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This archived article originally published in 1992 is outdated. For current guidelines, see Healthcare-associated Infections.
CDC/ATSDR Protocol for Handling Occupational Exposures to Human Immunodeficiency Virus (HIV)
Centers for Disease Control, Office of Health and Safety
Publication date: 11/10/1992
Table of Contents
Protocol for Handling Occupational Exposures to Human Immunodeficien Virus (HIV)
Table 1; Designated CDC Physicians for Consultation when Handling Occupational Exposures to HIV
Table 2; Incident Form
Description of Incident
IntroductionThe purpose of this document is to describe the procedures to be followed when a Centers for Disease Control and Prevention (CDC) employee (including visiting scientists, fellows, students, contractors, etc) is occupationally exposed to blood or fluids that may place him/her at risk of infection with human immunodeficiency virus (HIV). A definition of "occupational exposure" is included, and considerations for prompt use of the drug zidovudine (AZT) are outlined in the consent/declination form. This document does not cover an important part of the protocol for handling occupational exposures to HIV: employee education through both worker orientation and ongoing inservice educational activities. The educational activities should familiarize employees with their personal risk of occupational exposure to HIV, the use of universal precautions for protection against occupational exposures to bloodborne pathogens, and the actions to be taken following an occupational exposure to HIV. These materials will be developed under the direction of the CDC Office of Health and Safety (OHS).
General Principles for Handling Occupational Exposures to HIVEach incident of occupational exposure to potentially infectious blood or fluids (i.e., those requiring universal precautions) should be treated as a medical emergency because certain interventions that may be appropriate must be initiated promptly to be effective. If a worker sustains an occupational exposure, first aid should be administered as necessary (including wound cleansing and irrigation with soap and water), and both the exposed worker and the source fluids should be tested for antibodies to hepatitis B virus (HBV) or HIV to determine the possible need for the exposed worker to receive appropriate prophylaxis.
In 1991, the Occupational Safety and Health Administration (OSHA) issued regulations designed to protect health care workers from occupational exposure to and infection from bloodborne pathogens. These regulations require that employers have an HBV vaccination and post-exposure follow-up program for all employees who anticipate contact with blood or fluids requiring universal precautions. Specific HBV postexposure guidelines are covered in a separate document (Hepatitis B Immunization Program, CDC Occupational Health Clinic). If the source fluid is known to be infected with HIV, or needs to be evaluated for that possibility, this document provides the protocol which should be followed. Because postexposure use of zidovudine is a consideration that requires prompt action, employees who handle blood or any specimens requiring universal precautions should be familiar with this protocol. The postexposure period is not the optimal time to first consider the use of zidovudine.
To expedite the appropriate procedures following an occupational exposure to HIV, supervisors and employees should be familiar with the actions outlined in this document for exposures during duty hours and non-duty hours. Ideally, the employee should immediately notify the supervisor (or someone who can act on behalf of the supervisor), who should accompany the employee to the clinic as quickly as possible. The employee should move expeditiously to the clinic, even if there is no one to accompany him/her.
It has been observed that employees experiencing the stress of injury and possible exposure to HIV-containing materials appreciate being accompanied by their supervisor or other coworker. Such a person may provide psychological support, serve as the employee's "advocate" to assure prompt attention, or otherwise provide assistance.
