JSTOR

HBV

SHEA recommends that HBV‐infected healthcare providers who test either positive for HBV “e” antigen (HBeAg) or negative for HBeAg but who have circulating HBV burdens of greater than or equal to 10⁴ genome equivalents (GE) per milliliter of blood routinely use double‐gloving for all invasive procedures, for all contact with mucous membranes or nonintact skin, and for all instances in patient care for which gloving is recommended, and that they not perform those Category III activities identified as associated with a risk for provider‐to‐patient HBV transmission despite the use of appropriate infection control procedures (details of the procedures identified as associated with increased risk for transmission are given in Table 2).

SHEA recommends that a healthcare provider who has a circulating HBV burden of less than 10⁴ GE/mL be allowed to perform those Category III activities identified as associated with a risk for provider‐to‐patient transmission of bloodborne pathogens, so long as the infected provider (1) is not detected as having transmitted infection to patients; (2) obtains advice from an Expert Review Panel (the function of the Expert Review Panel is discussed in more detail in Recommendation 8, below) about continued practice; (3) undergoes follow‐up routinely by Occupational Medicine staff (or an appropriate public health official), who test the provider twice per year to demonstrate the maintenance of a viral burden of less than 10⁴ GE/mL; (4) also receives follow‐up by a personal physician who has expertise in the management of HBV infection and who is allowed by the provider to communicate with the Expert Review Panel about the provider’s clinical status; (5) consults with an expert about optimal infection control procedures (and strictly adheres to the recommended procedures, including the routine use of double gloving for Category II and Category III procedures and frequent glove changes during procedures, particularly if performing technical tasks known to compromise glove integrity [eg, placing sternal wires]); (6) agrees to the information in and signs a contract or letter from the Expert Review Panel that characterizes her or his responsibilities (discussed in more detail in Recommendation 8, below).

HCV

SHEA recommends that HCV‐infected providers who have circulating HCV viral burdens of greater than or equal to 10⁴ GE/mL routinely use double‐gloving for all invasive procedures, for all contact with mucous membranes or nonintact skin, and for all instances in patient care for which gloving is routinely recommended, and that they not perform those Category III activities identified as associated with a risk for provider‐to‐patient transmission of bloodborne pathogen infection despite the use of appropriate infection control procedures. SHEA also recommends that an HCV‐infected provider who has a viral burden of less than 10⁴ GE/mL not be excluded from any aspect of patient care, including the performance of Category III procedures (Tables 1 and 2), so long as the infected provider (1) is not detected as having transmitted infection to patients; (2) obtains advice from an Expert Review Panel about continued practice; (3) undergoes follow‐up routinely by Occupational Medicine, who tests the provider twice annually to demonstrate the maintenance of a viral burden of less than 10⁴ GE/mL; (4) also receives follow‐up by a personal physician who has expertise in the management of HCV infection and who is allowed by the provider to communicate with the Expert Review Panel about the provider’s clinical status; (5) consults with an infection control expert about optimal infection control procedures (and strictly adheres to the recommended procedures, including the routine use of double‐gloving during Category II and Category III procedures and frequent glove changes during procedures, particularly if performing technical tasks known to compromise glove integrity [eg, placing sternal wires]); 6) agrees to the information in and signs a contract or letter from the Expert Review Panel that characterizes her or his responsibilities (discussed in more detail in Recommendation 8, below).

HIV

SHEA recommends that HIV‐infected providers who have circulating HIV viral burdens of greater than or equal to GE/mL routinely use double‐gloving for all invasive procedures, for all contact with mucous membranes or nonintact skin, and for all instances in patient care for which gloving is recommended, and that they not perform those Category III activities identified as associated with a risk for provider‐to‐patient transmission of bloodborne pathogen infection despite the use of appropriate infection control procedures (Tables 1 and 2). SHEA recommends that an HIV‐infected provider who has a viral burden of less than GE/mL not be excluded from any aspect of patient care, including the performance of Category III procedures, so long as the infected provider (1) is not detected as having transmitted infection to patients; (2) obtains advice from an Expert Review Panel about continued practice; (3) undergoes follow‐up routinely by Occupational Medicine (or an appropriate public health official), who tests the provider twice annually to demonstrate the maintenance of a viral burden of less than GE/mL; (4) also receives follow‐up by a personal physician who has expertise in the management of HIV infection and who is allowed by the provider to communicate with the Expert Review Panel about the provider’s clinical status; (5) consults with an expert about optimal infection control procedures (and strictly adheres to the recommended procedures, including the routine use of double‐gloving for Category II and Category III procedures and frequent glove changes during procedures, particularly if performing technical tasks known to compromise glove integrity [eg, placing sternal wires]); and (6) agrees to the information in and signs a contract or letter from the Expert Review Panel that characterizes her or his responsibilities (discussed in more detail in Recommendation 8, below).

General Recommendations

The rationale for these recommendations is presented below (in the section Background and Rationale). SHEA argues for comprehensive education concerning bloodborne pathogens for all healthcare providers and trainees. SHEA recommends managing infected providers in the context of a comprehensive approach to the management of all impaired providers. SHEA emphasizes the importance of patient safety as well as provider privacy and medical confidentiality. The Society also emphasizes the importance of offering employees who have disabilities reasonable accommodation for their disabilities. The guideline discusses exposure management in detail and, in general, recommends adherence to existing guidelines for managing exposures to these viruses. SHEA underscores that practitioners who are institutionally based and who develop one of these bloodborne pathogen infections are ethically bound to report their infections to their institutions’ occupational medicine providers and to engage in the processes outlined below. Further, practitioners who are not institutionally based and who develop one of these bloodborne pathogen infections are ethically bound to engage their public health departments (consonant with state and local laws), as described below. Finally, the society encourages routine voluntary, confidential testing of providers, emphasizing that providers who conduct Category III procedures should know their immune or infection status with respect to each of these 3 bloodborne pathogens. Specific details and the rationale for these recommendations are included in the body of the guideline.

Provider‐to‐Patient Transmission of HBV

With respect to HBV transmission, through 1994, investigators at the Centers for Disease Control and Prevention (CDC) had identified 42 instances of provider‐to‐patient transmission of HBV (375 patients).¹¹ Subsequently, 2 additional clusters of provider‐to‐patient transmission of HBV infection were reported that involved surgeons who tested positive for HBeAg.^12,13

In one of these more recent clusters, 4 patients acquired clinical hepatitis B infection from an orthopedic surgeon following surgeries conducted by the infected provider.¹³ In a second, more recent cluster, 19 of the 144 susceptible patients whose surgical team included an HBV‐infected thoracic surgery resident became infected.¹² No specific events or breaks in technique were identified in either cluster that could explain the transmissions, although the thoracic surgery resident did not wear double gloves. Since 1996, there have been an additional 10 reports of hepatitis B transmission from providers to patients. These cases have generally been associated with HBV‐infected surgeons; one case was associated with an infected dentist^14,15 (I. Williams, CDC, personal communication). An important report from the United Kingdom underscored the potential for transmission from providers who are infected with so‐called “pre‐core” mutants of HBV.¹⁴ Such providers are HBeAg negative but have a high circulating viral burden. This report¹⁴ underscores the importance of directly measuring viral burden, as opposed to assaying for surrogate markers of viral burden (such as HBeAg). Only one relatively recent report is from North America: in this large outbreak, 75 patients were infected from procedures involving placement of subdermal electroencephalogram electrodes by an HBeAg‐positive technician.¹⁶ Although infection control procedures in this electroencephalography clinic were deemed inadequate, no specific mechanism for transmission was identified.

