Who pays for hepatitis B vaccine screening tests

NOTICE: This is an OSHA Archive Document, and may no longer represent OSHA Policy. It is presented here as historical content, for research and review purposes only.

November 9, 1990

Ms. Wanda L. Hurr
Director of Legal Services
Wisconsin Association of
Nursing Homes, Inc.
[Recipient address omitted]
Dear Ms. Hurr:

This is in response to your letter of October 10 addressed to William E. Funcheon, Jr., Assistant Regional Administrator for Technical Support in the Occupational Safety and Health Administration (OSHA) Chicago Regional Office. Your letter was referred to this office for response.

While your letter to Mr. Funcheon addresses the specific issue of payment for the cost of the screening test for the hepatitis B vaccine, the sample release form which you enclosed should also be addressed as a general matter.

Until a final standard addressing occupational exposure to bloodborne pathogens is promulgated, OSHA is enforcing a number of current standards which are applicable to the hazards of bloodborne disease. In addition to several general industry standards, we are enforcing the general duty clause, section 5(a)(1) of the Occupational Safety and Health Act of 1970 (OSH Act), which requires an employer to "furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees."

It is OSHA's interpretation of section 5(a)(1) that the hepatitis B vaccine is a feasible method of preventing contraction of the disease. OSHA requires that the cost of the vaccine be borne by the employer. To provide the vaccine free-of-cost but to require that a pre-test be performed and paid for by the employee creates an impediment to acceptance of the vaccine and is inconsistent with OSHA's intent which is to remove, as much as possible, obstacles to the employee's acceptance of the vaccine.

We agree with you that if the employee prefers to determine his or her immune status prior to vaccination, there is no authority requiring employers to bear the cost of the prevaccination serologic testing. However, your sample release form is ambiguous in this regard and it is unclear whether or not you are, in fact, requiring employees to determine their immune status prior to vaccination. Such a requirement, at cost to the employee, would be viewed as a violation of section 5(a)(1) of the OSH Act.

In fact, the Centers for Disease Control (CDC) does not recommend routine prevaccination serologic testing for susceptibility to the hepatitis B virus, and states that the decision to test potential vaccine recipients for prior infection is primarily a cost-effectiveness issue which "should be based on whether the costs of testing balance the cost of vaccine saved by not vaccinating individuals who have already been infected" (Morbidity and Mortality Weekly Report, February 9, 1990). Such testing is usually cost-effective for groups with the highest risk of infections and marginally so for groups at intermediate risk.

Another principal objection to the sample release form is the waiver-of-liability provision. Under section 5(a)(1), all at risk employees have a right to receive free hepatitis B vaccine, regardless of whether they waive liability. If the liability waiver is deleted, it would not violate section 5(a)(1) to require employees to sign forms indicating consent to the vaccination and informing them of the benefits and risks of the vaccine and the procedures for obtaining the vaccine.

There are, however, a number of misconceptions in your release form concerning the safety and efficacy of the vaccine which we must point out. You state, for instance, that the vaccine "may produce immunity in 82-87% of recipients. The vaccines are prepared from plasma of individuals who are carriers of the hepatitis virus or from yeast derivatives using recombinant DNA technology". In fact, plasma-derived vaccine is no longer being produced in the United States and the currently licensed recombinant hepatitis B vaccine series induces an adequate antibody response in more than 90% of healthy adults.

You also state that "studies involving the use of the vaccine in pregnant and nursing women have not been performed and the vaccine will be given in these situations only if clearly needed...". While it is true that data are not available on the safety on the hepatitis B vaccine for the developing fetus, the CDC states that "because the vaccines contain only noninfectious HBsAg particles, there should be no risk to the fetus. In contrast, HBV infection of a pregnant woman may result in severe disease for the mother and chronic infection of the newborn. Therefore, pregnancy or lactation should not be considered a contraindication to the use of this vaccine for persons who are otherwise eligible" (Ibid.).

We understand that the lengthy description in your form of potential side effects from the vaccine stems from your concern regarding the issue of liability. With respect to the danger of the plasma-derived vaccine, it should be noted again that it is no longer being produced and is available only to hemodialysis patients, other immunocompromised hosts, and persons with known allergy to yeast.

It is OSHA's perception that your form could just as easily, and certainly should, include a list of the health effects and costs of infection with the hepatitis B virus. Since it does not, your presentation of the issue appears to be one-sided and could be construed as an attempt to dissuade employees from accepting the vaccine.

I hope this information is helpful to you.

Sincerely,

Patricia K. Clark Director
Directorate of Compliance Programs

[OSHA correspondence, the requester’s materials, and NIOSH reference material are reproduced on the source page; omitted here.]