Canadian Disclosure Guidelines

1. Canadian Disclosure Guidelines

2. Disclosure - Background • Process began: May 2006 • Background research and document prepared • First working draft created • National consultation – May/June 07 • Consultation kicked off by national conference call May 2007: >450 participants • Further discussion and revisions • Finalized version of the guidelines developed

3. Objectives • Facilitate patient/healthcare provider communications that respect and address the needs of patients and strengthen relationships; • Promote a clear and consistent approach to disclosure; • Promote interdisciplinary teamwork; and • Support learning from adverse events.

4. Introduction • “Achieving a culture of patient safety requires open, honest and effective communication between healthcare providers and their patients. Patients are entitled to information about themselves and about their medical condition or illness, including the risks inherent in healthcare delivery. Autonomy, the patient’s right to control what happens to his or her body, is the cornerstone of the informed consent discussion.” p.8

5. Guiding Principles • Patient-centered healthcare; • Patient autonomy; • Healthcare that is safe; • Leadership support; • Disclosure is the right thing to do; and • Honest and transparent.

6. Application of the Guidelines • Healthcare providers in healthcare facilities, independent practice, and/or the community. • Not intended to dictate the policies or provide rigid practices for disclosure • Variations expected and encouraged to facilitated adaptation to local circumstances • Disclosure policies should be developed with legal advice from counsel familiar with applicable legislation.

7. Definitions • Disclosure is the process by which an adverse event is communicated to the patient by healthcare providers. • Adverse event (AE) results in unintended harm to the patient, and is related to care and/or services provided to the patient rather than to the patient’s underlying medical condition. • Harm is an outcome that negatively affects a patient’s health and/or quality of life.

8. Reporting & Disclosing • Reporting is different from disclosure • Refers to communication internally or externally to appropriate authorities. • Disclosure is the act of providing information to the patient and/or their family.

9. What Patients Want to Know • The facts of what happened; • Steps that were and will be taken to minimize harm; • That the healthcare provider regrets what happened; and • What will be done to prevent similar harm in future.

10. Avoiding the Word “Error” • AEs rarely arise from a single event; • A series or cascade of events; • Provider error may seem logical choice; • Often a result of latent events: • Equipment & facilities design; • Training & maintenance; • Organizational factors (P&Ps). • Providers are still responsible and accountable for their work (Just Culture).

11. Culture of Patient Safety • Importance of open reporting culture • System failures • Just Culture • Patient Support • Access to further healthcare • Emotional support (formal and informal) • Healthcare Provider Support • Emotional • Communication Training

12. Understanding Harm

13. Threshold For Disclosure

14. Leadership Role

15. Disclosure Process

16. What to Disclose • Initial Disclosure (As soon as reasonably possible): • Known facts including: medical condition, inherent risks, further investigations & treatment • If appropriate, a commitment is made to learn more about the event • Expression of regret • Post Analysis • Continue preliminary discussions • Improvements made to prevent similar events • Expression of regret, possibly an apology and acknowledgement of responsibility, if appropriate.

17. Documentation • Consistent with legal & regulatory requirements • Time, place & date of meetings • Identities of all attendees • Facts presented • Offers of assistance and responses • Questions raised & answers given • Plans for follow-up & key contacts

18. Particular Circumstances • Paediatric • Capacity Issues • Communication Issues • Language and/or Cultural Diversity • Research Settings • Multi-Patient Disclosure • Multi-Jurisdictional Disclosure

19. Elements of a Disclosure Policy • Policy statement & objectives; • Definitions of key term; • Provision for patient support; • Provision for healthcare provider; support and education; • Disclosure process; and • Special circumstances.

20. Policy Outline: Disclosure Process • Threshold for disclosure • Preparing to disclose • Who should disclose & participants • When should it occur • Where • What • How should it be conducted • Apology/Regret • Documentation

21. Expression of Regret Apology: An expression of sympathy or regret, a statement that one is sorry. • Early expression communicates genuine concern and sympathy; • Subsequent expressions of regret may be important; • When the institution is responsible, acknowledge the responsibility and provide an apology; • Apology is NOT an expression of liability, that is a decision for the court; • Avoid using “negligence”, “fault”, and “failure to meet the standard of care”.

22. Questions and Comments The Canadian Patient Safety Institute would like to acknowledge funding support from Health Canada. The views expressed here do not necessarily represent the views of Health Canada