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ARO Training & Consulting Bloodborne Pathogens Module 6: Blood and Body Fluid Exposure Follow-up Page 69 Blood and Body Fluid Exposure Follow-up Objectives: Describe the role of immunization with respect to prevention of HBV, HCV and HIV infections. Describe the role of prophylactic treatment with respect to prevention of HBV, HCV and HIV infections, following exposure to blood or body fluids. Describe post-exposure concerns and follow-up procedures that should be initiated following exposure to blood and/or body fluids. Describe safety measures associated with prevention of blood-borne pathogen infection following exposure. Introduction As discussed previously, HBV infection is largely preventable through immunization; however, currently there is no vaccine available for use in preventing HCV and HIV infections. Although occupational exposures to blood can be prevented in many cases by the use of appropriate barriers, adherence to safe handling policies and the use of devices with safety features, accidents still occur. Development, implementation and communication of a post-exposure follow-up protocol is essential to ensure that exposed workers receive treatment, testing, follow-up management, and counselling that may help prevent infection, unnecessary worry and anxiety. Risk of infection following exposure to blood HBV The risk of BBP infection following percutaneous exposure to blood is directly proportional to: - the probability that the blood contains hepatitis B surface antigen (HBsAg) - the immune status of the recipient - the efficiency of transmission Probability of blood containing HbsAg The probability of the source blood being HBsAg positive ranges from 1 to 3 per thousand (0.1 – 0.3%) in the general population, to 5-15% in high risk groups: - immigrants from highly endemic regions (China and Southeast Asia, subSaharan Africa, most Pacific islands and the Amazon Basin) - intravenous drug users (IDU) - men who have sex with men - household (sexual and non-sexual) contacts of HBV carriers ARO Training & Consulting Bloodborne Pathogens Module 6: Blood and Body Fluid Exposure Follow-up Page 70 Recipient Immune Status There is essentially no risk of contracting HBV infection following exposure to blood, if the worker has been immunized with HBV vaccine and has developed an adequate antibody response to the HBsAg. If the worker is non-immune (HBsAb-negative), the risk of infection following exposure to HBV infected blood varies, depending on the presence of ‘e’ antigen (HBeAg) in the source patient’s blood. As discussed previously, the relative risk of HBV transmission to a non-immune individual following needle-stick exposure to HBeAg-negative blood ranges from 1-6%; whereas, in HBeAg-positive blood the risk of transmission ranges from 1940%. HBeAg-positive blood is associated with a higher transmission rate, presumably because the number of infectious viral particles is greater than in HBeAg-negative blood. Efficiency of transmission Blood contains the highest concentration of blood-borne viruses of all body fluids, and is the most important mode of transmission in the health-care setting. Percutaneous injuries</b> are the main source of occupational exposures to blood-borne pathogens. The Canadian Needle Stick Surveillance Network (CNSSN) indicated that during the first 6 months of data collection in 2000-2002, HCWs in 12 participating centres were exposed to 497 known patient sources 48 of which tested positive for a blood-borne pathogen. HCV accounted for more than half of the blood-borne pathogens, HBV accounted for 15 %, and HIV accounted for 20%. In addition, 3 of the source patients were positive for HIV and HCV. Link: The Canadian Needle Stick Surveillance Network. http://www.hcsc.gc.ca/pphb-dgspsp/publicat/ccdr-rmtc/01vol27/27s3/27s3n_e.html Percutaneous exposure The risk of infection following exposure to HIV and/or HCV-positive blood is much lower than that for HBV-positive blood, possibly due to higher concentrations of virus in the blood of HBV-infected patients. HCV The relative risk for infection after a needle-stick or sharps injury involving HCVinfected blood is approximately 2.7%. ARO Training & Consulting Bloodborne Pathogens Module 6: Blood and Body Fluid Exposure Follow-up Page 71 HIV Currently, the relative risk of infection following one needle-stick exposure to blood from a patient known to be infected with HIV is approximately 0.3-0.5%. Published studies on HIV sero-prevalence rates in