal vendor) and generator (EHS & Insurance Office) provides a handwritten signature and date of acceptance on the manifest. The EHS & Insurance Office will retain the green copy and give the transporter the remaining copies of the manifest. The TSD facility must also sign the manifest upon receipt of the hazardous waste shipment. At this point, the transporter is given the yellow copy and the TSD facility keeps the pink copy and returns the original white copy with all signature blocks signed and dated to the EHS & Insurance Office. The TSD facility must treat listed and characteristic hazardous waste to meet appropriate standards before land disposal. SQGs must determine whether their waste is restricted from land disposal. This can be done by testing, process knowledge, or a combination of both. SQGs shipping hazardous waste must attach a statement to the manifest declaring whether any land disposal restrictions (LDR) apply to the waste. The LDR includes information on the constituents, categories, and testing data, if available. ACC’s hazardous waste disposal vendor will handle land ban testing of hazardous waste and will attach the appropriate information and statement (typically a LDR) to the manifest. However, ACC is still responsible for their waste and must also maintain land ban documentation for at least three years. ACC has chosen to maintain land ban documentation indefinitely. The EHS & Insurance Office arranges vendor-performed routine hazardous waste disposal pickups at the end of each semester. Approximately one month prior to each pickup, the EHS & Insurance Office will contact all hazardous waste generators and request they complete a Chemical Waste Request for Disposal Form, identifying the hazardous wastes each generator has for the upcoming waste shipment. If a Hazardous Waste Tag is used, the bottom section of the tag must also be sent to the EHS & Insurance Office at this time. These requests are then compiled into a master list and provided to the hazardous waste disposal vendor. More frequent vendor pickups for hazardous waste may be scheduled by the EHS & Insurance Office based on needs at individual Campuses or areas. The generator requesting hazardous waste disposal service shall ensure that their waste containers meet the following requirements: 1. The containers are not sitting in the corridors or areas where waste could cause a health exposure to personnel. 2. The containers are correctly identified by chemical name/common name. Chemical formulas are not acceptable. When a Hazardous Waste Disposal Tag is completed, fill 20 in the accumulation start date on the disposal tag, separate the bottom part of the tag, and Inter Office mail it to the EHS & Insurance Office. 3. Labeled containers of liquid/solid chemical waste that are to be stored in the in the 180-Day Accumulation Storage Area. Complete a Chemical Waste Request for Disposal Form for all containers of hazardous waste materials. Instructions for this form are available from EHS & Insurance’s Web site. 4. Containers of liquid and solid waste are in good condition so that handling can be done in a safe manner and that containers do not leak at a later date. Containers must be suitable for the types of chemicals they hold and must be suitable for storage for at least 180 days. Containers must be closed or sealed in such a manner that leakage will not occur. ACC’s hazardous waste disposal vendor will not pickup containers with improper caps, leaks, outside contamination, or improper labeling. 5. All hazardous waste containers are properly segregated and clearly marked regarding the contents, hazards and other pertinent information. 6. Inform the EHS & Insurance Coordinator (ext.3-1021) of any special handling requirements. 7. For lab packs send a Lab Pack Waste Request for Disposal form that includes a list of all chemicals and quantities to the EHS & Insurance Office. K. SQG Emergency Preparedness and Contingency Planning SQGs must designate an Emergency Coordinator to coordinate all emergency response measures. The emergency coordinator must be on the premises or on call. The EHS & Insurance Director is the Emergency Coordinator for all ACC campuses. EHS & I Office will provide the required signs for each generating area at each campus to post next to the telephone or in a visible location on outside waste storage buildings. These signs will contain the following information: 1. Post the name and telephone number of the emergency coordinator; 2. Location of fire extinguishers and spill control material, and if present, fire alarm; and 3. The telephone number of Campus Police Dispatch and the fire department, unless the campus has a direct alarm As part of a facility’s contingency planning, the EHS & Insurance office will attempt to make arrangements with the appropriate local emergency response authorities regarding the type of waste handled at the facility and the potential need for these organization’s services. The arrangements should include the following: 1. Arrangements to familiarize police, fire departments, and emergency response teams with the layout of the facility, properties of hazardous waste handled at the facility and associated hazards, places where facility personnel would normally be working, entrances to roads inside the facility, and possible evacuation routes; 2. Where more than one police and fire department might respond to an emergency, agreements designating primary emergency authority to a specific police and fire department; 3. Agreements with State emergency response teams, emergency response contractors, and equipment suppliers; and 4. Arrangements to familiarize local hospitals with the properties of hazardous waste handled at the facility and the types of injuries or illnesses that could result from fires, explosions or releases at the facility. 21 L. Hazardous Waste Management Recordkeeping & Reporting 1. Hazardous Waste Manifest – SQGs are required to keep a copy of each signed manifest for three years from the date the waste was accepted by the initial transporter. However, the EHS & Insurance Office has opted to maintain manifests indefinitely. 2. Land Ban Documentation - SQGs are required to retain on-site a copy of all notices, certifications, waste analysis data (including Land Disposal Restrictions for at least three years. As with the manifest, the EHS & Insurance Office will maintain them indefinitely. 3. Contingency Plans – SQGs are not required to maintain a written contingency plan. 4. Annual Waste Summary – SQGs must submit an annual waste summary to the TCEQ. SQGs may submit their summary in written format. The TCEQ uses this information to calculate a generator’s annual waste generation fee. V. Other Regulated Waste A. Used Dry Solid Materials Used dry solid materials (paper, rags, towels, gloves, or Kim Wipes, etc.) contaminated with a listed hazardous constituent or with extremely toxic chemicals must be double-bagged in heavy-duty plastic bags and disposed as hazardous waste. Do not use biohazard bags. ACC has also opted to treat dry solid materials contaminated with a characteristic hazardous constituent (a wipe in contact with a flammable solvent such as acetone) as hazardous waste. This is due to the potential for these type materials to also have been in contact with a listed hazardous constituent or extremely toxic chemical. The EHS & Insurance Office has permitted an alternative to hazardous waste disposal of dirty solvent rags with use of a commercial laundry service, G & K Services. In this case, G & K Services routinely picks up dirty solvent rags (that are typically stored in red metal flip top cans) for laundering and replaces them with clean rags. B. Used Oil, Used Oil Filters and Used Antifreeze Used oil is any petroleum-based or synthetic oil that has been used. Used oil that has not been contaminated with any other hazardous material is considered to be a non-hazardous waste. Used oil should be stored in storage containers (30 or 55-gallon metal or poly drums if possible) or tanks. Label all containers and tanks with the words “Used Oil”. Keep containers and tanks in good condition. Do not allow tanks to rust, leak, or deteriorate. As a good management practice, keep containers and tanks closed unless adding to or removing used oil. Do not mix any hazardous material or waste with used oil. To be sure that your used oil does not become contaminated with hazardous waste, store it separately from all solvents and chemicals and do not mix it with anything. Used oil contaminated with a listed hazardous waste must be managed and disposed of as a hazardous waste. EPA hazardous waste code “F002” must be used on used oil that is listed due to halogenated contaminants. Non-contaminated used oil does not require an EPA hazardous waste code. Used oil is sent out for vendor recycling at ACC. When a used oil pick up is required, contact the EHS & Insurance Office and a pick up will be scheduled. Used oil can be accumulated indefinitely provided it is non-contaminated. Please accumulate at least 55 gallons before calling for a pick up. 22 Used oil filters are also picked up for vendor recycling. Texas law prohibits the dumping of used oil on land, in