Advice to the Profession: Disclosure of Harm

Despite the best efforts of health professionals, the delivery of medical care can sometimes result in unexpected outcomes and expose a patient to harm or potential harm. Harm is not always preventable, nor is it necessarily an indicator of substandard care, but its impact can deeply affect patients and their families.

Physicians may also be significantly impacted when their patients experience negative health care outcomes. Physicians sometimes feel ill-equipped to disclose and discuss the harm that has occurred with patients and families, and may also struggle to find the support they need to conduct these conversations effectively.¹

This document is intended to help physicians interpret their disclosure obligations as set out in the Disclosure of Harm policy and provide guidance around how these obligations may be effectively discharged.

Why disclose? Legal and ethical imperatives

Physicians have a legal duty to disclose errors made in the course of medical treatment. The courts have also found that where a medical error is not fully disclosed, the non-disclosure can negate the patient’s ability to provide valid consent for subsequent treatment.²

The professional expectations set out in the policy build upon these legal obligations. The expectations reflect the underlying principle that full disclosure helps foster openness, transparency, and good communication in the delivery of medical treatment. These are integral to promoting patient autonomy and maintaining trust, both in the physician-patient relationship and the medical profession generally.

Physicians and other health care practitioners may feel that disclosure could decrease trust in the profession and increase the likelihood of litigation. However, research suggests that an open, honest disclosure discussion – including an apology, where appropriate – can have a positive impact on patient trust and reduce the risk of litigation.³

Finally, on a practical level, disclosure can help physicians and health care institutions prevent future incidents, thereby improving overall quality of care and patient safety outcomes. Disclosure also ensures that the patient can access, and make informed decisions about, timely and appropriate interventions that may be required as a result of an unexpected health care outcome.

What incidents must be disclosed?

In considering what kinds of incidents must be disclosed, remember that the purpose of disclosure is not to attribute blame. Rather, disclosure aims to provide patients with a full understanding of all aspects of their health care, as well as the information they need to make autonomous, informed medical decisions.

Harm to patients may arise in a number of ways, including through:

• the natural progression of the patient’s medical condition;
• a recognized risk inherent to the investigation or treatment; and
• events or circumstances, such as individual or systemic failures, that resulted in unnecessary harm to the patient (also known as “patient safety incidents”).

The cause of harm is often complex and may arise out of two or more of the above contributing factors. However, the policy expectations and this advice document are primarily meant to help physicians navigate disclosure discussions in situations where something has gone wrong with a patient’s care, rather than situations where the patient’s condition worsens due to a progressive illness.

1. Harmful incidents

A “harmful incident” is an incident that led to patient harm. Patients expect, and are entitled to know about, any harm they have experienced. Physicians must disclose all incidents that have resulted in harm to the patient, no matter the cause. These situations are also sometimes known as “adverse events.” For example:

• The wrong unit of blood was infused and the patient died from a haemolytic reaction.
• A patient with a known allergy to penicillin is administered penicillin and suffers an allergic reaction.
• A cancer patient was inadvertently administered too much opioid medication, and requires an opioid antagonist and temporary respiratory support.

2. No-harm incidents

A “no-harm incident” is a situation where an incident with the potential for harm has reached the patient, even though the patient has not experienced any immediate, discernible, or clinically apparent harmful effects. For example:  

• A patient is mistakenly administered the wrong vaccine.
• A relevant finding in the body of a laboratory report is missed, although there had been no clinically apparent effect on the patient’s health at the time the mistake was discovered.

In determining whether an incident is a no-harm incident, it is useful to recall and apply the definition of “harm” set out in the policy. In other words:

• does the incident have the potential to negatively affect the patient’s health or quality of life; and
• did the incident reach the patient?

If the answer to both these questions is yes, the incident is a no-harm incident and must be disclosed.

No-harm incidents must be disclosed to patients because of the potential that harm might manifest in the future.⁴ Where a potentially harmful incident has reached a patient, there must be certainty about whether harm has occurred, and this certainty can only be achieved by discussing the incident with the patient. Acknowledgment of the incident will also allow the patient, family, and health care team to monitor and potentially intervene to prevent potential future harm.

Moreover, disclosure may be necessary to the informed consent process to ensure that the patient can make fully informed decisions with respect to any subsequent treatment.

3. Near miss incidents

A “near miss incident” is a potentially harmful incident that did not reach the patient due to timely intervention or good fortune. These are also known as “close calls.” For example:

• The wrong unit of blood was issued to a patient but the error was detected before the infusion began.
• A medication error is made – for example, the prescription does not match the discharge summary order or a patient with a similar name is almost dispensed another patient’s medication – but the error is caught by the pharmacist prior to dispensing to the patient.
• The wrong site is prepared for surgery but the mistake is found while completing the pre-operative checklist.

In each instance of a near miss, such as those described above, physicians must consider whether it needs to be disclosed to the patient, using their professional judgment in the specific clinical context and taking into account the factors set out in the policy.

Alignment with the “critical incident” regime

Physicians working in hospitals will be familiar with the regulation under the Public Hospitals Act⁵ that requires the disclosure of “critical incidents”. A critical incident is defined by the regulation as any unintended event that occurs in the hospital that:

• results in death or serious disability, injury, or harm to the patient; and
• does not result primarily from the patient’s underlying medical condition or from a known risk inherent in providing the treatment.

