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SHEA: Test viral load of infected HCWs
New guidelines for HIV, HBV, HCV
Do some health care workers infected with HIV or hepatitis B or C pose a risk to their patients? Should they be restricted from performing exposure-prone procedures? A new guideline by the Society for Healthcare Epidemiology of America (SHEA) seeks to answer these longstanding and controversial questions by specifically targeting health care workers with a high viral load of circulating virus.
The SHEA guideline identifies the most exposure-prone procedures and specifies how and why some health care workers should face restrictions. The precautions range from double-gloving and other safety measures to an outright restriction on performing certain exposure-prone procedures if they have a high viral load defined as equal to or greater than 104 genome equivalents per milliliter of blood for HBV and HCV and equal to or greater than 5x102 genome equivalents per milliliter of blood for HIV.1
In a precedent-setting position, the SHEA guideline also suggests that health care workers infected with hepatitis B or C or HIV should be tested at least every six months to determine their viral load. All infected health care workers would consult an Expert Review Panel, comply with infection control precautions, and follow up regularly with occupational medicine staff or public health clinicians, the guideline states.
However, in what some say is a glaring omission, the guideline does not address routine testing of surgeons and other OR personnel, except to say that testing should not be mandatory and that health care workers performing invasive, exposure-prone procedures are "ethically obligated" to know their status. The guideline represents an update of the 1997 SHEA guideline, "Management of Healthcare Workers Infected with Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus and Other Bloodborne Pathogens."
The Centers for Disease Control and Prevention guideline dates from 1991 and covers only HBV and HIV. However, the scientific understanding and treatment of HIV and hepatitis B and C have advanced considerably in the past two decades.
"We felt the science had progressed to the point where we really could define [these] issues define the points where there was minimal risk to the patient while still allowing infected providers to pursue their livelihood," says Neil Fishman, MD, director of health care epidemiology, infection prevention and control at the University of Pennsylvania Health System in Philadelphia, an author of the guideline and president of SHEA. "The primary viewpoint was [the dictum of patient safety], 'Above all, do no harm.'"
In that regard, SHEA urges healthcare providers to comply with institutional policies and procedures designed to protect patients. Healthcare providers have an ethical responsibility to promote their own health and well-being, and a responsibility to remove themselves from care situations if it is clear that there is a significant risk to patients despite appropriate preventive measures, the guideline states.
However, infection with a bloodborne pathogen does not itself justify restriction on the practice of an otherwise competent healthcare provider, SHEA notes in the guideline. Healthcare providers infected with bloodborne pathogens should seek ongoing care and treatment. Restrictions may be justifiably imposed when a healthcare provider has a physical or mental impairment that affects his or her judgment and/or jeopardizes patient safety. Examples might include exudative lesions or weeping dermatitis; a history of poor infection-control technique or adherence to proper technique; mental confusion; or a prior incident of transmitting a bloodborne pathogen to a patient, the guideline states.
Janine Jagger, PhD, MPH, director of the International Health Care Worker Safety Center at the University of Virginia in Charlottesville, affirms that it is not necessary to sacrifice patient health and safety to spare healthcare workers' practice rights. With advances in the treatment and prophylaxis of HBV, HCV and HIV, there are new opportunities for policies that protect both patient and healthcare worker, she notes. It is essential for surgeons to be fully engaged with the policy process, she says.
"Today, it is no longer in the interest of surgeons not to know their bloodborne pathogen status although some may still need to be convinced of that," she says.
HCV viral levels 'arbitrary'
The guideline drew criticism both for what it contains and what it does not. Its authors readily acknowledge that it does not follow the usual rigorous standards of scientific evidence. In fact, the authors note that the cut-off levels of viral load are "arbitrary." HCV research and experience, in particular, provides little basis for a specific value, they say: "This level was chosen in the absence of data that definitively associate a given level with either a clear risk for transmission or, more importantly, an absence of risk."
"There will never be a randomized control study of the risk of transmission of hepatitis B, hepatitis C or HIV. For ethical reasons, that could never happen," explains Fishman, who is also associate professor of medicine in the Division of Infectious Diseases at the University of Pennsylvania. However, there is evidence of a relationship between greater "circulating viral burden" and a higher risk of transmission, the guideline states.
