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Quality Assurance Reviews - An Update: Quality of Care
Information Protection Act, 2004
Kristin L. Taylor
Presented at the HIROC-OHA conference held on June 7-8, 2004
… As the practice of medicine becomes more
complex and more specialized, the individual
physician becomes more dependant upon his
colleagues.
The process of continuing education and the
process of determining whether or not services
1
Note: The terms “peer review”, “quality assurance review”, “error and risk management review”,
“ethics review”, “utilization review”, “outcome review” and “medical review” can be used interchangeably in
the context of this paper. All are meant to describe reviews undertaken to examine and assess the quality of
care given to patients.
2
(1996) 137 D.L.R. (4th) 410.
•
TORONTO
•
OTTAWA
•
In discussing, the importance of confidentiality in peer
review, Dr. McLaughlan in his written report, continues:
MONTRÉAL
The Nova Scotia Supreme Court in Foley v. Cape Breton Regional Hospital2
quoted at length from the report of an expert witness regarding peer review
activities in a matter where the patients' families were seeking disclosure of
investigation reports following the death of three patients at the Hospital.
Concerning the expert's view, the Court stated:
•
It is becoming relatively commonplace for hospitals to undertake quality
assurance or peer reviews1 in the wake of an apparent medical error.
Confidentiality is a crucial element in these peer review activities. Without
confidentiality assurances, physicians and other health care professionals would
refuse to participate in or fail to bring candour to such activities. Peer review is an
essential component of hospital administration to ensure that quality of care
standards are maintained and that health care providers are open and frank in their
discussions pertaining to the quality of care provided by each other.
VANCOUVER
Introduction
CALGARY
I.
Quality Assurance Reviews - An Update: Quality of Care Information Protection Act, 2004, by Kristin L. Taylor
being provided are at a satisfactory level
requires regular reassessment. Sometimes this
can be done by self-assessment, but often it is
necessary to have one's work assessed by a
peer in order to obtain objectivity. In short, the
entire process whereby a person becomes a
physician and practiscs [sic] medicine creates a
mindset to assist other physicians and not to do
anything which may harm him. Intellectually,
physicians realize that there is need to analyze
the work of the profession in a critical way, but
they will do only if they feel confident that it is
going to be used only for the betterment of the
profession and its ervice [sic] to the public.
On the other side of the coin, in the process of
peer review the individual physician must allow
his peers to examine his dirty linen, tell him how
dark is the shade of grey, and how he can make
it cleaner. … peer review is a process in which
many, if not most, will participate only if they
believe that they are not exposing themselves to
an unacceptable risk. They must believe that
their soul-searching is behind closed doors and
will not be used to destroy them. Not only must
it be confidential, but the physicians must feel
secure with that confidentiality.
IMPORTANCE OF PEER REVIEW TO
HOSPITALS. Hospitals, as corporate citizens,
have a responsibility to see that the care that
they provide to the public is of the highest quality
possible.
No hospital can maintain its
accreditations
without
Quality
Assurance
Programs being carried out on a regular basis. ...
Quality Assurance Programs also involve peer
review in many different forms. All of the
professional people in the hospital should be
carrying out peer review on a regular basis.
DOES THE PUBLIC HAVE AN INTEREST IN
PEER REVIEW? ... the public wants to see that
the hospital to which it will turn for emergency
health care has a three year accreditation and it
wants to know that the Accreditation Council has
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Quality Assurance Reviews - An Update: Quality of Care Information Protection Act, 2004, by Kristin L. Taylor
checked to see that the quality assurance
programs are in place. Peer review is part of
those quality assurance programs. Does the
public have an interest in peer review? Yes, it
does.3
Issues can arise regarding the production of the documentation generated by a
peer review process if, after its completion, a legal action is commenced regarding
the subject matter reviewed. Generally, in the course of a civil action, any relevant
documentation regarding the cause of action must be produced to the other side
unless protected by a classification of “litigation privilege”. The courts have held
that if a review or investigation is completed because the dominant purpose was
the expectation of litigation, the documentation generated can be declared
privileged and production can be refused. However, if the review or investigation is
undertaken solely for internal purposes, then a successful claim for privilege may
be more difficult.
II.
