December 2, 1996

David Gude, M.D.
Director of Professional Services
Texas MedClinic
204 East Rhapsody Drive
San Antonio, Texas 78216

Dear Dr. Gude:

Thank you for your letter dated October 15, where you raised an issue relating to the Occupational Safety and Health's Administration (OSHA) standard on Occupational Exposure to Bloodborne Pathogens. You have asked about the specific requirement to obtain a healthcare professional's written opinion in the "pre-exposure vaccination setting."

The Bloodborne Pathogens standard, 29 CFR 1910.1030, requires the employer to obtain and provide the employee with a healthcare professional's written opinion of a medical evaluation prior to the initial inoculation of the Hepatitis B vaccine. This requirement can be found in paragraph (f)(5)(i). The written opinion shall be limited to whether Hepatitis B vaccination is indicated for an employee and if the employee has received such a vaccination. The second circumstance that requires a written opinion, and the one you are familiar with, is found in paragraph (f)(5)(ii). This written opinion must be obtained for post-exposure evaluations.

The purpose of obtaining an evaluation prior to receiving the vaccine is that some employees may be allergic to a component of the vaccine. Following the evaluation, the healthcare professional can proceed to administer the first inoculation on this same visit. The written opinion ensures the employer that an evaluation was done, informs the employer regarding the employee's HBV vaccination status, and allows the employer to provide a copy to the employee.

Thank you for your interest in occupational safety and health. If you have further questions, please feel free to call Wanda Bissell of my staff at (202) 219-8036 Ext. 45.

Sincerely,



Ruth McCully, Director
Office of Health Compliance Assistance




October 15, 1996

Mr. John B. Miles, Jr.
Directorate of Compliance Programs
Dept. of Labor - OSHA
200 Constitution Ave. NW
Washington, D.C. 20210

Dear Sir,

I am writing to you with regards to an issue relating to the Bloodborne Pathogens regulation which was published December 6, 1991, specifically Section (f)(5), The Healthcare Professional's Written Opinion. I have always understood this section to refer exclusively to a Post-Exposure Evaluation. Apparently, OSHA has now sited at least two national companies for failing to have a Healthcare Professional's Written Opinion in the pre-exposure vaccination setting.

In other words, some OSHA compliance officers apparently interpret that prior to administration of any vaccine, an individual assessment by a Healthcare Professional should be undergone by the employee to determine whether or not the vaccine is indicated or contraindicated.

My position as a provider of occupational services in the San Antonio, Texas area is that this is an unnecessary addition to this regulation. Unless the individual has an absolute contraindication to the vaccine (which can be determined by a very brief questionnaire) then there should be no reason for a healthcare provider to perform an assessment on each new employee. To do so only adds unnecessary costs to the employer and additional administrative burden to all.

The companies I deal with, are making a very genuine effort to comply with both this standard as well as other OSHA regulations. It is my hope that there has been some misinterpretation and, in fact, it was never OSHA's intention to require a Healthcare Professional's Written Opinion in a pre-exposure setting. Please advise me in a timely fashion so that I may change the recommendation I am providing to numerous clients in the San Antonio area.

Thank you for you attention in this matter.

Sincerely,



David Gude, M.D.
Director of Professional Services