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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.
DOL-OSHA-DEP-2020-008 - This document does not have the force and effect of law and is not meant to bind the public in any way. This document is intended only to provide clarity to the public regarding existing requirements under the law or agency policies.
August 19, 2020
Ms. Yvonne Jones
Infection Prevention and Control Department
17273 State Route 104
Chillicothe, Ohio 45601
Dear Ms. Jones:
Thank you for your letter to the Occupational Safety and Health Administration (OSHA). Your letter was forwarded to the Directorate of Enforcement Programs for a response. You requested a clarification on the requirements of the Bloodborne Pathogens standard, 29 CFR § 1910.1030, regarding post-exposure evaluation and follow-up for employees who have had a bloodborne pathogens exposure incident and are possibly at risk from infection, such as by the hepatitis B virus (HBV) or the human immunodeficiency virus (HIV). This letter constitutes OSHA’s interpretation only of the requirements discussed and may not be applicable to any questions not delineated within your original correspondence. Your questions are paraphrased below, followed by OSHA’s responses.
Question 1: Does the blood of an employee exposed to blood or other potentially infectious material (OPIM) only need to be tested if the source individual is positive (for HIV or HBV), as implied by the U.S. Public Health Service (USPHS) guidelines?
Response: No. The Bloodborne Pathogens standard at 29 CFR § 1910.1030(f)(1)(ii)(D) requires that post-exposure evaluation and follow-up be “[p]rovided according to recommendations of the U.S. Public Health Service current at the time these evaluations and procedures take place, except as specified by this paragraph (f).” [Emphasis added.] As explained in the preamble to the Bloodborne Pathogens standard,
OSHA thus defers specific details of medical practice to the USPHS recommendations, except as provided by paragraph (f). The exception implies that the standard, in certain areas such as an employer responsibility and requiring a health care professional’s written opinion, has set some more specific procedures and requirements than the USPHS recommendations. …Paragraph (f)(3)(iii) states that it is the employer’s responsibility, following an exposure incident, to make available to an exposed employee collection and testing of blood for HBV and HIV serological status.1
Therefore, it is the employer’s responsibility to meet the requirement at paragraph (f)(3)(iii)(A), to collect and test the exposed employee’s blood for HBV and HIV after consent is obtained, regardless of the status of the source patient. You ask why the exposed employee is offered testing if the source patient is negative. It is necessary that testing be offered to the exposed employee for a number of reasons: (1) the exposed employee may be concerned that the source patient’s negative test result may be a false negative; (2) the source patient may have contracted a bloodborne disease subsequent to a previous negative test result; and, (3) the exposed employee may not want to wait for a pending test result of the source patient before starting post-exposure prophylaxis (PEP), which is medically recommended, for example, for potential HIV exposures, as we explain further below (see Question 2). Testing of the exposed employee’s blood under these circumstances is also necessary to assist the treating physician(s) in determining appropriate prophylactic and follow-up treatment.
In addition, paragraph (f)(3)(iii)(B) allows exposed employees who have consented to baseline blood collection but not to HIV testing the opportunity for future testing without the need for an immediate decision. The intent of this provision of the standard is to give the exposed employees time to decide, based on factors such as the source patient’s status (if known), and after counseling and education, whether to have their baseline samples tested. The preamble states:
OSHA believes that it is of great importance for employees to have the opportunity to obtain knowledge about baseline serologic testing after exposure incidents, and that this provision of opportunity for future testing rather than a demand for an immediate decision by the employee will encourage employees to consent to blood collection at the time of exposure.2
Pursuant to paragraph (f)(3)(iii)(B), employees involved in an exposure incident have at least 90 days following baseline blood collection to decide if they wish to have their blood tested.3
Question 2: What is meant by “as soon as feasible” in regards to collection and testing of an exposed employee’s blood?
Response: The Bloodborne Pathogens standard at paragraph (f)(3)(iii)(A), states: “The exposed employee’s blood shall be collected as soon as feasible and tested after consent is obtained.” OSHA answered a question similar to yours regarding what is meant by “as soon as feasible” in a November, 2013 letter of interpretation to Captain Cynthia Wilkerson.4 The letter states,
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.”5
We would also note that Bloodborne Pathogens standard at paragraph (f)(3) states, “Following a report of an exposure incident, the employer shall make immediately available to the exposed employee a confidential medical evaluation and follow-up, including at least the following elements…” As stated in the OSHA Bloodborne Pathogens Enforcement Directive, CPL 02-02-069, “The word ‘immediately’ is used in the standard to emphasize the importance of prompt medical evaluation and prophylaxis.6 An exact time was not given in the standard because the time limit on the effectiveness of post-exposure prophylactic measures can vary depending on the infection of concern.” For example, the CDC recommends that for health care workers with suspected or known exposure to HIV, PEP be started as soon as possible, within hours, and not be delayed while waiting for the source patient’s test results. If the source patient later tests negative for HIV, then PEP can be stopped. In addition, reevaluation of the exposed employee within 72 hours after exposure is strongly recommended.7
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA’s requirements are set by statute, standards, and regulations. Our letters of interpretation do not create new or additional requirements but rather explain these requirements and how they apply to particular circumstances. This letter constitutes OSHA’s interpretation of the requirements discussed. From time to time, letters are affected when the agency updates a standard, a legal decision impacts a standard, or changes in technology affect the interpretation. To assure that you are using the correct information and guidance, please consult OSHA’s website at www.osha.gov. If you have further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.
Patrick J. Kapust, Acting Director
Directorate of Enforcement Programs
1 56 Federal Register at 64154, 64158 (Dec. 6, 1991).
2 56 Federal Register at 64159.
3 OSHA recommends confirming with the blood testing laboratory that its test method is valid for a 90-day sample holding period.
4 See /laws-regs/standardinterpretations/2013-11-27-0.
5 The Centers for Disease Control and Prevention (CDC) is the United States Public Health Service agency responsible for issuing guidelines and making recommendations regarding infectious diseases.
6 See /enforcement/directives/cpl-02-02-069-0.
7 Updated US Public Health Service Guidelines for the Management of Occupational Exposures to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis, Infection Control and Hospital Epidemiology. Vol. 34, No. 9 (September 2013), pages 19-20. Available at: https://stacks.cdc.gov/view/cdc/20711.