The scope of incidents that fall under the Disclosure of Harm policy is therefore broader than those included in the definition of critical incident, which applies to only a subset of “harmful incidents.”

Physicians involved in the review of critical incidents pursuant to the Quality of Care Information Protection Act, 2016 (QCIPA)⁶ may have questions about how the QCIPA process could affect their disclosure obligations. You may find additional guidance on these issues through the Ontario Hospital Association.

Disclosure as an ongoing obligation

Disclosure is an ongoing obligation, which means that physicians must disclose relevant information as soon as possible when it becomes available. Full disclosure may therefore require a series of discussions, depending on the nature and complexity of the incident, and taking into account the time it could take for harm to develop following the incident.

The nature of the information disclosed will depend on how much time has passed since the incident occurred, the stage of the investigation, and the condition of the patient. For example, at an early stage, physicians might choose to focus on the circumstances that caused the incident and any immediate implications for the patient’s treatment plan, with a commitment to follow up once further investigation occurs or more facts are discovered. At all stages, it is important for physicians to communicate only what is known and to avoid speculation.

Subsequent physicians are also subject to disclosure obligations. Where you are concerned that an incident warranting disclosure has not been disclosed, you must discuss the matter with the previous physician. A constructive and respectful discussion may help clarify the particular facts and circumstances of the incident, the evolution of the case, and the obligations of the previous physician around disclosure. If you continue to have concern about the clinical care or outcome, consider working with the previous physician in a sensitive manner to create a plan for disclosure. It will be helpful for you to document your conversations with the other physician. Ultimately, you may be responsible for disclosure to the extent that you have sufficient knowledge about the incident to do so.

The role of apologies

A full and sincere apology may contribute to a successful disclosure discussion.⁷ Such an apology can be greatly appreciated by patients and their family, and can assist in promoting trust and reducing litigation risk.⁸ Patients also say that the manner in which an apology is delivered can be extremely important; the most effective apologies demonstrate sincerity, empathy, and genuine concern for the patient’s well-being.⁹ Apologies should therefore be tailored in each individual circumstance, avoiding a formulaic approach.

Physicians sometimes hesitate to apologize to patients because of concern about legal implications. It is important to note that an apology is not an admission of legal liability, nor does it absolve physicians of harm that has occurred or shield them from a finding of liability in the future.

Physicians have identified a number of additional barriers to an apology, including a lack of training and self-confidence in conducting the disclosure discussion effectively. It is common, in the context of a difficult disclosure conversation, to feel uncertain about what to say to patients and their families, and the confidence required to conduct these conversations effectively is often obtained through practice and training. You may wish to access further educational resources and materials regarding the delivery of apologies (and disclosure generally), including the Canadian Patient Safety Institute’ s Canadian Disclosure Guidelines: Being Open with Patients and Families and the Canadian Medical Protective Association’s Disclosing harm from healthcare delivery: Open and honest communication with patients.

Additional tips

The following tips and guidance may be helpful in thinking about disclosure and apologies:

• Try to reassure the patient or substitute decision-maker that you will do everything you can to address their concerns.
• Outline a plan for prompt and thorough intervention to mitigate the harm.
• Where multiple physicians are involved in a hospital setting, note that ultimate responsibility for disclosure will generally lie with the Most Responsible Physician as the physician with primary responsibility for managing the medical care of a patient at a specific point in time.
• Consider whether it would be appropriate to transfer the patient to the care of another physician and make the patient aware of any changes to their health care team.
• Consider the patient’s cultural and ethnic identity, as well as their language of choice, and enable access to family and/or interpretive support where possible.
• Convey sincerity through tone of voice, body language, gestures, and facial expression.
• Consider contacting the CMPA and/or the CPSO’s Physician Advisory Service for advice prior to proceeding with disclosure.

Endnotes

^1. Canadian Patient Safety Institute, Canadian Disclosure Guidelines: Being Open with Patients and Families (2011) p. 16.

^2. Gerula v. Flores, 1995 CanLII 1096 (ONCA). Physicians who work in hospitals or other health care facilities may be subject to additional disclosure requirements as established by their particular institution, as well as the requirements of Regulation 965, made under the Public Hospitals Act, relating to the disclosure of “critical incidents.”

^3. Gerald B. Robertson and Justice Ellen I. Picard, Legal Liability of Doctors and Hospitals in Canada, 5th Ed. (2017), p.  263; American Academic of Pediatrics, “Policy Statement: Disclosure of Adverse Events in Pediatrics” (December 2016) Pediatrics, 138:6.

^4. Disclosing harm from healthcare delivery: Open and honest communication with patients, Canadian Medical Protective Association (2015).

^5. R.R.O. 1990, Reg. 965.

^6. S.O. 2016, c. 6, Sched. 2.

^7. McLennan et al., “Apologies in medicine: Legal protection is not enough” (2015) CMAJ, 187(5), p. E157; Wolk et al., “Institutional disclosure: Promise and problems” (2014) Journal of Healthcare Risk Management, 33:3, p. 30.

^8. Levinson et al., “Disclosure of Medical Error” (2016) JAMA, 316:7, p. 765; American Academic of Pediatrics.

^9. McLennan et al, p. E157; Wolk et al., p. 30.