Cal/OSHA Requirement

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.

1. The employee has already received the complete vaccination series.
2. Antibody testing has revealed that the employee is immune.
3. The vaccination is contraindicated for medical reasons. The employer may not require an employee to be screened for antibodies in order to receive the vaccination.

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.

CDC Guidelines

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.

Epidemiology and Risk Factors

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).

Hepatitis B in Health-Care Settings

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.

Vaccine Effectiveness

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).

Vaccine Duration of Immunity

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).

Vaccine Safety

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.

Recommendations

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).

Pre-Exposure

Unvaccinated and Incompletely Vaccinated HCP and Trainees: Pre- and Post-vaccination Serologic Testing

• Pre-vaccination serologic testing for previous infection is not indicated for the majority of persons being vaccinated because of occupational risk unless the hospital or health-care organization considers such testing cost-effective (3,52,69--72). However, such testing is indicated for HCP and is cost-effective in certain high-risk populations (see HCP and Trainees at Additional Risk), regardless of vaccination status (71,73).
• All unvaccinated persons whose work- and training-related activities involve reasonably anticipated risk for exposure to blood or other infectious body fluids (e.g., HCP, long-term--care facility staff, and public safety workers) should be vaccinated with the complete, ≥3-dose hepatitis B vaccine series.
• Persons with an incomplete series are not considered protected and should complete the ≥3-dose series.
• Because higher risk has been reported during the professional training period, the vaccination series should be completed before trainees have contact with blood; vaccination should be offered in schools of medicine, dentistry, nursing, laboratory technology, and other allied health professions.
• To determine the need for revaccination and to guide post-exposure prophylaxis, postvaccination serologic testing should be performed for all HCP at high risk for occupational percutaneous or mucosal exposure to blood or body fluids. Postvaccination serologic testing is performed 1--2 months after administration of the last dose of the vaccine series using a method that allows detection of the protective concentration of anti-HBs (≥10 mIU/mL). Persons determined to have anti-HBs concentrations of ≥10 mIU/mL after receipt of the primary vaccine series are considered immune, and the result should be documented. Immunocompetent persons have long-term protection and do not need further periodic testing to assess anti-HBs levels. Postvaccination testing for persons at low risk for mucosal or percutaneous exposure to blood or body fluids (e.g., public safety workers and HCP without direct patient contact) likely is not cost effective (52); however, persons who do not undergo postvaccination testing should be counseled to seek immediate testing if exposed.
• Persons determined to have anti-HBs concentrations of <10 mIU/mL soon after receipt of the primary vaccine series should be revaccinated. For these persons, administration of a second complete 3-dose series on an appropriate schedule, followed by anti-HBs testing 1--2 months after the third dose, usually is more practical than conducting serologic testing after each additional dose of vaccine.
• Persons who do not have a protective concentration of anti-HBs (≥10 mIU/mL) after revaccination (i.e., after receiving a total of 6 doses) should be tested for HBsAg and anti-HBc to determine infection status. Those determined not to be infected but who have anti-HBs <10 mIU/mL (nonresponders) should be considered susceptible to HBV infection and should be counseled about precautions to prevent HBV infection and the need to obtain hepatitis B immune globulin (HBIG) post-exposure prophylaxis for any known or likely exposure to HBsAg-positive blood (72). Persons determined to be infected (anti-HBc-positive) and positive for HBsAg should be provided counseling regarding how to prevent HBV transmission to others and referred for further evaluation (e.g., HBV viral load testing), care, treatment, and other services, as appropriate (69--71). Persons who are HBsAg-positive and who perform exposure-prone procedures should seek counsel from a review panel comprised of experts with a balanced perspective (e.g., HCPs’ personal physicians and infectious disease specialists) regarding the procedures that they can perform safely. They should not be excluded from work (69). Persons who were infected in the past (anti-HBc- positive but negative for HBsAg) require no vaccination or treatment.

Post-Exposure

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.

Unvaccinated and Incompletely Vaccinated HCP and Trainees

• Unvaccinated or incompletely vaccinated persons who experience a workplace exposure from persons known to be HBsAg-positive should receive 1 dose of hepatitis B immune globulin HBIG (i.e., passive vaccination) as soon as possible after exposure (preferably within 24 hours). The effectiveness of HBIG when administered >7 days after percutaneous or permucosal exposures is unknown.
• Hepatitis B vaccine should be administered in the deltoid muscle as soon as possible after exposure; HBIG should be administered at the same time at another injection site. The 3-dose hepatitis B vaccine series should be completed for previously unvaccinated and incompletely vaccinated persons who have needlestick or other percutaneous exposures, regardless of the HBsAg status of the source and whether the status of the source is known. To document protective levels of anti-HBs (≥10mIU/mL), postvaccination testing of persons who received HBIG for post-exposure prophylaxis should be performed after anti-HBs from HBIG is no longer detectable (4--6 months after administration).

