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Hepatitis B virus infected physicians and disclosure of
transmission risks to patients: A critical analysis
Diana L
Barrigar,1 David C Flagel,2 and
Ross EG Upshur 3
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=59900
1PGY-1
McGill University, Faculty of Medicine, Montreal,
Quebec, Canada
2Department
of Humanities and Languages, Hazen Hall, Room 104,
University of New Brunswick, Saint John, New Brunswick,
E2L 4L5, Canada
3Primary
Care Research Unit, Sunnybrook and Women's College
Health Sciences Centre, Department of Family and
Community Medicine and Public Health Sciences and Joint
Centre for Bioethics, University of Toronto, 2075 Bay
view Avenue A 100 Toronto, Ontario, M4N 3M5, Canada
Corresponding
author.
Diana
L Barrigar:
dianabarrigar@hotmail.com ; David C Flagel:
flagel@unbsj.ca ; Ross EG Upshur:
rupshur@idirect.com
Received September 26, 2001; Accepted October 25, 2001.
Abstract
Background
The potential for transmission of
blood-borne pathogens such as hepatitis B virus from
infected healthcare workers to patients is an important
and difficult issue facing healthcare policymakers
internationally. Law and policy on the subject is still
in its infancy, and subject to a great degree of
uncertainty and controversy. Policymakers have made few
recommendations regarding the specifics of practice
restriction for health care workers who are hepatitis B
seropositive. Generally, they have deferred this work to
vaguely defined "expert panels" which will have the
power to dictate the conditions under which infected
health care workers may continue to practice.
Discussion
In this paper we use recent
Canadian policy statements as a critical departure point
to propose more specific recommendations regarding
disclosure of transmission risks in a way that minimizes
practice restriction of hepatitis B seropositive health
care workers without compromising patient safety. The
range of arguments proposed in the literature are
critically examined from the perspective of ethical
analysis.
Summary
A process for considering the
ethical implications of the disclosure of the
sero-status of health care workers is advanced that
considers the varied perspectives of different
stakeholders. |
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Background
The ethical issues surrounding
health care workers infected with blood borne viruses
and practice restrictions has drawn increasing
attention. [1-15].
Many of the analyses have dealt exclusively or at least
significantly with the issue of disclosure of
seropositivity as a means for infected HCWs to continue
to practice [3-9].
However, most have focussed on HIV and have not
adequately addressed the unique features of HBV,
particularly its preventability and higher
transmissibility, which distinguish it from HIV.
Of the few papers which have
focused on HBV-infected HCWs, none have adequately
addressed the issue of disclosure of seropositivity as a
means for infected HCWs to continue to practise.
Ristinen and Mamtani advocate disclosure of
seropositivity as a means of allowing patients to
participate in care, however, their discussion is quite
superficial and does not address all of the primary
stakeholders in the issue [2].
Blatchford et al discuss an actual case of an HBV-infected
dentist, and the results of a survey of exposed
patients. They also advocate disclosure of
seropositivity, but argue this primarily from the
patient's right to know perspective and do not address
the issues from the HCW's perspective [4].
Thus, what appears to be missing
from the literature is a comprehensive examination of
disclosure of HCW seropositivity and its role in
determining appropriate practice restrictions for HCWs
infected with hepatitis B virus. In this paper we review
the arguments from the literature, including the
interests of the at-risk patient, the infected HCW, and
the health care system. We attempt to provide a
comprehensive and practical approach to including
disclosure of seropositivity in a system of practice
restriction for HBV-infected HCWs. |
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Epidemiology of HBV transmission
HBV is transmitted by percutaneous
or permucosal exposure to infectious body fluids, by
sexual contact with an infected person, and perinatally
from an infected mother to her infant [16].
It differs from other transmissible pathogens in several
important ways. First, it is more highly transmissible
than HIV or hepatitis C virus (HCV). In fact, HBV may be
transmitted from HCWs to the patient despite full
compliance with universal precautions and correct
infection control procedures [17].
An estimated 240 to 2,400 transmissions occur per
million procedures by an HBV-infected HCW compared to
2.4 to 24 per million transmission rate by an
HIV-infected HCW [17].
Chronic carrier status is identified serologically by a
positive hepatitis B "surface" antigen (HBsAg) titre.
Although it was once thought that only individuals
testing positive for hepatitis B "envelope" antigen (HBeAg)
in addition to HBsAg were at risk of transmitting the
infection, it is now known that surgeons who are
carriers of HBV without detectable levels of serum HBeAg
can transmit HBV to patients during procedures [18].
