infection control and hospital epidemiology march 2010, vol. 31, no. 3 s h e a g u i d e l i n e SHEA Guideline for Management of Healthcare Workers Who Are Infected with Hepatitis B Virus, Hepatitis C Virus, and/or Human Immunodeficiency Virus David K. Henderson, MD Louise Dembry, MD, MS, MBA Neil O. Fishman, MD Christine Grady, RN, PhD Tammy Lundstrom, MD, JD Tara N. Palmore, MD Kent A. Sepkowitz, MD David J. Weber, MD, MPH for the Society for Healthcare Epidemiology of America From the National Institutes of Health Clinical Center, Bethesda, Maryland (D.H.), the Department of Quality Improvement Support Services, Yale���New Haven Hospital, New Haven, Connecticut (L.D.), the Division of Infectious Diseases, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania (N.F.), the Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland (C.G.), the Section of Infectious Diseases, Providence Hospital and Medical Center, Southfield, Detroit, Michigan (T.L.), the Infectious Disease Fellowship Training Program, National Institutes of Health Clinical Center, Bethesda, Maryland (T.P.), Infectious Diseases Service, Memorial Sloan-Kettering Cancer Center, New York, New York (K.S.), and the Division of Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina (D.W.). Note: A statement about authorship appears at the end of the text. Received November 10, 2009 accepted November 23, 2009 electronically published January 20, 2010. 2010 by The Society for Healthcare Epidemiology of America. All rights reserved. 0899-823X/2010/3103-0001$15.00. DOI: 10.1086/650298 executive summary This guideline provides the updated recommendations of the Society for Healthcare Epidemiology of America (SHEA) re- garding the management of healthcare providers who are infected with hepatitis B virus (HBV), hepatitis C virus (HCV), and/or the human immunodeficiency virus (HIV). For the reasons cited in the guideline, SHEA continues to recommend that, although some aspects of the approach to and administrative management of each of these infectious syndromes in healthcare providers are similar, separate man- agement strategies for healthcare workers who are infected with these unrelated viruses remain appropriate. As we did in both prior iterations of this document, SHEA emphasizes the use of appropriate infection control procedures to min- imize exposure of patients or providers to blood, emphasizes that transfers of blood from patients to providers and from providers to patients should be avoided, and recommends that infected healthcare providers should not be totally pro- hibited from participating in patient-care activities solely on the basis of a bloodborne pathogen infection. The types of procedures assessed by the panel as associated with an in- creased risk for provider-to-patient transmission of these pathogens are discussed in detail. For each pathogen, rec- ommendations are graduated according to the relative viral load level of the infected provider (Tables 1 and 2). However, SHEA emphasizes that, because of the complexity of these cases, each such case will be slightly different from the next, and each should be independently considered in context. 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 non- intact 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 ap- propriate infection control procedures (details of the pro- cedures identified as associated with increased risk for trans- mission 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 blood- borne pathogens, so long as the infected provider (1) is not detected as having transmitted infection to patients (2) ob- tains advice from an Expert Review Panel (the function of the Expert Review Panel is discussed in more detail in Rec- ommendation 8, below) about continued practice (3) un- dergoes follow-up routinely by Occupational Medicine staff (or an appropriate public health official), who test the pro- vider 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 man- agement 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

204 infection control and hospital epidemiology march 2010, vol. 31, no. 3 table 1. Summary Recommendations for Managing Healthcare Providers Infected with Hep- atitis B Virus (HBV), Hepatitis C Virus (HCV), and/or Human Immunodeficiency Virus (HIV) Virus, circulating viral burden Categories of clinical activitiesa Recommendation Testing HBV !104 GE/mL Categories I, II, and III No restrictionsb Twice per year x104 GE/mL Categories I and II No restrictionsb NA x104 GE/mL Category III Restrictedc NA HCV !104 GE/mL Categories I, II, and III No restrictionsb Twice per year x104 GE/mL Categories I and II No restrictionsb NA x104 GE/mL Category III Restrictedc NA HIV !5#102 GE/mL Categories I, II, and III No restrictionsb Twice per year x5#102 GE/mL Categories I and II No restrictionsb NA x5#102 GE/mL Category III Restrictedd NA note. These recommendations provide a framework within which to consider such cases however, each such case is sufficiently complex that each should be independently considered in context by the expert review panel (see text). GE, genome equivalents NA, not applicable. a See Table 2 for the categorization of clinical activities. b No restrictions recommended, so long as the infected healthcare 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 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 the recommended threshold (see text) (4) also receives follow-up by a personal physician who has expertise in the management of her or his 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 (see text). c These procedures permissible only when viral burden is !104 GE/mL. d These procedures permissible only when viral burden is !5# GE/mL. 102 if performing technical tasks known to compromise glove integrity [eg, placing sternal wires]) (6) agrees to the infor- mation 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 proce- dures, 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 in- fection despite the use of appropriate infection control pro- cedures. SHEA also recommends that an HCV-infected pro- vider who has a viral burden of less than 104 GE/mL not be excluded from any aspect of patient care, including the per- formance of Category III procedures (Tables 1 and 2), so long as the infected provider (1) is not detected as having trans- mitted 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 pro- vider 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 man- agement 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 con- trol 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

