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Excellent Care for All Act Updates

Critical Incident Reporting


Update as of September 2011 - ECFAA and New Directive on Medication Incidents/ IV Fluids

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As you are aware, the Excellent Care for All Act, 2010 legislates that hospital annual quality improvement plans must be developed having regard to its aggregated critical incident data as compiled based on disclosures of critical incidents pursuant to regulations made under the Public Hospitals Act (PHA).  Following disclosure of a critical incident, hospital boards are now required to ensure that the hospital administrator establishes a system for analyzing the critical incident and developing a system-wide plan to avoid or reduce the risk of further similar incidents. In addition, as of January 1, 2011, the PHA Regulation 965 was amended to ensure that the administrator provides aggregated critical incident data to the quality committee at least two times per year.

The MOHLTC has recently issued a directive that as of October 1, 2011, all Ontario hospitals will be required to report all critical incidents related to medication / IV fluids through the National System of Incident Reporting (NSIR) within 30 days following the disclosure of the critical incident to the Medical Advisory Committee (MAC), administrator and/or patient.

The new reporting requirement of critical incidents related to medication / IV fluids to NSIR is designed to capture a subset of all hospital critical incident reporting. Hospitals are expected to maintain their internal system of incident reporting while fulfilling the new requirement of reporting critical incidents related to medication / IV fluids to NSIR.

What is NSIR?

NSIR is a free web-based tool that allows users to securely and anonymously report, analyze, discuss and share information on patient safety incidents. The system is designed to complement risk management software that hospitals currently have in place.

What this means for hospitals

Hospitals will be required to report all critical incidents related to medication/ IV fluids to both their internal incident reporting system and to NSIR. These incidents are a small subset of critical incidents, all of which are not required to be reported under the purview of the new directive.

Mandatory to be reported to NSIR

Not mandatory to be reported to NSIR*

Cannot be reported to NSIR

All Critical Incidents related to Medication/IV fluids

Non-critical medication/ IV fluid incidents

Non-medication/ IV fluid incidents

*All incidents related to medication/ IV fluids may be reported to NSIR, however only those meeting the requirements of a critical incident are mandated to be reported. Non medication/ IV fluid incidents cannot be reported to NSIR as the system does not yet support this.

What is the difference between an adverse event, a critical incident and a critical incident related to medication/IV fluids?

Adverse events are unintended injuries or complications that are caused by health care management, rather than by the patients underlying disease, and that lead to death, disability at the time of discharge or prolonged hospital stays (Canadian Adverse Event Study, 2004). Adverse events include all critical incidents and critical incidents related to medication/ IV fluids.

In Reg 965 of the Public Hospitals Act (PHA), a critical incident is defined as any unintended event that occurs when a patient receives treatment in a hospital :

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

Critical incidents related to medication/ IV fluids are a subset of critical incidents. These are incidents related to medication/ IV fluids that follow the definition of a critical incident as outlined in Reg 965. The reporting of these incidents to NSIR is required by the new directive.

For example, an incident of a patient with congestive heart failure who was prescribed an incorrect dose of digoxin and subsequently died would be classified as a critical incident related to medication reportable to NSIR.

Non-critical incidents related to medication/ IV fluids (near misses, moderately harmful incidents) can be reported to NSIR at the discretion of the hospital. This is not required by the new directive.

Please see the diagram below :

Critical incidents related to medication/ IV fluids are a subset of critical incidents. Adverse events encompass all critical incidents. Presently, only critical incidents related to medication/ IV fluids are required to be reported to NSIR
Critical incidents related to medication/ IV fluids are a subset of critical incidents. Adverse events encompass all critical incidents. Presently, only critical incidents related to medication/ IV fluids are required to be reported to NSIR.

Where can I find more information about NSIR and Critical Incident Reporting?

OHA Conference: Critical Incident Reporting - Partnering for Shared Learning
OHA will be hosting a conference on September 22, 2011 which provides an overview of the new directive and requirements, reinforces the importance of this initiative in improving patient safety and shares learnings from other jursidictions on how to leverage critical incident reporting to its fullest capacity. In partnership with OHA, CIHI, MOHLTC and ISMP Canada, the conference is targeted to patient safety professionals to ensure compliance with the new directive and promote quality in critical incident reporting.

Additional information is available.

Will any NSIR education courses be held?

The Canadian Institute for Health Information (CIHI) will be administering three web-conference education courses on NSIR data analysis and compliance that targets those responsible for risk management and quality improvement activities within your organization. The first course will focus on the NSIR minimum data set and the key system features of the data entry tool. The second course will provide a case study which will improve understanding of the coding process. The final course will demonstrate how to learn from NSIR data using the built-in analytic tool.

For additional information regarding registration, dates and scheduling, please contact nsir@cihi.ca.

A guidance document for critical incident reporting is available.

For questions about Excellent Care for All, please email ECFAA@ontario.ca

Update - as of December 7, 2010

Important amendments have been made to Regulation 965 of the Public Hospitals Act to expand the reporting of critical incidents and reduce the risk of future incidents. These changes do not fall under the Excellent Care for All Act (ECFAA), but have been introduced as part of the government's broader quality strategy.

What this Means for Hospitals

Critical incident reporting : the existing requirement that hospitals disclose critical incidents to patients has been expanded to include disclosure to the Medical Advisory Committee (MAC) and hospital administration. This amendment to Regulation 965 of the Public Hospitals Act came into effect on July 1, 2010.

Critical incident analysis and planning : following disclosure of a critical incident, hospital boards are now required to ensure that the hospital administrator establishes a system for analyzing the critical incident and developing a system-wide plan to avoid or reduce the risk of further similar incidents. In addition, as of January 1, 2011, the PHA Regulation 965 will be amended to ensure that the administrator provides aggregated critical incident data to the quality committee at least two times per year.

What is a critical incident?

A critical incident is defined in Regulation 965 of the Public Hospitals Act 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 patients' underlying medical condition or from a known risk inherent in providing the treatment

Supporting data-driven decision making

Current hospital information systems collect a variety of data that may or may not be coded or categorized in a way that facilitates the analysis of critical incidents. This results in inconsistent data, and reduces the potential for identifying trends in safety issues. Standardized data collection and analysis are critical if hospitals are to gather the evidence they need to take appropriate action and make appropriate plans to ensure patient safety.

To support standardized data collection, the Ministry of Health and Long-Term Care has developed Guidelines for Critical Incident Reporting which provide hospitals with a recommended data structure for patient safety incident reporting. Although the reporting of critical incidents as outlined in Regulation 965 suggests that only certain (critical) incidents be reported, comprehensive patient safety incident reporting is essential for providing hospitals with the information needed to make healthcare safety improvements. As with any quality improvement initiative, high quality data is required to drive the improvement process.

Further information

The OHA has developed Questions and Answers that provide some additional clarification and guidelines to support implementation of these new disclosure requirements.

For questions about Excellent Care for All, please email ECFAA@ontario.ca

Related Regulations

Public Hospitals Act, Regulation 965

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