Seroconversion rates after exposure to the virus in a
non-immunized individual range from 1930% if the source
person is HBeAg positive and 5% if the source person is
HBeAg negative [17].
In terms of prevalence of HBV
infection among HCWs, data from the most recent U.S.
National Health and Nutrition Examination (NHANES) did
not show an increased prevalence of chronic HBV
infection among adults with a medical occupation as
compared to the rest of the sample. However the NHANES
study did not separate out specialities within medicine,
e.g. surgeons, where there may be a higher prevalence of
HBV infection. This study estimated a prevalence of HBV
infection in the U.S. population of 5.5%, with 0.33%
being chronically infected, in the period between 1976
and 1980 compared to 4.9%, with 0.42% being chronically
infected, between 1988 and 1994[19].
Besides its high transmissibility
relative to HCV and HIV, HBV also differs in its
preventability by immunization. In Canada, this consists
of 3 intramuscular doses of a recombinant vaccine,
administered in a series of 3 injections over 6 months
(at 0, 1 and 6 months), with a 9599% protective immune
response observed among pediatric and young adult
populations [20].
Immune response to the vaccine series is lower in adults
over age 40 and immunocompromised individuals [20].
Fractionated anti-HBs immunoglobulin (HBIG) is often
used in combination with the vaccine series for
post-exposure prophylaxis, however, there is no
consensus as to how much additional protection, if any,
it offers [16].
It is also important to know that
hepatitis B is endemic to many developing countries. The
vast majority of chronic carriers worldwide are
individuals who were born in areas of high endemicity
(i.e., where ≥ 8% of the population is HBsAg-positive)
and who contracted the virus during early childhood or
perinatally, i.e., via vertical transmission from mother
to neonate [21].
For example, in East Asian, Southeast Asian and Pacific
Island countries, 35 to 50% of HBsAg-positive women are
also HBeAg-positive. If a mother is HBeAg-positive, her
infants have a 70 to 90% risk of becoming infected if
they do not receive immunoprophylaxis at birth, which is
not routinely available in most countries where the
virus is endemic. Forty-five per cent of the world's
population live in areas of high endemicity which
include Africa, most of Asia (except Japan and India),
most Pacific Island groups, most of the Middle East, the
Amazon Basin of South America, and areas inhabited by
special populations such as native Alaskans, Australian
aborigines, and New Zealand Maoris [21].
In summary, HBV differs from other
transmissible pathogens such as hepatitis C and HIV by
virtue of its higher transmissibility, its
preventability, and its endemicity to many developing
countries. |
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Current policy on practice
restrictions for HBV-infected health care workers
The Laboratory Centre for Disease
Control (LCDC) of Health Canada recently issued
recommendations for health care institutions and
individual HCWs regarding transmission of bloodborne
pathogens to patients by infected HCWs [17].
The recommendations are advisory in nature but represent
one of the most authoritative sources of guidance for
Canadian physicians and their provincial/regional
licensing bodies. We will be focusing on the
recommendations regarding disclosure of risks to
patients, but we will briefly outline the LCDC approach
toward practice restrictions as this will provide the
context for the disclosure recommendations.
According to the LCDC
recommendations, HCWs and student HCWs who perform or
will perform "exposure-prone procedures" and who test
positive for HBsAg should be referred to an expert panel
for assessment. If they are HBeAg positive, they should
also cease practice immediately, whereas those who are
HBeAg negative may continue to practise pending the
panel's assessment. Those who refuse screening are
presumed HBeAg positive and treated as such. The expert
panels are to be established by the provincial and
territorial regulatory bodies, and are responsible for
addressing the issue of whether the HCW is safe to
continue practising exposure-prone procedures. The LCDC
advises the expert panel to consider factors such as the
type of infection and viral load; procedural techniques;
skill and experience of the HCW; evidence of prior
transmission by the HCW; the HCW's compliance with
universal precautions and other infection control
practices; and the likelihood of compliance with the
practice recommendations. From this list, it appears as
if the LCDC expects the panel primarily to perform a
harm-benefit analysis based on the individual
circumstances. LCDC also recommends that "relevant
ethical principles" be considered in the decision
making, but fails to provide further guidance in this
area.
The LCDC guidelines also address
the protection of HCW privacy and confidentiality. In
the case of physicians, their recommendations stipulate
that the professional regulating body be notified of the
seropositivity of any practising physician, and that
others, including members of the expert panel who will
be making practice recommendations, should be given
personal health information "strictly on a "need to
know' basis." Similarly, the LCDC recommended steps to
protect the infected physician's identity when
disclosure to patients was considered.
