Volume: 24S4 - July 1998

Proceedings of the Consensus Conference on Infected Health Care Workers:
Risk for Transmission of Bloodborne Pathogens

Prepared by the
Division of Nosocomial and Occupational Infections
Bureau of Infectious Diseases
Laboratory Centre for Disease Control
Health Protection Branch
Health Canada

TABLE OF CONTENTS

Summary

Introduction

Goals, Objectives and Working Groups

The Consensus Conference Process

Exposure-prone Procedures

Risk Assessment

Methods to Reduce the Transmission of HBV, HCV or HIV from an Infected HCW to the Patient

Immunization and Screening

Referral to the Expert Panel to Assess the Risk of Transmission of HBV, HCV or HIV by the Infected HCW

Managing the Risk After an Infected HCW has Practice Modifications Imposed

Trace-back and Look-back Activities

Disclosure to Patients

Retraining and Supporting Infected HCWs

Definitions

References

Response from the Canadian Medical Association

Response from the Canadian Dental Association

Appendix 1 List of participants

The Laboratory Centre for Disease Control of Health Canada would like to extend its sincere appreciation for the support of the following sponsors: Merck Frosst Canada Inc. and SmithKline Beecham Pharma Inc.

This publication was produced by the Document Dissemination Division at the Laboratory Centre for Disease Control, Health Canada. To obtain additional copies or subscribe to the Canada Communicable Disease Report, please contact the Member Service Centre, Canadian Medical Association, 1867 Alta Vista Drive, Ottawa, ON, Canada K1G 3Y6, Tel.: 888-855-2555 or by FAX: (613) 731-9102.

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SUMMARY

The Laboratory Centre for Disease Control (LCDC) of Health Canada held a consensus conference on "Infected Health Care Workers: Risk for Transmission of Bloodborne Pathogens", on November 20-21, 1996. A wide range of opinion was sought (see Appendix 1 for a list of participants). This document represents the consensus achieved at that meeting as agreed upon by the participants at the final "consensus achieving" session.

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INTRODUCTION

In December 1992, national recommendations were published in the Canada Communicable Disease Report⁽¹⁾ (CCDR) from a national Consensus Conference and a series of meetings organized by LCDC on issues relating to the transmission of certain bloodborne pathogens (hepatitis B virus [HBV] and  human immunodeficiency virus [HIV]) from health care workers (HCWs) to patients in the health care setting. In 1995 and 1996 these recommendations were extended to hepatitis C virus (HCV). The recommendations included the following key points:

• Mandatory testing of HCWs was not justified; routine disclosure of an infected HCW's serologic status was not justified.

• HCWs with occupational or personal risk factors were encouraged to seek voluntary testing for HBV and HIV (and HCV).

• HCWs have a moral and ethical obligation to be tested following a significant exposure (see Definitions) of a patient to the HCW's blood or high-risk body fluid.

• The collaborative establishment of programs for hepatitis B vaccination of HCWs needed to be developed within provinces by government, professional associations, institutions for training in health care disciplines and health care facilities.

• Seeking medical evaluation is a fundamental ethical principle for HCWs infected with HIV or HBV (or HCV).

• Any HCW with an infectious disease that could put a patient at risk was encouraged to seek medical evaluation by the primary care physician; this physician was encouraged to seek advice on assessment of risk for transmission of infection in the health care setting through an established consultation mechanism. This mechanism was to be established, ideally, in each province. It should ensure confidentiality. It is not necessary to know the HCW's identity.

• Criteria for the evaluation of risk for transmission of a bloodborne pathogen by the HCW include medical evaluation, application of infection control practices, and risk of injury from sharp objects.

• Supportive, nonthreatening programs were to be developed through licensing and/or professional organizations.

• Invasive procedures were defined not as procedure-specific, but according to the surgical technique, environment, competence of the practitioner, exposure and patient cooperation.

Since publication of these recommendations LCDC has continued to receive enquiries from provincial and territorial departments of health, medical officers of health, HCWs and the public about whether and to what extent the practice of HCWs infected with a bloodborne pathogen should be limited. This and other repeated requests for further definition of the consultative mechanism recommended in 1992 led to the 1996 Consensus Conference.

Although it is recognized that the transmission of bloodborne pathogens from patients to HCWs is important, this was not discussed at the meeting. (For an in-depth analysis and recommendations see Infection control guidelines: preventing the transmission of bloodborne pathogens in health care and public service settings. CCDR 1997; Vol 23S3. For the postexposure protocol see An integrated protocol to manage health care workers exposed to bloodborne pathogens. CCDR 1997; Vol 23S2.)

GOALS, OBJECTIVES AND WORKING GROUPS

The goals of the Consensus Conference were as follows:

1. to understand the epidemiology of the transmission of bloodborne pathogens from infected HCWs to patients, and

2. to revise the recommendations to prevent and manage the transmission of bloodborne pathogens from HCWs to patients.

The specific objectives of the Conference were

1. to present up-to-date information on the current risk assessment and management of the transmission of bloodborne pathogens inside and outside Canada;

2. to discuss contextual factors and their relationship to the risk of transmission of bloodborne pathogens;

3. to revise, as appropriate, existing guidelines/models for risk assessment and risk management from the point of view of HWCs, consumers and responsible bodies (e.g. licensing bodies, professional associates, employers).

A number of working groups were formed to discuss the following issues:

1. risk analysis

2. immunization and screening

3. trace-back and look-back activities

4. practice modifications

5. disclosure

6. retraining and support of HCWs.