exposed HCWs are needed to effectively determine the extent of occupational risk of HIV infection. There are more than 50 documented episodes of occupationally acquired HIV infection in the U.S., of which almost 40% occurred during phlebotomy. In Canada, there has been only one documented case of HIV transmission to a HCW – infection occurred following a needle-stick injury. Mucous membrane exposure HBV The risk of transmission following mucous membrane exposure is unknown. HCV The risk of HCV transmission following blood exposures to the eye, nose or mouth is currently unknown, but thought to be small. HIV The risk of seroconversion approximately 0.09%. following mucous membrane exposure is Non-intact skin exposure The risk of HBV and HCV transmissions following exposure to non-intact skin is unknown. HIV transmissions following exposure of non-intact skin to blood have been documented, but the relative risk is currently unknown, although it is expected to be less than the risk following mucous membrane exposure, and far less than that from percutaneous injection. Relative Risk HBV The risk of contracting HBV infection following exposure to various body fluids is unknown. Although HBsAg is found in several body fluids, the concentration of infectious HBV particles is 100-1000 times lower than the concentrations of HBsAg, and is not an efficient source of transmission. HCV The risk of contracting HCV infection following exposure to various body fluids other than blood is unknown. ARO Training & Consulting Bloodborne Pathogens Module 6: Blood and Body Fluid Exposure Follow-up Page 72 HIV The risk of HIV transmission following exposure to fluids or tissues, other than HIV-infected blood, has not been quantified, but is thought to be lower than the probability associated with exposure to blood. Recommendations concerning the management of health care workers following an occupational exposure to bloodborne pathogens have recently been published as a supplement to the Canada Communicable Disease Report entitled "An Integrated Protocol to Manage Health Care Workers Exposed to Bloodborne Pathogens". Exposure follow-up (Act/Report/Test/Treat/Surveillance/ /Document) Act Report Initial testing Treat Surveillance testing Document Act Immediately! Needle-sticks and cuts - express (squeeze) fluid from wound, if appropriate (needle-stick) - wash site well with disinfectant soap and water - bandage wound Splash to mucous membranes Nose, mouth or skin - flush with water Eyes - irrigate with clean water, saline or sterile irrigants Report the Exposure Report the exposure to your immediate supervisor, the occupational health clinic, and risk management. Your supervisor must complete the appropriate forms for Worker’s Compensation in the event that time is missed from work. ARO Training & Consulting Bloodborne Pathogens Module 6: Blood and Body Fluid Exposure Follow-up Page 73 Confidential 24-hour service should be available to HCWs in the event of a blood and/or body fluid exposure. Occupational health will counsel the HCW, order blood tests, refer the HCW for treatment as appropriate, investigate and follow-up exposures, and document the incident. Initial Testing Follow-up testing should be available to all personnel who are concerned about possible infection through occupational exposure. Post-exposure testing protocols may vary slightly from one institution to another. Initial (Baseline) Testing - All Exposures Once an exposure has occurred, a blood sample should be drawn and tested for HBsAb, if testing has not been performed within the previous 12 months. Exposed workers should also be tested for antibodies to HCV and HIV. Testing for HBsAg and antibodies to HCV and HIV should also be performed on the exposure source - consent from the source individual is required before blood samples can be collected and tested. If the source refuses testing, s/he should be considered infectious. Treatment and Counselling - HBV Follow-up testing should be available to all personnel who are concerned about possible infection through occupational exposure. Source Negative for HBV If the source individual is negative for HBsAg and the worker has not been vaccinated, HBV vaccination should be initiated to provide protection against future exposures. If the worker has been vaccinated, and demonstrates adequate levels of HBsAb no further action is necessary. If the worker has inadequate levels of HBsAb, a second series of vaccine should be initiated. Source HBV Status Unknown, Source Refuses Testing, or is HBV