Since disclosure to patients is the
focus of this paper, we have provided the LCDC
recommendations on disclosure in full:
"1. Provided that the infected HCWs
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 HCWs
infected status to patients before an exposure-prone
procedure is carried out is not required as a way of
protecting patients from blood-borne 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."
It is worthwhile knowing the policy
positions of other professional associations in order to
serve as a comparison to the LCDC recommendations on
practice restriction and disclosure to patients. The
Canadian Medical Association (CMA) policy recommends
that "physicians who test positive for HBsAg cease
activities of their practice that could expose patients
to their body fluids until their practice has been
reviewed by an expert committee" [22].
In terms of practice restriction, the final decisions
are left up to the expert committee, but the CMA offers
some guidance for achieving this. In particular, the CMA
recommends if HBV infectivity could not be reduced to
"acceptable levels", the physician's practice should be
restricted by directing the physician.
"to practise only on immune or
infected patients when his or her body fluids could come
into contact with those of the patient; and in the event
the patient's immune status is unknown, not to practise
specified procedures during which his or her body fluids
could intermingle with those of the patient"[22].
The CMA does not define what it
considers "acceptable levels" of infectivity. For
comparison sake, the U.S. Centre for Disease Control
(CDC) issued recommendations in 1991 which differ from
the LCDC recommendations on the topic of disclosure to
patients [23].
These recommendations stated that
"HCWs who are infected with HIV or
HBV (and are HBeAg positive) 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 HCW's
seropositivity before they undergo exposure-prone
invasive procedures."
These CDC guidelines have been
subject to much criticism, and we will be examining
those critiques before recommending a policy regarding
practice restriction and disclosure of seropositivity
which could be applied to either U.S. or Canadian health
care systems |
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Discussion
Ethical problems with the LCDC
recommendations on disclosure to patients
It is worthwhile pointing out some
concerns with the LCDC's general approach to practice
restrictions. First, the current recommendations leave
too much discretion in the hands of the elusive expert
panels. More detailed guidelines with regard to practice
restriction would do more to ensure that infected HCWs
are treated according to a fair process, and are not as
vulnerable to the particular biases and experiences of
the members of the expert panel overseeing their case.
As well, a New Jersey court case involving a surgeon
with AIDS drew attention to the conflict of interest of
colleagues sitting on such a committee [3].
Their judgement may be influenced by fears of becoming
infected themselves at some point in their career.
As for the LCDC recommendations on
disclosure of risks to patients, they fall short of
current legal requirements for informed consent and have
some other ethical drawbacks as well. In terms of an
ethical analysis of these disclosure recommendations,
there are three parties whose interests we must keep in
mind: the infected HCW's interests in keeping his/her
career and in performing his/her role to improve the
health of patients, the patient's interest in not
contracting a potentially fatal infection, and society's
interest in maintaining an effective and affordable
health care system. This involves addressing ethical
arguments such as the HCW's right to privacy, the HCW's
right to freedom from discrimination, the duty of HCWs
to provide benefit for their patients and not do them
harm, and the patient's right to autonomy and informed
choice. In addition, the societal benefits and/or
burdens of any policy should also be considered. Any
policy recommendations should also be legally prudent.
The case for disclosure of
serological status
The process of informed choice and
its legal requirements have evolved with the purpose of
enhancing and protecting patient autonomy in medical
decision-making. Failure of physicians to disclose
"material, special or unusual risks" regarding a medical
treatment or procedure to which a patient consents may
result in a battery or negligence suit against the
physician [3,7,24].
Risks meriting disclosure are determined in Canadian
courts by what a "reasonable person in the patient's
position" would want to know in order to decide whether
or not to undergo a procedure. Risks of 1% or less have
been deemed "material" by Canadian courts if the
consequences are adequately serious that a reasonable
person in the patient's position would want to know
those risks before consenting to a procedure [7,24].
With regards to blood-borne
pathogens in particular, an Ontario court held that the
risk (described in evidence as "infinitesimally small')
of contracting hepatitis through a blood transfusion
ought to have been disclosed in a 1989 case [7,24].
The risk of contracting HBV via an invasive procedure
when the serological status of the HCWs involved is
unknown can be calculated by multiplying the prevalence
of chronic HBV infection (0.42%) with the risk of
transmission (2402,400 per million). This results in a
transmission risk of between 1 and 10 per million.
