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ADVERSE HEALTH EVENT MANAGEMENT

International and Canadian Practices

A Background Document Prepared for theTask Force on Adverse Health Events

Deborah Gregory, Ph.D.

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Table of Contents

Executive Summary .............................................................................................................4Introduction ..........................................................................................................................6Background ..........................................................................................................................6Objective ..............................................................................................................................6Methodology ........................................................................................................................6Findings................................................................................................................................6

Recommendations of the National Steering Committee on Patient Safety .....................6Recommendations of the Baker and Norton Report ........................................................7Adverse Health Event Management at the National Level ..............................................8

Health Canada ..............................................................................................................8Canadian Council on Health Services Accreditation ...................................................9Canadian Patient Safety Institute (CPSI) ...................................................................10

Reporting and Learning Systems ...................................................................................11International Initiatives ..................................................................................................13

World Health Organization ........................................................................................13United States ..............................................................................................................13United Kingdom .........................................................................................................13Australia .....................................................................................................................14Canada ........................................................................................................................14

Canadian Institute for Health Information .........................................................14Canadian Medication Incident Reporting and Prevention System ....................15Canadian Adverse Event Reporting and Learning System (CAERLS) .............16Regional and Provincial Initiatives ....................................................................17

Incident Reporting Information System (IRIS) project .................................17Regional Occurrence System Enhanced (ROSE) Project ..............................17Patient Safety Reporting System (PSRS) ......................................................18

Summary ....................................................................................................................18Provincial Legislation – Quality of Care Committees ...................................................19Provincial Incident Reporting and Investigation Legislation ........................................19

Saskatchewan .............................................................................................................20Manitoba ....................................................................................................................21Quebec .......................................................................................................................22Ontario .......................................................................................................................22Summary ....................................................................................................................23

Disclosure ......................................................................................................................23Adverse Health Event Management – Policies of Select Canadian Organizations .......24

Alberta ........................................................................................................................24Calgary Health Region ...................................................................................24

Manitoba ....................................................................................................................26Winnipeg Regional Health Authority ............................................................26

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Saskatchewan .............................................................................................................27Saskatoon Health Region ...............................................................................27

Apology Legislation in Canada .....................................................................................29Conclusions ........................................................................................................................31Appendix A Canadian Council on Health Services Accreditation .............................33Appendix B Canadian Patient Safety Institute Disclosure Guidelines .......................35Appendix C Legislation Reference Table ...................................................................38Appendix D Adverse Event/Critical Incident Reporting Laws ..................................39Appendix E List of RHAs/ HCO Policies Reviewed .................................................43Appendix F Select RHAs/ HCO Policies ...................................................................44References ..........................................................................................................................72

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Executive Summary

IntroductionStudies’ related to medical error in Canada1, Australia2, the United Kingdom3, and the United States4 have resulted in growing awareness and heightened concerns related to patient safety within the health system. In response to these concerns, global effort has been placed on patient safety in general, and more specifically, on adverse event management.

BackgroundThe Secretary to Cabinet (Health Issues) in his role as Chair, Task Force on Adverse Health Events, has been mandated by the provincial government of Newfoundland and Labrador to address the following objectives in its terms of reference: (1) to examine and evaluate how the health system identifies, evaluates, responds and communicates with regard to adverse events within the health system; and (2) to examine relevant best practices in other jurisdictions.

ObjectiveThe objective of this paper is to facilitate an understanding of the international, national, provincial and organizational “leading practices” in adverse health event management.

MethodsA scan of existing practices and an extensive review of the literature inform the composition of this paper. In addition, the Task Force sought to learn from the experiences of experts in the field of adverse health event management. Fifteen expert consultations were conducted from five Canadian provinces (Alberta, Manitoba, Saskatchewan, Nova Scotia and Ontario) and four countries (Australia, Ireland, the United Kingdom and the United States). Valuable insight was gleaned from the interview transcripts of these experts who so willingly gave of their time. The dialogue with key informants will comprise a separate but complementary report to the literature review.

FindingsA review of the relevant literature suggests that there are many lessons to be learned from the pioneers (UK, US and Australia) in the field of adverse health event management. In Canada, a tremendous amount of work has been done at the national level and within the provinces and territories. However, in order to learn from adverse health events it is necessary to have in place standard definitions, a standardized adverse health event taxonomy, standardized methods of reporting and timely and appropriate feedback mechanisms to ensure that changes are made to improve patient safety. The Calgary Health Region is considered by many as the country’s most progressive.5 It can be used as an exemplar of adverse health event management.

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ConclusionsIn undertaking a review of relevant “leading practices” in other jurisdictions, we were afforded the opportunity to examine and learn about the management of adverse health events from international, national, provincial, regional and organizational perspectives. Clearly, the pioneers in the field of adverse health event management (i.e., the UK, Australia, and the US) have much to offer in the way of lessons learned. The WHO is providing leadership in the area of adverse event reporting, learning systems and the standardization of taxonomy for classifying adverse events.

At a national level, the Canadian Patient Safety Institute (CPSI) has taken a lead role in the development and publication of Canadian Disclosure Guidelines, developing a strategy to create a Pan-Canadian reporting and learning system. It has also developed the Canadian Root Cause Analysis Framework, a quality improvement tool to help individuals and organizations determine all of the contributing factors and root causes that led to an event (e.g., critical incidents and close calls). CPSI is currently engaged with key stakeholders and partners in the development of a Canadian inter-professional, competency-based framework for patient safety.

At the provincial level, a variety of initiatives have been undertaken to address the reporting of “critical incidents” or accidents. A number of these initiatives are tied to legislation and regulations. However, a major limitation is the lack of standardization of definitions and terminology used within and between provinces, within and between regions, and between organizations. It is difficult to say, with any degree of certainty, whether one practice or policy is leading the way in the field of adverse event management, in part, because of the paucity of evaluative outcomes research being conducted in this area.

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Introduction

Studies’ related to medical error in Canada6, Australia7, the United Kingdom8 and the United States9 have resulted in growing awareness and heightened concerns related to patient safety within the health system. In response to these concerns, global effort has been placed on patient safety in general, and more specifically, on adverse event management.

Background

The Secretary to Cabinet (Health Issues) in his role as Chair, Task Force on Adverse Health Events, has been mandated by the provincial government of Newfoundland and Labrador to address the following objectives in its terms of reference: (1) to examine and evaluate how the health system identifies, evaluates, responds and communicates with regard to adverse events within the health system; and (2) to examine relevant best practices in other jurisdictions.

Objective

The objective of this paper is to facilitate an understanding of the international, national, provincial and organizational “leading practices” in adverse health event management.

Methodology

A scan of existing practices and an extensive review of the literature inform the composition of this paper. In addition, insight has been gleaned from the interview transcripts of 15 national and international expert consultants well versed in the area of adverse health event management. The dialogue with key informants will comprise a separate but complementary report to the literature review.

Findings

Recommendations of the National Steering Committee on Patient Safety

In 2004 the National Steering Committee on Patient Safety produced a report titled Building a Safer System –A National Integrated Strategy for Improving Patient Safety in Canadian Health Care10. The following recommendations of the report are relevant to an effective response system.

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Adopt nonpunitive reporting policies within a quality-improvement framework across the health care system.

Develop a greater focus on improvement through education and remediation, versus blame and punishment, in legal, regulatory and human resource processes.

Review, and where applicable, revise The Evidence Act and related legislation within all Canadian jurisdictions to ensure that data and opinions associated with patient safety and quality-improvement discussions, related documentation and reports are protected from disclosure in legal proceedings. The protection would extend to this information whether used internally or shared with others, for the sole purpose of improving safety and quality. Wording within the applicable acts should ensure that all facts relating to an adverse event are recorded on a health record that is accessible to the patient or designated next of kin, and are not considered privileged.

Undertake an analysis of the capabilities and costs of systems for monitoring adverse events, critical incidents and near misses.

Recommend the types of surveillance systems, including relevant patient-safety indicators, to be developed and supported in Canadian health care. The recommendations would be based on the findings of the review proposed in the previous recommendation outlined above.

Publicly report measures of health care quality and safety.

Recommendations of the Baker and Norton Report

Baker and Norton11 completed a review of patient safety initiatives elsewhere in the world and provided recommendations for initiatives within Canada. The relevant recommendations for the Task Force are:

Develop better reporting systems:

New regional and national reporting systems and mechanisms should be pilot tested and evaluated. Key evaluation points must include the linkage of discovered adverse events to improvement efforts. Pilot projects should be undertaken to assess the effectiveness of such efforts. While most work to date has occurred in acute-care facilities, new systems to identify adverse events and errors should be tested at all levels of the system –

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acute, chronic and community. There should be expanded support for the existing and developing national and provincial Adverse Drug Event (ADE) reporting systems.Health care organizations should be strongly encouraged and supported in heightening their focus on errors, adverse events and near misses, and to link this to improvement work and system change.Support should be provided to develop curricula and learning experiences in patient safety at all educational levels (undergraduate and postgraduate and continuing professional education).Canadian professional colleges and organizations should be encouraged to be active in the areas of disclosure policy and legislation and to lobby for appropriate legislation to enable them to expand their efforts.Patient safety programs and initiatives should be integrated into the Canadian Council on Health Services Accreditation standards and other health care accreditation standards.Legislation change could enhance the reporting of errors and near misses and should be encouraged and supported.

Adverse Health Event Management at the National Level

At the national level, a number of organizations are taking lead roles in the optimization of patient safety and adverse health event management, including the Canadian Council on Health Services Accreditation, the Canadian Patient Safety Institute and Health Canada, among others. A brief overview of three organizations and their current and potential future roles is discussed in this section.

Health Canada

The Canada Vigilance Program collects data on adverse reactions (AR), defined as harmful and unintended responses to a health product. Guidelines for health professionals and consumers have been created for the voluntary reporting of suspected adverse reactions to health products. Adverse reactions to Canadian marketed health products include prescription, nonprescription, biologic, natural health and radiopharmaceutical products. An adverse reaction may include any undesirable patient effect suspected to be associated with health product use. An unintended effect, health product abuse, overdose, interaction (including drug-drug, and drug-food interactions) and unusual lack of therapeutic efficacy are all considered to be reportable adverse events.

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Canadian Council on Health Services Accreditation

The CCHSA (renamed Accreditation Canada in May 2008) is a not-for-profit, independent organization that has provided national and international health and social service organizations with voluntary, external-peer review programs and guidance for over 50 years.

In May 2003, the CCHSA Board approved Phase 1 of its Patient Safety Strategy, which focused on four domains: (1) accreditation program, (2) information, communication and education, (3) research, and (4) partnerships. The accreditation program was enhanced with the development of a list of reportable sentinel events and among other things the implementation of a mandatory reporting policy.12

In October 2004, the CCHSA’s Patient Safety Advisory Committee (PSAC) was established to provide direction and advice on the implementation of the Patient Safety Strategy. PSAC consisted of key stakeholders and the CCHSA’s partners in safety, including the Canadian Patient Safety Institute (CPSI), Institute for Safe Medication Practices (ISMP, Canada), Health Care Insurance Reciprocal of Canada (HIROC), Canadian Medical Protective Agency (CMPA) and the Canadian Institute for Health Information (CIHI).

In 2005, CCHSA developed standards promoting adverse event13 and near miss14 reporting- and-learning (the reference guide for sentinel events and near misses is presented in Appendix A).

An adverse event is “usually negative or unfavourable reactions or results that are unintended, unexpected, or unplanned.” A near miss is “an event or circumstance which has the potential to cause serious physical or psychological injury, unexpected death, or significant property damage, but did not actualize due to chance, corrective action and/or timely intervention. The CCHSA’s sentinel event policy is meant to improve the reporting and sharing of information across organizations. The CCHSA defines a sentinel event as “an unexpected incident, related to system or process deficiencies, which leads to death or major and enduring loss of function* for a recipient of health care services. * Major and enduring loss of function refers to sensory, motor, physiological, or psychological impairment not present at the time services were sought or begun. The impairment lasts for a minimum period of two weeks and is not related to an underlying condition.”

In January 2005, the CCHSA’s Patient Safety Goals and Required Organizational Practices (ROP) came into effect. An ROP is defined as “an essential practice that organizations must have in place to enhance patient/client safety and minimize risk.”

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Five ROPs are directly related to patient safety culture.15 More specifically, Canadian health care organizations seeking accreditation are required to

(1) adopt patient safety as a written, strategic priority/goal;

(2) provide quarterly reports to the board of directors on patient/client safety, including changes/improvements following incident investigation and follow-up;

(3) establish a reporting system for actual and potential adverse events, including appropriate follow-up, in compliance with any applicable legislation and within any protection afforded by legislation;

(4) implement a formal (transparent) policy and process of disclosure of adverse events to patients/families, including support mechanisms for patients, family and care/service providers;

(5) conduct one patient-safety related prospective analysis per year (e.g., Failure Modes and Effects Analysis) and implement recommended improvements/changes.

In 2007, CCHSA released its Patient Safety Strategy – Phase 2 and vision for 2007-2010. A review of the roles of adverse and sentinel events in the CCHSA accreditation program is currently underway. A provincial and national review of reporting requirements will be part of the process and the roles of adverse and sentinel events in the accreditation process will be clarified further).16 A major limitation is that accreditation is completely voluntary for Canadian hospitals and long-term care facilities. This may change based on the advice of the Health Council of Canada that all health care facilities be accredited as a condition of funding, and that the findings of the accreditation reports be made public.17 18

Canadian Patient Safety Institute (CPSI)

One of the recommendations of the National Steering Committee on Patient Safety report, Building a Safer System19, was the establishment of the Canadian Patient Safety Institute (CPSI). The CPSI was created to provide leadership and coordination for patient safety and quality improvement across the Canadian health care system. The federal Minister of Health announced the establishment of the CPSI on December 10, 2003. The institute is funded by Health Canada, but has an independent board of directors responsible to its members, including the provincial ministers of health and the public.

In March 2008, CPSI launched Canadian Disclosure Guidelines20 after two years of extensive effort and collaboration by a number of experts from key national organizations representing physicians, nurses, pharmacists, health care providers, patients and others. The Guidelines are intended to assist and support health care providers, inter-professional teams, organizations and regulators in developing and implementing disclosure policies,

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practices and training methods across Canada.21 A summary of the CPSI Disclosure Guidelines is presented in Appendix B.

CPSI is also exploring a pan-Canadian strategy for reporting and learning from adverse events.22 The CPSI, in collaboration with the Institute for Safer Medication Practices Canada and Saskatchewan Health, also developed the Canadian Root Cause Analysis Framework, a quality improvement tool to help individuals and organizations determine all of the contributing factors and root causes that led to an event (e.g., critical incidents and close calls).23 Finally, CPSI is engaged with key stakeholders and partners in the development of a Canadian inter-professional competency-based framework for patient safety.24

Reporting and Learning Systems

The primary purpose of reporting is to learn from experience…a good internal reporting system ensures that all responsible parties are aware of major hazards. Reporting is also important for monitoring progress in the prevention of errors. Thus the reporting of close calls, as well as adverse events, is valuable. External reporting allows lessons to be shared so that others can avoid the same mishaps.

Lucian L. Leape, MDNew Eng J Med, 2002

Adverse health event reporting and learning systems hold much potential for improving patient safety in general. However, the emphasis must be on lessons learned and sharing of the same, otherwise, the reporting of adverse health events will only result in the collection of interesting statistics.

In 2007 a review of relevant literature on adverse event reporting and learning systems from technology, implementation, learning and classification perspectives was performed.

The author classified the review into seven themes: (1) governance and legislative frameworks for national reporting systems (2) taxonomy and classification systems used in data reporting and analysis (3) technical/design considerations and user issues (4) anonymous and confidential reporting systems (5) reporting by professionals and/or patients (6) financial implications, and (7) feedback systems to improve safety. Governance and legislative frameworks must be considered as well as incentives and barriers to implementing reporting systems. An overview of the national reporting systems in the UK, US, and Japan was provided. The author also emphasized the importance of a standardized taxonomy for coding and classification of events such as the WHO International Patient Safety Event Classification (IPSEC) currently being developed. Some of the technical/design considerations and user issues one must take into account include paper-based adverse event reporting systems versus electronic,

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use of information technology (e.g., personal digital assistants by physicians at the patient beside), categories of detail that should be included in a patient safety database (e.g., what, where, when, how and why an event happened, what action was taken or proposed, what was the impact of the event (e.g., harm to the patient, organization, etc.), and factor that did, or could have, minimized impact. The choice of anonymous or confidential reporting and learning systems needs careful consideration. Importantly, anonymous reporting does not allow the opportunity for follow-up if questions arise during the course of an investigation, sometimes making it difficult to get at the root cause (s) of the adverse event. The literature review addressed the barriers to reporting by health care professionals, and the differences in physician and nurse preferences for reporting systems. The author suggests that in order to overcome the barriers to reporting, a learning and nonpunitive culture of safety must be promoted, and legal protection provided for those reporting incidents. White states that very little information has been published about the specific costs associated with the development, implementation and maintenance of incident reporting databases. However, the author suggests that to properly prepare for the “financial implications” of an adverse event reporting and learning system, the following areas and their associated costs should be taken into account: feasibility testing, legal advice, computer form design, hardware, software, development of taxonomy/classification systems, user education, user awareness, user acceptance testing, data coding, data analysis, feedback reporting, external promotion of systems and incentive programs. Finally, White highlights the importance of providing frequent “feedback” to staff and notification of any changes made to improve the system.

Leape (2002) suggests that successful health care adverse event reporting systems are exemplified by the following characteristics: (1) nonpunitive (2) confidential (3) independent – data are analyzed by independent organizations (4) expert analysis (5) timely feedback provided to system users (6) systems-oriented solutions to reported problems, and (7) participant organizations are responsive to suggested changes.

In this section of the paper, attention is given to the initiatives that have been undertaken by a number of countries. Although the Task Force is cognizant of the fact that many countries have reporting and learning systems in place (e.g., Japan, Denmark, the Netherlands, the Czech Republic and so on), it will focus only on the World Health Organization and three specific countries (the United States, the United Kingdom and Australia). Finally, several Canadian initiatives, either underway or being considered at a provincial or national level, will be presented.

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International Initiatives

World Health Organization

Adverse event and critical incident reporting and learning systems have been developed in several countries and summarized by others.25 The WHO draft guidelines on adverse event reporting and learning systems were developed in collaboration with Dr. Lucian Leape from Harvard’s School of Public Health.26 The goal of the development of such guidelines was to help countries develop or improve existing systems.27 The draft guidelines highlight a number of key characteristics of successful reporting and learning systems: reporting is safe for the individuals who report; reporting leads to a constructive response; expertise and adequate human and financial resources are available to allow for meaningful analysis and learning and the reporting system is capable of disseminating information and recommendations for change.28

United States

In 1999, the Institute of Medicine released its landmark report To Err is Human: Building a Safer Health System.29 One of the report’s recommendations was the establishment of a national mandatory reporting system in hospitals, followed by an expansion to all sites engaged in patient care. As of September 2005, 25 American states had passed legislation and/or regulations related to the reporting of critical incidents and adverse events occurring in a hospital setting; however, the requirements for these reporting systems vary from state to state.30 In addition, there is limited evidence of the sharing of information at the national level.31

United Kingdom

A landmark report published in 2000, An Organization with a Memory32, and the UK’s government response, Building a Safer NHS 33led to the establishment of the National Patient Safety Agency (NPSA). The NPSA was created to coordinate efforts to report and learn from mistakes and problems that affect patient safety in health care. It is a system for reporting and tracking adverse events and near misses. The NPSA tries to promote an open and fair culture in the NHS, encouraging all health care staff to report incidents without undue fear of personal reprimand. It collects and analyzes information on patient safety incidents from NHS organizations, staff and patients. A core function of the NPSA was the development of the National Reporting and Learning System (NRLS), an anonymous mandatory reporting system that is responsible for collecting reports of patient safety incidents (actual and potential adverse events) from all service settings across England and Wales, and, importantly, learning from such reports. All reporting by individuals is anonymous, but it is mandatory for NHS Trusts to submit any reported

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adverse event to the NRLS. The NRLS was launched in February 2004.

An evaluative report reviewing the progress of the NRLS was released by NPSA in February 2008.34 Over 800 staff participated in the review. A major finding was the insufficient progress in improving patient safety. The staff suggested that the NPSA (1) build on the system currently in place but improve it (2) make the system quicker and easier to use (3) get to the most serious issues quickly (4) streamline routes of reporting, and (5) provide more targeted feedback for organizations and specialties.

Australia

The Australian Advanced Incident Monitoring System (AIMS) is a confidential error reporting system. Patient Safety International, a subsidiary of the Australian Patient Safety Foundation, developed the AIMS software tool to consistently capture information on close calls and critical incidents, allowing for in-depth analysis of both types of events. Patient Safety International (PSI) is a leading provider of incident management software to help health care services improve the quality of care by reducing medical errors, waste and harm to patients. The AIMS consists of a confidential incident report form completed at a local level, and an anonymous monitoring system.

The AIMS incident management software is used by over 400 Australian hospitals, as well as at sites in South Africa, New Zealand and the United States. AIMS captures adverse event and near miss information across acute care, community care, disability care, mental health and residential aged care (nursing homes). Unlike other systems, AIMS includes a standardized classification (ontology) that is recognized by the World Health Organization and the US Institute of Medicine. The software is currently in use in over half the Australian public health system and allows a comparison of critical incidents and appropriate interventions to reduce the risk of recurrences among those participating in the surveillance system. A national reporting system, therefore, does not truly exist in Australia.

Canada

Canadian Institute for Health Information

The Canadian Institute for Health Information (CIHI) collects information on a number of patient safety indicators: (1) obstetrical trauma during childbirth, (2) foreign objects left in after a procedure, (3) post admission pulmonary embolism or deep-vein thrombosis and (4) in-hospital falls and hip fractures. In a 2006 survey of primary care physicians the findings suggested that almost three of five primary care doctors reported that there was no documented process for follow-up and analysis of adverse events.35

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Canadian Medication Incident Reporting and Prevention System

The Canadian Medication Incident Reporting and Prevention System (CMIRPS)36 is a system that reports, analyses and manages voluntarily reported medication incident data on a national basis. The Canadian Institute for Health Information, Health Canada and the Institute for Safe Medication Practice Canada are collaborating parties of CMIRPS. The CMIRPS coalition is comprised of the Canadian Association of Chain Drug Stores; the Canadian Healthcare Association; the Canadian Institute for Health Information; the Canadian Medical Association; the Canadian Nurses Association; Canadian Pharmacists Association; Canada’s Research Based Pharmaceutical Companies; Canadian Society of Hospital Pharmacists; College of Family Physicians of Canada; Consumers Association of Canada; Health Canada - Marketed Health Products Directorate, Health Products and Foods Branch (Secretariat); Institute for Safe Medication Practices Canada; and The Royal College of Physicians and Surgeons of Canada. CMIRPS promotes an open, “blame-free” system that encourages health care practitioners to voluntarily share their medication incident experiences.

The purposes of the CMIRPS program are to coordinate the capture, analysis and dissemination of information on medication incidents; enhance the safety of the medication-use system for Canadians; and support the effective use of resources through the reduction of potential or actual harm caused by preventable medication incidents.

The goals of the CMIRPS information system are to collect data on medication incidents; facilitate the implementation of reporting of medication incidents; facilitate the development and dissemination of timely, targeted information designed to reduce the risk of medication incidents facilitate the development and dissemination of information on best practices in safe medication use systems.

