- Standard Number:
OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov.
February 1, 1993
Mr. Baruch A. Fellner
Gibson, Dunn & Crutcher Lawyers
1050 Connecticut Avenue, N. W.
Washington, D.C. 20036-5306
Dear Mr. Fellner:
This is in response to your letter of September 25, 1992, requesting clarification of the Occupational Safety and Health Administration (OSHA) standard on Occupational Exposure to Bloodborne Pathogens Standard, 29 CFR 1910.1030. Specifically, you inquired as to the extent of the employer's obligation to follow-up with its employees to assure that the hepatitis B vaccination series is administered.
The first issue which we would like to address is the fact that your client's exposure control plan provides for written confirmation by the health care professional within 15 days "after the employee has completed the vaccinations." This is an incorrect interpretation since the standard requires in section (f)(5) that the written opinion be obtained by the employer and provided to the employee "within 15 days of the completion of the evaluation." In most cases of pre-exposure vaccination, therefore, this written opinion would follow the administration of the first shot in the series. On a related note, page 62 of OSHA instruction CPL 2-2.44C, "Enforcement procedures for the Occupational Exposure to Bloodborne Pathogens," is currently being revised to state that the written opinion includes indication for vaccine and whether such vaccination was initiated.
Your basic concern is that employer monitoring of employee compliance with the directions of the administering physician would create an "impractical and overwhelming" administrative burden. OSHA does not require that the employer make extraordinary efforts to ensure completion of the series. However, we would look for good faith efforts on the part of the employer to ensure that employees are reminded about completing the vaccination series. Documentation of written or verbal reminders to the employee would constitute a good faith effort. Since the standard allows the employee to decline the vaccination at any time, a completed declination form would also constitute documentation where an employee's failure to return for the second or third injections constitutes a refusal to complete the series.
Your letter goes on to state that your client goes beyond the requirements of the standard by arranging for the first appointment with the health care professional. Since this appointment/evaluation is included in the term "made available," your client is following the requirements of the standard by doing so; this does not constitute "an obligation beyond what is required."
You also state in your letter that the employer would have to monitor the employees' appointments in order "to assure that employees are following doctors' orders before employees are allowed to return to areas of occupational exposure." This is not accurate as the standard simply requires that the employee be evaluated and receive the first dose of the vaccine within ten days of initial assignment to a job involving occupational exposure. Employees with occupational exposure may certainly continue to work pending completion of the series.
With regard to the exposure control plan which you submitted, it is not OSHA's practice to review and approve sample plans. The final determination of compliance is made by the compliance officer and takes into account all factors pertaining to the plan at a particular worksite. However, a cursory review of the document found that paragraph #2 under "Hepatitis B Vaccination" is incorrect for the reasons stated above. The same holds true for Section I of your client's agreement with the attending health care professional. Lastly, subsections (c) through (e) of Section II are neither comprehensive nor entirely accurate.
We hope this information is responsive to your concerns. Thank you for your interest in worker safety and health.
Roger A. Clark,
Directorate of Compliance Programs
September 25, 1992
Mr. Roger A. Clark
U.S. Department of Labor
OSHA/Room No. N3468
200 Constitution Avenue, N.W.
Washington, D.C. 20210
Re: Hepatitis B Vaccination Procedure
Dear Mr. Clark:
This letter seeks a formal opinion from the Occupational Safety and Health Administration ("OSHA") on behalf of my client, one of the leading clinical laboratory companies in the United States. Through a national network of laboratories, the company offers a broad range of testing services used by medical professionals in the diagnosis, monitoring and treatment of disease. It has grown into a nationwide network of laboratories and collecting stations, serving customers in almost every state, and employing thousands of people nationwide, with a substantial annual turnover.
The company has developed an exhaustive Exposure Control Plan (the "Plan") to bring it into compliance with the bloodborne pathogen standard at 29 CFR 1910.1030. While the standard presents many practical implementational questions, the purpose of this letter is to seek OSHA's guidance and approval of one part of the Plan dealing with the employer's obligation to make available the hepatitis B vaccine and vaccination series to all employees who have occupational exposure. 29 CFR 1910.1030(f).
One narrow issue that has arisen involves the extent to which an employer is obligated to follow up with its employees to assure that the vaccine and vaccination series are administered. The Plan provides, in part, for written confirmation by the physician administering the hepatitis B vaccination within 15 days after the employee has completed the vaccinations. It also requires that the administering physician maintain records of the vaccination process, including the dates of all injections. See attachments describing the applicable provisions and the draft agreement with the licensed physician. As you know, this vaccination series is administered over a protracted period of time, sometimes as long as six months. The practical question is the extent to which an employer's obligation to make the hepatitis B vaccine available to its employees requires the employer to monitor their appointments and to assure that employees are following doctors' orders before employees are allowed to return to areas of occupational exposure.
The company believes that the standard does not require the monitoring of employee compliance with the directions of the administering physician. Such an administrative burden would be impractical and overwhelming and is not included within the standard's requirement that the hepatitis B vaccination be made available to affected employees. The company's view of its obligation in this regard is supported by OSHA Instruction CPL 2- 2.44C Section M6(b) (at p. 56) which states in relevant part: "The term `made available' includes the health care professional's evaluation and arranging for the administration of the first dose of the hepatitis B vaccination series to begin within . . . ten days." (emphasis added). It would, therefore, appear that OSHA contemplated the logistics of the administration of the hepatitis B vaccination series to be in the hands of the employee and health care professional, rather than the responsibility of the employer. Nevertheless, the company does arrange for the first appointment, an obligation beyond what is required under the OSHA Instruction. Any further obligations would also appear to be unnecessary.
In sum, we are seeking formal approval by OSHA of the attached Plan provisions respecting the company's limited obligation to make available the hepatitis B vaccination series. In particular, we seek OSHA's concurrence with the company's position that it has no affirmative obligation to monitor the administration of such vaccinations, to ascertain that all appointments are kept by its employees, or otherwise to assure that the health professional is doing his/her job.
I would welcome the opportunity to meet with you to discuss this matter, as well as other issues that have arisen in the company's attempt to comply comprehensively with this complex but necessary regulation. Please call me at (202) 955-8591 in order to arrange such a meeting.
Very truly yours,
Baruch A. Fellner