Cal/OSHA requires the Hepatitis B (HBV) vaccination be made available to employees who are occupationally exposed to bloodborne pathogens within ten working days of initial assignment. In addition, Cal/OSHA requires the employer to provide the employee with information on its efficacy, safety, method of administration, benefits and that it is provided at no cost to the employee.
An exception to the vaccination should be noted in the employee medical record.
HBV vaccinations are administered in three doses, with the second and third doses administered at 1 month and 6 months after the first. Vaccinations should be received intramuscularly (in the deltoid). A December 1997 update in CDC recommendations now makes mandatory post-vaccination screenings for employees provided with the Hepatitis B vaccine. Serological conversion should be tested within one to two months of the last shot of the three-shot series. If the screening shows the vaccine did not work, the employer is required to offer to pay for a second vaccine series. The U.S. Public Health Service does not recommend routine serologic testing and booster shots.
If an employee agrees to the vaccination, the employer is to pay for the vaccination, post-vaccination screening, and, if indicated, a second vaccination series. Check with public health clinics, outpatient clinics, hospital occupational health services departments, or a physician for information where employees can receive the vaccination.
If an employee declines the vaccination, the employer must ensure the employee signs a declination form. The declination’s wording must be identical to that found in the regulation (Appendix A, Section 5193, Bloodborne Pathogens).
If an employee initially declines the vaccination then decides to have it, the employer must pay for the vaccination, post-vaccination screening, and second vaccination series, if necessary.
The following paragraphs are excerpted from Immunization of Health-Care Workers: Recommendations of the Advisory Committee on Immunization Practices (ACIP), CDC MMWR November 25, 2011 / 60 (RR-07); 1-45.
Hepatitis B is an infection caused by the hepatitis B virus (HBV), which is transmitted through percutaneous (i.e., breaks in the skin) or mucosal (i.e., direct contact with mucous membranes) exposure to infectious blood or body fluids. The virus is highly infectious; for nonimmune persons, disease transmission from a needlestick exposure is up to 100 times more likely for exposure to hepatitis B e antigen (HBeAg)--positive blood than to HIV-positive blood (14). HBV infection is a well recognized occupational risk for U.S. HCP and globally. The risk for HBV is associated with degree of contact with blood in the work place and with the hepatitis B e-antigen status of the source persons (15). The virus is also environmentally stable, remaining infectious on environmental surfaces for at least 7 days (16).
In 2009 in the United States, 3,371 cases of acute HBV infection were reported nationally, and an estimated 38,000 new cases of HBV infection occurred after accounting for underreporting and underdiagnosis (17). Of 4,519 persons reported with acute HBV infection in 2007, approximately 40% were hospitalized and 1.5% died (18). HBV can lead to chronic infection, which can result in cirrhosis of the liver, liver failure, liver cancer, and death. An estimated 800,000--1.4 million persons in the United States are living with chronic HBV infection; these persons serve as the main reservoir for continued HBV transmission (19).
Vaccines to prevent hepatitis B became available in the United States in 1981; a decade later, a national strategy to eliminate HBV infection was implemented, and the routine vaccination of children was recommended (20). During 1990--2009, the rate of new HBV infections declined approximately 84%, from 8.5 to 1.1 cases per 100,000 population (17); the decline was greatest (98%) among persons aged <19 years, for whom recommendations for routine infant and adolescent vaccination have been applied. Although hepatitis B vaccine coverage is high in infants, children, and adolescents (91.8% in infants aged 19--35 months and 91.6% in adolescents aged 13--17 years) (21,22), coverage remains lower (41.8% in 2009) for certain adult populations, including those with behavioral risks for HBV infection (e.g., men who have sex with men and persons who use injection drugs) (23).
During 1982, when hepatitis B vaccine was first recommended for HCP, an estimated 10,000 infections occurred among persons employed in a medical or dental field. By 2004, the number of HBV infections among HCP had decreased to an estimated 304 infections, largely resulting from the implementation of routine pre-exposure vaccination and improved infection-control precautions (24--26).
The risk for acquiring HBV infection from occupational exposures is dependent on the frequency of percutaneous and mucosal exposures to blood or body fluids (e.g., semen, saliva, and wound exudates) containing HBV, particularly fluids containing HBeAg (a marker for high HBV replication and viral load) (27--31). The risk is higher during the professional training period and can vary throughout a person’s career (1). Depending on the tasks performed, health-care or public safety personnel might be at risk for HBV exposure; in addition, personnel providing care and assistance to persons in outpatient settings and those residing in long-term-care facilities (e.g., assisted living) might be at risk for acquiring or facilitating transmission of HBV infection when they perform procedures that expose them to blood (e.g., assisted blood-glucose monitoring and wound care) (32--34).
A Federal Standard issued in December 1991 under the Occupational Safety and Health Act mandates that hepatitis B vaccine be made available at the employer’s expense to all health-care personnel who are exposed occupationally to blood or other potentially infectious materials (35). The Federal Standard defines occupational exposure as reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that might result from the performance of an employee’s duties (35). Occupational Safety and Health Administration (OSHA) vaccination practice requirements (e.g., pre-exposure and post-exposure antibody testing) are based on current ACIP recommendations. OSHA regulations might have accelerated the use of hepatitis B vaccine in HCP (36).
