Pressure mounts for CDC to change guidelines for infected HCWs
Special Report: Managing HIV-positive Health Care Workers
Pressure mounts for CDC to change guidelines for infected HCWs
Discrimination, job loss blamed on current guidelines
Two advisory committees reviewing federal guidelines for managing HIV-positive health care workers have found that substantive revisions are warranted because of new findings on the risk of HIV transmission and seven years of negative impact on health care workers. The committees will complete a draft of their recommendations for revision within the next several months, health officials say.
"I believe that years of experience and clinical studies warrant a change," says Lawrence Gostin, JD, professor of law at Georgetown University Law Center in Washington, DC, and a member of the working group. "The current guidelines are more restrictive and burdensome on health care workers and the health care system than is necessary."
The two committees - the Advisory Committee on HIV and STD Prevention and the Hospital Infection Control Practices Advisory Committee - met in early March. They were asked to consider the following three options for the Centers for Disease Control and Prevention:
· take no action at this time;
· recommend no change in recommendations but publish a summary of new scientific evidence;
· change the recommendations and address specific issues.
The working group supported the last option, stating that the guidelines don't reflect current knowledge of risks and practices of infected health care workers. Revisions could end discriminatory practices and encourage health care workers to know their HIV status, the group says. It expressed concern, however, that any revision would draw attention to the issue, which has receded from public attention in recent years.
Reflecting a time of fear and high emotionsThe CDC published its initial guidelines, Recommendations for Preventing Transmission of HIV and Hepatitis B (HBV) to Patients During Exposure-prone Invasive Procedures, in 1991.1 Publication came after an emotional year of political debate that grew out of the famous Florida dental case, in which the CDC documented for the first time that an HIV-positive health care worker had infected a patient.
Attempting to find a middle ground between legislative proposals for mandatory testing of health care workers vs. allowing infected workers to hide their HIV infection, the CDC issued guidelines with two major elements:
· Health care workers infected with HIV or HBV should refrain from performing exposure-prone procedures unless they have been cleared by an expert review panel.
· If infected health care workers are allowed to continue performing those procedures, they must notify patients of their serostatus.
The second requirement has been criticized as effectively making the review panel process irrelevant because few patients would be willing to undergo an operation performed by an HIV-infected surgeon. At the same time, notification essentially overrides a health care worker's right to confidentiality of a medical condition, opening the door for discrimination and loss of career, Gostin said.
The toll on health care workers' lives and careers has been great enough that the President's Advisory Council on HIV/AIDS passed a resolution in 1995 requesting that the CDC review its guidelines.
"If a patient discloses his HIV status to a physician, there is the duty to confidentiality. But once the health care worker's disclosure is made to the patient, the patient has no ethical responsibility to maintain that confidentiality," Gostin explained. "As a result, there can be widespread disclosure of a person's status, and this has been deeply burdensome."
Another criticism of the guidelines has been the recommendation that review panels determine on their own what procedures are deemed "exposure-prone." Although a group of professional organizations failed to devise a list of such procedures, arguing that technique, skill, and medical status of the health care worker were also important factors in the risk of HIV exposure, the CDC left its recommendation intact. Consequently, it required states to come up with their own definitions.
Basis for making changesThe working group based its recommendation for revisions on the following observations:
· Scientific knowledge now supports the argument that recommendations for managing HIV and HBV in health care workers should be addressed separately. Also, enough is known about hepatitis C virus (HCV) that recommendations should be considered for its management.
· The risk of provider-to-patient HIV transmission is so low that the provision for prospective patient disclosure should be removed. However, self-disclosure or patient notification would be appropriate in certain circumstances. A recommendation for consideration would be a policy encouraging self-disclosure to a supervisor, who could monitor the health care worker's health status.
The group also noted that patient notification might be warranted in two situations:
- exposure to an infected health care worker's blood, allowing possible consideration for offering a patient postexposure prophylaxis;
- for purposes of conducting "look back" investigations where transmission of a bloodborne pathogen has been documented.
· In making revisions, the CDC should focus on injury prevention rather than practice restrictions. Recent studies have shown that safer infection control practices, such as double gloving and sharps injury prevention techniques, and new devices, such as blunted suture needles, have significantly reduced injuries.