Although very small, this risk is that of acquiring a
potentially fatal disease, and as such it would be very
difficult to argue that it should not be disclosed to
patients. The manner of disclosing this risk will vary
with each individual and it is difficult to know if a
blanket statement commonly used by HCWs such as "there
is a 1% risk of infection from this procedure" is
adequate, or whether they ought to specify the source of
the infection. Acquiring HBV as a result of an invasive
procedure is certainly a qualitatively different outcome
than having one's recovery complicated by a superficial
wound infection.
The more difficult question is
whether HCWs who are known to be HBV-seropositive ought
to disclose their serological status to patients prior
to procedures. This changes the risk of transmission
from between 1 and 10 per million to between 240 and
2,400 per million. This represents a 200-fold increase
in risk but the absolute risk is still less than one per
cent. Disclosure of this increased risk would enhance
patient autonomy by allowing individual patients to
decide whether or not to have a procedure performed by
an infected HCW based on the significance of the
infection risk to the patient. For many patients, e.g.,
a young patient undergoing a common and widely available
procedure, this risk will likely be considered very
significant and they probably will choose to have the
procedure performed by someone else. Alternatively,
consider a terminally ill patient undergoing a
palliative procedure, for whom the risk of acquiring a
blood-borne pathogen with primarily long-term
complications may not be particularly significant. It
may be more important, for example, for such a patient
to have the procedure performed as soon as possible by
an HCW with whom they have a long-standing and trusting
relationship. These two scenarios are illustrative of
the different values patients may have, and offering
patients the choice of having a procedure performed by a
known infected HCW allows them to make a decision based
on their individual values and priorities.
Such an approach is legally prudent
as well. In 1993 the Maryland Court of Appeals, using a
"reasonable patient" disclosure standard similar to
Canada's, ruled that a surgeon who was HIV seropositive
did have a duty to warn patients of his/her infected
condition or refrain from operating upon them [7].
The ruling also stipulated patients could recover
damages for their fear of acquiring AIDS for the period
of time between learning of the surgeon's seropositive
status and receiving HIV-negative results. With the
higher transmission rate of HBV by an infected HCW to a
patient, it is likely that courts would require the same
duty of HBV-seropositive HCWs.
Further, a 1991 Newsweek
poll reported that 95% of the American public wanted
surgeons to be required by law to tell their patients if
they are HIV-infected [7,15].
Ninety-four percent wanted disclosure from physicians
and dentists, and 90% wanted disclosure from all HCWs.
Thus, the seropositive status of HCWs and the risk it
poses to patients is something that "reasonable"
patients want to know.
Thus, from the perspectives of
promoting patient autonomy and doing what is legally
prudent, there are very strong cases in favour of
infected HCWs disclosing their serological status to
patients as a requirement of performing invasive
procedures. However, there are ethical challenges to
such a disclosure policy which need to be addressed.
These come from two different camps those who argue
that disclosure in and of itself is not sufficient for
protecting patients from significant transmission risks
and those who argue disclosure should not be required
for infected physicians to continue to practise. We will
examine these arguments in turn.
The duty of health care workers to
benefit their patients and do them no harm
All physicians and most other
health care workers will at some time in their life have
heard the potent expression "primum non nocere", which
translated means "above all, do no harm." This phrase is
often quoted, but as Beauchamp & Childress acknowledge,
"its origins are obscure and its implications unclear."[25]
However, it provides the foundation for the ethical
principle of nonmaleficience, which "asserts an
obligation not to inflict harm intentionally"[25].
In this vein, Tereskerz et al.
argue that infected HCWs not perform any procedures
which present a risk of transmission of blood-borne
pathogens to patients and that there be national policy
involving lists of procedures which health care workers
with specific infections should refrain from performing
[3].
They do not consider disclosure of transmission risk to
patients an adequate measure for protecting patients,
however they acknowledge it to be a useful temporary
measure to provide "limited" protection for patients
until a more ideal national policy regarding practice
restriction is put in place. They argue that "patients
may find it difficult to evaluate scientific information
concerning risk and may be reluctant to request an
alternative physician when their own physician is
infected"[3].
Thus, on the basis of preventing patients from harm,
they propose quite strict practice restrictions which
would vary according to the specific pathogen with which
the health care worker was infected and the specific
procedures to be performed.
While their proposal is noteworthy
for its interest in protecting patients from harm, it
may be overly paternalistic when considering disclosure.