Vaccinated HCP and Trainees

• Vaccinated HCP with documented immunity (anti-HBs concentrations of ≥10 mIU/mL) require no post-exposure prophylaxis, serologic testing, or additional vaccination.
• Vaccinated HCP with documented nonresponse to a 3-dose vaccine series should receive 1 dose of HBIG and a second 3-dose vaccine series if the source is HBsAg-positive or known to be at high risk for carrying hepatitis. If the source is known or determined to be HBsAg- negative, these previously nonresponding HCP should complete the revaccination series and undergo postvaccination testing to ensure that their response status is documented. Postvaccination testing of persons who received HBIG for PEP should be performed after anti-HBs from HBIG is no longer detectable (4--6 months after administration).
• Vaccinated HCP with documented nonresponse to two 3-dose vaccine series should receive 2 doses of HBIG, 1 month apart if the source is HBsAg-positive or known to be at high risk for carrying hepatitis; no additional vaccination is necessary. If the source is known or determined to be HBsAg-negative, these previously nonresponding HCP need no additional testing or treatment.
• Vaccinated HCP with no documentation of postvaccination serologic response who are exposed to an HBsAg- positive source should have serum obtained for anti-HBs testing immediately. Those determined to have protective levels of antibody (anti-HBs ≥10 mIU/mL) require no additional treatment; those with concentrations <10 mIU/mL should receive 1 dose of HBIG, along with a booster dose of hepatitis B vaccine. To document protective levels of anti-HBs (≥10mIU/mL), postvaccination testing of persons who received HBIG for post-exposure prophylaxis should be performed after anti-HBs from HBIG is no longer detectable (4--6 months after administration).
• Vaccinated HCP with no documentation of postvaccination serologic response who are exposed to a source with unknown infection status should be tested for anti-HBs. Those determined to have protective levels of antibody require no additional treatment; those with concentrations <10 mIU/mL should receive a booster dose of hepatitis B vaccine and serologic testing 1--2 months later.
• Vaccinated HCP with no documentation of postvaccination serologic response who are exposed to a source known to be HBsAg-negative require no testing or treatment.

HCP and Trainees at Additional Risk

• Regardless of vaccination history, HCP and trainees in certain high-risk populations, including those born in geographic regions with high HBsAg prevalence (≥8%) and intermediate (2%--7%) prevalence (71), unvaccinated U.S-born HCP whose parents were born in regions of high HBsAg prevalence, HIV-positive HCP, HCP who have disclosed having engaged or currently engaging in high-risk substance abuse or sexual behaviors, and HCP who require immunosuppressive therapy or who are on hemodialysis should be tested for HBsAg and anti-HBc/anti-HBs to determine infection status. For those who are unvaccinated, blood should be drawn for testing before the first dose of vaccine is administered, and vaccination should be administered during the same health-care visit. Persons testing negative for hepatitis B infection or immunity should be managed in the same manner as other uninfected HCP. Persons determined to be HBsAg-positive should be provided counseling regarding how to prevent HBV transmission to others and referred for further evaluation (e.g., HBV viral load testing), care, treatment, and other services as appropriate (69--71). Persons who are HBsAg-positive and who perform exposure-prone procedures should seek counsel from a review panel comprised of experts with a balanced perspective (e.g., personal physicians of HCP and infectious disease specialists) regarding the procedures that they can perform safely. They should not be excluded from work (69). Additional information regarding pre-vaccination testing for HCP with other hepatitis B risk factors and for pregnant women has been published previously (52,71). HCP receiving hemodialysis should be provided annual anti-HBs testing and should be administered a booster dose of vaccine when anti-HBs levels decline to <10 mIU/mL (52).
• For other immunocompromised HCP (e.g., HIV-infected persons, hematopoietic stem-cell transplant recipients, and persons receiving chemotherapy), the frequency of postvaccination testing and the need for booster doses has not been determined (52).

Other Considerations

• Occupational health programs and others responsible for infection prevention and control should identify all staff whose work-related activities involve exposure to blood or other potentially infectious body fluids in a health-care, laboratory, public safety, or institutional setting (including employees, students, contractors, attending clinicians, emergency medical technicians, paramedics, and volunteers); provide education to staff to encourage vaccination; and implement active follow-up, with reminders to track completion of the vaccine series and postvaccination testing among persons receiving vaccination (72).
• In partnership with state and local health authorities, household, sex, or needle-sharing contacts of HBsAg-positive HCP and trainees should be identified, tested, vaccinated (if indicated), and provided with counseling and referral for needed services, when appropriate.