The CMIRPS collects reports on potential and actual incidents related to any medication and occurring at any stage of the medication-use system: prescribing, order communication, product labeling and packaging, compounding, dispensing, distribution, administration, monitoring, documentation or use. Incident reports can be submitted by health care professionals, institutions such as hospitals, and from patients themselves.Medication incidents may involve improperly prescribed medication, improper administration or incorrect dosage or protocol.

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Canadian Adverse Event Reporting and Learning System (CAERLS)

The Canadian Patient Safety Institute is currently engaged in a process to establish the Canadian Adverse Event Reporting and Learning System (CAERLS), one of its strategic business plan goals. As an initial step, a review of leading national and international practices was conducted in the reporting of adverse events, medical error and critical incident reporting, and related improvement mechanisms designed to facilitate knowledge transfer, learning and, ultimately, to improve patient safety. 37 A comprehensive review38 of the published literature on adverse event reporting and learning systems in health care for the Canadian Patient Safety Institute encompassed an examination of governance and legislative frameworks; taxonomy and classification systems; technical/design considerations and user issues; anonymous and confidential reporting systems; reporting by professionals and/or patients; financial implications; and, feedback systems to improve safety.

In 2007, CPSI commissioned a separate review39 focusing on provincial, territorial and federal legislation and policy related to the reporting and review of adverse events in health care in Canada. As part of the review, the authors addressed key enablers and barriers for the reporting and review of incidents on a national scale. The authors (1) analyzed the application of provincial and federal legislation, (2) reviewed policies at provincial and regional levels, (3) conducted surveys of health care regions, hospitals and other health delivery organizations, and (4) interviewed experts and key stakeholders interested in the reporting of incidents. The report’s findings indicated that while some provinces have enacted legislation for the mandatory reporting of adverse health events, the reporting of adverse events remains at the institutional level in many other provinces. Importantly, the prohibition of the sharing of patient safety information, both within and outside of the province, would act as a significant barrier to the creation of a national reporting system. Other factors that would prove to be challenging include “a lack of a common approach, shared definitions, and other elements need to collect and compare data on a provincial basis, let alone on a pan-Canadian basis” (page 2). 40 The authors recommend the development of local capabilities to collect and analyze reports within organizations and regions. They suggest the establishment of a provincial body (e.g., Minister or other separate body) responsible for reporting in each province. The provincial body would be responsible for coordination of the reporting by institutions and professionals in health care in compliance with legislation within that province. De-identified information would be shared by the provincial body with a national body (i.e., a pan-Canadian body) that had the capacity to disseminate information and warnings on a national basis. Finally, in order to learn from lessons across the country, a framework for the classification of incidents on a pan-Canadian level would be required.

The collaborating organizations of CMIRPS (Health Canada, Canadian Institute for Health Information, and the Institute for Safe Medication Practices) are exploring the possible integration of CAERLS and CMIRPS.41

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Regional and Provincial Initiatives

Several initiatives are currently underway in a number of regional health authorities/health care organizations including the British Columbia Incident Reporting Information System (IRIS) Project; Regional Occurrence System Enhanced (ROSE) Project, Eastern Health, Newfoundland and Labrador; and Patient Safety Reporting System (PSRS), Capital Health (Halifax), Nova Scotia.

Incident Reporting Information System (IRIS) project

The IRIS project42 is an initiative of the British Columbia Patient Safety Task Force. It is a collaborative effort of all six BC Health Authorities and the Health Protection Program. The project is funded by Canada Health Infoway, British Columbia Ministry of Health and the Health Authorities. The project will consist of four stages: (1) feasibility study 2003/04 (2) package selection, 2005/06 (3) pilot implementation, and (4) provincial rollout 2007-2010. The exercise will cover all facilities in the community. The objective of the project is to enable the identification, management, analysis, learning and sharing lessons acquired. DATIX43 software, a web-based incident, complaints and claims reporting tool, will be used in all regions of the province. Anyone with access to an organization’s intranet will be able to report incidents directly into the DATIXWeb software using easy-to-use web pages. Managers receive an automatic email with details of incidents. They can complete the details of the investigation through the web and also run analyses incidents. DATIX uses a standard coding system for clinical and nonclinical adverse events and near misses. The Calgary Health Region is also a client of DATIX and will be implementing the reporting tool across its region in the near future.44

Regional Occurrence System Enhanced (ROSE) Project

The Regional Occurrence System Enhanced (ROSE) Project45 proposed by Eastern Health will entail the development and implementation of an electronic occurrence reporting system (OCR) across the continuum of patient care encompassed by the Eastern Health Regional Authority in Newfoundland and Labrador. The project will consist of three stages: (1) requirements finalization and implementation planning (2) staged implementation and testing, and (3) benefits determination/evaluation. The project has five broad objectives (1) to enhance the development of a patient safety culture through intense education and ongoing support initiatives (2) to improve the efficiency and effectiveness of the occurrence reporting system(3) to improve communications related to occurrence reporting and implementation of action plans (4) to support related quality, research and evaluation activities (5) to explore opportunities for collaboration throughout development, implementation, evaluation, and knowledge transfer.46

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Patient Safety Reporting System (PSRS)

Findings from two patient safety culture surveys conducted in 2003 and 2005 at Capital Health (Halifax) suggested that staff believed that they “… would probably be treated in a negative way for reporting or discussing errors or serious occurrences” by 45.4% in 2003 and 50.4% (p=0.03) in 2005. Capital Health recently developed and launched an in-house incident reporting system. The Patient Safety Reporting System (PSRS), an intranet-based online reporting and data retrieval system created on a network platform provided by CCD Systems, was implemented at three pilot sites in June 2007, and in 2008 the system was expanded across the region. The program allows computerized reporting of patient safety issues from a network-ready computer. Report completion and delivery occurs immediately after the clinical staff or physician completes the report online, thereby eliminating the handling of paper forms and time-intensive data entry. The system will, upon completion of the event entry, send an email notification to the responsible clinical leaders and/or physician, allowing them to review and follow-up their reports immediately and enhance system accountability. Past practice included Risk Management assigning a severity rating to the event; however, with the new system the individual entering the event is able to assign the severity or patient impact to the actual event or near miss. Confidentiality of the new reporting system is anticipated to increase staff/physician confidence in the reporting system.47

Summary

Learning is more than the analysis of an adverse incident – it is about ensuring there is a change based on well-designed action plans. These must be realistic, achievable and sustainable, with all stakeholders involved in their development.48

Adverse health reporting and learning systems have been developed and implemented in a number of countries. Canadian organizations and institutions that have adopted or are engaged in the development of reporting and learning aspects of adverse health care management should remain cognizant about the challenges experienced by other countries and organizations (e.g., National Patient Safety Agency –UK – National Reporting and Learning System). More specifically, an evaluation observation coming out of the UK in relation to the NRLS suggests that

despite the high volume of incident reports collected by the NPSA … there are too few examples where these have resulted in actionable learning for local NHS organizations. The National Reporting and Learning System (NRLS) is not yet delivering high-quality, routinely available information on patterns, trends, and underlying causes of harm to patients (p.6). 49

Provincial reporting and learning initiatives are slowly beginning to emerge. Each province and territory has established individual policies and guidelines for reporting

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adverse health events. Furthermore, in many areas policies and guidelines vary between jurisdictions and or regional health authorities and or organizations. Finally, the focus of adverse health event reporting has been on the acute-care setting (i.e., institutions). Gaps in patient safety and adverse health event reporting have been identified in long-term care50 and home care51. The Health Council of Canada’s 2007 Annual Report stressed the importance of implementing standardized, systematic reporting of adverse health events across the continuum of health care (i.e., acute care, long-term care, and community). The Council cautioned that without such an approach jurisdictions would be “unable to collect and monitor information, understand the extent of the errors, and share learning and knowledge” (page 47). 52

It is important to remain focused on the purposes of establishing national reporting and learning systems: to collect information, disseminate lessons learned and transfer the knowledge and learning to all health system stakeholders. Lessons learned from pioneers (the US, the UK, and Australia) in the field of adverse health event management will be very helpful in the planning and implementation of a pan-Canadian reporting and learning system.

Provincial Legislation – Quality of Care Committees

Legislative and regulatory frameworks focused on quality of health care services exist in all Canadian provinces and territories. A detailed listing is provided in Appendix C. Details associated with various pieces of legislation specific to the Newfoundland and Labrador setting are presented and discussed elsewhere in this report.

Information related to quality of care committees is protected by legislation. The intent of the legislation is to protect and prevent the information from being used in subsequent legal or disciplinary proceedings, thereby encouraging full participation of health care providers in quality improvement. Quality improvement programs in hospitals/institutions often use quality of care committees to analyze clinical outcomes, adverse events and close calls. Recommendations arising from the analyses are used to help correct any system failures that are identified. Some jurisdictions explicitly prohibit the sharing of any findings, conclusions or recommendations of a quality improvement committee to persons other than in management responsible for their implementation.53

Provincial Incident Reporting and Investigation Legislation

Three provinces (Saskatchewan, Manitoba and Quebec) have legislation that requires the reporting of various types of incidents that occur in health care facilities (hospitals, long- term care, child care, personal care homes). Saskatchewan and Manitoba, in particular, have moved from a voluntary reporting of adverse events to a more comprehensive

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legislated process, including mandatory reporting and shared learning, in an effort to reduce the potential of critical incident reoccurrence. As of July 1st, 2008, Ontario will become the most recent province to amend legislation, thereby mandating the disclosure of critical incidents to patients.

CPSI engaged a group to conduct a review of provincial, territorial and federal legislation and policy related to the reporting and review of adverse events in health care in Canada.54 A legislation reference table is presented in Appendix C. The review identified only three provinces that address adverse events/critical incidents in their legislation. The key provisions of the statutes summarized by Baker, Grosso, Heinz et al are included in Appendix D.

In this section of the paper, an overview of established provincial incident reporting, the investigation legislation of three provinces (Saskatchewan, Manitoba and Quebec) and new legislation in Ontario as of July 1st, 2008 are discussed.

Saskatchewan

In 2002, Saskatchewan became the first Canadian province to enact legislation requiring mandatory reporting of adverse events to the provincial Department of Health.

On September 15, 2004, the government of Saskatchewan passed legislation requiring the reporting and investigation of occurrences of critical incidents in health care. The aim of such legislation is reporting for learning to enhance patient safety. A critical incident is defined as:

A serious adverse health event including, but not limited to, the actual or potential loss of life, limb or function related to a health service provided by, or a program operated by, a regional health authority (RHA) or a health care organization (HCO).55

Saskatchewan’s Personal Care Homes Regulations (R.R.S. 2000, c. P.-6.01, Reg 2 amended by Saskatchewan Regulations 69/2002 and 89/2003), mandate reporting of “serious incidents.” This includes “any occurrence, accident or injury that is potentially life threatening” as well as “ any harm or suspected harm suffered by a resident as a result of unlawful conduct, improper treatment or care, harassment or neglect on the part of any person” (s.13 (1)). Licensees must notify the “resident’s supporter,” their physician, the department responsible and the regional health authority. They are also obligated to provide a written report to the government department responsible, outlining a number of things including “any actions taken…to solve the problems…and to prevent recurrences of the serious incident” (s.13(2)(b)).

The Saskatchewan Critical Incident Reporting Guidelines56 lists the critical incidents

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that must be reported to the Department of Health. Since 2004, notification of “critical incidents” must be made by health care organizations to their regional health authorities. This guideline was adapted from the US National Quality Forum, Serious Reportable Events in Health Care: A Consensus Report published in 2002.57 It is the responsibility of the authority to directly notify the minister. Investigations and written reports are to follow (Act to Amend the Regional Services Act, (2004); Critical Incident Reporting Guideline and Saskatchewan Critical Incident Regulations). Details of the report must include a description of the circumstances surrounding the incident, the identification of potential contributing factors that upon modification could prevent a reoccurrence of the event, actions taken and future plans of action the organization or authority might identify as a result of the critical incident investigation. The names of patients, health care providers or any other individuals with knowledge of the critical incident are protected by a confidentiality provision in the legislation, and therefore cannot be named in any report arising from the investigation of the critical incident.

Manitoba

In 2005, the Manitoba government passed legislation to amend the Regional Health Authorities Act and the Manitoba Evidence Act. 58 The amendments contained mandatory critical incident reporting requirements. A critical incident is defined as:

Unintended event that occurs when health services are provided to an individual and result in a consequence to him/her that (a) is serious and undesired, such as death, disability, injury or harm, unplanned admission to hospital or unusual extension of hospital stay, and (b) does not result from the individual’s underlying health condition or from risk inherent in providing the health service.59

Manitoba does not have a “common list” or guideline of reportable critical incidents similar to the one used in Saskatchewan. However, once identified, the channel for reporting a critical incident is similar to that of Saskatchewan, the health care organization would report the event to the regional authority, which in turn would report the incident directly to the Minister of Health. If a critical incident occurs, the regional health authority, health corporation or health care organization must ensure (1) that appropriate steps are taken to fully inform the individual, as soon as possible, about the facts of what actually occurred with respect to the critical incident (2) its consequences for the individual as they become known, and (3) the actions taken and to be taken to address the consequences of the critical incident, including any health services, care or treatment that are advisable. A complete record must be made about the critical incident, which must address the preceding points. The individual who experienced the critical incident may examine the report and receive a copy, free of charge.

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Quebec

The government of Quebec amended legislation in an effort to mandate when and what a patient should be told after an accident or incident occurs in institutions. The amended legislation ensures a specific right to be informed of an accident. An “accident” is defined as “an action or situation where a risk event occurs which has or could have consequences for the state of health or welfare of the user, a personal member, a professional involved or a third person”.60 An “incident” is defined as “an action or situation that does not have consequences for the state of the health or welfare of a user, a personal member, a professional involved or a third person, but the outcome of which is unusual and could have had consequences under different circumstances”. 61

Health care facilities’ obligations concerning disclosure of accidents, declaration of accidents and incidents, allowance of support for patients, their families and health care workers involved in the accident, creation of a risk- and-quality management committee, accreditation on patient safety, quality and risk management and the development of a local registry are addressed in Bill 113. The Bill also makes provision for a province-wide registry of incidents and accidents.62

Ontario

In February 2003, the Council of the College of Physicians and Surgeons of Ontario approved a policy that mandates disclosure of a critical incident.63 The disclosure of a critical incident in Ontario was addressed at a provincial level in July 2008, with a new regulation that amends Regulation 965 under the Public Hospitals Act. 64 The amendment mandates the disclosure of a critical incident to a patient.

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 the treatment.

Hospitals are expected to adopt and implement the regulation; however, they may also retain or develop expanded disclosure policies that exceed (but do not contravene) the requirements of the Act. The boards are responsible for ensuring that hospital administrators establish a system for ensuring the disclosure of every critical incident. Policies and procedures for staff reporting will be based on what is most appropriate for their particular facility.

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Summary

The definition of reportable incidents varies between the three provinces that have legislated adverse event reporting requirements. The most inclusive definition is in the Saskatchewan Critical Incident Report Guideline. In each of the provinces, the minister must be notified of a critical incident occurrence, and a report must follow. While detailed reporting guidelines are available in Saskatchewan, institutions in Quebec are responsible for developing written recording and provision of information procedures as they relate to adverse event occurrences. Manitoba and Saskatchewan have very similar requirements when it comes to reporting critical incidents; however, Manitoba does not have a detailed reporting guideline process such as the one used in Saskatchewan. In Ontario, the boards will be responsible for ensuring that hospital administrators establish a system for ensuring the disclosure of every critical incident. The policies and procedures for staff reporting will be facility-specific.

Disclosure

A number of comprehensive overviews of open disclosure are available in the literature (Canadian Patient Safety Institute, 2006; Australian Commission on Safety and Quality in Health Care, 2008).65 66 Open disclosure policies have been developed and implemented in a number of countries over the last five years:

Australia - Open Disclosure Standard: A National Standard for Open Communication in Public and Private Hospitals, Following an Adverse Event in Health Care (2003); 67

UK - Being Open -Communicating Patient Safety Incidents with Patients and Carers: NHS (2005); 68

US - When Things go Wrong: Responding to Adverse Events (2006)69 and;Canada - Canadian Disclosure Guidelines (2008). 70

Most recently, CPSI launched the Canadian Disclosure Guidelines (CPSI, 2008). 71 The guidelines are based on a national and international environmental scan and review of the literature. The purpose of the guidelines is to provide support for the development and implementation of policies, procedures and training methods (e.g., Canadian root cause analysis) as they relate to adverse health events disclosure processes to health care providers, interdisciplinary teams, organizations and regulators. The approach to the disclosure process in these guidelines is purported to occur in two stages: (1) initial disclosure and (2) post analysis disclosure. During the initial disclosure, consideration should be given to the following: (a) participants in the disclosure discussions (b) when disclosure should take place (c) the setting and location of the disclosure (d) what to disclose, and (e) how will disclosure occur. During the initial disclosure, the guidelines suggest providing facts, explaining the care plan, avoiding speculation, expressing regret, outlining expectations, arranging follow-up, identifying a contact and documenting.

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During the second phase of disclosure, further facts and any actions taken are provided to the patient/family with an appropriate expression of regret. The information is documented. The Task Force will not be duplicating the extensive efforts of CPSI on identifying an appropriate disclosure process; rather, the Task Force will review the applicability of the CPSI Disclosure Guidelines to the Newfoundland and Labrador setting.

Additionally, the Newfoundland and Labrador Commission of Inquiry on Hormone Receptor Testing in Breast Cancer has a policy focus and includes a review of both the policy and legal issues raised in its Terms of Reference. The Commission engaged six experts to prepare disclosure obligation papers to assist the Commission with its policy development role. The papers are available at http://www.cihrt.nl.ca/partIIoftheinquiry.html.72The papers focused on the following topics:

Legal and Ethical Obligations of Public Health Authorities and Government 1. (Dickens, G.);Examining Disclosure Options: Procedures for Disclosing Adverse Events: A 2. Literature Review (Espin, S.);Disclosing Unanticipated Outcomes to Patients: International Trends and Norms 3. (Gallagher, T.H.);Disclosure: Ethical and Policy Considerations (Hébert, P.C.); and4. The Legal Duty of Physicians to Disclose Medical Errors (Robertson, G.B.).5.

Adverse Health Event Management – Policies of Select Canadian Organizations

As part of the work of the Task Force, we identified and examined a number of policies related to the management of adverse health events at the organizational, regional, provincial and federal levels. A complete listing of the policies reviewed is presented in Appendix E. The Task Force has decided to focus on three regional policies only in this section. The policies are presented in Appendix F.

Alberta

Calgary Health Region

The Calgary health region is considered by many to be the country’s most progressive. 73 A quality improvement framework - with patient safety as a focal point- and a supporting program were developed after the region’s first full accreditation in 1999.74 A number of regional safety policies exist between the region/providers and patients (i.e., disclosure of harm policy), between providers and the region (reporting hazards, close calls and harm policy), between the region and its providers (i.e., just and trusting culture policy) and

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between the region and its principal health care partners/stakeholders (i.e., informing). Detailed procedure manuals complement each of the regional policies. Reporting focuses on all types of incidents (i.e., harm, close calls and hazards) and is done on a voluntary basis to the Calgary Health Region. Sharing of information for the purpose of learning and making system improvements within the region and in other health care organizations is fostered.

One of the guidelines used in the region focuses on the “Immediate and Continuing Management of Serious (Potential) Adverse Events.” The purpose of the guideline is “to outline the immediate and continuing roles and responsibilities of senior administrators or medical leaders in the Calgary Health Region when potentially serious adverse events have or may have occurred” (page 4). The guideline is used as a framework to assist senior administrators/medical leaders in decision-making, planning and taking actions. The initial and critical steps in the immediate management can be captured in the acronym RESPOND. The RESPOND checklist addresses the following steps:

R esuscitate/react – to the patient’s immediate needsE nvironment – ensure that it is safe for patients and providersS ecure equipment – for examination and evaluationP rotect other patients – that they cannot be immediately harmedO ffer support - to the patients/families and health care providers involvedN otify – appropriate clinicians/administrators and complete a Safety Learning ReportD isclosure – acknowledge the adverse event

Actions associated with RESPOND are outlined in the procedure manual.

Once the immediate management of the potentially serious adverse event has been addressed, a senior administrator/medial leader is accountable for the continued management of the event (i.e., patient/family, health care provider(s) involved, region). A second checklist focuses on advocacy, communication and evaluation (ACE) and actions that may or may not be taken.

A dvocate – and continue to support the patient/family and health care provider(s) involved:

Assigning a patient advocate, providing ongoing support for the patient/family and health care providers are key actions.

C ommunicate – important information to the patient/family, health care providers and/or other stakeholders:

Disclosing to the patient/family, completing a safety learning report (required in the event of a patient suffering fatal or severe harm, but also strongly encouraged when a patient has suffered from moderate or minimal harm or experienced a close call), and informing principal partners and stakeholders.

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E valuate – the potentially serious adverse event so that the Region can learn and make improvements, where appropriate, for the safety of the next patient.

Key actions include:Conducting a safety analysis (if there is reason to suggest that system contributing factors may be associated with the potentially adverse event or risk thereof (close call)). The Safety Analysis does not review or assess the performance of individuals, and would not be conducted by persons who have administrative responsibilities for the area and health care providers involved.And/or an administrative review (when there is evidence or probable reason to suggest that individual contributing factors may be associated with the potentially adverse event or risk thereof (close call)). An administrative review is conducted by individuals with administrative responsibilities for the actions of the individuals involved. The reviews are not conducted under the direction of the clinical safety committee; therefore, Section 9 of the Alberta Evidence Act does not apply to these documents. The provincial privacy legislation does not permit the release of the outcome of the administrative reviews.

A summary of three presentations by Dr. Ward Flemons, VP Health Outcomes that focus on the operational response to an adverse event, acting on the management of an adverse event and embracing a culture of safety are presented in an accompanying document – Provincial Forum on Adverse Health Events – Summary Proceedings.

Manitoba

Winnipeg Regional Health Authority

The Winnipeg Regional Health Authority (WRHA) Patient Safety team75 develops and supports programs and initiatives with the goal of reducing unnecessary patient injuries and deaths in the region. The regional team is led by Dr. Rob Robson, Chief Patient Safety Officer and Harvard-trained health care mediator. A comprehensive strategy to improve the region’s capacity to effectively manage and learn from adverse events – or what the region refers to as Critical Clinical Occurrences (e.g., medication errors, misdiagnosis, equipment failures and so on) – was implemented by the authority. The Regional Integrated Patient Safety Strategy has four focal points: (1) promoting culture change with the aim of moving from a culture of blame, fear and retribution to a safety culture that encourages openly discussing adverse events, asking questions and making improvements (2) directly involving patients by way of a Patient Safety Advisory Council (3) learning from clinical practice (e.g., Critical Clinical Occurrence), and (4) promoting change in care delivery with the aim of enhancing acceptable standards of care.

The WRHA has two regional policies available on its website that apply to all WRHA governed sites and facilities (including hospitals and personal care homes), and are

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specifically related to reporting, investigating, disclosing and learning from critical incidents. The policies, Critical Incident Management and Learning76 and Disclosure of Information Related to Care and Treatment77, were adopted by the WRHA in 2007. The Disclosure of Information Policy mandates the disclosure of pertinent clinical information, not only following critical incidents but in other patient-centered care circumstances. The Reporting of critical incidents or provisional critical incidents within the regional authority for any individual including employees and medical staff is mandatory. Provincial legislation dealing with critical incident reporting provides protection from litigation for the work of committees created to investigate such incidents. It is also mandatory for the regional authority to report critical incidents to the Ministry initially (i.e., after the event has been confirmed as a critical incident), to submit a status report on the critical incident within 30 days to Manitoba Health, and to submit a copy of the final report within 90 calendar days of the critical incident or upon completion of a critical incident review.