Definition of Occupational ExposureAn occupational exposure that may place an employee at risk of HIV infection is defined as a percutaneous injury (e.g., a needlestick or cut with a sharp object), contact of mucous membranes, or contact of skin (especially when the exposed skin is chapped, abraded, or afflicted with dermatitis or when the contact is prolonged or involves an extensive area) with blood, tissues, or other potentially infectious body fluids (i.e., those to which universal precautions apply). These fluids include: a) semen, vaginal secretions, breast milk or any other body fluid visibly contaminated with blood, because these substances have been implicated in the transmission of HIV infection; b) cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, and amniotic fluid, because the risk of transmission of HIV from these fluids has not yet been determined; and c) laboratory specimens that contain HIV (e.g., suspensions of concentrated virus, unfixed tissues or organs, organ cultures, and blood, organs, or other tissues from experimental animals infected with HIV). (MMWR 1990;39[No.RR-1]:1-14, and Fed Register 1991;56:64175)
For purposes of this protocol, the occupational exposure must be to a fluid known to be infected with HIV (e.g., positive for: antibodies to HIV, HIV p24 antigen, HIV DNA by polymerase chain reaction or other molecular biological technique [e.g., in-situ hybridization], or HIV culture). Persons known or suspected to be HIV positive include patients meeting the AIDS definition or known to be infected with HIV, or patients with epidemiologic evidence suggesting that the source individual may have recently been exposed to HIV. In situations where the source fluid is of unknown HIV infection status and lacks identifying information, it should be promptly tested for HIV antibodies by the Serology Section (Telephone 639-3174), Laboratory Investigations Branch, Division of HIV/AIDS, NCID. If the occupational exposure occurs while performing a medical procedure (i.e., venipuncture), the source individual should be asked to consent to HIV antibody testing, according to local/state laws. If the source individual cannot be identified, or is identified but not readily available to provide informed consent, the fluid should be tested for HIV antibodies only after removal of any identifying information.
Protocol for Handling Occupational Exposures to Human Immunodeficien Virus (HIV)CDC, Atlanta, During Duty Hours --
A. Employee should immediately clean exposed surfaces (by washing the skin with soap and water, or irrigating the mucous membranes with sterile normal saline or water), apply first aid to local wound as needed, and report exposure(1) to his/her supervisor. This incident is to be treated as a medical emergency.
B. Employee and supervisor should go to Occupational Health Clinic (OHC), 1600 Clifton Road (Building 4, Room 121, telephone 639-3385), for immediate medical evaluation and to complete an incident form. (If supervisor or designated safety liaison is not immediately available, the employee should report to the OHC. The OHC Medical Director should be informed that the supervisor was not available and should continue to attempt to contact the supervisor). The OHC Medical Director provides additional medical treatment to the wound,as necessary, and makes an initial assessment of risk. The OHC Medical Director also counsels employee on the risk of HIV infection, discusses the option to take zidovudine (AZT) with employee, and draws a baseline blood sample. If zidovudine use becomes a consideration, the OHC Medical Director discusses it with employee. If employee chooses to take zidovudine, OHC Medical Director promptly provides him/her with the drug and employee signs the informed consent form. (At his/her discretion, the OHC Medical Director may contact a Designated CDC Physician(2) for telephone consultation). Regardless of the employee's decision to take zidovudine, the OHC Medical Director initiates referral to outside Consulting Physician(3) for appropriate follow-up.
C. Supervisor takes copy of bottom portion of incident form, which does not contain personal identifiers, and routes through appropriate channels to CIO Director or Acting Director.
D. CIO Director or Acting Director notifies Office of Health and Safety (OHS) of the incident for follow-up investigation.
CDC, Atlanta, During Non-Duty Hours --
A. Employee should immediately clean exposed surfaces (by washing the skin with soap and water, or irrigating the mucous membranes with sterile normal saline or water), apply first aid to local wound as needed, and report exposure(4) to his/her supervisor, or the designated safety liaison, if he/she is immediately available. The supervisor or designated safety liaison promptly calls the Consulting Physician(5) to arrange for immediate evaluation, medical treatment as necessary, counseling on risk of HIV infection, consideration of zidovudine use, and baseline blood sample. At his/her discretion, Consulting Physician may contact Designated CDC Physician(6) for advice. (If supervisor or designated safety liaison is not immediately available, the employee should call the Consulting Physician [telephone 355-3161] to arrange for immediate evaluation).