sewers, and in waterways. Texas has also banned used oil and used oil filters from being placed in or accepted for disposal in a landfill. Currently ACC has one area, Riverside Campus Automotive, which generates used oil and used oil filters for vendor recycling. Used antifreeze removed from vehicles may be a hazardous waste. The EPA or TCEQ have not issued specific regulations for used antifreeze, but general rules for hazardous waste can apply. After antifreeze goes through a radiator it may be contaminated with gasoline, oils and metals (includes lead, mercury, cadmium, chromium, copper and zinc). Metals and benzene (from gasoline) are toxic and may cause the used antifreeze to be a hazardous waste. Antifreeze would also be considered hazardous if it were mixed with a hazardous material such as a degreasing solvent or gasoline. In addition, antifreeze could be hazardous if it comes from an old car where the antifreeze has been sitting for years and has picked up enough metals to be characterized as hazardous for metals content, e.g., >5 parts per million (ppm) lead, or if the pH is ≥12.5. ACC’s disposal option for used antifreeze is vendor recycling, if available. If ACC’s used antifreeze cannot be recycled, it must be disposed of as hazardous waste. Used antifreeze should never be dumped into a sanitary sewer, storm drain, ditch, dry well or septic system. Many sewage treatment agencies responsible for wastewater treatment prohibit waste antifreeze disposal into sanitary sewers. Waste antifreeze disposed of down storm drains or into surface? causes serious water quality problems and may harm people, pets and wildlife. C. Gas Cylinders Gas cylinders should be returned to the manufacturer or distributor whenever possible. Non-returnable gas cylinders should be labeled and disposed of as hazardous waste. D. Photographic Processing Waste Photographic lab waste containing silver must be disposed as hazardous waste. However, silver recovery units include a filtration system that removes the silver. Photographic lab effluent that does not contain silver may be discarded through the sanitary sewer system. Please notify the EHS& Insurance Office if you have this type of equipment. E. Unknown Chemical Waste "Unknown" chemical waste will be handled by the EHS & Insurance Office. Place a waste disposal tag on the container using "unknown" for the chemical waste description. In addition, mark or label the container as ‘hazardous waste’. ACC will manage the waste as hazardous until testing results indicate otherwise. Any area generating an unknown chemical waste will be required to supply a documented 23 corrective action provided by the Dean, Director or unit head of the generating area. F. Universal Waste Universal waste is any hazardous waste subject to 40 CFR Part 273 (Standards for Universal Waste Management) and 30 TAC 335.261 (Universal Waste Rule). As part of EPA’s commitment to reinvent environmental regulations, the Agency issues the “Universal Waste Rule.” This rule was designed to encourage recycling and proper disposal of certain common hazardous waste wastes while also reducing the regulatory burden on facilities that generate these wastes. Basically, the TCEQ Universal Waste Rule offers alternatives to the otherwise applicable regulations for managing five types of hazardous waste in Texas: A. B. C. D. E. Batteries including lead-acid as described in 40 CFR 273.2; Pesticides as described in 40 CFR 273.3; Mercury Thermostats as described in 40 CFR 273.4; Lamps (mercury, metal halide, etc.) as described in 40 CFR 273.5; and Paint and paint related waste as described in 30 TAC 335.262(b). For more information please refer to the EHS & I Office web site Universal Waste Procedures or contact EHS & I Office for additional information. G. Biohazardous Waste Sharps (needles, razor blades, scalpel blades, syringes, glass Pasteur pipettes, etc.) are classified as biohazardous waste even if they are not contaminated. Sharps must be encapsulated (placed in a "puncture resistant" container or plastic/metal container and filled with paraffin or plaster of paris). Discard the containers of sharps as bio-hazardous waste. For additional information on disposal of bio hazardous waste, please refer to the EHS & I Office web site Bio-Hazardous Waste Procedure (link to procedure) or contact the EHS & Insurance Office for additional information. H. Contractor Waste Any hazardous waste that is generated in conjunction with contractor / vendor work performed for ACC falls under the same regulatory requirements as if ACC is the generator. Project managers, project coordinators and purchasing are responsible for clearly delineating in the contract that is responsible for managing the hazardous waste generated by a contracted project. The contract must clearly state that the vendor assumes responsibility for disposing of hazardous waste generated by a project in adherence to all applicable state and federal regulations. If it is not clearly stated in the contract that the vendor is responsible for hazardous waste disposal, ACC is responsible for proper disposal of any hazardous waste generated from the project being performed for the College. The project manger will be required to follow procedures outlined in this document. ACC still retains ultimate responsibility as generator of the hazardous waste. Refer to Contractor Safety Manual. 24 VI. Source Reduction and Hazardous Waste Minimization Hazardous waste regulations have evolved from emphasis on reduction to the prevention of environmental pollution. The Pollution Prevention Act of 1990 (Federal Regulation) made the prevention of pollution and reduction of waste generation, a national priority. The Texas Waste Reduction Policy Act (Senate Bill 1099 of 1991) requires Large Quantity Generators to prepare and implement a Source Reduction and Waste Minimization Plan. At this time, ACC is not required to develop a Plan due to being a Small Quantity Generator. Appendix E has been included in the event a Plan is required to be developed due to an increase in generator status. The Plan will be developed and coordinated by the EHS & Insurance Office. The key to the Plan is "front-end minimization". Front-end minimization means reducing hazardous waste by reducing the quantities of hazardous chemicals used and by substituting less hazardous materials. Teaching laboratories and other working groups (Physical Plant, Power Plant, etc.) that generate hazardous waste should review their purchasing practices and systems, chemical usage patterns, and workplace activities to identify potential points of their operations where source reduction and waste minimization can be implemented. • Prudent Practices and Special Concerns 1. Minimizing Quantities of Hazardous Waste – It is common practice to order chemicals in larger quantities than necessary to take advantage of reduced costs of substances. As a result, aging reagents or solvents are left for disposal. With the current high disposal costs, often disposal is more than the initial acquisition cost of the chemicals. It is estimated that as much as 40% of laboratory hazardous waste may be unused chemicals. Besides reducing the disposal cost, smaller inventories reduce exposure to personnel. Storage of unused chemicals for an extended period of time tends to increase the risk of an accident. Another way to reduce quantities of waste is by precipitating out the active chemicals and drying or filtering the water from the hazardous waste. As waste technology advances, the removal of non-hazardous materials and separation of chemicals from waste is becoming more desirable. This is often most easily accomplished at the point of generation. 2. Substitution - Substitution of non-hazardous or less hazardous chemicals for a hazardous chemical is a commonly used method of reducing hazards and wastes. Examples include using hot water and soap for cleaning instead of toxic, flammable organic solvents; "Nochromix" instead of toxic chromic/sulfuric acids; water-based paints instead of oil-based paints; spiritfilled thermometers instead of mercury-filled thermometers; and non-carcinogenic solvents instead of carcinogenic solvents. Substitution is not always possible but should be accomplished when practical. 3. Surplus Chemical Exchange - The concept of exchanging excess solvents and reagents with other labs or departments needing these materials reduces purchasing and disposal costs. It has 25 been established that other labs can use about 30% to 40% of excessive or unused materials. Exchange of materials should be emphasized. EHS and I Office must be contacted to arrange for transportation of chemicals. Chemicals shall be transported by vendors that are certified / licensed to transport chemicals. 