On July 20, 2007, the Minister of Health and Long-Term Care amended the Hospital Management Regulation made under the Public Hospitals Act to require hospitals to establish a system that ensures disclosure of critical incidents to patients as soon as practicable after they occur. The legislation will come into force on July 1, 2008.

The ultimate responsibility for ensuring compliance with this new legislation rests with the hospital’s board of directors. The new year is fast approaching, and hospital boards of directors and hospital administrators should therefore take steps now to ensure that a system for the disclosure of critical incidents is in place by July 1, 2008.

A "critical incident" is defined in the legislation as any unintended event that occurs when a patient receives treatment 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 terms "serious disability, injury or harm" are not defined in the regulation. The Canadian Patient Safety Institute’s definition of "critical incident" as "an event resulting in serious harm (loss of life, limb or vital organ) to the patient, or the serious risk thereof" may be of assistance to hospitals in determining what events will be considered to be critical incidents under the new legislation until it is judicially considered.

Hospitals will be required to disclose to patients affected by critical incidents: (a) the material facts of what occurred with respect to the critical incident; (b) the consequences for the patient of the critical incident; and (c) the actions taken and recommended to be taken to address the consequences to the patient of the critical incident, including any health care or treatment that is advisable. The content and date of the disclosure must be noted in the patient’s medical record regardless of whether the patient was an in-patient or an out-patient.

If the affected patient is incapable, disclosure must be made to the patient’s substitute decision maker, and if the affected patient has passed away, disclosure must be made to the patient’s estate trustee or substitute decision maker.

 The board will also be responsible for ensuring the administrator establishes a system for disclosing to affected patients any systemic steps the hospital is taking or has taken to avoid or reduce the risk of further similar critical incidents. The disclosure of systemic steps must also be "recorded" although the regulation does not require this to be part of the patient’s medical record. It should be noted that the hospital is not required by this legislation to take any systemic steps to reduce risk; in other words, the obligation to disclose systemic steps only applies if the hospital has independently decided to take systemic steps following a review of the incident. As well, disclosing such information is expressly subject to the provisions of the Quality of Care Information Protection Act, 2004 which provides statutory protection for certain quality assurance information.

As the legislation requires that a system for the disclosure of critical incidents be in place by July 1, 2008, we recommend that Ontario public hospitals begin taking steps now to develop and implement the systems described above. Many hospitals may already have formal or informal policies in place with respect to the disclosure of adverse events. Those hospitals should review their existing policies to ensure compliance with these amendments. Any systems relating to the disclosure of critical incidents should also be carefully reviewed to ensure they comply with the Quality of Care Information Protection Act, 2004.

You can access the recent amendments to the Hospital Management Regulation at: http://www.e-laws.gov.on.ca/html/source/regs/english/2007/elaws_src_regs_r07423_e.htm

You can access the Public Hospitals Act and the Hospital Management Regulation in their entirety at: http://www.e-laws.gov.on.ca