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THE CONSENSUS CONFERENCE PROCESS

Participants at the Consensus Conference were invited following their identification by stakeholder groups, professional organizations and governmental agencies. However, at the conference it was recognized that participants may have presented their personal views on an issue and not necessarily those of the organizations that selected them.

For this meeting, consensus was broadly defined as agreement that the recommendation under discussion, though not perfect, was acceptable to participants. Consensus was further clarified as being more than a simple majority; however, unanimity was not required. During the final "consensus achieving" session of the meeting, the chair declared consensus if 70% to 80% of the participants indicated, by raised hand, that they supported the recommendation under discussion and no participant expressed unyielding disagreement with the recommendation.

There were more than 70 recommendations accepted at the meeting. Although consensus was achieved for these recommendations, support for some was stronger than for others, and some disagreement existed. For example, the recommendation concerning mandatory hepatitis B immunization and subsequent mandatory testing for antibodies to determine effective immunization (or if there is no antibody response to the vaccine, for disease) was debated in depth and was supported by 70% to 80% of participants. After the meeting, the first draft of this report was reviewed by the Steering Committee, working group chairs and rapporteurs; the second draft was reviewed by all participants. During the second review, concerns about some of the recommendations were raised by the Canadian Dental Association (CDA) and the Canadian Medical Association (CMA), and these organizations requested that the report not be published. In response to their request, LCDC consulted with all the conference participants, asking their opinion about whether to publish the results of the meeting, given the concerns expressed by the CDA and CMA^*. On the basis of this consultation, Health Canada decided to publish the Consensus Conference recommendations and to provide CDA/CMA with an opportunity to respond (see pages 19 and 21).

The recommendations reflect current knowledge presented at the conference and held by participants, corroborated by a systematic review of the literature (1987 to 1997). The recommendations are subject to change in the light of future developments. They provide details on how to prevent transmission of infection from health care workers to patients as well as detailing a specific framework within which HCWs, employers, regulatory bodies, local public health agencies or occupational health services can assess and manage the risk that infected HCWs pose to patients.

Because of the complex nature of some of the recommendations it is recognized that many will require phase-in time to allow efficient, effective implementation. In addition, in order for these recommendations to be effective, HCWs must be assured that the confidentiality of the infected HCW's infection status will be protected. HCWs must also be assured that although these recommendations are designed to protect patients, decisions regarding the infected HCW's practice will not be taken without due consideration of all the factors. Finally, HCWs must be assured that, when required, a solid support system will be available to advise on the medical, psychologic, financial and professional options.

EXPOSURE-PRONE PROCEDURES

Attempts have been made by at least two other countries to proactively manage infected HCWs. In 1991 the Centers for Disease Control and Prevention (CDC) in the United States published recommendations for preventing the transmission of HIV and HBV to patients⁽²⁾. States were required by law to show that they had implemented the CDC recommendations or recommendations equivalent to them. Whether HCWs who test positive for HIV, or hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) should continue to perform exposure-prone procedures^** was left to the discretion of an expert panel. If the decision was made that they could continue with such procedures, then they were responsible for notifying their patients of their seropositivity before the procedure.

In the United Kingdom, HCWs who test positive for HIV,  HBeAg and hepatitis C virus (HCV) infection^{(3, 4)}, are required to stop performing invasive procedures^*** .

The new Canadian definition for the term "exposure-prone procedures"^**** is used for the purpose of managing the risk of bloodborne pathogens transmitted in Canada. They are procedures during which transmission of HBV, HCV or HIV from a HCW to patients is most likely to occur and includes the following:

1. digital palpation of a needle tip in a body cavity (a hollow space within the body or one of its organs⁽⁵⁾) or the simultaneous presence of the HCW's fingers and a needle or other sharp instrument or object in a blind or highly confined anatomic site, e.g. during major abdominal, cardiothoracic, vaginal and/or orthopedic operations, or

2. repair of major traumatic injuries, or

3. major cutting or removal of any oral or perioral tissue, including tooth structures, ^*****

during which there is a potential for the patient's open tissues to be exposed to the blood of an injured HCW.

Some concerns have been raised about the looseness of the definition. It is recognized that to determine every situation in which there is a significant risk of transmission of a bloodborne pathogen would be difficult, and therefore this definition is meant to provide a framework for the practitioner and/or expert panel in making an informed decision about the factors in a specific case.

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RISK ASSESSMENT

Estimated risk of transmission from a HCW infected with HBV, HCV or HIV to a patient following a significant exposure

Assessing the risk of transmission of a bloodborne pathogen by an infected HCW to a patient is the first step in planning measures to control the exposure and to decrease the incidence of transmission.

Mathematical models of risk suggest that per 1,000,000 procedures by an infected health care worker the following may occur:

1. 240-2,400 transmissions of HBV;

2. 50-500 transmissions of HCV⁽⁶⁾;  

3. 2.4 to 24 transmissions of HIV (average sporadic risk)⁽⁷⁾; however, this risk would be higher for a HCW known to have transmitted the infection at least once⁽⁶⁾.

Documented reports indicate a total of 42 HCWs in the U.S. and other developed countries who had transmitted HBV to approximately 375 patients from the 1970s to the end of 1994⁽⁸⁾. These 42 HCWs included one HBeAg positive orthopedic surgeon in Nova Scotia, who requested that his surgical privileges be withdrawn after he was linked to two cases of hepatitis B among his surgical patients⁽⁹⁾. Two other patients were subsequently linked with transmission from surgery by the same surgeon⁽¹⁰⁾.

