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NEW ENGLAND BAPTIST HOSPITAL EMPLOYEE HEALTH INFECTION CONTROL POLICY GUIDELINES Section VI-O #2 Page 1 of 22 _________________________________________________________________________________________________ BLOOD/BODY FLUID EXPOSURE PROTOCOL _______________________________________________________________________________ Subject: Effective Date: March, 2006 Supersedes: 3/04 Approved By: Infection Control Committee, 3/15/06 Author: Jeanine Shaughnessy, RN, CS, MSN, COHN-S Eileen O’Donnell, RN, BSN __________________________________________________________________________________________________ PURPOSE To provide specific guidelines and procedures for the Employee Health, and Ambulatory Services personnel for implementation of the Hospital policy on Blood/Body Exposure Control Plan. For the purpose of this protocol, the Employee Health Clinician may be interchangeable with the clinicians in other designated areas (specifically, Ambulatory Services and Occupational Medicine Clinic). I. PERSONNEL ISSUES A. Employee Exposure 1. 2. Report to: Employee Health Monday – Friday (7:30am – 3:30pm) Ambulatory Services Monday- Friday (3:30 pm – 10:00 pm) Weekends/Holidays (7:00 am – 10:00 pm) Night Nursing Coordinator Monday- Friday (10:00 pm – 7:30 am) Weekends/Holidays (10:00 pm – 7:00 am) Completion of Incident Report Form The designated Employee Health Department clinician responsible for the New England Baptist Hospital (NEBH) employees shall ensure that the Incident Report Form has been completed including the name and medical record number of the source patient (if known), and the “Employee” box has been checked off on the form. 3. Treatment of an Exposure Site Wounds and skin sites that have been in contact with blood or body fluids 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, the 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. 4. Registration/Baseline Serology The designated Employee Health Department clinician responsible for the New England Baptist Hospital (NEBH) employees shall create a separate, confidential exposure file. Send the employee to the lab with the appropriate lab requisitions for the following serology’s: HBsAG, HBsAB, Anti-HCV, ALT, and Anti-HIV (only if consent signed). Any testing or treatment for a work-related injury or illness will be provided free of charge to the employee. The visit will be documented on the Blood/Body Fluid Exposure Record form (Appendix A). Should an employee be seen in Ambulatory Services this information will be forwarded to the designated Employee Health Clinician for NEBH employees. A unique exposure incident number will be used for all lab work for privacy reasons. Access to assigned numbers are restricted and unidentical. Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 2 of 24 5. 6. Identification/Assessment of Source Patient A. If source patient is known, Employee Health Clinician shall: 1) Review patient’s medical record for evidence of known viral Hepatitis/HIV, request HBsAG, Anti-HCV, ALT, and HIV testing of the patient, and provide appropriate prophylaxis to the employee (Appendix B, L & M). 2) Document patient’s medical record number and Hepatitis/HIV status on the Blood/Body Fluid Exposure record form (Appendix A). 3) If source patient has known Hepatitis B, provide appropriate prophpylaxis to the NEBH employee (Appendix B) B. If source patient is unknown, the designated Employee Health Department clinician responsible for NEBH employees shall: 1. provide baseline testing for HBsAg, HBsAB, Anti-HCV, ALT, HIV antibody (need informed written consent): 2. provide followup testing for HBsAg, Anti-HCV and HIV antibodies in 3 months, 6 months and 12 months after exposure. 3. provide appropriate post-exposure prophylaxis for exposure to hepatitis B virus (Appendix B) and HIV post exposure prophylaxis for percutaneous injuries (Appendix M) or for mucous membrane and contact skin (Appendix N) HIV Status of Source Patient A. If HIV status of source patient is unknown, the designated Employee Health clinician responsible for the NEBH employees shall: 1. Place the red informational letter to the attending physician (Appendix C) regarding the Occupational Blood/Body Fluid Exposure, the Source Patient Consent for HIV Antibody Testing form (Appendix D), completed lab slip and completed doctors order sheet in the source patient’s medical record in the Physician’s Order Section. 2. Contact the patient’s attending physician, advise the physician of the exposure incident involving his/her patient, request that the physician obtain source patient’s informed consent for HIV testing, and request physician to notify the designated Employee Health Department clinician, responsible for the NEBH employees, of the patient’s decision regarding HIV testing. If attending physician not readily available, request permission to have designee (eg, Fellow, Resident, Hospitalist) sign consent with source patient. > If source patient consents to HIV testing, charges for testing will be free of charge as coded by the letter “R” on top right hand corner of lab slip and results of testing will be forwarded to Employee Health. The nurse assigned to the source patient is responsible for notifying the laboratory and providing patient’s name and room number, and request that the blood be drawn. Phlebotomist will pick up lab slip and yellow copy of HIV Consent form prior to drawing of blood to ensure source patient signed consent form. These results will be forwarded to the designated Employee Health clinician, responsible for the NEBH employees. > If source patient declines HIV testing, the signed declination form will be obtained by the attending physician and forwarded to Employee Health Department. The signed declination will be placed in the employees’ confidential record. 