Updated May 2010

I. INTRODUCTION

Several clinical studies have demonstrated that HIV transmission can be significantly reduced by the administration of antiretroviral (ARV) agents. A dramatic decline in vertical transmission was observed in the AIDS Clinical Trial Group (ACTG) 076 study,¹ in which pregnant women and their newborns received monotherapy with zidovudine (ZDV), and in the HIVNET 012 study,² in which single-dose nevirapine was compared with ZDV. A Centers for Disease Control and Prevention (CDC) retrospective case-control study³ of ZDV use after occupational HIV exposure in healthcare workers (HCWs) showed an 81% reduction in risk of HIV infection in persons who received ZDV. This study also identified characteristics of both the exposure and the source patient that placed the HCWs at highest risk for HIV acquisition. These studies led to the development of guidelines in 1998 for post-exposure prophylaxis (PEP) after an occupational exposure.

HAART, generally consisting of two nucleoside agents and a protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI), has changed the standard of care for patients with chronic, established HIV infection. These potent regimens are used for PEP, although randomized clinical trials on which to base recommendations are unlikely to be conducted. To develop these guidelines for occupational PEP, the New York State Department of Health AIDS Institute (NYSDOH AI) has reviewed the available PEP studies, the current standards for the use of HAART in established HIV infection, and other issues that would affect the timely administration of optimal PEP. These guidelines update the previously issued guidelines of 2003.

Because there are no clinical trials on which to definitively base recommendations, the following NYSDOH AI guidelines are based on best practice evidence and constitute the considered opinion of a group of expert clinicians in the field of adult HIV medicine. New York State recommendations differ from those published by CDC (see Appendix B). The consensus opinion of this Committee continues to support a more aggressive approach to block HIV infection after occupational exposure. The recommendation to initiate PEP must take into account the potential benefit of preventing infection versus the risk of toxicity from the medications used for PEP.

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II. RATIONALE FOR PEP

January 2008

Recommendation:

The Committee recommends the use of HAART regimens for all significant-risk occupational exposures when the HCW is evaluated within 36 hours of exposure.

Because the ultimate goals of PEP are to maximally suppress any limited viral replication that may occur and to shift the biologic advantage to the host cellular immune system to prevent or abort early infection, the Committee recommends the use of HAART regimens for all significant risk exposures.

Experimental models of HIV infection demonstrate the following sequence of events. After percutaneous or mucosal exposure to HIV, local replication of virus occurs in tissue macrophages or dendritic cells; host cytotoxic T cells will kill productively infected target cells. However, if infection cannot be contained at this stage, it is followed within 2 to 3 days by replication of HIV in regional lymph nodes; viremia then follows within 3 to 5 days of virus inoculation. Acceptance of this sequence of events carries significant implications. Given the rapid appearance of productively infected cells following the introduction of virus, regimens with the most rapid onset of activity, multiple sites of antiviral action, and greatest strength, such as HAART, are most effective.

In vivo evidence from a small study of HCWs who were exposed percutaneously to HIV but who did not seroconvert suggests that limited viral replication may occur without establishment of infection. HIV-specific T-cell proliferative responses were observed in the majority of these individuals. Because the T-cell proliferative response is major histocompatibility complex (MHC) class I specific, limited viral replication within the tissue macrophages is inferred. Acceptance of this sequence of events also carries important implications. If limited HIV replication following exposure is a frequent event, then the argument to use HAART becomes even stronger.

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III. RISK FACTORS ASSOCIATED WITH HIV TRANSMISSION

January 2008

Considered collectively, the cases of HCW seroconversion reported to the CDC and the data from the CDC retrospective case-control study provide insight into the risk factors associated with occupational HIV infection. Blood or visibly bloody fluids or other potentially infectious material (e.g., semen; vaginal secretions; and cerebrospinal, synovial, pleural, peritoneal, pericardial, and amniotic fluids) are the only source fluids that carry meaningful risk. Exposure to saliva, tears, sweat, or non-bloody urine or feces does not require PEP.

Analysis of the characteristics of an exposure has yielded a hierarchy of relative risk (RR) associated with occupational acquisition of HIV (see Table 1).

The mean risk following an occupational percutaneous exposure is roughly 1 in 300 (0.3%). However, the mean risk may be significantly higher in cases in which more than one of the above risk factors is present (e.g., in persons who incur a deep injury with a hollow-bore needle from a patient with HIV who has a high viral load due to ineffective or no ARV therapy).

After a mucous membrane exposure, the average risk of seroconversion is approximately 9 in 10,000 (0.09%). In this analysis, the use of ZDV PEP by HCWs in the CDC study was shown to reduce the risk of HIV acquisition by 81%.³

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IV. RECORDING INFORMATION FOLLOWING OCCUPATIONAL EXPOSURE

January 2008

Recommendation:

When an occupational exposure occurs, the following information should be recorded in the HCW’s confidential medical record:

• Date and time of the exposure
• Details of the procedure being performed and the use of protective equipment at the time of the exposure
• The type, severity, and amount of fluid to which the HCW was exposed
• Details about the exposure source
• Medical documentation that provides details about post-exposure management

Specific OSHA requirements regarding documentation may be found at http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10051

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V. GENERAL MANAGEMENT CONSIDERATIONS

January 2008

Recommendations:

Wound and skin sites should be cleansed with soap and water immediately. The HCW should not attempt to squeeze the wound. Exposed mucous membranes should be flushed with water.

PEP is recommended for exposure to blood or visibly bloody fluid or other potentially infectious material (e.g., semen; vaginal secretions; and cerebrospinal, synovial, pleural, peritoneal, pericardial, and amniotic fluids) associated with potential HIV transmission and in any of the exposure situations outlined in Table 2.

If HIV serostatus of the source is unknown, voluntary HIV testing of the source should be sought. In New York State, specific informed consent for HIV testing is required (see Appendix C).

Rapid testing is strongly recommended for the source patient, and for those organizations subject to OSHA regulations, rapid testing is mandated for occupational exposures. Rules regarding confidentiality and consent for testing are identical to those for other HIV tests (see Appendix C for a special consent form for testing the source patient).

If the rapid test result is positive, the result should be given to the source patient. To establish a diagnosis of HIV infection, the test must be confirmed by a Western blot assay, which should be performed as soon as possible.

If the result from testing the source patient is not immediately available and PEP is indicated based on assessment, the initiation of PEP should not be delayed pending the test result.

Rapid testing is strongly recommended for the source patient, and for those organizations subject to OSHA regulations, rapid testing is mandated for occupational exposures. Results from rapid testing are usually available in 30 minutes. If the test result is not immediately available, the initiation of PEP should not be delayed pending the test result. A negative result would indicate that HIV PEP may not be needed. If the result of the HIV test from the source patient is negative, the HCW should be informed of the small chance that it could be a false-negative result if the source patient has been recently infected (during the “window period”). PEP should be recommended in situations when a significant risk exposure has occurred and there is a strong likelihood that the source patient has recently acquired HIV infection.