In a hepatitis B outbreak in the Toronto area which occurred from 1992 to 1996, at least 75 people developed hepatitis B following electroencephalography with subdermal needle electrodes. The most serious complication was the death of one person who was classified as a possible case. The cause of the outbreak was attributed to poor infection control practices and an EEG technologist who was positive for HBeAg⁽¹¹⁾. Viral DNA sequencing confirmed that the HBV from the EEG technologist was identical to that of four outbreak cases for whom testing was feasible. EEG technologists are unregulated HCWs, and little information is available regarding risks in this and other unregulated service industries such as tattooing, skin piercing and electrolysis.

Recently in the U.K., 20 patients developed hepatitis B following cardiovascular surgery performed by a surgeon who was HBeAg positive⁽¹²⁾. HBV DNA sequencing was identical in 14 of the 16 cases, and in two situations differed by only one nucleotide. In addition, one HBeAg positive surgeon transmitted HBV to two patients who, in turn, transmitted the infection to their sexual partners, as confirmed by HBV DNA sequencing⁽¹³⁾. In England, four surgeons who were HBeAg negative but had pre-core stop codon mutations (genetically unable to make e antigen)⁽⁸⁾ were shown by DNA sequencing to have each transmitted the infection to one patient^{(14, 15)}. Subsequent testing identified two more transmissions from one of the surgeons. CDC does not have any reports of HBV transmission from dentists to patients since 1987, when universal precautions were implemented^{(8, 16)}. However, studies have not demonstrated a reduction in transmission of HBV from surgeons to patients since the introduction of universal precautions⁽⁸⁾.

There have been two recent reports of probable HCV transmission from HCWs to patients, which occurred during cardiothoracic surgery. In the U.K. one patient is known to have been infected by the surgeon⁽⁴⁾; in Spain five patients were infected, and the implicated source was their surgeon⁽¹⁷⁾.

HIV transmission from a HCW to patients was first documented in 1990, and involved a Florida dentist who transmitted HIV to six patients^{(18, 19)}. One patient, who was seen from 1987 to 1989, did not have dental extractions or root canal therapy and seroconverted in the absence of other risk factors. More recently, in France, HIV transmission occurred in one patient following prolonged orthopedic surgery⁽²⁰⁾.

Retrospective studies carried out for CDC as of January 1, 1995, for patients of HIV infected HCWs indicate that of the 22,171 patients treated by 51 infected HCWs (29 dentists and dental students, 8 physicians and medical students, 13 surgeons or obstetricians, and 1 podiatrist) 113 had an HIV infection, but in none of these cases was transmission documented from the infected HCW to the patient. Three investigations are still ongoing⁽²¹⁾. However, the people tested represented only 17% of the patients seen by the infected HCWs. The recently reported transmission in France⁽²⁰⁾ confirms that the risk is not hypothetical.

Three parameters of risk influencing transmission of infection from HCW to patient^{(7, 22)}

1. the risk of percutaneous exposure

The types of surgery that carry the greatest risk of transmission of bloodborne pathogens from an injured HCW to the patient include major surgical procedures,  i.e. emergency, trauma, cardiac, intravascular, gynecologic, intra-abdominal and orthopedic procedures⁽²³⁾. In these examples, injuries to the HCW may occur while he or she is working with needles, sharp instruments or wire closures. The scientific evidence available shows that HBV can be transmitted from HCWs to the patient even with full compliance with universal precautions and correct infection control procedures⁽²⁴⁾. The outbreak cited here involved a thoracic surgery resident who had had acute hepatitis B 6 months earlier. Following transmission, this same HBeAg positive surgeon participated in a laboratory study in which he tied sutures with gloved hands for 1 hour. Small paper-cuts on the fingers were observed and a saline rinse of space between gloves and hands was HBsAg positive⁽⁸⁾. Estimates of the rates of percutaneous injuries to surgeons during surgery varies from 1.3 to 15.4%⁽⁸⁾.

2. the risk of recontact with the patient

Once the infected HCW is injured, it is possible to change the gloves or surgical instrument if the injury is noticed. If changes in equipment or gloves are not made, then recontact with the patient by the instrument could expose the patient to a bloodborne pathogen. In one study, the recontact rate was 2% of observed procedures in four hospitals. The rate increased to 4.2% on the gynecologic service, with a high recontact rate of 8.5% for vaginal hysterectomies in which "blind" suturing is often performed and direct contact between the surgeon's and the patient's blood is possible. In another study it was found that after an injury in the operating room, the rate of  recontact of the sharp object with the patient's wound was 32%⁽²⁵⁾.

3. the risk of seroconversion

This depends on the prevalence of infection in surgeons and dentists and the risk of seroconversion from a specific bloodborne pathogen.

1. the prevalence of infection in surgeons and dentists

Few data are available regarding the prevalence of bloodborne pathogens in Canadian surgeons and dentists. U.S. data are presented in Table 1.

ii) known risk of seroconversion if one is exposed to a source person with HCV, HBV or HIV

The level of the viral titre, the length of time the source person is infectious and the seroconversion rate influence the rate of transmissibility (Table 2).

If the source person is positive for HBeAg, then the viral load is very high and HBV is approximately 100 times more transmissible than HIV after a significant percutaneous blood exposure. However, if the source person is negative for HBeAg but is HBsAg positive, then the risk is less: HBV is about 20 times more infectious than HIV⁽²⁸⁾. The risk of transmission of HCV after a significant exposure is approximately 10 times less than that of HBV⁽²⁷⁾.