Although such clusters continue to occur (acknowledging that the United States does not have systemic surveillance measures to detect such cases), they appear to be occurring less frequently than in the past. In contrast, the problem of patient‐to‐patient transmission of HBV and HCV arising from inadequate infection control precautions, such as reuse of multidose vials of medication, has become increasingly important as a cause of iatrogenic bloodborne pathogen infection.¹⁷

Provider‐to‐Patient Transmission of HCV

Provider‐to‐patient transmission of HCV has been extremely uncommon in the United States and has had a reasonably unique epidemiology in this county. Conversely, transmission of HCV from infected providers has been somewhat more frequently detected in Europe (Table 3). As noted above, for all of these pathogens, provider‐to‐patient transmission of HCV is extremely unlikely in the course of routine (ie, noninvasive) patient care. The risk for provider‐to‐patient transmission of HCV appears to be even smaller than the risk for HBV transmission in the course of noninvasive patient care, presumably because most individuals chronically infected with HCV have circulating viral loads that are orders of magnitude lower than those of the hepatitis B carriers who have been identified as transmitting infection to their patients.

Table 3.  Summary of Reports of Provider‐to‐Patient Hepatitis C Virus Transmission from the United Kingdom

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Several instances of provider‐to‐patient transmission of HCV have been reported in the literature.^18‐32 The first documented instance of provider‐to‐patient transmission of HCV was reported from England in 1995 (Table 3).²³ A patient who had undergone cardiac surgery developed acute HCV infection and had no risk factors for infection. The first assistant surgeon on the operative team was found to be infected with HCV. A “look‐back” study of the patients for whom the surgeon had provided care revealed that only one of the surgeon’s 278 patients developed HCV infection with a strain identical to the surgeon’s.²¹ During the time the UK investigation was in process, an additional instance of provider‐to‐patient transmission of HCV was reported from Spain.²² The detection of 2 unexpected cases of HCV infection among cardiac surgery patients participating in a study of transfusion‐transmitted infections prompted a look‐back study of the patients of a chronically HCV‐infected surgeon. The Spanish look‐back study identified an additional 4 HCV infections (ie, totaling 6 [2.7%] of the 222 patients who had been operated on by the surgeon).²² Five of the 6 HCV strains isolated from these patients were closely related to the strain isolated from the surgeon, and each of these patients had undergone valve replacement surgery.²²

An HCV‐infected gynecologist in the UK transmitted infection to several patients. After a single patient became infected after a gynecological procedure,^24,33 a detailed look‐back study tested more than 4,500 patients, of whom 3,628 had undergone “high risk, exposure‐prone procedures” that were performed by the surgeon in the previous 20 years. Seven additional patients were found to have HCV infection caused by strains of HCV closely related to the strain recovered from the surgeon (Table 3).²⁶

Ross and coworkers²⁸ from Germany reported the results of a look‐back study of 207 of the 229 patients operated on by an HCV‐infected orthopedic surgeon. Three of the 207 were found to be HCV infected, but only 1 (a patient who had undergone a total hip arthroplasty with trochanteric osteotomy) was infected with a strain that was similar to the strain recovered from the HCV‐infected orthopedist.²⁸ Subsequently, these same investigators also conducted a look‐back study of the patients of an HCV‐infected obstetrician/gynecologist. The look‐back study was prompted by the detection of an unanticipated instance of HCV infection in a patient who had undergone a cesarean delivery. This patient was found to be infected with an HCV strain that was virtually identical to the strain infecting the obstetrician/gynecologist who had performed the procedure.²⁹ The investigators screened 2,286 of the obstetrician/gynecologist’s 2,907 patients and found no further evidence of transmission.²⁹

Three additional patient‐to‐provider look‐back studies involving the potential for transmission of HCV from healthcare worker to patient have been reported from the United Kingdom (Table 3).^27,34,35 In the first of these studies, 3 infections (among 1,900 patients) were attributed to an HCV‐infected provider. In the second, 1 infection was found among 749 patients of an HCV‐infected provider.³⁵ In the third, a look‐back study has been reported as being initiated in the United Kingdom, although no results from the study have been published;²⁷ letters were sent to 228 patients of an HCV‐infected practitioner offering follow‐up testing, after an index case was identified as linked to the practitioner following an “exposure‐prone” procedure.

Several reports involve HCV‐infected anesthesiologists. In the United Kingdom,³¹ an HCV‐infected anesthesiologist infected a patient during a procedure in which the anesthesiologist endotracheally intubated the patient, inserted a peripheral venous catheter, and provided general anesthesia. He did not participate in any procedure considered to be “exposure‐prone.” The anesthesiologist vehemently denied injection drug use³¹; however, in several similar cases described below, drug diversion was implicated as the cause of bloodborne pathogen transmission.

Ross and colleagues³⁶ reported a cluster of 5 cases of HCV infection from an anesthesia assistant. The anesthesia assistant purportedly acquired acute HCV infection as a result of an occupational exposure to an HCV‐infected patient in the operating room (presumably, by contaminating an open wound on a finger of his right hand). This assistant may have presented an increased risk for transmission, since he was working while developing acute HCV infection and before having a detectable immunologic response at a time when his viral burden was likely high. In the course of 3 weeks (during which his finger was purportedly still weeping) he infected 5 patients. He vehemently denied drug abuse, but the similarity of this case to the case described by Sehulster and colleagues³⁷ (discussed below) is striking. An important feature of this cluster is the fact that the anesthesia assistant did not follow universal/standard precautions. He did not wear gloves (even when he had the open lesion on his right hand). Ross and colleagues³⁶ suggest that if the anesthesia assistant had followed universal/standard precautions, these infections would have likely been prevented.

In another highly unusual case, a child acquired HCV infection from his mother, who was functioning as his healthcare provider.³⁸ The child was a hemophiliac whose mother administered his frequently required clotting‐factor concentrate infusions. The mother (who had chronic HCV infection) did not wear gloves and recalled several instances in which she stuck her own finger with the needle (often with her own blood visible). Sequence analysis demonstrated that the HCV isolates from the mother and the child were identical.³⁸

For reasons that are not certain, look‐back studies from the United Kingdom have found substantially more cases of transmission. Grouping the various studies from the United Kingdom yields a transmission rate of 0.19% (15 patients infected of 7,656 patients tested) without inclusion of index cases, and 0.26% with the inclusion of index cases. In contrast, studies from Germany have found no additional cases of transmission among more than 3,000 people tested, beyond the index cases that prompted the look‐back studies. However, if one includes the index cases, the transmission rate for these studies is 0.13% (similar to the rate for the studies from the United Kingdom).

