Disclosure of Critical Incidents & Patient Safety Events

1. Disclosure of Critical Incidents & Patient Safety Events CHRMN Annual Conference September 24, 2014 Melanie de Wit

2. Terminology • Critical incident • Terminology from the Public Hospitals Act MngmtReg, 2010 • Unintended event resulting in deathor 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 consequences), • No harm (event reaches patient); and • Near miss events (event does not reach patient, “close call”)

3. 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

4. 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

5. 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

6. 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 disclose • Disclosure policy – key points • Disclosure done by HCP who can answer questions • Avoid speculation • Express regret • Identify contact

8. 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

9. Investigation – Critical incident • ECFAA requires that hospitals have a system for ensuring that • (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

10. 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

11. 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

12. 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 proceedings • Information is not subject to disclosure under FIPPA

13. QCIPA review cont’d • Information may only be disclosed for limited purposes: • 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 result

14. 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

15. 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 privilege” • Advantage: can be waived • Disadvantage: won’t know prospectively whether privilege applies • **Confidentiality is essential for claim of quality assurance privilege**

16. 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 work Confidentiality statement at outset of review meetings

17. 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

18. 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

19. 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

20. 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- Large-Scale Adverse Events, New England Journal of Medicine, 363, 978-986 • Examples: privacy breach, sterilization failure, infectious disease, food contamination

21. 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

22. 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

23. 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?

24. The importance of process • Pittman Estate v. BainPittman 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”

25. 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

26. 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

27. Should patients be notified? Examples • Privacy breach

28. 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

29. Should patients be notified? Examples • Sterilization failure

30. Should patients be notified? Examples • Sterilization failure or “reusable” syringes • Only know actual harm if test patients, e.g., for blood-borne pathogens • 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 FarkasTRUS biopsy class action: No transmission of disease found

31. Should patients be notified? Examples • Diagnostic Imaging

32. 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

33. How should patients be notified? • Minimize unnecessary patient distress • Medium, mannerand 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’

34. 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 disclosure • Stress of receiving reasonable notice should no longer be compensable in negligence claim • Lakeridge v. Healey

35. Thank you Questions? mdewit@blg.com 416-367-6180