The rate of seroconversion from a mucous exposure (0.09% for HIV) is less than from a percutaneous exposure (0.3% for HIV). Although mucous membrane and skin exposures may account for about 50% of exposures from patient to surgeon in the surgical setting⁽²⁹⁾, it is likely that the rate of mucous cutaneous exposure that occurs from the infected HCW to the patient is lower, as the patient's surgical site is fully draped. In an occupational setting, blood is the only fluid to which the patient would likely be exposed.

Perception of risk by the public

Along with the actual risks of transmission of HBV, HCV or HIV the risk perceived by the public has to be considered in determining an acceptable risk. A lay person's perception of risk can lead him or her to believe that a) even if only one life is saved, an action is worth taking, and b) any identifiable risk of transmission is unacceptable⁽³⁰⁾. When zero risk is not attainable, recommendations must strike a balance between the rights and reasonable expectations of the public and the rights and responsibilities of individual HCWs, health care facilities, professional organizations, licensing bodies and governmental health departments. The public has rights that must be protected, but the public also has responsibilities. In this situation the public's responsibilities include the following:

1. basing perceptions on reliable information and sound scientific principles, and

2. giving due consideration to the rights of the infected HCW.

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METHODS TO REDUCE THE TRANSMISSION OF HBV, HCV OR HIV FROM AN INFECTED HCW TO THE PATIENT

Preamble

It is important to decrease the number of opportunities by which surgeons can expose a patient to their infected blood. Once a task analysis has been performed, then the appropriate interventions can be focused and control measures can be put in place for those procedures that pose a risk to the patient.

Participants at the Consensus Conference discussed the industrial hygiene model of control measures, including engineering controls, administrative actions, work practices and personal protective equipment, to decrease exposures to bloodborne pathogens⁽³¹⁾. Items higher on the control list, i.e. engineering controls, are more effective, as the decision is less likely to be in the hands of the practitioner at the time of intervention with the patient.

Engineering controls may consist of design modifications to sharp instruments in order to make them safer - for instance, the use of blunt rather than sharp needles⁽³²⁾. Administrative measures include the adoption of appropriate policies, e.g. hepatitis B immunization of HCWs, hepatitis B immunization as a condition of employment, and direction about how infected HCWs are to be treated in the workplace.

Work practice controls include changes in standard operating room procedures intended to reduce the handling of sharp instruments. Examples include the announcement of the intention to pass sharp instruments, the use of transfer basins or the "hands-free" (see Definitions) technique⁽³³⁾.

HCWs initiated universal precautions in the operating room in 1987 to protect the operating team from exposure to the patient's blood; these should also protect the patient by reducing exposure to blood from an infected HCW⁽³⁴⁾. Universal precautions are now considered the minimum standard of practice and are an example of how work practices can be changed. Studies indicate that compliance with universal precautions varies and is generally low. Kelen has reported compliance in the emergency department of 55% in situations of profuse bleeding and during major procedures⁽³⁵⁾. In 1991, Courington reported compliance of HCWs in the operating room to be 25%⁽³⁶⁾. A Canadian study of HCWs in emergency departments, dental clinics and plastic surgery clinics noted that 31.3% of HCWs were compliant⁽³⁷⁾; however, this study was not limited to exposure-prone procedures. In a study of active surgical staff and residents in secondary and tertiary care teaching hospitals affiliated with the University of Toronto, it was found that only in less than 5% of the time did surgeons use work practice controls to prevent sharps injuries, such as the "no touch" technique (see Definitions), not handling sharps and increased use of less dangerous equipment⁽³⁸⁾. Low compliance with universal precautions means a loss of protection for the patient and the HCW, and it interrupts a barrier designed to prevent injury and thus exposure to potentially contaminated blood.

Personal protective equipment is the last choice of control methods to be used in the industrial hygiene model because compliance by modifying the behaviour of the worker is necessary for each situation⁽³⁸⁾. Personal protective equipment, e.g. gloves, should be used whenever there is a likelihood of exposure to blood from the patient to the HCW and from the HCW to the patient. Double gloves have been recommended for many surgical procedures, since they decrease the amount of blood the patient is exposed to⁽³⁹⁾.

Participants at the Consensus Conference were strongly in favour of increasing support for measures to increase compliance in infection control.

Recommendations

1. Compliance with current infection control methodologies should be promoted and strongly supported to reduce the risk of injury and potential transmission of bloodborne pathogens from the patient to the HCW and also from the HCW to the patient.

2. Compliance with universal precautions should be monitored, e.g. in the employee performance appraisal or in a manner consistent with the status of HCWs who have hospital privileges or are unregulated workers.

3. Universal precautions should be expanded, on the basis of a risk analysis of the procedure, to include engineering, administrative, work practice, and personal protective equipment controls to prevent the transmission of a bloodborne pathogen from HCWs to patients.

4. Engineering controls should be pursued with vigour to reduce potential exposures to blood.

5. Administrative measures should include a mechanism for reporting exposure incidents in each organization or jurisdiction.

6. Exposure incident reports should be reviewed on a regular basis to determine factors that contribute to their occurrence, with the goal of decreasing the incidence.

7. Work place practices should be modified to reduce the potential for transmission of bloodborne pathogens, e.g. the "no touch" technique.

8. Personal protective equipment, e.g. gloves, should be worn if there is a likelihood of exposure to blood⁽¹⁾. Double gloving should be considered if the HCW is performing exposure-prone procedures.

9. The education of HCWs on the transmission of bloodborne infections and the principles and benefits of universal precautions and other infection control measures should be initiated during their early training as students and continue throughout their careers to support compliance. Education should also include information on the risk assessment of procedures and control measures to prevent the exposure of  bloodborne pathogens to another person.