In 2008, Dr. Robson and Elaine Pelletier, a patient safety process analyst for the region, published an article in Health Care Quarterly that focused on the factors that led the WRHA to develop a process to identify cases involving patient harm following critical incidents in the health care system. The coauthors described the main steps that would lead to early compensation discussions with patients in cases when preventable contributing factors were under the control of WRHA.78

Saskatchewan

Saskatoon Health Region

All critical incidents are reported through a region-wide reporting process in compliance with Section 58 of the Regional Health Services Act and its corresponding regulations- The Regional Health Services Critical Incident Regulations – and the Accountability Agreement with Regional Health Authorities and Saskatchewan Health.

Critical incident is defined according to the legislation and regulations. The Saskatchewan Critical Incident Reporting Guideline (2004) is adapted from the 2002 National Quality Forum Serious Reportable Events in Health Care: A Consensus Report. The guideline provides a list of reportable events including surgical events (e.g., surgery performed on a wrong body part, on the wrong patient), patient death or disability associated with product or device events (e.g., contaminated drugs, devices or biologics), patient protection events (e.g., an infant discharged to the wrong person), care management events (e.g., patient death or disability associated with hemolytic reaction due to the administration of ABO-incompatible blood or blood products), environmental events (e.g., patient death associated with a fall while being cared for by an RHA or Health Care Organization), and criminal events (e.g., sexual assault of a patient that occurs on the grounds owned or

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controlled by an RHA or HCO).

The Saskatoon Health Region Critical Incident Reporting Policy was revised in September 2007. Critical incidents must be reported immediately to the Director of Risk Management or designate. During the weekend or night shift, the most senior administrator on call is contacted through the Switchboard or the appropriate on-call process. The administrator then notifies the Director of Risk Management and appropriate senior managers. The event is entered into the Safety Reporting System (computer-based) or a confidential Safety Report is completed by staff member, physician, volunteer or student of the service/dept/area who was involved in, witness to, or became aware of the critical incident. This must happen within 24 hours of the critical incident occurring or when the incident is recognized as a critical incident and be in accordance with the procedures outlined in the Safety Reporting Policy (#7311-50-006).

When the Safety Report form is completed, it must be submitted to Risk Management within 48 hours of the critical incident. Other reporting forms or documentation that may have been completed (i.e., a medication error report) must accompany the confidential Safety Report. When the Safety Reporting System (computer-based) is used, automatic notification of the appropriate individuals will occur. Safety Reports are not part of the health record. The original report is filed in Risk Management. A factual note of the event and the patient assessment must be documented in the patient’s/resident’s chart.

Risk Management notifies the appropriate senior management that a critical incident has occurred. Risk Management, according to the legislation, shall notify the Minister of Health of a critical incident within three business days following the incident or the date the regional health authority becomes aware of it. Notification to the Minister of Health by Risk Management shall include de-identified, factual information about the critical incident.

Saskatoon Health Region shall investigate the critical incident through a nonpunitive, multidisciplinary review (Appendix B – Multidisciplinary Case Review) The investigation includes:

the circumstances leading up to and culminating in the critical incident; any current practice, procedure or factor involved in the health service that contributed to the critical incident; actions considered, developed or required as follow-up to the critical incident; andimplementation of any recommendations resulting from the critical incident review.

Risk Management, according to the legislation, will provide a written report of de-identified factual information including actions taken, planned and the quality improvements the RHA will be implementing as a result of the critical incident review.

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The report must be submitted within 60 days of the RHA becoming aware of the critical incident.

Appropriate senior managers within SHR will receive a copy of the written report of de-identified factual information including the actions taken, planned and any quality improvements that will be implemented as a result of the critical incident multidisciplinary case review. Feedback/direction will be provided to appropriate stakeholders to implement quality improvements as required.

The region and its affiliates also have a Disclosure of Adverse/Unanticipated Events Policy that became effective in October 2007. The policy addresses multijurisdictional disclosure and multiperson disclosure. Further details are provided in Appendix F.

Apology Legislation in Canada

Apology legislation may be divided into three categories:

Expressions of sympathy, regret or benevolence; 1. Limited apology legislation; and 2. Comprehensive apology legislation.3. 79

Derwin elaborates on the differences among the three categories. The first type of legislation makes expressions of sympathy, regret or benevolence inadmissible in court actions. A number of American states have passed laws protecting “expressions of sympathy, regret or benevolence”. According to Derwin, such laws are not true apology laws and serve a very limited purpose.80 As many as 36 states have adopted “apology laws”, thereby providing legal protection related to disclosure; however, the degree of protection varies.81 The second category of legislation protects apologies, but is limited in scope. Limited apology legislation may exclude apologies offered in certain types of actions, such as sexual assault lawsuits, tobacco litigation or intentional torts. The third type of apology legislation is comprehensive, protecting all forms of apologies, including apologies which admit liability. The Apology Act of Manitoba82, the Uniform Apology Act83, Apology Act, S.B.C. 2006, Chap. 19 (British Columbia)84 and the Evidence Act, S.S. 2006, c. E-11.2, Section 23.1(1) (Saskatchewan)85 are all forms of comprehensive apology legislation. Health Care providers’ fears that information, opinion or speculation offered during the course of an investigation would be used against them in a medical malpractice lawsuit, inhibited reporting in the past. The intent of the legislation was to provide the protection to do so without fear of reprisal. It was felt that the legislation provided by the Apology Act would encourage health care professionals and institutions to apologize for their errors without that apology being admissible as evidence of fault.

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On May 18, 2006 British Columbia became the first province to enact apology legislation.

86 This was followed by Saskatchewan in 2006 and Manitoba in 2007. In 2006, the British Columbia Ministry of Attorney General carried out a review87 of the academic literature, and focused on factors in favour and against apology legislation. Theses factors are listed below.

Factors in favour of apology legislation include:To avoid litigation and encourage the early and cost-effective resolution of a. disputes;To encourage natural, open and direct dialogue between people after injuries; andb. To encourage people to engage in the moral and humane act of apologizing after c. they have injured another, and to take responsibility for their actions.

Negative factors include:Public confidence in the courts could be adversely affected if a person who has a. admitted liability in an apology is not found liable;Insincere and strategic apologies could be encouraged; andb. Apologies encouraged by such legislation might create an emotional vulnerability c. in some plaintiffs who may accept settlements that are inappropriately low.

In the British Columbia and Manitoba Apology Acts, 88 89apology is defined as

an expression of sympathy or regret, a statement that one is sorry or any other words or actions indicating contrition or commiseration, whether or not the words or actions admit or imply an admission of fault in connection with the matter to which the words or actions relate.

The Yukon Legislative Assembly is also considering an apology act.90 As was the case for the Manitoba Apology Bill, Bill 103 is modeled after the British Columbia legislation. The apology for an adverse event is inadmissible in court for the purpose of proving liability in British Columbia, Manitoba, and Saskatchewan. The legislation in British Columbia, Manitoba and the Yukon addresses the issue of insurance in the following manner:

an apology does not, despite any wording to the contrary, in a contract of insurance, and despite any other enactment, void, impair or otherwise affect insurance coverage that is available, or that would, but for the apology, be available to the person in connection with that matter.

Ontario was the fourth and most recent province to consider an Apology Act. In April, 2008, A Private Members Bill (Bill 59) entitled the Apology Act, 2008, was tabled by Sault Ste. Marie Liberal MPP David Orazietti.91 The intent of the Act is to allow an individual to express an apology in connection with any civil matter, without that apology

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being considered an implied or expressed admission of fault or liability, or admissible as such in any court of law. It is anticipated that by removing the threat of litigation from an apology, more open communications in the health care environment will occur. The Ontario Medical Association and the Canadian Medical Protective Association welcomed the introduction and passing of Bill 59.92

The Uniform Law Conference of Canada was held in Prince Edward Island in 2007. The Conference, founded in 1918, harmonizes the laws of the provinces and territories, and also where appropriate, federal laws. At the 2007 Conference, recommendations on the Uniform Apology Act were adopted. The Act provides that an apology is not admissible in civil proceedings for the purpose of proving liability and that an apology is not an admission of liability. The conference suggested that: “As an alternative to a separate statute, a jurisdiction may wish to enact the provisions of the Uniform Apology Act as an amendment to its Evidence Act.” 93

A section common to all existing and draft apology legislation in Canada provides that an apology will not disentitle a person to insurance coverage, even if their policy or provincial legislation stipulates otherwise. Another similarity is the use of the term “person”. Person, under provincial interpretation legislation, is defined as a person or corporation.

The existing and draft apology legislation in Canada is generally consistent, although there are some minor differences in wording. Some legislation for example uses the term “notwithstanding,” while other legislation uses the term “despite.” Saskatchewan’s legislation refers to an event or occurrence, while the remaining legislation uses the term “matter.”

Another distinction arises the Manitoba legislation and the draft Yukon legislation, neither of which include a clause that precludes an apology from being considered an acknowledgement of a claim for purpose of their respective limitations legislation.

The Canadian Patient Safety Institute supported the enactment of the Ontario Apology Act and is advocating that apology legislation be adopted by all Canadian provinces and territories.

Conclusions

In undertaking a review of relevant “leading practices” in other jurisdictions, we were afforded the opportunity to examine and learn about the management of adverse health events from international, national, provincial, regional and organizational perspectives. Clearly, the pioneers in the field of adverse health event management (i.e., the UK, Australia, and the US) have much to offer in the way of lessons learned. The WHO is

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providing leadership in the area of adverse event reporting and learning systems and the standardization of taxonomy for classifying adverse events.

At a national level, the Canadian Patient Safety Institute (CPSI) has taken a lead role in the development and publication of Canadian Disclosure Guidelines and developing a strategy to create a pan-Canadian reporting and learning system. It has also developed the Canadian Root Cause Analysis Framework, a quality improvement tool to help individuals and organizations determine all of the contributing factors and root causes that led to an event (i.e., critical incidents and close calls). CPSI is currently engaged with key stakeholders and partners in the development of a Canadian interprofessional competency-based framework for patient safety.

At the provincial level, a variety of initiatives have been undertaken to address the reporting of “critical incidents” or accidents. A number of these initiatives are tied to legislation and regulations. However, a major limitation is the lack of standardization of definitions and terminology used within and between provinces, within and between regions, and between organizations. It is difficult to say, with any degree of certainty, whether one practice or policy is leading the way in the field of adverse event management; this in part, because of the paucity of evaluative outcomes research being conducted in this area.

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Appendix A Canadian Council on Health Services Accreditation

In January 2005, the CCHSA’s Patient Safety Goals and Required Organizational Practices (ROP) came into effect. An ROP is defined as “an essential practice that organizations must have in place to enhance patient/client safety and minimize risk”. These goals and required organizational practices are meant to be widely applicable (i.e., acute care, long-term care, community settings). Five ROPs are directly related to patient safety culture. CCHSA conducts an evaluation of implementation and evidence of compliance of the ROPs as part of the accreditation process. Information is provided by the participating organization to surveyors to test for compliance and evidence that must be in place for each practice. Surveyors are provided with suggested methods (e.g., team interviews, staff interviews, documentation review, and so on) to assess compliance. The test for compliance and the required evidence are highlighted below. Methods for surveyors are not addressed in this report.

The ROP for Patient Safety Area94 are as follows:

to adopt patient safety as a written, strategic priority/goal; 1. Tests for complianceIs patient/client safety written as a strategic priority/goal?Are resources allocated to support the organization’s implementation of the patient safety strategic priority/goal?Required evidenceDocumentation to ensure that patient/client safety is a written, strategic priority/goal, e.g. review strategic plan, annual report, and/or list of organizational goals.

to provide quarterly reports to the Board of directors on patient/client safety, 2. including changes/improvements following incident investigation and follow-up;

Tests for complianceIs there written evidence of patient/client safety-related quality reports provided to the Board?Do the quarterly reports demonstrate activities and accomplishments that support the strategic priority/goal?Is there evidence of the Board’s involvement in supporting activities identified in the quarterly reports?Required evidenceReview self-assessment info for L&P 5.4. {Board receiving useful, timely, and accurate information so that it can identify issues, address concerns, and make informed decisions]Documentation re: quarterly reporting to the board.

to establish a reporting system for actual and potential adverse events, including 3.

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appropriate follow-up, in compliance with any applicable legislation and within any protection afforded by legislation;

Tests for complianceIs there a reporting policy and process for actual and potential adverse events?Are improvements made following incident investigation and follow-up?Required evidenceReporting policy and process in place and used.

to implement a formal (transparent) policy and process of disclosure of adverse 4. events to patients/families, including support mechanisms for patients, family, and care/service providers;

Tests for complianceIs there a policy and process for disclosure, including support mechanisms for patients, family, and care/service providers?Required evidencePolicy and process for disclosure is implemented.

to conduct one patient-safety related prospective analysis per year (e.g., Failure 5. Modes and Effects Analysis) and implement recommended improvements/changes.

Tests for complianceHas at least one prospective analysis been completed within the past year?Documented evidence of at least one prospective analysis completed in the past year.Required evidenceEvidence of improvements/changes.

Non-compliance with any one ROP results in a conditional award. Organizations have six months to follow-up by putting the appropriate processes and systems in place to meet the requirements of the ROP. The organization is required to demonstrate compliance through a report or focused visit within six months. Four categories are used to assess compliance with ROPs: (1) not in place (2) in development (3) fully implemented, and (4) a leading practice.

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Appendix B Canadian Patient Safety Institute Disclosure Guidelines

Released in March 2008, the Canadian Patient Safety Institute disclosure guidelines95 are the product of a national working group. They were designed for an audience of health care providers, organizations, ministries and regulatory and professional bodies, to support and encourage the development or enhancement of disclosure guidelines in each such organization, and recognizing that the CPSI guidelines would be adapted as appropriate in each setting.

Principles of the CPSI guidelines: 1) patient centred health care; 2) patient autonomy; 3) safe health care; 4) leadership support; 5) disclosure is the right thing to do; 6) honesty and transparency.

In some cases a patient may be defined as the substitute decision maker. All aspects of disclosure must be governed by applicable privacy laws and policies.

CPSI recognizes the importance of disclosure as a basis for respecting patient rights, as the basis for ethical professional behaviour, to ensure trust and confidence in providers and health care institutions and to reduce legal liability. It points out that the CCHSA requires accredited health care organizations to adopt a transparent and formal disclosure policy what includes supports for patients, family and care or service providers.

The term “error” is not used in the guidelines because it suggests negligent action that can be attributed to specific people. Often, disclosure needs to happen before complete assessments of causation have been completed, so it may be too early to call the cause an error. Usually adverse events are the product of system factors or the interplay of events. Avoiding the term “error” allows for a more supportive environment for disclosure and learning from adverse events.

Creating a culture of patient safety includes ensuring that there is a channel for the reporting of adverse events, whether inside or outside the organization. A safety culture recognizes that systems failure is often the main cause of an adverse event. The lessons learned from an AE are used to repair system components so that the adverse event can be prevented in the future.

Patients should be supported by providing them with timely access to further health care, including clinical investigations, treatments and transfers; designating a staff person to provide emotional and practical support; facilitating support from family, friends, etc; and assisting patients to access other professional support, such as social workers, counselors and community services.

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Providers also need training in how to properly undertake disclosure; they also need support when adverse events occur and disclosure becomes necessary. Guidance and instruction on how to effectively communicate and respond to unintended patient outcomes should be integrated into undergraduate and graduate curricula for all health care providers.

The first priority after an adverse event is to attend to the patient, deal with any emergency, and ensure the prevention and mitigation of harm.

The disclosure process may consist of more than one conversation with the patient; it may be a dialogue over time. The initial disclosure should occur as soon as possible after an event; this is principally the obligation of the provider, but sometimes the organizational leadership or management may provide advice or assistance. The discussion will generally focus on the medical condition, further investigations and treatments, and associated risks. At this stage, even if an adverse event is recognized, it is unlikely that all the contributors may be known. The facts that are known should be communicated and, if appropriate, a commitment made to learn more. If the plan for further investigation is known, it should be communicated. Also appropriate is an expression of regret, avoidance of blame and speculation, and the provision of emotional and practical support.

The second stage is post analysis disclosure. Additional facts and the reasons for the events, if known, may be discussed. The involvement of leadership/management is likely to be more significant at this stage in determining what is disclosed. Leadership/management and providers must consider not only “the information needs of the patient, but also any restrictions or requirements on information exchange that might arise from the application of national or provincial legislation, regulations or local institutional/hospital by-laws and policies. The advice of legal counsel may be required.” Patients may be told of what improvements have been made, and as appropriate further expression of regret, an apology or an acceptance of responsibility may be included.

When an investigation is conducted by a legally protected quality of care or similar committee, it is important to be aware of how the law around this process will impact information exchange. Providers and patients should be aware of the limitations in discussing some of the investigative information.

An organizational policy for disclosure may be flexible in order to recognize the different levels of harm and the varying levels of administrative response and communication support. The organization should support the patient-provider relationship by implementing an organized and practical disclosure process. Disclosures should be appropriately documented according to established policy.

Close calls need only be disclosed depending on their circumstance, although each event has its own unique issues and sense of whether the event could happen again. In general,

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if an event did not reach the patient, there may be no requirement to disclose. But if the event reached the patient, and there is potential for harm, the event should be disclosed. Even if it reached the patient but there is no potential for harm, the event generally should be disclosed. Depending on the circumstances, a consultation with an ethics committee may be advisable.

Regarding multiple-patient disclosure, disclosure should be one patient at a time, and in-person, if possible. If not, it should be done by registered letter or by telephone with opportunity for follow-up. “In addition, disclosure should be timed, if possible, to occur with all patients involved at approximately the same time and, if possible, prior to any informing process, especially media coverage, being considered.”

Where more than one RHA is involved, the RHA involved in the actual adverse event should if possible lead the disclosure process. Ideally, representatives from both jurisdictions should participate. Effective communication and consultation regarding the facts should occur first. The matters should be addressed on a case-by-case basis.

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38

App

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x C

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efer

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Tab

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Legi

slat

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Ref

eren

ce T

able

Evi

denc

eH

ealth

Info

rmat

ion

Priv

acy/

Free

dom

of I

nfor

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and

Gen

eral

Pri

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Adv

erse

Eve

nt/C

ritic

al In

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nt

AB

Albe

rta

Evid

ence

Act

, R.S

.A. 2

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c.

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ealth

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rmat

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Act,

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c. H

-5.

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of I

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and

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/A

BC

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Act

, R.S

.B.C

, c. 1

24.

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dom

of I

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and

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, R.S

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itoba

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.C.S

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utho

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App

endi

x D

A

dver

se E

vent

/Cri

tical

Inci

dent

Rep

ortin

g L

aws

Tabl

e 1:

A R

evie

w o

f pro

vinc

ial,

terr

itoria

l and

fede

ral l

egis

latio

n an

d po

licy

rela

ted

to th

e re

porti

ng a

nd re

view

of a

dver

se

even

ts in

hea

lth c

are

in C

anad

a: A

ppen

dix

5, A

dver

se E

vent

/Crit

ical

Inci

dent

Rep

ortin

g La

ws. 9

6

Wha

t is r

epor

ted?

How

is th

e ev

ent r

epor

ted?

To w

hom

is th

e ev

ent r

epor

ted?

MB

53.1

“C

ritic

al In

cide

nt”

mea

ns a

n un

inte

nded

eve

nt th

at o

ccur

s w

hen

heal

th se

rvic

es a

re p

rovi

ded

to a

n in

divi

dual

that

resu

lts in

a

cons

eque

nce

to h

im o

r her

that

(a

) is s

erio

us a

nd u

ndes

ired,

such

as d

eath

, dis

abili

ty, i

njur

y or

ha

rm, u

npla

nned

adm

issi

on to

hos

pita

l or u

nusu

al e

xten

sion

of

hosp

ital s

tay,

and

(b

) doe

s not

resu

lt fr

om th

e in

divi

dual

’s u

nder

lyin

g he

alth

co

nditi

on o

r fro

m a

risk

inhe

rent

in p

rovi

ding

the

heal

th se

rvic

es.

(<<i

ncid

ent c

ritiq

ue>>

)

“Crit

ical

Inci

dent

Rev

iew

Com

mitt

ee”

mea

ns a

com

mitt

ee o

f one

or

mor

e in

divi

dual

s est

ablis

hed

unde

r sub

sect

ion

53.3

(1) o

r 53.

4 (1

). (<

<com

ité d

’exa

men

des

inci

dent

s crit

ique

s>>)

53.2

(2) I

f a c

ritic

al in

cide

nt o

ccur

s whe

n a

regi

onal

hea

lth

auth

ority

, hea

lth c

orpo

ratio

n or

pre

scrib

ed h

ealth

car

e or

gani

zatio

n is

pro

vidi

ng h

ealth

serv

ices

to a

n in

divi

dual

, the

aut

horit

y,

corp

orat

ion

or o

rgan

izat

ion

mus

t ens

ure

that

(a)a

ppro

pria

te st

eps a

re ta

ken

to fu

lly in

form

the

indi

vidu

al, a

s so

on a

s pos

sibl

e, a

bout

(i) th

e fa

cts o

f wha

t act

ually

occ

urre

d w

ith re

spec

t to

the

criti

cal

inci

dent

(ii) i

ts c

onse

quen

ces f

or th

e in

divi

dual

as t

hey

beco

me

know

n, a

nd(ii

i) th

e ac

tions

take

n an

d to

be

take

n to

add

ress

the

cons

eque

nces

of

the

criti

cal i

ncid

ent,

incl

udin

g an

y he

alth

serv

ices

, car

e or

tre

atm

ent t

hat a

re a

dvis

able

;

(b) a

com

plet

e re

cord

is p

rom

ptly

mad

e ab

out t

he c

ritic

al in

cide

nt,

whi

ch in

clud

es(i)

the

fact

s of w

hat a

ctua

lly o

ccur

red

with

resp

ect t

o th

e cr

itica

l in

cide

nt(ii

) its

con

sequ

ence

s for

the

indi

vidu

al a

s the

y be

com

e kn

own,

and

(iii)

the

actio

ns ta

ken

and

to b

e ta

ken

to a

ddre

ss th

e co

nseq

uenc

es

of th

e cr

itica

l inc

iden

t, in

clud

ing

any

heal

th se

rvic

es, c

are

or

treat

men

t tha

t are

adv

isab

le;

(c) t

he re

cord

des

crib

ed in

cla

use

(b) i

s ava

ilabl

e to

be

exam

ined

an

d co

pied

by

the

indi

vidu

al a

t no

cost

.

53.3

(1) E

xcep

t as p

rovi

ded

in su

bsec

tion

(6),

if a

criti

cal i

ncid

ent

occu

rs w

hen

heal

th se

rvic

es a

re p

rovi

ded

to a

n in

divi

dual

by

a he

alth

cor

pora

tion

or a

pre

scrib

ed h

ealth

car

e or

gani

zatio

n, th

e co

rpor

atio

n or

org

aniz

atio

n m

ust p

rom

ptly

(a) n

otify

the

regi

onal

hea

lth a

utho

rity

for t

he h

ealth

regi

on in

w

hich

the

criti

cal i

ncid

ent t

ook

plac

e ab

out t

he c

ritic

al in

cide

nt, i

n ac

cord

ance

with

the

guid

elin

es e

stab

lishe

d by

the

regi

onal

hea

lth

auth

ority

, to

inve

stig

ate

and

repo

rt re

spec

ting

the

criti

cal i

ncid

ent.