guideline on hcws infected with hbv, hcv, and/or hiv 205 GE/mL routinely use double-gloving for all invasive 2 5 # 10 procedures, for all contact with mucous membranes or non- intact 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 in- fection despite the use of appropriate infection control pro- cedures (Tables 1 and 2). SHEA recommends that an HIV- infected provider who has a viral burden of less than 5 # GE/mL not be excluded from any aspect of patient care, 2 10 including the performance of Category III procedures, so long as the infected provider (1) is not detected as having trans- mitted 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 2 5 # 10 physician who has expertise in the management of HIV in- fection 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 tech- nical 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 char- acterizes 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 comprehen- sive 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��� occu- pational medicine providers and to engage in the processes outlined below. Further, practitioners who are not institu- tionally based and who develop one of these bloodborne path- ogen infections are ethically bound to engage their public health departments (consonant with state and local laws), as described below. Finally, the society encourages routine vol- untary, 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. introduction In 1990, in response to public and professional concern that arose in the wake of a highly publicized cluster of cases of provider-to-patient transmission of the human immunodefi- ciency virus (HIV) in a Florida dentist���s practice,3-8, SHEA, in collaboration with the Association for Practitioners in In- fection Control, published a position paper concerning the administrative management of healthcare providers who are infected with certain bloodborne pathogens.9 As additional information became available, in 1997 SHEA issued an up- dated position paper discussing the management of health- care workers infected with hepatitis B virus (HBV), hepatitis C virus (HCV), HIV, or other bloodborne pathogens.10 The purpose of the present guideline is to provide updated guid- ance from SHEA regarding the administrative management of providers infected with these bloodborne pathogens, given the progress in the field since 1997. Despite the widespread use of the hepatitis B vaccine, HBV remains the most commonly transmitted bloodborne path- ogen in the healthcare setting. Although continued wide- spread administration of the vaccine should eventually mit- igate this risk, any guideline for the years 2009 and beyond must include recommendations for HBV-infected providers. Similarly, the past 12 years��� experience has provided insight in the factors influencing the risk for provider-to-patient transmission of HCV. Because we do not have a hepatitis C vaccine yet, and, with the prevalence of HCV infection rising around the world, this flavivirus is likely to become the most frequently transmitted bloodborne pathogen in health care in the years ahead. Provider-to-patient transmission of HIV has been extremely rare, with no cases reported worldwide since 2003. Nonetheless, the first instance of transmission of HIV from an infected provider to a patient was the driving force for the creation of guidelines and recommendations about providers infected with bloodborne pathogens. This document provides updated information about each virus and the healthcare risks associated with infected prac- titioners and then addresses a series of questions relevant to the management of providers infected with each of these viruses. We then make recommendations about the manage- ment of providers infected with these bloodborne pathogens, citing the available evidence supporting the recommenda- tions. The evidence base for these recommendations is limit- ed at best. By the very nature of the topics being discussed, di- rect hypothesis-driven experimentation is virtually impossi- ble, and may be complicated further by a low rate of voluntary

table 2. Categorization of Healthcare-Associated Procedures According to Level of Risk for Bloodborne Pathogen Transmission Category I: Procedures with de minimis risk of bloodborne virus transmission ��� Regular history-taking and/or physical or dental examinations, including gloved oral examination with a mirror and/or tongue depressor and/or dental explorer and periodontal probe ��� Routine dental preventive procedures (eg, application of sealants or topical fluoride or administration of prophylaxisa), diagnostic procedures, orthodontic procedures, prosthetic procedures (eg, denture fabrication), cosmetic procedures (eg, bleaching) not requiring local anesthesia ��� Routine rectal or vaginal examination ��� Minor surface suturing ��� Elective peripheral phlebotomyb ��� Lower gastrointestinal tract endoscopic examinations and procedures, such as sigmoidoscopy and colonoscopy ��� Hands-off supervision during