4. Unknown - Unknowns are a special problem in labs, especially when labs change occupants or processes. Labs should be cleaned up and old unneeded chemicals disposed of by the occupant who is terminating the use of the lab. Immediately label all chemicals so that they do not become unknowns. All chemicals, mixtures and solutions should be clearly labeled at all times. All unknowns will have to be analyzed by an EPA certified laboratory in order to have constituents or characteristics identified to allow for proper waste classification. Although analysis is often expensive and time consuming, there is no alternate solution to proper identification of unknown hazardous waste or materials. Cost for analysis and identification of any unknowns, whenever necessary, is the responsibility of the generator of the unknown hazardous waste and will be accomplished prior to request for disposal. 5. Special Laboratory Disposal Methods - The EPA and the TCEQ provide several regulatory exclusions that allow generators to treat hazardous waste without a permit. One on-site treatment method is elementary neutralization. This treatment is used to neutralize corrosive (D002) wastes. For example, small amounts of common inorganic acids (except hydrofluoric and chromic acids) can be diluted and neutralized to a pH between 5 and 10 and disposed of via the sanitary sewer. Hazardous chemicals can be treated to reduce the hazard or the quantity of waste in the laboratory ONLY if the treatment procedure is included as part of the written experimental protocol. This must be approved through the EHS & Insurance Office. Inert, non-toxic salts, sugars and buffers can be diluted and disposed via the sanitary sewer. Contact the EHS & Insurance Office before any treatment or disposal of chemical waste is performed in the laboratory. 6. Reactive Materials - Reactive wastes include cyanides, sulfides, air and/or water reactives, oxidizers, explosives, and flammable solids. Special care must be exercised when handling these materials to prevent contact with incompatible materials, such as air, water or organic materials. Reactives should be isolated from other hazardous waste and should be stabilized whenever possible. For example, water reactives should be stored in a desiccator and picric acid should always be saturated with water. 7. Disposal Costs - A lab-pack is the most common and most expensive method of packaging nonbulkable solid chemical waste, such as toxics and reactives, for disposal. Chemical waste materials in various sized containers are packed into metal drums for transportation and final disposal. An inert packing material (vermiculite) is used to surround and protect the containers. Lab-packs contain a maximum of 17 gallons of waste chemicals per 55-gallon drum, 8 gallons per 30-gallon drum, and 1 gallon per 5-gallon pail. The most recent disposal cost of a 55-gallon lab-pack averages about $550.00. This cost includes preparation, packaging, labeling, transportation, and ultimate treatment or disposal. 26 8. VII. Non-hazardous Waste Disposal - All chemical wastes that do not meet the definition of a RCRA hazardous waste must still be disposed of properly to protect human health and the environment. In most cases, disposal via the sanitary sewer or the trash is not permitted; however, there are exceptions, which will be made by the EHS & Insurance Office on a case-by-case basis. Emergency Procedures Chemical-using personnel and students (specify - what about students?) are required to receive training on the hazards associated with chemicals used and how to respond to emergencies). ACC Hazard Communication Program requires that ACC employees be informed of hazardous materials that they might use or be exposed to at work. In addition, the program should include training on handling spills and other emergencies. Material Safety Data Sheets (MSDSs) are a source of this information and should be maintained for all chemicals used or stored within a workplace. Special cleanup supplies should be available and employees should be trained on how to use these supplies. The EHS & Insurance Office can provide additional information on handling specific chemical spills. Hazardous waste disposal procedures should be followed for disposal of contaminated clothing, rags, absorbent materials or other waste generated from clean up of spills or leaks. All chemical-using areas should post emergency numbers to be used and develop a response scenario for emergencies. All chemical users should know emergency numbers and develop a response scenario for emergencies. Refer to ACC Hazardous Material Spill Procedure APPENDIX A: DEFINITIONS Accumulation Start Date The date when a hazardous waste container is full. This is the date from which a Small Quantity Generator has 180 days to dispose of the waste. Acutely Hazardous Waste Wastes are considered "acutely hazardous". These are wastes that the EPA has determined to be so dangerous in small amounts that they are regulated the same way large amounts of other hazardous wastes are. These include all "P" listed wastes and mixtures under EPA waste codes F020, F021, F022, 27 F023, F026 and F027 from non-specific sources found in the federal regulations (40 CFR Part 261 Subpart D.). 180-Day Accumulation Storage Area – Site designated by the Environmental Health Safety & Insurance Office to be used for the storage of hazardous wastes prior to shipment to permitted disposal facilities. Characteristic Hazardous Waste Waste that exhibit one or more of the four characteristics referenced in the federal regulations (40 CFR Part 261 Subpart C) is considered hazardous. Disposal The discharge, deposit, injection, dumping, spilling, or placing of any solid waste or hazardous waste (whether containerized or non-containerized) into or on any land or water so that such solid waste or any constituent thereof may enter the environment or be emitted into the air or discharged into any water, including ground waters. EPA Identification Number – The number assigned by the Environmental Protection Agency to each generator, transporter, and processing, storage or disposal facility.. Facility – Includes all contiguous land, and structures, other appurtenances, and improvements on the land used for storing, processing, or disposing of municipal hazardous waste or industrial solid waste. Generator – Any person, by site, who produces municipal hazardous waste or industrial solid waste; any person who possesses municipal hazardous waste or industrial solid waste to be shipped to any other person; or any person whose act first causes the solid waste to become subject to regulation. Person refers to an individual, trust, firm, corporation, Federal Agency, State, political subdivision of a State, municipality, or any interstate body. Hazardous Material – A substance or material, including a hazardous substance, which has been determined by the Secretary of Transportation to be capable of posing an unreasonable risk to health, safety, and property when transported in commerce, and which has been so designated. Hazardous Waste – Any solid waste material listed or identified in Title 40 Code of Federal Regulations, Part 261, Subpart C and D or exhibiting the characteristics of ignitability, corrosivity, reactivity, or E.P.A. toxicity also defined in Part 261. Tables containing the listing and characteristics of hazardous wastes are shown in Appendix B. Lab Pack - 28 Method of categorizing unused, obsolete or unknown chemicals, determining the optimum disposal process, and implementing lab pack disposal. Qualified personnel pack these materials in compliance with EPA and DOT regulations. For example, the EPA requires that carriers be federally licensed and insured and that disposal facilities comply with their standards. The DOT mandates that waste materials be packaged, labeled and shipped according to its regulations. Listed Hazardous Waste Over 400 commercial chemical products and wastes from specific industrial and manufacturing processes are listed as hazardous wastes in the Code of Federal Regulations (40 CFR Part 261 Subpart D.) Listed wastes have a chemical specific or generic mixture identification number assigned by the EPA. For example; Phenol is U188, a certain chlorinated solvent mixture might be F002 depending of the mixture. Listed waste consists of four lists defined by the EPA, the K-list, F-list, U-list and P-list. Manifest – A legal document containing required information, which must accompany shipments of Municipal Hazardous Waste or Class I-Industrial Solid Waste transported on public roads or thoroughfares. Mixed Waste – A radioactive waste that is also a hazardous waste. Permit – A written document issued by EPA or TCEQ that, by its conditions, authorizes the construction, installation, modification, or operation of a specified municipal hazardous waste or industrial solid waste storage, processing, or disposal facility in accordance with specified limitations. Person Any individual, corporation, organization, government or governmental subdivision or agency, business trusts, partnership, association or any legal entity. Processing – The extraction of materials, transfer, volume reduction, conversion to energy, or other separation and preparation of solid waste for reuse or disposal, including the treatment or neutralization of hazardous waste, designed to change the physical, chemical, or biological character or composition of any hazardous waste so as to neutralize such waste, or as to recover energy or material from the waste or so as to render such waste non-hazardous or less hazardous; safer to transport, store, and dispose; or amenable for recovery, amenable for storage, or reduced in volume. Recyclable Materials – Wastes that are recycled. Recycled material is used, reused, or reclaimed. Reclaimed material – Is processed or regenerated to recover a usable product. Examples: Recovery of lead from spent batteries, or regeneration of spent solvent. 