Unfortunately, the uncertainties occasionally associated with a given exposure may complicate the decision-making process, especially for an inexperienced clinician, and may possibly delay the prompt (within 2 hours) initiation of PEP. Uncertainties may exist about whether or not the source patient is HIV-infected and what constitutes a viable definition of a significant exposure. For the inexperienced clinician, rather than emphasize the relative risk of a particular exposure, the NYSDOH AI Medical Care Criteria Committee believes that the critical decision point should be to determine whether the HCW has had a percutaneous, mucocutaneous, or non-intact skin exposure to potentially HIV-infected blood, visibly bloody fluids, or other potentially infectious material. For these exposures, prompt initiation of PEP followed by telephone or in-person consultation with a clinician experienced in HIV PEP is recommended (see Section XI: Resources for Consultation).

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VI. IMPLEMENTING PEP

January 2008

Recommendations:

PEP should be initiated as soon as possible, ideally within 2 hours and generally no later than 36 hours post-exposure. The prescribing provider should ensure that the HCW has access to the full course of ARV medications.

HAART is always recommended for at-risk exposures. Any variance from the recommended regimens should be made in consultation with an HIV Specialist or an occupational health clinician experienced in providing PEP (see HIV Specialist).

ARV medications for PEP should be readily available to HCWs who sustain a known or highly suspect occupational exposure to HIV. In establishing plans for providing PEP, employers should determine the following:

• How PEP will be made available within 1 to 2 hours of an exposure
• How a 24- to 48-hour supply of PEP will be made available for urgent use
• Who will be given authority for releasing drugs for this purpose
• How the HCW will obtain PEP drugs to complete the 4-week regimen (some individuals may be reluctant to go to their local pharmacy)

Confidential baseline HIV antibody testing of the HCW should be obtained at the time the occupational exposure is reported or within 72 hours of initiating PEP.

Confidential HIV testing of the source should be obtained as soon as possible after the exposure. A special consent form for testing the source patient is available and must be used (see Appendix C).

If the source patient’s HIV test result is negative, the HCW should be informed of the small chance that it could be a false-negative result if the source patient has been recently infected. PEP should be recommended in situations when a significant risk exposure has occurred and the clinician suspects that the source patient has a strong likelihood of having recently acquired HIV infection.

If a recommendation to begin PEP is declined, this decision should be documented in the medical record of the HCW.

All patients placed on PEP should be re-evaluated within 72 hours of their exposure. This allows for further clarification of the nature of the exposure, review of available source patient serologies, and evaluation of adherence to and toxicities associated with the PEP regimen.

A total of 4 weeks of treatment is recommended. This treatment duration is based on animal data and is generally recommended by HIV Specialists.

If an HCW presents for evaluation of a high-risk exposure at a time >36 hours after the incident, rather than late initiation of PEP, close monitoring of the HCW for signs and symptoms of acute HIV infection is generally recommended with subsequent introduction of HAART if acute seroconversion occurs.

Animal models of PEP have shown that effective ARV treatment is most likely to prevent infection when initiated within 24 hours of experimental exposure.^4-8 It is unknown whether initiation of PEP beyond this point confers protection. Most ARV drugs require an intracellular activation step that delays the onset of antiviral activity. Thus, clinicians should begin PEP as soon as possible, ideally within 2 hours and generally not later than 36 hours following exposures that carry the risk of HIV transmission. An absolute elapsed time after which PEP should not be administered, however, cannot be stated with certainty.

Late initiation of PEP (1-2 weeks after an exposure) may blunt initial viremia and block the clinical signs and symptoms associated with seroconversion, yet rebound of viral replication and the appearance of clinical symptoms would occur with cessation of PEP. If an HCW presents for evaluation of a high-risk exposure at a time >36 hours after the incident, rather than late initiation of PEP, close monitoring of the HCW for signs and symptoms of acute HIV infection is recommended with subsequent introduction of HAART if acute seroconversion occurs. Approximately 50% of persons who become infected with HIV will have a mononucleosis-like illness within 2 to 6 weeks after the exposure.

ARV drugs for PEP should be readily available to HCWs who sustain a known or highly suspected occupational exposure to HIV. The employer should determine who will pay for PEP and whether the Workers’ Compensation plan will cover these drugs. HCWs should not be expected to pay out-of-pocket for PEP, even if it is reimbursed at a later date.

The employer of personnel covered by the Bloodborne Pathogen Standard is obligated to provide post-exposure care, including prophylaxis, at no cost to the employee. The employer may subsequently attempt to obtain reimbursement from Workers’ Compensation. Appendix F provides information regarding employer issues and responsibilities.

Consultation with an HIV Specialist (see HIV Specialist) to determine the composition of the PEP regimen is recommended, but if a Specialist is not readily available, the initiation of PEP should not be delayed. Phone consultation with an HIV Specialist or an occupational health clinician experienced in providing PEP would be appropriate. Expert advice may also be obtained from the National Clinicians’ Consultation Center PEP line at 1-888-HIV-4911 (1-888-448-4911). Optimal management of the HCW who has had an occupational exposure to a bloodborne pathogen balances the benefits of preventing infection with the risks of medication-induced side effects and toxicity (see Figure 1).

Figure 1: PEP Following Occupational Exposure (January 2008)

* See Appendix A for dosing recommendations in patients with renal impairment.

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VII. RECOMMENDED PEP REGIMENS

January 2008

Recommendations:

Clinicians should initiate three-drug ARV therapy for significant occupational exposures to HIV. The preferred PEP regimen is shown in Table 3. Alternative agents may be used in the setting of drug intolerance or toxicity (see Table 3 and Appendix A).

The PEP regimen should be continued for 4 weeks.

When the source is known to be HIV infected and information regarding previous ARV therapy, current level of viral suppression, or genotypic/phenotypic resistance profile is available, the clinician, in consultation with an HIV Specialist, should individualize the regimen to more effectively suppress viral replication.

The Committee chose tenofovir as the third agent because it achieves high intracellular levels and has been effective in trials of PEP in primates. The combination of 2 NRTIs plus tenofovir has high failure rates for treatment of established HIV infection and is only recommended for PEP where the goal is prevention of infection and not treatment.

As experience with occupational PEP continues to accumulate, it has become increasingly clear that non-adherence to PEP is multifactorial. Factors affecting adherence include ARV drug intolerance, regimen complexity, fear, anxiety, expense, frustration, and beliefs that the regimen will not work. Although there are no clinical trial data (other than that on zidovudine), based on post-exposure animal data using tenofovir⁹ and its excellent tolerability and simplicity, the Committee now recommends the simpler standard PEP regimen of zidovudine, lamivudine, and tenofovir. Substitutions for tenofovir include the PIs nelfinavir and lopinavir/ritonavir (co-formulated as Kaletra). If these cannot be used, an NNRTI may be considered. In the setting of renal insufficiency, tenofovir and lamivudine may require dose reduction or be contraindicated (see Appendix A). The package insert for these agents should be consulted.