B. This incident is to be treated as a medical emergency. Therefore, if Consulting Physician is unavailable, the supervisor, designated safety liaison, or employee contacts the lobby security desk guard in the 1600 Clifton Road facility (telephone 639-2888). The supervisor or security guard immediately calls the first available Designated CDC Physician to meet with employee as soon as possible, at the CDC lobby security desk, 1600 Clifton Road. Upon arrival, the CDC Physician obtains the keys to Occupational Health Clinic (OHC) from the security guard and accompanies the employee to OHC (Building 4, Room 121) to administer first aid as necessary and conduct the initial assessment of risk. CDC Physician counsels employee on risk of HIV infection, informs him/her about the option to take zidovudine, and draws a baseline blood sample. If employee chooses to take zidovudine, CDC Physician promptly provides him/her with the drug and employee signs the informed consent form while at the clinic. (Zidovudine is kept at CDC's secured OHC facility with forms for handling occupational exposures to HIV).
C. To comply with OHS requirements, employee and supervisor go to OHC on the first business day following the exposure and complete an incident form. The OHC Medical Director reviews initial evaluation, zidovudine option, and verifies that baseline blood sample has been collected. If employee has not seen the Consulting Physician, OHC Medical Director contacts Consulting Physician to arrange for employee to receive appropriate follow-up, regardless of employee's decision to take zidovudine.
D. Supervisor takes the bottom portion of incident form, which does not contain personal identifiers, through appropriate channels to CIO Director or Acting Director.
E. CIO Director or Acting Director notifies OHS of the incident for follow- up investigation.
(1) See attached definition of occupational exposure.
(2) See attached list of Designated CDC Physicians.
(3) In Atlanta, the Consulting Physician is Dr. Carlos Lopez (Telephone number 355-3161). When referred and approved by CDC supervisor or EHSC Medical Director, services provided by Dr. Lopez are paid by CDC.
(4) See attached definition of occupational exposure.
(5) In Atlanta, the Consulting Physician is Dr. Carlos Lopez (Telephone number 355-3161). When referred and approved by CDC supervisor, services provided by Dr. Lopez are paid by CDC. (6) See attached list of Designated CDC Physicians.
Table 1; Designated CDC Physicians for Consultation when Handling Occupational Exposures to HIVTable 1
Table 2; Incident FormTable 2
Description of IncidentPlease describe the incident, at a minimum addressing each of the following seven items (using space below):
- Procedure involved
a. concentration of virus
b. obtaining or handling a patient specimen
- Specific equipment involved (i.e., cytocentrifuge, cell sorter, glass pipette, needle (size , scalpel, other sharp, etc.)
- Body surface(s) exposed
a. skin (specify whether intact, abraded, or chapped, and duration
e. percutaneous injury (specify depth of injury, whether fluid was injected, type of fluid injected)
This form is turned in to the Occupational Health Clinic Medical Director. A photocopy of the bottom portion (below the interrupted line) is hand carried to the CIO Director or Acting Director.
- Type of fluid (specify whether serum, whole blood, concentrated virus culture, etc.)
- Personal protection employed
e. other (specify)
- Initial treatment
- Determination of need to meet with coworkers to determine commonality of incident and potential for repeated injuries or exposures by others.
Zidovudine Preventive Therapy: Informed Consent/Declination for Zidovudine (AZT) AdministrationThe Centers for Disease Control and Prevention and Prevention offers the drug zidovudine (AZT) to employees who sustain an occupational exposure to HIV. The purpose of taking zidovudine is to possibly reduce your risk of infection with HIV. The scientific rationale for using zidovudine after an exposure, the possible side effects of this medicine, and the plan for monitoring you for side effects to the medicine or for evidence of infection are outlined below. Presently, CDC cannot make a recommendation either for or against the use of zidovudine following an occupational exposure to HIV because there are not sufficient data from either animal or human studies documenting the safety or efficacy of zidovudine when used for this purpose. Ideally, AZT treatment should begin within one hour of the exposure.
