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PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ EMPLOYEE HEALTH INFECTION CONTROL POLICY GUIDELINES Section VI-O #2 Page 1 of 22 _________________________________________________________________________________________________ BLOOD/BODY FLUID EXPOSURE PROTOCOL – NEBH EMPLOYEES ONLY _______________________________________________________________________________ Subject: Effective Date: March, 2001 Supersedes: 3/99 Approved By: Infection Control Committee Author: Irene M.E. Anderson, M.S.A., R.N., COHN-S/CM __________________________________________________________________________________________________ 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 Occupational Medicine Clinician may be interchangeable with the clinicians in other designated areas. I. PERSONNEL ISSUES A. Employee Exposure 1. 2. Report to: Occupational Medicine-Employee Health Monday - Friday (8AM4PM) Ambulatory Services Monday- Friday after 4 P.M. Weekends/Holidays Completion of Incident Report Form The designated Occupational Medicine Center 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. Registration/Baseline Serology The designated Occupational Medicine Center 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, Anti-HBS, Anti-HBc, Anti-HCV, SGPT (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) page 7. Should an employee be seen in Ambulatory Services this information will be forwarded to the designated Occupational Medicine Clinician for NEBH employees. 4. Identification/Assessment of Source Patient a. If source patient is known, Occupational Medicine Clinician shall: 1 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O # 2 Page 2 of 22 NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ EMPLOYEE HEALTH INFECTION CONTROL POLICY GUIDELINES b. 5. 1) Review patient’s medical record for evidence of known viral Hepatitis/HIV, request HBsAG, Anti-HBc, Anti-HCV, and HIV testing of the patient, and provide appropriate prophylaxis to the employee (Appendix B & M) page 8 &21 . NOTE: At this time their is insufficient data to warrant routine testing of source patients for Hepatitis C antibody and the Centers for Disease Control are not requesting such testing but the Infection Control Committee strongly recommends these tests to protect NEBH employees. 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 A, B, C, provide appropriate prophylaxis to the NEBH employee (Appendix B). If source patient is unknown, the designated Occupational Medicine Center clinician responsible for the New England Baptist Hospital (NEBH) employees shall follow the Hepatitis B algorithm (Appendix B) and Post Exposure Prophylaxis algorithm ( Appendix M) for the appropriate prophylaxis. HIV Status of Source Patient If HIV status of source patient is unknown, the designated Occupational Medicine Center clinician responsible for the New England Baptist Hospital (NEBH) employees shall: a. Place the informational letter to the attending physician (see Appendix C) page 9 regarding the Occupational Blood/Body Fluid Exposure and the Source Patient Consent for HIV Antibody Testing form (see Appendix D) page 10 in the source patient’s medical record in the left front plastic pocket of the record binder. b. 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 Occupational Medicine Center clinician, responsible for the New England Baptist Hospital (NEBH) employees, of the patient’s decision regarding HIV testing. >If source patient consents to HIV testing, charges for testing will be free of charge and forwarded to Occupational Medicine, notify laboratory, provide patient’s name and room number, and request that blood be drawn . Phlebotomist will pick up 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 Occupational 2 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O # 2 Page 3 of 22 NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ EMPLOYEE HEALTH INFECTION CONTROL POLICY GUIDELINES Medicine Center clinician, responsible for the New England Baptist Hospital (NEBH) employees. > 6. If source patient declines HIV testing, obtain the signed declination form and place in the employees’ confidential record. Follow-Up a. If source patient is seronegative If source patient has no clinical evidence or risk factors for HIV infection, no follow-up of exposed employee shall be required following the initial visit. However, routine serologic testing for HIV at baseline, 6 weeks, and three months shall be strongly recommended to satisfy the minimum eligibility requirements for the Employee HIV Benefit Plan. b. If source patient is seropositive, high risk or is unknown source: 1) As soon as possible after the exposure, preferably within two hours, the employee shall be counseled regarding the risk of infection.