CHRMN – Disclosure Presentation September 24, 2014

Disclosure of Critical Incidents &
Patient Safety Events
CHRMN Annual Conference
September 24, 2014
Melanie de Wit
• Critical incident
• Terminology from the Public Hospitals Act Mngmt Reg, 2010
• Unintended event resulting in death or serious disability/injury/harm
• Exception: known risk or underlying condition
• Statutory obligations related to investigation and disclosure
• Patient safety event
• Broader term that also includes
• Lower harm (event reaches patient, results in < serious
• No harm (event reaches patient); and
• Near miss events (event does not reach patient, “close call”)
Critical incident or Patient safety event?
• What is “serious disability, injury or harm”?
• Oxford Dictionary – important, demanding consideration,
not slight or trifling
• Legal Dictionary – important, weighty, momentous, grave
• What is “does not result primarily from the patient’s
underlying medical condition or from a known risk
inherent in providing the treatment”?
• Clear – wrong side surgery; retained sponge
• Less Clear – adverse outcome that is a recognized risk of
the treatment
Disclosure – Critical Incidents
• 2 legal obligations to patient:
• As soon as practical, disclose to the patient (or SDM)
• (a) the material facts of what occurred;
• (b) the consequences for the patient as they become
known; and
• (c) the actions taken and recommended to address the
consequences to the patient (eg. treatment)
• Following the review, disclose systemic steps, if any, that the
hospital is taking/has taken to reduce the risk of similar
critical incidents
• Both disclosures must be documented in chart
Disclosure – Critical incidents
• The board has an obligation to ensure that there is a
system for ensuring the disclosure of a critical incident,
as soon as is practicable after the CI occurs
• (a) to the MAC;
• (b) to the administrator; and
• (a) to the affected patient/SDM
• Aggregated critical incident data to Board min. 2x/year
• Feed into annual quality improvement plan
Disclosure – Patient safety event
• Canadian Disclosure Guidelines
• Harm to patient = disclose
• Reached patient, no harm = generally disclose
• Did not reach patient (near miss) = generally do not
• Disclosure policy – key points
Disclosure done by HCP who can answer questions
Avoid speculation
Express regret
Identify contact
Apology Act, 2009
• “apology” means an expression of sympathy or
regret, saying sorry, etc.
• Apologies are inadmissible, do not constitute
admission of fault, cannot void insurance
Investigation – Critical incident
• ECFAA requires that hospitals have a system for ensuring
• (1) critical incidents are analyzed, and
• (2) that a plan is developed with systemic steps to avoid or
reduce the risk of further similar incidents
• Critical incidents must be subject to a quality review
Investigation – Patient safety event
• Patient safety events that are not critical incidents
may be subject to a quality review
• Hospital policy should set out process and criteria
for triggering formal systems reviews of patient
safety events
• Severity of harm
• Frequency of similar events
• Potential for harm
Conducting the quality review
• Hospitals want to foster a culture of patient safety
• Patient safety work is not effective without robust
participation from staff
• The importance of confidentiality to robust
participation from staff
Options for conducting a quality review:
1- QCIPA review
• Quality of Care Information Protection Act (2004)
• Provides for privileged (protected) reviews of quality of
care issues
• Committee must be specifically designated
• Information from these reviews (“quality of care
information”) cannot be used or disclosed in legal
• Information is not subject to disclosure under FIPPA
QCIPA review cont’d
• Information may only be disclosed for limited
• To management for quality of care purposes
• By management to employees/consultant for quality
of care purposes
• To eliminate or reduce significant risk of serious bodily
harm to persons
• To patient: facts learned in review, changes made as
QCIPA review cont’d
• “quality of care information” does not include,
• information in a patient’s medical record
• information contained in a record that is required by
law to be created or to be maintained
• facts contained in a record of an incident which are
not recorded in the patient’s chart
• the fact that a quality of care committee met or
conducted a review
• when the meeting or review took place
Options for conducting a quality review:
2- Quality review outside of QCIPA
• There are reasons for/against reviewing patient
safety events through QCIPA, may be case-specific
• May still be able to claim “quality assurance
• Advantage: can be waived
• Disadvantage: won’t know prospectively whether privilege applies
• **Confidentiality is essential for claim of quality
assurance privilege**
Quality reviews – Best practices
• Centralize record-keeping
• Label documents clearly as confidential &
privileged, to be used only for patient
safety purposes
• No dissemination outside of patient safety
• Confidentiality statement at outset of
review meetings
Confidentiality & Privilege
• Confidentiality and confidential atmosphere
important in system reviews
• Absence of culture of confidentiality = chilling effect
on communications necessary for robust patient
safety work
• Unless done under QCIPA, courts will evaluate on a
case by case basis whether information is protected
by privilege – so either way, confidentiality is key
Incident report
• Often first communication of a patient safety event
outside of circle of care
• Completed proximate to event, before author is able
to appreciate all factors that led to event
• Often completed by a health care provider who is
acutely impacted by event
Incident report
• Assume it will be disclosed to the patient in the
course of litigation
• Do not file on patient’s chart
• Incident reporting form should be structured to elicit
relevant factual information
• Emphasize factual, concise documentation
Multi-patient safety incidents
• “…individual events or a series of related events that
injured or increased the risk that many patients
would be injured because of health care
management. The increased risk was not anticipated
by health care professionals, and was not
recognized at the time of the incident.”