Present State of Law in Ontario
At the present time, all Canadian provinces, with the exception of Ontario, have in
place legislation which protects from disclosure, information and records pertaining
to certain hospital committees in certain circumstances.4 However, Bill 31 – Health
Information Protection Act, 2004 has received Royal Assent. Schedule B to this
Act is the Quality of Care Information Protection Act, 2004. This Act deals
specifically with the issue of the protection of quality assurance information from
disclosure. It will come into force in November of 2004.
The next section will look at the new legislation closely. However, there will still be
occasions where the common law will have to be relied upon to protect quality
assurance/peer review information from being disclosed in a litigation process. It is
therefore imperative for hospitals to understand the implications of the common
law on this issue.
A.
Common Law - Are quality assurance reviews “privileged”?
In addition to litigation privilege, the Supreme Court of Canada has acknowledged
the existence of another class of documentation to be declared privileged if certain
criteria are met. Named after a noted American professor of the law of evidence,
3
Ibid. at 426.
See the Act respecting Health Services and Social Services (L.R.Q.), c.S.-4.2, ss. 190, 213, 214 and
218; Evidence Act, R.S.N.L 1990, c.E-16, s.6.1 (amended); Medical Act, R.S.P.E.I., c.M-5, s.38; Evidence
Act, R.S.A., 1980, c.A-21, s.9; Evidence Act, R.S.N.S., 1989, c.154, s.60; Evidence Act, R.S.M., 1987, c.E150, s.9; Saskatchewan Evidence Act, ss.1989-90, c.57, s.35.1 (as amended); Evidence Act, R.S.N.B., 1973, cE-11, s.43.3; Evidence Act, R.S.B.C., 1996, c.124.
4
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Quality Assurance Reviews - An Update: Quality of Care Information Protection Act, 2004, by Kristin L. Taylor
the “Wigmore Test” for common law privilege was detailed in Slavutych v. Baker5
where the court outlined four criteria which, if met, classify a document as
privileged thereby protecting it from production in a litigation action. The criteria
are:
1. The communications must originate in a confidence that they will not be
disclosed;
2. This element of confidentiality must be essential to the full and satisfactory
maintenance of the relation between the parties;
3. The relation must be one which in the opinion of the community ought to be
sedulously fostered; and
4. The injury that would inure to the relation by the disclosure of the
communications must be greater than the benefit thereby gained for the
correct disposal of litigation.6
There is much case law where the Wigmore Test has been successfully applied
thereby classifying a document as privileged. In Slavutych v. Baker, the court
applied the test to a tenure form sheet completed by a professor at the University
of Alberta. On this form were comments made by the professor that were adverse
to the interests of a colleague in his application for a tenured position at the
University. The court held that the tenure form sheet was privileged and should,
therefore, not be disclosed. With respect to the fourth criteria, the court placed
particular emphasis on the fact that there had been assurances made by the
University to the professor that the form would remain confidential and as such, the
professor agreed to complete the sheet.
A similar argument has been made regarding quality assurance review
documentation where, throughout the investigation, assurances are made to the
participants of the review that the opinions expressed are to remain confidential.
There had been several unsuccessful attempts to apply the test to documentation
generated by a hospital’s clinical review committees. Only recently has the Ontario
court supported arguments that information generated during a specific peer
review process should be considered privileged following application of the
Wigmore criteria.
In Steep et al. v. Scott et al.7, a motion was brought by the plaintiffs to compel the
defendant Hospital to produce two documents contained in the Hospital’s Affidavit
of Documents. The action pertained to a medical malpractice allegation stemming
5
6
7
(1975) 55 D.L.R. (3d) 224.
Ibid. at 229.
(2002), 62 O.R. (3d) 173.
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Quality Assurance Reviews - An Update: Quality of Care Information Protection Act, 2004, by Kristin L. Taylor
from the birth of the minor plaintiff, Liam Steep. Liam sustained severe brain injury
at birth. The two documents at issue were memoranda between physicians who
agreed to take part in a quality assurance review process following Liam’s birth. In
the Affidavit of Documents, and again at the motion, the Hospital took the position
that the memoranda were privileged under common law.