The experience in the United States is quite different. Injection drug use on the part of the infected provider appears to play a more central role in provider‐to‐patient HCV transmission. Williams and colleagues³⁹ recently reviewed the US experience, noting that 4 episodes of transmission have been detected. The first involved an HCV‐infected surgical technician who infected approximately 40 of 346 patients during a 3‐month period.^37,39 This healthcare provider admitted self‐injecting anesthesia medications and then using the same syringe to administer drugs to patients. The second involved an anesthesiologist who acquired HCV infection from one patient and subsequently, during the anesthesiologist’s acute phase of infection, transmitted the same strain of HCV to a patient; no further transmissions were identified. This anesthesiologist was also suspected to be abusing narcotics.^20,39 The third case of HCV transmission is more similar to those seen in the United Kingdom. An HCV‐infected cardiac surgeon was found to have infected as many as 14 of the 937 patients who could be evaluated from over a decade of surgical practice.³⁹ Narcotics abuse was not suspected. Interestingly, following an expert review of the surgeon’s practice, the surgeon was treated for his HCV infection and was allowed to continue to practice; he continued to perform cardiovascular procedures that would by any measure be considered exposure‐prone. He made modifications to his technique, including the use of double gloves and other safety devices, and in addition, his patients were prospectively tested for HCV infection; to date no additional instances of transmission have been detected. The fourth report describes a certified registered nurse anesthetist who transmitted HCV to at least 15 of 164 patients during a 4‐month period coinciding with the acute phase of his own HCV infection. The certified registered nurse anesthetist did not perform exposure‐prone procedures and a specific mechanism of transmission was not identified; however, similar to the first 2 cases, the nurse anesthetist was suspected of abusing patient medications.³⁹ A fifth instance of provider‐to‐patient transmission of HCV in the United States is currently under investigation, but the details are not yet available (J. Perz, CDC, personal communication).

Although the precise mode of transmission for HCV for the majority of these cases remains unknown, the circumstances surrounding several of the cases suggest that transmission was associated with percutaneous exposures. Clearly, at least in the United States, a number of the instances of provider‐to‐patient HCV transmission have been associated with diversion of patients’ drugs to healthcare providers who were abusing injectable narcotics. Although the contribution of injection drug use to provider‐to‐patient transmission of HCV has been most noticeable in the United States, 2 additional cases, one from Spain, the other from Israel, underscore its potential importance. In the cluster of cases from Spain, an anesthesiologist who was addicted to opiates was diverting some of patients’ narcotics for personal use and then injecting the patients with the same syringe that he had used, thereby infecting more than 200 patients.^18,40 In the report from Israel, an injection drug–using anesthesiologist infected 33 patients by diverting some patients’ drugs to himself and then using the same apparatus for injecting the drugs into the patient.³² Detection of underlying injection drug use in these circumstances is difficult, at best, so one cannot say for certain the extent to which this behavior may have influenced the other cases reported in the literature.

Summarizing the world literature and excluding those reports in which injection drug use was considered to be a contributing factor for transmission, there were 2 gynecologists, 3 cardiac or thoracic surgeons, 1 anesthesiologist, and 1 orthopedic surgeon involved in the instances of transmission. These data lend credence to the hypothesis that “exposure‐prone, invasive procedures” are likely to pose the largest risk for provider‐to‐patient transmission of HCV.

Provider‐to‐Patient Transmission of HIV

In the 25 years since HIV was first isolated, only 4 instances of HIV transmission from infected health care workers to 1 or more patients have been reported.^3‐8^,41‐45 One cluster of infections occurred in the United States in 1990;^3‐8 2 cases occurred in France,^41,42,44,45 and 1 instance of transmission occurred in Spain.⁴³

The US cluster involved a dentist who had acquire immune deficiency syndrome (AIDS); 6 of his patients became HIV infected. Their HIV isolates were linked to his, both epidemiologically and by DNA sequencing.^3‐8 A thorough investigation by the CDC and viral phylogeny findings suggested practitioner‐to‐patient spread, though the precise mechanism or mechanisms of transmission were not determined. Although the dentist was a patient in his own practice, no infection control deficiencies were identified that would readily explain HIV transmission to the 6 patients. Additionally, the dentist did not recall occupational injuries that could have created an opportunity for cross‐contamination. Despite substantial speculation, no data were uncovered suggesting intentional transmission.

The second instance of provider‐to‐patient HIV transmission involved an orthopedic surgeon in France who transmitted HIV to 1 patient. Transmission was confirmed through DNA sequence analysis of viral isolates obtained from the surgeon and the patient.^42,45 The surgeon was not aware of his infection until surveillance case definition AIDS was diagnosed. French investigators initiated a look‐back study of the surgeon’s 3004 patients since 1983. Investigators successfully contacted 2458 patients and performed HIV serologic tests on 983. One patient was found to have acquired HIV infection. This patient had 3 procedures performed by the surgeon, had a negative HIV serology before undergoing the first of the 3 procedures, and was found to be infected with HIV when she underwent testing before the third procedure.^42,45 The authors of the manuscript speculated that both the extended length of the initial procedure (10 hours) and the high likelihood that the surgeon had a high viral burden (since he had far advanced, untreated disease) contributed to the transmission. No breaches in recommended infection‐control practices were identified in retrospect.

The third episode of provider‐to‐patient HIV transmission also was detected in France. In this unusual case, transmission of HIV is suggested to have occurred from an infected nurse to a patient, although no clear mechanism for transmission could be identified.⁴⁴ The investigators conducted a look‐back study focusing on 7,580 patients for whom the infected nurse had provided care. They were able to locate 5,308 patients, and they serologically tested 2,293.⁴¹ No additional infections were identified. The nurse was coinfected with HCV and had both a high HIV viral burden and advanced HCV‐induced hepatic disease, including clotting abnormalities. HCV was apparently not transmitted to the patient, but the HIV isolates from patient and provider were closely related. The nurse was unaware of either viral infection, though she became symptomatic enough to require hospitalization within 2 weeks of the date on which transmission was thought to have occurred. She denied injection drug use.

The fourth case occurred in Spain; a woman was infected with HIV by her obstetrician/gynecologist during cesarean delivery. Spanish officials conducted a look‐back evaluation of the physician’s patients. Of 275 patients on whom the practitioner had performed procedures, 250 could be tested, and none were found to be infected.⁴³

More than 4 dozen look‐back studies have been conducted evaluating the HIV antibody status of patients retrospectively identified as having received medical or dental care from an HIV‐infected practitioner^5,46‐57 (Lisa Panlilio, CDC, personal communication). None of these studies identified transmission of HIV infection. To our knowledge, only the report from France described above, in which an orthopedic surgeon infected one of his patients, identified iatrogenic transmission of HIV in a look‐back study.^42,45 In the United Kingdom, no cases of HIV transmission from a healthcare worker to a patient have been detected, despite 28 patient notification exercises and testing of more than 11,000 patients between 1988 and 2006 (F. Ncube, MD, Health Protection Agency Centre for Infections, United Kingdom, personal communication). One unusual cluster of patient‐to‐patient HIV transmission in a surgical practice in Australia has been described in the literature;⁵⁸ however, the practitioner providing the care was not infected.