7. Follow-Up Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 3 of 24 A. If source patient is HIV seronegative If source patient has no clinical evidence or risk factors for HIV infection, baseline serologic testing will be provided. Follow-up HIV testing will be provided in 6 months for employee (Serologic testing for HIV at baseline and 6 months shall be strongly recommended to satisfy the minimum eligibility requirements for the Employee HIV Benefit Plan.) A unique exposure incident number will be assigned to the employee for HIV testing to ensure confidentiality. B. If source patient is HIV seropositive, high risk or is unknown source: 1) As soon as possible after the exposure, eg, hours rather than days, the employee shall be counseled regarding the risk of infection (Appendix M & N). Baseline serologic testing of the exposed employee for HIV shall be performed after consent for testing (Appendix E) has been obtained. A unique exposure incident number will be assigned to the employee for HIV testing. This number will be used on the laboratory slip in place of the employee’s name and/or medical record number for privacy purposes. Access to assigned numbers are restricted and confidential. The employee HIV consent resides in the Employee Health Department in a locked file. 2) The designated Employee Health Clinician and/or Infection Control Physician for NEBH, shall be requested to provide counseling regarding Post Exposure Prophylaxis (PEP). The National Prophylaxis hotline is available as a resource, 24-hours a day, 7 days a week for consultation at 1-888-448-4911. See Appendix O for additional occupational exposure management resources. 3) The employee shall be: a) Advised to report and seek medical evaluation for any acute febrile illness that occurs within 12 weeks following the exposure. b) Offered follow-up visits and serologic testing for HIV at baseline and intervals of six weeks, and three (3), six (6) and twelve (12) months post-exposure to determine if HIV seroconversion has occurred. NOTE: HIV Seroconversion usually takes place within one month. c) Encouraged to follow U.S. Public Health Service recommendations for preventing transmission of HIV during the initial follow-up period, especially during the first 12 weeks (contained in Appendix I). d) Counseled by the designated Employee Health Clinician and/or Infection Control Physician on call regarding PEP therapy. Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 4 of 24 4) 5) If employee agrees to PEP prophylaxis, the designated Employee Health Clinician and/or Employee Health Physician responsible for NEBH employees shall: a) Ensure that the employee is given the medication information sheet and has signed the Informed Consent for Antiviral Prophylaxis Following an Occupational Exposure to Blood and/or Body Fluids (Appendix F). b) Order baseline lab studies: CBC with diff & platelets, U/A with microscopic exam (only if protease inhibitor prescribed), ALT, AST, Alk. Phos., Total Bilirubin, BUN, Creatinine, lipid panel and CPK. Adjustments in baseline lab studies can be made if source HIV testing will be available within 24 hours. c) Order a Stat HCG (pregnancy test) if the employee is a woman of child bearing age. If the employee is pregnant, contact her obstetrician immediately prior to dispensing antiviral prophylaxis. d) Provide the “starter” doses which can be obtained from Ambulatory Services pyxis system if post exposure prophylaxis will be initiated (Appendix G). Post-exposure prophylaxis should be initiated as soon as possible after exposure (hours rather than days). If the employee chooses to take antiviral therapy, the following protocol shall be followed: a) The exposed employee shall follow up with the designated Employee Health Clinician and/or Infection Control Physician within 7 days. b) CBC with diff & platelets, U/A with microscopic exam (only if protease inhibitor provided), ALT, AST, Alk. Phos., Total Bilirubin, BUN, Creatinine and CPK shall be checked every two weeks while taking antiviral therapy through the Employee Health Department. c) Abnormal lab results shall be reviewed by the Employee Health Clinician in collaboration with the Infection Control Physician. d) When administering PEP an important goal is the completion of a 4-week regimen. However, if the employee develops complications or experiences side effects from the therapy, the designated Employee Health Clinician in collaboration with the Infection Control Physician responsible for NEBH employees will meet with the employee and a decision will be made whether or not to continue the therapy. NOTE: If, after counseling, the employee declines follow up at NEBH, she/he shall be advised to contact the Massachusetts Department of Health for further information regarding available resources. Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 5 of 24 C. If source patient declines testing: The designated Employee Health Clinician responsible for NEBH employees shall use the available clinical information on the source patient to advise the employee on the risk of infection. Guided by this information, the employee will be permitted to proceed either as if the source patient was seropositive. D. If source is unknown and employee chooses antiviral therapy: The designated Employee Health Clinician responsible for NEBH employees and the employee will discuss the circumstances of the exposure and may collaborate with the Infection Control Physician in deciding whether to pursue serial HIV testing of the employee. NOTE: In accordance with OSHA guidelines, an employee undergoing postexposure evaluation is entitled to have a baseline specimen frozen and stored for up to 365 days, however the Infection Control Committee has decided to increase this to one year for possible later HIV screening. B. E. If source patient is HBsAg negative, provide baseline testing for HBsAg and no further testing is required. F. If source patient has known Hepatitis B, provide appropriate prophylaxis to NEBH employee (Appendix B) G. If source patient is Anti-HCV negative, provide baseline testing for Anti-HCV and ALT and follow up testing in 6 months. H. If source patient is Anti-HCV positive, provide baseline testing for Anti-HCV and ALT. At 1 month, 3 months, 6 months and 12 months and obtain Hepatitis C viral, RNA by quantitative by PCR, anti-HCV and ALT. If employee becomes Anti-HCV positive and/or ALT is significantly abnormal, the following blood tests may be obtained: ALT, total bilirubin, direct bilirubin, AST, ALK Phos, gamma glutamyl transpeptidase, total protein, and albumin. Additional follow up with hepatologist and/or infection disease physician may be indicated. Student/Contractor/Vendor/Visitor/Out-of-State Student/Non-Baptist Employed Practitioner/Physician/Resident Exposure The results of source patient testing will be provided to the exposed individual and/or his/her designated health care provider according to the current protocols and recommendations of the CDC. Initial exposure steps are the same as for employee. Follow-up is different in that person will follow-up with their own provider or own Employee Health Department. C. Employee Counseling The designated Employee Health Clinician responsible for NEBH employees shall: 1. Provide and review the following information with the employee: a. b. c. Post-Exposure Results Form (Appendix H) Important Points For You to Know Following an Occupational Blood/Body Fluid Exposure (Appendix I). Universal/Standard Precautions Sheet (if appropriate) (Appendix J). Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 6 of 24 2. Make a follow-up appointment within two weeks with the employee for the purpose of: a. b. c. Providing additional prophylaxis treatment/counseling. Reviewing laboratory testing results and providing written opinion and laboratory results by the designated Employee Health Clinician responsible for NEBH employees (Appendix H). Initiating post Exposure Follow-Up protocol form (Appendix K) and making an appointment for the employee to have next scheduled laboratory screening tests. 3. Follow-up notice sent prior to follow-up date to home address. If employee is a no show, a second and final notice will be sent. 4. Complete and send copy of the Employee Incident Report form to the employer’s manager for completion and safety precautions follow up. REFERENCES: CDC, Updated US Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Post Exposure Prophylaxis. MMWR 2005; 55 (No.RR-9); 1-17. CDC, Updated US Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV and HIV and Recommendations for Post Exposure Prophylaxis. MMWR 2001; 50 (No.RR-11); 1-42. CDC, Public Health Service Guidelines for the Management of Health-Care Worker Exposures to HIV and Recommendations for Postexposure Prophylaxis. MMWR (supplement) May 15, 1998:47(No.RR-7) CDC. Public Health Service statement on management of occupational exposure to human immunodeficiency virus, including considerations regarding zidovudine postexposure use. MMWR 1990;39(no. RR-1). CDC. Case-control study of HIV seroconversion in health-care workers after percutaneous exposure to HIVinfected blood-France, United Kingdom, and United States, January 1988-August 1994. MMWR 1995;44:929-33. Federal Register, Vol. 56, No. 235, 29 CFR Part 1910. 1030, Occupational Exposure to Bloodborne Pathogens, Final Rule, pp. 64175-82, December, 1991. Gerberding JL. Management of occupational exposures to blood-borne viruses. N. Engl J Med 1995;332:444-51. Horan, C. CDC convenes experts to discuss HIV post exposure management. Assoc. of Occ Health Professionals; 1996, May/June;6-8. Kinloch-de loes S, Hirschel BJ, Hoen B, et al. A controlled trial of zidovudine in primary human immunodeficiency virus infection. N Engl J Med 1995;333:408-13. Tokars JI, Marcus R, Culver DH, et al. Surveillance of HIV infection and zidovudine use among health care workers after occupational exposure to HIV-infected blood. ANN Intern Med 1993;118;913-9. Update: Provisional Public Health Service Recommendations for Chemoprophylaxis after Occupational Exposure to HIV. MMWR 1996;45(no.22).468-472. BBFEmp2MAR06 REVISED: DISTRIBUTION: 12/20/2000, 3/01, 03/04 3/06 Employee Health, Infection Control and Ambulatory Services Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 7 of 24 APPENDIX A NEW ENGLAND BAPTIST HOSPITAL / EMPLOYEE HEALTH BLOOD BODY FLUID EXPOSURE RECORD Name_________________________________________ Staff code_____________________________________ Date of Incident_________________________ Immunization History:________________________ Name_____________________________________ MR # _____________________ Unknown_________ HBV Immunization: Date Dose #1__________ Standing Orders to patient chart Attending notified (Date/Time)___________________ ________________ Physician letter to patient chart __________________ #2__________ Testing After Exposure #3__________ Date Results HBsAg _______ _______ Anti-HCV _______ _______ ALT _______ _______ HIV Consent _______ Yes No if no, documented in MR Antibody Status and Date Tested____________________________ Tetanus Booster Date___________ Testing After Exposure HBsAg Anti-HBs Anti-HCV Date _______ _______ _______ Results _______ _______ _______ ALT _______ _______ HIV Consent _______ Blood saved for ONE year Anti-HIV #1(exp.)______ #2(6wk)______ #3(3mo)______ #4(6mo)______ Anti-HIV Transfusion IV Drug Use History of Hepatitis History of Hemophilia Abnormal Liver Function Test Pertinent Sexual Activity Consent for Release of Testing Results Treatment Tetanus Booster HBV Booster HBIG - Dose #1 #2 Antiviral(s) Started Stopped ______ Risk Factors Yes No Yes No ______ ______ ______ ______ Date ______ ______ ______ ______ ______ ______ _______ N/A ______ ______ ______ ______ ______ ______ Yes ____ ____ ____ ____ No ____ ____ ____ ____ Unknown _____ _____ _____ _____ ____ ____ _____ ____ ____ _____ ____ ____ _____ Route of Exposure: Percutaneous-punctured or broke the skin Mucous membrane-contact with mouth, eyes or other mucous membranes Skin-was skin intact Bite-bite where the skin was broken Blood visible on device before exposure __Yes __No __Yes __No Exposed to (identify type of fluid)_________________________________________________________________________ Body Part __________________ Describe the depth of the injury: Superficial-injuries such as a scratch Moderate-those injuries that are more serious than scratch, but not so serious that they would be considered to be deep (eg, superficial laceration or tissue avulsion) Deep-injuries that touched bone or muscle contracted. Device/item involved in incident________________ Was device/item a safety device __Yes Was device/item part of prepacked kit? __Yes __No __No Who was holding device when incident occurred?__________________ Equipment Manufacturer and Brand Name of device__________________________________________________________ Circumstances under which exposure occurred: 1. Type of Work______________________________________________________________________________________ 2. What was cause of incident? (accident, equipment failure, etc.) _______________________________________________ List Personal Protective Equipment worn: Gloves: Single__ Double__ Eye Protection __ Face Shield__ Mask__ Gown__ Signature:_________________________________________ Other:____________________________ Rev 3/06 Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 8 of 24 APPENDIX A (Continued) What suggestion does the employee have for preventing similar injuries in the future: Signature of Employee______________________________________________ Date________ Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 9 of 24 Appendix B Recommended Postexposure Prophylaxis for Exposure to Hepatitis B Virus Vaccination and antibody response status of exposed workers* Source HBsAg¹ positive Treatment Source HBsAg¹ negative Source unknown