Canadian Disclosure Guidelines

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

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.

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

Guiding Principles

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

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.

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.

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.

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.

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).

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

Understanding Harm

Threshold For Disclosure

Leadership Role

Disclosure Process

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.

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

Particular Circumstances

• Paediatric

• Capacity Issues

• Communication Issues

• Language and/or Cultural Diversity

• Research Settings

• Multi-Patient Disclosure

• Multi-Jurisdictional Disclosure

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.

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

Expression of Regret

• 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”.

Apology: An expression of sympathy or regret, a statement that one is sorry.

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

Questions and Comments