HBV

The previous version of this SHEA guideline¹⁰ relied on the presence of HBeAg as a surrogate marker of infectivity and did not consider direct measurement of the HBV DNA viral burden in making recommendations about practice restrictions. One major advance since the publication of the previous guideline is the recognition that presence of HBeAg is not a sensitive marker for HBV infectivity. Indeed, several instances of provider‐to‐patient transmission of HBV have involved providers who were infected with strains of HBV that did not produce HBeAg (so‐called “pre‐core” mutants).^14,107 The use of HBeAg as a surrogate marker for infectivity has been effectively replaced by molecular tests that measure a patient’s circulating viral burdens with precision. A third major advance is the availability of antiviral medications and other approaches to treat HBV infection. The past decade has seen the development of treatment strategies that, for the first time, offer some hope of reducing patients’ viral burdens, and also of producing durable remissions, if not cures. The US Food and Drug Administration has approved 7 antiviral agents (interferon‐α, peg interferon, lamivudine, telbivudine, adefovir, tenofovir, and entecavir) for the treatment of chronic hepatitis B in the United States; others (eg, emtricitabine and clevudine) are currently under evaluation. Of patients who received monotherapy with one of the approved agents for 1 year, 14%–30% became negative for HBeAg, and 21%–67% developed undetectable HBV DNA levels.¹⁰⁸ The role of combination therapies is at too preliminary a stage to judge their efficacy; however, some studies have suggested that therapy with combinations of some of the newer nucleoside and nucleotide analogues (eg, truvada) are superior, or preferable, to monotherapy for patients who have HBeAg or high circulating levels of HBV DNA.¹⁰⁸ Although the evidence base for the use of antiviral and/or immunological therapy for hepatitis B is not yet fully adequate (ie, current therapy for chronic hepatitis B infection most often does not eradicate HBV and most studies demonstrate limited long‐term efficacy), the role of therapy, the impact on the potential transmission risk, and the impact on practice restrictions have not yet been fully investigated.

HCV

As is the case with HBV, in the past decade we have gained more sophistication and precision in our ability to measure the circulating viral burdens of patients infected with HCV. In addition, new antiviral agents and combinations of agents have been employed with increasing success to treat individuals who have acute and chronic HCV infection. A National Institutes of Health Consensus Development Conference and 2 academic professional societies have published congruent treatment guidelines for individuals who are chronically infected with HCV.^109‐112 These guidelines emphasize that individuals who have chronic hepatitis C infection who are 18 years of age or older, have detectable HCV RNA in serum, and evidence of chronic hepatitis (either elevated serum alanine aminotransferase levels or active hepatitis and/or fibrosis) should be treated, assuming they are willing to participate in the therapy and that there are no contraindications to the use of the indicated antiviral agents. Also of importance are the several published studies that suggest that acute HCV infection can be treated with nearly 100% success.^113‐116 Whether these recommendations might apply to HCV‐infected practitioners who want to be able to perform exposure‐prone invasive procedures (whether or not they have evidence of chronic hepatitis) is not addressed in this guideline.

HIV

Substantial progress also has been made for HIV. Tests to monitor HIV RNA viral load are now routine, and highly active antiretroviral therapy has been routinely given for more than a decade. None of the existing guidelines have incorporated treatment of the infected practitioner into the decision about practice restriction for HIV‐infected providers who wish to continue performing exposure‐prone invasive procedures.

HBV

Existing US guidelines, published in 1991 and not, to date, ever revised,¹⁰⁵ recommend that “healthcare providers who perform exposure‐prone procedures and who do not have serologic evidence of immunity to HBV from vaccination or from previous infection should know their HBsAg status and, if that is positive, should also know their HBeAg status. If infected with HBV (and HBeAg positive) providers 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. Such circumstances would include notifying prospective patients of the healthcare worker’s seropositivity before they undergo exposure‐prone invasive procedures.”¹⁰⁵

Several countries have issued modified guidelines for the management of HBV‐infected providers based on the infected provider’s circulating viral burdens. Unfortunately, the evidence base for these recommendations is minuscule, and the existing recommendations are quite disparate.

In the United Kingdom, HBV‐infected providers who are HBeAg positive may not conduct exposure‐prone invasive procedures; HBV‐infected providers who are HBeAg negative but have HBV DNA levels of greater than 10³ GE/mL may not conduct exposure‐prone invasive procedures; and HBV‐infected providers who are HBeAg negative and have HBV DNA levels of less than 10³ GE/mL may conduct exposure‐prone invasive procedures but must be retested at least every 12 months to ensure that the level of viremia remains below 10³ GE/mL.¹²¹ More recently, authorities in the United Kingdom have also recommended¹²² that HBV‐infected healthcare providers who are HBeAg negative and who have pretreatment HBV DNA levels of 10³–10⁵ GE/mL could be allowed to perform exposure prone procedures if they are receiving suppressive oral antiviral therapy and if their viral loads have decreased to below 10³ GE/mL. The major challenge associated with this latter recommendation is the development of an effective monitoring strategy to make certain that the circulating viral burden remains less than 10³ GE/mL.¹²² The availability of various testing systems further complicates monitoring.

A European consortium was convened to create recommendations for HBV‐infected providers and reached slightly different conclusions.¹²³ In their recommendations, HBV‐infected providers who are HBeAg positive are instructed that they may not perform exposure‐prone procedures.¹²³ HBV‐infected providers who are HBeAg negative but have HBV DNA levels of less than 10⁴ GE/mL may conduct exposure‐prone invasive procedures but must be retested at least annually to make certain that the circulating viral burden remains below 10⁴ GE/mL.¹²³ These guidelines also emphasize that providers who are detected as having transmitted HBV should not perform exposure‐prone procedures, and HBV‐infected providers who have been treated and whose posttreatment DNA levels have fallen to less than 10⁴ GE/mL may conduct exposure‐prone procedures but must be retested every 3 months to ensure that the viral burden remains below 10⁴ GE/mL.¹²³

Scientists from the Netherlands published a third set of recommendations suggesting that HBV‐infected providers who have HBV DNA levels of less than 10⁵ GE/mL may conduct exposure‐prone invasive procedures, but must be retested at least annually.¹²⁴

In a thoughtful analysis, van der Eijk et al¹²⁵ listed the challenges to standardizing recommendations for practice restrictions for HBV‐infected providers, emphasizing that guidelines have to strike a balance between excluding providers unnecessarily and patient safety. More recently, the Viral Hepatitis Prevention Board, a European consortium whose mission is to contribute to the control and prevention of viral hepatitis, convened a meeting of international experts from the public and private sectors to try to harmonize these recommendations.¹²⁶ This meeting identified a number of issues that the contributors felt needed to be addressed before development of standardized recommendations, and consensus could not be achieved.¹²⁶ Included in this list of issues are the following: (1) the variability of HBV DNA levels among chronically infected individuals; (2) the paucity of data linking levels of viremia to risk for transmission; (3) the variable reliability and reproducibility of the molecular tests used to measure HBV DNA, as well as the variability between the differing test systems; (4) the lack of standardization among the different tests used to detect HBV DNA; and (5) the variability and durability of therapeutic antiviral effects and, specifically, the length of time viremia can be effectively suppressed before “escape” mutant viruses emerge.