Immediately after the occupational exposure you will be provided first aid, be counseled about the risk of HIV infection, be offered the option to take zidovudine, and have a baseline blood sample drawn for HIV testing. You will also be asked to complete an incident form.
Your decision to receive or not receive zidovudine will not affect your current job, nor will it affect any other treatment or follow-up to which you are entitled as a result of this exposure. Furthermore, your decision will not compromise whatever benefits may be available to you under the Federal Employees Liability Act.
BE SURE TO READ THIS CONSENT FORM CLOSELY AND TO ASK THE PHYSICIAN WHO HAS GIVEN IT TO YOU ANY QUESTIONS THAT YOU MAY HAVE REGARDING THIS PROTOCOL.
Current estimates indicate that the average risk of transmission of HIV after a single percutaneous exposure (e.g., a needlestick or cut with a sharp object) to HIV-infected blood is about 0.3%. The risk of HIV transmission after a single exposure of mucous membranes or skin to HIV- infected blood is less than the risk of a percutaneous exposure. The risk of transmission after occupational exposure to potentially infectious fluids other than blood (i.e., fluids for which universal precautions are recommended) is unknown. If infection with HIV results, present evidence suggests that the vast majority of persons with HIV infection will develop AIDS, for which there is no known cure. The risk of HIV infection for persons who take zidovudine following an occupational exposure cannot be determined at present because of the relatively small number of persons studied.
In at least eight reported incidents, use of zidovudine after an exposure to HIV has failed to prevent infection. One instance involved the transfusion of HIV-infected blood, another involved the suicidal self- injection of several milliliters of infected blood, and a third instance was an assault on a prison guard with a needle and syringe containing HIV- infected blood. In the fourth and fifth instances, HIV infection occurred after accidental intravenous injection of HIV-infected blood into a patient during a nuclear medicine procedure. In these five instances, the circumstances resulted in injection of a larger amount of blood than would be expected from most needlestick injuries and might have accounted for the failure of zidovudine to prevent HIV infection. In two additional cases, zidovudine failed to prevent HIV infection in health care workers who were exposed to HIV-infected blood after a needlestick. In one instance, zidovudine was begun within 6 hours after the injury, and in the other instance it was begun within 8 hours after the injury. For these two individuals, zidovudine was begun later than has been recommended (ideally it should be given within one hour of the eligible exposure). In an ongoing CDC-sponsored follow-up study of health care workers who sustained occupational exposures to HIV-infected blood, information about zidovudine use has been collected since October 1988. Of 718 health care workers enrolled from October 1988 through November 1991, none have become infected with HIV. Of these, 205 (29%) took zidovudine after the exposure.
Experimental studies using mice and cats indicate that use of zidovudine modified or prevented infection with animal retroviruses when treatment was started shortly after exposure to the virus. Limited studies involving the use of zidovudine following exposure of primates to simian immunodeficiency virus (SIV) have not prevented infection. HIV infection was suppressed but not prevented in experimental mice (SCID-hu) who were given 250 mg/kg/day of zidovudine within two hours of exposure. In this study mice were followed for two weeks after the exposure, but no information is available beyond that time. Although the effectiveness of zidovudine use to prevent HIV infection in humans (after HIV exposure) has not been established, some expert consultants recommend that, if zidovudine is to be used for this purpose, it should be administered shortly after an exposure and continued for 6 weeks. The Food and Drug Administration (FDA) has recognized that zidovudine effectively blocks the replication of HIV and has approved its use for certain patients with symptomatic HIV infection. The FDA, however, has not approved zidovudine as a treatment to prevent infection following a recognized exposure. Therefore, such use involves the use of an approved drug for an unlabeled indication.