Instead of allowing patients to determine for themselves
what degree of risk they are willing to accept, an
expert committee would decide what level of risk is
acceptable to patients in the course of deciding which
procedures an infected HCW may perform.
There are also other methods of
preventing HBV transmission which may be implemented
instead of, or in addition to, practice restrictions.
For example, surgical patients could be offered
immunization prior to elective invasive procedures. This
would have the added benefit of protecting them from
contracting HBV via other modes of transmission, e.g.
sexual contact or IV drug use. Current costs of
serological tests and vaccinations may be considered
prohibitive factors, but there are enough proponents of
universal HBV vaccination that these costs should not be
difficult to justify. HBV vaccination is currently
funded by provincial ministries of health as part of
child immunization programs (either as infants or at 12
years of age), and is also offered by public health
units to individuals in high risk populations. Providing
HBV vaccination routinely to surgical patients would
simply be an extension of a pre-existing public health
program.
It is also worth considering the
HCW's own interests in avoiding harm to their patients.
Although there are certainly other benefits to be gained
from a career in health care, the majority of HCWs are
at least partially attracted to their profession by the
desire to help people by improving their health,
well-being and/or quality of life. Certainly most HCWs
would feel at least some degree of remorse if they
learned they had transmitted HBV to one of their
patients. Surely, they would also want to avoid the
legal difficulties which would ensue.
In addition to the duties to
provide benefit and do no harm to patients, another
important role of the HCW is that of educator. Health
care workers are generally regarded with respect by
patients and often have the opportunity to serve as
societal role models. If an HCW were to reveal his/her
own seropositivity in a positive manner, this could help
reduce the stigmas and fears associated with HBV and
other infectious diseases.
In summary, the combination of
disclosing seropositivity and offering vaccination to
patients undergoing invasive procedures sufficiently
minimizes the harm to patients to make this approach
both ethically and legally acceptable in terms of
protecting patients' interests. It would also contribute
to the role of the HCW as healer and educator. However,
other important interests of health care workers such as
their right to privacy and freedom from discrimination
have yet to be addressed.
The discriminatory nature of a
disclosure of serological status policy
Several authors have argued that
infected HCWs should not be discriminated against on the
basis of their infective status [1,5,7,26].
Pinching is wary of restricting the practice of infected
HCWs, and points out "those professionals whose work
puts them at most risk from blood-borne infections from
their patients are in effect regarded as having lesser
health rights if potential transmission goes the other
way"[26].
Norman Daniels considers the conflict between patients'
and HCWs' perceptions of risks and discusses the
distinction between objective and subjective risk. On
the one hand, he points out that patients' perceptions
of transmission risks are likely to be exaggerated, but
respecting a patient's right to choose which risks they
will accept for themselves suggests we accept patients'
subjective perceptions of transmission risks. "In
contrast," he writes "the insistence on protecting the
rights of handicapped workers is intended to protect
them against the exaggerated or fabricated perceptions
of fellow workers and employers; the tendency is to
insist that the significance of the risks they impose on
others be objectively determined [5]."
Indeed it is this tension between patients' and HCWs'
interests which is at the heart of this debate.
In Canada, legal protection against
discrimination on the basis of a "handicap" can be
derived from the Charter of Rights and Freedoms,
the Canadian Human Rights Act, and the provincial
Human Rights Codes [7].
The provincial codes are probably most important in this
debate, since they cover matters within provincial
jurisdiction, which includes most health care settings.
Since at least 1992 the Ontario Human Rights Commission
has interpreted protection against discrimination to
extend to all persons infected with HIV, including those
who are asymptomatic [7].
Flanagan summarizes the protection from discrimination
of HIV-infected workers under the Ontario Human
Rights Code as being legally binding unless
"1) the infected worker is
reasonably likely to pose a serious risk to the health
and safety of her patients; 2) this risk is not similar
to the other types of risks that are associated with the
delivery of health care and generally tolerated in
society; and 3) even after accommodation the remaining
risk to the health or safety of her patients outweighs
the benefits of enhancing equality for the HIV-infected
HCW"[7].
Flanagan thus argues that although
there is some risk associated with HIV-infected HCWs
continuing to practice, this risk is extremely small and
within the range of risks society has long tolerated in
the delivery of health care.