29 Satellite Accumulation Area – An area, system, or structure used for temporary accumulation of hazardous waste prior to transport to the central accumulation area. Solid Waste – Any garbage, refuse, sludge from a waste treatment plant, water treatment plant, or air pollution control facility or other discarded material, including solid, liquid, semi-solid, or contained gaseous material resulting from industrial, municipal, commercial, mining and agricultural operations, and from community and institutional activities. Storage – The holding of solid waste for a temporary period, at the end of which the waste is processed, disposed of, recycled, or stored elsewhere. Texas Solid Waste Number – The number assigned by the TCEQ to each generator, transporter, and processing, storage, or disposal facility. TCEQ The Texas Commission on Environmental Quality is the governing agency responsible for regulating the discharge of pollutants into waters of the state; regulates hazardous and industrial solid waste generation, storage, transportation, treatment and disposal; and regulates the cleanup of inactive and abandoned hazardous waste sites in the State of Texas. Transporter – Any person who conveys or transports municipal hazardous waste or industrial solid waste by truck, ship, pipeline or other means. Universal Waste – Any hazardous waste subject to 40 CFR Part 273 and 30 TAC 335.261 to include: F. Batteries including lead-acid as described in 40 CFR 273.2; G. Pesticides as described in 40 CFR 273.3; H. Mercury Thermostats as described in 40 CFR 273.4; I. Lamps as described in 40 CFR 273.5; and J. Paint and paint related waste as described in 30 TAC 335.262(b). Used Oil Used oil is any petroleum-based or synthetic oil that has been used Waste – Any material for which there is no use and is to be discarded as valueless. 30 APPENDIX B: IDENTIFICATION OF HAZARDOUS WASTE 40 CFR Subpart C—Characteristics of Hazardous Waste § 261.20 General. § 261.21 Characteristic of ignitability. § 261.22 Characteristic of corrosivity. 31 § 261.23 Characteristic of reactivity. § 261.24 Toxicity characteristic. Subpart D—Lists of Hazardous Wastes § 261.30 General. § 261.31 Hazardous wastes from non-specific sources. § 261.32 Hazardous wastes from specific sources. § 261.33 Discarded commercial chemical products, off-specification species, container residues, and spill residues thereof. § 261.35 Deletion of certain hazardous waste codes following equipment cleaning and replacement. § 261.38 Comparable/Syngas Fuel Exclusion. Appendix I to Part 261—Representative Sampling Methods Appendix II to Part 261 [Reserved] Appendix III to Part 261 [Reserved] Appendix IV to Part 261 [Reserved for Radioactive Waste Test Methods] Appendix V to Part 261 [Reserved for Infectious Waste Treatment Specifications] Appendix VI to Part 261 [Reserved for Etiologic Agents] Appendix VII to Part 261—Basis for Listing Hazardous Waste Appendix VIII to Part 261—Hazardous Constituents Appendix IX to Part 261—Wastes Excluded Under §§260.20 and 260.22 Appendix C - SATELLITE ACCUMULATION AREA WEEKLY INSPECTION FORM 32 Following 2 forms will be posted on web and hyperlinked to program 180 Day Accumulation Area Inspection Sheet Weekly Inspection Date: _______________________________ Location: Department: ______________________________ Contact Person: __________________ Inspected by: _____________________________ 33 Accumulation Time 1. Is the beginning date of accumulation clearly indicated on each container? □ N/A □ Yes □ No 2. Has accumulation time limitation been exceeded? □ N/A □ Yes □ No 3. Has accumulation quantity been exceeded? □ N/A □ Yes □ No 4. Is each container being used to collect waste marked “Hazardous Waste” and identifiable contents? □ N/A □ Yes □ No Comment: Containers 1. Are containers in good condition? □ N/A □ Yes □ No 2. Are all containers kept closed and stored in a safe manner? □ N/A □ Yes □ No 3. Is waste compatible with container? □ N/A □ Yes □ No 4. Any noticeable chemical contamination on the containers? □ N/A □ Yes □ No 5. Are containers inspected weekly for leakage and deterioration? □ N/A □ Yes □ No Comment: Storage 1. Are incompatible wastes appropriately separated? □ N/A □ Yes □ No 2. Does the storage area have containment protection? □ N/A □ Yes □ No 3. Are spill cleanup supplies available? □ N/A □ Yes □ No A. Date and time of inspection? □ N/A □ Yes □ No B. Name of inspector? □ N/A □ Yes □ No C. Recorded observation and date of repairs/remedial action? □ N/A □ Yes □ No Comment: 4. Does the inspection log include: Comment: 34 Discharges 1. Is there any evidence of spills or leaks from the waste? □ N/A □ Yes □ No 2. Is there any evidence of fires or explosion from the waste? □ N/A □ Yes □ No Comment: Security 1. Is area secured from Unauthorized Entry? □ N/A □ Yes □ No 2. Is the area have a “Danger - Unauthorized Personnel Keep Out” sign posted? □ N/A □ Yes □ No 3. Does the area have a “Danger - No Smoking” sign posted? □ N/A □ Yes □ No 4. Are emergency contacts and phone numbers posted? □ N/A □ Yes □ No Comment: 35 WEEKLY 180 DAY ACCUMULATION AREA INSPECTION LOG SUMMARY Submit to EHS & I by 5th of Following Month Month ____________________, ___________ Date/Time Inspector 1 2 3 4 Place a " √ " in the Category that is "Satisfactory" Place an "X" in the Category that is "Not Satisfactory" Place "N/A" if it does not apply 36 5 6 7 8 9 10 11 12 13 14 Comments 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. General Order General Cleanliness Building Condition Spill Containments Equipment A. Eye protection B. Spill pillows, plastic disposal bags C. Gloves, tyvek suits, etc. D. Sock / absorbent E. Mop, broom, bucket, dustpan Fire extinguishers Locks Ground Wire Electrical/Lights Telephone Ventilation Emergency Eyewash Emergency Shower Drum Storage A. Drum Condition C. Isle Width B. RCRA Stickers D. Non-leaking Drum President/Executive Vice President: Date: Waste Management Appendix A BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH :DVWH0DQDJHPHQW$SSHQGL[$ (Generators of less than 50 pounds of regulated medical waste per month, who ship less than 50 pounds per shipment) Waste Management Appendix B BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH :DVWH0DQDJHPHQW$SSHQGL[% Waste Management Appendix C Directory of Dental Waste Recyclers Notice and Disclaimer This Directory of Dental Waste Recyclers has been compiled from information supplied by companies listed in websites and other public information sources. It is provided solely for general informational purposes and should not be used as a substitute for a dentist's own evaluation of a prospective recycler. A listing in this directory does not indicate, and is not to be interpreted as, an endorsement by the American Dental Association (ADA) of the listed recycler, the accuracy of the information in a recycler’s listing or the recycler’s services or products. The ADA provides no guarantees or warranties for the recyclers and/or their services as listed in this directory. The information in this directory is current as of March 2012. Since information may change, the directory will be updated periodically. Users who become aware of any updates can send new information to [email protected] or can fax updates to 312/440-2536. ADA recommends that dentists contact recyclers before recovering waste, such as amalgam, and ask about any specific handling instructions the recycler may have. It is important to select a reputable recycler that complies with applicable federal and state law, and provides adequate indemnification for its acts and omissions. Some Questions You May Wish to Ask Your Recycler … What kind of waste do you accept? Do your services include pick up of waste from dental offices? If not, can waste be shipped to you? Do you provide packaging for storage, pick up or shipping of waste? If packaging is not provided, how should the waste be packaged? What types of waste can be packaged together? Do your procedures comply with ANSI/ADA Specification 109: Procedures for Storing Dental Amalgam Waste and Requirements for Amalgam Waste Storage/Shipment Containers?1 Does your company have an EPA or applicable state license? Does the company use the proper forms required by the EPA and state agencies? How much do your services cost? Do you accept whole filters from the vacuum pump for recycling? Do you pay for clean non-contact amalgam (scrap)? Do you accept extracted teeth with amalgam restorations? Is disinfection required for amalgam waste? 