In the United States, HBV transmission has been associated with e antigen-positive status. However, the SHEA guideline notes a report from the United Kingdom in which health care providers were infected with a "pre-core" mutant of HBV that caused them to be e antigen negative but to have a high viral load.2 The authors note that the restrictions in Europe are greater for HBV and HIV than those recommended in the SHEA guideline. (The European Consortium could not reach consensus on HCV infected providers.) The United Kingdom guideline states that HCV-infected providers with circulating RNA should not conduct exposure-prone procedures.
In contrast, the current CDC guideline states that health care workers who are HIV-positive or HBV-positive with the e antigen "should not perform exposure-prone procedures unless they have sought counsel from an expert review panel and been advised under what circumstances, if any, they may continue to perform these procedures." It does not cite specific procedures as exposure-prone or recommend any specific action on the part of the expert review panels.3
"We did review all of the European guidelines. But we felt that the evidence that was available did not support the European recommendations, that they were a little out of date," Fishman says.
Yet without data to support a cut-off level in which transmission occurs more frequently above the cutoff than below it the recommendation for viral load status for hepatitis C is problematic, says Miriam J. Alter, PhD, an HCV expert and director of the Infectious Disease Epidemiology Program at the Institute for Human Infections and Immunity at the University of Texas Medical Branch at Galveston.
"It's very hard to defend a policy in which the data are so lacking unless you're choosing zero risk, and this is not what this [guideline] is choosing," says Alter, who is also the Robert E. Shope Professor in Infectious Disease Epidemiology.
Most cases of HCV transmission in the United States have been linked to contamination of multidose vials, reuse of syringes, or medication abuse (and needle-sharing) on the part of the health care worker. In one case, a Long Island, NY, surgeon infected 14 of 937 patients over a 10-year period. Investigations of five HCV-infected providers in the United Kingdom found 15 probable cases of transmission to patients among 5,868 patients tested, or a transmission rate of about .26%.4
Transmission risk is higher from HBV-positive individuals who are also e-antigen positive – which corresponds to a higher viral load. Alter cautions that the viral load can vary, and that facilities need to consistently use the same test for viral load because of possible variations among those of different manufacturers.
And what about patients? Should they be informed of their surgeon's HBV, HCV or HIV status? SHEA states that infected health care workers should not be required to inform patients of their infection status. Fishman notes that the SHEA panel included an ethicist. "We did consider the ethics of the recommendations and situations," he says. The guideline also was reviewed by representatives of the American College of Surgeons and the American College of Occupational and Environmental Medicine, he says.
No mandate for HCW testing?
The guideline relies on health care workers to report their status. Yet if health care workers don't know their HIV, HBV or HCV status, there is no opportunity to consider restrictions. The guideline states that health care providers performing the most exposure-prone procedures are "ethically obligated" to know their status, and that any provider who inadvertently exposes a patient to his or her blood or body fluid should notify the patient and undergo testing.
Still, in the absence of specific recommendations for testing – either at hire or periodically – the health care provider may avoid the issue altogether. Both SHEA and CDC recommend against mandatory testing of health care providers. This position hasn't changed, although in 2006, CDC recommended that all HIV testing should be routine for patients "in all health care settings."5
The guideline advocates strict adherence to infection control practices. Yet there has been relatively low compliance with sharps safety practices and devices in U.S. operating rooms, says Jane Perry, MA, associate director of the International Healthcare Worker Safety Center at the University of Virginia. According to 2007 data from the EPINet (Exposure Prevention Information Network) surveillance, more sharps injuries occur in the OR than any other hospital locale and 24% of all injuries are from suture needles.
Perry also notes that surgeons have the highest under-reporting rate of sharps injuries and blood exposures in most studies. Promoting safe practices and encouraging reporting of bloodborne pathogen exposures is important for institutions and all health care workers involved in exposure-prone procedures, says Fishman. "It's critical that the various institutions have mechanisms in place to survey adherence to safe practices by all providers," he says.
Jagger favors a proactive approach: "It all hinges on accurate reporting of percutaneous injuries during surgical procedures," she says. "Institutions need to develop mandatory reporting policies specifically for the OR with rigorous administrative checks."