or not available for testing Unvaccinated HBIG² x 1 and initiate HB vaccine series§ Initiate HB vaccine series Initiate HB vaccine series Previously vaccinated Known responder** No treatment No treatment No treatment Known nonresponder" HBIG x 1 and initiate revaccination or HBIG x 2^ No treatment If known high risk source, treat as if source were HBsAg positive Antibody response unknown Test exposed person for antiHBs# No treatment Test exposed person for antiHBs 1. If adequate# no treatment is necessary 2. If inadequate# administer vaccine booster and recheck titer in 1-2 months 1. If adequate,** no treatment is necessary 2. If inadequate”, administer HBIG x 1 and vaccine booster *Persons who have previously been infected with HBV are immune to reinfection and do notrequire postexposure prophylaxis. ¹ Hepatitis B surface antigen. ² Hepatitis 8 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., anti-HBs 10 mlU/mL). " A nonresponder is a person with inadequate response to vaccination (ie., serum 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. Source: CDC, Updated US Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV and HIV and Recommendations for Post Exposure Prophylaxis. MMWR 2001; 50 (No.RR-11); 1-42. Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 10 of 24 APPENDIX C NEW ENGLAND BAPTIST HOSPITAL EMPLOYEE HEALTH/ EMPLOYEE HEALTH INFECTION CONTROL OCCUPATIONAL EXPOSURE PHYSICIAN LETTER Employee Health New England Baptist Hospital 125 Parker Hill Avenue Boston, MA 02120 (617) 754-5804 Date:____________________________ Dear Dr._________________________________________. Our employee from New England Baptist Hospital sustained an Occupational Blood/Body Fluid Exposure on ____________________________from your patient _________________________________________________ whose medical record number is ______________________. In order to test your patient for HIV status we need their consent. We ask the attending physician to obtain this consent from their patient in the event the patient has any questions regarding the HIV antibody test. You will find an enclosed HIV consent form. Once you have obtained the consent from your patient, blood will be drawn free of charge by New England Baptist Hospital. These results will be shared with the employee and the Employee Health Clinician. If you have any questions please do not hesitate to contact me. Thank you for your cooperation in this matter. Sincerely, Employee Health Clinician Reviewed by Med. Rec. Committee 12/96,10/03 Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 11 of 24 APPENDIX D NEW ENGLAND BAPTIST HOSPITAL EMLOYEE HEALTH/INFECTION CONTROL PATIENT CONSENT FOR HIV ANTIBODY TESTING (Human Immunodeficiency Virus Antibody) I UNDERSTAND THAT MY BLOOD WILL BE TESTED FOR THE PRESENCE OF ANTIBODY TO THE HIV VIRUS WHICH IS THE VIRUS IMPLICATED IN THE ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS). I UNDERSTAND THAT THIS IS NOT A TEST FOR THE VIRUS ITSELF. I UNDERSTAND THAT CONFIRMATORY TESTS ARE AVAILABLE BUT THAT NEITHER A POSITIVE NOR A NEGATIVE TEST CAN BE USED ALONE TO DIAGNOSE AIDS. I UNDERSTAND THAT TEST RESULTS WILL BE ENTERED IN MY MEDICAL RECORD. I UNDERSTAND THAT MY PHYSICIAN MAY BE REQUIRED TO REPORT POSITIVE RESULTS TO HEALTH OFFICIALS. I FURTHER UNDERSTAND THAT ADDITIONAL INFORMATION AND COUNSELING ARE AVAILABLE THROUGH MY PHYSICIAN. I elect to have the HIV Antibody Testing. I acknowledge that I have been given all the information I desire concerning the blood test, its expected benefits and risks and have had all my questions answered. I do not elect to have the HIV Antibody Testing. __________________________________________________________________________________ (PRINT) LAST NAME FIRST NAME _______________________________________ SIGNATURE OF PATIENT ___________________________________________ DATE _______________________________________ PHYSICIAN’S NAME ___________________________________________ PATIENTS MEDICAL RECORD NUMBER _______________________________________ SIGNATURE OF WITNESS ___________________________________________ DATE NOTE: SEND THIS CONSENT FORM TO PATHOLOGY LABORATORY TO BE REVIEWED BY THE PATHOLOGIST AND FORWARDED TO MEDICAL RECORDS PATHOLOGY OFFICE USE:_________________________________________________________ occmed/hivsent/12/28/00/IA WHITE - MEDICAL RECORD YELLOW- LAB Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 12 of 24 APPENDIX E NEW ENGLAND BAPTIST HOSPITAL EMPLOYEE HEALTH/ INFECTION CONTROL HIV ANTIBODY TEST CONSENT for Occupational Exposure Human immunodeficiency virus (HIV) is the cause of acquired immunodeficiency syndrome (AIDS). All persons infected with HIV can spread it to others through unprotected sex, needle sharing, and donating blood or other tissues. Infected mothers can pass HIV to their newborns. Testing for HIV infection is voluntary. WHAT THE TEST MEANS The HIV test tells if HIV antibody is in the blood. Antibody is the body’s reaction to the virus. A positive test means that a person is infected with HIV and can pass it to others. The test does not tell how long the infection has been present. By itself a positive test does not mean that a person has AIDS, which is the most advanced stage of infection. A negative test means that antibody to HIV cannot be detected. This usually means that the person has never been infected with HIV and is now not carrying the virus. In some cases, however, the infection may have happened too recently for the test to turn positive. The blood test usually turns positive in one month after infection. In rare cases it may take six months or longer to turn positive. Therefore, if you were infected recently, a negative test could be false. False negative results (a negative testing in someone who is infected, or a false positive test in someone who is not infected) are rare. Indeterminate results (when it is unclear whether the test is positive or negative) also are rare. When a test result is inconsistent with the patient’s history, a repeat test or special confirmatory test may help to determine whether a person is or is not infected. PRIVACY AND CONFIDENTIALITY HIV test results will be held in the strictest confidence. Your test results will not be released to any other person, agency, company, or government without your specific written permission, except as permitted by law. I understand I will receive a copy of my lab results on my two week follow-up visit. In the event the test results are positive, I will be offered counseling and referral for further health care. I elect to have the HIV Antibody Testing. I