10. Proficiency testing for infection control measures should be performed on both students and HCWs.

11. Education standards for infection control measures should be in place for unregulated HCWs, e.g. midwives.

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IMMUNIZATION AND SCREENING

Preamble

As one of the main medical principles is to "do no harm", it is essential that HCWs who perform exposure-prone procedures take measures to prevent transmission of infection. It is possible that there are also HCWs infected with a bloodborne pathogen who perform exposure-prone procedures and are not aware of their infectious status.

Hepatitis B

In 1992, participants at the Consensus Conference on Bloodborne Pathogens agreed that all HCWs exposed to blood or blood products or at risk for occupational exposure to sharps injuries should be immunized with hepatitis B vaccine⁽¹⁾. U.S. data indicate that HCWs have not complied⁽⁴⁰⁾, but we do not have Canadian data.

Participants at the 1996 Conference discussed post-immunization testing for HCWs as a method of identifying nonresponders⁽⁴¹⁾. They also discussed an assessment for infection status for those who perform exposure-prone procedures and who do not have detectable antibodies against hepatitis B surface antigen (anti-HBs). Up to 50% of HCWs would not have adequate levels of this antibody within 7 years after immunization⁽⁴²⁾, either because of waning antibodies in those who still have immunologic memory or because of primary vaccine failure. For HCWs and student HCWs whose antibody levels were not tested within 4 to 8 weeks after the last hepatitis B vaccination and who perform or will perform exposure-prone procedures, occupational health departments may proceed in one of several ways; there was no consensus among Conference participants on a preferred method. They may boost those HCWs whose antibody status is unknown and then test for anti-HBs, or do anti-HBs testing on those without post-immunization serology, boost (if required) with a dose of vaccine, and then carry out post-booster serology.

There was general agreement that mandatory immunization against hepatitis B with follow-up testing and screening for non-responders and people with hepatitis B infection is necessary. However, some concerns were raised by participants about mandatory versus voluntary immunization. This practice may cause some practitioners to refuse to come forward, whether or not they are infected. Some felt that practitioners may want to have patients tested before surgery and might refuse to perform procedures on those who have bloodborne pathogens.

Hepatitis C and HIV

Participants discussed the current knowledge related to the screening of HCWs for antibodies to HCV and antibodies to HIV, the value of  HCWs knowing their serologic status and the value of informing the expert panel (see next section) if one performs exposure-prone procedures. It was acknowledged at the Conference that legislative changes may be needed to allow HCWs' test results to be sent to either regulatory bodies (for the regulated HCW) or to local public health agencies (for the non-regulated HCW). Confidentiality should be maintained throughout the whole process of testing through notification and assessment.

Recommendations

1. All HCWs who are exposed to blood or [manufactured] blood products or at risk for occupational exposure to sharps injuries should be immunized with hepatitis B vaccine⁽¹⁾ for their own protection.

2. Immunization for hepatitis B should be mandatory for HCWs who perform or who will perform exposure-prone procedures. Mandatory hepatitis B immunization applies also to student HCWs who perform or will perform exposure-prone procedures.

3. HCWs and student HCWs who perform or who will perform exposure-prone procedures should have mandatory testing for antibody protection 4-8 weeks after immunization against hepatitis B (anti-HBs > 10 international units per litre [IU/L]).

4. HCWs and student HCWs who perform or will perform exposure-prone procedures and who are found on post-HB immunization testing to be nonresponders, as well as HCWs and student HCWs who refuse or have a valid medical contraindication to immunization, should be screened for infection regularly (HBsAg, antibody to hepatitis B core antigen [anti-HB core]), e.g. annually (see recommendation 9).

5. Informed pre-test and post-test counselling is an essential component in all screening programs.

6. HCWs and student HCWs who perform or will perform exposure-prone procedures and who test positive for HBsAg should be tested for HBeAg. If they are HBeAg positive, they should be referred to an expert panel (see next section) for assessment and cease practice pending the panel's recommendations.

7. HCWs and student HCWs who perform or will perform exposure-prone procedures and who test HBeAg negative should also be referred to the expert panel but do not need to cease practice while they are waiting for the panel's recommendations.

8. HCWs and student HCWs who perform or will perform exposure-prone procedures and refuse screening will be presumed to be HBeAg positive, will cease practice, and will be referred to the expert panel.

9. HBsAg and HBeAg testing, as specified in recommendations 4 and 6, should be done after employment but before job placement or before hospital privileges are granted and on renewal of privileges, e.g. annually.

10. The work institution for HCWs or the education facility for student HCWs should keep records that document immunization and testing.

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REFERRAL TO THE EXPERT PANEL TO ASSESS THE RISK OF TRANSMISSION OF HBV, HCV OR HIV BY THE INFECTED HCW

Preamble

When a HCW is infected with a bloodborne pathogen and performs exposure-prone procedures, additional measures need to be taken to assess the risk of transmission in the tasks performed and the method of practice. The appropriate measures can then be put in place to limit any added risk of transmitting infections that this individual poses.

Participants at the Consensus Conference agreed that the consultation mechanism should include referral to an expert panel for any HCW or student who is infected with a bloodborne pathogen and who performs or will perform exposure-prone procedures. The panel's mandate would be to assess the transmission risk to patients posed by the infected HCW during exposure-prone procedures and make recommendations on the HCW's practice.