There are possible side effects and other risks associated with the use of this drug. Among these are well recognized short-term, reversible side effects of zidovudine therapy and possibly long-term side effects which have not yet been identified. Short-term side effects may include the following: headache, nausea, vomiting, diarrhea, hepatitis, sleepiness, muscle aches and pain, anemia, and a decrease in the number of white blood cells which help in defending you from other infections. It is possible that one of these effects might be severe enough to require dose reduction or discontinuation of therapy. In the CDC-sponsored study, side effects were reported in 74% of 174 health care workers who completed 6 weeks of follow-up. Zidovudine therapy had to be stopped because of side effects in 32% of these workers. Long-term side effects of 6 weeks of therapy have not been reported, although experience is limited in this area. Side effects have decreased by dose reduction in many cases.
There is a remote possibility that zidovudine may either lead to the development of a cancer (carcinogenesis) or cause alterations in your genetic material (mutagenesis). For these reasons, if you choose to take zidovudine it is recommended that you avoid pregnancy throughout the time the drug is taken, whether you are male or female. Pregnancy can be effectively prevented either by avoiding sexual contact or by using any of various means of contraception. Regardless of the contraceptive method chosen, latex condoms should be used during sexual contact because they can prevent HIV transmission in addition to providing contraceptive protection.
It is not known whether zidovudine can cause harm to the fetus when it is given to a pregnant woman or whether it can affect reproductive capacity. To assess the safety of zidovudine use during pregnancy, the Burroughs- Wellcome Company has developed a registry to evaluate pregnancy outcomes of women who took zidovudine during pregnancy. Adverse pregnancy outcomes have not been observed among women who were followed to term. However, these data must be interpreted with caution because they are insufficient to make conclusive recommendations. Physicians are encouraged to register pregnant women who elect to take zidovudine by telephoning the pregnancy registry, (919) 248-8465 (collect) or 1-800-722-9292. Thus, if you are pregnant and elect to take zidovudine, you may be requested to participate in this registry. Also, it is unknown whether zidovudine is excreted in human milk. However, because of the potential for transmission of HIV via breast milk if the mother is infected, exposed mothers may choose to discontinue breast-feeding whether or not they are receiving zidovudine.
Because there is not enough information to recommend an exact zidovudine preventive schedule, you have the option to choose one of the two treatment schedules currently offered. At the National Institutes of Health, employees who choose to receive zidovudine are given two 100 mg. capsules every 4 hours (6 times daily) for 42 days (6 weeks). At San Francisco General Hospital, employees who choose to receive zidovudine are given two 100 mg. capsules every 4 hours (5 times daily; no dose is given at 4:00 a.m.) for 28 days (4 weeks). Regardless of your choice, if you decide to start taking zidovudine, the drug will be made available promptly through the CDC Occupational Health Clinic or the Consulting Physician's office, depending on where you are seen first. Your medication will be provided at two week intervals through the treating physician. You will be required to visit the treating physician every other week for 8 weeks and at 3, 6, 9, and 12 months from the date of your exposure. At each of these visits, one to three tablespoons of blood will be drawn from an arm vein. Although the risk of serious physical injury associated with blood drawing is virtually nonexistent, there may be some pain at the site of entry of the needle, and a small bruise may develop.
Upon visiting the Consulting Physician or the CDC Occupational Health Clinic Medical Director you will receive a physical examination and routine laboratory tests will be performed on your blood and urine. If there is any evidence of a significant blood disorder, kidney disease, liver disease, or other condition which may increase the chances that you may experience side effects of zidovudine treatment, you will be promptly notified by the treating physician to discontinue therapy and return all unused medicine.
Your blood will be tested to help determine if you are experiencing side effects from the treatment as well as to determine if you have developed antibody to HIV. If severe side effects associated with zidovudine treatment occur, the dose of the drug may be reduced. The dose may be returned to the original level if the side effects disappear after the dose is reduced. If the side effects do not disappear, treatment may be discontinued. Treatment with zidovudine is voluntary. If you choose to take the medicine you may subsequently elect to discontinue therapy at any time. If you do so, please notify the Consulting Physician or the CDC Occupational Health Clinic Medical Director of this decision within 24 hours of discontinuing the drug.