Daniels and Gostin draw similar
conclusions. However, all authors were considering
primarily the case of HIV-infected HCWs. Does the
100-fold greater transmission risk for HBV change their
conclusions? Daniels quotes risks of death due to
general anaesthesia as 10 per million, which by his data
was 10 times greater than the risk of being infected by
a surgeon known to have HIV infection, but by newer data
(2.4 to 24 per million) is roughly equivalent. More
importantly, what these authors do not acknowledge is
that routinely acceptable risks, such as the risk of
dying from anaesthetic use, are still disclosed
to patients even though the vast majority of patients
are willing to accept these risks. There will always be
the rare patient who will refuse surgical procedures
with a high cure rate because of their unwillingness to
accept the low risks of anaesthetic and surgical
complications. Therefore, this is not a good argument
for not disclosing transmission risks, especially since
HBV is 100 times more transmissible than HIV.
It should also be acknowledged that
many HCWs who are chronic carriers of HBV acquired the
disease by virtue of being born or spending their early
childhood in a region of the world with high prevalence
of the virus. Thus, restricting the practice of these
HCWs represents a degree of discrimination against
people from certain regions of the world or from special
populations, such as aboriginal groups. Barring entry to
professional educational programs on the basis of HBV
seropositivity provokes similar ethical debates,
although they are beyond the scope of this paper. Once
again, the risks to patients and coworkers need to be
weighed against the negative effects to the individual
and the population group from which he/she comes.
Clearly, a policy which minimizes practice restrictions
for these HCWs without compromising patient safety is
preferable to a more restrictive policy.
Privacy argument
Several authors consider another
argument, which is that the serological status of an
infected HCW is information which need not be disclosed
to the patient because it is private information about
the HCW [1,5,7].
They consider other factors affecting physician
performance such as stress, fatigue, medication side
effects, family problems, legal disputes, etc. which may
affect physician performance and cause harm to patients
to the same degree as representing a transmission risk
of a blood-borne pathogen. Do patients have a right to
know this type of private information about HCWs which
might affect their consent decision? What about other
private information such as the HCW's performance on
exams, history of malpractice suits, or substance abuse?
Presumably, HCWs performing far below the standard level
of care will be reported within their institution or to
their governing body enough times that corrective action
will be taken, but what about the majority of HCWs who
perform slightly below optimal performance? Like the
discrimination argument, the potential harm to patients
must be weighed against the invasion of the HCW's
privacy and the resulting consequences to his/her
practice.
The legal precedents here do not
bode well for infected HCWs wishing to keep their
privacy. In a 1992 New Jersey case, Behringer Estate
v Princeton Medical Center, a plastic surgeon with
AIDS brought suit against the hospital for invasion of
privacy and breach of confidentiality [3,27].
The hospital was informing patients of his illness, and
as a result his practice declined. The surgeon argued
the risk of transmission was too remote to be disclosed
and that the physical condition of the physician did not
need to be disclosed under the law of informed consent.
The court ruled in favour of the hospital, stating
"physicians performing invasive procedures should not
knowingly place a patient at risk because of the
physician's physical condition"[27].
The court stated
"a reasonably prudent patient would
find information that his physician is infected with HIV
material to his decision to consent to a seriously
invasive procedure because the potential harm is severe
and the risk, while low, is not negligible. Moreover, he
can avoid the risk entirely without any adverse
consequences for his health: by choosing another equally
competent physician (where available) he can obtain all
the therapeutic benefits without the risk of contracting
HIV from his physician. The patient, then can
demonstrate not only that the information is material to
his decision, but that he would have made a different
decision had he been given the facts" [28].
In summary, there seem to be
sufficient legal precedents in favour of disclosing the
serological status of an infected HCW as part of
informed consent for an invasive procedure. Perhaps
there is some line that needs to be drawn in terms of
what personal information about the physician can be
protected from patients, but if it has any bearing on
patient safety the courts will likely rule in favour of
the patients, as they have in every case to date. The
only other form of legal protection would have to come
from statutory law, and it is difficult to foresee this
as a priority for legislators.
In ethical terms, it may be helpful
to distinguish between restrictions on an infected HCW's
practice which are unfortunate vs those which are
unfair. It would certainly be considered unfortunate if
a surgeon's vision was damaged such that his/her
operative complication rate went up dramatically. Would
it be considered unfair if this surgeon's operating
privileges were taken away? It would be unfair if one
surgeon's privileges were taken away for this reason and
another surgeon's privileges were unchanged. The type of
fairness being considered falls under the theoretical
term "formal" justice, and involves treating like cases
alike and treating different cases differently [25].
The other type of fairness or justice that should be
considered is distributive justice, which involves
distributing the benefits and burdens of a policy or
decision equally among the different groups involved. It
certainly is unfair if infected HCWs bear all the
burdens of what is a public health problem, but we argue
that this unfairness is best remedied through
compensatory measures, i.e. retraining and/or financial
compensation, rather than putting patients at risk.