53.3

(2) P

rom

ptly

upo

n be

ing

notifi

ed a

bout

a c

ritic

al in

cide

nt

unde

r sub

sect

ion

(1),

the

regi

onal

hea

lth a

utho

rity

mus

t not

ify th

e m

inis

ter a

bout

the

criti

cal i

ncid

ent.

53.3

(3) A

crit

ical

inci

dent

revi

ew c

omm

ittee

est

ablis

hed

unde

r su

bsec

tion

(1) m

ust,

in a

ccor

danc

e w

ith th

e he

alth

cor

pora

tion’

s or

pres

crib

ed h

ealth

car

e or

gani

zatio

n’s d

irect

ions

,(a

) inv

estig

ate

the

criti

cal i

ncid

ent a

nd, d

urin

g th

e in

vest

igat

ion,

pr

ovid

e in

form

atio

n an

d re

ports

to th

e co

rpor

atio

n or

org

aniz

atio

n as

requ

este

d; a

nd(b

) upo

n co

mpl

etin

g th

e in

vest

igat

ion,

repo

rt its

find

ings

and

re

com

men

datio

ns to

the

corp

orat

ion

or o

rgan

izat

ion

in w

ritin

g.

53.3

(4) I

n ac

cord

ance

with

gui

delin

es e

stab

lishe

d by

the

regi

onal

he

alth

aut

horit

y, th

e he

alth

cor

pora

tion

or p

resc

ribed

hea

lth

care

org

aniz

atio

n m

ust p

rovi

de in

form

atio

n an

d re

ports

to th

e au

thor

ity a

bout

the

criti

cal i

ncid

ent a

nd th

e cr

itica

l inc

iden

t re

view

com

mitt

ee’s

inve

stig

atio

n, in

clud

ing

a w

ritte

n re

port

upon

co

mpl

etio

n of

the

inve

stig

atio

n.

53.3

(5) T

he re

gion

al h

ealth

aut

horit

y m

ust p

rovi

de in

form

atio

n an

d re

ports

to th

e m

inis

ter a

bout

the

criti

cal i

ncid

ent a

nd th

e cr

itica

l in

cide

nt re

view

com

mitt

ee’s

inve

stig

atio

n, in

clud

ing

a w

ritte

n re

port

upon

com

plet

ion

of th

e in

vest

igat

ion.

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

225

40

Wha

t is r

epor

ted?

How

is th

e ev

ent r

epor

ted?

To w

hom

is th

e ev

ent r

epor

ted?

QC

8. “

Acc

iden

t” m

eans

an

actio

n or

situ

atio

n w

here

a ri

sk e

vent

oc

curs

whi

ch h

as o

r cou

ld h

ave

cons

eque

nces

for t

he st

ate

of h

ealth

or

wel

fare

of t

he u

ser,

a pe

rson

al m

embe

r, a

prof

essi

onal

invo

lved

or

a th

ird p

erso

n.

183.

1 Th

e or

gani

zatio

n pl

an o

f an

inst

itutio

n m

ust a

lso

prov

ide

for

the

crea

tion

of a

risk

man

agem

ent c

omm

ittee

.

The

num

ber a

nd m

embe

rs o

f tha

t com

mitt

ee a

nd th

e ru

les

gove

rnin

g its

func

tioni

ng sh

all b

e de

term

ined

by

by-la

w o

f the

bo

ard

of d

irect

ors o

f the

inst

itutio

n.

The

com

posi

tion

of th

e co

mm

ittee

shal

l ens

ure

a ba

lanc

ed

repr

esen

tatio

n of

the

empl

oyee

s of t

he in

stitu

tion,

of u

sers

, of t

he

pers

ons p

ract

isin

g in

a c

entre

ope

rate

d by

the

inst

itutio

n an

d, if

ap

plic

able

, of t

he p

erso

ns w

ho, u

nder

a se

rvic

e co

ntra

ct, p

rovi

de

serv

ices

to u

sers

on

beha

lf of

the

inst

itutio

n. T

he e

xecu

tive

dire

ctor

or

the

pers

on th

e ex

ecut

ive

dire

ctor

des

igna

tes s

hall

be e

x of

ficio

a

mem

ber o

f the

com

mitt

ee.

183.

2 “I

ncid

ent”

mea

ns a

n ac

tion

or si

tuat

ion

that

doe

s not

hav

e co

nseq

uenc

es fo

r the

stat

e of

hea

lth o

r wel

fare

of a

use

r, a

pers

onal

m

embe

r, a

prof

essi

onal

invo

lved

or a

third

per

son,

but

the

outc

ome

of w

hich

is u

nusu

al a

nd c

ould

hav

e ha

d co

nseq

uenc

es u

nder

di

ffere

nt c

ircum

stan

ces.

8. T

he u

ser i

s als

o en

title

d to

be

info

rmed

, as s

oon

as p

ossi

ble,

of

any

acci

dent

hav

ing

occu

rred

dur

ing

the

prov

isio

n of

serv

ices

that

ha

s act

ual o

r pot

entia

l con

sequ

ence

s for

the

user

’s st

ate

of h

ealth

or

wel

fare

, and

of m

easu

res t

aken

to c

orre

ct th

e co

nseq

uenc

es

suffe

red,

if a

ny, o

r to

prev

ent s

uch

an a

ccid

ent f

rom

recu

rrin

g.

183.

2 Th

e fu

nctio

ns o

f the

com

mitt

ee in

clud

e se

ekin

g, d

evel

opin

g an

d pr

omot

ing

way

s to

iden

tify

and

anal

yze

the

risk

of in

cide

nts o

r 1)

ac

cide

nts i

n or

der t

o en

sure

the

safe

ty o

f use

rs a

nd,

in p

artic

ular

ly in

the

case

of n

osoc

omia

l inf

ectio

ns,

prev

ent s

uch

risks

and

redu

ce th

eir r

ecur

renc

e;m

ake

sure

that

supp

ort i

s pro

vide

d to

the

vict

im a

nd

2)

the

clos

e re

lativ

es o

f the

vic

tim; a

ndes

tabl

ish

a m

onito

ring

syst

em in

clud

ing

the

crea

tion

3)

of a

loca

l reg

iste

r of i

ncid

ents

and

acc

iden

ts fo

r the

pu

rpos

e of

ana

lyzi

ng th

e ca

uses

of i

ncid

ents

and

ac

cide

nts,

and

reco

mm

end

to th

e bo

ard

of d

irect

ors o

f th

e in

stitu

tion

mea

sure

s to

prev

ent s

uch

inci

dent

s and

ac

cide

nts f

rom

recu

rrin

g an

d an

y ap

prop

riate

con

trol

mea

sure

s.

223.

1 A

ny e

mpl

oyee

of a

n in

stitu

tion,

any

per

son

prac

tisin

g in

a

cent

re o

pera

ted

by a

n in

stitu

tion,

any

per

son

unde

rgoi

ng tr

aini

ng

in su

ch a

cen

tre o

r any

per

son

who

, und

er a

serv

ice

cont

ract

, pr

ovid

es se

rvic

es to

use

rs o

n be

half

of a

n in

stitu

tion

mus

t, as

soon

as

pos

sibl

e af

ter b

ecom

ing

awar

e of

any

inci

dent

or a

ccid

ent.

repo

rt it

to th

e ex

ecut

ive

dire

ctor

. Suc

h in

cide

nts o

r acc

iden

ts sh

all b

e re

porte

d in

the

form

pro

vide

d fo

r suc

h pu

rpos

es, w

hich

shal

l be

filed

in th

e us

er’s

reco

rd.

The

exec

utiv

e di

rect

or o

f the

inst

itutio

n or

the

pers

on d

esig

nate

d by

the

exec

utiv

e di

rect

or sh

all r

epor

t, in

non

-nom

inat

ive

form

, all

repo

rted

inci

dent

s or a

ccid

ents

to th

e ag

ency

at a

gree

d in

terv

als o

r w

hene

ver t

he a

genc

y so

requ

ires.

235.

1 Th

e bo

ard

of d

irect

ors o

f an

inst

itutio

n sh

all,

by b

y-la

w,

esta

blis

h ru

les t

o be

follo

wed

on

the

occu

rren

ce o

f an

acci

dent

, so

that

all

the

nece

ssar

y in

form

atio

n is

dis

clos

ed to

the

user

, to

the

repr

esen

tativ

e of

an

inca

pabl

e us

er o

f ful

l age

or,

in th

e ev

ent o

f th

e us

er’s

dea

th, t

o th

e pe

rson

s ref

erre

d to

in th

e fir

st p

arag

raph

of

sect

ion

23.

278.

Eve

ry in

stitu

tion

mus

t tra

nsm

it an

ann

ual r

epor

t of

its a

ctiv

ities

, inc

ludi

ng a

ctiv

ities

rela

ted

to ri

sk a

nd q

ualit

y m

anag

emen

t, to

the

agen

cy a

nd to

the

min

iste

r with

in th

ree

mon

ths

afte

r the

end

of i

ts fi

scal

yea

r. Th

e re

port

mus

t be

filed

in th

e fo

rm

dete

rmin

ed b

y th

e m

inis

ter a

nd m

ust c

onta

in a

ny in

form

atio

n re

quire

d by

him

and

by

the

agen

cy.

431.

With

a v

iew

to im

prov

ing

the

heal

th a

nd w

ell-b

eing

of t

he

gene

ral p

ublic

, the

min

iste

r sha

ll de

term

ine

prio

ritie

s, ob

ject

ives

an

d or

ient

atio

ns in

the

field

of h

ealth

and

soci

al se

rvic

es a

nd se

e to

th

eir i

mpl

emen

tatio

n. H

e sh

all i

n pa

rticu

lar…

6.2)

from

the

cont

ent o

f the

loca

l reg

iste

rs re

ferr

ed to

in se

ctio

n 18

3.2,

est

ablis

h an

d m

aint

ain

a na

tiona

l reg

iste

r of i

ncid

ents

and

ac

cide

nts h

avin

g oc

curr

ed d

urin

g th

e pr

ovis

ion

of h

ealth

serv

ices

an

d so

cial

serv

ices

for t

he p

urpo

se o

f mon

itorin

g an

d an

alyz

ing

the

caus

es o

f inc

iden

ts a

nd a

ccid

ents

, ens

urin

g th

at m

easu

res a

re ta

ken

to p

reve

nt su

ch in

cide

nts a

nd a

ccid

ents

from

recu

rrin

g an

d en

surin

g th

at c

ontro

l mea

sure

s are

impl

emen

ted,

whe

re a

ppro

pria

te …

. [6.

2 is

not

yet

in fo

rce]

.

226

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

40 41

Wha

t is r

epor

ted?

How

is th

e ev

ent r

epor

ted?

To w

hom

is th

e ev

ent r

epor

ted?

SK58

(1) I

n th

is se

ctio

n:“c

ritic

al in

cide

nt”

mea

ns a

n in

cide

nt th

at:

(a)

aris

es a

s a re

sult

of th

e pr

ovis

ions

of a

hea

lth

(i)

serv

ice

by a

regi

onal

hea

lth a

utho

rity,

a h

ealth

ca

re o

rgan

izat

ion

or th

e ca

ncer

age

ncy;

and

is

list

ed o

r des

crib

ed a

s a c

ritic

al in

cide

nt

(ii)

in th

e Sa

skat

chew

an C

ritic

al In

cide

nt

Repo

rtin

g G

uide

line,

200

4 pu

blis

hed

by th

e de

partm

ent,

as a

men

ded

from

tim

e to

tim

e, o

r an

y su

bseq

uent

edi

tion

of th

e Sa

skat

chew

an

Crit

ical

Inci

dent

Rep

ortin

g G

uide

line;

Ref

eren

ce sh

ould

be

mad

e to

the

Sask

atch

ewan

Cri

tical

In

cide

nt R

epor

ting

Gui

delin

e, 2

004

for a

list

of c

ritic

al

inci

dent

s tha

t mus

t be

repo

rted

to S

aska

tche

wan

Hea

lth.

58 (2

) A re

gion

al h

ealth

aut

horit

y sh

all,

in a

ccor

danc

e w

ith th

e re

gula

tions

:(a

) giv

e no

tice

to th

e m

inis

ter o

f the

occ

urre

nce

of a

ny c

ritic

al

inci

dent

that

aris

es a

s a re

sult

of a

hea

lth se

rvic

e pr

ovid

ed b

y th

e re

gion

al h

ealth

aut

horit

y;an

d(b

) inv

estig

ate

any

criti

cal i

ncid

ent m

entio

ned

in c

laus

e (a

) and

pr

ovid

e a

writ

ten

repo

rt to

the

min

iste

r with

resp

ect t

o th

at c

ritic

al

inci

dent

and

inve

stig

atio

n.

Sim

ilar p

rovi

sion

s req

uire

repo

rting

by

heal

th c

are

orga

niza

tions

(5

8(3)

) and

the

canc

er a

genc

y (5

8(4.

1)).

From

the

Cri

tical

Inci

dent

Reg

ulat

ions

:4(

1) A

regi

onal

hea

lth a

utho

rity

shal

l, in

acc

orda

nce

with

sect

ions

6

and

7, g

ive

notic

e to

the

min

iste

r of a

ny c

ritic

al in

cide

nt th

at

occu

rs:

in a

faci

lity

that

the

regi

onal

hea

lth a

utho

rity

(a)

oper

ates

; or

in re

latio

n to

a h

ealth

serv

ice

that

the

regi

onal

hea

lth

(b)

auth

ority

pro

vide

s or a

pro

gram

that

the

regi

onal

he

alth

aut

horit

y op

erat

es.

4(2)

Not

ice

purs

uant

to su

bsec

tion

(1) m

ust b

e gi

ven

with

in th

ree

busi

ness

day

s, or

as s

oon

as p

ossi

ble

ther

eafte

r, af

ter t

he d

ay o

n w

hich

:th

e cr

itica

l inc

iden

t occ

urs;

or

(a)

the

regi

onal

hea

lth a

utho

rity

beco

mes

aw

are

of th

e (b

) cr

itica

l inc

iden

t.

Sim

ilar p

rovi

sion

s set

out

not

ice

to b

e pr

ovid

ed b

y he

alth

car

e or

gani

zatio

ns (5

(1) a

nd (2

)).

6 Fo

r the

pur

pose

s of s

ectio

ns 4

and

5, n

otic

e m

ay b

e gi

ven:

(a) o

rally

by

tele

phon

e or

in p

erso

n; o

r(b

) in

writ

ing,

incl

udin

g tra

nsm

issi

on b

y fa

csim

ile o

r ele

ctro

nic

mai

l.

7 Su

bjec

t to

sect

ion

10, n

otic

e re

quire

d by

sect

ion

4 an

d 5

mus

t in

clud

e:a

sum

mar

y of

the

fact

s tha

t led

to th

e cr

itica

l (a

) in

cide

nt;

a su

mm

ary

of th

e he

alth

stat

us o

f the

per

son

to

(b)

who

m th

e cr

itica

l inc

iden

t rel

ates

;(i)

bef

ore

the

criti

cal i

ncid

ent;

and

(ii) a

fter t

he c

ritic

al in

cide

nt;

the

actio

ns th

at th

e re

gion

al h

ealth

aut

horit

y or

hea

lth

(c)

care

org

aniz

atio

n, a

s the

cas

e m

ay b

e, h

as ta

ken

or

will

be

taki

ng to

inve

stig

ate

the

criti

cal i

ncid

ent;

and

a st

atem

ent a

s to

whe

ther

the

criti

cal i

ncid

ent h

as

(d)

been

repo

rted

to a

ny o

rgan

izat

ion

that

is n

ot p

art

of th

e re

gion

al h

ealth

aut

horit

y or

hea

lth c

are

orga

niza

tion,

as m

ay b

e th

e ca

se, a

nd th

e na

mes

of

thos

e or

gani

zatio

ns, i

f any

.

From

the

Cri

tical

Inci

dent

Reg

ulat

ions

:8(

1) A

regi

onal

hea

lth a

utho

rity

shal

l inv

estig

ate

any

criti

cal

inci

dent

des

crib

ed in

subs

ectio

n 4(

1) a

nd p

repa

re a

writ

ten

repo

rt w

ith re

spec

t to

each

crit

ical

inci

dent

des

crib

ed in

subs

ectio

n 4(

1)

and

prep

are

a w

ritte

n re

port

with

resp

ect t

o ea

ch c

ritic

al in

cide

nt

that

it in

vest

igat

es.

8(2)

A w

ritte

n re

port

requ

ired

by su

bsec

tion

(1) m

ust i

nclu

de:

a de

scrip

tion

of th

e ci

rcum

stan

ces l

eadi

ng u

p to

and

(a

) cu

lmin

atin

g in

the

criti

cal i

ncid

ent;

a st

atem

ent i

dent

ifyin

g an

y cu

rren

t pra

ctic

e,

(b)

proc

edur

e or

fact

or in

volv

ed in

the

prov

isio

n of

the

heal

th se

rvic

e or

the

oper

atio

n of

the

prog

ram

that

:co

ntrib

uted

to th

e oc

curr

ence

of t

he c

ritic

al

(i)

inci

dent

; and

if co

rrec

ted

or m

odifi

ed, m

ay p

reve

nt th

e (ii

) oc

curr

ence

of a

sim

ilar c

ritic

al in

cide

nt in

the

futu

re;

a de

scrip

tion

of th

e ac

tions

take

n an

d th

e ac

tions

(c

) in

tend

ed to

be

take

n by

the

regi

onal

hea

lth a

utho

rity

as a

resu

lt of

the

inve

stig

atio

n; a

nd

any

reco

mm

enda

tions

aris

ing

from

the

inve

stig

atio

n(d

)

8(3)

The

regi

onal

hea

lth a

utho

rity

shal

l sub

mit

the

writ

ten

repo

rt to

the

min

iste

r im

med

iate

ly o

n co

mpl

etio

n of

the

repo

rt.

8(4)

If a

n in

vest

igat

ion

and

a w

ritte

n re

port

requ

ired

by

subs

ectio

n (1

) can

not b

e co

mpl

eted

and

the

repo

rt su

bmitt

ed to

th

e m

inis

ter w

ithin

60

days

afte

r the

day

on

whi

ch, t

he re

gion

al

heal

th a

utho

rity

beca

me

awar

e of

the

criti

cal i

ncid

ent,

the

regi

onal

hea

lth a

utho

rity

shal

l adv

ise

the

min

iste

r of t

he d

elay

, the

re

ason

s for

the

dela

y an

d th

e an

ticip

ated

dat

e of

com

plet

ion

of

the

repo

rt, w

hich

is to

be

not l

ater

than

180

day

s afte

r the

day

on

whi

ch th

e re

gion

al h

ealth

aut

horit

y be

cam

e aw

are

of th

e cr

itica

l in

cide

nt.

Sim

ilar p

rovi

sion

s set

out

how

a c

ritic

al in

cide

nt m

ust b

e re

porte

d by

a h

ealth

car

e or

gani

zatio

n (9

(1)-

(4))

.

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

227

42

43

Ont

ario

Not

e: In

Feb

ruar

y 20

03, t

he C

ounc

il of

the

Col

lege

of

Phys

icia

ns a

nd S

urge

ons o

f Ont

ario

(CPS

O) a

ppro

ved

a po

licy

that

man

date

s dis

clos

ure

of a

crit

ical

inci

dent

, and

th

e C

anad

ian

Med

ical

Pro

tect

ive A

ssoc

iatio

n (C

MPA

) en

cour

ages

app

ropr

iate

dis

clos

ure

of h

arm

.

Subs

ectio

n 1

(1) o

f Reg

ulat

ion

965

of th

e R

evis

ed

Reg

ulat

ions

of O

ntar

io, 1

990

is a

men

ded

by a

ddin

g th

e fo

llow

ing

defin

ition

:

“crit

ical

inci

dent

” m

eans

any

uni

nten

ded

even

t tha

t oc

curs

whe

n a

patie

nt re

ceiv

es tr

eatm

ent i

n th

e ho

spita

l,(a

) tha

t res

ults

in d

eath

, or s

erio

us d

isab

ility

, inj

ury

or

harm

to th

e pa

tient

, and

(b) d

oes n

ot re

sult

prim

arily

from

the

patie

nt’s

und

erly

ing

med

ical

con

ditio

n or

from

a k

now

n ris

k in

here

nt in

pr

ovid

ing

the

treat

men

t; (“

inci

dent

crit

ique

”)

Sect

ion

2 of

the

Reg

ulat

ion

is a

men

ded

by a

ddin

g th

e fo

llow

ing

subs

ectio

ns:

The

boar

d sh

all e

nsur

e th

at th

e ad

min

istra

tor e

stab

lishe

s a

syst

em fo

r ens

urin

g th

e di

sclo

sure

of e

very

crit

ical

in

cide

nt, a

s soo

n as

is p

ract

icab

le a

fter t

he c

ritic

al

inci

dent

occ

urs,

(a) t

o th

e af

fect

ed p

atie

nt;

(b) i

f the

affe

cted

pat

ient

is in

capa

ble,

to a

per

son

law

fully

aut

horiz

ed to

mak

e tre

atm

ent d

ecis

ions

on

beha

lf of

the

patie

nt; o

r(c

) if t

he a

ffect

ed p

atie

nt h

as d

ied,

(i) to

the

patie

nt’s

est

ate

trust

ee, o

r to

the

pers

on w

ho

has a

ssum

ed re

spon

sibi

lity

for t

he a

dmin

istra

tion

of

the

patie

nt’s

est

ate

if th

e es

tate

doe

s not

hav

e an

est

ate

trust

ee, o

r(ii

) to

a pe

rson

who

was

law

fully

au

thor

ized

to m

ake

treat

men

t de

cisi

ons o

n be

half

of th

e pa

tient

imm

edia

tely

prio

r to

the

patie

nt’s

dea

th, o

r who

wou

ld

have

bee

n so

aut

horiz

ed if

the

patie

nt h

ad b

een

inca

pabl

e.

(5)

The

disc

losu

re re

ferr

ed to

in su

bsec

tion

(4) s

hall

incl

ude,

(a) t

he m

ater

ial f

acts

of w

hat o

ccur

red

with

re

spec

t to

the

criti

cal i

ncid

ent;

(b) t

he c

onse

quen

ces f

or

the

patie

nt o

f the

crit

ical

inci

dent

, as t

hey

beco

me

know

n;

and

(c) t

he a

ctio

ns ta

ken

and

reco

mm

ende

d to

be

take

n to

add

ress

the

cons

eque

nces

to th

e pa

tient

of t

he c

ritic

al

inci

dent

, inc

ludi

ng a

ny h

ealth

car

e or

trea

tmen

t tha

t is

advi

sabl

e.(6

) Su

bjec

t to

the

Qua

lity

of C

are

Info

rmat

ion

Prot

ectio

n A

ct, 2

004,

the

boar

d sh

all e

nsur

e th

at th

e ad

min

istra

tor

esta

blis

hes a

syst

em fo

r ens

urin

g th

at a

t an

appr

opria

te

time

follo

win

g a

disc

losu

re o

f a c

ritic

al in

cide

nt u

nder

su

bsec

tion

(4),

ther

e be

a d

iscl

osur

e to

the

pers

on re

ferr

ed

to in

cla

uses

(a) t

o (c

) of s

ubse

ctio

n (4

) of t

he sy

stem

ic

step

s, if

any,

that

the

hosp

ital i

s tak

ing

or h

as ta

ken

in

orde

r to

avoi

d or

redu

ce th

e ris

k of

furth

er si

mila

r crit

ical

in

cide

nts,

and

that

the

cont

ent a

nd d

ate

of th

is fu

rther

di

sclo

sure

be

reco

rded

.

