Could reopening HIV guidelines lead to restrictions for infected providers?
HICPAC urging CDC to add HCV, revisit painful debate
The chief infection control advisory committee to the Centers for Disease Control and Prevention is urging the agency to reopen one of the most controversial chapters in its history, and update guidelines on health care workers infected with HIV and hepatitis.
A letter from the Hospital Infection Control Practices Advisory Committee (HICPAC) to be mailed before the next HICPAC meeting in June will request the CDC to reconsider the guidelines, which were issued in 1991 after a wrenching national debate spurred by reported provider transmission of HIV to six patients in a Florida dental practice.1-3 The CDC recommendations issued in the wake of the case essentially call for health care workers who perform invasive procedures primarily surgeons and dentists to know their HIV status and hepatitis B virus e-antigen (HBeAg) status. If infected, these workers are to consult state and local expert review panels regarding their continuing practice.4 In discussing the issue at a December meeting at the CDC, HICPAC members agreed to send a letter to CDC leadership in the Centers for Infectious Diseases and the hospital infections program that states the following:
"Five years have now elapsed since the CDC guidelines were issued. During this time, additional information regarding risk and effectiveness of interventions has accumulated. New therapies, especially for HIV, are available and may permit new approaches. Hepatitis C [virus], not discussed in the original guidelines, has been increasingly recognized as a major blood borne pathogen, and a potential nosocomial risk. The time is now right to review CDC’s 1991 guidelines and to issue updated guidelines for the management of the hepatitis B, HIV [and] HCV infected health care worker. While HICPAC’s official charge would allow this committee to take on this review process, we strongly urge CDC to convene a broader technical advisory group with the fiscal and staffing resources necessary to effectively accomplish the task. In addition to HICPAC representation, we recommend this group also include other key knowledge holders and stakeholders necessary for this process to produce a credible and accepted product."
Though no additional cases of HIV transmission from health care workers to patients have been documented in CDC "look-back" studies, since the CDC guidelines were written there have been outbreaks of both HBV and HCV in patients treated by infected surgeons.5,6 (See related abstract and commentary, p. 21.)
Few have forgotten, however, that current CDC policy was hammered out in a highly charged debate that saw many medical groups refusing to assist the agency for fear that mandatory testing and discriminatory practices against infected providers would follow. Indeed, at one point during the 1991 debate, Sen. Jesse Helms (R-NC) introduced an amendment which the Senate approved by a vote of 81-18 calling for a minimum 10-year prison term for HIV-infected health care workers who perform invasive procedures without informing patients. However, Congress eventually enacted a compromise law that requires states to adopt the CDC guidelines or equivalent measures to ensure their share of federal public health dollars. Public health officials have been reluctant to reopen the issue, in part due to concerns that more Draconian measures will be enacted into state or federal law. (See related stories in Hospital Infection Control, September 1991, pp. 121-128; June 1995, pp. 74-76.)
States oppose reopening issue
While CDC officials have been reluctant to address the political ramifications of the guidelines, David Bell, MD, chief of the HIV infections branch in the CDC hospital infections program clarified at a meeting of the Society for Healthcare Epidemiology of America (SHEA) that state health departments were advising the CDC not to reopen the issue. In comments to members at the 1995 meeting in San Diego, Bell said:
"State health departments have told us that they have figured out how to deal with this issue in their states and that reopening the public debate would not be helpful to them at this time. Concerns have also been expressed that although the HIV look-back data are reassuring, there are substantial limitations in these data. These limitations, combined with the HBV risk to patients now appearing, if anything, more compelling than it did in 1991 and hepatitis C transmission from a surgeon to patients reported, could result in enough scientific uncertainty in a public debate that legislative solutions could follow, which probably also would not be helpful."
Asked about HICPAC’s request to reopen the guidelines, Bell said the issue is under discussion at the agency and the guidelines will be considered for revision if warranted by clinical data.
"The only thing I can say is we are reviewing the scientific data that may be pertinent," he tells Hospital Infection Control. "If there is compelling new scientific information, that would outweigh any concerns about the guidelines being politicized. We have to focus on the science. That is what we are discussing right now."