HCV

No US Public Health Service guidelines address the management of providers infected with HCV, including the 1991 CDC recommendations.¹⁰⁵The UK guidelines¹⁰⁹ are quite proscriptive regarding hepatitis C, stating that HCV‐infected providers who have circulating HCV RNA may not conduct exposure‐prone invasive procedures. Further, trainees found to have circulating HCV RNA should be restricted from starting training in exposure‐prone invasive procedures.¹²⁷ The UK guidelines also address treatment, noting that HCV‐infected providers who have circulating HCV RNA who receive antiviral treatment and become HCV RNA negative for a period of 6 months can be permitted to return to performing exposure‐prone invasive procedures but must be retested in 6 months to confirm the durability of the response.¹⁰⁹

The European Consortium could not reach consensus about the management of HCV‐infected providers, concluding that “on balance it is not recommended that exposure‐prone procedures be forbidden for HCV‐infected healthcare workers.”¹²³ Similarly, the scientists from the Netherlands addressed only HBV infection, and did not discuss HCV‐infected providers.¹²⁴ Furthermore, the findings of the Viral Hepatitis Prevention Board with respect to HBV (eg, variable HBV DNA levels, paucity of data linking levels of viremia to risk for transmission, variable rates of reliability and reproducibility of molecular tests used to measure HBV DNA, variability and lack of standardization of the differing test systems, variability and durability of therapeutic antiviral effects, and length of time viremia can be effectively suppressed before “escape” mutant viruses emerge) also apply to individuals chronically infected with HCV.

HIV

The UK guidelines¹¹⁷ recommend restriction of the practice of HIV‐infected providers.¹⁰⁵ The US guidelines recommend that HIV‐infected practitioners, “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. Such circumstances would include notifying prospective patients of the HCW’s seropositivity before they undergo exposure‐prone invasive procedures.”¹⁰⁵ Neither guideline bases recommendations on the clinical status of the infected provider or on the viral burden of the HIV‐infected provider.

1. Should healthcare providers who are infected with HBV be allowed to practice? If so, under what clinical, serological, or viral burden parameters?

Discussion. We have chosen a cut‐off of 10⁴ GE/mL to separate providers who can and cannot perform Category III procedures. 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. As noted above, one modeling experiment suggested that the most common types of exposure to a provider who had a viral burden of 10⁴ GE/mL would be associated with an exposure to less than 1 virion.¹⁰⁰ In addition to that modeling experiment, another important piece of evidence that supports this threshold is the fact that, in all of the instances of transmission from an HBeAg‐negative provider to a patient in which the source provider’s viral burden has been measured, the implicated provider had a circulating viral burden in excess of 10⁴ GE/mL,¹²³ except in one case,¹⁴¹ and the validity of that one case has been questioned, because the sample was taken from the provider more than 3 months after the transmission occurred.¹²⁴ Setting the cutoff for the circulating HBV viral burden at 10³ GE/mL would have resulted in restricting the practices of 58% of the HBV‐infected providers in the United Kingdom and nearly 95% of such providers in the Netherlands.¹²⁶

These guidelines suggest a cutoff of 10⁴ GE/mL and allow an individual who has a circulating viral load of less than 10⁴ GE/mL to continue to conduct Category III procedures as long as the individual (1) is not detected as having transmitted infection to patients; (2) obtains advice from an Expert Review Panel about continued practice; (3) undergoes follow‐up routinely by Occupational Medicine staff (or an appropriate public health official), who tests the provider twice per year to demonstrate the maintenance of a viral burden of less than 10⁴ GE/mL; (4) also receives follow‐up by a personal physician who has expertise in the management of HBV infection and who is allowed by the provider to communicate with the Expert Review Panel about the provider’s clinical status; (5) consults with an infection control expert about optimal infection control procedures (and strictly adheres to the recommended procedures, including the routine use of double‐gloving for Category II and Category III procedures, use of puncture‐resistant gloves, use of blunted surgical needles,^86,97‐99 use of “hands‐free” technique,¹⁴² and other work practice controls, among many others); and (6) agrees to the information in and signs a contract or letter from the Expert Review Panel that characterizes her or his responsibilities (discussed in more detail in Recommendation 8, below). If a provider is receiving treatment for this infection, the efficacy of the treatment should be considered in the context of the specific infection being treated. In general, because of their very high viral burdens, providers who have acute HBV infection and those who have HBV infection in the absence of immunological responses should not perform Category III procedures. Providers whose infections have resolved and who have no evidence of circulating virus should not be restricted in any way.

Individuals relying on these guidelines must keep in mind that each such case must be evaluated on its own merit and that the molecular testing strategies discussed in the document are subject to several limitations. These include (1) the fact that infected individuals’ HBV DNA levels may vary over time, (2) there are limited scientific data linking levels of viremia to risk for transmission, (3) the fact that the different currently marketed test for measuring HBV viral burden may produce variable results (4) the varying level of reproducibility of these molecular tests, (5) the fact that antiviral therapy may produce transient or limited responses (particularly with respect to monotherapy for HBV), and (6) the variety of virological and patient‐related factors (eg, adherence to the recommended antiviral regimen) that may contribute to the development of “escape” mutants. SHEA underscores that these guidelines are, of necessity, malleable and modifiable as more information becomes available.

Antiviral therapy clearly reduces the circulating HBV viral burden to levels below acceptable cutoff values.¹⁴³ Since, to date, therapies have been suppressive and not curative, this approach is associated with the clear possibility of antiviral agent–related toxicity, as well as the theoretical possibility of fostering resistance among viruses from the infected provider. The effect of therapy should be considered carefully by the Occupational Medicine physician and the Expert Review Panel, as well as by the provider’s personal physician who has expertise in the management of HBV infection.

2. Should healthcare providers who are infected with HCV be allowed to practice? If so, under what clinical, serological or viral burden parameters?

Discussion. These guidelines recommend that HCV‐infected healthcare providers who have circulating viral burdens of less than 10⁴ GE/mL not be restricted from any aspect of health care so long as the infected provider follows the detail of the recommendation. Specifically, the provider must be willing to consult with, and follow the recommendations of, an infection control expert. The infected provider must strictly adhere to the recommended procedures (eg, routine use of double‐gloving for Category II and III procedures, frequent glove changes during procedures, particularly if performing technical tasks known to compromise glove integrity [eg, placing sternal wires], use of puncture‐resistant gloves, blunted surgical needles,^86,97‐99 “hands‐free” technique^142,144 and other work practice controls, among many others). Finally, the infected provider must agree to the information in, and sign, a contract or letter from the Expert Review Panel that characterizes her or his responsibilities. One might have easily argued for no restrictions whatsoever for HCV‐infected providers, on the basis of the experience in the United States alone.

The selection of a practice‐restriction‐threshold of 10⁴ GE/mL is arbitrary, but, as noted above (in the section Legal Issues), some European guidelines have taken a far more restrictive tack. Because there have been virtually no such cases in the United States, we have, nonetheless, chosen a conservative cutoff for restricting practitioners. We have recommended practice restrictions for providers who perform Category III procedures whose viral burdens are 10⁴ GE/mL or greater. We have based this decision on the in vitro HBV data cited above (in the section Pathogenesis and Transmission Risk), as well as the clinical experience with patient‐to‐provider transmission of HCV in the United Kingdom. In addition, we note that therapy for HCV is becoming increasingly effective, so that many providers who are identified as infected with HCV can have their infections eradicated. Studies of the efficacy of the treatment of acute HCV infection often demonstrate cure rates in excess of 95%, with studies of the treatment of chronically infected individuals demonstrating cure rates of up to 70% or 80%, particularly for individuals infected with a treatment‐favorable genotype.^145‐147

Individuals relying on these guidelines must keep in mind that each such case must be evaluated on its own merit and that the molecular testing strategies discussed in the document are subject to several limitations. These include (1) the fact that infected individuals’ HCV RNA levels may vary over time, (2) the paucity of scientific data linking levels of viremia to risk for transmission, (3) the fact that the different currently marketed test for measuring HCV viral burden may produce variable results, (4) the varying level of reproducibility of these molecular tests, (5) the fact that antiviral therapy may produce transient or limited responses, and (6) the variety of virological and patient‐related factors (eg, adherence to the recommended antiviral regimen) that may contribute to the development of “escape” mutants. SHEA underscores that these guidelines are, of necessity, malleable and modifiable as more information becomes available.