acknowledge that I have been given all the information I desire concerning the blood test, its expected benefits and risks and have had all my questions answered. I do not elect to have the HIV Antibody Testing and understand my blood will be held for 365 days should I decide to have the testing. If I decide to have the testing, it is my responsibility to notify the Employee Health Clinician within the 365 day period. I understand that on day 366 my blood will be discarded. ___________________________________________________________________________________________ PRINT (LAST NAME) (FIRST NAME) _______________________________________ SIGNATURE OF PATIENT ___________________________________________ DATE _______________________________________ SIGNATURE OF WITNESS ___________________________________________ DATE occmed/hivsent12/28/00/ia WHITE- OCCMED YELLOW-LAB Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 13 of 24 APPENDIX F NEW ENGLAND BAPTIST HOSPITAL EMPLOYEE HEALTH/ INFECTION CONTROL INFORMED CONSENT FOR ANTIVIRAL PROPHYLAXIS FOLLOWING AN OCCUPATIONAL EXPOSURE TO BLOOD AND/OR BODY FLUIDS Information Regarding ANTIVIRAL PROPHYLAXIS As a part of the Post Exposure Follow Up and Treatment Protocol, the New England Baptist Hospital offers and makes available to employees who are occupationally exposed to material which may contain human immunodeficiency virus (HIV), the virus which causes AIDS, a course of prophylactic (preventive) treatment with single or combined antiviral medications. For exposure for which PEP is considered appropriate, knowledge about the efficacy and toxicity of PEP is limited. Only zidovudine has been shown to prevent HIV transmission in humans. Although there is no data to address whether adding other antiretroviral drugs provides any additional benefit for PEP, experts recommend combination drug regimens because of increased potency and concerns about drugresistant virus. Studies to date of HCW’s exposed to human blood infected with HIV indicate that the risk of infection is low, but directly related to the type of exposure as well as the volume, concentration, and viability of the innoculum. Even a short course of antiviral medications may have important and serious side effects. The most common is nausea; the most important is anemia. Most short term risks are reversible. There may also be important long term risks such as an increased risk of cancer. AZT has been found to cause cancer in lab animals. The applicability of this research to humans is not known. The treatment may involve risks which are currently unforeseeable to the person receiving antiviral medication or to the embryo or fetus if the person is or may become pregnant. I have read the above and I have considered the potential risks of treatment and the unproven nature of the treatment. I have decided that I wish to receive the recommended antiviral therapy. I understand that this course of treatment is made available subject to the following conditions: I will receive antiviral therapy under the supervision of a designated Employee Health Clinician from New England Baptist Hospital who will prescribe the drug(s). As an employee, I will be provided with review/monitoring of follow up testing for short term adverse reactions. The course of treatment will be provided to me without cost. It is my responsibility to comply with recommended testing while taking the antiviral medication(s). As a non-employee I will contact my health care provider of choice for follow up and inform New England Baptist Hospital who my provider will be. I understand that it is uncertain whether the medication(s) has any effects on sperm, ova, or embryo. I should avoid conception, breast feeding, and/or organ donation during this course of treatment. Information about my treatment and the results of lab tests obtained to monitor the effects of medications will be kept in my confidential post exposure follow up chart separate from my Employee Health chart and medical record. Post exposure counseling has been provided to me. I have reviewed the above information and any questions I have regarding treatment have been answered to my satisfaction. I,__________________________________________________request administration of this unproved and unapproved use of AZT and/or combination of antiviral medication(s) to me. I have decided not to receive the offered/recommended/not recommended antiviral therapy (circle appropriate therapy). Exposed Individual: Witness: __________________________________________ Date:______________________________________ ___________________________________ Date:_______________________________ EH/Forms/Anti Pro/12/00,10/03,4/04 Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 14 of 24 APPENDIX G NEW ENGLAND BAPTIST HOSPITAL EMPLOYEE HEALTH/ INFECTION CONTROL OCCUPATIONAL EXPOSURE PHARMACY PROTOCOL Basic and Expanded Post-Exposure Prophylaxis Employees potentially exposed to Human Immunodeficiency Virus (HIV) contaminated fluids may elect to receive prophylactic treatment. The employee should begin treatment as soon after exposure as possible (preferably hours rather than days) Prophylaxis therapy may consists of: 1. Basic regimen with Nucleoside analogue Zidovudine-600mg/daily in divided doses . Lamivudine-300mg/daily in divided doses. ***Combivir is the combination of Zidovudine(300mg) and Lamivudine(150mg). It is given as 1 tab, twice a day. 2. Expanded regimen with HIV Protease inhibitors. Kaletra (Lopinavir 133.3 mg, Ritonavir 33.3 mg) 3 caps BID with food Or other protease inhibitors ***The drugs are in the Pyxis under brand names.**** Employee Health Department issues a two week supply of medications. Ambulatory Care Unit (ACU) will issue a 4 day supply medications The Pharmacy dispensing procedure is as follows: A written and signed prescription is required before medication is dispensed. The prescription will not have a patient name, but will be for “Occupational Exposure.” Employee Health Department (new or continued treatment) 1. 2. 