Accordingly, the recommendations we propose below allow
for an infected HCW to continue to practise invasive
procedures on susceptible patients only if he/she is
willing to disclose his/her seropositivity. If privacy
is more important to the HCW, then he/she should be
given retraining and financial compensation
opportunities. We should also remember that many HCWs
have disability insurance plans of some kind which are
designed to make up a percentage of the lost income due
to health reasons. However, there are many HCWs,
particularly physicians, who do not have coverage, and
not all plans will provide compensation for entities
such as HBV infection.
Systemic effects of disclosure vs
non-disclosure
There are several utilitarian
arguments to be made in favour of non-disclosure.
Daniels argues "we get better protection against HIV
transmission by emphasizing infection controls than we
do by isolating and switching from, or restricting the
practice of, HIV-infected surgeons and other health care
workers [5]."
He argues resources are more effectively utilized in the
areas of general infection control measures and
epidemiological research.
Daniels' arguments in this regard
are very compelling. Certainly measures taken to screen
for and restrict the practices of infected HCWs should
not be at the expense of education, improvements in
infection control, and epidemiological research.
However, we know how much the courts favour disclosure,
thus we are obliged to consider the time and resources
which would be lost in legal disputes if disclosure did
not occur. As well, it may be practically difficult for
a HCW to have imposed practice restrictions and for them
not to disclose to patients and co-workers the reason
for the restrictions. The resulting rumours may end up
being worse than the reality.
There are other systemic
implications to be considered, in particular,
interference in the delivery of services. Since risks to
HCWs of contracting a blood-borne pathogen are higher
than the risks to patients, more HCWs may refuse to
treat sero-positive patients [5,7].
They may demand that patients be screened for
blood-borne pathogens and risk factors prior to
performing invasive procedures [5].
HCWs may also be less willing to undergo serological
testing if they fear the consequences of a positive
result [26].
The current climate of uncertainty
as to what happens to HCWs who are discovered to be
HBsAg-positive undoubtedly contributes to the fear that
HCWs who perform invasive procedures must feel. The
prospect of having one's entire career and livelihood
decided by an "expert panel" with few governing
guidelines is certainly worthy of fear. If the
guidelines were more directive and allowed HCWs more
opportunity to practice under conditions which did not
represent unacceptable compromises for patients, this
would likely relieve some of the fear and anxiety
amongst HCWs who perform invasive procedures.
In summary, it is hard to clearly
favour any policy approach over another in terms of
utilizing the least resources or causing the least
interference in the delivery of health care services.
What about retrospective
disclosure?
A recent survey of patients in
Scotland who had been informed by letter of their
exposure to a HBeAg positive dentist provides support
for retrospective disclosure of exposure to a
newly-discovered seropositive HCW [4].
The survey was mailed to a random sample of 528 patients
representing 10% of the patients in 3 of the 4 health
board areas, and 291 (55%) responses were received.
Ninety-three percent of respondents to this survey felt
that patients should always be informed if they have
been treated by an infectious health care worker, even
if the risk was very small. Sixty-one percent of
respondents agreed they should have been informed by
letter, whereas 29% preferred to be informed in person.
In the discussion, Blatchford et
al. refer to the Association for Practitioners in
Infection Control (APIC) rationale for recommending
retrospective patient notification [29].
They state three purposes behind such exercises:
"1. It may enable patients infected
by disease transmitted from the health care worker to be
identified.
2. Exposed patients may be offered
a prophylactic medical intervention to reduce their risk
of subsequently developing the disease.
3. Epidemiological studies to
define the risk of transmission of disease from health
care workers to patients may be undertaken."
Blatchford et al. point out a
deficit in the APIC statement in that it does not
consider the patient's right to information as rationale
for doing retrospective notification.
Although the patients can no longer
make a decision about undergoing the procedure performed
by the infected HCW, because this has already occurred,
the information is important to them for making informed
decisions about the rest of their lives. They will need
this information to get the necessary screening to see
if transmission has occurred and follow-up to avoid
complications if transmission has occurred. They should
also be educated about their risk of transmitting the
infection to others and associated prevention measures.
Arguments against retrospective
notification of patients are the time and costs
involved, and the creation of undue anxiety, as only a
small minority of patients notified will have contracted
the infection. However, if the patients discovered at a
later date that they had been exposed and not notified
of the exposure, this would certainly have deleterious
consequences with regard to their trust in the health
care professions and the patient-HCW relationship.
