Hepatitis B vaccine consent forms and liability waivers

July 22, 1993
Ms. Anne M. Sturtz
Assistant General Counsel
VOCA Corporation
[Recipient address omitted]
Dear Ms. Sturtz:
This is in response to your letter of November 9, 1992, to Mr. David Kennedy of our Columbus, Ohio, area office. You requested an interpretation of the Occupational Safety and Health Administration (OSHA) regulation, 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens." Specifically, you inquired about the permissibility of a consent form with a waiver of liability. Your letter was referred to this office for response.
The consent form you enclosed with your November 9, correspondence cannot be used because the sentence which releases the employer from liability constitutes a violation of OSHA's requirement that the vaccine be offered at no cost to the employee. We concur with the Chicago Regional Office letter of January 6, which states that asking employees to waive possible future legal rights is considered a cost to employees.
Your letter stated that VOCA offers prescreening, free of charge, to employees who elect to participate in the vaccination program. This is allowed by the standard since your program is not a prerequisite for receiving the hepatitis B vaccine. Also permitted under the standard is the requirement for employees who receive the vaccine to sign an informed consent form, provided that the information is not biased. For example, a lengthy description of all potential side effects of the vaccine and no explanation of the benefits of receiving the vaccine (i.e., the health effects which may result from actual contraction of the disease) would not be acceptable.
The consent form you sent along with your November 9, letter is acceptable until the last sentence, which releases VOCA from all responsibility for reactions that may occur from the immunization.
The fact that OSHA prohibits the liability waiver does not mean that you are necessarily liable should an accident occur. OSHA does not have the authority to determine liability for injuries or illnesses; such liability is a matter of state worker's compensation or tort law. We do, however, have the responsibility to ensure that employees who have occupational exposure to blood or other potentially infectious materials are offered the hepatitis B vaccine at no cost.
In a telephone conversation you had with a member of my staff on April 27, you expressed VOCA's desire to be sure your employees make an informed decision before accepting the hepatitis B vaccine, and that they understand there could be contraindications. The bloodborne pathogens training, as required by paragraph 1910.1030(g)(2)(vii)(I), must include information on the hepatitis B vaccine, including information on its efficacy and safety. Since employees are required to receive this training before receiving the vaccine, they will have received the necessary information to make an informed decision. Further, you are required to keep on file the healthcare professional's written opinion, in which the person administering the vaccine has determined, through consultation with the employee and/or the employee's medical records, whether any contraindications can be determined for the employee. Complying with these two requirements should reassure you that your employees have been informed as to both the benefits and risks of the vaccine before they receive the first dose.
We hope this has been responsive to your concerns. Thank you for your interest in employee safety and health.
Sincerely,
Roger A. Clark, Director
Directorate of Compliance Programs

[Earlier OSHA correspondence, supporting material, and requester letters reproduced on OSHA page; omitted here.]

[Corrected 3/27/2009]