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Critical Incident Reporting Requirements

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					                                                                                             June 2010


    Critical Incident Reporting Requirements
                         Frequently Asked Questions
On May 5, 2010, Regulation 156/10 was filed which amends Regulation 965 (Hospital
Management Regulation) under the Public Hospitals Act to expand the current
requirement for hospitals to disclose critical incidents to patients to include disclosure to
the Medical Advisory Committee (MAC) and hospital administrator. A summary of the
requirements to disclose critical incidents is set out below.

What information are hospitals required to disclose?

a) Disclosure of critical incidents

Hospitals are required to disclose any critical incident as defined below. The disclosure
must include:

     (a) The material facts of what occurred with respect to the critical incident;
     (b) Consequences for the patient of the critical incident, as they become known;
         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.

b) Disclosure of systemic steps taken by the hospital

Hospitals are required, at an appropriate time following disclosure of a critical incident,
to disclose to the patient the systemic steps, if any, that the hospital is taking or has
taken in order to avoid or reduce the risk of further similar critical incidents, and that the
content and date of the disclosure be recorded. ∗


∗
  Hospital disclosure of systemic steps taken to avoid or reduce the risk of further or similar critical
incidents is subject to the Quality of Care Information Protection Act (QCIPA). The relationship between a
hospital’s obligations under QCIPA and Regulation 965 are are outlined in the OHA’s Quality of Care
Information Protection Act Toolkits (publication #317 and publication #320).
What is a “critical incident”?

A “critical incident” is defined as any unintended event that occurs when a patient
receives treatment in the hospital;

     (a) That results in death, or serious disability, injury or harm to the patient, and
     (b) Does not result primarily from the patient’s underlying medical condition or
         from a known risk inherent in providing treatment.

Who should the disclosure be provided to?

Disclosure of critical incidents must be made to the Medical Advisory Committee (MAC),
the hospital administrator and the affected patient. If the patient is incapable, disclosure
can occur to a person lawfully authorized to make decisions on behalf of the patient. If
the patient has died, the disclosure shall occur (in this order) to:

     (a) To the patient’s estate trustee;
     (b) To the person who has assumed responsibility for the administration of the
         estate, if the estate does not have an estate trustee; or
     (c) To a person lawfully authorized to make treatment decisions on behalf of the
         patient immediately prior to the patient’s death.

When should this disclosure take place?

The disclosure of the critical incident should take place as soon as is practicable after
the critical incident occurs. The disclosure to the patient of the systemic steps taken by
the hospital should take place at an appropriate time following the disclosure of a critical
incident.

Who is required to ensure that the disclosure to the patient occurs?

The hospital administrator (as defined in section 1 of the Public Hospitals Act) is
required to establish a system to ensure the disclosure of critical incidents.

What is the role of the hospital board in the disclosure process?

Section 2 of Regulation 965 prescribes the roles and responsibilities of a hospital board
of directors. The board is required to ensure that the hospital administrator establish a
system for ensuring the disclosure of any critical incident, as soon as is practicable after
the critical incident occurs.



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What is the role of the hospital board in analyzing critical incidents?

The board is required to ensure that the administrator establishes a system for
ensuring, following the disclosure of a critical incident, that the incident is analyzed and
a plan developed with the systemic steps to avoid or reduce the risk of further similar
critical incidents.

How should the critical incident be analyzed?

Regulation 965 does not expressly provide how the critical incident should be analyzed.
Many hospitals already have processes in place for this type of analysis. For example,
many hospitals analyze critical incidents through their quality of care committees
established under the Quality of Care Information Protection Act (QCIPA), or through an
incident review system outside the QCIPA framework where a review under QCIP is not
appropriate.

Our hospital has disclosed to the patient that a critical incident has occurred. Is
this something we need to document in the patient’s record?

Subsection 19(1) of Regulation 965 provides that every administrator of a hospital shall
ensure that a system is established for the keeping of records of personal health
information for each patient.