Dis

clos

ure

of C

ritic

al In

cide

nts

A n

ew re

gula

tion

com

es in

to e

ffect

in Ju

ly 2

008

that

am

ends

Reg

ulat

ion

965

unde

r the

Pub

lic H

ospi

tals

Act

in

orde

r to

man

date

the

disc

losu

re o

f a c

ritic

al in

cide

nt to

a

patie

nt.

Hos

pita

ls w

ill b

e ex

pect

ed to

ado

pt a

nd im

plem

ent t

he

regu

latio

n, h

owev

er, t

hey

may

als

o re

tain

or d

evel

op

expa

nded

dis

clos

ure

polic

ies t

hat e

xcee

d (b

ut d

o no

t co

ntra

vene

) the

requ

irem

ents

of t

he A

ct. T

he a

men

dmen

ts

plac

e re

spon

sibi

lity

on h

ospi

tal a

dmin

istra

tors

to se

t up

a sy

stem

for e

nsur

ing

the

disc

losu

re o

f crit

ical

inci

dent

s;

ther

efor

e, it

will

be

thei

r tas

k to

des

igna

te st

aff d

utie

s ar

ound

repo

rting

, and

to e

stab

lish

inte

rnal

pro

toco

ls b

ased

on

wha

t is m

ost a

ppro

pria

te fo

r the

ir pa

rticu

lar f

acili

ty.

228

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

42

43

Appendix E List of RHAs/ HCO Policies Reviewed

Institute Province*Calgary Health Region AlbertaAlberta Health Quality Council AlbertaSaskatoon Health Region SaskatchewanWinnipeg Regional Health Authority ManitobaSunnybrook Health Sciences Centre OntarioMcGill University Health Centre QuebecCapital Health Halifax Nova ScotiaHealth Canada Federal Agency

*Policies of the four Regional Health Authorities of Newfoundland and Labrador are reviewed in greater detail in another section of this report.

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

229

44

App

endi

x F

Se

lect

RH

As/

HC

O P

olic

ies

Juri

sdic

tion

Polic

y Ti

tlePo

licy

Alb

erta

C

alga

ry H

ealth

Reg

ion

Not

e: T

he p

olic

ies a

nd

proc

edur

es a

re se

para

te

docu

men

ts w

ithin

the

regi

on.

The

follo

win

g pr

oced

ures

are

av

aila

ble:

Imm

edia

te &

1.

C

ontin

uing

M

anag

emen

t of

Serio

us (P

oten

tial)

Adv

erse

Eve

nts

Con

duct

ing

an

2.

Adm

inis

trativ

e R

evie

wC

ondu

ctin

g a

3.

Safe

ty A

naly

sis

Dis

clos

ing

Har

m

4.

to P

atie

nts

Info

rmin

g 5.

Pr

inci

pal H

ealth

Pa

rtner

s &

Stak

ehol

ders

–

Safe

ty H

azar

ds,

Failu

res,

Fixe

s

Rep

ortin

g H

arm

, Clo

se C

alls

and

Haz

ards

Ref

eren

ce N

umbe

r 162

6Ef

fect

ive

Dat

e: 2

006/

10/1

8N

ext r

evie

w: 2

008/

10/1

8

Defi

nitio

ns

CLO

SE C

ALL

mea

ns a

situ

atio

n w

here

a

patie

nt w

as n

early

har

med

, but

for o

ne o

r m

ore

reas

ons,

the

patie

nt w

as “

save

d” fr

om

harm

.

HA

RM

mea

ns a

n un

expe

cted

or n

orm

ally

av

oida

ble

outc

ome

that

neg

ativ

ely

affe

cts

a pa

tient

’s h

ealth

and

/or q

ualit

y of

life

, and

oc

curs

or h

as o

ccur

red

durin

g th

e co

urse

of

rece

ivin

g he

alth

car

e or

serv

ices

from

the

Reg

ion

(mod

ified

from

the

Ont

ario

Col

lege

of

Phy

sici

an a

nd S

urge

ons,

Dis

clos

ure

of

Har

m P

olic

y, F

eb. 2

003)

. S

ever

e ha

rm -

a pa

tient

suffe

rs c

ompl

ete

loss

of l

imb

or o

rgan

func

tion

or re

quire

s in

terv

entio

n to

sust

ain

life.

M

oder

ate

harm

- a

patie

nt su

ffers

par

tial

loss

of l

imb

or o

rgan

func

tion.

M

inim

al h

arm

- a

patie

nt su

ffers

har

m th

at

is le

ss e

xten

sive

and

doe

s not

invo

lve

loss

of

limb

or o

rgan

func

tion.

N

o ap

pare

nt h

arm

– a

t the

tim

e of

the

even

t or

repo

rting

of t

he e

vent

, the

pat

ient

doe

s not

ap

pear

to su

ffer a

ny h

arm

, but

cou

ld d

o so

in

the

futu

re.

The

Reg

ion

requ

ires i

ts h

ealth

car

e pr

ovid

ers t

o re

port

all s

ituat

ions

whe

re p

atie

nts h

ave

suffe

red

fata

l or

seve

re h

arm

. The

Reg

ion

stro

ngly

enc

oura

ges h

ealth

car

e pr

ovid

ers t

o re

port

all s

ituat

ions

whe

re p

atie

nts

have

suffe

red

mod

erat

e or

min

imal

har

m o

r exp

erie

nced

a c

lose

cal

l. Th

e R

egio

n st

rong

ly e

ncou

rage

s its

he

alth

car

e pr

ovid

ers t

o re

port

all h

azar

ds.

Th

e R

egio

n en

cour

ages

its p

atie

nts,

fam

ilies

, vol

unte

ers a

nd v

isito

rs to

repo

rt al

l situ

atio

ns w

here

pat

ient

s ha

ve su

ffere

d ha

rm o

r exp

erie

nced

clo

se c

alls

and

any

haz

ards

that

cou

ld le

ad to

pat

ient

har

m. T

he R

egio

n is

com

mitt

ed to

revi

ewin

g al

l rep

orte

d ha

zard

s and

all

situ

atio

ns w

here

pat

ient

s hav

e su

ffere

d ha

rm o

r ex

perie

nced

clo

se c

alls

.

This

pol

icy

appl

ies t

o al

l Cal

gary

Hea

lth R

egio

n he

alth

car

e pr

ovid

ers w

orki

ng, t

rain

ing

or v

olun

teer

ing

in

Reg

ion

faci

litie

s or s

ervi

ces.

Hea

lth c

are

prov

ider

s will

com

plet

e a

Safe

ty L

earn

ing

Rep

ort t

o re

port

haza

rds a

nd si

tuat

ions

whe

re p

atie

nts

have

suffe

red

harm

or e

xper

ienc

ed c

lose

cal

ls.

The

Reg

ion

has a

resp

onsi

bilit

y to

lear

n fr

om h

azar

ds a

nd si

tuat

ions

whe

re p

atie

nts h

ave

suffe

red

harm

or

expe

rienc

ed c

lose

cal

ls so

that

impr

ovem

ents

can

be

mad

e to

the

safe

ty o

f pat

ient

car

e.

230

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

44 45

Dis

clos

ing

Har

m to

Pat

ient

s R

efer

ence

Num

ber 1

627

Effe

ctiv

e D

ate:

200

6/10

/18

Nex

t rev

iew

: 200

8/10

/18

The

Reg

ion

is c

omm

itted

to o

pen

and

hone

st d

iscu

ssio

ns w

ith p

atie

nts/

fam

ilies

whe

n pa

tient

s hav

e su

ffere

d ha

rm. T

he R

egio

n de

fines

this

com

mun

icat

ion

proc

ess w

ith p

atie

nts/

fam

ilies

as d

iscl

osur

e. T

he R

egio

n is

al

so c

omm

itted

, whe

n it

is a

ppro

pria

te, t

o di

sclo

sure

whe

n a

patie

nt h

as e

xper

ienc

ed a

clo

se c

all.

In th

ese

situ

atio

ns, d

iscl

osur

e is

dis

cret

iona

ry a

nd b

ased

on

serv

ing

the

grea

test

goo

d fo

r the

pat

ient

.

This

pol

icy

appl

ies t

o al

l Cal

gary

Hea

lth R

egio

n he

alth

car

e pr

ovid

ers w

orki

ng, t

rain

ing

or v

olun

teer

ing

in

Reg

ion

faci

litie

s or s

ervi

ces.

Th

e di

sclo

sure

pro

cess

incl

udes

: A

ckno

wle

dgin

g ha

rm to

the

patie

nt/fa

mily

;

Prov

idin

g an

apo

logy

for h

arm

; and

Dis

cuss

ing

fact

ual i

nfor

mat

ion

with

the

patie

nt/fa

mily

abo

ut h

ow h

arm

occ

urre

d an

d

reco

mm

enda

tions

that

hav

e be

en m

ade

to im

prov

e th

e sy

stem

.

Dur

ing

the

disc

losu

re p

roce

ss, t

he R

egio

n w

ill p

rovi

de/fa

cilit

ate

care

and

supp

ort f

or th

e pa

tient

s/fa

mili

es

and

heal

th c

are

prov

ider

s inv

olve

d –

incl

udin

g tre

atm

ent,

coun

selin

g, d

ebrie

fing,

and

oth

er fo

rms o

f as

sist

ance

that

may

be

appr

opria

te.

In m

ost c

ases

, the

hea

lth c

are

prov

ider

mos

t res

pons

ible

for t

he p

atie

nt’s

car

e w

ill d

iscl

ose

to th

e pa

tient

/fa

mily

. In

som

e ci

rcum

stan

ces,

as d

icta

ted

by th

e se

verit

y of

the

harm

, the

pat

ient

’s c

urre

nt h

ealth

and

the

heal

th o

f the

hea

lth c

are

prov

ider

(s) i

nvol

ved,

dis

clos

ure

may

als

o in

volv

e a

Reg

ion

adm

inis

trato

r and

/or a

m

edic

al le

ader

.

The

Reg

ion

reco

gniz

es th

e im

porta

nce

of d

iscl

osur

e in

mai

ntai

ning

and

rebu

ildin

g tru

st b

etw

een

patie

nts/

fam

ilies

, the

Reg

ion

and

its h

ealth

car

e pr

ovid

ers w

hen

patie

nts h

ave

suffe

red

harm

or e

xper

ienc

ed c

lose

ca

lls.

The

Reg

ion

reco

gniz

es th

at th

e di

sclo

sure

pro

cess

mus

t be

resp

ectfu

l of t

he si

tuat

ion,

supp

ort t

he n

eeds

of

patie

nts/

fam

ilies

and

the

heal

th c

are

prov

ider

s inv

olve

d, a

nd a

dher

e to

app

ropr

iate

legi

slat

ion.

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

231

46

Just

and

Tru

stin

g C

ultu

reR

efer

ence

Num

ber 1

628

Effe

ctiv

e D

ate:

200

6/10

/18

Nex

t rev

iew

: 200

8/10

/18

The

Reg

ion

is c

omm

itted

to p

rom

otin

g a

just

and

trus

ting

cultu

re o

f saf

ety

in w

hich

its h

ealth

car

e pr

ovid

ers

can

read

ily re

port

harm

, clo

se c

alls

and

haz

ards

so th

at th

e R

egio

n ca

n le

arn

and

wor

k to

impr

ove

the

safe

ty

of p

atie

nt c

are.

Whe

n he

alth

car

e pr

ovid

ers h

ave

been

invo

lved

in si

tuat

ions

whe

re th

ere

has b

een

failu

re in

the

prov

isio

n of

ca

re to

a p

atie

nt, t

he R

egio

n co

mm

its to

: pr

ovid

ing

appr

opria

te c

are

and

supp

ort t

o th

e pa

tient

s/fa

mili

es a

nd

heal

th c

are

prov

ider

s inv

olve

d;

eval

uatin

g al

l sys

tem

ic fa

ctor

s tha

t may

hav

e co

ntrib

uted

to fa

ilure

; and

follo

win

g es

tabl

ishe

d fa

ir pr

oced

ures

fo

r eva

luat

ing

the

actio

ns a

nd b

ehav

iors

of h

ealth

car

e pr

ovid

ers.

This

pol

icy

appl

ies t

o al

l Cal

gary

Hea

lth R

egio

n ad

min

istra

tors

and

med

ical

lead

ers.

Reg

ion

adm

inis

trato

rs a

nd m

edic

al le

ader

s will

use

a fr

amew

ork

and

follo

w p

roce

dure

s tha

t are

just

and

fair

whe

n co

nduc

ting

adm

inis

trativ

e re

view

s to

eval

uate

hea

lth c

are

prov

ider

s’ ac

tions

and

beh

avio

rs. T

he

fram

ewor

k (S

ee N

ote

1 in

Ref

eren

ces)

incl

udes

thre

e ty

pes o

f act

ions

and

beh

avio

rs a

nd th

e R

egio

n’s

resp

onse

s to

them

: N

ote

1: B

ased

on

the

wor

k of

Dr.

Jan

Dav

ies (

U o

f C, F

acul

ty o

f Med

icin

e, D

ept.

of

Ana

esth

esia

) and

the

wor

k of

Jam

es R

easo

n (U

nive

rsity

of M

anch

este

r, U

K).

ERR

OR

S –

whe

n th

ere

has b

een

failu

re in

the

prov

isio

n of

car

e to

a p

atie

nt, a

nd th

e he

alth

car

e pr

ovid

er d

id

not d

evia

te fr

om e

stab

lishe

d po

licie

s, pr

oced

ures

, sta

ndar

ds o

r gui

delin

es, t

hen

the

heal

th c

are

prov

ider

will

no

t be

disc

iplin

ed b

y th

e R

egio

n.

NO

N-C

OM

PLIA

NC

E –

whe

n th

ere

has b

een

failu

re in

the

prov

isio

n of

car

e to

a p

atie

nt, a

nd th

e he

alth

ca

re p

rovi

der d

evia

ted

from

est

ablis

hed

polic

ies,

proc

edur

es, s

tand

ards

or g

uide

lines

, the

n th

e R

egio

n w

ill

com

mit

to e

valu

ate:

o th

e ap

prop

riate

ness

of i

ts p

olic

ies,

proc

edur

es, s

tand

ards

or g

uide

lines

; and

of t

he c

ircum

stan

ces t

hat l

ed to

th

e no

n-co

mpl

iant

act

ion(

s), b

efor

e de

term

inin

g an

app

ropr

iate

cou

rse

of a

ctio

n.

INTE

NTI

ON

TO

HA

RM

– w

hen

ther

e ha

s bee

n fa

ilure

in th

e pr

ovis

ion

of c

are

to a

pat

ient

, and

the

heal

th c

are

prov

ider

inte

nded

to c

ause

har

m, t

hen

the

Reg

ion

will

seek

dis

cipl

inar

y ac

tion

and

crim

inal

in

vest

igat

ions

may

resu

lt. (T

hese

situ

atio

ns a

re e

xtre

mel

y ra

re.)

232

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

46 47

Info

rmin

g Pr

inci

pal H

ealth

Par

tner

s &

Stak

ehol

ders

– S

afet

y H

azar

ds, F

ailu

res,

Fixe

sR

efer

ence

Num

ber 1

629

Effe

ctiv

e D

ate:

200

6/10

/18

Nex

t rev

iew

: 200

8/10

/18

The

Reg

ion

is c

omm

itted

to c

omm

unic

atin

g op

en, h

ones

t and

tim

ely

info

rmat

ion

to it

s prin

cipa

l hea

lth

partn

ers a

nd st

akeh

olde

rs a

bout

safe

ty h

azar

ds, f

ailu

res a

nd fi

xes.

The

Reg

ion

defin

es th

is p

roce

ss a

s in

form

ing.

The

Reg

ion

info

rms i

ts p

rinci

pal h

ealth

par

tner

s and

stak

ehol

ders

abo

ut sa

fety

haz

ards

, fai

lure

s and

fixe

s to:

co

mm

unic

ate

impo

rtant

cha

nges

in ri

sks t

o pa

tient

s’ w

ell-b

eing

from

kno

wn

haza

rds;

mai

ntai

n tru

st

thro

ugh

trans

pare

nt c

omm

unic

atio

n in

situ

atio

ns w

here

failu

res h

ave

affe

cted

or h

ave

the

pote

ntia

l to

affe

ct

confi

denc

e in

the

care

and

serv

ices

pro

vide

d by

the

Reg

ion;

fos

ter a

cul

ture

of s

harin

g in

form

atio

n ab

out

patie

nt sa

fety

whi

ch w

ill le

ad to

furth

er sy

stem

impr

ovem

ents

.

This

pol

icy

appl

ies t

o se

nior

man

agem

ent o

f the

Cal

gary

Hea

lth R

egio

n.

The

Reg

ion’

s prin

cipa

l hea

lth p

artn

ers h

ave

a rig

ht to

kno

w a

bout

any

subs

tant

ial c

hang

es in

risk

s to

thei

r w

ell-b

eing

from

safe

ty h

azar

ds th

at a

re k

now

n to

the

Reg

ion.

Th

e R

egio

n’s s

take

hold

ers h

ave

a rig

ht to

kno

w a

bout

any

safe

ty h

azar

d or

failu

re th

at h

as o

ccur

red

with

in

the

Reg

ion

and

coul

d pr

esen

t a ri

sk to

thei

r wel

l-bei

ng. T

he R

egio

n’s s

take

hold

ers a

lso

have

a ri

ght t

o kn

ow

wha

t rec

omm

enda

tions

hav

e be

en m

ade

to im

prov

e pa

tient

car

e.

The

Reg

ion

has a

dut

y to

mai

ntai

n th

e co

nfide

nce

of it

s prin

cipa

l hea

lth p

artn

ers i

n th

e ca

re a

nd se

rvic

es th

at

it pr

ovid

es.

Alb

erta

Hea

lth Q

ualit

y C

ounc

ilD

iscl

osur

e of

Har

m to

Pat

ient

s and

Fam

ilies

, Pr

ovin

cial

Fra

mew

ork,

July

200

6.Th

e fr

amew

ork

is a

con

sens

us d

ocum

ent b

y th

e H

ealth

Qua

lity

Net

wor

k w

hich

is a

HQ

CA

col

labo

rativ

e co

nsis

ting

of h

ealth

aut

horit

ies,

the

Min

istry

, the

AM

A, C

olle

ge o

f Pha

rmac

ists

, the

Col

lege

of P

hysi

cian

s an

d Su

rgeo

ns, C

olle

ge a

nd A

ssoc

iatio

n of

regi

ster

ed n

urse

s, an

d th

e fe

dera

tion

of re

gula

ted

heal

th

prof

essi

ons.

The

doc

umen

t sta

tes t

hat w

ith th

is fr

amew

ork

Alb

erta

ns w

ill k

now

that

gui

delin

es fo

r dis

clos

ure

are

unde

rsto

od a

nd a

ccep

ted

by a

ll he

alth

aut

horit

ies a

nd p

rofe

ssio

nal b

odie

s.

The

fram

ewor

k is

a g

uide

line

to e

nabl

e he

alth

aut

horit

ies a

nd p

rofe

ssio

nal b

odie

s to

deve

lop

and

adju

st th

eir

own

spec

ific

polic

ies a

nd p

roce

dure

s in

a m

anne

r whi

ch is

con

sist

ent w

ith th

e pr

ovin

cial

fram

ewor

k. (

Ther

e do

es n

ot a

ppea

r to

be a

ny le

gisl

ativ

e ba

ckin

g fo

r thi

s fra

mew

ork,

just

a v

olun

tary

con

sens

us th

at it

repr

esen

ts

good

pol

icy.

)

The

fram

ewor

k w

ill b

e su

ppor

ted

on a

n on

goin

g ba

sis w

ith d

iscl

osur

e ed

ucat

ion

prog

ram

s, an

d di

ssem

inat

ion

of c

omm

unic

atio

n m

ater

ials

for p

atie

nts,

fam

ilies

and

hea

lth c

are

prov

ider

s.

The

docu

men

t rec

ogni

zes i

n se

vera

l pla

ces t

hat d

iscl

osur

e m

ust b

e ac

com

pani

ed b

y su

ch th

ings

as

info

rmat

ion

on w

hat h

appe

ned,

the

caus

es, a

nd w

hat w

ill b

e do

ne to

ens

ure

the

sam

e th

ing

does

not

hap

pen

agai

n. H

owev

er, i

t doe

s not

add

ress

the

syst

ems n

eces

sary

to e

nsur

e th

at g

ood

info

rmat

ion

is a

vaila

ble

to

supp

ort t

hose

asp

ects

of d

iscl

osur

e. U

nles

s the

re is

a re

porti

ng sy

stem

and

an

asse

ssm

ent s

yste

m, t

here

will

be

onl

y pa

rtial

info

rmat

ion

on w

hich

to b

ase

a di

sclo

sure

. Th

e qu

ality

of t

he o

ther

par

ts o

f the

syst

em a

re

esse

ntia

l if s

ucce

ssfu

l dis

clos

ure

is to

take

pla

ce.

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

233

48

Whe

n sh

ould

dis

clos

ure

occu

r? D

iscl

osur

e sh

ould

occ

ur w

hen

a pa

tient

exp

erie

nces

har

m w

hile

rece

ivin

g he

alth

car

e [H

arm

is d

efine

d as

“an

une

xpec

ted

or n

orm

ally

avo

idab

le o

utco

me

that

neg

ativ

ely

affe

cts t

he

patie

nt’s

hea

lth a

nd o

r qua

lity

of li

fe, w

hich

occ

urs o

r occ

urre

d in

the

cour

se o

f hea

lth c

are

treat

men

t and

is

not

due

dire

ctly

to th

e pa

tient

’s il

lnes

s.”];

whe

n an

adv

erse

eve

nt o

ccur

s and

ther

e is

no

appa

rent

har

m to

th

e pa

tient

but

the

pote

ntia

l for

har

m re

mai

ns; w

hen

an a

dver

se e

vent

was

nar

row

ly a

void

ed p

rior t

o ha

rm

occu

rrin

g to

the

patie

nt (i

n th

is c

ircum

stan

ce d

iscl

osur

e is

dis

cret

iona

ry a

nd n

eeds

to b

e de

term

ined

on

a ca

se

by c

ase

basi

s by

the

heal

th c

are

team

– a

s to

whe

ther

dis

clos

ure

is in

the

best

inte

rest

s of t

he p

atie

nt –

thou

gh

no c

riter

ia a

re p

rovi

ded)

. D

iscl

osur

e sh

ould

take

pla

ce a

s soo

n as

pos

sibl

e, a

t mos

t with

in o

ne o

r tw

o da

ys

follo

win

g th

e di

scov

ery

of h

arm

.

The

fram

ewor

k pr

ovid

es g

uida

nce

for t

he k

ind

of se

tting

for m

eetin

gs (p

rivat

e), w

ho sh

ould

be

pres

ent (

2-3

peop

le id

eally

incl

udin

g th

e di

rect

pro

vide

r), a

nd su

gges

ts th

at th

e H

ealth

Boa

rds o

f Alb

erta

, CM

PA a

nd

othe

r res

pect

ive

insu

rers

“sh

ould

be

info

rmed

and

con

sulte

d as

app

ropr

iate

prio

r to

the

disc

losu

re m

eetin

g.”