Drafted by HICPAC member David Fleming, MD, state epidemiologist at the Oregon Health Department in Portland, the position statement was briefly considered for inclusion in a draft of a HICPAC guideline for infection control in health care personnel. That guideline is nearing completion, but is slated to be discussed again at the HICPAC June meeting before it is published in the Federal Register. (See related story, p. 22.) Fleming noted to fellow HICPAC members that the request could be included in the personnel health draft guideline in an attempt to spur CDC action on the matter. Though agreeing with the need to reconsider the issue, HICPAC member Susan Florenza, MD, argued it would be inappropriate to use HICPAC guidelines as "a sounding board," and suggested the committee make the request in the form of a letter.
"I hear what Dave is saying and I agree with him," said Florenza, who is director of AIDS surveillance at the New York City Department of Health. "We really want to have a lot of pressure being brought to bear that this guideline should be updated, as painful and as political a can of worms as it is. "
Another committee member, however, warned against getting into an adversarial position with the CDC in attempting to force the agency’s hand on a policy issue with few easy answers.
"It is silly for us to get an adversarial position on this," said HICPAC member Ronald Nichols, MD, professor of medicine in the department of surgery at Tulane University School of Medicine in New Orleans. "How do I know what we should do with hepatitis C do you? What should we do with a hepatitis B e-antigen-positive surgeon, should we take away his practice? Do you want to do that?"
In light of such concerns, the committee agreed to draft the request as a letter and address the issue more generically in its draft of the personnel health guideline. As proposed at the meeting, the HICPAC health care personnel guideline will address the issue with the following statement:
"The risk posed to patients from health care personnel infected with blood borne pathogens such as hepatitis B and HIV has been the subject of much concern and debate. There are no data to indicate that infected workers who do not perform invasive procedures pose a risk to patients. Consequently, work restrictions for these workers are not appropriate. The extent to which infected workers who perform certain types of invasive procedures pose a risk to patients and the restrictions that should be imposed on these workers have been much more controversial. In 1991, CDC recommendations regarding this issue were issued. Subsequently, Congress mandated that each state promulgate rules or laws implementing the CDC guidelines or equivalent as a condition for continued federal public health funding to that state. All states have complied with this mandate, and these legal directives now should guide action. There is a fair degree of state-to-state variation regarding specific provisions, however. Local or state public health officials should be contacted to determine the regulations applicable in a given area."
UK restrictions, HIV look-backs
Though both HICPAC members and CDC officials are hesitant to discuss specific issues that may be considered in reopening the guidelines, several developments that have occurred since the 1991 guidelines were published would inevitably be discussed if the matter is reopened. For example, while HBV was addressed in the original guidelines, subsequent provider-to-patient outbreaks in the United Kingdom have resulted in more restrictive measures for HBV-infected surgeons there, including mandatory screening and restricted practices for the HbeAg-infected. (See related story in Hospital Infection Control, August 1995, pp. 97-101.) In addition, the aforementioned HBV outbreak in the United States has been followed by discussions of whether "shearing" injuries due to suture knot-tying could be a factor in transmission.
With regard to HCV, the CDC hepatitis branch recommended last year that hospitals begin tracking health care workers’ occupational exposures to the virus.7 In doing so, however, the agency stopped short of recommending any restrictions for health care workers infected with HCV. The agency cited several factors, including the following:
The risk of transmission from an infected worker to a patient appears to be very low.
There are no serologic assays that can determine infectivity.
There are insufficient data to determine the threshold concentration of virus required for transmission.
As recommended for all health care workers, those who are HCV-positive should follow strict aseptic technique and standard precautions, including appropriate use of hand washing, protective barriers, and care in the use and disposal of needles and other sharp instruments, the HCV guidelines note.
"The risk that an HCV infected individual will transmit the virus may be related to the type and size of the inoculum and the route of transmission, as well as the titer of virus, but there are insufficient data on the threshold concentration of virus needed to transmit infection," the CDC concluded in the HCV guidelines. "In the absence of such data and standardized tests to measure infectivity, it is difficult to counsel anti-HCV positive persons about their risk of transmission to others."
