SHEA: Test viral load of infected staff

Risk of transmission of HIV, HBV, HCV addressed

[Editor's note: This is the first part of a two-part series on a new guideline from the Society for Healthcare Epidemiology of America (SHEA) regarding health care providers who are infected with hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). In this issue, we give you an overview of what the guideline did and did not include, which procedures are at greatest risk of transmission to patients, and the recommendations for infected staff. In next month's issue, we discuss how to decide which workers to test and further explain the new guideline.]

Do some health care workers infected with HIV or hepatitis B virus (HBV) or hepatitis C virus (HCV) pose a risk to their patients? Should they be restricted from performing exposure-prone procedures?

A new guideline from 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 virus 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 health care providers to comply with institutional policies and procedures designed to protect patients. 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 provider, SHEA notes in the guideline. Providers infected with bloodborne pathogens should seek ongoing care and treatment. Restrictions may be justifiably imposed when a health care 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 health care workers' practice rights. With advances in the treatment and prophylaxis of HBV, HCV and HIV, there are new opportunities for policies that protect patient and health care worker, she notes. It is essential for surgeons to be fully engaged with the policy process, she says.

Reference

  1. Henderson DK, Dembry L, Fishman NO, et al. SHEA guideline for management of health care workers who are infected with hepatitis B virus, hepatitis C virus, and/or human immunodeficiency virus. Infect Control Hosp Epidemiol2010; 31:203-232.

Resource

HCV viral levels said 'arbitrary'

The new guideline from the Society for Healthcare Epidemiology of America (SHEA) regarding the management of health care providers who are infected with hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) drew criticism 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 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. Fishman 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.1

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 (HBeAg) "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.2

"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%.3

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.

References

  1. Perry JL, Pearson RD, and Jagger J. Infected health care workers and patient safety: A double standard. Am J Infec Control2006; 33:299-303.
  2. Incident Investigation Teams and others. Transmission of hepatitis B to patients from four infected surgeons without hepatitis B e antigen. N Engl J Med1997; 336:178–184.
  3. Centers for Disease Control and Prevention. Recommendations for preventing transmission of human immunodeficiency virus and hepatitis B virus to patients during exposure-prone invasive procedures. MMWR 1991; 40:1–9. Available at www.fda.gov. Accessed on March 18, 2010.

No mandate for staff testing?

The new guideline from the Society for Healthcare Epidemiology of America (SHEA) regarding the management of health care providers who are infected with hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) 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. SHEA and the 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."1

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 operating room than any other hospital locale and 24% of all injuries are from suture needles. (www.healthsystem.virginia.edu.) 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 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. Fishman is also associate professor of medicine in the Division of Infectious Diseases at the University of Pennsylvania.

"It's critical that the various institutions have mechanisms in place to survey adherence to safe practices by all providers," he says.

Janine Jagger, PhD, MPH, director of the International Health Care Worker Safety Center at the University of Virginia in Charlottesville, favors a proactive approach to the issue.

"It all hinges on accurate reporting of percutaneous injuries during surgical procedures. Institutions need to develop mandatory reporting policies specifically for the OR with rigorous administrative checks," Jagger says. "Only then will patients benefit from the same post-exposure protocol that is offered by law to blood-exposed healthcare workers."

Reference

  1. Centers for Disease Control and Prevention. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR 2006; 55:1-17.

SHEA identifies invasive, exposure-prone cases

A New Society for Healthcare Epidemiology of America (SHEA) guideline for health care workers infected with bloodborne viruses include the following procedures at greatest risk of transmission to patients. They are Category III: Procedures for which there is definite risk of bloodborne virus transmission or that have been classified previously as "exposure-prone":