Th

e fr

amew

ork

does

not

say

why

the

insu

rer s

houl

d be

con

sulte

d.

Wha

t sho

uld

be d

iscl

osed

? A

t all

disc

losu

re m

eetin

gs “

info

rmat

ion

shar

ed sh

ould

be

fact

ual a

nd a

gree

d up

on th

roug

h a

proc

ess o

f con

sens

us b

y th

e he

alth

car

e te

am p

rior t

o in

itiat

ing

the

disc

losu

re p

roce

ss.”

(Th

is

impl

ies t

hat a

ll m

embe

rs o

f the

team

hav

e a

veto

. Th

is d

oes n

ot a

ppea

r to

supp

ort t

rue

disc

losu

re if

one

m

embe

r of t

he te

am d

oes n

ot a

gree

. So

me

guid

ance

nee

ds to

be

prov

ided

.) In

form

atio

n sh

ould

be

rela

ted

to

the

even

t and

not

abo

ut a

ny in

divi

dual

s – th

e fa

cts s

houl

d be

rela

ted

to th

e pa

tient

’s d

iagn

ostic

, tre

atm

ent a

nd

care

info

rmat

ion

(wha

t hap

pene

d, th

e se

quen

ce o

f eve

nts,

diag

nost

ic te

st re

sults

, con

sequ

ence

s of t

he h

arm

, ch

ange

s to

treat

men

t pla

n an

d an

y ot

her r

elev

ant f

actu

al in

form

atio

n).

In re

gard

to Q

AC

s whi

ch a

re c

over

ed b

y th

e Ev

iden

ce A

ct, t

he fr

amew

ork

says

that

all

fact

s sho

uld

be

disc

lose

d to

a p

atie

nt a

nd fa

mily

. O

nly

fact

s sho

uld

be sh

ared

. “A

ll ot

her i

nfor

mat

ion

colle

cted

dur

ing

an in

vest

igat

ion

and

Qua

lity

Ass

uran

ce C

omm

ittee

reco

rds m

ust r

emai

n co

nfide

ntia

l and

pro

tect

ed.”

Pe

rson

s who

car

ry o

ut th

e Q

A p

roce

ss in

vest

igat

ion

mus

t not

be

incl

uded

on

the

disc

losu

re te

am.

The

lead

pe

rson

on

the

inve

stig

atio

n is

resp

onsi

ble

for c

omm

unic

atin

g th

e fa

cts t

o an

“ap

prop

riate

indi

vidu

al o

r de

partm

ent w

ithin

the

heal

th a

utho

rity

adm

inis

tratio

n fo

r app

rova

l.” T

hese

indi

vidu

als w

ill b

e re

spon

sibl

e fo

r det

erm

inin

g ho

w th

e fa

cts w

ill b

e sh

ared

with

the

patie

nt a

nd fa

mily

. “O

nly

new

fact

s tha

t wou

ld h

ave

othe

rwis

e be

en o

n th

e pa

tient

’s c

hart,

as w

ell a

s act

ions

bei

ng ta

ken

to tr

y to

pre

vent

a si

mila

r eve

nt fr

om

happ

enin

g ag

ain,

shou

ld b

e sh

ared

.” (

This

pro

cess

may

pre

vent

a fu

ll ex

plan

atio

n of

the

caus

es o

f an

even

t, es

peci

ally

if th

e ca

uses

reve

al in

form

atio

n ab

out a

n in

divi

dual

hea

lth c

are

prov

ider

or r

equi

res a

ssum

ptio

ns

to b

e m

ade

that

fall

shor

t of f

acts

.)

The A

lber

ta fr

amew

ork

incl

udes

an

exte

nsiv

e ex

plan

atio

n of

the

deta

ils o

f dis

clos

ure

– th

e m

eetin

g, w

ho

shou

ld d

iscl

ose,

to w

hom

, the

type

of d

ocum

enta

tion,

the

conv

ersa

tion,

how

to d

iscl

ose

and

prov

idin

g em

otio

nal s

uppo

rt.

234

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

48 49

Mul

ti-ju

risdi

ctio

nal d

iscl

osur

e ar

ises

whe

n a

patie

nt is

tran

sfer

red

from

one

hea

lth a

utho

rity

to a

noth

er,

or fr

om a

priv

ate

setti

ng to

a p

ublic

setti

ng.

In c

erta

in si

tuat

ions

the

even

t in

an o

rigin

atin

g se

tting

may

no

t be

iden

tified

unt

il la

ter.

In si

tuat

ions

whe

re d

isag

reem

ent o

ccur

s, it

is a

ntic

ipat

ed th

at th

e or

gani

zatio

n di

scov

erin

g th

e ha

rm a

nd th

e en

tity

whe

re th

e ev

ent o

ccur

red

will

agr

ee h

ow, w

hen

and

who

will

dis

clos

e to

the

patie

nt. (

This

sent

ence

soun

ds w

rong

in th

e Alb

erta

doc

umen

t.) W

here

imm

edia

te d

iscl

osur

e is

not

cr

ucia

l, ef

forts

shou

ld b

e m

ade

to c

onta

ct th

e or

igin

atin

g ju

risdi

ctio

n to

info

rm th

em o

f the

situ

atio

n an

d th

e pl

anne

d pr

oces

s for

dis

clos

ure.

If p

ossi

ble,

repr

esen

tativ

es fr

om b

oth

juris

dict

ions

shou

ld b

e in

volv

ed.

With

the

adop

tion

of th

e pr

ovin

cial

fram

ewor

k it

is a

ntic

ipat

ed th

at th

e di

sclo

sure

pro

cess

will

be

cons

iste

nt

betw

een

juris

dict

ions

and

dis

agre

emen

ts w

ill b

e ra

re.

If th

ere

is st

ill d

isag

reem

ent,

the

HQ

C w

ill b

e av

aila

ble

to m

edia

te th

e re

solu

tion

of is

sues

in a

con

fiden

tial a

nd a

nony

mou

s man

ner.

Mul

ti-pa

tient

dis

clos

ure

shou

ld n

ot o

ccur

in a

gro

up se

tting

; ste

ps sh

ould

be

take

n to

ens

ure

that

all

patie

nts

are

cont

acte

d pr

ior t

o a

rele

ase

to th

e m

edia

; pat

ient

s can

be

cont

acte

d by

regi

ster

ed m

ail o

r tel

epho

ne o

r a

face

-to-f

ace

mee

ting,

and

opp

ortu

nitie

s sho

uld

alw

ays b

e m

ade

for a

face

-to-f

ace

mee

tings

.

The A

lber

ta d

ocum

ent a

lso

incl

udes

a g

loss

ary,

an

over

view

of r

elev

ant l

egis

latio

n, a

nd sa

mpl

es o

f co

mm

unic

atio

ns m

ater

ials

pre

pare

d fo

r dis

tribu

tion

to p

eopl

e in

the

heal

th sy

stem

.

Sask

atch

ewan

Sask

atoo

n H

ealth

Reg

ion

Crit

ical

Inci

dent

Rep

ortin

gD

ate

Effe

ctiv

e: S

epte

mbe

r 200

4D

ate

Rev

ised

: Sep

tem

ber 2

007

Not

e: T

he c

ritic

al in

cide

nt p

olic

y is

cur

rent

ly

unde

r rev

isio

n no

w th

at th

e pr

ovin

ce h

as

gone

thro

ugh

a pe

riod

of th

ree

year

s of

legi

slat

ed re

porti

ng.

All

criti

cal i

ncid

ents

will

be

repo

rted

thro

ugh

a re

gion

-wid

e re

porti

ng p

roce

ss in

com

plia

nce

with

Sec

tion

58 o

f the

Reg

iona

l Hea

lth S

ervi

ces A

ct a

nd it

s cor

resp

ondi

ng re

gula

tions

– T

he R

egio

nal H

ealth

Ser

vice

s C

ritic

al In

cide

nt R

egul

atio

ns –

and

the A

ccou

ntab

ility

Agr

eem

ent w

ith R

egio

nal H

ealth

Aut

horit

ies a

nd

Sask

atch

ewan

Hea

lth.

Crit

ical

Inci

dent

is d

efine

d ac

cord

ing

to th

e le

gisl

atio

n an

d re

gula

tions

:

Cri

tical

Inci

dent

mea

ns a

serio

us a

dver

se h

ealth

eve

nt in

clud

ing,

but

not

lim

ited

to, t

he a

ctua

l or p

oten

tial

loss

of l

ife, l

imb

or fu

nctio

n re

late

d to

a h

ealth

car

e se

rvic

e pr

ovid

ed b

y, o

r bei

ng p

rovi

ded

by, a

regi

onal

he

alth

aut

horit

y or

hea

lth c

are

orga

niza

tion

(see

App

endi

x A

Sas

katc

hew

an C

ritic

al In

cide

nt R

epor

ting

Gui

delin

e fo

r exa

mpl

es o

f ser

ious

repo

rtabl

e ev

ents

).

Crit

ical

inci

dent

s mus

t be

repo

rted

imm

edia

tely

to th

e D

irect

or o

f Ris

k M

anag

emen

t or d

esig

nate

. D

urin

g th

e w

eeke

nd o

r nig

ht sh

ift, t

he m

ost s

enio

r adm

inis

trato

r on

call

is c

onta

cted

thro

ugh

switc

hboa

rd o

r th

e ap

prop

riate

on-

call

proc

ess a

nd th

e ad

min

istra

tor w

ill n

otify

the

Dire

ctor

of R

isk

Man

agem

ent a

nd

appr

opria

te se

nior

man

ager

s – re

fer t

o on

-cal

l pro

cess

for y

our a

rea.

The

even

t is e

nter

ed in

to th

e Sa

fety

Rep

ortin

g Sy

stem

(com

pute

r-bas

ed) o

r a c

onfid

entia

l Saf

ety

Rep

ort i

s co

mpl

eted

by

a st

aff m

embe

r, ph

ysic

ian,

vol

unte

er o

r stu

dent

of t

he se

rvic

e/de

pt./a

rea

who

wer

e in

volv

ed in

, w

itnes

s to

or b

ecom

e aw

are

of th

e cr

itica

l inc

iden

t with

in 2

4 ho

urs o

f the

crit

ical

inci

dent

occ

urrin

g or

whe

n th

e in

cide

nt is

reco

gniz

ed a

s a c

ritic

al in

cide

nt a

nd a

ccor

ding

to th

e pr

oced

ure

outli

ned

in S

afet

y R

epor

ting

Polic

y (#

7311

-50-

006)

. Ti

me

fram

e is

impo

rtan

t to

over

all r

epor

ting,

how

ever

, thi

s sho

uld

not d

isco

urag

e cr

itica

l inc

iden

ts b

eing

repo

rted

at a

ny ti

me.

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

235

50

Whe

n th

e Sa

fety

Rep

ort f

orm

is c

ompl

eted

, it m

ust b

e su

bmitt

ed to

Ris

k M

anag

emen

t with

in 4

8 ho

urs o

f th

e cr

itica

l inc

iden

t occ

urrin

g. O

ther

repo

rting

form

s or d

ocum

enta

tion

that

may

hav

e be

en c

ompl

eted

(ie.

a

med

icat

ion

erro

r rep

ort)

mus

t acc

ompa

ny th

e co

nfide

ntia

l Saf

ety

Rep

ort w

hen

subm

itted

. W

hen

the

Safe

ty

Rep

ortin

g Sy

stem

(com

pute

r-bas

ed) i

s use

d, a

utom

atic

not

ifica

tion

to th

e ap

prop

riate

indi

vidu

als w

ill o

ccur

.

Imm

edia

te id

entifi

catio

n of

any

med

icat

ion,

med

icat

ion

cont

aine

r, su

pplie

s or e

quip

men

t th

at m

ay h

ave

cont

ribut

ed to

the

occu

rren

ce m

ust o

ccur

. Pa

ckag

ing

and

all c

ompo

nent

s of t

he e

quip

men

t sho

uld

be

save

d. Q

uara

ntin

e th

e ob

ject

s afte

r lab

ellin

g “D

O N

OT

USE

” (im

med

iate

ly c

onta

ct C

linic

al E

ngin

eerin

g if

biom

edic

al e

quip

men

t is i

nvol

ved)

. Ph

otog

raph

s may

be

nece

ssar

y fo

r doc

umen

tatio

n.

Safe

ty R

epor

ts a

re N

OT

part

of th

e he

alth

reco

rd.

The

orig

inal

repo

rt is

file

d in

Ris

k M

anag

emen

t. A

fact

ual

note

of t

he e

vent

and

the

patie

nt a

sses

smen

t MU

ST b

e do

cum

ente

d in

the

patie

nt’s

/resi

dent

’s c

hart.

Ris

k M

anag

emen

t will

not

ify a

ppro

pria

te se

nior

man

agem

ent t

hat a

crit

ical

inci

dent

has

occ

urre

d. R

isk

Man

agem

ent,

acco

rdin

g to

the

legi

slat

ion,

shal

l not

ify th

e M

inis

ter o

f Hea

lth o

f a c

ritic

al in

cide

nt w

ithin

th

ree

busi

ness

day

s fol

low

ing

the

inci

dent

occ

urre

nce

or th

e da

te th

e re

gion

al h

ealth

aut

horit

y be

com

es

awar

e of

the

inci

dent

.

Not

ifica

tion

to th

e M

inis

ter o

f Hea

lth b

y R

isk

Man

agem

ent s

hall

incl

ude

de-id

entifi

ed, f

actu

al in

form

atio

n ab

out t

he c

ritic

al in

cide

nt.

SHR

shal

l inv

estig

ate

the

criti

cal i

ncid

ent t

hrou

gh a

non

puni

tive,

mul

tidis

cipl

inar

y re

view

(App

endi

x B

–

Mul

tidis

cipl

inar

y C

ase

Rev

iew

) inc

ludi

ng:

the

circ

umst

ance

s lea

ding

up

to a

nd c

ulm

inat

ing

in th

e cr

itica

l inc

iden

t;an

y cu

rren

t pra

ctic

e, p

roce

dure

or f

acto

r inv

olve

d in

pro

vidi

ng th

e he

alth

serv

ice

that

con

tribu

ted

to th

e oc

curr

ence

of t

he c

ritic

al in

cide

nt;

actio

ns c

onsi

dere

d, d

evel

oped

or r

equi

red

as fo

llow

-up

to th

e cr

itica

l inc

iden

t; an

dim

plem

enta

tion

of a

ny re

com

men

datio

ns re

sulti

ng fr

om th

e cr

itica

l inc

iden

t rev

iew.

Ris

k M

anag

emen

t, ac

cord

ing

to th

e le

gisl

atio

n, w

ill p

rovi

de a

writ

ten

repo

rt of

de-

iden

tified

fact

ual

info

rmat

ion,

incl

udin

g ac

tions

take

n, p

lann

ed a

nd q

ualit

y im

prov

emen

ts th

e R

HA

will

be

impl

emen

ting

as a

re

sult

of th

e cr

itica

l inc

iden

t rev

iew,

with

in 6

0 da

ys o

f the

RH

A b

ecom

ing

awar

e of

the

criti

cal i

ncid

ent.

App

ropr

iate

seni

or m

anag

ers w

ithin

SH

R w

ill re

ceiv

e a

copy

of t

he w

ritte

n re

port

of d

eide

ntifi

ed fa

ctua

l in

form

atio

n, in

clud

ing

actio

ns ta

ken,

pla

nned

and

any

qua

lity

impr

ovem

ents

that

will

be

impl

emen

ted

as a

resu

lt of

the

criti

cal i

ncid

ent m

ultid

isci

plin

ary

case

revi

ew.

Feed

back

/dire

ctio

n w

ill b

e pr

ovid

ed to

ap

prop

riate

stak

ehol

ders

to im

plem

ent q

ualit

y im

prov

emen

ts a

s req

uire

d.

236

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

50 51

Not

e: T

he p

olic

y is

supp

orte

d by

a p

acke

t of i

nfor

mat

ion

for m

anag

ers,

staf

f and

pa

tient

s/cl

ient

s reg

ardi

ng

disc

losu

re.

Dis

clos

ure

of A

dver

se/U

nant

icip

ated

Eve

nts

Dat

e Ef

fect

ive:

Oct

ober

200

7Th

e Sa

skat

oon

Hea

lth R

egio

n an

d af

filia

tes b

elie

ves t

hat p

atie

nts/

clie

nts/

resi

dent

s and

thei

r fam

ilies

are

en

title

d to

info

rmat

ion

abou

t the

out

com

es o

f tes

ts, t

reat

men

t and

car

e. I

n so

me

case

s, po

or o

utco

mes

are

a

resu

lt of

an

adve

rse

even

t (A

E).

The

Sask

atoo

n H

ealth

Reg

ion

and

affil

iate

s are

com

mitt

ed to

resp

ectin

g th

e rig

hts o

f pat

ient

s/cl

ient

s/re

side

nts a

nd th

eir f

amili

es to

be

info

rmed

abo

ut su

ch e

vent

s.

Dis

clos

ure

of a

dver

se/u

nant

icip

ated

eve

nts1 t

o pa

tient

s/cl

ient

s/re

side

nts a

nd th

eir f

amili

es is

an

inte

gral

par

t of

Sas

kato

on H

ealth

Reg

ion’

s pat

ient

/clie

nt/re

side

nt sa

fety

initi

ativ

e; it

ens

ures

ope

n, h

ones

t and

con

stan

t co

mm

unic

atio

n to

allo

w fo

r inc

reas

ed tr

ust a

nd sa

tisfa

ctio

n be

twee

n pa

tient

s/cl

ient

s/re

side

nts a

nd th

e he

alth

ca

re te

am; a

join

t res

pons

ibili

ty o

f the

Sas

kato

on H

ealth

Reg

ion

orga

niza

tion

and

the

clin

ical

per

son(

s)

invo

lved

; a p

rofe

ssio

nal r

espo

nsib

ility

of a

ll ca

re p

rovi

ders

2 .

Effe

ctiv

e co

mm

unic

atio

n is

at t

he h

eart

of s

afe

and

effe

ctiv

e he

alth

car

e

Dis

cuss

ions

with

the

patie

nt/c

lient

/resi

dent

or f

amily

may

be

war

rant

ed if

ther

e is

a c

hang

e in

the

treat

men

t pl

an o

r una

ntic

ipat

ed e

vent

or o

utco

me

of w

hich

the

patie

nt/c

lient

/resi

dent

or f

amily

may

not

oth

erw

ise

be

awar

e.

Crit

ical

inci

dent

s3 mus

t be

repo

rted

to R

isk

Man

agem

ent i

mm

edia

tely

.

Com

mun

icat

ion

of a

n ad

vers

e/un

antic

ipat

ed e

vent

mus

t occ

ur w

hen

harm

has

com

e to

the

patie

nt/c

lient

/re

side

nt.

Con

sulta

tion

shou

ld o

ccur

with

car

e pr

ovid

ers a

nd R

isk

Man

agem

ent i

n ca

ses o

f a n

ear m

iss o

r har

m n

ever

re

achi

ng th

e pa

tient

/clie

nt/re

side

nt to

det

erm

ine

if di

scus

sion

with

the

patie

nt/c

lient

/resi

dent

or f

amily

is

war

rant

ed.

Com

mun

icat

ion

of a

n ad

vers

e/un

antic

ipat

ed e

vent

shou

ld o

ccur

as s

oon

as p

ossi

ble

subs

eque

nt to

a

trigg

erin

g ev

ent.

Idea

lly, t

hey

shou

ld o

ccur

with

in 2

4-48

hou

rs o

f the

hea

lth c

are

team

bec

omin

g aw

are

of

the

even

t.

The

patie

nt/c

lient

/resi

dent

or f

amily

will

be

the

reci

pien

ts o

f the

adv

erse

/una

ntic

ipat

ed e

vent

info

rmat

ion.

Com

mun

icat

ion

of a

n ad

vers

e/un

antic

ipat

ed e

vent

will

idea

lly b

e pr

ovid

ed b

y a

team

. Th

e te

am w

ill

likel

y in

clud

e th

e m

ost r

espo

nsib

le p

hysi

cian

(at t

he ti

me

of th

e ev

ent),

a re

pres

enta

tive

for t

he re

gion

(a

man

ager

/dire

ctor

for t

he a

rea)

and

in so

me

case

s, de

pend

ing

on th

e se

verit

y of

har

m a

nd c

ircum

stan

ces,

a re

pres

enta

tive

from

Ris

k M

anag

emen

t. L

ead

for t

he d

iscu

ssio

ns sh

ould

rest

with

thos

e w

ho h

ave

the

mos

t kn

owle

dge

of th

e ev

ent.

All

mem

bers

of t

he h

ealth

car

e te

am in

volv

ed sh

ould

be

awar

e th

at c

omm

unic

atio

n w

ith th

e pa

tient

/clie

nt/

resi

dent

or f

amily

has

occ

urre

d.

Oth

er su

ppor

t res

ourc

es su

ch a

s the

clie

nt re

pres

enta

tive

or so

cial

wor

ker (

with

app

ropr

iate

per

mis

sion

) may

be

incl

uded

in th

e di

scus

sion

to a

ssis

t pat

ient

s/cl

ient

s/re

side

nts a

nd fa

mili

es b

y pr

ovid

ing

supp

ort d

urin

g an

d su

bseq

uent

to th

e di

scus

sion

.

The

disc

ussi

on sh

ould

take

pla

ce in

a p

rivat

e, q

uiet

loca

tion.

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

237

52

Fact

ual i

nfor

mat

ion

shou

ld b

e pr

ovid

ed p

rofe

ssio

nally

, com

pass

iona

tely

, tru

thfu

lly a

nd w

ith th

e ab

senc

e of

bla

min

g st

atem

ents

. O

pini

ons s

houl

d no

t be

disc

usse

d. D

iscl

osur

e of

the

circ

umst

ance

s sho

uld

not b

e de

laye

d be

caus

e al

l fac

ts a

re n

ot k

now

n. T

he re

cipi

ent o

f the

info

rmat

ion

shou

ld b

e m

ade

awar

e th

at a

ll fa

cts

may

not

yet

be

know

n, a

nd a

follo

w-u

p di

scus

sion

shou

ld b

e pl

anne

d to

dis

clos

e ne

w fa

cts.

An

offe

r of a

polo

gy o

r an

expr

essi

on o

f reg

ret c

an b

e of

fere

d an

d is

not

an

adm

issi

on o

f gui

lt.

Perti

nent

hea

lth re

cord

doc

umen

tatio

n w

ill b

e av

aila

ble

for t

he d

iscu

ssio

n, a

nd p

atie

nts/

clie

nts/

resi

dent

s and

fa

mili

es w

ill b

e pr

ovid

ed w

ith in

form

atio

n ab

out h

ow to

acc

ess t

heir

heal

th in

form

atio

n.

The

initi

ator

of t

he d

iscu

ssio

n m

ust d

ocum

ent t

he c

onte

nt o

f the

mee

ting

in th

e pa

tient

’s/c

lient

’s/re

side

nt’s

he

alth

reco

rd in

clud

ing

date

and

tim

e of

mee

ting;

par

ticip

ants

– (i

nclu

ding

nam

es a

nd re

latio

nshi

p to

the

patie

nt/c

lient

/resi

dent

), an

d fa

ctua

l acc

ount

of t

he in

form

atio

n sh

ared

.