There was agreement on the need for the expert panel to have experience in local public health, occupational health, infection control and infectious diseases, and to include a professional from the same specialty as the infected HCW. A microbiologist or virologist on the panel was also considered important by some participants, and some believed that a lay person with expertise in the field of risk analysis, ethics or policy making might make an important contribution. Others felt that the inclusion of an additional member to present the perception of risk from a non-health care provider's point of view was inappropriate. It was noted that the situation may arise in which one person may have expertise in more than one area. Many participants thought that the same members would need to be called upon each time the panel is required, although some felt that this would not be practical.

Most participants thought that the expert panel should meet within 7 days of a request, but some felt that this was unrealistic in today's setting. It will be important that the panel's review be completed before the HCW's short-term disability insurance expires.

Many participants felt that the infected HCW should be present at the expert panel hearing, if that individual wishes; however, some participants disagreed.

Recommendations

1. All HCWs who perform exposure-prone procedures have an ethical obligation to know their serologic status with reference to the bloodborne pathogens of  HBV, HCV and HIV.

2. HCWs who perform exposure-prone procedures and who learn that they are infected with a bloodborne pathogen are ethically obligated to report the fact to their profession's regulatory body, e.g. the College of Physicians and Surgeons of Canada or the College of Nurses in accordance with provincial regulations, or to the local public health agency or occupational health service if their profession does not have a regulatory body.

3. Regulatory bodies should take an active role in overseeing the infected HCW's practice as part of their obligation to regulate their members for the protection of the public.

4. Expert panels should be established by the provincial and territorial regulatory bodies^****** in consultation with provincial and territorial bodies and other professional organizations. Expert panels would work at a regional or provincial and territorial level, depending on the needs and size of the population.

5. The expert panel should be activated when a HCW who performs exposure-prone procedures is found to be infected with HBV, HCV or HIV.

6. The expert panel should minimally include a local public health specialist, an occupational health specialist, an expert from the same specialty as the infected HCW, an infection control expert, an infectious diseases specialist, and an expert in risk assessment, ethics or policy.

7. The expert panel may be contacted by the infected HCW or his/her primary care physician, the HCW's regulatory body, a public health official, the occupational health service, the employer (if the occupational health service does not exist) or a HCW representative, depending on the situation.

8. The expert panel must convene within 7 days if the HCW's practice has been affected by the pending decision and complete its review as soon as possible, including notification of the decision to the affected HCW.

9. The expert panel should review the current literature on the bloodborne pathogen in question. When addressing the issue of whether the HCW is safe to continue practising exposure-prone procedures the panel should consider the following:
   1. the specific infection and viral load, e.g. HBeAg positive
   2. risk analysis of work activities with special reference to exposure-prone procedures 
   3. procedural techniques
   4. the skill and experience of the HCW
   5. evidence of prior transmission by the HCW
   6. compliance with universal precautions and other infection control practices
   7. the likelihood of compliance with the practice recommendations

   8. relevant ethical principles

10. Infected HCWs may attend the meeting of the panel to present their case and may be accompanied by a medical, legal or ethical advisor(s).

11. There should be a timely appeal process available.

12. The primary care physician is responsible for the medical management of the infected HCW.

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MANAGING THE RISK AFTER AN INFECTED HCW HAS PRACTICE MODIFICATIONS IMPOSED

Preamble

Participants discussed the HCW who has practice modifications imposed by the expert panel and is unable to perform exposure-prone procedures because there is a real risk that he or she will expose the patient to a bloodborne pathogen. Enforcement and public protection are the responsibilities of the regulatory bodies for regulated HCWs and of the public health agency or occupational health service for unregulated HCWs.

Techniques for ensuring privacy and confidentiality were discussed at the Consensus Conference, as confidentiality is a vital principle. As far as possible, confidentiality must be maintained throughout the whole process of the expert panel consultation. If the infected HCW chooses not to attend the panel meeting, and if the panel decides not to modify the HCW's practice, his or her identity need be known only by the referring body or person. If practice modifications are imposed, however, the identity of the HCW will need to be communicated to whichever body will be responsible for monitoring or enforcing the modifications. Concerns were raised about personal health information; this information should be given strictly on a "need to know" basis.

Other approaches were mentioned, such as the possibility of immunizing all surgical patients with hepatitis B vaccine on admission to hospital or early treatment for patients in the operating room who may have been exposed to bloodborne pathogens because of an injury by the HCW. There was no consensus on these approaches.

Recommendations

1. The mechanisms of contacting the expert panel and of disseminating its findings must ensure confidentiality; the expert panel need not know the identity of the infected HCW unless practice modifications are recommended (or unless the HCW chooses to attend the meeting).

2. When practice modifications are recommended, the identity of the infected HCWs must be revealed by the referring body to the expert panel and to the regulatory body, if the HCW is regulated, or to the local public health agency or occupational health service, if the HCW is unregulated.

3. These bodies will have the responsibility for establishing a continuous and comprehensive monitoring program to ensure that the expert panel's recommendations are followed by the infected HCW.

4. The regulatory body in the case of regulated HCWs, and the public health agency or occupational health service in the case of unregulated HCWs should review the HCW's modified and non-modified practices and their applicability as the health status of the HCW changes.

5. The person monitoring the HCW's compliance must inform the regulatory body or the local public health or occupational health service (for the unregulated HCW) if a HCW does not comply with the expert panel's decision to modify his or her practice. Failure to follow the recommendations would necessitate referral to the regulatory body or local public health for action to revoke/restrict the licence.

6. Personal health information should be given strictly on a "need to know" basis.

7. The individual (e.g. the employer) responsible for monitoring the practice modifications  does not need to know the HCW's exact diagnosis, i.e. which bloodborne pathogen the worker has. This individual need know only what the practice modifications/work restrictions are.