Recommendations for restricting the
practice of HBV-infected HCWs
What we propose below is a set of
recommendations to be considered by governing bodies
when making decisions about restricting the practice of
HBV-infected HCWs. These recommendations take into
account the relatively high transmissibility of HBV, the
available means of preventing HBV transmission, and the
legal and ethical arguments in favour of disclosure to
patients of transmission risks, including the elevated
risks if an involved HCW is known to be seropositive.
The recommendations do not mandate disclosure or
non-disclosure, but offer infected HCWs further
opportunities to practise invasive procedures without
jeopardizing patient safety and autonomy if they are
willing to relinquish some privacy and reveal their
seropositive status.
1. All patients undergoing
exposure-prone procedures should be informed of the risk
of acquiring a blood-borne pathogen such as HBV during
the procedure, regardless of their HBV status. This
should be disclosed as part of the general pre-operative
consent process, along with other routine risks such as
hemorrhage, wound infection, and anaesthetic risks.
2. All patients undergoing
exposure-prone procedures should be asked for
documentation of a complete immunization series or of
positive HBsAg serology if previously performed.
Patients with no such documentation should be tested for
protective antibodies as part of the pre-operative
workup. Patients who are not immune should be offered
the option of vaccination prior to undergoing an
elective or non-urgent procedure.
3. Physicians (or other HCWs) with
known HBsAg seropositivity (regardless of their HBeAg
status) should be allowed to perform exposure-prone
procedures on patients with documented immunity to HBV,
either from previous infection or from immunization.
They need not disclose their seropositivity to these
patients, as the transmission risk is no longer an
issue.
4. HBV-seropositive HCWs may
perform an exposure-prone procedure on a patient who is
not immune to HBV provided the patient is a) informed of
the elevated risk of infection during the procedure due
to the HCW's known seropositivity, b) offered the
services of a replacement seronegative HCW to perform
the procedure, and c) after considering these options,
the patient chooses to have the procedure performed by
the infected HCW.
5. When an HCW is discovered to
test positive for HBsAg, all patients who underwent
exposure-prone procedures performed by the HCW should be
traced and notified of their now elevated risk of having
contracted HBV during the procedure. They should be
offered serological testing and counselling. This
process should be a public health responsibility, and
not the responsibility of the infected HCW.
It should be noted that these
recommendations may not be practical for student HCWs
who are HBV seropositive. It will be more difficult for
these to keep their seropositivity confidential as they
rotate frequently through different services. A large
number of people would need to know the practice
restrictions which apply to them in order to avoid
putting non-immune patients at risk of contracting HBV.
As well, disclosure opportunities to patients would be
more difficult, since students are often requested to
assist in procedures with minimal advance notice, and
students do not have the same type of relationship with
patients as staff HCWs. |
|
Summary
Hepatitis B vims is unique amongst
transmissible pathogens due to its high transmissibility
and its preventability, and therefore ethically and
legally acceptable practice restrictions for
HBV-infected HCWs are not necessarily equivalent to
those for HIV- or HCV-infected physicians. Policy
regarding practice restriction of HBV-infected HCWs
should take into account the interests of patients, HCWs
and the implications of any policy to the health care
system at large. The current policy in Canada leaves too
much discretion in the hands of vaguely defined expert
panels, and is likely contributing to fear and anxiety
amongst HCWs who are at risk of acquiring and
transmitting infectious pathogens. Providing vaccination
against HBV to patients undergoing elective procedures
reduces transmission risks and complements existing
vaccination programs. Allowing HBsAg-positive HCWs to
practise without restrictions on patients who have
already been infected with or vaccinated against
HBV-would allow these HCWs to continue their career with
minimal interference. This also avoids undue
discrimination against these HCWs. The option for these
HCWs to disclose their seropositivity to susceptible
patients provides an opportunity for patients to choose
what risks they are willing to accept in the course of
their health care, for HCWs to educate their patients
about infectious diseases such as HBV, and for infected
HCWs to perform more exposure-prone procedures.
Retraining and financial compensation should be
available for those HCWs who choose not to disclose. |
|
Competing Interests
None declared |
|
Acknowledgements
The authors would like to thank
Shari Gruman for help in preparing the manuscript. Dr
Upshur is supported by a research scholarship from the
Department of Family and Community Medicine, University
of Toronto and a New Investigator Award from the
Canadian Institutes of Health Research. |
|
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