December 21, 1992

Marsha B. Richards, R.N.
L.T.C. Nurse Specialist
American Health Care Association
1201 L Street, N.W.
Washington, D.C. 20005-40914

Dear Ms. Richards:

This is in response to your letter of August 25, addressed to Dorothy L. Strunk, Acting Assistant Secretary for the Occupational Safety and Health Administration (OSHA). Your letter contained six questions concerning 29 CFR 1910.1030, the "Occupational Exposure to Bloodborne Pathogens Standard." Your questions are addressed in the order in which you presented them.

Question 1:

Section 1910.1030(f)(5)(i) requires the health care professional's written opinion for hepatitis B vaccine. Please clarify that this requires the nursing facility to ensure that an employee who has accented the offer to receive the hepatitis B vaccination is provided, before the vaccine is administered, a written opinion from a licensed health care professional stating that the vaccination is indicated and that there are no medical contraindications to the receipt of the vaccine. It is our interpretation that 1910.1030(f)(5)(i) requires a written medical opinion from a licensed health care professional should an employee indicate that he/she has previously received the hepatitis B vaccination series or at the time an employee completes the vaccination series.

Answer:

The health care professional's written opinion, required by paragraph (f)(5)(i) of the standard, is limited to very specific information regarding the employee's hepatitis B vaccine status, including indication for vaccine and whether such vaccination was completed. This written opinion follows the medical evaluation of the employee which must be performed prior to administering the vaccine. It serves the purpose of ensuring that the employer is provided with documentation that a medical assessment of the employee's ability to receive the hepatitis B vaccination was completed as well as informing the employer regarding the employee's hepatitis B vaccination status.

If an employee declines to accept the vaccination due to prior immunization, the medical documentation to that effect should be included in the employee's medical file if at all possible. If it is not feasible to obtain such documentation, the employee must sign the mandatory declination form included as Appendix A to the standard.

Question 2:

A situation has developed in which a facility has been providing the hepatitis B vaccine to certain employees under the OSH Act general duty clause and since December 6, 1991 under the bloodborne pathogens final standard. However, in doing so, the facility has not obtained and therefore has no record of a written opinion from a licensed health care professional as required in the final standard. Should the facility obtain a written opinion, after the fact, for those employees that received the vaccine? If so, should the facility go back further than July 6, 1992, the effective date of this section of the standard? How far? Since the written opinion can not be "back dated," will compliance officers issue citations for failure to obtain this written opinion in a timely manner?

Answer:

Vaccinations administered after the July 6 effective date of the standard must be accompanied by the health care professional's written opinion. For employees who received the vaccine according to current guidelines of the U.S. Public Health Service prior to that date, every attempt should be made to obtain a copy of the medical documentation to that effect; however, a health care professional's written opinion is not required.

Question 3:

There seems to be some misunderstanding, in several states but particularly in the state of Indiana, regarding the prescreening component versus the written opinion of the health care professionals supervising the bloodborne pathogen program for employees. Some have indicated that they do not want to write an opinion on whether the HBV vaccination is indicated for an employee, especially if that person is not their patient.

Reportedly, some have been told by both local counsel and Indiana's OSHA officials that an employee cannot require such an opinion, citing section 1910.1030(f)(2)(ii) which we believe refers to not making participation in a prescreening program a prerequisite for receiving hepatitis B vaccination. Is this not different from the "written opinion of a health care professional" which is required at 1910.1030(f)(5)(i)?

Answer:

The bloodborne pathogens standard clearly states that the employer must obtain a written opinion from the health care professional under certain circumstances. If the health care professional who is administering the hepatitis B vaccine is unwilling to provide the employer with a written opinion regarding the employee's ability to receive the vaccine, then the employer will not be in compliance with the standard.

Your question indicates some confusion concerning paragraph (f)(2)(ii) of the standard which refers to a prescreening program to test employees for current hepatitis B serological status. This type of program cannot be used as a prerequisite for offering of the vaccine. This is to be differentiated from the requirement set forth in paragraph (f)(5)(i) requiring the employer to obtain and provide the employee with the health care professional's written opinion of the medical evaluation of the employee prior to initial inoculation. Serological status may be included in this evaluation but it cannot be required.

Your letter notes with particular concern practices in the state of Indiana. You should be aware Indiana operates its own state occupational safety and health program which is overseen and monitored by federal OSHA. A state plan must enforce regulations that are at least as effective as the federal ones but they may also be more stringent. You should, therefore, contact each state program in which your members are located for specific information on their individual state requirements. A list of state plans is enclosed for your information.

Question 4:

A question has arisen as to whether or not it is necessary that the facility obtain and maintain on record a written order (prescription) from a physician in order for an employee to be administered the hepatitis B vaccine.

Answer:

See answers to questions #1 and #3 above; the health care professional's decision to administer the vaccine (i.e., prescription) is considered part of the initial evaluation.

Question 5:

According to the definitions in the standard, a licensed health care professional "is a person whose legally permitted scope of practice allows him or her to independently perform the activities required by paragraph (f)." Who, in addition to a physician, would be considered to fit this definition? Would a Registered Professional Nurse meet this definition if acting alone?

Answer:

The legal scope of practice for health care professionals, including registered nurses, is regulated by each state. In a number of states, nurse practitioners may prescribe and administer vaccinations independently as well as perform all other requirements of paragraph (f). Other health care workers may perform certain procedures, such as administration of the vaccine, only under the supervision of another licensed health care professional. You will need to contact the regulating body in each state in order to provide the proper information to your members.

Question 6:

The CDC Guidelines for Prevention of Transmission of HIV and HBV to Health care and Public Safety Workers, dated February 1989, makes two (2) references to laundry services, specifically the handling of soiled linens. On page 12, CDC acknowledges that "soiled linens may be contaminated with pathogenic "microorganisms" and recommends that "soiled linens should be handled as little as possible," minimally agitated, and "bagged at the location where it was used." The section related to laundry on page 41, for the most part reiterates these recommendations but adds that soiled linens "should not be sorted rinsed in patient-care areas." Would this preclude the rinsing of linens soiled with feces in dirty utility room hoppers? AHCA is requesting OSHA to clarify that for compliance with the bloodborne pathogen standard, "soiled" linen means the same as "contaminated" laundry in that it refers to linen which has been soiled with blood or other potentially infectious materials.

Answer:

For purposes of the bloodborne pathogens standard, "soiled" linen is not the same as "contaminated" laundry. Soiled linen simply means any used linen. Contaminated laundry, which is a subset of soiled linen, is defined in the standard as laundry which has been soiled with blood or other potentially infectious materials or which may contain sharps. This term is used to clarify OSHA's intent to differentiate certain linens which require special handling. In addition to hazards created by the presence of blood or other potentially infectious materials on linens in patient care areas, the potential presence of contaminated sharps in used laundry creates a special hazard which emphasizes the need to handle certain laundry as contaminated.

Contaminated laundry must be handled with a minimum of agitation and must be bagged or containerized at the location where it was used. While it may not be sorted or rinsed in the location of use, this requirement does not preclude "rinsing of linens soiled with feces in dirty utility room hoppers", as you inquired in your letter.

The issue of "soiled" linen arises only in the context of labeling. If a facility chooses to use universal precautions in the handling of all soiled laundry or ships to a facility which uses universal precautions in the handling of all soiled laundry, alternative labeling or color coding is permitted.

We hope this information is responsive to your concerns. Thank you for your interest in worker safety and health.

Sincerely,



Roger A. Clark, Director
Directorate of Compliance Programs