Positive If the source is unknown or refuses testing, s/he should be considered infectious for HBV. If the patient tests positive for HBV (HBsAg-positive and/or HBeAg-positive), s/he is considered infectious for HBV. In these cases, the exposed worker should be tested for HBsAb, and treated as described below. ARO Training & Consulting Bloodborne Pathogens Module 6: Blood and Body Fluid Exposure Follow-up Page 74 HBV Immunized Worker If the HCW has received 3 HBV vaccine doses and demonstrates antibodies to HBV (within past year), no further action is necessary. If the HCW has received 2 HBV vaccine doses and demonstrates antibodies to HBV, resume vaccination schedule. If HBV antibody levels are inadequate, the exposed worker should receive {glossary}prophylactic{/glossary} treatment - one dose of vaccine and one dose of {glossary}hepatitis B immune globulin{/glossary} (HBIG) within 48 hours of exposure. Non-Immunized Worker Non-immunized workers should receive prophylactic treatment - HBV vaccine and a single dose of hepatitis B immune globulin (HBIG) within 48 hours of exposure. If the worker has not been immunized, or has only been partially immunized, and is non-immune (i.e. HBsAb negative), a single dose of hepatitis B immune globulin (HBIG) is recommended within 48 hours of exposure, and if the worker has not previously received HBV vaccine or completed the vaccine schedule, immunization should be resumed or continued. Treatment and Counselling - HCV Follow-up testing should be available to all personnel who are concerned about possible infection through occupational exposure. If the source individual's HCV status is unknown, or s/he refuses testing or tests positive for HCV, surveillance testing should be performed in the exposed worker. Surveillance testing for anti-HCV should be performed at a minimum of 6 and 12 months, and possibly even at 3 months following exposure. All illnesses occurring during this period (especially those involving fever) should be reported to the healthcare provider. Treatment and Counselling - HIV Follow-up testing should be available to all personnel who are concerned about possible infection through occupational exposure. When the HIV status of the source individuals is unknown, or if the source refuses testing or tests positive for HIV, surveillance testing should be performed on the exposed worker. Testing for anti-HIV should be performed at 3, 6 and 12 months following exposure. ARO Training & Consulting Bloodborne Pathogens Module 6: Blood and Body Fluid Exposure Follow-up Page 75 All illnesses occurring during this period (especially those involving fever) should be reported to the healthcare provider. HBV Prophylactic Treatment HBV vaccines are 70%-88% effective when given within 1 week after HBV exposure (optimally within 24 hours of exposure). Hepatitis B immune globulin (HBIG), a preparation of immunoglobulin with high levels of antibody to HBV (anti-HBs), provides temporary passive protection following exposure to HBV. HBIG alone or in combination with vaccine is effective in preventing HBV infection in approximately 90% of cases. HBV infection during pregnancy can cause severe illness in the mother and chronic infection in the newborn. HBV vaccine and HBIG therapy is safe for use during pregnancy and while breast-feeding, and should be administered following exposure to HBV infected blood. HCV Prophylactic Treatment Currently, there is no available HCV vaccine (vaccine development has been problematic due to the rapid mutation rate and multiple genotypes). Immune globulin and antiviral agents (interferon with or without ribavirin) are not recommended for post-exposure prophylaxis (PEP) of hepatitis C. Clinical trials have not been conducted to adequately assess post-exposure use of antiviral agents (interferon +/- ribavirin) for prevention of HCV infection, and FDA-approval does not extend to prophylactic treatment. Following exposure to an HCV-positive source, the HCV status of the exposed worker should be determined initially, and follow-up testing should be performed to determine if infection develops. HIV Prophylactic Treatment Although drugs for the treatment of existing HIV infection have been approved by the FDA, they have not been approved as prophylactic treatment to prevent infection; however, physicians may prescribe any approved drug if it is their professional judgment that use of the drug is warranted. Results from a small number of studies suggest that the use of some antiretroviral drugs after certain occupational