|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 http://www.osha.gov.
March 29, 2011
Ms. Katherine West
Infection Control/Emerging Concepts, Inc.
7715 Knightshayes Drive
Manassas, Virginia 20111
Dear Ms. West:
Thank you for your November 19, 2010, letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP). You specifically asked whether the failure of medical/clinical laboratories to provide rapid hepatitis C virus (HCV) testing of source individuals following occupational exposure incidents would be considered a violation of OSHA's Bloodborne Pathogens standard, 29 CFR 1910.1030. We apologize for the delay in responding to your inquiry. 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.
As mentioned in your inquiry, OSHA previously issued an interpretation letter to you (dated January 8, 2007) which outlined the enforcement policy regarding the use of rapid testing to detect human immunodeficiency virus (HIV) infectivity. This previous letter was an interpretation of paragraph 1910.1030(f)(3)(ii)(A) which requires: "The source individual's blood shall be tested as soon as feasible and after consent is obtained in order to determine HBV and HIV infectivity." (boldface added). The very specific provisions in this paragraph of the standard apply to the testing of source individuals suspected of being infected with either hepatitis B virus (HBV) or HIV. Given the language in this paragraph that specifies only HBV and HIV, OSHA is only able to compel employers to use rapid test methods for testing source individuals suspected of being infected with HBV or HIV, but not HCV. However, OSHA does recommend that employers use rapid HCV screening for the source, when feasible. A laboratory's failure to perform one of the currently available "rapid" testing methods in lieu of other FDA-licensed or approved screening kits to determine HCV infectivity would not be considered a violation of the Bloodborne Pathogens standard.
Your letter mentioned a 2003 CDC guidance document entitled Guidelines for Laboratory Testing and Result Reporting of Antibody to Hepatitis C Virus, which encouraged laboratories to use a screening test that utilizes a "signal-to-cut-off (s/co) ratio" method for HCV screening. It is important to note that while these CDC recommendations provide a rationale for using rapid test kits to perform HCV screening, in many cases, supplemental confirmatory testing will still be needed to make a positive diagnosis of HCV infection, even after rapid HCV testing is performed.
Please know that the Agency is aware of the importance of source testing and of employee testing following occupational exposure incidents, and that OSHA in no way considers HBV and HIV to be the only pathogens of concern. As you may know, the use of post-exposure prophylaxis for preventing HCV infection is currently not supported. This is of significant concern to us as it leaves at-risk workers with less desirable post-exposure management options (i.e., monitoring to achieve early detection of infection and treatment to decrease the likelihood of chronic disease). As such, OSHA supports and encourages the testing of source individuals suspected of being infected with HCV. Such testing, as you point out, is valuable in directing treatment options to possibly prevent chronic illnesses in at-risk workers. Rapid HCV testing of source individuals is one of the ways that this can be achieved.
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 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 http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at 202-693-2190.
Thomas Galassi, Director
Directorate of Enforcement Programs
Cc: Glenn Cox, Director
Virginia Occupational Safety and Health