Reports of nevirapine-induced hepatotoxicity among people receiving PEP have led to the recommendation that nevirapine be considered as an alternative component of the PEP regimen only when NRTIs and PIs are not an option.¹⁰ Use of efavirenz in a PEP regimen should only be considered in men and in women not capable of bearing children because it has been associated with teratogenicity in animal studies and in humans anecdotally.

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VIII. MONITORING THE HCW FOLLOWING OCCUPATIONAL EXPOSURE

January 2008

Recommendations:

Clinicians should closely monitor people receiving PEP to detect ARV-induced toxicities (see Antiretroviral Therapy¹¹ for monitoring recommendations).

Because of the complexity and potential adverse effects of the treatment regimens, longitudinal care of the exposed HCW should be provided either directly by or in consultation with an HIV Specialist or an experienced occupational health clinician who is familiar with the most current PEP guidelines.

Sequential confidential HIV testing should be obtained at baseline, 1, 3, and 6 months post-exposure even if PEP is declined (see Table 4). In New York State, if the test result is positive, a Western blot assay must be performed to confirm the diagnosis of HIV infection. See Appendices D and E for specific counseling recommendations.

If the HCW presents with signs or symptoms of acute HIV seroconversion, immediate consultation with an HIV Specialist should be sought for optimal diagnostic testing and treatment options.

The HCW should be evaluated weekly over the first month to assess PEP adherence, adverse effects of the ARV therapy, interval physical complaints, and emotional status (see Antiretroviral Therapy¹¹ for monitoring recommendations, Long-Term Complications of Antiretroviral Therapy¹² for adverse drug effects, and HIV Drug-Drug Interactions¹³ for important drug interactions).

Post-exposure care involves simultaneous attention to multiple issues: the emotional state of the exposed HCW, adherence to the PEP regimen, monitoring for potential adverse effects, and sequential HIV testing to exclude acquisition of infection. Providers should be aware of the resources within the community that offer medical and counseling services needed following occupational exposure.

Approximately 50% of HCWs for whom PEP is initiated do not complete therapy due to side effects or non-adherence. When an HCW is potentially occupationally exposed to HIV, longitudinal medical follow-up of the HCW is necessary regardless of whether PEP is initiated and/or completed, in order to test sequentially for HIV infection. For HCWs receiving PEP, follow-up is necessary to also monitor for adverse effects of the PEP regimen, and maximize adherence to the prescribed regimen.

When infection occurs, the ELISA will generally be positive within 3 weeks of the onset of symptoms and is virtually always positive within 3 months following exposure. The confirmatory Western blot may yield an indeterminate result during the early stages of seroconversion. Subsequent testing should be performed to confirm definite seroconversion.

Approximately 50% of patients acutely infected with HIV will experience at least some symptoms of the acute retroviral syndrome. Symptoms may include pharyngitis, morbilliform rash, thrush, lymphadenopathy, and hepatosplenomegaly. Acute HIV infection is often not recognized in the primary care setting because of the similarity of the symptom complex with that of the “flu” or other common illnesses. When acute HIV seroconversion is suspected based on the clinical scenario, a plasma HIV RNA assay should be used in conjunction with an HIV-1 antibody test to diagnose acute or primary HIV infection. See Diagnostic, Monitoring, and Resistance Tests for HIV for further information on HIV testing, and Diagnosis and Management of Acute HIV Infection for further information on management of acute HIV infection.

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IX. PEP FOR THE PREGNANT HCW

January 2008

Recommendations:

Before administering PEP to a pregnant woman, the clinician should discuss the potential benefits and risks to her and to the fetus. Drugs to avoid during pregnancy are listed in Table 5.

Based on increasing clinical experience with HAART, PEP is indicated at any time during pregnancy when a significant exposure has occurred, despite possible risk to the woman and the fetus. Expert consultation should be sought. When PEP is indicated, it should be initiated ideally within 2 hours and generally no later than 36 hours post-exposure.

Efavirenz, which has been associated with teratogenicity in monkeys, should not be used in pregnant women.

The combination of didanosine and stavudine should be avoided due to an increased risk of mitochondrial toxicity in pregnant women.

Unboosted indinavir should not be used in pregnant women in the second or third trimester due to a substantial decrease in antepartum indinavir plasma concentrations.

Clinicians should advise women who may have been exposed to HIV through occupational exposure to avoid breastfeeding for 6 months after the exposure.

Initiation of PEP at any time during pregnancy requires a careful discussion of the risks and benefits of this therapy. In addition to the risk of seroconversion for the HCW, there is a high risk of transmission to the fetus or breastfeeding infant, should the pregnant HCW develop the acute retroviral syndrome. Although birth defects and adverse effects on human fetuses have generally not been associated with the currently available ARV agents, exposure of a fetus to ARV agents during pregnancy carries a theoretical risk of teratogenicity.

The recommendation to initiate PEP in the breastfeeding patient presents several concerns. Both HIV and ARV drugs may be found in breast milk. As such, breastfeeding should be avoided for 6 months after the exposure to prevent HIV transmission and potential drug toxicities. Because HIV infection is most often diagnosed within 3 months of exposure, some women may prefer to breastfeed between 3 to 6 months following exposure. Clinicians should discuss the risks and benefits with the HCW. The infant’s pediatrician should be informed of any potential exposure to HIV or ARV medications.

For additional information, refer to NYSDOH guidelines on Management of the HIV-Infected Pregnant Woman.¹⁴

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X. OCCUPATIONAL EXPOSURES TO HEPATITIS B AND C

May 2010

Recommendation:

When an occupational exposure occurs, the source patient should be evaluated for both hepatitis B and C. (AII)

The risk of transmission of HBV and HCV from an occupational exposure is significantly greater than the risk of HIV transmission. The risk of HCV infection following a needlestick is 1.8%, whereas the risk of HBV infection ranges from 1% to 30% depending on the presence of hepatitis e antigen (see Table 6). The risk of transmission of HCV from a single mucous membrane exposure is negligible.

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A. Hepatitis B Virus Post-Exposure Management

Recommendations:

The hepatitis B vaccine series should be initiated in non-HBV-immune HCWs who sustain a blood or body fluid exposure. (AI)

Administration of prophylactic hepatitis B immune globulin (HBIG) and the initiation of the hepatitis B vaccine series is recommended when the non-HBV-immune HCW sustains a blood or body fluid exposure to a source patient with known acute or active HBV (see Table 7). (AI) Both HBIG and the first dose of the hepatitis B vaccine series should be ideally administered within 24 hours of exposure (AII); HBIG should not be given later than 14 days post-exposure. The three-dose HBV vaccine series is given at 0, 1 to 2 months, and 6 months.