8. Provincial and territorial expert panels may choose, if they wish, to work together to standardize their assessment and management approaches.

9. LCDC should be a resource for the expert panels, the regulatory, public health or occupational health service in providing the latest scientific information on the transmissibility of bloodborne pathogens.

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TRACE-BACK AND LOOK-BACK ACTIVITIES

Preamble

Look-back notification programs for patients of an infected HCW can be undertaken not only to identify and treat those patients and prevent further transmission but also to supplement research findings, clarify legal or ethical issues, evaluate risk or reassure the public. Infected HCWs may be identified in any of the following ways:

1. disclosure by the HCW,

2. identification through a voluntary or mandatory screening program, or

3. identification during the follow-up of another infected patient(s).

Well-designed investigations always need to be carried out to describe accurately the transmission level or transmission parameters when an infected HCW may have transmitted a bloodborne pathogen to a patient. Participants discussed whether it is necessary to initiate a trace-back if only a single patient met the criteria; the extent of the trace-back or look-back (i.e. how far back in time); the type of surveillance required to maximize identification; and the person responsible for initiating the look-back. Other necessary parts of the notification process include assembling the names of the people to be notified, making sure the response team is in place and ready, notifying all the patients at the same time, and being prepared to answer the public's questions, possibly by means of a telephone hot line. Some participants felt that it is not always feasible to notify all the patients at once. Instead, the most recent patients should be notified first, followed by the other patients as soon as possible. Some participants thought the accumulated results of testing should be centralized.

Since there is a dearth of published evaluations of notification programs in Canada, the recommendations made here are based solely on expert opinion. There was no agreement on the time period for the length of look-back if the date of the infection is not known; it will need to be based on the analysis of the specific case. Health care funding sources should appreciate the new additional cost to facilities or agencies to protect the public, because notification programs are new in Canada and could entail considerable investment of resources.

Recommendations

1. A trace-back should be done if a single patient infected within the previous 12 months is found to have no identifiable personal risks of infection but has undergone an exposure-prone procedure within the appropriate infection risk time frame.

2. A trace-back should be done if two or more patients are infected with a particular bloodborne pathogen in a time period of more than 12 months and have been found to have no identifiable personal risks of infection but have undergone an exposure-prone procedure within the appropriate incubation period at the same hospital or by the same  person. In addition, a trace-back is necessary when a clinician performing exposure-prone procedures finds a bloodborne infection in his or her patient(s) within 12 months after the procedure.

3. During a trace-back, the infected HCW should be identified through a quick, focused discussion with those HCWs most likely to be the source of infection, and serologic testing of these HCWs should be done. Advanced virologic methods should be used to establish the link more firmly.

4. The public health laboratory should be involved, whenever possible, to ensure appropriate testing, reporting and accountability.

5. If a HCW is implicated during a trace-back but refuses to be tested, he/she should be treated as though test results were positive for the virus under examination and referred to the expert panel.

6. To maximize identification by trace-back the local public health surveillance for these newly acquired infections should be of high quality:
   1. infections from these bloodborne pathogens (including HIV) should be reportable to the local public health agency;
   2. interviews should identify risk factors for all newly found persons infected, including a history of an exposure-prone procedure;
   3. data should be constantly reviewed, i.e. cases from one HCW or institution; and

   4. good communication should be maintained between clinicians and the public health agency.

7. A look-back and a notification program should be done when the professional practice of an infected HCW is modified or restricted because of the risk posed by his or her infection. Such a modification acknowledges that transmission may have occurred since the time of infection of the HCW.

8. No look-back or notification program need take place if the expert panel assessing the HCW does not recommend practice modification or restrictions.

9. The retrospective period covered by the notification program should take into account the time of acquisition of the HCW's infection, if known, and the times when exposure-prone procedures were performed.

10. The infected HCW's employing facility or facility where the HCW practises should be the primary agent in a notification program, with appropriate collaboration with the local public health agency.

11. If the HCW is unregulated, the primary agency responsible in a notification program is the local public health agency.

12. Notification may be multijurisdictional if the HCW has practised in more than one location during the look-back period.

13. Physicians and the medical officer of public health or equivalent should be encouraged to allow their information systems to be used in look-back programs. Current addresses are often difficult to obtain, and their databases could greatly assist the studies.

14. Notification programs should take all reasonable steps to encourage patients to be tested, for their own benefit and that of their families. Such steps may include the use of the media, clearly worded notification letters, information to local practitioners, and specific recommendations regarding testing, all respecting confidentiality.

15. Other necessary parts of the notification process should include assembling the names of the people to be notified, making sure the response team is in place and ready, notifying all the patients at once, and being ready to answer the public's questions, possibly by means of a telephone hot line.

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DISCLOSURE TO PATIENTS

Preamble

Participants discussed whether the identity of the HCW should be divulged after a significant exposure of the patient has taken place and whether the HCW who is infected with a bloodborne pathogen should inform the patient before performing a procedure that could result in a significant exposure.

In the United States, the CDC's recommendation is that "HCWs who are infected with HIV or HBV [and are HBeAg positive] should not perform exposure-prone procedures unless . . . [he/she] notifies patients of the HCW's seropositivity before they undergo exposure-prone procedures"⁽²⁾. Few states, however, have put this recommendation into practice.

If HCWs see disclosure as a threat to their livelihood they are less likely to want to know their serologic status or to seek testing voluntarily. If the expert panels make fully informed and valid decisions about the extent of the risk posed by infected HCWs who perform exposure-prone procedures and institute practice modifications or restrictions that the HCW follows, participants felt that disclosure would be unnecessary.