3. Employee Health clinician will write on a blank prescription pad, Occupational, Exposure (must be exact) for a 2 week supply of nucleoside analogue and if indicated HIV protease inhibiter or other drugs as ordered.. A written and signed prescription is brought to the Pharmacy by a member of clinic staff. In exchange for this signed prescription, a two week supply of medication will be given to the staff member. The employee being treated for possible exposure will be given their drug(s) with proper instructions prior to leaving the Employee Health Department. Ambulatory Care Unit (new prescriptions only) When the Employee Health Department is closed, the Ambulatory Care Unit treating the employee may dispense a one to four day supply of medication from the Pyxis system. Pharmacy The Pharmacy will bill or charge Workers Compensation for this. All bills will be forwarded to Employee Health for approval. * The CDC recommends the use of zidovudine in all exposure prophylaxis treatments. Lamivudine should usually be added to zidovudine for its synergistic activity. Kaletra (a protease inhibitor) or combination deemed appropriate by consulting clinician based on source (viral load, potential resistance & current drug) should be added for exposure with the highest risk for HIV transmission. The decision on which antiretroviral combination will be used will be made by the employee and advising physician/NP. Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 15 of 24 APPENDIX H NEW ENGLAND BAPTIST HOSPITAL NEW ENGLAND BAPTIST HOSPITAL EMPLOYEE HEALTH/ INFECTION CONTROL OCCUPATIONAL EXPOSURE TEST RESULTS I understand that I have had a blood or body fluid exposure. The risk of this exposure, the results from my laboratory tests and the source laboratory tests (if applicable) have been explained to me. The results are the following: EMPLOYEE LAB TEST HbsAg Anti- Hbs Anti- HCV ALT HIV RESULT DATE SOURCE * LAB TEST HbsAg Anti- HCV ALT HIV RESULT DATE *You are obliged to keep the source information strictly confidential I understand that the Hepatitis B Vaccine is indicated not indicated I have been informed of the results of the evaluation and of any medical conditions resulting from the exposure that require further evaluation or treatment.. _______________________________________ Employee Signature _______________________________________ Health Care Professional Signature _______________________________________ Date WHITE COPY- OM Rev: 12/00,3/01,10/03, 3/06 occmed/forms/results/ia YELLOW COPY - EMPLOYEE Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 16 of 24 APPENDIX I NEW ENGLAND BAPTIST HOSPITAL EMPLOYEE HEALTH/INFECTION CONTROL IMPORTANT POINTS FOR YOU TO KNOW FOLLOWING AN OCCUPATIONAL EXPOSURE You shall be counseled regarding the risk of Hepatitis B infection from your exposure. If you have not had Hepatitis B vaccine, you will be strongly advised to begin the Hepatitis B vaccine series immediately. You may also be offered Hepatitis B Immune Globulin (HBIG) for added protection as appropriate. You shall also be counseled regarding the risk of HIV infection from your exposure. It is important for you to be tested for HIV antibody to determine your baseline and the appropriate follow-up for your exposure. If the result is negative, you may be retested at pre-determined intervals to determine if HIV transmission has occurred. In addition, the source patient will also be requested to submit to HIV antibody testing. You should know that it is not easy to get HIV even after a known exposure. The average risk for HIB infection from all types of percutaneous exposures to HIV-infected blood is 3 in 1000 exposed. The risks after mucous membrane and skin exposures to HIV-infected blood are approximately 1 in 1000 and less than 1 in 1000 respectively. You will be scheduled for a follow-up appointment with Employee Health Department to receive the results of your laboratory tests regardless of the outcomes of these tests. The Employee Health Department utilizes a confidential coded system. No names are used in the ordering of laboratory tests and the confidentiality of your tests will be strictly respected. New England Baptist Hospital is committed to providing quality health care to all patients, regardless of HIV status. Although data from the Centers for Disease Control (CDC) indicate the risk of infection to health care workers to be very small, we recognize that treatment of patients with this disease exposes employees to some risk. We are also aware that employees who are not health care workers may be exposed to HIV in the course of their employment. Therefore, we want to provide support to those workers who might become infected with HIV. The New England Baptist Hospital has developed an HIV Benefit Plan. The plan provides financial assistance and other support services to an employee who becomes HIV positive as a result of a workrelated incident at the institution. The financial assistance provides a lump sum payment of $200,000.00. This payment is in addition to any amounts that are payable under the institution’s benefit plan, Workers’ Compensation, and other insurance plans. This program is provided at no cost to eligible participants. Eligibility requires a baseline HIV test within five(5) days of the exposure incident and repeat HIV test after 6 months. Please refer to the “Work-Related HIV Benefit Plan” booklet for further details of the plan. You shall be counseled during this follow-up period to follow the CDC recommendations for preventing transmission of HIV, including refraining from blood, semen, or organ donation. CDC also advises using appropriate protection during sexual intercourse. Use of latex condoms and water soluble lubricant are recommended. Women are advised to refrain from breast feeding and planning to get pregnant in the period while undergoing testing to prevent possible exposure of the infant to HIV infection. You shall be counseled to report and seek medical evaluation for any acute fever, especially one associated with a body rash, swollen lymph nodes, muscle achiness, fatigue, or malaise which occurs during the follow-up period, especially during the first 12 weeks after exposure. Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 17 of 24 Important Points for You to Know Following an Occupational Exposure (cont.) Page 2 If, after investigation, the source patient is found to be HIV positive, you will be offered a baseline physical examination by a physician designated by Employee Health or by your own PCP. An Infectious Disease physician or your PCP will discuss antiviral therapy with you. Be advised there is no PROVEN or APPROVED treatment to prevent HIV infection from occurring. Although AZT has not been proved to prevent HIV infection, findings of a new research study printed in the 1995 MMWR summarizes the findings of factors associated with risk for and prevention of HIV infection in Health Care Workers following occupational exposure. The analysis of the study data suggests the use of AZT post exposure may be protective as the study model indicated the risk for HIV infection was reduced in Health Care Workers who used AZT. Studies to date of Health Care Workers exposed to human blood infected with HIV indicate that the risk of infection is low, but DIRECTLY related to the type of exposure as well as the volume, concentration, and viability of the innoculum. Even short courses of antiviral therapy may have important and serious side effects: * The most common is nausea. The most important is anemia. Most short term risks are reversible. * There may also be other important risks such as bone marrow depression. * The treatment may involve risks which are currently unforseeable to the person receiving the antiviral prophylaxis or to the embryo or fetus if the person is or may become pregnant. This information sheet is designed to assist you during the post-exposure follow-up period and is intended to anticipate any questions you may have about specific tests, procedures, and prophylaxis. If you have any additional questions, please ask the Employee Health Clinician or your designated physician. Rev: 11/96,12/00,3/01,10/03 Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 18 of 24 APPENDIX J NEW ENGLAND BAPTIST HOSPITAL EMPLOYEE HEALTH/ INFECTION CONTROL POST-EXPOSURE REVIEW OF UNIVERSAL/STANDARD PRECAUTIONS Universal/Standard precaution techniques shall be utilized for all New England Baptist Hospital patients (inpatients and outpatients) regardless of their diagnoses. These techniques shall also apply to the handling of all medical equipment and materials contaminated by blood or body fluid. Each employee shall utilize protective barriers when having direct contact or potential exposure to blood or body fluid(s) via mucous membrane or non-intact skin. Gloves Gloves shall be worn whenever hands are likely to be in contact with blood, body fluid, or body secretions. Hands shall be washed routinely before and after any job-related task that may potentially expose the employee to blood, body fluid, or body secretion. The following are examples but not necessarily all inclusive of activities which require wearing of gloves: o o o o o o o o o o o o Examining patients Drawing blood Starting IV’s Invasive or operative procedures Endoscopy, colonoscopy, bronchoscopy Handling lab specimens, soiled waste, or soiled linen Intubation Suctioning Catheter insertion Cleaning soiled equipment Administering injections Handling tubes of blood Hands shall be washed after removing gloves. Gowns Gowns shall be worn if soiling of clothing is likely to occur; for example, when performing the following of similar activities: o o o o Cleaning soiled equipment Handling grossly contaminated linen Operative or other procedures which produce extensive splattering of blood or body fluids Cleansing the skin of incontinent patients o o o Endoscopy, colonoscopy, bronchoscopy Intubation Insertion of arterial or central lines Gowns shall be removed if they become grossly contaminated. Masks and Safety Glasses (Goggles) Masks and goggles shall be worn whenever it is likely that eyes and/or mucous membrane might be splashed with blood or body fluids; for example, during the following activities: o o Intubation Suctioning o o Emptying drainage devices Insertion of arterial or central lines o o Contact with patient with productive cough Operative or other invasive procedures which produce splattering of blood or body fluids Needles and Sharps Contaminated needles and sharps, e.g., needles, scalpels, blades, pipettes, glass slides, etc., shall be handled with extreme caution. Contaminated sharps shall be disposed of in the closest puncture resistant container immediately after use. Each employee shall observe the following rules: Do not recap, bend, or break needles under any circumstances; Remove and replace puncture resistant sharps disposal containers as soon as they are full; Use needle-safe devices; Communicate with colleagues of whereabouts of sharps when appropriate; Be constantly alert to injury potential when handling sharps Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 19 of 24 Post-Exposure Review of Universal Precautions Page 2 Infectious Waste Trash that is heavily contaminated or saturated with blood or body fluids shall be discarded into covered hazardous waste receptacles. Soiled linen shall be bagged at the point of origin; linen that is heavily soiled or wet with blood or body fluids, shall be placed in an impervious bag. Reporting of Puncture Wound or Exposure to Blood or Body Fluid I understand it is my responsibility to report any puncture wound or other exposure to blood or body fluids immediately (within the hour of exposure) to Employee Health or other designated areas to ensure appropriate HIV/HBV follow-up and management. Rev: 10/03 OccMed/Forms/BBFEduca/11/2000/IA Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 20 of 24 APPENDIX K NEW ENGLAND BAPTIST HOSPITAL EMPLOYEE HEALTH/ INFECTION CONTROL POST-EXPOSURE FOLLOW UP FORM NAME:________________________________ EXPOSURE DATE:______________________ Today’s Date:__________________________ TYPE OF FOLLOW UP 2 WEEK 1 MONTH 3 MONTHS 6 MONTHS 12 MONTHS Since your last visit, have you had or do you have any of the following signs or symptoms? (Please check all that apply) fever chronic lymphadenopathy (swollen glands) joint/muscle pain body rash other (specify) night sweats malaise/fatigue weight loss - unexpected flu-like symptoms none of the above Any concerns or comments:_______________________________________________________ ______________________________________________________________________________ ----------------------------------------------------------------------------------------------------------------------------------------To be completed by the Employee Health Clinician: HIV AB drawn yes no Comments_____________________________________________________________________ ______________________________________________________________________________ _______________________________________ Employee Health Clinician Rev: 10/03, 3/06 occmed/forms/POSTF-U/12/2000/ia Date Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 21 of 24 APPENDIX L Recommended HIV Postexposure Prophylaxis for Percutaneous Injuries Infection Status of Source Exposure type HIV-Positive Class 1 * HIV-Positive Class 2* Source of unknown HIV status Unknown Source - HIV – Negative Less Severe-- Recommend basic 2-drug PEP Recommend expanded 3-drug PEP Generally, no PEP warranted; however, consider basic 2-drug PEP for source with HIV risk factors ++ Generally, no PEP warranted; however consider basic 2-drug PEP** in settings where exposure to HIV infected persons is likely