Mee

ting

note

s are

to b

e ta

ken

and

kept

on

file

by th

e m

anag

er/d

irect

or in

volv

ed.

The

revi

ew p

roce

ss th

at w

ill b

e co

nduc

ted

shou

ld b

e pr

ovid

ed to

the

patie

nt/c

lient

/resi

dent

and

fam

ily.

In m

ost c

ases

invo

lvin

g a

criti

cal i

ncid

ent,

a m

ultid

isci

plin

ary

revi

ew w

ill o

ccur

. Qua

lity

impr

ovem

ent

reco

mm

enda

tions

from

the

revi

ew c

an b

e sh

ared

with

the

patie

nt/c

lient

/resi

dent

and

fam

ily if

so d

esire

d.

The

occu

rren

ce o

f an

AE

can

have

sign

ifica

nt e

mot

iona

l and

psy

chol

ogic

al im

pact

on

the

invo

lved

pro

vide

rs’

care

for t

he p

atie

nt/c

lient

/resi

dent

. Su

ppor

t for

the

prov

ider

s inv

olve

d in

an

adve

rse/

unan

ticip

ated

eve

nt w

ill

be p

rovi

ded/

faci

litat

ed b

y th

e Sa

skat

oon

Hea

lth R

egio

n. S

uppo

rts su

ch a

s the

Em

ploy

ee F

amily

Ass

ista

nce

Prog

ram

(EFA

P), R

isk

Man

agem

ent o

r Soc

ial W

ork

can

be o

ffere

d.

Mul

ti-ju

risdi

ctio

nal d

iscl

osur

e:

Ther

e m

ay b

e di

sclo

sure

s tha

t ext

end

beyo

nd ju

risdi

ctio

nal b

orde

rs, s

uch

as a

pat

ient

rece

ives

car

e an

d ha

rm

occu

rs a

s a re

sult

of th

e ca

re in

the

orig

inat

ing

juris

dict

ion,

but

is n

ot d

iscl

osed

and

/or u

nkno

wn

prio

r to

the

trans

fer t

o an

othe

r jur

isdi

ctio

n.

Effe

ctiv

e co

mm

unic

atio

n an

d co

oper

atio

n be

twee

n ju

risdi

ctio

ns is

key

. Id

eally

, all

juris

dict

ions

shou

ld b

e a

part

of th

e di

sclo

sure

. Th

e le

ad fo

r the

syst

em re

view

will

typi

cally

fall

with

in th

e re

spon

sibi

lity

of th

e ju

risdi

ctio

n in

whi

ch th

e ev

ent o

ccur

red.

Mul

ti-pe

rson

dis

clos

ure:

Ther

e m

ay b

e di

sclo

sure

s tha

t inv

olve

mor

e th

an o

ne p

atie

nt/re

side

nt/c

lient

. Ini

tial c

onta

ct m

ay in

clud

e a

regi

ster

ed le

tter,

tele

phon

e ca

ll, o

r an

invi

tatio

n to

an

in-p

erso

n m

eetin

g. A

ppro

pria

te c

linic

ians

shou

ld b

e in

volv

ed a

nd/o

r adv

ised

of t

he d

iscl

osur

e.

1 Adv

erse

/una

ntic

ipat

ed e

vent

is d

efine

d as

an

unde

sire

d an

d un

plan

ned

occu

rren

ce d

irect

ly a

ssoc

iate

d w

ith th

e ca

re o

r ser

vice

s pro

vide

d to

a p

atie

nt/c

lient

in th

e he

alth

car

e sy

stem

”. T

he o

ccur

renc

e m

ay re

sult

from

“co

mm

issi

on o

r om

issi

on (e

.g.,

adm

inis

tratio

n of

the

wro

ng m

edic

atio

n) a

nd c

an in

clud

e pr

oble

ms i

n pr

actic

e, p

rodu

cts,

proc

edur

es a

nd sy

stem

s.” C

CH

SA 2

003

238

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

52 53

2 Pol

icy:

Phy

sici

an D

iscl

osur

e of

Adv

erse

Eve

nts a

nd E

rror

s tha

t Occ

ur in

the

Cou

rse

of P

atie

nt C

are.

C

olle

ge o

f Phy

sici

ans a

nd S

urge

ons o

f Sas

katc

hew

an, 2

002

and

Prof

essi

onal

Cod

es o

f Eth

ics (

Hea

lth C

are

Prof

essi

onal

s of S

aska

tche

wan

)

3 “C

ritic

al In

cide

nt”

mea

ns a

serio

us a

dver

se h

ealth

eve

nt in

clud

ing,

but

not

lim

ited

to, t

he a

ctua

l or p

oten

tial

loss

of l

ife, l

imb

or fu

nctio

n re

late

d to

a h

ealth

car

e se

rvic

e pr

ovid

ed b

y, o

r bei

ng p

rovi

ded

by, a

regi

onal

he

alth

aut

horit

y or

hea

lth c

are

orga

niza

tion.

SH

R’s

Crit

ical

Inci

dent

Rep

ortin

g Po

licy

7311

-50-

008.

Mul

tidis

cipl

inar

y C

ase

Rev

iew

: A c

oord

inat

ed a

ppro

ach

to m

anag

ing

risk

.

Ris

k M

anag

emen

t or t

he a

dmin

istra

tor o

n ca

ll w

ill d

iscu

ss th

e ci

rcum

stan

ces w

ith a

ppro

pria

te se

nior

m

anag

emen

t, in

clud

ing

Chi

ef o

f Sta

ff (if

app

ropr

iate

) and

app

ropr

iate

vic

e pr

esid

ent o

r oth

er se

nior

m

anag

emen

t if d

eem

ed a

ppro

pria

te.

At t

he d

irect

ion

of se

nior

man

agem

ent,

an A

d H

oc M

ultid

isci

plin

ary

Rev

iew

Tea

m m

ay b

e ap

poin

ted.

The

faci

litat

or w

ill b

e a

mem

ber o

f the

Dep

artm

ent o

f Ris

k M

anag

emen

t.

The

mem

bers

hip

of th

e re

view

team

will

incl

ude:

The

atte

ndin

g ph

ysic

ian

(if in

volv

emen

t in

the

even

t),Th

e de

partm

ent m

anag

er(s

), di

rect

or(s

), ge

nera

l man

ager

(s) a

nd/ o

r dep

artm

ent h

ead

of th

e de

partm

ent(s

) in

volv

ed,

Sele

cted

staf

f who

pro

vide

d ca

re, (

e.g.

nur

sing

staf

f, re

side

nts,

JUR

SIs)

and

, ot

her c

onsu

ltant

s at t

he d

iscr

etio

n of

the

team

.

Man

date

of t

he m

ultid

isci

plin

ary

revi

ew te

am:

Ris

k M

anag

emen

t or d

esig

nate

will

be

resp

onsi

ble

for g

athe

ring

all o

f the

rele

vant

info

rmat

ion.

To m

eet w

ith 1

4 da

ys o

f the

occ

urre

nce.

To re

view

the

heal

th re

cord

, rel

ated

doc

umen

tatio

n su

rrou

ndin

g th

e oc

curr

ence

, and

any

rele

vant

pol

icie

s, pr

oced

ures

and

/ or p

roto

cols

.To

inte

rvie

w in

divi

dual

s who

may

pro

vide

add

ition

al re

leva

nt fa

cts o

r per

tinen

t bac

kgro

und

info

rmat

ion

To su

mm

ariz

e th

eir fi

ndin

gs in

a re

port

to th

e Se

nior

Man

agem

ent s

pons

ors w

ithin

21

days

of t

he o

ccur

renc

e.

The

repo

rt w

ill c

onci

sely

des

crib

e th

e ci

rcum

stan

ces t

hat a

re b

elie

ved

to h

ave

led

to th

e ac

tual

or p

oten

tial

adve

rse

outc

ome

and

the

reco

mm

ende

d m

easu

res t

o pr

even

t a si

mila

r occ

urre

nce

(if in

fact

ther

e ar

e an

y).

Doc

umen

tatio

n is

to b

e co

ncis

e an

d fo

cuse

d on

the

fact

s of t

he to

pic.

No

copi

es a

re d

istri

bute

d of

any

repo

rts

prep

ared

for t

his p

roce

ss.

All

docu

men

ts a

re c

lear

ly m

arke

d, “

PRIV

ILEG

ED A

ND

CO

NFI

DEN

TIA

L –

FOR

M

EDIC

AL

QU

ALI

TY IM

PRO

VEM

ENT

PUR

POSE

S.”

If e

mai

l is u

sed,

mes

sage

s beg

in w

ith th

e no

te,

“Con

fiden

tial –

for M

edic

al Q

ualit

y Im

prov

emen

t Pur

pose

s” a

nd sh

ould

be

disc

arde

d as

soon

as p

ossi

ble.

R

epor

ting

outs

ide

of th

is in

tern

al re

view

pro

cess

shou

ld o

nly

be d

one

on th

e ad

vice

of R

isk

Man

agem

ent

and/

or l

egal

cou

nsel

for t

he R

egio

n.

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

239

54

Man

itoba

W

inni

peg

Reg

iona

l Hea

lth

Aut

hori

ty

Crit

ical

Inci

dent

Man

agem

ent a

nd L

earn

ing

Reg

iona

l Pol

icy

Polic

y N

umbe

r 10.

50.0

40D

ate:

June

200

7

Crit

ical

Inci

dent

is d

efine

d as

an

unin

tend

ed e

vent

that

occ

urs w

hen

heal

th se

rvic

es a

re p

rovi

ded

to a

n in

divi

dual

and

resu

lt in

a c

onse

quen

ce to

him

/her

that

(a) i

s ser

ious

and

und

esire

d, su

ch a

s dea

th, d

isab

ility

, in

jury

or h

arm

, unp

lann

ed a

dmis

sion

to h

ospi

tal o

r unu

sual

ext

ensi

on o

f hos

pita

l sta

y, a

nd (b

) doe

s not

resu

lt fr

om th

e in

divi

dual

’s u

nder

lyin

g he

alth

con

ditio

n or

from

risk

inhe

rent

in p

rovi

ding

the

heal

th se

rvic

e.

“Pro

visi

onal

Crit

ical

Inci

dent

” is

an

even

t tha

t may

mee

t the

abo

ve c

riter

ia b

ut h

as n

ot y

et b

een

desi

gnat

ed

a C

I. le

gal p

rivile

ge a

s des

crib

ed in

The

Reg

iona

l Hea

lth A

utho

ritie

s Am

endm

ent a

nd M

anito

ba E

vide

nce

Am

endm

ent A

ct d

oes n

ot b

egin

unt

il a

“Pro

visi

onal

Crit

ical

Inci

dent

” is

des

igna

ted

as a

Crit

ical

Inci

dent

by

the

faci

lity/

prog

ram

/set

ting.

The

refo

re, a

ny in

form

atio

n co

llect

ed p

rior t

o de

sign

atin

g th

is e

vent

is n

ot

lega

lly p

rivile

ged.

Any

indi

vidu

al, i

nclu

ding

em

ploy

ees a

nd m

edic

al st

aff,

who

bec

omes

aw

are

of s

CI s

hall

prom

ptly

repo

rt it

in th

e m

anne

r des

igna

ted

by th

e W

RH

A C

hief

Pat

ient

Saf

ety

Offi

cer i

n ac

cord

ance

with

The

Reg

iona

l Hea

lth

Aut

horit

ies A

men

dmen

t and

Man

itoba

Evi

denc

e Act

.A

ny in

divi

dual

, inc

ludi

ng e

mpl

oyee

s and

med

ical

staf

f, w

ho b

ecom

es a

war

e of

a C

I sha

ll pr

ompt

ly re

port

it in

the

man

ner d

esig

nate

d by

the

WR

HA

Chi

ef P

atie

nt S

afet

y O

ffice

r, in

acc

orda

nce

with

The

Reg

iona

l H

ealth

Aut

horit

ies A

men

dmen

t and

Man

itoba

Evi

denc

e Am

endm

ent A

ct.

3.2

With

the

goal

of e

ncou

ragi

ng a

cul

ture

of r

epor

ting,

the

WR

HA

shal

l sup

port

indi

vidu

als w

ho re

port

a C

I in

goo

d fa

ith.

3.3

The

WR

HA

shal

l ens

ure

all C

Is a

re a

ppro

pria

tely

inve

stig

ated

(inc

ludi

ng d

ebrie

fing

of a

ppro

pria

te st

aff,

patie

nts a

nd fa

mily

whe

neve

r pos

sibl

e) in

ord

er to

pro

mot

e sy

stem

-wid

e le

arni

ng th

roug

h th

e ap

poin

tmen

t of

Crit

ical

Inci

dent

Rev

iew

Com

mitt

ees (

CIR

C),

as d

escr

ibed

in T

he R

egio

nal H

ealth

Aut

horit

ies A

men

dmen

t an

d M

anito

ba E

vide

nce A

men

dmen

t Act

, and

as d

etai

led

in se

ctio

n 4.

0 be

low.

3.4

In th

e sp

irit o

f est

ablis

hing

a ju

st a

nd fa

ir le

arni

ng c

ultu

re, t

he W

RH

A sh

all n

ot d

isci

plin

e an

y st

aff

mem

ber i

nvol

ved

in e

vent

s lea

ding

to a

CI a

nd sh

all t

reat

the

even

t as a

lear

ning

opp

ortu

nity

, exc

ept a

s ou

tline

d in

sect

ions

3.5

.

3.5

Whe

n a

staf

f mem

ber o

r med

ical

staf

f has

dem

onst

rate

d di

sreg

ard

for p

atie

nt sa

fety

or h

as a

cted

in b

reac

h of

any

pol

icie

s or o

blig

atio

ns, W

RH

A re

serv

es th

e rig

ht to

add

ress

such

inst

ance

s in

an a

ppro

pria

te m

anne

r in

acc

orda

nce

with

app

licab

le p

olic

ies o

r pro

cess

es, c

olle

ctiv

e ag

reem

ents

or m

edic

al st

aff b

y-la

ws e

ven

whe

n su

ch a

staf

f mem

ber o

r med

ical

staf

f is i

nvol

ved

in a

CI.

3.6

The

WR

HA

shal

l eva

luat

e th

e im

plem

ente

d re

com

men

datio

ns a

risin

g fr

om C

I rev

iew

s. Le

sson

s lea

rned

sh

all b

e sh

ared

with

all

appr

opria

te in

divi

dual

s and

org

aniz

atio

ns, a

s det

aile

d in

sect

ion

4.0

belo

w.

3.7

Dis

clos

ure

of th

e C

I sha

ll oc

cur i

n ac

cord

ance

with

the

WR

HA

Pol

icy

# 10

.50.

030

– D

iscl

osur

e of

C

ritic

al In

cide

nts a

nd a

s des

crib

ed in

The

Reg

iona

l Hea

lth A

utho

ritie

s Am

endm

ent a

nd M

anito

ba E

vide

nce

Am

endm

ent A

ct.

240

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

54 55

3.8

No

reco

rd o

r inf

orm

atio

n, in

clud

ing

an o

pini

on o

r adv

ice,

pre

pare

d so

lely

for t

he u

se o

f a C

IRC

, or

colle

cted

, com

pile

d or

pre

pare

d by

a C

IRC

for t

he so

le p

urpo

se o

f car

ryin

g ou

t its

dut

ies,

may

be

prod

uced

in

any

lega

l pro

ceed

ing.

3.9

No

witn

ess i

n a

lega

l pro

ceed

ing

may

be

aske

d or

per

mitt

ed to

ans

wer

any

que

stio

n or

mak

e an

y st

atem

ent a

bout

a C

IRC

pro

ceed

ing.

Any

indi

vidu

al w

ho o

bser

ves o

r has

kno

wle

dge

of a

Crit

ical

Inci

dent

(CI)

or a

Pro

visi

onal

CI s

hall:

4.

1.1

ensu

re th

at th

e pa

tient

(s) a

nd p

erso

nnel

are

safe

guar

ded,

4.

1.2

Iden

tify

and

secu

re a

ny p

ertin

ent e

quip

men

t/sup

plie

s. D

eter

min

e if

the

room

or s

cene

nee

ds to

be

secu

red,

e.g

. in

the

case

of a

suic

ide,

hom

icid

e, su

spic

ious

dea

th.

4.

1.3

Rep

ort t

he C

I/ Pr

ovis

iona

l CI b

y ca

lling

the

WR

HA

Crit

ical

Inci

dent

Rep

ortin

g Li

ne, 2

4 ho

urs a

day

, 7

days

a w

eek.

(Not

e: P

atie

nt S

afet

y ar

e no

long

er a

ccep

ting

the

pape

r rep

ort f

orm

). C

alle

rs w

ho c

hoos

e to

, m

ay re

port

anon

ymou

sly.

(N

ote:

repo

rted

eve

nts a

ccep

ted

by th

e W

RHA

Cri

tical

Inci

dent

Rep

ortin

g Li

ne

will

be

clas

sifie

d as

Pro

visi

onal

CIs

unt

il de

sign

ated

as a

Cri

tical

Inci

dent

by

the

invo

lved

faci

lity/

prog

ram

/se

tting

.)

4.

1.4

At t

he c

alle

r’s d

iscr

etio

n, n

otify

his

/her

man

ager

/sup

ervi

sor t

o pr

ovid

e as

sist

ance

/sup

port.

Em

ploy

ees

are

enco

urag

ed to

pro

vide

the

info

rmat

ion

to th

eir m

anag

er/s

uper

viso

r, fo

llow

ing

usua

l lin

es o

f rep

ortin

g.

4.2

The

info

rmat

ion

colle

cted

from

the

CI R

epor

ting

Line

at t

he P

rovi

ncia

l Hea

lth C

onta

ct C

entre

will

be

sent

to th

e W

RH

A P

atie

nt S

afet

y C

I dat

abas

e ap

plic

atio

n.

4.3

A P

rovi

sion

al C

I not

ifica

tion

emai

l (co

ntai

ning

de-

iden

tified

info

rmat

ion)

will

aut

omat

ical

ly b

e se

nt

from

the

data

base

app

licat

ion

to id

entifi

ed re

cipi

ents

at t

he in

volv

ed fa

cilit

y, W

RH

A P

rogr

ams,

WR

HA

Pa

tient

Saf

ety,

and

Man

itoba

Hea

lth. (

Not

e: In

form

atio

n in

the

notifi

catio

n em

ail i

s not

lega

lly p

rivi

lege

d.)

4.4

Dur

ing

regu

lar w

orki

ng h

ours

(08:

00-1

7:00

), a

faci

lity/

prog

ram

/set

ting

repr

esen

tativ

e (a

s ide

ntifi

ed b

y th

e fa

cilit

y/pr

ogra

m/s

ettin

g) sh

all:

4.4.

1 D

eter

min

e w

heth

er o

r not

the

repo

rted

even

t mee

ts th

e de

fined

CI c

riter

ia. I

f ass

ista

nce

is n

eede

d w

ith

this

step

, con

tact

the

WR

HA

Pat

ient

Saf

ety

Team

. 4.

4.2

If th

e ev

ent i

s des

igna

ted

as a

CI,

ensu

re th

at:

4.4.

2.1

App

ropr

iate

dis

clos

ure

to th

e pa

tient

/fam

ily m

embe

r(s)

has

occ

urre

d.

4.4.

2.2

An

indi

vidu

al h

as b

een

desi

gnat

ed to

pro

vide

ong

oing

con

tact

and

supp

ort f

or th

e pa

tient

and

fam

ily

mem

bers

as a

ppro

pria

te.

4.4.

2.3

Ther

e is

app

ropr

iate

ong

oing

supp

ort f

or st

aff m

embe

r(s)

and

phy

sici

an(s

) inv

olve

d.

4.4.

2.4

Any

stud

ent/t

rain

ee c

onta

cts h

is/h

er su

perv

isor

for s

uppo

rt.

4.4.

2.5

The

site

insu

rer i

s not

ified

whe

n ap

prop

riate

. 4.

4.3

Ensu

re th

at a

Crit

ical

Inci

dent

Rev

iew

Com

mitt

ee (C

IRC

) is n

amed

to in

vest

igat

e th

e C

I (se

e A

ppen

dix)

. Col

labo

rate

as n

eede

d w

ith th

e W

RH

A P

atie

nt S

afet

y Te

am to

det

erm

ine

the

leve

l and

m

embe

rshi

p of

the

CIR

C.

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

241

56

4.4.

4 B

y th

e en

d of

the

next

bus

ines

s day

, adv

ise

the

WR

HA

Pat

ient

Saf

ety

Team

in w

ritin

g (p

refe

rabl

y by

em

ail)

whe

ther

or n

ot th

e re

porte

d ev

ent h

as b

een

desi

gnat

ed a

Crit

ical

Inci

dent

. If t

he e

vent

has

bee

n de

sign

ated

as a

CI,

indi

cate

that

a C

IRC

has

bee

n es

tabl

ishe

d an

d pr

ovid

e th

e na

mes

and

title

s of t

he C

IRC

m

embe

rs. (

Not

e: L

egal

pri

vile

ge b

egin

s onc

e th

e ev

ent h

as b

een

desi

gnat

ed a

s a C

I by

the

faci

lity/

prog

ram

/se

tting

/WRH

A Pa

tient

Saf

ety.)

4.

4.5

With

in 2

8 ca

lend

ar d

ays o

f the

CI,

send

a st

atus

repo

rt to

the

WR

HA

Pat

ient

Saf

ety

Team

(pre

fera

bly

via

emai

l) w

hich

is m

arke

d “P

rivile

ged

unde

r Sec

tion

9 of

the

Man

itoba

Evi

denc

e Act

” an

d co

ntai

ns th

e fo

llow

ing

info

rmat

ion:

4.4.

5.1

Dat

e of

the

CI,

any

chan

ges i

n th

e co

nditi

on o

f the

pat

ient

, ind

icat

ion

that

a re

view

has

bee

n co

mpl

eted

or i

s in

prog

ress

, rev

iew

find

ings

and

reco

mm

enda

tions

(if t

he re

view

has

bee

n co

mpl

eted

) and

th

e st

eps t

aken

to in

form

the

patie

nt/fa

mily

of t

he u

nfol

ding

con

sequ

ence

s to

the

patie

nt’s

hea

lth.

4.4.

6 W

ithin

88

cale

ndar

day

s of t

he C

I, se

nd a

cop

y of

the

CIR

C’s

writ

ten

final

repo

rt to

the

WR

HA

Pat

ient

Sa

fety

Tea

m (p

refe

rabl

y vi

a em

ail).

The

repo

rt m

ust b

e m

arke

d “P

rivile

ged

unde

r Sec

tion

9 of

the

Man

itoba

Ev

iden

ce A

ct”

and

cont

ain

the

findi

ngs,

reco

mm

enda

tions

and

follo

w-u

p ac

tion

plan

.

4.5

Dur

ing

regu

lar w

orki

ng h

ours

(08:

00-1

7:00

), th

e W

RH

A P

atie

nt S

afet

y Te

am sh

all:

4.5.

1 Ve

rify

as n

eede

d, in

col

labo

ratio

n w

ith th

e Pa

tient

Saf

ety

repr

esen

tativ

e fr

om th

e fa

cilit

y/pr

ogra

m/

setti

ng (a

s des

igna

ted

by th

e fa

cilit

y/pr

ogra

m/s

ettin

g), w

heth

er o

r not

a P

rovi

sion

al C

I mee

ts th

e de

fined

CI

crite

ria.

4.5.