Dudzinski, DM et al. (2010) The Disclosure Dilemma- LargeScale Adverse Events, New England Journal of Medicine, 363,
• Examples: privacy breach, sterilization failure,
infectious disease, food contamination
Challenges of a multi-patient incident
• Typically involves the retrospective detection of a
potential harm to multiple patients
• Often do not know that actual harm has occurred
• Many/most patients experienced no harm or near miss
• Pool of potentially affected patients may be very large
& may or may not be readily identifiable
• Probability of harm and its severity will vary on a case
by case basis
Challenges of a multi-patient incident
• May be urgent: balance between conducting a timely
and thorough risk assessment
• Risk assessment and notification are resource
intensive and multidisciplinary
• Balancing harm from potential risk with harm
from disclosure
Should this be disclosed?
• In multi-patient events
• Concern that some patients may have been harmed,
but usually risk has not yet been assessed/quantified
• For some/most/all patients, the event did not reach
them or the event reached them but did no harm
How to decide whether, when and who to notify?
The importance of process
• Pittman Estate v. Bain Pittman Estate v. Bain (1994),
112 DLR (4th) 257 (Sup.Ct.)
• Conduct a lookback in a timely fashion
• Use medical and scientific knowledge to ascertain the risk
• Design an effective program, based upon administrative
capabilities and reasonable priorities, to warn the blood recipient
in a timely manner
• Notify patient or patient’s physician “in a manner and in a time
commensurate with the risk to their health”
Multi patient events:
Should patients be notified?
• Conduct risk assessment
• Multidisciplinary- may include clinical specialties, epidemiologist,
microbiologist, etc.
• Ascertain likelihood of clinical consequences (how likely?) and
severity of consequences (how bad?)
• Consider whether external experts should weigh in
• Create list of potentially affected patients
• Involvement of IT, Facilities, etc.
• Be wary of over- or under-notification
Should patients be notified? (cont’d)
• Consult more broadly in close calls
• Ethics, legal, patient representative
• Question: Would the reasonable patient in these circumstances
want to know?
• Urgency is determined by the ability to prevent,
identify or mitigate future harm through clinical
testing or treatment
• Ie. Where intervention to mitigate the risk is possible (eg.
availability of prophylactics), urgency is highest
• Urgency impacts ability to thoroughly assess risk at the outset
Should patients be notified? Examples
• Privacy breach
Should patients be notified? Examples
• Privacy breach
PHIPA statutory disclosure duty
If PHI “stolen, lost, or accessed by unauthorized persons”
Notify “the individual”
“At the first reasonable opportunity”
Timing issues
Involvement of Privacy Commissioner
PHIPA s. 65 damages for privacy breach
Montfort lost and then found USB class action
Should patients be notified? Examples
• Sterilization failure
Should patients be notified? Examples
• Sterilization failure or “reusable” syringes
• Only know actual harm if test patients, e.g., for blood-borne
• Literature research, consult expert re risk of harm
• Statistical analysis of risk of harm and numbers involved
• 1 in million risk of HIV?
• 1 in 100,000 risk of Hep B?
• Ultimately a medical decision
• Involve public health
• If material risk of harm, proceed with notice/testing protocol
• Sunnybrook v Farkas TRUS biopsy class action: No
transmission of disease found
Should patients be notified? Examples
• Diagnostic Imaging
Should patients be notified? Examples
• Diagnostic Imaging
• In contrast with sterilization example, review could be done without
notifying patients
• But should it?
• Pathology/radiology tests have baseline error rate
• Some errors more obvious than others. A lot of judgment involved.
• Some require context
• Many errors will have been caught in other follow up
• If clinically significant error found, must notify
• At what point in a review process do we notify patients that their
images/specimens are under review?
• Ethical issues re notice to next of kin
• Miramichi class action
How should patients be notified?
• Minimize unnecessary patient distress
• Medium, manner and content of disclosure are important
• In person vs by phone vs by letter vs website statement
• Consider volume of patients affected, urgency, required follow
up testing/treatment, relationship to care providers
• Who authors the notification?
• Level of detail and clarity of language
• Availability of follow up supports
• Multidisciplinary: clinical, legal, ethics, communications, privacy, IT
• Potential exists for claim of ‘negligent notification’
Multi patient events
• If considering review/notice, tell HIROC from day one
• Considerable experience on these issues
• Every multiple patient situation unique, needs
careful reflection
• Need plan/resources for follow-up in place if going to do
• Stress of receiving reasonable notice should no
longer be compensable in negligence claim
• Lakeridge v. Healey
Thank you
[email protected]

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