OSHA: Use rapid HIV test after HCW exposure
ICP whistle-blower prompts national ruling
Hospitals and other medical facilities that do not use rapid HIV assays to test source patients after a blood exposure to a health care worker risk citations and fines by the Occupational Safety and Health Administration (OSHA), Hospital Infection Control has learned.
A spokeswoman in the compliance office at OSHA headquarters in Washington, DC, confirmed the ruling, which was prompted by a letter of interpretation written by national OSHA in response to ICP consultant Katherine West, BSN, MSEd, CIC, of Control/Emerging Concepts business in Manassas, VA.
"Our letters do not set new standards, but they basically interpret how OSHA looks at what available information is out there," the OSHA compliance spokeswoman says. "The bloodborne pathogen standard is a performance oriented standard. It is written in language that allows us to make interpretations as things change. As something new gets developed we can make a determination that [new measures are required]. This part of the standard says source testing needs to be done immediately [after worker exposure] or as soon as feasible. Before you could use rapid HIV testing it wasn't feasible. Now that it is feasible, our interpretation is that the easiest, fastest method is what needs to be done. That is what the letter says, and certainly if we can go into a facility where that is an issue it is something we could cite."
Last year, West decided to try to do something about a disturbing trend she observed in consultation with hospitals, medical offices, and fire and public safety workers that comprises the national client base for her consulting practice. Though many inexpensive rapid HIV tests are now on the market to test source patients following blood exposures, medical and public safety workers are being routinely put on potentially toxic regimens of post-exposure prophylaxis (PEP) for weeks while awaiting the results of conventional tests, she says.
"What I was finding all across the country was that hospitals were refusing to do rapid HIV testing — some, even for their own staff," she says. "They would put these people on PEP in some areas for weeks until they got source patient HIV testing results back. I was also finding hospitals that would do rapid testing for their employees but not for fire and rescue or law enforcement. There was a double-standard of care. I just finally had had it and I wrote a letter to OSHA."
West successfully argued in her letter to OSHA that the agency should follow its stated intent of enforcing Centers for Disease Control and Prevention guidelines, which recommend using rapid HIV tests on source patients following exposures.
Cites CDC guidelines
In the letter to OSHA, West noted that the CDC updated its recommendations for HIV in the document "Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis," dated Sept. 30, 2005. CDC notes on pages 6-7 of this document that, "Rapid HIV testing of source patients can facilitate making timely decisions regarding the use of HIV PEP after occupational exposures to sources of unknown HIV status. Because the majority of occupational HIV exposures do not result in transmission of HIV, potential toxicity should be considered when prescribing PEP.
Rapid HIV testing is quick, inexpensive, and accurate. The cost for a medical facility to purchase a test kit is $10 to $20, West noted. No laboratory equipment is needed to perform these tests. In addition, medical facilities that do not have Clinical Laboratory Improvement Act (CLIA) licensure can use the OraQuick rapid test since it has a waiver from the Department of Health and Human Services. The accuracy of these tests has been proven to be nearly 100%, West emphasized in the letter.
"Once the laboratory receives source patient blood for testing, it can confirm HIV status within one hour," she told OSHA. "Confirmation of negative HIV status means that the exposed employee does not need to be placed on toxic antiretroviral drugs. Confirmation of positive HIV status gives the exposed employee the initial information needed to make a decision regarding taking HIV PEP."
Compliance manual is clear
OSHA compliance directive CPL 2-2.69 provides that "The compliance officer should determine if the employer's plan ensures immediate and confidential post-exposure and follow-up procedures in accordance with the current CDC guidelines," West continued. In addition, it provides that, "Where medical practice is an issue, and the compliance officer believes that access to care was delayed or denied or the employer was not following accepted post-exposure procedures, the Regional Bloodborne Pathogens Coordinator shall be contacted. A heath care professional in the Directorate of Technical Support will be consulted if necessary." Since it is the responsibility of employers to ensure that CDC guidelines are being followed, it appears that their reporting to OSHA of hospital failure to conduct rapid HIV testing would result in a citation to the hospital, she stressed.
The $64,000 question
West's compelling argument came down to a $64,000 question: Is it an OSHA violation under 29 CFR 1910.1030 for a medical facility subject to OSHA jurisdiction not to perform rapid HIV testing on a source patient in an exposure incident?
The answer, which will have implications for medical practices nationwide was clarification that, indeed, rapid HIV testing of source patients is generally required by OSHA for compliance with the bloodborne pathogen standard. West received a letter from Richard Fairfax, director of OSHA enforcement programs that states that "an employer's failure to use rapid HIV antibody testing when testing is required by paragraph (f)(3)(ii)(A) would usually be considered a violation of that provision."
The confirmation HIC received from the national OSHA compliance office would appear to nail-in the ruling. While the ultimate outcome of this development depends on how aggressively OSHA enforces the rapid test requirement. West is getting the word out and reminding hospitals and other health care providers that they risk running afoul of OSHA if they let exposed employees languish on PEP drugs and suffer their side effects instead of doing the right thing through rapid HIV testing. Moreover, employee complaints may prompt an OSHA inspection so as word of the ruling gets out hospitals and medical facilities may be vulnerable to a surprise inspection.
"The hospital is an employer, therefore they must offer it," she says. "Now for fire and rescue, their employers must ensure that the hospitals are going to do it. I am advising them to have hospitals sign letters for agreement."
Asked about what motivated one ICP consultant to seek national action on OSHA enforcement, West noted her concern for the workers on needless, potentially toxic PEP regimens and quoted a sign hanging in her office: "I wondered why somebody didn't do something. Then I realized that I am somebody."