(Appendix M page 21) Baseline serologic testing of the exposed employee for HIV shall be performed after consent for testing (Appendix E) page 11 has been obtained. 2) The designated Occupational Medicine Clinician or Infection Control Physician for NEBH ,shall be requested to provide counseling regarding post exposure prophylaxis (PEP) 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, six, and 12 months post-exposure to determine if seroconversion has occurred. NOTE: 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). 3 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM 4 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O # 2 Page 4 of 22 NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ EMPLOYEE HEALTH INFECTION CONTROL POLICY GUIDELINES d) Counseled by the designated Infection Control Physician on call regarding PEP therapy. 4) 5) If employee agrees to PEP, the designated Occupational Medicine Clinician or Infection Control 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) page 12. b) Order CBC,diff, & platelets; U/A with microscopic exam; SGPT, Alk. Phos., Total Bilirubin, Creatinine. c) If the employee is a woman of child bearing age, order a stat HCG (pregnancy test). If the employee is pregnant, contact her obstetrician immediately prior to dispensing antiviral prophylaxis. d) If antiviral prophylaxis will be initiated, provide the “starter” doses, which can be obtained from the pharmacy (Appendix G) page 13. If the employee chooses to take antiviral therapy, the following protocol shall be followed: a) The exposed employee shall follow up with the designated Infection Control Physician within 5 days. b) CBC,diff, & platelets; U/A with microscopic exam; SGOT, Alk. Phos., Total Bilirubin, Creatinine shall be checked every two weeks while taking antiviral therapy through the Occupational Medicine Center. c) Abnormal lab results shall be reviewed by the Occupational Medicine Clinician in collaboration with the Infection Control Physician who prescribed the AZT therapy. d) If the employee develops complications or experiences side effects from the therapy, the designated Occupational Medicine 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. 5 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI –O #2 Page 5 of 22 NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ EMPLOYEE HEALTH INFECTION CONTROL POLICY GUIDELINES NOTE: If, after counseling, the employee declines follow-up at NEBH, s/he shall be advised to contact the Massachusetts Department of Health for further information regarding available resources. c. If source patient declines testing: The designated Occupational Medicine 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, or as if the source patient were seronegative. d. If source is unknown and employee chooses antiviral therapy: The designated Occupational Medicine 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 post-exposure evaluation is entitled to have a baseline specimen frozen and stored for up to 90 days, however the Infection Control Committee has decided to increase this to one year for possible later HIV screening. B. 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. C. Employee Counseling The designated Occupational Medicine 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) page 14 Important Points For You to Know Following an Occupational Blood/Body Fluid Exposure (Appendix I) page 15. Universal/Standard Precautions Sheet (if appropriate) (Appendix J) page 16. 6 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O #2 Page 6 of 22 NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ EMPLOYEE HEALTH INFECTION CONTROL POLICY GUIDELINES 2. Complete the Blood/Body Fluid Exposure Required Information Checklist (Appendix K) page 17. 3. Make a two week follow-up appointment with the employee for the purpose of: a. b. providing additional prophylaxis treatment/counseling. Reviewing laboratory testing results and providing written opinion and laboratory results by the designated Occupational Medicine Clinician,responsible for NEBH employees (Appendix H). c. Initiating post Exposure Follow-Up protocol form (Appendix L) page 18 and make an appointment for the employee to have next scheduled laboratory screening tests. 