No PEP warranted More severe ** Recommend expanded 3-drug PEP Recommend expanded 3-drug PEP Generally, no PEP warranted; however, consider basic 2-drug PEP for source with HIV risk factors ++ Generally, no PEP warranted; however consider basic 2-drug PEP in settings where exposure to HIVinfected person is likely No PEP warranted * HIV-Positive, Class 1 - asymptomatic HIV infection or known low viral load (e.g., <1,500 RNA copies/mL); HIV-Positive, Class 2-symptomatic HIV infection, AIDS, acute seroconversion, or known high viral load. If drug resistance is a concern, obtain expert consultation. Initiation of postexposure prophylaxis (PEP) should not be delayed pending expert consultation, and because expert alone cannot substitute for face-to-face counseling, resources should be available to provide immediate evaluation and follow-up care for all exposures. Source of unknown HIV status (e.g., deceased source person with no samples available for HIV testing) - Unknown source (e.g, a needle from a sharps disposal container). -- Less severe (e.g.. solid needle and superficial injury). The designation "consider PEP" indicates that PEP is optional and should he based on an individualized decision between the exposed person and the treating clinician. ++ If PEP is offered and taken and the source is later determined to be HIV-negative. PEP should be discontinued ** More severe (e.g., large-bore hollow needle, deep puncture, visible blood on device, or needle used in patient’s artery or vein) Source: CDC, Updated US Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV and HIV and Recommendations for Post Exposure Prophylaxis. MMWR 2001; 50 (No.RR-11); 1-42. Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 22 of 24 APPENDIX M Recommended HIV Postexposure Prophylaxis for Mucous Membrane Exposures and Nonintact skin Infection Status of Source Source of unknown Unknown Source HIV status Exposure type HIV-Positive Class 1” HIV -Positive Class 2” HIV Negative Small Volume ** Consider basic 2-drug PEP Recommend basic 2drug PEP Generally. no PEP warranted; however, consider basic 2-drug PEP for source with HIV risk factors Generally, no PEP warranted; however consider basic 2drug PEP in settings where exposure to HIV infected persons is likely No PEP warranted Large Volume Recommend basic 2drug PEP Recommend expanded 3-drug PEP Generally, no PEP warranted; however, consider basic 2-drug PEP for source with HIV risk factors Generally, no PEP warranted; however consider basic 2drug PEP in settings where exposure to HIV-infected person is likely No PEP warranted * For skin exposures, follow-up is indicated only if there is evidence of compromised skin integrity (e.g., dermatitis, abrasion, or open wound). ” HIV-Positive, Class 1 - asymptomatic HIV infection or known low viral load {e.g., <1,500 RNA copies/mL). HIV-Positive, Class 2-symptomatic HIV infection, AIDS, acute seroconversion, or known high viral load. If drug resistance is a concern, obtain expert consultation. Initiation of postexposure prophylaxis (PEP) should not be delayed pending expert consultation, and because expert consultation alone cannot substitute for face-to-face counseling, resources should be available to provide immediate evaluation and fol1ow-up care for all exposures. Source of unknown HIV status (e.g. deceased source person with no samples available for HIV testing) Unknown source (e.g., splash from inappropriately disposed blood). ** Small volume (i.e., a few drops). The designation, “consider PEP”, indicates that PEP is optional and should be based on an individualized decision between the exposed person and the treating clinician. If PEP is offered and taken and the source is later determined to be HIV-negative, PEP should be discontinued. Large volume (i.e., major blood splash). Source: CDC, Updated US Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV and HIV and Recommendations for Post Exposure Prophylaxis. MMWR 2001; 50 (No.RR-11); 1-42. Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 23 of 24 APPENDIX O Occupational Exposure Management Resources National Clinicians' Postexposure Prophylaxis Hotline {PEPline) Run by University of California San Francisco/San Francisco General Hospital staff; supported by the Health Resources and Services Administration Ryan White CARE Act HIV/AIDS Bureau AIDS Education and Training Centers and CDC Phone: (888) 448-4911 Internet: <http://www.ucsf.edu/hivcntr> Needlestick! A website to help clinicians manage and document occupational blood and body fluid exposures. Developed and maintained by the University of California, Los Angeles (UCLA), Emergency Medicine Center, UCLA School -of Medicine, and funded in party by CDC and the Agency for Healthcare Research and Quality. Internet: <http:// www.needlestick.mednet.uc1a.edu> Hepatitis Hotline Phone: (888) 443-7232 Internet: <http://www.cdc.gov/hepatitis> Reporting to CDC: Occupationally acquired HIV infections and failures of PEP Phone: (800) 893-0485 HIV Antiretroviral Pregnancy Registry Phone:(800) 258-4263 Fax: (800) 800-1052 Address: 1410 Commonwealth Drive Suite 215 Wilmington, NC 28405 Internet: < http//www.glaxowellcome.corn/ preg_reg/antiretroviral> Food and Drug Administration Report unusual or severe toxicity to antiretroviral agents Phone: (800) 332-1088 Address: MedWatch HF-2, FDA 5600 Fishers Lane Rockville, MD 20857 Internet: <http://www .fda.gov/medwatch> HIV / AIDS Treatment Information Service Internet: <http://www.hivatis.org> Employee Health-Blood/Body Fluid Exposure Protocol Section VI-O #2 Page 24 of 24 Appendix P NEW ENGLAND BAPTIST HOSPITAL EMPLOYEE HEALTH 617-754-5804 BLOOD/BODY FLUID EXPOSURE FOLLOW-UP The following dates are when it is strongly recommended you follow up after your blood and body fluid exposure: Exposure Date: _____________ 2 weeks-for results only 1 Month ___________________ 3 Months: _________________ 6 Months: _________________ 12 Months: _________________ Additional Instructions: __________________________________________________. One notice will be mailed to you prior to each recommended follow up. You may also contact Employee Health at any time with questions or concerns. Please call us if you develop any flu-like symptoms such as rash, fever, unexplained weight loss, fatigue, swollen glands, muscle/joint pain, or night sweats. Finally, if you transfer to another department, change your address or change your telephone number, please let us know as we use the information you supplied to us for communicating with you. Thank You __________________________ Employee Health Provider