Needlestick injuries and wounds should be washed with soap and water and should not be squeezed. Mucous membranes should be flushed with water. (AIII)

Initiation of the HBV vaccine series within 12 to 24 hours of an exposure has been demonstrated to be 70% to 90% effective in preventing HBV infection. The combination of vaccine and HBIG achieves a similar level of efficacy. Among known non-responders to vaccination, one dose of HBIG is 70% to 90% effective in preventing HBV when administered within 7 days of percutaneous HBV exposure,¹⁵ and multiple doses have been shown to be 75% to 95% effective.¹⁶ Pregnant women can safely receive both the HBV vaccination and HBIG.

When considering PEP for HBV exposures, both the source patient’s HBsAg status and the HCW’s vaccination status should be considered (see Table 7). Determination of antibody response of previously vaccinated HCWs should be based on information available at presentation. It is not recommended that decision-making be delayed while testing for anti-HBs. If antibody response is unknown, follow recommendations for “antibody response unknown” in Table 7.

Both HBIG and the first dose of the hepatitis B Vaccine should be ideally administered within 24 hours of exposure; HBIG should not be given later than 14 days post-exposure. The three-dose HBV vaccine series is given at 0, 1 to 2 month, and 6 months. Hepatitis B antibodies should be obtained 1 to 2 months after completion of the third dose of the vaccine; however, levels may be falsely elevated if the exposed person received HBIG within the past 3 to 4 months.

Even if the risk of exposure to HBV is not deemed significant, HBV vaccination should still be advised for all non-HBV-immune HCWs (see Hepatitis B Virus guidelines for more information). Household, sex, and needle-sharing contacts of HBsAg-positive individuals should be identified and vaccinated according to the guidelines for patients exposed to known HBsAg-positive individuals.

 

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B. Hepatitis C Virus Post-Exposure Management

Recommendations:

Clinicians should consider concurrent exposure to HCV when HCWs present with an HIV exposure. (AII)

Neither immunoglobulin nor antiviral agents are recommended for HCV post-exposure prophylaxis.

When HCV infection is identified, the HCW should be referred for medical management to a gastroenterologist or other clinician with experience in treating HCV. (AII)

Currently, no effective prophylaxis for HCV has been identified. Immunoglobulin and antiviral agents are not recommended for HCV post-exposure prophylaxis (PEP). However, if an individual becomes acutely infected with hepatitis C and is diagnosed at that time, immediate referral to a gastroenterologist or other specialist experienced in the treatment of hepatitis C is recommended. Recent data suggest that early treatment of acute hepatitis C with interferon is highly effective, perhaps as high as 95%.¹⁸

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1. Baseline Management

Recommendations:

Following an exposure to blood or body fluid, the clinician should assess the risk for exposure to HCV. (AII) Wounds should be washed with soap and water, and should not be squeezed. (AII) Mucous membranes should be flushed with water.

Once the clinician has determined that exposure to blood or body fluid has occured, the following baseline tests should be obtained (see Table 8 for follow-up according to baseline results):

Source Patient:

• HCV antibody test (e.g., EIA/ELISA), and if positive, HCV RNA test or RIBA

Exposed HCW:

• Liver panel including liver enzymes
• HCV antibody, and if positive, HCV RNA test

If the source patient is tested with an EIA/ELISA and found to be positive, then follow-up testing is necessary to confirm the source patient’s status. According to the most recent Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis (2001), either HCV RNA or RIBA may be used as the confirmatory test. However, most clinicians currently obtain HCV RNA testing, instead of RIBA, to confirm a positive antibody screening result. When the source patient tests positive by either RIBA or HCV RNA test, the exposed person should be managed as if the source has chronic HCV.

Clinicians should educate exposed HCWs about the natural history of HCV infection and should counsel exposed HCWs about the following:

• Avoidance of alcohol and, if possible, medications that may be toxic to the liver.
• Risk of transmission related to:
  • Blood-to-blood contact, including sharing personal care items that may have come in contact with another person’s blood, such as razors or toothbrushes; occupational needlestick injuries; and sharing needles, syringes, or other equipment to inject drugs
  • Sexual activity
  • Donating blood, plasma, organs, tissue, or semen
  • Perinatal transmission
• Hepatitis C virus is not spread via food or water and is not transmitted by:
  • Sharing eating utensils
  • Hugging, kissing, or holding hands
  • Coughing or sneezing
  • Breastfeeding: HCV is not transmitted by breastfeeding; however, clinicians should advise women who may have been exposed to HIV to avoid breastfeeding for 6 months after the exposure.

Factors that may increase the risk of sexual transmission include sex with multiple partners, history of STIs, including HIV, or any other practice that might disrupt mucous membranes. The potential need for mental health counseling should be anticipated and offered as needed.

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2. Post-Exposure Follow-Up for HCV

Recommendations:

If the source patient is known to be positive for HCV antibody and/or HCV RNA, the follow-up schedule for the exposed HCW should be as follows (AII):

Week 4:                      HCV RNA and liver panel
Week 12:                    HCV RNA and liver panel
Week 24:                    Liver panel and HCV antibody

If at any time the serum ALT level is elevated, the clinician should repeat HCV RNA testing to confirm acute HCV infection. (AIII)

At any time that exposed HCWs test positive for HCV RNA, the clinician should refer for medical management and possible treatment by a clinician with experience in treating HCV. (AIII)

For HCWs exposed to hepatitis C-infected source patients, regular follow-up with HCV RNA testing is recommended in addition to HCV antibody testing, because HCV RNA testing can identify acute infection within 2 weeks of exposure, whereas accuracy of the antibody test can be delayed up to several months after acute infection (i.e., “window period”). Seroconversion with the ELISA antibody test occurs in 50% of patients within 9 weeks of exposure, in 80% of patients within 15 weeks of exposure, and in at least 97% of patients within 6 months of exposure.¹⁹ The ELISA test is highly sensitive but relatively nonspecific, resulting in a low positive predictive value in low-prevalence populations. Positive HCV ELISA antibody test results require confirmation by a quantitative viral load assay, such as HCV PCR.

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XI. RESOURCES FOR CONSULTATION

May 2010

Persons who have responsibility for providing PEP may need expert advice and consultation, as well as assistance in helping their clients obtain medication.
The following resources are the preferred initial contacts for expert consultation:

• The National Clinicians’ Consultation Center PEP line at 1-888-HIV-4911 (1-888-448-4911).
• For further education of health providers or for consultation regarding setting up PEP services, contact: CEI PEP, Testing and Diagnosis Center
• The AIDS Institute is a secondary resource for consultation and referrals. The Institute (1-212-417-4536) is open between 8:30 AM and 5:00 PM. At other hours, a NYSDOH operator at 1-518-465-9720 will connect the caller with the Department of Health Duty Officer who can refer the caller to an appropriate resource in his/her geographic area.

Appendix F provides information regarding employer issues and responsibilities.