exposures may reduce the chance of HIV transmission. Post-exposure prophylaxis (PEP) is recommended for certain occupational exposure that pose a risk of HIV transmission. ARO Training & Consulting Bloodborne Pathogens Module 6: Blood and Body Fluid Exposure Follow-up Page 76 PEP is not recommended when there is no risk of transmission, because the drugs used to prevent infection may have serious side-effects. Pregnancy should not rule out the use of post-exposure treatment, if it is warranted. The potential benefits and risks associated with the use of anti-HIV drugs should be discussed with the healthcare provider in order that the individual can make an informed decision about prophylactic treatment. As described earlier, following exposure to an HIV-positive source, the HIV status of the exposed worker should be determined initially, and follow-up testing performed as early as 6 weeks post-exposure, and then again at 3 months, 6 months and 12 months to determine whether {glossary}seroconversion{/glossary} and transmission has occurred. HBV Prophylactic Treatment Side-effects HBV vaccine and HBIG are considered very safe; however, any unusual reaction should be reported. The most common side-effects include pain at the injection site and fever (mild to moderate). HBV Vaccine Rarely, temporary or permanent hair loss has been reported following HBV immunization. Rarely, anaphylaxis has been reported in vaccine recipients (1/600,000), and although none of the persons who developed anaphylaxis died, anaphylactic reactions can be life-threatening, and further HBV vaccination is contraindicated in persons with a history of anaphylaxis after a previous dose of vaccine. HBIG HBIG is prepared from human plasma containing a high titer of antibody to HBsAg (HBsAb). The plasma is first screened for HBsAg and antibodies to HIV (anti-HIV) and HCV (anti-HCV), and then processed to inactivate and eliminate HIV, HCV and other viruses. The most common side-effects following HBIG treatment involve local pain and tenderness at the injection site, itching and swelling. Anaphylactic reactions have been reported rarely - individuals with a history of anaphylactic reaction to immunoglobulins should not receive HBIG. ARO Training & Consulting Bloodborne Pathogens Module 6: Blood and Body Fluid Exposure Follow-up Page 77 HIV Prophylactic Treatment Side-effects Side-effects have been associated with all HIV antiviral drugs – the most common side-effects include upset stomach (nausea, vomiting, diarrhea), fatigue, or headache. Serious side-effects following combination antiviral therapy have been reported – symptoms include stones, hepatitis, and suppressed blood cell production. If prophylactic treatment is given, the exposed individual should be checked for drug toxicity (complete blood count and kidney and liver function tests) before starting treatment, and then again 2 weeks after starting treatment. Surveillance Testing HCV Positive or high-risk source Workers who initially test negative for HCV antibodies (baseline testing) should be retested again as early as 6 weeks post-exposure, then 3 months, 6 months, and 12 months, to determine whether seroconversion and HCV transmission has occurred. Any sudden or severe flu-like illness occurring during the follow-up period should be reported to a healthcare practitioner, especially if fever, rash, muscle-aches, fatigue, malaise, or swollen glands are involved. HIV Positive or high-risk source Workers who initially test negative for HIV antibodies should be retested as early as 6 weeks post-exposure, then again at 3 months, 6 months, and possibly 12 months, to determine whether seroconversion and HIV transmission has occurred. Exposed workers should refrain from donating blood, and be strongly encouraged to use barrier protection during sexual intercourse during the followup period. Any sudden or severe flu-like illness occurring during the follow-up period should be reported to a healthcare practitioner, especially if fever, rash, muscle-aches, fatigue, malaise, or swollen glands are involved. Seronegative Source If the source is known to be negative for HBsAg and antibodies to HCV and HIV, and has no known high-risk behaviours, exposed workers should receive baseline testing, and follow-up testing 3 months later, as recommended by the healthcare practitioner. ARO Training & Consulting Bloodborne Pathogens Module 6: Blood and Body Fluid Exposure Follow-up Page 78 Source Unknown, Unidentified or Refuses to be Tested If the source is unknown, decisions