  • general surgery, including nephrectomy, small bowel resection, cholecystectomy, subtotal thyroidectomy other elective open abdominal surgery;
  • general oral surgery, including surgical extractions, hard and soft tissue biopsy (if more extensive and/or having difficult access for suturing), apicoectomy, root amputation, gingivectomy, periodontal curettage, mucogingival and osseous surgery, alveoplasty or alveoectomy, and endosseous implant surgery guideline on health care workers (HCWs) infected with hepatitis B virus (HBV), hepatitis C virus (HCV), and/or HIV;
  • cardiothoracic surgery, including valve replacement, coronary artery bypass grafting, other bypass surgery, heart transplantation, repair of congenital heart defects, thymectomy, and open-lung biopsy;
  • open extensive head and neck surgery involving bones, including oncological procedures;
  • neurosurgery, including craniotomy, other intracranial procedures, and open-spine surgery;
  • non-elective procedures performed in the emergency department, including open resuscitation efforts, deep suturing to arrest hemorrhage, and internal cardiac massage;
  • obstetrical/gynecological surgery, including cesarean delivery, hysterectomy, forceps delivery, episiotomy, cone biopsy, and ovarian cyst removal, and other transvaginal obstetrical and gynecological procedures involving hand-guided sharps
  • orthopedic procedures, including total knee arthroplasty, total hip arthroplasty, major joint replacement surgery, open spine surgery, and open pelvic surgery;
  • extensive plastic surgery, including extensive cosmetic procedures (e.g., abdominoplasty and thoracoplasty);
  • transplantation surgery (except skin and corneal transplantation);
  • trauma surgery, including open head injuries, facial and jaw fracture reductions, extensive soft-tissue trauma, and ophthalmic trauma;
  • interactions with patients in situations during which the risk of the patient biting the physician is significant, such as interactions with violent patients or patients experiencing an epileptic seizure;
  • any open surgical procedure with a duration of more than three hours, probably necessitating glove change.

Source: Henderson DK, Dembry L, Fishman NO, et al. SHEA guideline for management of health care workers who are infected with hepatitis B virus, hepatitis C virus, and/or human immunodeficiency virus. Infect Control HospEpidemiol 2010; 31:203-232.


Infected HCWs should agree to IC training

According to a new guideline from the Society for Healthcare Epidemiology of America (SHEA), the following recommendations apply to health care workers infected with HIV or hepatitis B or C:

  • Responsibilities of the health care provider.
  1. Agrees to twice yearly follow-up by occupational medicine, including measurement of viral burden using tests specified by the panel.
  2. Agrees to twice yearly evaluations by a private physician who has expertise in the provider's specific bloodborne pathogen infection and agrees to have this physician discuss the results of these evaluations with the provider's Expert Review Panel.
  3. Agrees to formal training in infection control via a course identified by the infection control expert, or, alternatively agrees to counseling by the infection control professional concerning the use of appropriate infection control procedures, safety devices and work practice controls.
  4. Agrees to follow the recommended procedures and practices identified in the previous item (responsibility 3).
  5. Agrees to notify the occupational medicine or the public health authority participating in the panel regarding any change in provider status that may increase risk to the patient (e.g., new neurological findings, development of another contagious disease [e.g., tuberculosis]).
  6. Acknowledges the ethical obligation to do so, and agrees to report instances immediately in which a patient exposure may have occurred to the hospital epidemiologist or to appropriate institutional/public health authorities identified in the contract, so that the potentially exposed patient may receive appropriate post-exposure management and counseling.
  7. If receiving treatment, agrees to continue treatment as prescribed and agrees to notify occupational medicine if the treatment regimen is modified for any reason.
  8. Agrees to re-evaluation by expert panel and revision of contract should clinical status or viral burden change.
  • Responsibilities of the institution and/or public health authorities.
  1. Agrees to convene Expert Review Panel at least twice annually (see text) to assess provider's clinical and virologic status as well as the provider's ongoing performance and her or his ability to continue to perform requested procedures.
  2. Agrees to maintain provider's medical privacy and confidentiality.
  3. Agrees to develop and follow institutional or provider-based follow-up procedure for potential patient exposure that makes every effort to ensure practitioner confidentiality.
  4. Panel participants should have no liability.
  5. Develops process for notifying hospital risk management.