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17. Weinbaum CM, Williams I, Mast EE, et al. Recommendations for identification and public health management of persons with chronic hepatitis B virus infection. MMWR Recomm Rep 2008;57(RR-08):1-20. Available at: www.cdc.gov/mmwr/preview/mmwrhtml/rr5708a1.htm 

18. Szmuness W, Stevens CE, Harley EJ, et al. Hepatitis B vaccine: Demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States. N Engl J Med 1980;303:833-841. [PubMed]

19. Centers for Disease Control and Prevention. Recommendations for preventing transmission of infections among chronic hemodialysis patients. MMWR Recomm Rep 2001;50(RR-5):1-43 Available at: www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm

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APPENDIX A

ANTIRETROVIRAL DRUGS

The tables that follow include antiretroviral agents recommended for PEP (zidovudine, lamivudine, tenofovir) as well as alternative antiretroviral drugs because the recommended regimen may require alteration based on factors such as prior use of antiretroviral therapy in the person who is the source of the exposure. For information on all antiretroviral medications, see Antiretroviral Therapy.

The following tables indicate dosage, toxicity, and dose adjustment recommendations for a 4-week course of prophylaxis. Because there are toxicity and dose adjustment considerations for all of these medications when used for chronic treatment, other references should also be consulted. The tables also include letters that reference FDA pregnancy categories as described below.

Recommended PEP Medication: Zidovudine (ZDV)

Recommended PEP Medication: Lamivudine (3TC)

Recommended PEP Medication: Emtricitabine (FTC)

Recommended PEP Medication: Tenofovir (TDF)

Alternative PEP Medication: Stavudine (d4T)

Alternative PEP Medication: Efavirenz (EFV)

Alternative PEP Medication: Nevirapine (NVP)

Alternative PEP Medication: Nelfinavir (NFV)

Alternative PEP Medication: Indinavir (IDV)

Alternative PEP Medication: Lopinavir/ritonavir (LPV/r)

FDA Pregnancy Categories

A Adequate and well-controlled studies of pregnant women fail to demonstrate a risk to the fetus during the first trimester of pregnancy (and there is no evidence of risk during later trimesters).

B Animal reproduction studies fail to demonstrate a risk to the fetus and adequate and well-controlled studies of pregnant women have not been conducted.

C Safety in human pregnancy has not been determined, animal studies are either positive for fetal risk or have not been conducted, and the drug should not be used unless the potential benefit outweighs the potential risk to the fetus.

D Positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experiences, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.

X Studies in animals or reports of adverse reactions have indicated that the risk associated with the use of the drug for pregnant women clearly outweighs any possible benefit.

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APPENDIX B

OCCUPATIONAL EXPOSURE TO HIV: COMPARISON OF NYSDOH AND CDC RECOMMENDATIONS

Table 1: Occupational Exposure to HIV: Comparison of NYSDOH and CDC Recommendations

* See CDC. Updated USPHS Guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis. MMWR Morb Mortal Wkly Rep 2001;50(RR-11):1-67.† See Appendix A for dosing recommendations in patients with renal impairment.‡ Seroconversion virtually always detected by 6 months.

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APPENDIX C

INFORMED CONSENT FORM DOH-4054

For the most recent Informed Consent forms, please visit: http://www.nyhealth.gov/forms/doh-4054.pdf

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APPENDIX D

HIV COUNSELING AND EDUCATION FOR HEALTHCARE WORKERS AFTER AN OCCUPATIONAL EXPOSURE

Although the risk of HIV transmission from an occupational exposure is low when compared with hepatitis B virus (HBV) and even hepatitis C virus (HCV), the emotional impact of such an exposure on the worker is often profound. Studies have shown that healthcare workers (HCWs) experience acute psychological distress after an exposure. For some, it may trigger a serious psychological and/or career crisis; exacerbate existing personal problems, such as marital difficulties; create fear of social repercussions; and disrupt sexual relationships and childbearing plans. The need for comprehensive counseling that addresses both psychosocial and disease transmission issues applicable to all bloodborne viruses is evident.

This section provides guidance on issues that may present during each phase of post-exposure management. Although it is intended for situations in which the HIV exposure is known, the principles apply to a number of circumstances (e.g., the HCW is waiting for the patient’s test results or the patient has refused testing), each of which creates its own anxiety for HCWs.

The term “counselor” will be used to denote any individual who is providing psychological support for an exposed HCW. Regardless of title, counselors should be well versed in issues of HIV infection, available support services, and the general concerns of exposed and infected individuals.

Several subjects should be covered in post-exposure counseling, including assessment of transmission risk from the exposure, information about medical follow-up and laboratory testing, and education to prevent secondary transmission. The counselor must assess the emotional status and ability of the HCW to be actively involved in the decision-making process and must gauge accordingly and tailor to each situation the scope and timing of information provided.

Initial Counseling Session

The initial counseling session should occur as soon as possible after the exposure and seek to accomplish the following tasks:

• Establish a trusting environment. This is among the most important aspects of post-exposure counseling; the HCW needs the counselor’s full attention. One should communicate support, concern, confidence, competence, and confidentiality. The worker may need to hear that his/her job is not in jeopardy and that the purpose of counseling is not punitive in nature.
• Assess the HCW’s emotional status. Acknowledge feelings the HCW may be experiencing and allow for their expression. Each person’s coping strategies are unique; reactions may include hysteria, anger, fear, disbelief, silent acceptance, etc.
• Describe the post-exposure protocol. Indicate what services are provided by the employer, who will be involved in the process, what support services are available and how they can be accessed, and what is expected from the HCW. If there are needs identified that cannot be met within the organization, referral to the appropriate resources should be offered.
• Review the relative risk of transmission represented by the specific exposure. Scientifically accurate information about the known risk of seroconversion following an occupational exposure to HIV should be accessible to the counselor and employee. Discussion should include the significance of the exposure and whether similar events have led to infection. Counselors should periodically update their knowledge of relevant epidemiological data to ensure that current information is provided.
• Obtain informed consent for HIV testing as required by New York State law (Article 27-F).
• Describe confidential HIV testing. The most important reason for immediate post-exposure testing is to establish a baseline record of the HCW’s HIV status at the time of exposure. In the rare event of seroconversion, subsequent claims for Workers’ Compensation or avenues of legal recourse will rely on the establishment of this fact. For this reason, anonymous testing programs, which use no personal identifiers, are not recommended for individuals who desire documentation of testing. If there is reluctance to receive confidential testing through the institution’s resources, the counselor may suggest that the worker see his/her personal healthcare provider or visit an alternative site that offers confidential testing.
• Explain HIV testing. Describe the testing process and interpretation of various test results within the context of post-exposure management. If test methods other than ELISA and Western blot are used (e.g., PCR), these also should be described.

Most individuals who become infected will develop antibodies within 1 month after exposure. For this reason, HIV antibody testing after an occupational exposure is performed serially (i.e., baseline, 1, 3, and 6 months). Repeatedly negative/nonreactive test results are more likely to represent the true serostatus of the individual, assuming there have been no other exposures in the interim.

