InfoLAW: Reporting & Disclosure of Adverse Events

An adverse event in healthcare can arise when there is an unexpected outcome or complication that negatively affects a patient’s care. It can involve prolonged hospitalization, injury, or death and is often due to complications in the management of the patient’s care.

If a patient is unintentionally harmed by the provision of healthcare services (i.e. an adverse event or critical incident)¹, a nurse may wonder what steps they should take. The patient, and/or their substitute decision maker,² and healthcare administrators need to be aware of the circumstances and what to do when an adverse event occurs. This infoLAW addresses common questions nurses may have about their involvement in adverse events.

What is the difference between reporting and disclosure?

Reporting generally refers to the transfer of information from front line health care providers, either involved in the adverse event or in its discovery, to healthcare administrators. Most provincial or territorial legislation requires regional health authorities, health corporations and prescribed healthcare organizations to establish written procedures for the recording of critical incidents.³ In some jurisdictions, further reporting is done by the health institution to a governmental authority for a more detailed analysis.⁴ Reporting allows healthcare administrators to respond appropriately to the particular incident and to take steps to reduce the risk of a similar event occurring in the future. As employers are typically responsible for what happens on their premises, their employees, and others who are bound by contract to do so, must adhere to the employer’s policy on reporting adverse events. When an adverse event is reported, it will normally trigger some form of investigation and further action, in accordance with legislation and/or internal workplace policy.

An example of reporting that nurses may encounter in their practice are adverse drug reactions. Nurses will most likely be asked to report all adverse drug reactions to their employer. In fact, health facilities are now required to report serious drug reactions and medical device incidents to Health Canada.⁵

Disclosure of adverse events, on the other hand, is the process of providing information to a patient or the patient’s family. The extent of disclosure varies and is dependent upon what event occurred, as well as its severity. A close call or a simple, minor adverse event with no harm or minimal harm may not require communication to a patient. In more complex cases, there may be initial disclosure to the patient as well as follow-up communications as more is learned about the event. Some provinces have enacted legislation requiring the disclosure of adverse events to patients.⁶ Further, Healthcare Excellence Canada (formerly the Canadian Patient Safety Institute) has published Canadian Disclosure Guidelines to assist health institutions or independent practitioners in developing their own policies and procedures on disclosure.

Which comes first, reporting or disclosing?

Both are important aspects of adverse event management. Circumstances will dictate the order of events and the level of a nurse’s involvement. Nurses may be more involved in reporting adverse events than disclosing directly to patients, apart from what is required as an adverse event unfolds. Legislation and health institution policies typically set out a threshold of seriousness for an incident to be called an adverse event, which triggers an administrative investigation and disclosure, which may include an apology. When the matter is this serious, it is appropriate for healthcare administrators to complete their investigation and analysis after an initial disclosure. Post-analysis disclosures may contain information as to how future practices and systems will be improved.

Who discloses to the patient and what is disclosed?

Disclosure is a delicate process, with many factors contributing to the decision regarding who discloses what information to the patient. Ideally, those who disclose should be trained in the disclosure process and have strong interpersonal and communication skills. To this end, it may be that other health care professionals, (such as a surgeon if the adverse event occurred during an operation), are involved in disclosure rather than the nurse who was present during the adverse event.

As soon as possible after the adverse event, the patient is typically to be informed of the facts known at the time and consequences to their care and treatment, offered an expression of sympathy and regret, and given an overview of the investigative process that is underway. A record is to be kept of all of this information. If the investigation determines that a health care provider or organization is responsible for the adverse event, it would be appropriate to acknowledge this by apologizing to the patient as part of a post-analysis disclosure process. Please note that disclosure requirements differ from jurisdiction to jurisdiction.

If the patient receives an apology, will it prevent a lawsuit?

Not necessarily. Nurses may be subject to one or more investigations, including a civil lawsuit even in the presence of proper reporting, prompt disclosure, and an appropriate apology. Several provinces have enacted legislation to prevent an apology from being used as evidence of negligence. Statutory patient safety measures, such as apology legislation, vary across Canada. For more information on the legal status of an apology, please consult our InfoLAW on the topic.

It is recommended that nurses ensure they are in possession of current applicable information when involved in an adverse event. Risk management and quality assurance departments may act as good resources for nurses.

Adverse events occur, but understanding the principles related to reporting and disclosure can assist in mitigating potential risks or consequences. After taking the appropriate steps to address and perhaps stabilize the patient’s condition, it is best to act prudently and follow regulator and employer standards closely when reporting or disclosing an adverse event. Please remember that different jurisdictions, institutions, or employers may have different processes and reporting requirements.

CNPS beneficiaries can contact CNPS at 1-800-267-3390 to speak with a member of CNPS legal counsel. All calls are confidential.

1. Various phrases, such as adverse event or critical incident, are used to denote the unintended harm patients experience as a result of healthcare delivery. In this document, definitions for adverse event, close call, harm, disclosure and reporting are taken from the Disclosure Working Group, Canadian Disclosure Guidelines, Healthcare Excellence Canada, 2011.
2. The use of the word “patient” in this document encompasses a substitute decision maker if the patient is no longer capable of consenting to their own health treatment.
3. The Regional Health Authorities Act, C.C.S.M. c. R34, ss. 53.1-53.10
4. For example, under Manitoba’s The Regional Health Authorities Act, C.C.S.M. c. R34, ss. 53.1-53.10, there are criteria for reporting critical incidents to regional health authorities (RHAs). Health corporations and prescribed healthcare organizations (e.g. land and air ambulances) are to have a critical incident review committee investigate incidents and notify the RHA of critical incidents. A written report of their investigation must be submitted to the RHA and ultimately to the Minister of Health.
5. Health Canada, Canada Vigilance Adverse Reaction Reporting Form. 
6. Supra, at note 1. Patients must be notified when they suffer serious, undesired consequences of health services, such as death, disability, injury or harm, unplanned admission to hospital or unusual extension of a hospital stay.

April 2022

THIS PUBLICATION IS FOR INFORMATION PURPOSES ONLY. NOTHING IN THIS PUBLICATION SHOULD BE CONSTRUED AS LEGAL ADVICE FROM ANY LAWYER, CONTRIBUTOR OR THE CNPS. READERS SHOULD CONSULT LEGAL COUNSEL FOR SPECIFIC ADVICE.