4. Complete and send copy of the employee Incident Report form to the employer’s manager for completion and follow -up by the manager. REFERENCES: 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 HIV-infected 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. REVISED: 12/20/2000 7 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM DISTRIBUTION: Occupational Medicine-Employee Health, and Ambulatory Services 8 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O #2 Page 7 of 22 APPENDIX A NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ EMPLOYEE HEALTH BLOOD BODY FLUID EXPOSURE RECORD Employee Source Name____________________________________ Staff code_________________________________ Immunization History:______________________ Name_____________________________________ MR # _____________________ Unknown_________ HBV Immunization: Date Dose #1__________ Standing Orders to patient chart #2__________ ____________ Physician letter to patient chart _______________ #3__________ Antibody Status and Date Tested____________________________ Tetanus Booster Date___________ Testing After Exposure Testing After Exposure HBsAg Anti-HBs Anti-HBc Anti-HCV Date _______ _______ _______ _______ SGPT _______ HIV Consent _______ Blood saved for ONE year Anti-HIV #1(exp.)______ #2(6wk)______ #3(3mo)______ #4(6mo)______ #5(1yr) ______ Results _______ _______ _______ _______ _______ Yes No Yes No ______ ______ ______ ______ ______ Treatment Tetanus Booster HBV Booster HBIG - Dose #1 #2 Antiviral(s) Started Stopped Date ______ ______ ______ ______ ______ ______ N/A ______ ______ ______ ______ ______ ______ HBsAg Anti-HBc Anti-HCV SGPT Date _______ _______ _______ _______ Results _______ _______ _______ _______ HIV Consent _______ Yes No if no, documented in MR Anti-HIV _______ ______ Risk Factors Transfusion IV Drug Use History of Hepatitis History of Hemophilia Abnormal Liver Function Test Pertinent Sexual Activity Consent for Release of Testing Results Yes ____ ____ ____ ____ No ____ ____ ____ ____ Unknown _____ _____ _____ _____ ____ ____ _____ ____ ____ _____ ____ ____ _____ Informed of Source results____________________ Date of Incident____________ Time of Incident_______________ Route of Exposure______________________ Exposed to_____________________________________________________________________________________ Equipment Manufacturer and Brand Name ___________________________________________________________ List Personal Protective Equipment worn __________________________________________________________ Circumstances under which exposure occurred: 1. Type of Work____________________________________________________________________ __________________________________________________________________________________ 2. What was cause of incident? (accident, equipment failure, etc.) __________________________________________________________________________________ 3. Other Comments_________________________________________________________________ Signature:_________________________________________ occmed/bbf-up/11/2000/ia 9 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O #2 Page 9 of 22 APPENDIX B NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ EMPLOYEE HEALTH INFECTION CONTROL HEPATITIS STATUS AND HIV EXPOSURE ALGORITHM EXPOSURE EVENT SOURCE KNOWN Known Hepatitis B (+HBsAG) Known Hepatitis A Known Hepatitis C Draw HAV Give ISG Offer Hep A & B Vaccine Follow algorithm for Hepatitis B Repeat Anti-HCV in 6 mos. Employee Immune (Hx Disease/Vaccine) Draw Anti-HBs, HBsAG, Anti-HBc, Anti-HCV, SGPT, Anti-HIV (Results in 24 hours). +Anti-HBs No further treatment SOURCE UNKNOWN Discuss with designated Occupational Medicine Clinician. Draw Anti-HBs, HBsAG, AntiHBc, Anti-HCV, SGPT, Anti-HIV (Results in 24 hours). Offer ISG Employee Non-Immune Draw Anti-HBs, HBsAG, Anti-HBc, Anti-HCV, SGPT, Anti-HIV (Results in 24 hours). Offer #1 Hep B vaccine/schedule #2 in one month Give HBIG -Anti-HBs #4 Hepatitis B Booster Schedule #5 in one month Give HBIG occmed/hep/hiv/exposure/12/98/ia 10 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O #2 Page 9 of 22 APPENDIX C NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ EMPLOYEE HEALTH INFECTION CONTROL OCCUPATIONAL EXPOSURE PHYSICIAN LETTER Occupational Medicine-Employee Health Converse 5 125 Parker Hill Avenue Boston, MA 02120 (617) 754-5804, 754-5631 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 Occupational Medicine Clinician. If you have any questions please do not hesitate to contact me. Thank you for your cooperation in this matter. Sincerely, Occupational Medicine Clinician Reviewed by Med. Rec. Committee 12/96, 11 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O #2 Page 10 of 22 APPENDIX D NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ 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 12 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O #2 Page 11 of 22 APPENDIX E NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ 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 Occupational Medicine 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 13 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM _______________________________________ SIGNATURE OF WITNESS occmed/hivsent12/28/00/ia WHITE- OCCMED ___________________________________________ DATE YELLOW-LAB Section VI-O #2 Page 12 of 22 APPENDIX F NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ 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. There is no proven or approved treatment to prevent HIV infection from occurring. Antiviral medication has not been proved to prevent HIV infection following exposure to blood/body fluids. In addition, the use of antivirals in this situation has not been approved by the United States Food and Drug Administration. Although AZT has not been proved to prevent HIV infection, there is interest in it as a possible preventive measure because of animal studies in which early administration of AZT prevents or attenuates infection by viruses similar to HIV. The MMWR, December 1995, summarizes the findings of a new study of factors associated with risk for and prevention of HIV infection in health care workers (HCW’s) 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 HCW’s who used AZT. 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 Occupational Medicine Physician 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. 14 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM I have decided not to receive the recommended antiviral therapy. Exposed Individual: Witness: __________________________________________ ___________________________________ Date:______________________________________ Date:_______________________________ Occ. Med./Forms/Anti Pro/12/00 15 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O #2 Page 13 of 22 APPENDIX G NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ EMPLOYEE HEALTH INFECTION CONTROL OCCUPATIONAL EXPOSURE PHARMACY PROTOCOL Zidovudine(ZDV), Lamivudine(3TC) and Indinavir 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 within 1-2 hours) Prophylaxis therapy may consists of: zidovudine 200mg three times daily. lamivudine 150mg two times daily. indinavir 800mg every 8 hours(on an empty stomach). or other protease inhibitors. Occupational Medicine Center (Employee Health) issues a two week supply medications (84 capsules of zidovudine, 28 tablets of lamivudine and 84 capsules of indinavir). Ambulatory Services Unit (ASU) will issue a 4 day supply medications (24 capsules of zidovudine, 8 tablets of lamivudine and 24 capsules of indinavir) when the Employee Health is closed. 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.” Occupational Medicine Center (OMC)(new or continued treatment) 1. Occupational Medicine will write on a blank prescription pad, Occupational, Exposure (must be exact) for a 2 week supply of zidovudine, lamivudine and indinavir. 2. A written and signed prescription is brought to the Pharmacy by a member of OMC staff. 3. 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 Occupational Medicine Center. Ambulatory Services (new prescriptions only) 1 2. 3. When OMC is closed, the unit treating the employee (Ambulatory Services) may dispense a four day supply of zidovudine, lamivudine and indinavir from the Pharmacy. A written and signed prescription with Occupational, Exposure (must be exact) is brought to the Pharmacy by a member of the Ambulatory Services staff. In exchange for this signed prescription, a four day supply of medication is given to the staff member. The employee being treated for possible exposure will be given their drug(s) with proper instructions prior to leaving these areas. 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. Indinavir (a protease inhibitor) or Nelfinavir 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. 16 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM 17 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O #2 Page 14 of 22 APPENDIX H NEW ENGLAND BAPTIST HOSPITAL NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ 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- Hbc Anti- HCV SGPT HIV RESULT DATE SOURCE LAB TEST HbsAg Anti- Hbc Anti- HCV SGPT HIV RESULT DATE 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. _______________________________________ Employee Signature _______________________________________ Health Care Professional Signature _______________________________________ Date WHITE COPY- OM YELLOW COPY - EMPLOYEE occmed/forms/results/12/00/ia 18 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O #2 Page 15 of 22 APPENDIX I NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ 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 may be offered Serum Immune Globulin(SIG) and/or Hepatitis B Immune Globulin (HBIG) within 24 to 48 hours of the exposure. You will also be strongly advised to begin the Hepatitis B vaccine series immediately if you have not received it. 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 will need to 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 will be scheduled for a follow-up appointment with Employee Health 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. Work-Related HIV Benefit Plan for New England Baptist Hospital employees. 