• Discuss the significance of personal risk behavior and, if present, the possibility that a positive/reactive test result will be obtained on baseline testing.
• Educate the HCW on prevention of HIV transmission during the post-exposure period. Professional judgement should determine the scope and timing of this discussion, taking into consideration the event-specific risks. Exposed HCWs should be advised to:
  • use condoms or sexual abstinence to prevent sexual transmission and avoid pregnancy;
  • stop breastfeeding, if applicable;
  • defer from donating blood, plasma, organs, tissue, or sperm.

Post-exposure precautions should be maintained until HIV infection in the source and/or HCW has been ruled out. If a woman is pregnant, she should consult with her physician about the risk of infection to her fetus.

The clinical record should document that education to prevent transmission was provided.

• Discuss whether and with whom to share information about the exposure. A supportive environment is important to help with any emotional crisis that might follow. However, prudence in choosing with whom information about an HIV exposure is shared can avoid unanticipated repercussions. The worker also needs to consider the impact of this information on family, friends, and co-workers. Remind the worker of his/her continued obligation to protect the identity/confidentiality of the source individual.
• Establish a follow-up plan. It is good practice to see the employee again soon after the exposure (i.e., within 24-48 hours), to assess his/her coping abilities and answer any questions that may have arisen in the interim. At that time, the need for additional counseling can be determined. Give the HCW a telephone number or contact person to use in the event of a crisis.
• Explain that HIV test results should be given in person. Schedule a return appointment, reserving enough time in the event a positive/reactive result is received. Give special attention to the scheduling process and the location of counseling sites in order to respond with sensitivity to the issues of confidentiality and privacy. Acknowledge that waiting for HIV test results is an anxiety-provoking situation, and offer referral for support services.

Prior to the follow-up session, the counselor should review the range of needs that may be identified and should have on hand a list of resources for referral.

Ongoing Counseling

It may be necessary to establish ongoing counseling for the worker and possibly his/her spouse or sexual partner. In some cases, co-workers who witnessed the event, or who inadvertently contributed to the exposure, may need counseling support as well. The services the institution is able to offer and the circumstances that necessitate referral to another provider should be clearly defined.

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APPENDIX E

POST-TEST COUNSELING FOLLOWING OCCUPATIONAL HIV EXPOSURE

This section guides counselors in giving HIV test results based on the stage of post-exposure follow-up and HIV antibody test result.

I. General Concepts

• Give the test results immediately. A preliminary greeting, while appropriate, should not prolong the HCW’s anxiety. Each HCW comes with his/her own expectation of what he/she will be told, which may not be consistent with the result. This expectation will be influenced by several factors including the stage of follow-up, level of risk represented by the exposure, and any personal risk factors.
• Allow time to react to the information provided. Depending on the test result, many emotions may surface. The HCW’s expectations, anxiety level, relief, joy, disbelief, sadness, anger, or the absence of emotion may be seen.
• Explain the significance of the result. This will vary depending on what the result is and at what stage in the post-exposure series the test was performed. Counselors should give accurate information without creating false expectations.
• Evaluate the HCW’s understanding of the information and offer clarification as indicated; provide literature and/or written instruction as needed.
• Review risk reduction recommendations, and schedule the next appointment, as indicated.

II. Interpretation of Test Results

A. Negative Test Result

Baseline test: At the time of exposure, the HCW shows no evidence of HIV infection. This, however, does not indicate that infection has not occurred, especially if testing was performed within a few days of the exposure. Antibodies are usually produced within 1 to 3 months after infection but may take longer (in rare instances).

Follow-up test: The significance is determined by when it was performed during the follow-up series and the magnitude of the exposure. If the test is the first in the follow-up series (i.e., 6 weeks post-exposure), it is an encouraging sign, but the possibility of transmission cannot be ruled out.

At the 3-month stage, it is reasonable to tell the HCW that a negative result is a good indication that transmission has not occurred. However, a negative test at 6 months will provide greater reliability.

B. Indeterminate Test Result

Conveying an “indeterminate” result is problematic because of its uncertainty and because such a result is often difficult for HCWs to understand and accept.

General interpretation: An “indeterminate” HIV test result may be reported when the ELISA and Western blot test results do not conform to standards for reactive or non-reactive classification. In explaining the significance of this result, the counselor should first determine the laboratory-specific criteria used and the recommended explanation. Among the factors that the employee should be told can result in such an outcome are:

• an unrelated health condition, infection with HIV-2 or unusual HIV-1 subtypes, or some other unknown cause.
• less commonly, the HCW is in the window period of HIV seroconversion, especially if this test followed a negative baseline HIV antibody test.

Submission of another blood sample: Another blood sample submission should be encouraged. The testing laboratory should provide instructions for specimen resubmission and any additional clinical information that should be obtained.

In rare circumstances, an indeterminate result may be reported in subsequent HIV tests. If this should occur, the HCW should be referred by the counselor for clinical evaluation.

C. Positive Test Result

This test result indicates that the HCW is infected with HIV and able to transmit it to others. It does not mean the HCW has AIDS or will develop AIDS in the near future.

Baseline test: If the specimen was obtained at the time of the exposure or within 2 weeks of the incident (the earliest point when antibodies can be detected), the infection is not a result of that specific event. If the baseline test was obtained after this period, it cannot be known from this test alone whether infection was present at the time of exposure or whether transmission from the recent occupational exposure occurred.

Follow-up test: A positive HIV antibody test in the post-exposure follow-up period is supportive evidence that occupational transmission has occurred, assuming there has been no interim exposure to infection, occupational or non-occupational.

III. Counseling the Occupationally HIV-Infected HCW

Occupational HIV seroconversion, although rare, has a sobering impact on all involved: the affected employee; his/her family, friends and significant others; the counselor who has to give the test result; and the institution. There are many issues that will need to be addressed, and counseling the occupationally HIV-infected HCW is the first step in what will become a lengthy process for the HCW and the institution. The following describes in more detail the type of interaction that may take place:

Communicate the result in a straightforward manner, and allow the employee time to react. Do not anticipate a specific response; be prepared to support whatever reaction occurs.

Explain the significance of the result. The HCW is HIV infected, most likely as a result of the reported incident.

Offer the opportunity to have a second test to verify the positive/reactive result.

Address immediate concerns, including fear and the implications for one’s own personal health and mortality; concern about the reaction of family members and sexual partners; anxiety about job implications, especially if the HCW performs invasive procedures; and concerns that confidentiality might be breached.

Discuss the health implications. Having HIV infection does not mean the HCW has AIDS; however, it is important that the HCW establish a relationship with a physician experienced in HIV care who can monitor the HCW’s health status and recommend the appropriate drug regimen.

Discuss implications for secondary transmission. The HCW needs to understand that he/she is capable of transmitting the virus and will need information to prevent the spread through sexual contact. Recommendations for infection control, appropriate to the HCW’s job responsibilities and nature of patient interactions, should be reinforced. Based on the HCW’s job or professional responsibilities, a lengthier discussion and referral to an expert panel may be indicated.