1 American National Standard/American Dental Association Specification No. 109 - 2006. Procedures for storing dental amalgam waste and requirements for amalgam waste storage/shipment containers. Chicago: American Dental Association. BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH :DVWH0DQDJHPHQW$SSHQGL[& BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH :DVWH0DQDJHPHQW$SSHQGL[& c Mail-In √ √ √ √ Pick-Up √ √ √a √ Liquid Mercury √ √ √ √a Contact Amalgam √ √ √ √ √ Non-Contact Amalgam √ √ √ √ √ Extracted Teeth w/ Amalgam √ √ √ √ Amalgam Traps & Filters √ √ √ √ √ Sludge √ √ √ √b √ Fixer Solution √ √ √ √ Lead Foil Packages √ √ √ √ Based on the information supplied to us by the company, this company complies with the ANSI/ADA Specification No. 109: Procedures for Storing Dental Amalgam Waste a b and requirements for Amalgam Waste Storage/Shipment Containers. Service available in California only. Will accept if already coming to pick up crowns or bridgework. c No information supplied to us from the company regarding compliance with Specification No. 109. Clean Harbors, Inc. Norwell, MA (800) 282-0058 www.cleanharbors.com/ c Carolina Environmental Associates Burlington NC (336) 229-0058 Bethlehem Apparatus Company Hellertown, PA (610) 838-7034 www.bethlehemapparatus.com/ Barnes HazMat, Inc. Pacoima, CA (877) 600-6737 www.barneshazmat.com/ Amalgaway Indianapolis, IN (800) 267-1467 www.amalgaway.com/ Company/Contact Information Lead Aprons, Collars Radiograph-Related Waste Radiographs Dental Waste Recyclers Providing Nationwide Services Type of Dental Amalgam-Related Waste Program Medical Waste BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH :DVWH0DQDJHPHQW$SSHQGL[& √ √ √ √ √ √ √ √ √ √ √ √e √e √ √ √ Based on the information supplied to us by the company, this company complies with the ANSI/ADA Specification No. 109: Procedures for Storing Dental Amalgam Waste and e f d requirements for Amalgam Waste Storage/Shipment Containers. No amalgam waste accepted via mail-in. Limitations apply. Call for information. Pick up within 150 miles of Rogers, MN. √f √ √ √ √ √ Enviro-Chem, Inc. Rogers, MN (800) 225-8322 (800) 999-1294 (CA) www.enviro-chem.bz/ √ √e √e √e √ √e √e √ e √ e √ e √ e √ e √ e √ e √ e √ e √ e √ Mail-In EcoSolutions/Stericycle Milpitas, CA (866) 783-7422 http://www.stericycle.com/ √ √ Liquid Mercury √ √e √ Extracted Teeth w/ Amalgam Doral Refining Freeport, NY (800) 645-2794 www.doralcorp.com/ Non-Contact Amalgam √ Amalgam Traps & Filters √d Contact Amalgam √ Sludge Dental Refiners Stateline, Nevada (800) 786-1742 Pick-Up √ Fixer Solution √ Radiographs Dental Recycling North America Inc. New York, NY (800) 360-1001 www.drna.com/ Company/Contact Information Lead Foil Packages Radiograph-Related Waste Lead Aprons, Collars Dental Waste Recyclers Providing Nationwide Services, cont’d. Type of Dental Amalgam-Related Waste Program Medical Waste BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH :DVWH0DQDJHPHQW$SSHQGL[& √ Healthcare Compliance Service Palm Bay, FL (888)726-8505 www.hcstoday.com Pick-Up √g √ Liquid Mercury √ √ √ Contact Amalgam √ √ √ √ Non-Contact Amalgam √ √ √ √ √ Extracted Teeth w/ Amalgam √e √ √ √ √ Sludge √ √ √ √ √ √ √ √ √ Radiographs √ √ Based on the information supplied to us by the company, this company complies with the ANSI/ADA Specification No. 109: Procedures for Storing Dental Amalgam c g Waste and requirements for Amalgam Waste Storage/Shipment Containers. Available in New York City and surrounding areas. No information supplied to us from e the company regarding compliance with Specification No. 109. Limitations apply. Call for information. √ √ Greymart Metal Co. Brooklyn, NY (800) 238-1813 www.greymart.com/ c √ Green Lights Recycling, Inc. Blaine, MN (800) 208-8340 www.greenlightsrecycling.com Heritage Environmental Services Indianapolis, IN (888) 437-4224 www.heritage-enviro.com √ Mail-In Garfield Refining Company Philadelphia, PA (800) 523-0968 www.garfield-refining.com/ Company/Contact Information Amalgam Traps & Filters Radiograph-Related Waste Fixer Solution Dental Amalgam-Related Waste Lead Foil Packages Type of Program Lead Aprons, Collars Dental Waste Recyclers Providing Nationwide Services, cont’d. Medical Waste BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH :DVWH0DQDJHPHQW$SSHQGL[& Pick-Up √ √e √e √ e Non-Contact Amalgam √e √ √ √ Extracted Teeth w/ Amalgam √e √ √ √ Amalgam Traps & Filters Sludge √ √ √ √ Fixer Solution √ √ √ √e √e √e √e √ √ √ √e √e √ √ √ Radiographs √ √i Based on the information supplied to us by the company, this company complies with the ANSI/ADA Specification No. 109: Procedures for Storing Dental Amalgam Waste c and requirements for Amalgam Waste Storage/Shipment Containers. No information supplied to us from the company regarding compliance with Specification No. 109. i e h All states except AK, HI, and ME. Sharps program available at www.prepaidrecycling.com Limitations apply. Call for information. √ Stericycle Lake Forest, IL (800) 355-8773 www.stericycle.com/ √ √ √ √ Safety Kleen Plano, TX (800) 669-5740 www.safety-kleen.com/ √ √h √ √ Veolia Environmental Services Lombard, IL (800) 556-5267 www.veoliaes.com/ √ Liquid Mercury √ c Mail-In √ Contact Amalgam Mercury Waste Solutions, Inc. Union Grove WI (800) 741-3343 www.mwsi.com/ Mercury Refining Co., Inc. Albany, NY (800) 833-3505 www.mercuryrefining.com/ Company/Contact Information Lead Foil Packages Radiograph-Related Waste Lead Aprons, Collars Dental Waste Recyclers Providing Nationwide Services, cont’d. Type of Dental Amalgam-Related Waste Program Medical Waste BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH :DVWH0DQDJHPHQW$SSHQGL[& Mail-In √ Contact Amalgam √ Sludge √ Amalgam Traps & Filters √ Extracted Teeth w/ Amalgam √ Non-Contact Amalgam √ √ Fixer Solution Liquid Mercury Pick-Up Radiograph-Related Waste √ Lead Foil Packages Dental Amalgam-Related Waste Radiographs Mail-In √ Pick-Up √ Contact Amalgam √ Non-Contact Amalgam √ Extracted Teeth w/ Amalgam √ Sludge Amalgam Traps & Filters √ √ Radiographs Fixer Solution Liquid Mercury √ Based on the information supplied to us by the company, this company complies with the ANSI/ADA Specification No. 109: Procedures for Storing Dental Amalgam Waste and requirements for Amalgam Waste Storage/Shipment Containers. Metasys Miami, FL 877-METASYS (638-2797) www.ecotwo.com/ Company/Contact Information Lead Foil Packages RadiographRelated Waste Lead Aprons, Collars Dental Waste Recyclers Servicing All States Except Hawaii Type of Dental Amalgam-Related Waste Program Medical Waste Based on the information supplied to us by the company, this company complies with the ANSI/ADA Specification No. 109: Procedures for Storing Dental Amalgam Waste and requirements for Amalgam Waste Storage/Shipment Containers. WCM, Inc Carlsbad, CA (866) 436-9264 www.wastewise.com Company/Contact Information Type of Program Lead Aprons, Collars Dental Waste Recyclers Providing Nationwide Services, cont’d. Medical Waste BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH :DVWH0DQDJHPHQW$SSHQGL[& j Mail-In √ √ Pick-Up √M √ Liquid Mercury √k Contact Amalgam √ Non-Contact Amalgam √ √ Extracted Teeth w/ Amalgam √ √ Sludge Amalgam Traps & Filters Fixer Solution √ √ √ √ √ √ √ √ √ √ Radiographs √ Containers. Pick-up within 150 miles of Minneapolis. k Pick-up only. No information supplied to us from the company regarding compliance with Specification No. 109. Based on the information supplied to us by the company, this company complies with the ANSI/ADA Specification No. 109: Procedures for Storing Dental Amalgam Waste and requirements for Amalgam Waste Storage/Shipment c Maguire Refining, Inc. Minneapolis, MN (800) 486-2858 www.maguireref.com Enviro Medical Waste Inc. Miamisburg, OH (866) 669-9201 www.enviromedicalwaste.com/ c Company/Contact Information Lead Foil Packages RadiographRelated Waste Lead Aprons, Collars Dental Waste Recyclers Servicing All States Except Alaska & Hawaii Type of Dental Amalgam-Related Waste Program Medical Waste BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH :DVWH0DQDJHPHQW$SSHQGL[& Pick-Up √ √H √H Liquid Mercury √ √ Contact Amalgam √H √ √ √ Non-Contact Amalgam √ √ √ Extracted Teeth w/ Amalgam √ √ Amalgam Traps & Filters √ √ √ Fixer Solution Sludge √ √ √ √e √ √e √ √ √ Lead Foil Packages √ √ √ √ √e √e √ Based on the information supplied to us by the company, this company complies with the ANSI/ADA Specification No. 109: Procedures for Storing Dental Amalgam Waste and e requirements for Amalgam Waste Storage/Shipment Containers. Limitations apply. Call for information. Integrated Waste Control Hayward, CA (510) 583-7980 - Also provides pick-up services for sharps, glutaraldehyde √ √ AZ, CA, CO, ID, MT, NM, NV, OR, WA AERC Recycling Solutions Allentown, PA (610) 797-7608 – Main Corporate Office www.aercrecycling.com CA Only–San Francisco, Sacramento area √ Mail-In AL, AR, FL, GA, LA, MS, OK, TX AERC Recycling Solutions Allentown, PA (610) 797-7608 – Main Corporate Office www.aercrecycling.com Company/Contact Information Lead Aprons, Collars Radiograph-Related Waste Radiographs Dental Waste Recyclers ProvidingRegional or State Services Only Type of Dental Amalgam-Related Waste Program Medical Waste BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH :DVWH0DQDJHPHQW$SSHQGL[& c c c Pick-Up √ √ Liquid Mercury √ √ Non-Contact Amalgam √ Extracted Teeth w/ Amalgam Contact Amalgam Mail-In No information supplied to us from the company regarding compliance with Specification No. 109. Environmental Recycling Bowling Green, OH (800) 284-9107 www.envrecycle.com/ IN, MI, OH Envirolight & Disposal, Inc. St. Petersburg, FL. (800) 600-3738 www.envirodisp.com/ FL Fixer Solution √ √ Lead Foil Packages √ √ √ √ Lead Aprons, Collars Amalgam Traps & Filters Radiograph-Related Waste √ √ Radiographs Dental Waste Recyclers Providing Regional or State Services Only, cont’d. Type of Company/Contact Information Dental Amalgam-Related Waste Program Medical Waste Sludge Waste Management Appendix D BestManagement Practicesfor AmalgamWaste AmericanDentalAssociation¥October2007 BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH :DVWH0DQDJHPHQW$SSHQGL[' Uifgpmmpxjohjogpsnbujpoefnpotusbuftipxup nbobhfboesfdzdmfefoubmbnbmhbnxbtufupifmq qspufduuiffowjsponfou/ GlossaryofAmalgamWasteTerms ¦Amalgamcapturedevicejtbobqqbsbuvttvdibt bdibjstjefusbq-wbdvvnqvnqÝmufspsbnbmhbn tfqbsbupsuibudpmmfdutbnbmhbnqbsujdmft/ ¦Bnbmhbntmvehfjtbnjyuvsfpgmjrvjeboetpmje nbufsjbmuibudpmmfdutxjuijowbdvvnqvnqÝmufst- bnbmhbntfqbsbupstpspuifsbnbmhbndbquvsf efwjdftuibunbzcfvtfe/ ¦Contactamalgamjtbnbmhbnuibuibtcffojo dpoubduxjuiuifqbujfou/Fybnqmftbsffyusbdufe uffuixjuibnbmhbnsftupsbujpot-dbswjohtdsbq dpmmfdufebudibjstjef-boebnbmhbndbquvsfecz dibjstjefusbqt-Ýmufst-pstdsffot/ ¦DentalBestManagementPracticesbsfbtfsjft pgbnbmhbnxbtufiboemjohboeejtqptbmqsbdujdft uibujodmvef-cvubsfopumjnjufeup-jojujbujohcvml nfsdvszdpmmfdujpoqsphsbnt-vtjohdibjstjef usbqt-bnbmhbntfqbsbupstdpnqmjbouxjuiJTP 222542boewbdvvndpmmfdujpo-jotqfdujohboe dmfbojohusbqt-boesfdzdmjohpsvtjohbdpnnfsdjbm xbtufejtqptbmtfswjdfupejtqptfpguifbnbmhbn dpmmfdufe/ ¦Emptyamalgamcapsulesbsfuifjoejwjevbmmz eptfedpoubjofstmfgupwfsbgufsnjyjoh qsfdbqtvmbufeefoubmbnbmhbn/ ¦Non-contactamalgam)tdsbq*jtfydfttnjy mfgupwfsbuuiffoepgbefoubmqspdfevsf/ UifBEBsfdpnnfoetbhbjotuuifvtfpgcvml fmfnfoubmnfsdvsz-bmtpsfgfssfeupbtmjrvjepssbx nfsdvsz-gpsvtfjouifefoubmpgÝdf/Tjodf2:95- uifBEBibtsfdpnnfoefevtfpgqsfdbqtvmbufe bnbmhbnbmmpz/ Jgzpvtujmmibwfcvmlfmfnfoubmnfsdvszjouif pgÝdf-zpvtipvmesfdzdmfju/Difdlxjuibmjdfotfe sfdzdmfsupefufsnjofxifuifsuifzxjmmbddfqucvml nfsdvsz/Epopuqpvscvmlfmfnfoubmnfsdvszxbtuf jouifhbscbhf-sfecbhpsepxouifesbjo/Zpvbmtp tipvmedifdlxjuizpvstubufsfhvmbupszbhfodzboe nvojdjqbmjuzupÝoepvujgbcvmlnfsdvszdpmmfdujpo qsphsbnjtbwbjmbcmf/Tvdicvmlnfsdvszdpmmfdujpo qsphsbntqspwjefbofbtzxbzupejtqptfpgcvml nfsdvsz/ StepsforRecyclingAmalgamWaste 1.Tupdlbnbmhbndbqtvmftjobwbsjfuzpgtj{ft upnjojnj{fuifbnpvoupgbnbmhbnxbtuf hfofsbufe/ 2.BnbmhbnxbtufnbzcfnjyfexjuicpezÞvjet- tvdibttbmjwb-pspuifsqpufoujbmmzjogfdujpvt nbufsjbm-tpvtfqfstpobmqspufdujwffrvjqnfou tvdibtvujmjuzhmpwft-nbtlt-boeqspufdujwf fzfxfbsxifoiboemjohju/ 3.Dpoubdubobnbmhbnxbtufsfdzdmfsbcpvuboz tqfdjbmsfrvjsfnfoutuibunbzfyjtujozpvsbsfb gpsdpmmfdujoh-tupsjohboeusbotqpsujohbnbmhbn xbtuf/ JgzpvoffeupÝoebsfdzdmfs-difdlxjuizpvsdjuz- dpvouzpsmpdbmxbtufbvuipsjuzuptffxifuifs uifzibwfbobnbmhbnxbtufsfdzdmjohqsphsbn/ 4.Tupsfbnbmhbnxbtufjobdpwfsfeqmbtujd dpoubjofsmbcfmfeÒBnbmhbngpsSfdzdmjohÓpsbt ejsfdufeczzpvssfdzdmfs/Zpvssfdzdmfsnbzibwf jutpxosfrvjsfnfout-tpbtlzpvssfdzdmfsbcpvu dpoubjofstboexibunbzcfqmbdfejouifn/ 5.MpplgpssfdzdmfstxipdpnqmzxjuiuifBEB. 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BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB 3DJH :DVWH0DQDJHPHQW$SSHQGL[' Section 5: Other Regulatory Issues Backflow Prevention In some areas, state and local regulatory authorities are increasingly requiring dentists to install testable backflow prevention devices in their offices. The installation of such devices can cost thousands of dollars, with additional costs associated with their annual maintenance and testing, again, at the dentist’s expense. The primary concerns of the local regulators are centered on the supposed need to protect cross-connected water systems from potential aspiration of oral fluids through the high-speed handpiece, air/water syringe, and cuspidor. Such aspiration, which has been hypothesized might occur during a sudden drop in water pressure, has apparently resulted in concerns about bloodborne diseases being transmitted via water systems cross-connected to the dental unit. As a result of these concerns, both the ADA and CDC have published statements (attached) on this issue, which stress the negligible risk of bloodborne disease transmission as a result of backflow from the dental unit. It is hoped that these statements will help educate state and local regulators and minimize such regulatory activity in the dental office. ____________________________________________________________________________________________________________ 01/2008 Page 1 Other Regulatory Issues CDC - Backflow - Fact Sheets - Infection Control in Dental Settings - Oral Health MENU CDC A-Z SEARCH Division of Oral Health Backflow Prevention and the Dental Operative Unit Share Infection Control On this Page The Centers for Disease Control and Prevention (CDC) has been asked by the Backflow Prevention Devices American Dental Association (ADA), state and local health departments, and local Public Water Supplies water regulators to provide guidance and scientific information regarding the risk of Cross-connections contamination from cross-connections from the dental operative unit. The dental Viruses operative unit is a medical device at each dental chair through which water and Risk of Contamination compressed air flow during dental procedures. Cross-connections are the links Selected References through which contaminated materials may enter a potable water supply system when the pressure of the polluted source exceeds the pressure of the potable source (e.g., during a water main break). Backflow Prevention Devices Backflow prevention devices can be used to prevent back-siphonage of contaminated fluids into the public water supply and are regulated by the health authority or the plumbing-code enforcement agencies having jurisdiction. (Note: Antiretraction valves, used to prevent aspiration of patient materials into some dental handpieces and waterlines, are regulated by the Food and Drug Administration (FDA) and are not considered backflow prevention devices.) Public Water Supplies In some locations water regulators have required dental offices to install backflow prevention devices at the service connection or on individual dental operative units. Many of these requirements appear to be based on two assumptions. First, if a sudden drop in water pressure occurs, oral fluids may be aspirated from a patient's mouth into cross-connected water systems. Second, if aspiration does occur, it may result in a significant risk of transmission of blood-borne viruses from an infected patient to other patients or to persons who are using the same water system. Regulatory interventions ____________________________________________________________________________________________________________ 01/2015 Page 2 Other Regulatory Issues CDC - Backflow - Fact Sheets - Infection Control in Dental Settings - Oral Health of complex backflow prevention CDCrequiring - Backflow the - Factinstallation Sheets - Infection Control in Dental Settings - Oral Healthdevices in certain dental offices are based on the conclusion that a high degree of hazard of contamination exists. Available science suggests, however, that there is an extremely low risk of such contamination of public water supplies from cross-connections in dental operative units. Cross-connections in Dental Operative Units Possible sites for cross-connection in the dental operative unit are the cuspidor, high-speed handpiece, and air/water syringe. Today, most dental offices do not use cuspidors and those that are currently manufactured include an air-gap, which prevents backflow. Although a cross-connection is inherent in the design of the high-speed handpiece and air and water syringe, this cross-connection should be considered as very low risk. Both of these devices must have water to operate properly and, when in use, are observed continually by the dentist or hygienist. If water flow is disrupted for any reason, the dental worker would discontinue use of the device. Furthermore, in the unlikely event that a sudden drop in water pressure caused backflow to occur, the volume of aspirated fluid would be minuscule. Bloodborne Viruses (e.g., HIV, hepatitis B) One concern expressed during meetings with local water regulators is the possibility of contamination of public water supplies with blood-borne viruses such as human immunodeficiency virus (HIV)—the virus that causes acquired immune deficiency syndrome (AIDS). Scientific evidence indicates, however, that the route of transmission of blood-borne viruses is through intimate contact with blood or other potentially infectious body fluids. Transmission of bloodborne diseases has not been reported through the use of any type of water source and is considered highly unlikely. Unlike bacteria or fungi, viruses are unable to reproduce outside a living host, and any virus introduced into a water source would be greatly diluted and would probably become noninfectious. Because the hepatitis B virus (HBV), another bloodborne virus, is found in much higher concentrations in blood than is HIV, HBV is considered a more infectious agent. Studies show that the risk of transmission of HBV in sewage and other water is very low, thus, the risk of HIV transmission would