The duration of follow-up needed to detect evidence of HIV transmission or delayed toxicity among persons who take zidovudine is presently unknown. Employees taking zidovudine postexposure may require follow-up to detect HIV seroconversion for a longer period than that recommended for workers who do not take zidovudine. Regardless of the length of follow-up, you will be contacted if future information indicates the need for additional evaluation.
Because of the possibility of HIV infection and to prevent its transmission, you are advised to refrain from donating blood, semen, or organ(s), to consider refraining from breast feeding, and to either abstain from sexual intercourse or use latex condoms during sexual intercourse (including women who are pregnant) during the follow-up period, regardless of your choice to take zidovudine and your method of contraception.
The confidentiality of your medical records and any information collected as a result of your treatment with zidovudine are fully protected in accordance with applicable State and/or Federal laws.
Table 3; Option #1: Consent to take ZidovudineTable 3
Table 4; Option #2: Decline Pospexposure ZidovudineTable 4
POINT OF CONTACT FOR THIS DOCUMENT:To request a copy of this document or for questions concerning this document, please contact the person or office listed below. If requesting a document, please specify the complete name of the document as well as the address to which you would like it mailed. Note that if a name is listed with the address below, you may wish to contact this person via CDC WONDER/PC e-mail.
OFFICE OF HEALTH & SAFETY
Centers for Disease Control
1600 Clifton Rd NE,__MS(F-05)
Atlanta, GA 30333
Table 1Table 1. Designated CDC Physicians for Consultation when Handling Occupational Exposures to HIV This table has been removed on 12/14/2010 at the request of the Office of the Associate Director for Communication (OADC), because the article is outdated and the personal contact information no longer relevant.
Table 2Table 2. Incident Form =============================================================================== Centers for Disease Control and Prevention Retrovirus Medical Surveillance Program Initial report of a possible Exposure/Injury Involving HIV and other Retroviruses Employee: Program ID Number __ __ __ - __ __ __ __ Supervisor: ______________________________________ Date of Report:___________________________________ Date of Exposure/Injury:__________________________ Which virus? (Circle all that apply) HIV-l HIV-2 HTLV -I SIV HTLV-II STLV Other, specify________________________ Unknown Date of Incident___________________ Location: Bldg. ______________ Lab______________ Other_____________ ===============================================================================
Table 3Table 3. Option #1: Consent to take Zidovudine ============================================================================== I have read this consent form, have received a copy of the "Public Health Service Statement on management of occupational exposure to human immunodeficiency virus, including considerations regarding zidovudine postexposure use", have been given the opportunity to ask questions relevant to zidovudine treatment, and agree to treatment with zidovudine as outlined above. I understand that it is not known whether zidovudine can cause harm to the fetus when administered to a pregnant woman, nor whether it can affect reproductive capacity. I will contact Dr. Kasting at 639-3385, or Dr. Lopez at 355-3161 if I experience any adverse effects or have questions related to this treatment. ______________________________________________________________________________ Participant's Signature________________________ Date_________________________ Participant's Name Printed_____________________ Witness' Signature_____________________________ Date________________________ 1 copy participant 1 copy treating physician ==============================================================================
Table 4Table 4. Option #2: Decline to take Zidovudine ============================================================================== I have read this consent form, have received a copy of the "Public Health Service Statement on management of occupational exposure to human immunodeficiency virus, including considerations regarding zidovudine postexposure use", have been given the opportunity to ask questions relevant to zidovudine treatment, and decline treatment with zidovudine as outlined above. ______________________________________________________________________________ Participant's Signature ________________________ Date________________________ Participant's Name Printed______________________ Witness' Signature _____________________________ Date________________________ 1 copy participant 1 copy treating physician ==============================================================================