· Although expert panels seem to function effectively, there are inconsistencies among states. More direction is needed to help assess transmission risk of exposure-prone procedures, whose definition also needs to be clarified.
· More research is needed to assess and quantify the transmission risk of HCV, including more "look-back" studies. Also, recent evidence of HBV transmission by surgeons despite good infection control practices makes it important to examine the role of suture tying, micro-lesions, and protection of surgical gloves.
Since the CDC documented in 1991 that Florida dentist David Acer infected his patients, only one other case of provider-to-patient HIV transmission has been documented. Last year, an orthopedic surgeon in France with advanced HIV disease was shown to have infected a patient while he performed two lengthy hip operations lasting up to 10 hours. (For information on the results of look-back studies, see chart, at right.)
Indeed, the CDC has been involved in look-back studies of 53 HIV-positive health care workers with 22,759 patients tested for HIV.2 Among those patients, 113 were found to be HIV-positive. Investigations found that 28 of those patients were known to be infected prior to surgery, an additional 52 had well-established risk behaviors for HIV infection, and 15 others had potential risks for HIV infection. Only five patients had no identified risk, and genetic sequencing of virus showed the strains were not related, says Julie Gerberding, MD, MPH, director of HIV counseling and testing services at San Francisco General Hospital.
"So far there are no data to suggest that any look-back investigations have identified provider-to-patient transmission and this is a very large sample from which to study," she told the advisory committees.
Moreover, combination-drug therapies are capable of reducing viral load to undetectable levels, which has been linked to reduced likelihood of transmission. Also, viral-load assays can promptly and accurately monitor the success of treatment, Gerberding noted. However, there have been cases in which patients with relatively low viral load transmitted HIV to providers, she added.
Skin trauma from suture tying may be culpritAs for HBV, there is growing evidence that the virus can be transmitted during exposure-prone procedures. A 1992 CDC investigation confirmed that an infected cardiothoracic surgeon transmitted the virus to 19 patients. The investigation found no evidence of inadequate infection control practices or specific procedures responsible for the transmission. It is hypothesized that skin trauma from suture tying may have been responsible at the time the surgeon was highly infectious.3
Although no other provider-to-patient HBV cases have been documented in the United States, several cases have been identified in other countries since 1990, including six in the United Kingdom. In five of those cases, the surgeons tested negative for HBV antigens.
CDC officials also report that HCV was transmitted from a cardiac surgeon to five patients in Spain in 1996. The surgeon reported a high rate of percutaneous injuries during surgery, but no specific route of transmission was identified.
Shortly after the 1991 recommendations, Congress passed legislation requiring that states adopt equivalent guidelines. Most states followed the CDC language for their policy on managing HIV-positive health care workers. However, the response has been varied. Some states, for example, have statutes mandating that infected health care workers inform state health departments or licensing boards of their HIV status, while others simply recommend notification, says Douglas Morgan, MD, state AIDS director for New Jersey.
So far, 230 HIV-positive health care workers have been reviewed by health department licensing boards or expert review panels, according to a survey conducted by Minnesota health officials, Morgan told the committees. In all but two cases, the health care workers have not been disallowed to practice, nor have any been required to notify their patients, he said. The exceptions involved a physician who practiced poor infection control and another health care worker who suffered from psychological problems. Additionally, states have reviewed 40 health care workers infected with HBV and none were required to notify patients of their status, he noted.
While the working group agreed that expert review panels are needed, "we clearly believe that this one-size-fits all approach is not feasible and that individual health care workers represent different problems that need to be reviewed," he said. The creation of a single national panel, he added, was dismissed in favor of keeping existing ones and giving them local autonomy.
References1. Centers for Disease Control and Prevention. Recommendations for preventing transmission of HIV and hepatitis B virus to patients during exposure-prone invasive procedures. MMWR 1991; 40(No.RR-8):1-9.
2. Rober L, Chamberland M, Cleveland J, et al. Investigations of patients of health care workers infected with HIV. Ann Intern Med 1995; 122:653-657.
3. Harpaz R, Von Seidlein L, Averhoff F, 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.
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