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 $100,000.00. 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 12 weeks. 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 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. If, after investigation, the source patient is found to be HIV+, you will be offered a baseline physical examination by a physician designated by Employee Health or by your own PCP. 19 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM 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 20 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI Page 16 of 22 Important Points for You to Know Following an Occupational Exposure (cont.) Page 2 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 long term important risks such as an increased risk of cancer. * 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. Adapted from Deaconess Hospital/Karen Bithell, R.N. 11\2000\ia 21 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O #2 Page 17 of 22 APPENDIX J NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ EMPOYEE 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: of similar activities: for example, when performing the following o Cleaning soiled equipment o o o 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. 22 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O #2 Page 18 of 22 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. I have read and understand the post-exposure review of universal/standard precautions. All my questions have been answered. Date:_________________________ Signature:____________________________ OccMed/Forms/BBFEduca/11/2000/IA 23 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O #2 Page 19 of 22 APPENDIX K NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ EMPLOYEE HEALTH INFECTION CONTROL BLOOD BODY FLUID EXPOSURE CHECKLIST FOR OCCUPATIONAL HEALTH CLINICIAN EMPLOYEE NAME:________________________________ EXPOSURE DATE:___________________ EMPLOYEE CODE:________________ SOURCE PT NAME:_________________________________ SOURCE PT Source pt HIV consent form given to Nursing Coordinator or Primary Nurse to give to PCP Source pt Physician order sheet given to Nursing Coordinator or Primary Nurse to obtain lab work Received hard copy of results on Source pt HBsAG Anti-HCV Anti-HIV SGPT EMPLOYEE Employee pre-test counseling completed and educational material received and signed Employee signed HIV consent form Employee blood obtained and coded Received hard copy of results on Employee HBsAG OSHA recordable: Anti-HBs Anti-HCV SGPT Anti-HIV Hep B vaccine administered Other:____________________________________________________________________ Completed Post Blood Exposure Evaluation Form signed off by employee Gave copy of Post Blood Exposure Evaluation form to employee Scheduled follow-up appointment on employee Date:_______________ Time:____________ Signature of Occupational Health Clinician________________________________________________ occmed/form/bbf list/ia/12/2000 24 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O #2 Page 20 of 22 APPENDIX L NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ EMPLOYEE HEALTH INFECTION CONTROL POST-EXPOSURE FOLLOW UP FORM 6 WEEKS, 3 MONTHS, 6 MONTHS, 1 YEAR NAME:________________________________ EXPOSURE DATE:___________________ Todays date:__________________________ TYPE OF FOLLOW UP 6 WEEK 3 MONTHS 6 MONTHS 1 YEAR 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 other (specify) night sweats malaise/fatigue weight loss - unexpected none of the above Any concerns or comments:_______________________________________________________ ______________________________________________________________________________ --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------To be completed by the Occupational Medicine Clinician: Weight____________________ HIV AB drawn yes BP_________________________ no Comments_____________________________________________________________________ ______________________________________________________________________________ _______________________________________ Occupational Medicine Clinician Date 25 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM occmed/forms/POSTF-U/12/2000/ia 26 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI-O#2 Page 21 of 22 APPENDIX M NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/ EMPLOYEE HEALTH POSTEXPOSURE PROPHYLAXIS TREATMENT ADVICE 27 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM Section VI -O # 2 Page 22 of 22 APPENDIX M NEW ENGLAND BAPTIST HOSPITAL OCCUPATIONAL MEDICINE/EMPLOYEE HEALTH POSTEXPOSURE PROPHYLAXIS TREATMENT ADVICE 28 PLEASE NOTE: This on-line, read-only version of the Policy and Procedure is the OFFICIAL copy.08/12/17, 1:07 PM 29