surgical procedures and computer-aided remote or robotic surgical procedures ��� Psychiatric evaluationsc Category II: Procedures for which bloodborne virus transmission is theoretically possible but unlikely ��� Locally anesthetized ophthalmologic surgery ��� Locally anesthetized operative, prosthetic, and endodontic dental procedures ��� Periodontal scaling and root planingd ��� Minor oral surgical procedures (eg, simple tooth extraction [ie, not requiring excess force], soft tissue flap or sectioning, minor soft tissue biopsy, or incision and drainage of an accessible abscess) ��� Minor local procedures (eg, skin excision, abscess drainage, biopsy, and use of laser) under local anesthesia (often under bloodless conditions) ��� Percutaneous cardiac procedures (eg, angiography and catheterization) ��� Percutaneous and other minor orthopedic procedures ��� Subcutaneous pacemaker implantation ��� Bronchoscopy ��� Insertion and maintenance of epidural and spinal anesthesia lines ��� Minor gynecological procedures (eg, dilatation and curettage, suction abortion, colposcopy, insertion and removal of contraceptive devices and implants, and collection of ova) ��� Male urological procedures (excluding transabdominal intrapelvic procedures) ��� Upper gastrointestinal tract endoscopic procedures ��� Minor vascular procedures (eg, embolectomy and vein stripping) ��� Amputations, including major limbs (eg, hemipelvectomy and amputation of legs or arms) and minor amputations (eg, amputations of fingers, toes, hands, or feet) ��� Breast augmentation or reduction ��� Minimum-exposure plastic surgical procedures (eg, liposuction, minor skin resection for reshaping, face lift, brow lift, blepharoplasty, and otoplasty) ��� Total and subtotal thyroidectomy and/or biopsy ��� Endoscopic ear, nose, and throat surgery and simple ear and nasal procedures (eg, stapedectomy or stapedoto- my, and insertion of tympanostomy tubes) ��� Ophthalmic surgery ��� Assistance with an uncomplicated vaginal deliverye ��� Laparoscopic procedures ��� Thoracoscopic proceduresf ��� Nasal endoscopic proceduresg ��� Routine arthroscopic proceduresh ��� Plastic surgeryi ��� Insertion of, maintenance of, and drug administration into arterial and central venous lines ��� Endotracheal intubation and use of laryngeal mask ��� Obtainment and use of venous and arterial access devices that occur under complete antiseptic technique, using universal precautions, ���no-sharp��� technique, and newly gloved hands 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,j 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 hcws infected with hbv, hcv, and/or hiv 207 table 2. (Continued) ��� 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 ��� Nonelective 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 (eg, 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 for example, interactions with violent patients or patients experiencing an epileptic seizure ��� Any open surgical procedure with a duration of more than 3 hours, probably necessitating glove change note. Modified from Reitsma et al.1 a Does not include subgingival scaling with hand instrumentation. b If done emergently (eg, during acute trauma or resuscitation efforts), peripheral phlebotomy is classified as Category III. c If there is no risk present of biting or of otherwise violent patients. d Use of an ultrasonic device for scaling and root planing would greatly reduce or eliminate the risk for percutaneous injury to the provider. If significant physical force with hand instrumentation is anticipated to be necessary, scaling and root planing and other Class II procedures could be reasonably classified as Category III. e Making and suturing an episiotomy is classified as Category III. f If unexpected circumstances require moving to an open procedure (eg, laparotomy or thoracotomy), some of these procedures will be classified as Category III. g If moving to an open procedure is required, these procedures will be classified as Category III. h If opening a joint is indicated and/or use of power instruments (eg, drills) is necessary, this procedure is classified as Category III. i A procedure involving bones, major vasculature, and/or deep body cavities will be classified as Category III. j Removal of an erupted or nonerupted tooth requiring elevation of a mucoperiosteal flap, removal of bone, or sectioning of tooth and suturing if needed.2 reporting of both infection status and high-risk provider-to- patient transmission events. Most data that we have about this subject come from documented instances of transmis- sion. Many if not most of the conclusions from these studies are inferential. Some evidence comes from experimental lab- oratory studies or models. Thus, this guideline cannot have the scientific evidence-base found in many other guidelines. Nonetheless, we do have a broad experience working with these pathogens in the healthcare setting and the science base is much more robust than it was at the time the last guidance was published by SHEA in 1997. epidemiology Provider-to-Patient Transmission of HBV With respect to HBV transmission, through 1994, investi- gators 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 ad- ditional 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 fol- lowing 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 sur- gery resident became infected.12 No specific events or breaks in technique were identified in either cluster that could ex- plain the transmissions, although the thoracic surgery resi- dent 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 asso- ciated with HBV-infected surgeons one case was associated with an infected dentist14,15 (I. Williams, CDC, personal com- munication). 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