be even less. – For a bloodborne infection to be transmitted, four conditions, known as the "chain of infection," must be present: a susceptible host, or a person who is not immune an opening through which the microorganism may enter the host a microorganism that causes disease sufficient numbers of the organism to cause infection. The chance of all of these events happening in sequence represents the "risk of infection." Any break in one or more of these "links" in the chain would effectively prevent infection. This information strongly suggests that the risk of transmission of a bloodborne disease through contaminated water supplies is very low. Risk of Contamination from Cross-connections Although a theoretical possibility of contamination from cross-connections from dental operative units does exist, ____________________________________________________________________________________________________________ 01/2015 Page 3 Other Regulatory Issues http://www.cdc.gov/oralhealth/infectioncontrol/factsheets/backflow.htm[11/20/2014 1:44:46 PM] CDC - Backflow - Fact Sheets - Infection Control in Dental Settings - Oral Health available scientific evidence strongly implies that this risk is nearly zero. Installation of backflow prevention devices, when required, should be consistent with this very low degree of hazard. These suggestions are based on the following: HIV is not transmitted by water. Published evidence of a public health risk due to cross-connections in the dental operative unit does not currently exist. The American Water Works Association (AWWA) statement of policy recommends that the installation of backflow prevention devices be consistent with the degree of hazard resulting from cross-connections. Increasingly, dentists are using self-contained dental operative unit water systems that are not connected to the public water supply. In addition, the manufacturers' current infection control recommendations and directions for maintenance of each dental operative unit should be followed. The CDC's Division of Oral Health will continue to assess scientific information related to the quality of dental operative unit water and the safety of patient care delivery. Selected References and Additional Resources CDC. HIV and Its Transmission. En español. CDC. Viral Hepatitis B. Environmental Protection Agency. Cross-Connection Contol Manual [PDF–1.5M] . Related by Topic Overview for Infection Control Guidelines for Infection Control Fact Sheets for Infection Control in Dental Settings FAQs for Infection Control File Formats Help: How do I view different file formats (PDF, DOC, PPT, MPEG) on this site? Adobe PDFfile Page last reviewed: July 10, 2013 Page last updated: July 10, 2013 ____________________________________________________________________________________________________________ 01/2015 Page 4 Other Regulatory Issues CDC - Backflow - Fact Sheets - Infection Control in Dental Settings - Oral Health Content source: Division of Oral Health, National Center for Chronic Disease Prevention and Health Promotion Follow CDC CDC Media About CDC Legal Contact CDC Contact Us ____________________________________________________________________________________________________________ 01/2015 Page 5 Other Regulatory Issues Radiation Safety Dental radiation contributes a small percentage to the total radiation burden of the general population. Similarly, occupational exposure in dentistry is low compared to exposures in hospitals and medical offices.i However, use of appropriate measures ensures that dental radiation exposures remain as low as reasonably achievable. The limit for occupationally exposed personnel is 50 millisieverts (mSv) in any 1 year. The lifetime occupational effective dose is limited to 10 mSv times the value of the individual’s age. The National Council on Radiation Protection and Measurementi concludes that no dental personnel will receive occupational exposures that exceed these limits unless there are problems with the facility design, equipment, performance, or operating procedures. The radiation exposure limit for pregnant women is 0.5 mSv in a month. State laws and regulations set specific requirements that must be met for the equipment, frequency of inspections, etc. Contact your state radiation protection program to identify requirements for use of ionizing radiation (which includes x-rays) in your state. Training requirements for dental office personnel who take dental x-rays are frequently different and less intensive than for personnel who take medical x-rays. Training requirements for dental office personnel may typically be found in state dental practice acts or dental board regulations. Listing of state radiation protection programs: www.crcpd.org/Map/map.asp Questions to ask regarding state requirements for use of ionizing radiation: 1.What are the inspection and testing requirements for the facility, x-ray machine, radiation monitoring equipment and radiograph processing equipment? 2. Are there any permit or licensing requirements for dental offices using x-ray machines? 3. Is individual supervision of personnel required? 4.Are personnel required to wear dosimetry badges? 5.What is the training (and retraining) or certification requirement for personnel taking x-rays? 6. What are the dental office design requirements? 7. What are the shielding requirements? 8. What are the record keeping requirements? 9. What are the general equipment requirements? i ational Council on Radiation Protection and Measurements. NCRP Report No. 145: Radiation Protection in Dentistry. N 2003. ____________________________________________________________________________________________________________ 01/2008 Page 6 Other Regulatory Issues ERGO TIPS Low Back Pain Dentists and the dental team spend many hours a day assuming physically stressful body postures as they provide oral health care. This can ultimately contribute to the development or aggravation of low back pain, impacting not only the well being of the individual, but the efficiency and productivity of the office as well. Tips For Controlling Low Back Pain Symptoms • Adjust the height of your seat so that your feet can be flat on the floor and your knees are a little below the level of your hips (your thighs are slanted slightly downward). Allow the thighs to be supported. • Use proper lighting and magnification to reduce the amount of bending and twisting you must do to see the field of your work. • Let the loops do the work, not your back/neck. • Have your equipment and instruments placed so that you are not twisting to reach for them. Properly balanced posture and mindful use of one’s body may decrease cumulative trauma and may control the amount of pain one experiences. Low back pain may include aching, throbbing or stiffness in the lumbar and sacral areas of the back, and may also be experienced as sharp and piercing pain. It may also be experienced as numbness, tingling and /or shooting pain radiating down the back of the legs and into the feet and toes, or as weakness in the hips, legs, feet or toes. Causes The cause of low back pain can be varied and complex But very common sources of pain are tiny tears and inflammation of the muscles, tendons and ligaments supporting the spinal column, and pressure on nerve roots from vertebral changes, such as herniated discs, narrowing of joint spaces, and/or stenosis of the vertebral canal or foramen. There are also times when the cause of the pain is not known and this is often referred to as non-specific low back pain. Through OSHA’s Alliance Program this Ergo tip sheet was developed as a product of the OSHA and ADA Alliance for informational purposes only. It does not necessarily reflect the official views of OSHA or the U.S. Department of Labor. ___________________________________________________________________________________________________________ 01/2014 Page 7 Other Regulatory Issues ERGO TIPS Low Back Pain • Position yourself, relative to the patient, so that you do not have to twist or maintain an unbalanced posture to gain access to the oral cavity (sitting in a 12:00 position is ideal). Move the position of the patient, rather than bending and twisting your body, to do your work. • After mild trauma, such as slipping and landing on buttocks, in those older than 50 years • When sleep is disrupted or pain is worse at rest • With a history of prolonged steroid use • With a history of osteoporosis • Have a musculoskeletal evaluation and foot screening to see whether orthotics could be useful in easing the stress on your back. • With a history of recent infection or a temperature over 100º F • With a prior history of cancer or night pain • Take a few minutes every hour to stretch the spine, moving backwards and forwards if you have been standing up straight, or moving in the opposite direction of a posture you have been holding. • Loss of bowel or bladder function • Numbness or tingling in the groin or lower extremities • If standing for a long period of time, rest one foot on a small stool or step, alternating feet; also alternate doing this with standing on both feet. Other Resources • Rotate the scheduling of long, difficult cases with short, easier cases. American