Develop a plan of action. The next several hours and days are a critical time emotionally for the HCW. In preparing a plan of action, some of the issues that should be explored include:

Crisis intervention:

• What are the worker’s plans for the next 24 hours? How will he/she get home that day?
• Does the worker clearly understand the meaning of the test result?
• Does the HCW have a support system in place? Is a referral for psychosocial services or to a community-based support organization appropriate? (The counselor should provide referrals for emergency and ongoing psychological support services to all individuals undergoing HIV testing.)
• Does the HCW need assistance in disclosing results of the test to his/her partner(s)? What reaction is expected? (Remind the worker to carefully consider decisions to disclose HIV-related information to co-workers or others.)

Referral to medical care:

• Is the need for early medical evaluation clearly understood?
• Does the worker understand the importance of continuous adherence to HAART?
• Is the worker currently under the care of a physician? If so, does he/she anticipate any difficulty in divulging the results of the HIV test to the physician? If the worker does not have a physician or if he or she would like a referral to another provider, is the counselor able to assist? If not, where can referral information be obtained?
• What medical services are available through the employer?
• Will the HCW have to bear any financial burden?

Plan for referrals and follow-up:

Write out a summary of the action plan that was developed with the HCW. Include referrals made for medical and psychosocial intervention. In some cases, it may be appropriate to delay discussion of certain issues until the follow-up visit when a more comprehensive dialogue can take place. In such instances, the follow-up should occur within a few days of giving the positive/reactive test result.

During the initial session, or in subsequent appointments, a review of the modes of HIV transmission as well as risk-reduction strategies and basic infection control guidelines for the home and workplace should be discussed with the worker. The conversation should proceed in an interactive manner, allowing the employee to ask specific questions and allowing the counselor to clarify any misperceptions.

Written information:

Much of the information provided in the post-test counseling session may not be clearly understood by the affected worker. For this reason, printed material that highlights the recommendations and instructions given should be made available to the HCW for future reference. A list of referrals for medical and psychosocial support services should be included in the information package.

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APPENDIX F

POST-EXPOSURE MANAGEMENT: EMPLOYER ISSUES AND RESPONSIBILITIES

Organizations that employ health professionals or other persons who are at risk for occupational exposure to blood, body fluids, or other potentially infectious materials are generally required to establish policies and procedures that guide the management of such exposures. Private employers subject to OSHA must conform to the OSHA Bloodborne Pathogen Standard (OSHA Bloodborne Pathogen Standard 29 CFR, Part 1910.1030, and Compliance Directive CPL 2-2.44D, 11/05/99, Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens), and public employers are subject to PESH regulations. OSHA and PESH standards with regard to occupational exposure to bloodborne pathogens are identical. These regulations require that a management plan be in place.

The employer should ensure that any employee who sustains an occupational exposure has access to post-exposure services within 1 to 2 hours of a reported event. Services must be available 24 hours a day, every day. Organizations that do not have on-site occupational health services are encouraged to form agreements or contracts with another facility, Emergency Department, or private practitioner for such services.

Definition of Persons Covered:

Post-exposure policies should define who is included as an “employee” for purposes of providing care. In addition to staff who are clearly employed by an organization (e.g., nurses, laboratory personnel, housekeepers), consideration must be given to whether other individuals (e.g., medical/nursing students, house staff, attending physicians, volunteers, and pre-hospital care personnel) will be covered by the institution’s policy. In addition, the scope of services that will be provided must be delineated (e.g., laboratory testing, occupational health services, prophylactic drugs or vaccines), including whether there are limitations within the categories of individuals covered particularly with regard to Workers’ Compensation benefits.

Access to Occupational Health Services:

HCWs who sustain an occupational exposure should be ensured access to post-exposure services within 1 to 2 hours of a reported event. This may require 24-hour and weekend coverage. Procedures should identify where workers should go during regular work hours and whether there are differences for those who are working evening, night, or weekend shifts. Organizations that do not have on-site occupational health services should consider forming agreements or contracts with another facility or private practitioner for such services.

Post-exposure services for exposures to all bloodborne pathogens include but are not limited to:

• Post-exposure evaluation and follow-up post-exposure vaccinations.
• A full course of post-exposure prophylaxis medications, at no cost to the employee.
• Care provided under the supervision of a licensed physician or other licensed healthcare professional.
• The performance of laboratory tests by an accredited laboratory.
• Supportive counseling.

Federal law requires covered employers to ensure that all medical evaluations and procedures, vaccines, and post-exposure prophylaxis are made available to the employee within a reasonable time and place and are made available at no cost to the employee (OSHA, 29 CFR, Part 1910.1030, CPL 2-2.44D, 11/05/99, Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens).

PESH and OSHA’s Bloodborne Pathogen Standards indicate that the covered employer is responsible for all costs associated with an exposure incident. An employer may not require of the employee any out-of-pocket expenditures, such as requiring the employee to utilize workers’ compensation if prepayment is required or compelling an employee to use health insurance to cover these expenses unless the employer pays all premiums and deductible costs associated with the employees’ health insurance. In addition to services listed above, NYS Guidelines, “HIV Prophylaxis Following Occupational Exposure,” state that the following should be considered by the employer when establishing plans for providing PEP for exposures to HIV. The employer should ensure that:

• PEP will be made available within 1 to 2 hours of exposure, ideally within 1 hour.
• A “starter kit” or 3-day supply of the PEP will be made available to the employee.
• A mechanism is in place to provide the balance of the PEP medications needed to complete the 4-week regimen to the employee at no cost.

Access to Source Patient HIV-Related Information:

If already part of the health care team, the exposed employee may have access to the medical record and know the HIV status of the source patient, as well as information about drug resistance. Alternatively, the patient may have signed an informed consent form (see Appendix C) authorizing disclosure of this information to the exposed worker or to undergo consented HIV testing with disclosure of the test results to the exposed worker. When neither of these situations apply, New York regulations (10 NYCRR part 63.8m) now authorize disclosure of existing HIV-related information to persons who have been exposed in the workplace when significant risk exposure has occurred.

Consented Testing of the Source Patient for HIV:

• The source individual’s blood should be tested as soon as feasible after consent is obtained to determine HIV infectivity. Informed consent from the source patient should be obtained utilizing the form DOH-4054 (Rev. 6/00) “Informed Consent to Perform a Confidential HIV Test and Authorization for Release of HIV-Related Information for Purposes of Providing Post-Exposure Care to a Healthcare Worker Exposed to a Patient’s Blood or Body Fluids” (see Appendix C). If consent is not obtained for HIV testing, the employer should document that consent cannot be obtained.
• When the source individual is already known to be infected with HBV, HCV, or HIV, testing for the source individual’s known HBV, HCV, or HIV status need not be repeated. Testing for other bloodborne pathogens should still occur.
• With a signed release, results of the source individual’s HIV testing should be made available to the exposed employee.
• Information related to drug regimens, and, if available, resistance information should be made available to the exposed employee to determine the best regimen for the employee.