Subsection 19(4) of Regulation 965 sets out what is to be included in a patient’s medical
record. A new clause will require that the medical record of each patient contain reports
of any critical incidents with respect to the patient, including the information required to
be disclosed (as set out above) and a record of when any disclosure was made.

How does the regulation affect record keeping procedures for out-patients
visiting the hospital solely for diagnostic purposes?

Subsection 19(6) of Regulation 965 currently sets out the requirement for record-
keeping for out-patients who visit the hospital solely for diagnostic procedures. In
addition to the current requirements, Regulation 965 requires that all the following be
included in the out-patient record: (1) reports of any critical incidents regarding that
patient, including the information required to be disclosed as set out above, and (2) a
record of when the disclosure was made.




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What is the process for disclosing critical incidents to our MAC and hospital
administrator?

Regulation 965 does not provide a specific process for how disclosure to the MAC and
the hospital administrator should take place, only that the disclosure of the critical
incident should take place as soon as is practicable after the critical incident occurs.
The manner in which this disclosure takes place (e.g., written report to the MAC and
administrator, designated person responsible for disclosure) will depend on the unique
characteristics of the hospital.

Our hospital has disclosed to the MAC and the administrator that a critical
incident has occurred? Is this something we need to document?

While Regulation 965 does not expressly set out documentation requirements, hospitals
should ensure that their policies and procedures include a process for disclosure to the
MAC and the administrator, including the manner in which this disclosure is to be
documented.

Why wasn’t public input and stakeholder consultation conducted prior to the
filing of Regulation 156/10 to expand critical incident reporting requirements?

Unlike other legislation (e.g. the Personal Health Information Protection Act) the Public
Hospitals Act does not contain provisions that would require the Ministry to consult with
affected stakeholders or the public prior to the making of a regulation.

How does Regulation 965 affect our obligations under the Quality of Care
Information Protection Act?

The Quality of Care Information Protection Act provides statutory protection for certain
quality assurance information. Information that is collected by or prepared for a
designated quality of care committee is deemed to be “quality of care information” of a
hospital and cannot be disclosed except in the circumstances permitted by that Act.

Regulation 965 expressly provides that the requirement to disclose to the patient the
systemic steps the hospital is taking or has taken is subject to the requirements of the
Quality of Care Information Protection Act.

Regardless of whether a hospital chooses to have their quality of care committee
investigate a critical incident, the hospital is required to disclose to the MAC, the
hospital administrator and the patient:

    (a) The material facts of what occurred with respect to the critical incident;



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    (b) Consequences for the patient of the critical incident, as they become known;
        and
    (c) The actions taken and recommended to address the consequences to the
        patient of the critical incident including any health care or treatment that is
        advisable.

If a hospital chooses not to have the quality of care committee review the critical
incident (i.e., some other non-QCIPA committee reviews the critical incident), then the
hospital is required to disclose to the patient the systemic steps, if any, that the hospital
is taking or has taken in order to avoid or reduce the risk of further similar critical
incidents, and must record the content and date of the disclosure.

In circumstances where the critical incident is referred to the quality of care committee,
the provisions of the Quality of Care Information Protection Act would supersede the
hospital’s obligation under Regulation 965 to disclose to the patient the systemic steps
the hospital is taken. The details of the quality of care review (the “quality of care
information”) cannot be disclosed. However, the hospital should disclose to the patient
the systemic steps, if any, actually taken by the hospital.


On what date will hospitals be required to comply with these new requirements?

The amendments to Regulation 965 will come into force on July 1, 2010. The current
requirement to disclose critical incidents to patients continues and is expanded to
include disclosure to the MAC and the administrator on July 1.



For additional information, please contact Melissa Prokopy at mprokopy@oha.com or
416.205.1322 or Cyrelle Muskat at cmuskat@oha.com or 416.205.1316.




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