In its analysis, the Court applied the Wigmore test. The first criterion considered
was whether the communications originated in a confidence that they would not be
disclosed. This criterion was held to have been met by the Hospital as it was
apparent that the investigation was conducted by the Chief of the Department of
Obstetrics on the request of the Hospital and that all interviews took place on a
confidential basis.
The second and third conditions considered pertained to the essential nature of the
confidentiality to the maintenance of the parties’ relationships and that the
relationship was one which, in the opinion of the community, ought to be
sedulously fostered. The Hospital argued that the relationship between medical
staff and quality assurance committees depend upon open and candid
communication that only comes following the assurance that such communications
will be confidential. The plaintiff, on the other hand, relied on the mandatory nature
of quality assurance reviews pursuant to the Public Hospitals Act and argued that
reviews would take place whether or not they were confidential thereby making
confidentiality not essential to the process. The Court considered the arguments of
the parties and ultimately held that the second and third criterion had been met.
In support of the defendant’s position, Master Jane Egan stated:
In my view, the free exchange of information, promoted
by confidentiality, goes to the very core of successful
quality assurance reviews leading to the improvement
of quality care. It is in the public interest that hospital
care and services are effectively assessed and
improved to ensure a continuously improving quality of
health care.8
The fourth criterion considered pertained to whether or not the injury resulting from
the disclosure of the communications would be greater then the benefit gained by
the disclosure. The Court very carefully examined the facts of this case and
balanced the parties’ positions with regard to perceived injury following disclosure
or non-disclosure of the documentation. It was decided that the injury to the
relationship between the Chief of the Department and other staff participating in
8
Ibid. at para 26.
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Quality Assurance Reviews - An Update: Quality of Care Information Protection Act, 2004, by Kristin L. Taylor
the review process would be injured to a great degree if the memoranda were to
be disclosed. It was also held that the injury to the plaintiffs in this case was not of
a sufficient degree to tip the scale in favour of disclosing the document. The Court
ultimately held that the fourth Wigmore criterion had been met and the Hospital
was successful in protecting the two documents from disclosure.
As indicated above, this is the first case, after numerous attempts, to have been
successful in having quality assurance documents protected by privilege. Despite
this success, the decision of Master Egan is very fact-based and therefore, an
important conclusion to draw is that the question as to whether or not privilege
applies will be decided on the facts of each case and cannot be predicted with
certainty. The Steep decision is not a definitive statement of the law of quality
assurance privilege.
B.
Quality of Care Information Protection Act, 2004
The unpredictable common law protection will soon be supplemented with more
definitive legislative protection. The Quality of Care Information Protection Act,
2004 9(QCIPA) has been drafted to specifically protect quality assurance
information from disclosure.
Under QCIPA, subject to exceptions, information generated for the purposes of a
“quality of care committee” may not be disclosed and may not be accessed by
patients. The process by which this information is generated, protected and
disclosed is entirely mandated by the Act.
A “quality of care committee” is defined as a committee specifically designated as
a Quality of Care Committee (“Committee”). The functions of the Committee are:
“to carry on activities for the purpose of studying, assessing or evaluating the
provision of health care with a view to improving or maintaining the quality of the
health care or the level of skill, knowledge, and competence of the persons who
provide the health care”.
“Quality of care information” is defined as information collected by or prepared for a
Committee for the sole or primary purpose of assisting the Committee in carrying
out its functions. It also includes information which relates solely or primarily to
any activity that the Committee carries on as part of its functions. Information
excluded from the definition of “quality of care information” is:
-
information found in patient health records that pertains to the
provision of health care;
9
The third reading version which received Royal Assent can be found at
http:/www.onla.on.ca/documents/Bills/38-Parliament/Session1/b031ra_e.htm.
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Quality Assurance Reviews - An Update: Quality of Care Information Protection Act, 2004, by Kristin L. Taylor
-
information found in a record that was generated as a requirement of
law; and
any facts contained in an incident report pertaining to the provision of
healthcare if the facts are not fully recorded in the patient’s record.
The most important section of QCIPA is section 5:
5. (1) No person shall ask a witness and no court or other body holding
a proceeding shall permit or require a witness in the proceeding to
disclose quality of care information.
(2) Quality of care information is not admissible in evidence in a
proceeding.
