November 27, 2013

Captain Cynthia Wilkerson, MSC, USN
Director, Center for Clinical Laboratory Medicine
Tricare Management Activity
Office of the Assistant Secretary of Defense for Health Affairs
7700 Arlington Blvd., Suite 5101
Falls Church, VA 22042

Dear Captain Wilkerson:

Thank you for your July 19, 2013, letter to the Occupational Safety and Health Administration’s (OSHA) Directorate of Enforcement Programs. You requested a clarification of OSHA’s Bloodborne Pathogens (BBP) standard, 29 CFR 1910.1030. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence. For clarification, your specific questions are paraphrased below, followed by OSHA’s response.

Background: The BBP standard, at paragraph 1910.1030(f)(3)(ii)(A), requires the testing of the source individual’s blood “as soon as feasible” after an exposure incident. The term “as soon as feasible” is not precisely defined to allow some flexibility in light of the wide variety of situations which can occur. OSHA requires employers to follow the U.S. Public Health Service recommendations current at the time of required evaluations and procedures, except as specified in paragraph (f) of the standard. 29 CFR 1910.1030(f)(1)(ii)(D). At this time the most current guideline on the management of occupational exposure to HIV recommends rapid HIV testing and the administration of post-exposure prophylaxis (PEP); Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Post-exposure Prophylaxis, Infect Control Hosp Epidemiol 2013; 34(9): 875-892. As stated in OSHA’s letter of interpretation to Ms. Katherine West (1/8/2007), based on similar 2005 guidelines, failure of the employer to utilize rapid HIV testing would usually be considered a violation.

Question 1: Where source individual HIV testing is conducted at a site other than the location of the exposure incident(e.g., a phlebotomy site), is a 3-4 hour turnaround time from the exposure incident to the completion of the test considered “as soon as feasible?”

Response: As OSHA stated in the preamble to the Bloodborne Pathogens standard: “The statement that the source individual’s blood will be tested “as soon as feasible” is used instead of “as soon as possible,” which connotes extreme immediacy in medical environments.” While OSHA does not expect procedures necessary to sustain a patient’s life to be delayed, the testing must be done in a timely fashion. [56 FR 64004, 64158 (12/6/1991)]

Additionally, the U.S. Public Health Service Guidelines recommend that PEP be initiated as soon as possible, preferably within hours of exposure. PEP has been shown to be less effective when the administration is delayed. The CDC regards occupational exposures to HIV as urgent medical concerns that should be evaluated immediately. They recommend the use of three or more antiretroviral drugs. Because of the potential toxicity of the antiretroviral PEP drugs, the rapid HIV test should be conducted to determine the source individual’s positive HIV status prior to administering the PEP drugs.

It is important to note that at the time the BBP standard was promulgated, the rapid HIV test was not yet available. Since OSHA’s rule making, the U.S. Food and Drug Administration has approved at least six rapid HIV antibody screening test kits. All these kits are inexpensive and able to produce results within an hour. These kits also have extended shelf lives and may be stored at room temperature. As a result of the availability, cost, and performance of antibody testing kits, feasible means now exist for medical facilities or designated testing locations to have, on hand, rapid HIV antibody test kits. Therefore, given the ready availability and capability of the rapid HIV test kits and the CDC’s recommendation to administer the PEP within hours of exposure to a positive source test result, OSHA would consider obtaining a test result within three to four hours to be “as soon as feasible.”

Question 2: Should all employers whose employees have occupational exposure within the meaning of the BBP standard maintain a rapid HIV test kit on-site, or is access to a nearby facility that can test the sample within 3-4 hours after collection considered to meet the requirement that testing should be completed “as soon as feasible?”

Response: Many facilities do not administer their own post-exposure testing; however, that does not remove the employer’s obligation to make appropriate arrangements so that such testing can be expedited in accord with the requirements. OSHA encourages employers to use the rapid HIV test kits in more facilities, e.g., phlebotomy sites, if feasible, and with appropriate training.

Rapid HIV test kits are inexpensive, have extended shelf lives, and may be stored at room temperature; the results are available within an hour. Thus, rapid HIV test kits may be made readily available in most situations where employees have occupational exposure, providing the employer with the means to administer the test in the least amount of time feasible after the exposure incident. However, having the tests conducted off-site does not violate the standard as long as the test is conducted “as soon as feasible,” as discussed.

Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our letter of interpretation explains 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 http://www.osha.gov.

If you have any further questions, please feel free to contact the Office of Health Enforcement at 202-693-2190.

Sincerely,

Thomas Galassi, Director
Directorate of Enforcement Programs