Several developments concerning HIV also would likely be discussed, including the lack of additional reports of transmission to patients in the United States, and advances in drug therapies that led to new recommendations last year for a revised HIV post-exposure protocol for health care workers.8 While the implications of new drug therapies for HIV-infected health care workers are not clear, the CDC "look-back" studies underscore the low risk of their continuing practice. In the most recent report of the studies in 1995, the CDC found that no other HIV transmission has occurred in 22,171 patients of 51 HIV-infected health care workers.9 While noting that the risk of transmission is "very small," the findings are limited because the total number of patients only represents 17% of those treated by the infected providers. "Even a study population of 22,171 patients might lack sufficient statistical power to detect a low-frequency event, especially if, as seems likely, the risk for transmission is greatest for only a subset of health care workers or procedures," the CDC concluded. ". . . These limitations not withstanding, it seems likely that if HIV were easily transmitted from health care worker to patient, evidence of such transmission would have been detected in these investigations."
Investigations start with inexplicable cases’
Still, the look-back studies are not an ideal surveillance method to pick up another cluster of patients infected by a provider. Rather, the key to such events appears to be tracing a patient with no identified risk (NIR) factors back to a particular infectious health care worker, notes William Schaffner, MD, chairman of the department of preventive medicine at the Vanderbilt School of Medicine in Nashville, TN.10
"The look-back studies start with health care workers that are HIV-positive and then look at their patients," he says. "In truth, if you review the hepatitis B literature and the one case of transmission of HIV, those investigations did not start with the infected health care worker. They started with inexplicable cases of HBV and HIV."
But there is a lack of data on such cases, because most state and local health departments do not have the funding and resources to thoroughly investigate NIRs and attempt to trace them back to a potentially infected health care worker.
"Many of my colleagues in infection control are laboring under a misapprehension that the national HIV, hepatitis B, and hepatitis C surveillance systems are good enough to pick up cases of suspected transmission from a health care worker," Schaffner says. "I believe that notion is ill-founded. The surveillance systems were never designed to pick up something that subtle."
Similarly, there is no database on the workings of the various state and local review panels who assess infected health care workers, including information on how many health care workers have come before them and what kind of decisions are being made regarding their continuing practice.
"Except for information that is slowly accumulating about HCV and some additional information about HBV that has come out of the United Kingdom, we have not accumulated a whole lot more information about the risk of transmission from infected health care workers to patients," he says. "If you create a group that is going to discuss this again, we will go through the same agony, we’ll spill the same blood on the floor and have the same difficult discussions, but the argument will not be advanced much further because they aren’t any new data."
References
1. Centers for Disease Control and Prevention. Possible transmission of human immunodeficiency virus to a patient during an invasive dental procedure. MMWR 1990; 39:489-493.
2. Centers for Disease Control and Prevention. Update: Transmission of HIV infection during an invasive dental procedure Florida. MMWR 1991; 40:21-33.
3. Centers for Disease Control and Prevention. Update: Investigations of persons treated by HIV-infected health care workers United States. MMWR 1993; 42:329-331; 337.
4. Centers for Disease Control and Prevention. Recom mendations for preventing transmission of human immunodeficiency virus and hepatitis B virus to patients during exposure-prone invasive procedures. MMWR 1991; 40:1-9.
5. Harpaz R, et al. Transmission of hepatitis B virus to multiple patients from a surgeon without evidence of inadequate infection control. N Engl J Med 1996; 334:549-554.
6. Estaban JI, Gomez J, Martell M, et al. Transmission of hepatitis C virus by a cardiac surgeon. N Engl J Med 1996; 334:555-560.
7. Centers for Disease Control and Prevention. Issues and Answers: What is the risk of acquiring hepatitis C for health care workers and what are the recommendations for prophylaxis and follow-up after occupational exposure to hepatitis C virus? Hepatitis Surveillance Report no. 56. Atlanta; 1996.
8. Centers for Disease Control and Prevention. Update: Provisional public health service recommendations for chemoprophylaxis after occupational exposure to HIV. MMWR 1996; 45:468-472.
9. Robert LM, Chamberland M, Cleveland JL, et al. Investigations of patients of health care workers infected with HIV: The Centers for Disease Control and Prevention Database. Ann Intern Med 1995; 653-657.
10. Mishu B, Schaffner W. HIV-infected surgeons and dentists. Looking back and looking forward [editorial]. JAMA 1993; 269:1843-1844.
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