This section clearly and concisely provides the protection that Ontario health care
providers have been without, namely, the protection from disclosure of information
generated in peer review processes or quality assurance activities. “Proceeding”
has been defined to include any proceeding that is within the jurisdiction of the
Legislature and that is held in, before or under the rules of a court, tribunal,
commission, justice of the peace, coroner, College committee, arbitrator or
mediator.
What is important for hospitals to recognize is that, in order to ensure the
protection of the Act for quality assurance/peer reviews, only a hospital committee
designated specifically to carry out the functions described by the Act can be
involved in the process. This would include the work generated by delegates of
the Committee both before and during the quality of care review process. The
legislative protection would not be afforded in situations where reviews are carried
out by individuals or groups in the hospital which have not been properly
designated as a Committee or that a properly designated Committee works beyond
its mandated purpose. The information generated in these situations would fall to
the whim of the common law.10
Despite the provisions of the Personal Health Information Protection Act, 2004
(“PHIPA”) which has also received Royal Assent, a person may disclose any
information, including personal health information, to a Committee for the purposes
of the Committee. The disclosure of personal health information without the
patient’s knowledge or consent stops at the Committee. QCIPA stipulates that no
person shall disclose quality of care information except where permitted by the Act.
There are two such scenarios.
10
For an example of where the limitations of the legislative protection were challenged and considered
judicially please see Sinclair v. March [2000] B.C.J. No. 1676 (QL) and Doyle v. Green, (1991), N.B.J. No.
553, November 25, 1996.
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Quality Assurance Reviews - An Update: Quality of Care Information Protection Act, 2004, by Kristin L. Taylor
First, if the Committee considers it appropriate for the purposes of improving health
care, it may disclose quality of care information to the management of the health
facility. An example of this situation would be where a process in the hospital was
the subject of a quality assurance review and was found to be defective in some
way. The Committee may decide that it is appropriate to advise the management
of the Hospital of the defects so that steps can be taken to correct the problem.
A second scenario permitted by the Act pertains to where a person may disclose
quality of care information if the disclosure is necessary for the purposes of
eliminating or reducing a significant risk to a person or group of persons.
The Act also provides immunity to members of the Committee and participants in
the quality assurance review where their involvement is found to be in good faith.
It is an offence under the Act to disclose quality of care information in
contravention of the Act. It is also an offence to retaliate in anyway against
someone who has participated in a Committee process. The offence for an
individual is a fine of not more than $50,000 and for a corporation, not more than
$250,000. The Act allows for the possibility of a personal penalty on a director,
officer, member, employee or agent of a corporation who is found to have directed,
authorized, assented to, acquiesced in or participated in the commission of the
offence.
III.
Conclusion
Quality assurance reviews are an indispensable and time-honoured means of
examining medical errors with the goal of preventing further mishaps and
improving health care services. These are important objectives. Every other
province in Canada has recognized the importance of protecting these activities
from disclosure by legislative protection. Finally, Ontario is on the eve of having
similar protection.
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Quality Assurance Reviews - An Update: Quality of Care Information Protection Act, 2004, by Kristin L. Taylor
However, there will continue to be instances where information generated through
peer review/quality assurance reviews will not attract the protection of QCIPA.
Reviews conducted by individuals or groups not properly designated as quality of
care committees and information generated outside the scope of a quality of care
committee, will not be protected from disclosure. In those situations, hospital risk
management teams need to be aware that, in the absence of specific legislative
protection, the documentation generated will be exposed to the unpredictable
common law where a classification of a privileged document will not occur unless
the facts of the case allow the Wigmore criterion to be successfully applied. If
arguments are not successful, the documentation may be produced in a future
proceeding.
As a result, it is recommended that the person/committee
contemplating a quality assurance review should make an assessment of the
seriousness of the issue involved and decide whether or not the hospital’s insurer
or legal counsel should be contacted for further guidance before its work begins.
With the passing of QCIPA, the environment in which health care providers strive
to improve the quality of their practices will be enhanced. This legislation will allow
for open, honest and constructive self-appraisal without fear of disclosure.
Hospitals are encouraged to designate quality of care committees with the
purposes mandated by the act immediately.
Without QCIPA’s protection,
Hospital’s can be left with quality assurance processes vulnerable to disclosure
and with participants in the process being more concerned about their personal
exposure then the overall improvement of the provision of health care.
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