It is recognized that in some provinces and territories across Canada, regulatory bodies or local public health agencies do not have the authority to monitor practice modifications or restrictions for regulated or unregulated HCWs at the present time. Legislative changes may be necessary.

Recommendations

1. Provided that the infected HCW's health status and the exposure-prone procedures have been assessed by the expert panel and all the panel's recommendations are followed, disclosure of a HCW's infected status to patients before an exposure-prone procedure is carried out is not required as a way of protecting patients from bloodborne pathogens.

2. After a significant exposure from any HCW has occurred, the patient must be notified that he/she was exposed to the blood of a member of the HCW team (the HCW does not need to be identified by name).

3. The HCW has an obligation to be tested following a significant exposure to the patient. If the HCW tests positive for HBV, HCV or HIV the patient has the right to know to which pathogen he/she was exposed in order to access the appropriate post-exposure protocol⁽⁴¹⁾.

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RETRAINING AND SUPPORTING INFECTED HCWs

Preamble

HCWs who suspect or know that they are infected with a bloodborne pathogen should feel confident that by seeking testing or by reporting the infection they will receive appropriate advice and treatment as well as the support and encouragement to continue in practice in ways judged to be safe for their patients. Policies that support HCWs are more likely to be effective than those that exclude or punish them.

The elements of a support system were discussed as well as the responsibilities of the employing facility and the regulatory body of the infected HCW. Recommend-ations of the expert panel that modify or restrict the HCW's practice may have a serious impact on the HCW's financial and professional life. Some participants felt that provincial and territorial governments should encourage retraining where needed.

Recommendations

1. A support system should be established for HCWs infected with a bloodborne pathogen. Provincial or territorial regulatory bodies should ensure that the following key elements are available:

   1. a well-defined point of entry, preferably within a professional association, regulatory body or other group independent of the employer that can act in the best interests of the HCW;
   2. provision for safeguarding the confidentiality of the HCW's identity;
   3. a contact person at the point of entry who will ensure that support is available on an immediate and continuing basis and who will facilitate the HCW's access to
      1. appropriate medical care and counselling,
      2. isocial and psychologic support,
      3. professional advice on maintenance of registration,

      4. options for income security and retraining.

2. Each provincial and territorial health department should work with the relevant professional associations and regulatory bodies to establish a support system and a policy regarding its use. The professional associations have a responsibility to inform their full membership of this option, including those working in private practice or in a setting with few employees.

3. After HCWs have been identified as being infected with a bloodborne pathogen and await the recommendations from the expert panel, their professional association membership as well as salary and benefits, if applicable, should be retained.

4. As far as possible, infected HCWs should be accommodated in the workplace with meaningful work if their practices have been restricted during the waiting period.

5. Regulatory bodies, professional associations and health care facilities should encourage members to consider disability insurance for infection with a bloodborne pathogen. Such coverage may be available through group or private disability insurance. If the infection is occupationally acquired, compensation may be sought through the Workers' Compensation Board.

6. Professional associations should inform members about the types of coverage available.

7. Regulatory bodies, professional associations and health care facilities should inform members about the requirements for eligibility for such insurance (such as accident reports for injuries with an instrument, baseline testing, etc.).

8. Insurance companies should be encouraged to make disability insurance for occupational infection with bloodborne pathogens available to HCWs.

9. Insurance coverage should also be available to those who cannot identify the source of their infection or were infected under non-occupational circumstances.

10. Student HCWs should be made aware that if they acquire a bloodborne infection, their work practices could be modified.

11. Unregulated workers should seek guidance through their public health agency.

^*49 of 75 participants (65%) responded: 63% wanted LCDC to publish (22% wanted the recommendations published, 33% wanted the document published with an acknowledgement of CDA/CMA concerns, 8% wanted the recommendations published and gave direction to seek added input from CDA/CMA); and 37% did not want the recommendations published until CDA/CMA concerns had been addressed.

^** exposure-prone procedures (US): procedures implicated in the transmission of HIV and HBV from HCWs to patients or "that include digital palpation of a needle tip in a body cavity or the simultaneous presence of the HCW's fingers and a needle or other sharp instrument or object in a poorly visualized or highly confined anatomic site . . . [and further] that present a recognized risk of percutaneous injury to the HCW, and - if such injury occurs - the HCW's blood is likely to contact the patient's body cavity, subcutaneous tissues, and/or mucous membranes". It was later decided that whether a procedure was exposure-prone had to be decided on a case-by-case basis.

^*** invasive procedures (UK): defined as "those that include surgical entry into tissues, cavities, or organs; repair of major traumatic injuries; cardiac catheterisation and angiography; vaginal or Caesarean deliveries or other obstetric procedures during which bleeding may occur; manipulation, cutting, or removal of any oral or perioral tissue, including tooth structures, during which bleeding may occur"

^**** The term "invasive procedures" was used during the Consensus Conference. It was changed following review by a subgroup, which stated that "exposure-prone procedures" are invasive procedures that also present the opportunity for the patient to be exposed to the blood of the HCW.

^***** It is not the intent to include all invasive dental procedures as exposure-prone, although this is theoretically possible; rather, the goal is to identify those procedures involving a major opening in the oral or perioral tissue.

^****** Discussions at the Consensus Conference indicated that the Ministry of Health should ensure that the expert panel is established in conjunction with the professional organizations or regulatory bodies and also that the expert panel report to the regulatory body. Comments from participants indicate that it is more appropriate for the regulatory body to be responsible for establishing the expert panel, and that it is not possible, at the present time, for the Minister of Health to be responsible for how the regulatory body sets up the expert panels

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