3. Should healthcare providers who are infected with HIV be allowed to practice? If so, under what clinical, serological or viral burden parameters?

Discussion. These guidelines recommend that HIV‐infected healthcare providers who have circulating viral burdens of less than GE/mL not be restricted from any aspect of health care, so long as the infected provider follows the detail of the recommendation. Specifically, the provider must be willing to consult with, and follow the recommendations of, an infection control expert. The infected provider must strictly adhere to the recommended procedures, (eg, routine use of double‐gloving for Category II and III procedures; frequent glove changes during procedures, particularly if performing technical tasks known to compromise glove integrity [eg, placing sternal wires]; use of puncture‐resistant gloves blunted surgical needles,^86,97‐99 and “hands‐free” technique,^142,144 and other work practice controls, among many others). Finally, the infected provider must agree to the information in, and sign, a contract or letter from the Expert Review Panel that characterizes her or his responsibilities.

As is the case for our recommendations for HBV‐infected practitioners and HCV‐infected practitioners, we acknowledge that the selection of a practice‐restriction‐threshold of GE/mL is arbitrary; however, as noted above (in the section on Legal Issues), European guidelines have taken a far more restrictive tack. Because no provider‐to‐patient transmissions of HIV infection have been detected in the United States since the initial cases involving the Florida dentist (discussed in more detail in the sections Epidemiology and Current Published Guidelines, above), we have chosen to recommend permitting an HIV‐infected practitioner to conduct Category III procedures if his or her viral burden is suppressed below GE/mL. We chose GE/mL as the threshold, in part, because individuals who typically have their viral burdens suppressed to the “undetectable” range (generally <50 copies/mL) occasionally have levels that spike to GE/mL, despite ongoing effective antiretroviral therapy. We have recommended practice restrictions for a provider who performs Category III procedures and has a viral burden of GE/mL or greater. Because this recommendation represents a substantial departure from other similar guidelines, we have recommended a relatively low threshold for restriction. Since data do not exist to provide evidence for the most appropriate threshold, this lower threshold was selected solely on the basis of opinions of the committee that drafted this guideline. This threshold should be revisited on a regular basis and modified on the basis of additional accumulating experience. Our committee also noted that highly active antiretroviral therapy is continuing to improve to the point that most HIV‐infected providers can have their infections suppressed to this level or below. SHEA underscores that these guidelines are, of necessity, malleable and can be modified as more information becomes available.

Individuals relying on these guidelines must keep in mind that each such case must be evaluated on its own merit and that the molecular testing strategies discussed in the document are subject to several limitations. These include (1) the fact that infected individuals’ circulating HIV levels may vary over time, (2) the paucity of scientific data linking levels of viremia to risk for transmission, (3) the fact that the different currently marketed test for measuring viral burden may produce variable results, (4) the current variability in the level of reproducibility of these molecular tests, (5) the fact that antiviral therapy may produce transient or limited responses, and (6) the variety of virological and patient‐related factors (eg, adherence to the recommended antiviral regimen) that may contribute to the development of “escape” mutants. In general, because of their very high viral burdens, providers who are experiencing the HIV seroconversion illness should not perform Category III procedures.

4. For providers who are infected with HBV, HCV, and/or HIV and who have circulating viral burdens greater than the recommended cutoff values, which procedures should they be precluded from performing?

Discussion. Historically, the concept of “exposure‐prone” procedures has been a point of controversy, though several more recent guidelines and manuscripts have suggested that “exposure‐prone” procedures can be defined.^{1,109,117,121} In the previous version of this guideline, SHEA suggested that “exposure‐prone” procedures might be defined as those that have been “epidemiologically implicated” in patient‐to‐provider transmission. This approach has proved to be flawed; for example, one recent case‐cluster of provider‐to‐patient transmission of HBV suggested that the implantation of electroencephalography electrodes was implicated in the transmission of HBV.¹⁶ No guideline would include implantation of electroencephalography electrodes as an “exposure‐prone” procedure. Some authorities have suggested that providers, rather than procedures, might be exposure‐prone, suggesting that technical expertise and experience may play a more substantive role in the risk for provider‐to‐patient exposure, rather than the procedures themselves. We favor a modification of the approach taken by Reitsma et al¹; namely, 3 tiers of procedural risk (Table 2). Most guidelines do not consider the impact of the introduction of safer devices and safer work practice controls to the risk calculus for infections with these 3 pathogens. As noted above in the section Pathogenesis and Transmission Risk, the use of reinforced gloves,^91,92 double gloves, glove‐liners, or other devices or materials to protect the provider’s hands,^89,91,93‐96 and use of blunted suture needles,^86,97‐99 as well as a variety of other safer devices and work practices, have been shown to decrease the risks for percutaneous injuries. The members of the committee drafting this guideline emphasized that the consistent use of safety devices by a practitioner should be one factor considered by the Expert Review Panel when deciding about practice restrictions. Some members of the committee felt that consistent use of these procedures and techniques might move some procedures from Category III to Category II for individual practitioners.

5. If restricted from performing certain types of procedures, should providers who are infected with HBV, HCV, and/or HIV be restricted on the basis of (A) clinical status, (B) laboratory parameters of disease activity and/or progression (and, if so, at what specific “set‐points” for each infection), and/or (C) clinical performance (eg, technical skill or lack of adherence to important infection control procedures); and if so, who measures and who decides, and what are the criteria for restriction?

Discussion. SHEA recommends that restrictions should be based on various combinations of these data. Anyone clearly implicated in the transmission of one of these organisms should become the subject of scrutiny. The factors listed above (ie, clinical status, laboratory parameters, and clinical performance) all contribute to the assessment of the individual’s ability to practice safely. This ongoing assessment is one of the important roles that should be assumed by the Expert Review Panel (discussed in detail in Recommendation 8, below). The expert review panel and the occupational medicine physician should also consider the possibility of narcotics diversion in the transmission of these infections. Providers identified as acutely infected with any of these pathogens should be carefully evaluated for viral burdens and should engage the expert review panel through their occupational medicine and/or public health practitioners.

6. Should students, residents, fellows, and other trainees who are infected with HBV, HCV, and/or HIV be discouraged from entering certain specialties and/or subspecialities? How and by whom should these decisions be made?