The employer is responsible for establishing and implementing policies to protect the confidentiality of both the exposed employee and the exposure source (PH Law 27-F & 21 Title 111).

Disclosure of HIV-Related Information Under 10 NYCRR part 63.8 (m):

As of June 1, 2000, health regulations 10 NYCRR part 63.8 (m) permit disclosure of HIV-related information regarding the source individual to exposed individuals and their physicians. The process for accessing this information is straightforward and should be incorporated into the facility’s occupational exposure protocol. The procedure should be clearly delineated, should identify the designated medical officer responsible for implementing the procedure, and should emphasize the importance of a timely response. Detailed information regarding the regulations follows.

Note: These regulations do not authorize unconsented testing of the source patient.

Briefly, when an exposure incident occurs, the medical officer at the facility (occupational exposure designee) should:

• Assess the exposure for risk of transmission or potential risk of transmission.
• Obtain consent and test the exposed individual for HIV. The exposed individual must be either HIV negative or of unknown HIV status.
• Ensure that a copy of the exposure incident report and the request for disclosure of the source patient’s HIV status is placed in the medical record of the exposed person.

The medical officer may seek permission of the source patient to review the information contained in his/her medical chart. If the source patient is unavailable, unable to consent, or refuses, then permission to access the information may be obtained if the criteria in the regulations (as delineated below) have been met.

The regulations permit release of HIV-related information without consent of the source patient in the following circumstances:

• The incident must involve exposure to blood or other potentially infectious body fluid.
• The exposed individual must have contact with potentially infectious body substances to mucous membranes, non-intact skin, or to the vascular system. Examples of such contact may include needlesticks, puncture wound injuries, and direct saturation or permeation of non-intact skin by potentially infectious substances.
• The regulations apply to staff, employees, or volunteers in the performance of employment or professional duties in:

• A medical or dental office.
• A facility regulated, authorized, or supervised by the Department of Health, Office of Mental Health, Office of Mental Retardation and Developmental Disabilities, Office of Children and Family Services, Office of Alcoholism and Substance Abuse Services, or the Department of Correctional Services.
• Emergency response employee (paid or volunteer, including an emergency medical technician, a firefighter, a law enforcement officer or local correctional officer, or medical staff).

• An incident report documenting the details of the exposure is on record with supervisory staff.
• A request for disclosure of the HIV status of the source is made by the exposed person or by that person’s provider, as soon as possible after the alleged exposure if the initiation or continuation of post-exposure prophylactic treatment is being considered. The request is placed in the medical record of the exposed person.
• The medical provider for the exposed person or the medical officer designated by the facility reviews, investigates, and evaluates the incident and certifies that the information is necessary for an immediate decision regarding initiation or continuation of PEP for the exposed person provided that the exposed person’s status is either HIV negative or unknown, and the person has consented to an HIV test.
• In the event that the exposed person’s baseline test results indicate that he/she is already infected with HIV prior to the receipt of the information regarding the source’s HIV status, no disclosure of the source’s HIV status will be made.
• If the provider of the source patient or the medical officer (e.g., occupational health physician or infectious disease physician) designated by the facility determines through reasonable exercise of professional judgment that a risk of transmission has occurred or is likely to have occurred, he/she may release the HIV status of the source, if known. The release of information is limited to the exposed individual and his/her medical provider.

Procedures to facilitate rapid evaluation and voluntary testing for HIV, HBV, HCV and other bloodborne pathogens and/or disclosure of related information of the source individual should be in place.

Workers’ Compensation Program:

The Workers’ Compensation Law (WCL) has specific implications for employees exposed to HIV, as well as those rare cases that result in seroconversion. Individuals who manage such exposures should be familiar with these implications, as they should be able to counsel employees and refer them for legal and medical assistance accordingly.

The following is provided as background information but does not substitute for communicating directly with an organization’s Workers’ Compensation provider as situations arise.

• Filing an injury or illness claim When an HCW has an occupational exposure, the employer or the healthcare provider who initially treats an injured worker customarily submits the first report to the Workers’ Compensation Board and to the insurance carrier. However, an injured worker also may file a claim on his/her own behalf.

Workers who wish to file on their own behalf are required to report the injury to their employer, immediately if possible, but minimally within 30 days. If an immediate claim for benefits is not made, the employee has 2 years from the date of the accident to file with Workers’ Compensation. If the employee does not report the accident within 2 years, Workers’ Compensation will not consider the claim. Because options for other legal action may be affected by filing a claim with Workers’ Compensation, an injured employee may benefit from discussion with an attorney before filing.

• Documentation of claim In order to document a claim of occupationally acquired HIV infection, the employee who sustains an exposure that may cause transmission of HIV should have a confidential baseline HIV antibody test and the recommended series of follow-up testing. It is the responsibility of the claimant to provide evidence that proves the work-related cause of HIV infection. Documentation of a negative HIV test with seroconversion occurring after the injury or exposure is probative evidence of HIV infection resulting from occupational exposure. For this reason, anonymous testing programs, which prohibit the release of person-identified HIV antibody test results, are not recommended in the context of an occupational exposure.

• Benefits covered in an injury claim Workers’ Compensation covers only approved medical care. Consequently, in the event of an occupational exposure, all testing and medically recommended treatment generally would be covered. Although provisional guidelines for PEP have been published, it is not clear whether all Workers’ Compensation providers will cover antiretroviral drugs for PEP.

Impact on Employees Who Become HIV Positive Following Occupational Exposure:

• Determination of benefits: Each claim is reviewed on a case-by-case basis. Benefits are not automatically approved subsequent to filing of a claim. Insurance carriers who represent the employer organization determine whether to accept or dispute the claim made by the worker. Claims of occupationally acquired HIV infection can be expected to prompt a thorough investigation to rule out the possibility that another risk behavior was the cause of HIV infection.
• Scope of benefits: Workers’ Compensation does not provide cash awards for pain or suffering. At this time, the maximum weekly wage replacement benefit for total disability, regardless of the cause, is $400. Benefits are based on the worker’s income and will not increase unless proposed benefit maximums become law. In some cases, unions may have negotiated for supplemental payments from the employer.
• Confidentiality of information: The Workers’ Compensation system has historically allowed insurance carriers access to injury reports. However, access to an employee’s Workers’ Compensation file is strictly limited unless otherwise authorized by the claimant. The employer should disclose what circumstances necessitate filing a “C-2” form, what information is provided to the Workers’ Compensation Board and to the insurance carrier, and who has access to that information. The employer also should discuss who within the organization may have access to the information as a result of filing a claim.

If an employee has any questions or concerns about filing a claim with Workers’ Compensation, he/she should seek the advice of an attorney. Additional information for employees and employers on Workers’ Compensation is available through the board that oversees this program. The appropriate district office of the Workers’ Compensation Board should be contacted as necessary for guidance and informational material.

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APPENDIX G

REPORTING RESULTS OF TESTING FOR ANTIBODY TO HEPATITIS C VIRUS

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