Academy of Orthopedic Surgeons www.aaos.org • Take a break in between or during long cases. • Wear properly fitting, comfortable clothing, sterile gloves, masks, and shoes. McKenzie Institute International www.mckenziemdt.org • • Develop your core strength and loose excess abdominal weight to lessen the burden on your back. Exhaust all conservative treatment options before considering surgical intervention, unless there are extenuating circumstances. American College of Sports Medicine www.acsm.org Athlete’s Performance www.athletesperformance.com Arthritis Foundation www.arthritis.org American Physical Therapy Association www.apta.org Seek Medical Consultation Healthy People 2010 www.healthypeople.gov Seek medical consultation for low back pain, especially in the following instances: North American Spine Society www.spine.org • After recent significant trauma such as a fall from a height, a motor vehicle accident or other such accidents ____________________________________________________________________________________________________________ 01/2014 Page 8 Other Regulatory Issues ERGO TIPS Hand Pain Dentists, dental hygienists and dental assistants may experience hand pain in performing dental procedures. Typical Hand Motions That Aggravate Hand Pain Ganglion cysts non-cancerous, fluid-filled lumps usually found on the back of the wrist. Hand pain may include throbbing, aching, numbness and tingling, stiffness or diminished strength. Performing dental procedures in which you use your finger, thumb or wrist muscles frequently or for prolonged periods of time can lead to or aggravate conditions that cause hand pain. Trigger finger Swelling of the tendon or sheath surrounding the tendons of the finger or thumb joints causing resistance to movement and sometimes a popping noise. Carpal tunnel syndrome pressure on the median nerve as it enters the hand through a small opening (carpal tunnel) in the wrist, resulting in pain, numbness or tingling of the thumb, index and middle fingers. For further information see: http://orthoinfo. aaos.org/brochure/thr_report.cfm?thread_ id=8&topcategory=Hand Helpful Hints Holding the Wrist in a Non-Neutral Position: The wrist is bent (flexed) while the fingers arebeing used. Work with wrist in neutral position, when possible. In a neutral position, the wrist is held straight or in a slight extension. Tight Pinch Grip: The distal index finger joint is straight or hyperextended in a tight grip. Common Conditions That Cause Hand Pain Tendonitis/Tenosynovitis Inflammation or thickening of a tendon or the tendon sheath which may result in pain or difficulty of movement. Use a more relaxed grip, when possible. The distal finger joint is slightly flexed in arelaxed grip. Osteoarthritis Adegenerative joint disease characterized by erosion of the joint cartilage. Often results in pain and swelling of the finger joints, and development of nodules at the joint. ____________________________________________________________________________________________________________ 01/2014 Page 9 Other Regulatory Issues ERGO TIPS Hand Pain Exercise your hands after doing procedures by stretching your wrists and fingers. Especially stretch the area between the thumb and index finger. Use larger diameter instruments. Try them out to get one that feels right for you. Use instruments that reduce the time doing a procedure, such as an ultrasonic scaler, with variable and rapid speeds. Wear gloves that fit properly and do not restrict hand movement. http://www.shelterpub.com/_fitness/_office_fitness_ clinic/OFC_hwf.html Reduce the force on your hands and fingers, and the torquing of your hands by using hand instruments and powered tools that are lighter in weight, balanced, and well sharpened. Pace your work. Try not to schedule difficult procedures back to back. Try to break up or alternate tasks to minimize the amount of time spent doing the same task. Stabilize your hand when doing precise hand tasks. Your hand can be stabilized by resting the 4th and/or 5th digits on the cross arch or opposite arch; or resting the elbow on the chair back or arm. Adjust chair heights and position yourself so that you are working with your elbow placed lower than your shoulder, and your wrist placed even with or lower than your elbow. Ensure that all cords and hoses are long enough so you do not need to exert finger force to pull or support hoses and cords. If Pain Continues Seek medical evaluation and treatment of the condition. Most of these conditions are treated conservatively with modification of activities, splints, and anti-inflammatory medication. However, some cases may require steroid injections or surgery. Early treatment can help avoid injections or surgery. http://www.jdentaled.org/cgi/content/full/69/4/453/F3 Through OSHA’s Alliance Program this Ergo tip sheet was developed as a product of the OSHA and ADA Alliance for informational purposes only. It does not necessarily reflect the official views of OSHA or the U.S. Department of Labor. ____________________________________________________________________________________________________________ 01/2014 Page 10 Other Regulatory Issues ERGO SUCCESS Neck Pain The Use of Loupes Improves Posture and Health of One Hygienist The use of loupes while performing work on dental patients allowed hygienist to minimize the use of awkward postures. The Problem A few years into practicing dental hygiene, the hygienist began to experience back and neck pain. She realized that the postures she used were probably not ideal but was not sure how to correct them while still maintaining adequate views of the patient’s mouth. When the pain became more chronic she went to see a chiropractor. X-rays were taken of her spine and it was determined that the problems were muscle related. She went in for a series of adjustments with subsequent massage and ultrasound therapy which alleviated the pain, but required visits 3 times a week. This became very time consuming and eventually impossible to fit into her busy schedule. She self medicated with an occasional Motrin or Advil from that point on, but still worked in pain. The Solution In February 2006, she attended a seminar at the Midwinter Meeting of the American Dental Association on the topic of ergonomics. The speaker was a hygienist who discussed many changes that can be made in a hygienist’s workstation and equipment to improve the dental hygienist’s posture and extend the longevity of her career She advocated the use of surgical loupes because they provide much greater magnification than normal corrective eyeglass lenses. They improve the field of vision so the hygienist can then work with less bending and hunching of the body and with less eyestrain. Loupes can also be purchased with attached lighting, which more fully illuminates the field of work, again further reducing eyestrain and the attendant body tension. After the course, she stopped by a manufacturer’s booth to “test them out” and was very impressed. She made an appointment to have a technician come into the office to fit her for a pair. The technician measured the distance between the hygienist’s eyes and the patient’s mouth while the hygienist sat with proper posture in her clinician’s chair. The magnification was then tailored to suit her individual needs. No other changes were made to the workstation. The Impact The hygienist has been using surgical loupes for a little over a year and says she feels feel 100% better. Her back and neck pain are gone and she feels less tired after a day of work. In addition to working in a private dental practice, she is also on the faculty of a dental school. She shares her experience with her students, and uses loupes when demonstrating procedures. She does not recommend that students use loupes during their first year treating patients because they may have difficulty mastering mirror usage and the difference between direct and indirect vision, but approximately 50% of the second year students now use loupes. Although loupes are expensive, the savings in pain, fatigue, and the cost and time of medical visits have justified the expense. Kim Fvasula, RDH, works in a private dental practice in Chicago, and is on the faculty at the College of Dentistry, University of IllinoisChicago. Through OSHA’s Alliance Program this Ergo tip sheet was developed as a product of the OSHA and ADA Alliance for informational purposes only. It does not necessarily reflect the official views of OSHA or the U.S. Department of Labor. ____________________________________________________________________________________________________________ 01/2014 Page 11 Other Regulatory Issues ERGO SUCCESS Neck Pain Other Resources American College of Sports Medicine www.acsm.org American Academy of Orthopedic Surgeons www.aaos.org McKenzie Institute International www.mckenziemdt.org Athlete’s Performance www.athletesperformance.com Arthritis Foundation www.arthritis.org American Physical Therapy Association www.apta.org Healthy People 2010 www.healthypeople.gov North American Spine Society www.spine.org ____________________________________________________________________________________________________________ 01/2014 Page 12 Other Regulatory Issues