Discussion. A special problem arises when a training institution becomes aware that a trainee is chronically infected with a bloodborne pathogen. Each of these instances should be handled on a case‐by‐case basis, in consultation with the institution’s legal counsel, the house staff training director, infection control professionals, the Dean of the school, and others who are involved stakeholders. To date, these cases have been handled unevenly across the United States, with some institutions focusing on the disability‐law aspects and others focusing on liability.⁹⁰ The law concerning these issues is changing rapidly and is relatively untested in the higher courts. The institution, however, does have responsibility to make certain that the trainee is fully informed about the risks—both to the trainee and to his or her patients—associated with clinical practice. The institution should underscore the importance of appropriate treatment and the importance of adherance to infection control recommendations. The institution should assist the trainee in selecting a career path best suited to her or his specific situation and should provide reasonable accommodation to students and trainees who have disabling conditions. By adopting the modification of the position initially proffered by Reitsma et al¹ (ie, the 3‐tiered risk schema), SHEA advocates encouraging trainees who are infected with HBV, HCV, and/or HIV and whose infection(s) cannot be effectively cleared or whose infections cannot be suppressed below the thresholds identified in Recommendations 1, 2, and 3 (above), to select career paths that do not involve the highest‐risk procedures. In instances in which the decision is made to continue training, SHEA advocates having the student be closely supervised by an attending provider who is aware of the student’s status when the student is learning or performing Category II procedures.

7. Should providers infected with HBV, HCV, and/or HIV be subject to specific monitoring programs, and, if so, how and by whom and to whom should the data be reported?

Discussion. Because the guidelines recommend viral burden cutoffs for practice restrictions, SHEA believes that an ongoing monitoring program is essential. Most molecular assay results are reproducible only within about half an order of magnitude. A fraction of infected individuals have fluctuating viral burdens. SHEA recommends a major role for the Occupational Medicine practitioner in supervising the monitoring program. This role would include, but not be limited to, measuring the provider’s circulating viral burden at least twice annually and providing advice to the Expert Review Panel about the provider’s progress and ongoing clinical status. For independent practitioners working only from an office, these functions should be fulfilled by the city, county or state health department (consonant with state and local laws). Elements of follow‐up are summarized in Table 5.

Table 5.  Functions of the Expert Review Panel

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8. Prior recommendations have suggested the creation of an Expert Review Panel for assisting institutions in managing providers infected with bloodborne pathogens. Is there a role for such a panel in 2009 and beyond? If so, what is that role, and at what level should the committee be convened (eg, at the institutional, city, or state level), who should comprise such a committee, what should be the committee’s charge, and how and by whom should the committee be managed? Do committee members accept liability for participation?

Recommendation

Healthcare providers infected with HBV, HCV, and/or HIV should have their clinical status and laboratory data reviewed by an Expert Review Panel (A‐III). Such a panel could exist at a state, regional, county, city, or institutional level, consonant with the individual provider’s circumstance and with state and local laws. The review panel should include, but not necessarily be limited to, individuals who have expertise in the infected provider’s specialty or subspecialty, Healthcare Epidemiology, Infectious Diseases or Hepatology (specifically with expertise in the bloodborne pathogen[s] being discussed), Occupational Medicine, and/or hospital administration; the infected provider’s physician; a public health official (in states in which this issue is managed at the state level); a human resources professional; and, perhaps, an individual with legal and/or ethics expertise. The review panel will advise the healthcare provider, the Occupational Medicine physician, and/or the patient’s primary physician about the provider’s practice and about the advisability of her or his performing Category III procedures, as well as about the use of infection control interventions (A‐III). The panel will create a contract or letter detailing the provider’s responsibilities and those of the panel (Figure 1). Before the provider returns to practice, this document must be agreed to and signed by the provider and the panel chair (A‐III). The panel should reconsider the provider’s performance in the event any of the following occurs: the provider's viral load increases to above the recommended level for consideration of restrictions from performing Category III procedures; the provider develops another contagious disease (eg, tuberculosis); the provider develops another condition that might adversely effect patient safety (eg, HIV‐associated neurological impairment or hepatic encephalopathy); the provider fails to strictly adhere to recommended infection control practices; a patient is exposed to a potentially contaminated body fluid of the provider; and/or if there is evidence of provider‐to‐patient transmission (A‐III). The entity chartering the panel should indemnify the panel members against any legal risks and/or costs (A‐III).

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Figure 1.  Sample contract letter between an Expert Review Panel and a healthcare provider infected with a bloodborne pathogen. The letter delineates the specific recommendations of the panel and the responsibilities of the panel and of the infected provider. Table 7 provides more detail on the elements of such a letter or contract.

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Discussion. SHEA believes that the creation of an Expert Review Panel to assist in the management of these providers is an important aspect of a patient safety program. Such a program could exist at a state, county, city or institutional level. We believe that the fact that no such cases have received publicity in the United States since the early part of this decade is an indirect reflection of the efficacy of this approach. The basic functions of the Expert Review Panel are described in Table 5. The panel, at a minimum, should include representation from Hospital Epidemiology, Infectious Diseases, the provider’s specialty or subspecialty, Occupational Medicine (ie, the individual involved in monitoring the provider), hospital administration, and, perhaps, legal representation. Each case will be slightly different from the next, and each should be considered independently in context. These subtle differences underscore the importance of the Expert Review Panel. The panel should develop a formal letter or contract delineating its specific recommendations regarding the provider’s performance, training in infection control, conduct of specific procedures, follow‐up, and management, among other issues (Figure 1). Table 6 provides a list of issues for the infection control professional and the Expert Review Panel to consider when providing advice to infected providers regarding the performance of various procedures. Table 7 provides detail concerning the elements of this letter or contract. The requirement for a twice‐annual meeting of the panel may be met by a confidential conference call or secure electronic communication. The Occupational Medicine physician, the infection control professional, and/or the state epidemiologist can serve as gatekeepers for the twice‐annual review. So long as the contract is being fulfilled and no guideline violations are identified, additional face‐to‐face meetings of the Expert Review Panel may not be needed. In instances in which guideline violations are identified or in instances in which the provider’s clinical status has changed significantly, the entire review panel should meet to consider the new information. The committee emphasizes that the Expert Review Panel should not advise the practitioner about his or her health and treatment options; this responsibility falls to the provider’s personal physician.

Table 6.  Issues for the Hospital Epidemiologist and the Expert Review Panel to Consider When Providing Advice to Infected Healthcare Providers Regarding the Performance of Various Procedures

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Table 7.  Elements of the Contract between an Infected Healthcare Provider and the Expert Review Panel

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9. Are there any medical settings in which a healthcare provider infected with HBV, HCV, and/or HIV should be routinely required to notify patients of his or her bloodborne pathogen status; and, if so, what are the specific types of circumstances requiring notification?

Discussion. Societal views of patients’ rights are strong, and most patients feel that they have a right to know if their physician or other healthcare provider is infected with a potentially transmissible bloodborne pathogen (irrespective of the magnitude of risk).^118,148,149 A national survey conducted in 2004 demonstrates little change in public views of this issue.¹¹⁸ Case law has generally concluded that informed consent includes disclosure of risks that may be perceived by patients as being important even if, by rational consideration, they are negligible. These positions aside, in both previous versions of this guideline, we concluded that a requirement for such disclosure would very likely require a provider to abandon or substantially modify his or her practice—an unwarranted outcome in light of our current understanding of the risks for provider‐to‐patient transmission of these bloodborne pathogens. The existing 1991 US Public Health Service guidelines¹⁰⁵ require that patients who are to have “exposure‐prone invasive procedures” performed by HIV‐positive or HBeAg‐positive, HBV‐infected practitioners be notified of the practitioner’s infection status prior to the procedure. On the basis of the substantial changes in the risk profile since the previous version of this guideline was published (eg, new safety devices, new infection control strategies, better techniques for monitoring diseases, effective postexposure management, and effective therapy), SHEA feels even more strongly that such a position is unwarranted. If practitioners adhere to the components of this guideline with respect to modifying their practices when an increased level of risk is present, in the absence of an adverse patient exposure to blood or blood‐containing body fluids (discussed in Recommendation 11, below), the risk for provider‐to‐patient transmission is so small that it cannot be accurately measured. SHEA’s position on these issues remains essentially unchanged. An earlier iteration of the American Hospital Association Patients' Bill of Rights argues for disclosure of relevant information to patients,^150,151although this “Bill of Rights” has subsequently been replaced by a plain‐language document that does not directly address this issue. The American Medical Association Council on Judicial Affairs also includes a general statement in favor of patient disclosure.¹⁵²

10. Are there circumstances for which an infected healthcare provider should be required to obtain informed consent that includes disclosure of the provider’s serostatus from a patient prior to a procedure?