Data from a national, cross-sectional survey demonstrated that during 2002--2003, an estimated 75% of HCP had received the 3-dose hepatitis B vaccination series (37). Since 2002, rates of 1-dose and 3-dose vaccination coverage have remained stable. Data obtained through the National Health Interview Survey (NHIS) in 2009 demonstrated a ≥1-dose coverage rate of 75%--77% and a ≥3-dose rate of 67%--68% among HCP aged 18--49 years (23). Similarly, data obtained through the National Immunization Survey--Adult (NIS-Adult) in 2007 demonstrated a ≥3-dose coverage of 62% among HCP aged 18--64 years (38). The Healthy People 2020 goal (objective no. IID-15.3) of a hepatitis B vaccination coverage rate of 90% among HCP (39) has not been achieved.
The 3-dose vaccine series administered intramuscularly at 0, 1, and 6 months produces a protective antibody response in approximately 30%--55% of healthy adults aged ≤40 years after the first dose, 75% after the second dose, and >90% after the third dose (40--42). After age 40 years, <90% of persons vaccinated with 3 doses have a protective antibody response, and by age 60 years, protective levels of antibody develop in approximately 75% of vaccinated persons (43). Smoking, obesity, genetic factors, and immune suppression also are associated with diminished immune response to hepatitis B vaccination (43--46).
Protection against symptomatic and chronic HBV infection has been documented to persist for ≥22 years in vaccine responders (47). Immunocompetent persons who achieve hepatitis B surface antibody (anti-HBs) concentrations of ≥10 mIU/mL after pre-exposure vaccination have protection against both acute disease and chronic infection. Anti-HBs levels decline over time. Regardless, responders continue to be protected, and the majority of responders will show an anamnestic response to vaccine challenge (47--51). Declines might be somewhat faster among persons vaccinated as infants rather than as older children, adolescents, or adults and among those administered recombinant vaccine instead of plasma vaccine (which has not been commercially available in the United States since the late 1980s). Although immunogenicity is lower among immunocompromised persons, those who achieve and maintain a protective antibody response before exposure to HBV have a high level of protection from infection (52).
Among persons who do not respond to a primary 3-dose vaccine series (i.e., those in whom anti-HBs concentrations of ≥10 mIU/mL were not achieved), 25%--50% respond to an additional vaccine dose, and 44%--100% respond to a 3-dose revaccination series using standard or high dosage vaccine (43,53--58). Persons who have measurable but low (i.e., 1--9 mIU/mL) levels of anti-HBs after the initial series have better response to revaccination than persons who have no anti-HBs (49,53,54). Persons who do not have protective levels of anti-HBs 1--2 months after revaccination either are infected with HBV or can be considered primary nonresponders; for the latter group, genetic factors might be associated with nonresponse to hepatitis B vaccination (54,58,59). ACIP does not recommend more than two vaccine series in nonresponders (52).
Hepatitis B vaccines have been demonstrated to be safe when administered to infants, children, adolescents, and adults (52,60,61). Although rare cases of arthritis or alopecia have been associated temporally with hepatitis B vaccination, recent data do not support a causal relationship between hepatitis B vaccine and either arthritis or alopecia (61--63).
During 1982--2004, an estimated 70 million adolescents and adults and 50 million infants and children in the United States received ≥1 dose of hepatitis B vaccine (52). The most frequently reported side effects in persons receiving hepatitis B vaccine are pain at the injection site (3%--29%) and temperature of >99.9°F (>37.7°C) (1%--6%) (64--67). However, in placebo-controlled studies, these side effects were reported no more frequently among persons receiving hepatitis B vaccine than among persons receiving placebo (40,41,64--67). Revaccination is not associated with an increase in adverse events.
Hepatitis B vaccination is contraindicated for persons with a history of hypersensitivity to yeast or any vaccine component (4,64--66). Persons with a history of serious adverse events (e.g., anaphylaxis) after receipt of hepatitis B vaccine should not receive additional doses. As with other vaccines, vaccination of persons with moderate or severe acute illness, with or without fever, should be deferred until illness resolves (4). Vaccination is not contraindicated in persons with a history of multiple sclerosis, Guillain-Barré Syndrome, autoimmune disease (e.g., systemic lupus erythematosis and rheumatoid arthritis), or other chronic diseases. Pregnancy is not a contraindication to vaccination; limited data suggest that developing fetuses are not at risk for adverse events when hepatitis B vaccine is administered to pregnant women (4,68). Available vaccines contain noninfectious hepatitis B surface antigen (HBsAg) and do not pose any risk for infection to the fetus.
Two single-antigen hepatitis B vaccines, Recombivax HB (Merck & Co., Inc., Whitehouse Station, New Jersey) and Engerix-B (GlaxoSmithKline Biologicals, Rixensart, Belgium) and one combination hepatitis A and hepatitis B vaccine, Twinrix (GlaxoSmithKline Biologicals), are available in the United States. Primary vaccination consists of ≥3 intramuscular doses of hepatitis B vaccine or of the combined hepatitis A and hepatitis B vaccine. The hepatitis vaccine series does not need to be restarted if the second or third dose is delayed. Detailed vaccination recommendations are available in previously published guidelines (52). Vaccine schedules are available cdc.gov. In adults, hepatitis B vaccine always should be administered into the deltoid muscle. Longer needles (up to 1.5 inches in length) might be required for obese adults (4).
The need for post-exposure prophylaxis should be evaluated immediately after HCP experience any percutaneous, ocular, mucous-membrane or nonintact skin exposure to blood or body fluid in the workplace. Decisions to administer post-exposure prophylaxis should be based on the HBsAg status of the source and the vaccination history and vaccine- response status of the exposed HCP.
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