regarding follow-up testing should be based on the individual risk, in consultation with the healthcare provider. Serologic testing should be made available to workers concerned that they have been infected with HIV. Reference:http://www.hc-sc.gc.ca/pphb-dgspsp/publicat/noib-inpb/no41002_e.html Worker refuses follow-up If worker refuses to follow OH polices, he/she must sign a waiver indicating that he/she is aware of the consequences of exposure to HBV, HCV and HIV, and does not wish to comply with follow-up protocols. Documentation Exposed individuals should complete an incident report, report to risk management and complete Workmen’s Compensation Board (or local equivalent) documents, as required.. The circumstances of exposure should be recorded, including the activity during which the worker was exposed, work practices and protective equipment that were used, and a description of the source of exposure. Prevention of Transmission Following Exposure HBV If you are exposed to HBV and receive post-exposure treatment, it is unlikely that you will become infected and pass the infection on to others. No precautions are recommended. HCV Because the risk of becoming infected and passing the infection on to others after an exposure to HCV is low, no precautions are recommended. HIV During the follow-up period (especially the first 6-12 weeks following exposure when most persons are expected to show signs of infection), the exposed worker should follow the recommendations for preventing transmission of HIV - not donating blood, semen, or organs, and not having sexual intercourse. Condom use should be very strongly encouraged if the worker has been exposed to an HIV-positive, high risk or unknown source. ARO Training & Consulting Bloodborne Pathogens Module 6: Blood and Body Fluid Exposure Follow-up Page 79 Exposed women should consider not breast-feeding infants during the follow-up period to prevent the possibility of exposing their infants to HIV that may be in breast milk. Management of human bites When bites occur (police and correctional-facility officers are intentionally bitten by suspects or prisoners), routine medical and surgical therapy (including an assessment of tetanus vaccination status) should be implemented as soon as possible. Such bites frequently result in infection with organisms other than HIV and HBV. Victims of bites should be evaluated as described above for exposure to blood or other infectious body fluids. Saliva of some persons infected with HBV has been shown to contain HBV-DNA at concentrations 1/1,000 to 1/10,000 of that found in the infected person's serum. HBsAg-positive saliva has been shown to be infectious when injected into experimental animals and in human bite exposures. However, HBsAg-positive saliva has not been shown to be infectious following oral mucous membrane exposure, or through contamination of musical instruments or cardiopulmonary resuscitation dummies used by HBV carriers. Studies of nonsexual household contacts of HIV-infected patients suggest that the potential for salivary transmission of HIV is remote. The Importance of Hand washing Hands and other exposed skin surfaces should be washed immediately and thoroughly if contaminated with blood or other body fluids to which universal precautions apply, or potentially contaminated articles. Hands should always be washed after gloves are removed, even if the gloves appear to be intact. Hand washing should be completed using the appropriate facilities, such as utility or restroom sinks. Waterless antiseptic hand cleanser should be provided on responding units to use when hand-washing facilities are not available. When hand-washing facilities are available, wash hands with warm water and soap. When hand-washing facilities are not available, use a waterless antiseptic hand cleanser. The manufacturer's recommendations for the product should be followed. Reference:http://www.hc-sc.gc.ca/pphb-dgspsp/publicat/noib-inpb/no4-1002_e.html Compliance with post-exposure plan Among 77 HCWs exposed to patients with HCV, the follow-up rate was 84% at baseline, 31% presented for follow-up 3 months later, and only 12% presented for follow-up after 6 months. One HCW was anti-HCV positive at baseline (i.e., infected prior to exposure). Among 24 HCWs exposed to patients with HIV, the follow-up rates for anti-HIV was 75% at baseline, 54% presented for follow-up 6 weeks later and 33% presented for follow-up at 3 months. Reference:http://www.hc-sc.gc.ca/pphb-dgspsp/publicat/noib-inpb/no4-1002_e.html