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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 (240–2,400
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.
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