Discussion. If a practitioner adheres to the guidelines outlined in detail above, SHEA concludes that the risk for transmission would be so small that informed consent about the risk of transmission would not be required. In special circumstances associated with a known or anticipated increased level of risk (eg, a provider who has previously transmitted infection to a patient or a provider who has a viral burden in excess of those listed in these guidelines is performing a Category III procedure), obtaining informed consent is rational, prudent, and advised.

11. How should a provider‐to‐patient blood exposure or other hazardous body fluid exposure to HBV, HCV, and/or HCV be managed?

11A. Should a provider who is the source of a patient exposure be required to undergo testing for bloodborne pathogen infection?

Discussion. State laws and State policies and procedures vary substantially with respect to testing for bloodborne pathogens. Healthcare institutions electing to develop policies that compel testing of the source individual should make certain that such polices are legal in their jurisdictions and should apply such policies only to exposures for which scientific precedent establishes that HBV, HCV, or HIV transmission could occur.

11B. Should an inadvertently exposed patient be notified of the exposure?

Discussion. For a variety of reasons, in instances in which a provider‐to‐patient blood exposure occurs, the patient has a right to know that the exposure has occurred, irrespective of whether the provider is known to be infected with a bloodborne pathogen. The patient must be notified about the exposure and presented with options for postexposure treatment (as appropriate), as well as appropriate follow‐up.^153,154 In addition, the patient must receive counseling about the risk for transmission and the strategies that are effective in preventing subsequent transmission of the bloodborne pathogen to which the patient was exposed. Since any exposure to blood may place patients at risk for acquiring a bloodborne infection, patients should always be notified of such occurrences. The identity of the source (ie, the infected provider) should not be disclosed. Needlestick transmissions (as well as mucous membrane and nonintact‐skin transmissions) of HBV, HCV, and HIV infection have all been amply documented. Since negative serologic test results do not completely eliminate the possibility of transmission of bloodborne pathogens, any blood exposure creates a requirement for notification of the exposed patient. Notification also allows the exposed patient to have the option of receiving recommended postexposure management (eg, appropriate chemoprophylaxis or immunoprophylaxis). Institutions should designate a responsible person for informing an exposed patient and ensuring patient follow‐up. Ultimate responsibility for follow‐up should be assigned to the patient’s physician, even if the physician is the source of the exposure. The physician providing the follow‐up should receive expert guidance from a member of the Infection Control and/or Occupational Health staff. SHEA would not recommend that the source of the exposure be involved in counseling, informed consent, or test explanation, in light of the potential for conflict of interest. The hospital epidemiologist, infection control practitioner, or other staff knowledgeable both about the risks and routes of transmission of bloodborne pathogens, as well as the counseling of individuals exposed to bloodborne pathogens, should be available for support and consultation.

11C. Should an inadvertently exposed patient be required to undergo baseline serologic testing?

Discussion. Although the exposed patient cannot be compelled to have and may clearly choose not to have such testing performed, such testing would help establish the basis (and some of the best evidence) for a claim against the institution and/or the practitioner. Exposed patients should be made aware of the potential value and detriment of negative and positive test results. For patients who refuse testing (and consonant with state and local laws regarding testing), institutions should attempt to obtain informed consent from the patient to allow the institution to preserve a carefully labeled and dated baseline serum sample from the exposed patient. Although such samples cannot be tested against the patient’s will, these samples ultimately represent important evidence in such a case. Patients refusing to consent to serum storage should be asked to sign a form noting their declination for both serologic testing and serum storage.

11D. How (and by whom) should an inadvertently exposed patient be followed and, if appropriate, treated?

12. Should any, or perhaps all, providers be routinely tested for HIV infection?

13. If an infected provider is identified, under what circumstances should a look‐back study be conducted?

Discussion. Although look‐back studies may occasionally provide useful information, most look‐back studies have yielded no useful information, and all such investigations are extremely labor‐intense and resource‐intense.^48,57 SHEA recommends that such studies be conducted only when factors are identified that suggest an increased risk for provider‐to‐patient transmission of one of these bloodborne pathogens.

A variety of circumstances may prompt initiation of a look‐back study. These include (1) if an infected healthcare worker is identified during the investigation of a possible instance of healthcare‐associated transmission of one of these viruses, (2) if provider‐to‐patient transmission infection is documented or presumed, (3) if there is disclosure of a bloodborne pathogen infection associated with a viral burden higher than the thresholds defined in Recommendations 1, 2, and 3 (above), by a healthcare worker who has been conducting Category III procedures, or (4) if an ongoing screening program identifies an infected healthcare worker who has been conducting Category III procedures and who has a viral burden in excess of the thresholds noted in Recommendations 1, 2, and 3 (above). The goals for such an investigation include (1) the provision of information to patients regarding the nature and magnitude of risks to which they may have been exposed, (2) the identification of patients who may have become infected with one or more of these bloodborne pathogens as a result of healthcare interventions and who may benefit from treatment, (3) the prevention of additional instances of transmission, (4) the management of institutional risks, and (5) the reassurance of the public.

The decision about whether to conduct a look‐back study should be made on a case‐by‐case basis. Factors that would suggest an increased risk for provider‐to‐patient transmission that would prompt such a study include (1) identification of an infected patient in the practice of an infected provider (and the demonstration of that the patient’s and the provider’s viral isolates are related), (2) the healthcare provider’s clinical specialty and the types of procedures performed are among those associated with increased risk for transmission, (3) concern that a given provider fails to follow recommended infection control procedures, (4) evidence of substandard clinical practice (eg, high postoperative infection rates or frequent occupational exposures), and (5) comorbid medical diagnoses in the infected provider that might elevate risk (eg, conditions resulting in, for example, nonintact skin or early dementia).

The identification of a documented instance of provider‐to‐patient transmission of one of these 3 bloodborne pathogens should invariably result in a thorough look‐back exercise. In the absence of a documented instance of provider‐to‐patient transmission, the Expert Review Panel should evaluate the risk for transmission on a case‐by‐case basis. If a look‐back study is implemented, every effort should be made to preserve the privacy and medical confidentiality of the infected provider.

In instances in which the infected provider is institutionally based, the provider’s institution should be responsible for the notification program, with appropriate collaboration with the local and state public health authorities. In instances in which the provider is not institutionally based, local or state public health authorities should decide about the need for such a study. If the decision is made to initiate such a study, the decision should be made, and the study conducted, by the appropriate public health authorities.