2 C

olla

bora

te a

s nee

ded

with

the

faci

lity/

prog

ram

/set

ting

to d

eter

min

e th

e le

vel a

nd m

embe

rshi

p of

the

Crit

ical

Inci

dent

Rev

iew

Com

mitt

ee (C

IRC

). 4.

5.3

Parti

cipa

te in

and

/or c

hair

CIR

Cs a

s req

uire

d.

4.5.

4 A

s app

ropr

iate

, ens

ure

that

an

appr

opria

te p

erso

n pr

ovid

es o

ngoi

ng fo

llow

-up

and

supp

ort f

or th

e pa

tient

/fam

ily m

embe

rs.

4.5.

5 En

sure

that

Man

itoba

Hea

lth h

as re

ceiv

ed in

itial

not

ifica

tion

of th

e C

I. 4.

5.6

With

in 3

0 ca

lend

ar d

ays o

f the

CI,

ensu

re th

at M

anito

ba H

ealth

rece

ives

a c

opy

of th

e st

atus

repo

rt th

at in

clud

es:

the

date

and

tim

e of

the

CI,

furth

er d

etai

ls, c

ondi

tion

of th

e pa

tient

, ste

ps ta

ken

to in

form

th

e pa

tient

/fam

ily o

f the

unf

oldi

ng c

onse

quen

ces t

o th

e pa

tient

’s h

ealth

, con

firm

atio

n of

est

ablis

hmen

t of

a C

IRC

, ind

icat

ion

that

a re

view

has

bee

n co

mpl

eted

or i

s in

prog

ress

and

revi

ew fi

ndin

gs a

nd

reco

mm

enda

tions

(if t

he re

view

has

bee

n co

mpl

eted

). 4.

5.7

With

in 9

0 ca

lend

ar d

ays o

f the

CI o

r upo

n co

mpl

etio

n of

the

CI R

evie

w, e

nsur

e th

at M

anito

ba H

ealth

re

ceiv

es a

cop

y of

the

writ

ten

final

repo

rt. T

he re

port

mus

t be

mar

ked

“Priv

ilege

d un

der S

ectio

n 9

of th

e M

anito

ba E

vide

nce A

ct”

and

cont

ain

the

findi

ngs,

reco

mm

enda

tions

and

follo

w-u

p ac

tion

plan

.

4.5.

8 C

ourie

r the

fina

l CIR

C R

epor

t to

the

Chi

ef O

pera

ting

Offi

cer (

CO

O)/C

hief

Exe

cutiv

e O

ffice

r (C

EO)

of th

e in

volv

ed fa

cilit

y/se

tting

or,

in th

e ca

se o

f Com

mun

ity C

Is, t

o th

e V

P of

Com

mun

ity H

ealth

Ser

vice

s, w

hen

CI r

evie

ws a

re le

d by

a m

embe

r of t

he W

RH

A P

atie

nt S

afet

y Te

am.

242

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

56 57

4.6

Onc

e th

e Pr

ovis

iona

l CI h

as b

een

repo

rted

to th

e W

RH

A C

ritic

al In

cide

nt R

epor

ting

line,

afte

r hou

rs

(bet

wee

n 17

:00

and

08:0

0), o

r on

a w

eeke

nd o

r sta

tuto

ry h

olid

ay:

4.6.

1 A

des

igna

ted

repr

esen

tativ

e fr

om th

e fa

cilit

y/pr

ogra

m/s

ettin

g (a

s des

igna

ted

by th

e fa

cilit

y/pr

ogra

m/

setti

ng) i

f aw

are

of th

e Pr

ovis

iona

l CI,

shal

l not

ify th

e W

RH

A a

dmin

istra

tor o

n ca

ll by

pag

ing

her/h

im. T

he

notifi

catio

n sh

ould

incl

ude

the

nam

e an

d co

ntac

t inf

orm

atio

n of

the

pers

on re

porti

ng, t

ime

and

date

of t

he

Prov

isio

nal C

I, a

brie

f des

crip

tion

of th

e fa

cts,

and

the

patie

nt’s

con

ditio

n.

4.6.

2 Th

e W

RH

A a

dmin

istra

tor o

n ca

ll if

awar

e of

the

Prov

isio

nal C

I, sh

all n

otify

Man

itoba

Hea

lth b

y ca

lling

the

afte

r-hou

rs c

ellu

lar p

hone

. Th

e no

tifica

tion

shou

ld in

clud

e th

e na

me

and

cont

act i

nfor

mat

ion

of

the

pers

on re

porti

ng, t

ime

and

date

of t

he P

rovi

sion

al C

I, a

brie

f des

crip

tion

of th

e fa

cts,

and

the

patie

nt’s

co

nditi

on.

CR

ITIC

AL

INC

IDE

NT

RE

VIE

W C

OM

MIT

TE

ES

As s

oon

as p

ossi

ble

afte

r an

even

t is c

onfir

med

as a

CI,

a C

IRC

shou

ld b

e ap

poin

ted

by th

e si

te o

r set

ting

whe

re th

e C

I occ

urre

d. In

ord

er to

be

a m

embe

r of a

CIR

C, a

n in

divi

dual

mus

t hav

e co

mpl

eted

one

of t

he

wor

ksho

ps re

quire

d by

the

WR

HA

Pat

ient

Saf

ety

Team

. The

WR

HA

Pat

ient

Saf

ety

Team

mai

ntai

ns a

list

of

such

indi

vidu

als.

Cer

tain

indi

vidu

als m

ust b

e ex

clud

ed fr

om th

e C

IRC

, spe

cific

ally

any

one

who

: • H

as a

con

flict

of i

nter

est i

n th

e C

IRC

; e.g

., m

anag

er o

f the

invo

lved

uni

t; • W

as o

r is d

irect

ly in

volv

ed in

pro

vidi

ng c

are

to th

e pa

tient

; • H

as a

pot

entia

l fut

ure

role

in d

isci

plin

ary

mat

ters

aris

ing

from

that

CI o

r the

pro

gram

or s

ite in

volv

ed; e

.g.,

Man

ager

/Pro

gram

Dire

ctor

/Med

ical

Dire

ctor

; as o

utlin

ed in

3.5

; • I

s the

ong

oing

pat

ient

/fam

ily su

ppor

t per

son.

The

appr

opria

te si

ze a

nd ty

pe o

f CIR

C w

ill d

epen

d on

the

CI.

Ther

e ar

e a

num

ber o

f pos

sibi

litie

s:

1) S

ite b

ased

sing

le p

erso

n C

IRC

- t

he m

ost c

omm

on a

nd e

ffici

ent t

ype

of C

IRC

; 2)

Site

bas

ed C

IRC

mad

e up

of t

wo

or m

ore

pers

ons

- app

ropr

iate

if th

e ca

se is

com

plex

or i

nvol

ves m

ore

than

one

pro

gram

with

in a

site

; 3)

Reg

iona

l CIR

C m

ade

up o

f one

or m

ore

pers

ons

- app

ropr

iate

if th

e ca

se in

volv

es m

ore

than

one

faci

lity,

mor

e th

an o

ne p

rogr

am w

ithin

the

regi

on o

r if t

he

issu

es a

re h

ighl

y “v

isib

le”;

4)

Ext

erna

l CIR

C

- app

ropr

iate

if a

con

sulta

nt o

utsi

de th

e W

RH

A is

requ

ired.

In

all

case

s a C

IRC

will

: 1)

Rec

onst

ruct

the

sequ

ence

of e

vent

s:

• Deb

rief (

hear

the

stor

y of

) inv

olve

d st

aff;

• Deb

rief (

hear

the

stor

y of

) inv

olve

d pa

tient

and

fam

ily;

• Gat

her r

ecor

ds

2) M

eet w

ith p

erso

ns w

ho a

re so

urce

s of a

pplic

able

info

rmat

ion;

3)

Con

sult

with

pro

gram

team

rega

rdin

g re

com

men

datio

ns;

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

243

58

4) P

repa

re th

e fin

al re

port.

5)

Ens

ure

that

all

CIR

C d

ocum

ents

are

mar

ked

“Priv

ilege

d un

der S

ectio

n 9

of th

e M

anito

ba E

vide

nce A

ct”

and

stor

ed in

a c

onfid

entia

l file

in a

lock

ed o

ffice

.

As n

eede

d a

CIR

C w

ill:

1) S

eek

expe

rt op

inio

ns;

2) O

btai

n st

anda

rds a

nd p

roto

cols

from

ext

erna

l sou

rces

; 3)

See

k in

form

atio

n fr

om n

on-W

RH

A so

urce

s (e.

g., f

amily

phy

sici

an, p

aram

edic

s, ph

arm

acy,

lite

ratu

re, e

tc.);

4)

Con

vene

a m

eetin

g of

clin

ical

exp

erts

to a

ssis

t the

CIR

C to

form

ulat

e re

com

men

datio

ns.

Spec

ial s

ituat

ions

for a

CIR

C:

1) If

ther

e ar

e se

rious

con

cern

s abo

ut th

e co

mpe

tenc

e or

per

form

ance

of a

pro

vide

r, a

CIR

C m

ay a

nd sh

ould

co

ntac

t the

app

ropr

iate

Fac

ility

Sen

ior M

anag

emen

t mem

ber o

r the

Site

Exe

cutiv

e D

irect

or/C

omm

unity

Are

a D

irect

or d

irect

ly.

2) If

a C

IRC

mem

ber h

as a

man

dato

ry re

porti

ng d

uty

to a

lice

nsin

g bo

dy, t

he C

IRC

shou

ld m

ake

the

disc

losu

re p

refe

rent

ially

thro

ugh

the

appr

opria

te F

acili

ty S

enio

r Man

agem

ent m

embe

r or t

he S

ite E

xecu

tive

Dire

ctor

/Com

mun

ity A

rea

Dire

ctor

. 3)

If th

ere

are

serio

us c

once

rns a

bout

pos

sibl

e cr

imin

al a

ctiv

ity, a

CIR

C m

ay in

volv

e po

lice,

pre

fere

ntia

lly b

y no

tifyi

ng th

e ap

prop

riate

Fac

ility

Sen

ior M

anag

emen

t mem

ber o

r Site

Exe

cutiv

e D

irect

or/C

omm

unity

Are

a D

irect

or.

4) In

add

ition

, the

re m

ay b

e pa

ralle

l inv

estig

atio

ns u

nder

way

, e.g

., po

lice

inve

stig

atio

ns, a

dmin

istra

tive

revi

ews.

Th

e C

IRC

will

send

a c

opy

of th

e fin

al re

port

only

to th

e fa

cilit

y C

hief

Ope

ratin

g O

ffice

r/Chi

ef E

xecu

tive

Offi

cer a

nd th

e W

RH

A P

atie

nt S

afet

y O

ffice

r who

will

forw

ard

a co

py o

f the

fina

l rep

ort t

o th

e M

inis

ter o

f H

ealth

(Man

itoba

Hea

lth).

The

exc

eptio

n is

that

, upo

n re

ques

t, a

copy

of t

he fi

nal r

epor

t may

als

o be

sent

to

the

offic

e of

the

Con

tinui

ng M

edic

al E

xam

iner

and

, in

som

e ca

ses,

the

Prot

ectio

n of

Per

sons

in C

are

Offi

ce.

The

WR

HA

Chi

ef P

atie

nt S

afet

y O

ffice

r or d

esig

nate

will

pro

vide

pat

ient

s/fa

mili

es, f

acili

ties,

and

othe

rs

with

a d

e-id

entifi

ed a

bstra

cted

sum

mar

y of

the

even

t, fin

ding

s and

reco

mm

enda

tions

.

244

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

58 59

Dis

clos

ure

of In

form

atio

n Re

late

d to

Car

e an

d Tr

eatm

ent

Regi

onal

Pol

icy

Polic

y N

umbe

r 10.

50.0

30D

ate:

July

200

7

“C

ritic

al In

cide

nt”

(CI)

is a

n un

inte

nded

eve

nt th

at o

ccur

s whe

n he

alth

serv

ices

are

pro

vide

d to

an

indi

vidu

al a

nd re

sult

in a

con

sequ

ence

to h

im o

r her

that

: a)

is se

rious

and

und

esire

d, su

ch a

s dea

th, d

isab

ility

, inj

ury

or h

arm

, unp

lann

ed a

dmis

sion

to h

ospi

tal,

or

unus

ual e

xten

sion

of h

ospi

tal s

tay;

and

b)

doe

s not

resu

lt fr

om th

e in

divi

dual

’s u

nder

lyin

g he

alth

con

ditio

n or

from

a ri

sk in

here

nt in

pro

vidi

ng th

e he

alth

serv

ices

.

“D

iscl

osur

e” is

a p

roce

ss th

at in

clud

es sh

arin

g pe

rtine

nt in

form

atio

n w

ith th

e pa

tient

and

/or s

ubst

itute

de

cisi

on-m

aker

abo

ut th

e ca

re p

rovi

ded,

as w

ell a

s res

pond

ing

to q

uest

ions

. The

pro

cess

may

invo

lve

a nu

mbe

r of e

ncou

nter

s ove

r tim

e as

mor

e in

form

atio

n is

lear

ned

abou

t a p

artic

ular

situ

atio

n.

The

shar

ing

of p

ertin

ent i

nfor

mat

ion

abou

t car

e an

d tre

atm

ent p

rovi

ded

to p

atie

nts b

y st

aff/m

edic

al st

aff

will

be

inte

grat

ed in

to th

e ro

utin

e pr

oces

ses o

f pro

vidi

ng se

rvic

es. T

he sh

arin

g of

info

rmat

ion

will

occ

ur in

a

timel

y m

anne

r by

mea

ns o

f dis

cuss

ions

and

con

vers

atio

ns a

s wel

l as b

y pr

ovid

ing

acce

ss to

cur

rent

trea

tmen

t re

cord

s, up

on re

ques

t.

With

resp

ect t

o ev

ents

and

situ

atio

ns th

at fu

lfill

the

crite

ria to

be

cons

ider

ed a

cri

tical

inci

dent

(ref

er to

po

licy

10.5

0.04

0) a

ll em

ploy

ees a

nd m

embe

rs o

f med

ical

staf

f inv

olve

d in

dis

clos

ure

disc

ussi

ons w

hich

will

ta

ke p

lace

with

the

patie

nt a

nd/o

r sub

stitu

te d

ecis

ion-

mak

ers,

will

incl

ude

the

follo

win

g:

• The

fact

s of w

hat a

ctua

lly h

appe

ned;

• T

he c

onse

quen

ces f

or th

e pa

tient

and

the

step

s to

be ta

ken

to a

ddre

ss th

ose

cons

eque

nces

; • a

regr

et th

at th

e ev

ent o

ccur

red

and

resu

lted

in h

arm

to th

e pa

tient

; and

• t

he a

vaila

bilit

y of

cop

ies o

f the

hea

lth re

cord

.

The

shar

ing

of p

ertin

ent i

nfor

mat

ion

will

be

prov

ided

by

the

mos

t app

ropr

iate

per

son(

s) a

fter d

iscu

ssio

n w

ith

the

supe

rvis

or/m

anag

er o

f the

clin

ical

are

a. Q

uest

ions

to b

e co

nsid

ered

will

incl

ude:

• W

ho h

as th

e ap

prop

riate

kno

wle

dge

of th

e ev

ent d

etai

ls?

• Who

is c

omfo

rtabl

e sh

arin

g th

e in

form

atio

n?• W

ho h

as d

evel

oped

a tr

ust r

elat

ions

hip

with

the

patie

nt/fa

mily

?

Gui

delin

es F

or D

iscl

osur

e in

the

case

of C

ritic

al In

cide

nts:

1.

Wha

t eve

nts o

r situ

atio

ns o

ught

to b

e di

sclo

sed?

R

efer

to th

e de

finiti

on o

f crit

ical

inci

dent

as o

utlin

ed in

the

Crit

ical

Inci

dent

Man

agem

ent a

nd L

earn

ing

polic

y (1

0.50

.040

).

2. T

o w

hom

shou

ld th

e di

sclo

sure

be

mad

e?

Dis

clos

ure

shou

ld b

e m

ade

dire

ctly

to th

e pa

tient

and

/or h

is/h

er su

bstit

ute

deci

sion

-mak

er.

If th

e pa

tient

la

cks t

he c

apac

ity to

und

erst

and

the

info

rmat

ion,

dis

clos

ure

shou

ld b

e m

ade

avai

labl

e to

a p

erso

n au

thor

ized

by

the

regu

latio

ns to

rece

ive

info

rmat

ion

and

reco

rds o

n th

e in

divi

dual

’s b

ehal

f (se

e 2.

2).

3. W

hen

shou

ld d

iscl

osur

e ta

ke p

lace

?

The

initi

al d

iscl

osur

e of

the

Crit

ical

Inci

dent

shou

ld ta

ke p

lace

as s

oon

as is

pra

ctic

ably

pos

sibl

e af

ter i

t has

oc

curr

ed o

r has

bee

n id

entifi

ed.

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

245

60

4. W

ho o

ught

to d

iscl

ose

deta

ils to

clie

nts a

nd/o

r fam

ily?

Dis

clos

ure

may

bes

t be

acco

mpl

ishe

d by

a te

am o

f car

e pr

ovid

ers a

nd re

quire

s coo

rdin

ated

pla

nnin

g pr

ior

to th

e di

sclo

sure

. In

mos

t, th

e at

tend

ing

or m

ost r

espo

nsib

le p

hysi

cian

(s) s

houl

d be

incl

uded

in th

e gr

oup

mak

ing

the

disc

losu

re.

Thos

e in

volv

ed in

dis

clos

ure

disc

ussi

on, s

houl

d be

kno

wle

dgea

ble

abou

t the

det

ails

of

the

even

t as w

ell a

s com

forta

ble

unde

rtaki

ng su

ch d

iscu

ssio

ns.

Adv

ice

and

assi

stan

ce w

ill b

e av

aila

ble

thro

ugh

the

regi

onal

WR

HA

Pat

ient

Saf

ety

Team

. 5.

Wha

t oug

ht to

be

disc

lose

d?

This

is d

efine

d in

bot

h th

e le

gisl

atio

n an

d th

e C

ritic

al In

cide

nt M

anag

emen

t and

Lea

rnin

g po

licy

(10.

50.0

40).

In a

dditi

on to

a d

escr

iptio

n of

the

fact

s of w

hat a

ctua

lly o

ccur

red,

the

cons

eque

nces

for t

he in

divi

dual

and

the

step

s tha

t will

be

take

n to

add

ress

thos

e co

nseq

uenc

es, i

t is a

ppro

pria

te to

incl

ude

the

follo

win

g:

• An

expr

essi

on o

f reg

ret t

hat t

he C

ritic

al In

cide

nt o

ccur

red

and

caus

ed h

arm

to th

e cl

ient

. • A

n of

fer t

o pr

ovid

e co

pies

of t

he d

ocum

enta

tion

in th

e he

alth

reco

rd, a

s des

crib

ed in

the

legi

slat

ion

and

polic

y re

gard

ing

Crit

ical

Inci

dent

s.

Thes

e co

nsid

erat

ions

will

app

ly e

qual

ly to

thos

e ev

ents

that

do

not m

eet t

he c

riter

ia to

be

cons

ider

ed a

CI,

as w

ell a

s tho

se e

vent

s tha

t are

con

side

red

a C

I. In

mos

t cas

es, t

he m

ost r

espo

nsib

le st

aff m

embe

rs, l

ikel

y th

e ph

ysic

ian(

s) if

ava

ilabl

e, w

ill p

artic

ipat

e in

dis

cuss

ions

invo

lvin

g di

sclo

sure

of c

ritic

al in

cide

nts.

Whe

re

poss

ible

, an

offe

r of a

seco

nd o

pini

on, t

he in

volv

emen

t of o

utsi

de a

ssis

tanc

e, o

r the

tran

sfer

of c

are

to

anot

her p

rovi

der o

r fac

ility

.O

ntar

ioSu

nnyb

rook

Hea

lth

Scie

nces

Cen

tre

Acco

unta

bilit

y fo

r Pat

ient

Saf

ety*

Not

e: T

his p

olic

y is

cite

d in

the

follo

win

g ar

ticle

Etch

ells

, E.,

Lest

er R

., M

orga

n, B

., &

Jo

hnso

n B

. (20

05).

“Stri

king

a B

alan

ce: W

ho

is A

ccou

ntab

le fo

r Pat

ient

Saf

ety?

” H

ealth

C

are

Qua

rter

ly, 8

(Spe

cial

Issu

e), 1

46-1

50.

It is

a st

rate

gic

goal

of S

unny

broo

k H

ealth

Sci

ence

s Cen

tre to

be

the

safe

st h

ospi

tal i

n C

anad

a. T

o cr

eate

a

cultu

re th

at w

ill su

ppor

t the

goa

l, Su

nnyb

rook

has

ado

pted

, the

follo

win

g pr

inci

ples

abo

ut p

atie

nt sa

fety

th

at w

ill g

uide

Sun

nybr

ook

empl

oyee

s, ph

ysic

ians

, stu

dent

s, vo

lunt

eers

and

age

nts o

f the

hos

pita

l [th

eses

ca

tego

ries o

f ind

ivid

uals

will

be

refe

rred

to c

olle

ctiv

ely

as “

staf

f” th

roug

h th

is p

olic

y]:

The

orga

niza

tion

and

each

indi

vidu

al st

aff m

embe

r sha

re th

e ac

coun

tabi

lity

for e

nsur

ing

the

safe

st

1.

poss

ible

pat

ient

car

e an

d se

rvic

e.St

aff r

epor

ts o

f err

ors,

near

mis

ses a

nd a

dver

se e

vent

s are

a c

ritic

al c

ompo

nent

of p

atie

nt sa

fety

2.

an

d m

ust b

e re

porte

d di

ligen

tly a

nd w

ithou

t fea

r of r

epris

al b

y al

l sta

ff.Th

e m

ajor

ity o

f err

ors,

near

mis

ses a

nd a

dver

se e

vent

s inv

olve

com

pete

nt a

nd c

arin

g st

aff

3.

inte

ract

ing

with

com

plex

syst

ems.

Sunn

ybro

ok re

spon

ds to

repo

rts o

f err

ors,

near

mis

ses,

and

adve

rse

even

ts b

y ca

refu

lly e

xam

inin

g an

d im

prov

ing

the

syst

ems o

f car

e.Su

nnyb

rook

nee

ds a

nd v

alue

s the

par

ticip

atio

n of

staf

f and

pro

fess

iona

ls in

the

inve

stig

atio

n of

4.

th

e sy

stem

of c

are,

and

in c

reat

ing

and

test

ing

impr

ovem

ents

.Su

nnyb

rook

has

a re

spon

sibi

lity

to a

ddre

ss th

e ac

tions

of i

ndiv

idua

ls w

hen

thei

r act

ions

fail

to

5.

mee

t pro

fess

iona

l, pa

tient

car

e an

d/or

serv

ices

stan

dard

s. Th

ese

situ

atio

ns in

clud

e in

tent

iona

l act

s m

eant

to h

arm

or d

ecei

ve; p

hysi

cal o

r men

tal i

mpa

irmen

t of s

taff;

subs

tanc

e ab

use

by st

aff;

staf

f in

com

pete

nce.

If it

bec

omes

cle

ar th

at a

staf

f mem

ber c

anno

t pra

ctic

e in

a re

liabl

y sa

fe m

anne

r, in

spite

of e

duca

tion

and

coun

selin

g, th

is si

tuat

ion

will

be

treat

ed a

s a st

aff c

ompe

tenc

y is

sue

in

acco

rdan

ce w

ith p

rofe

ssio

nal s

tand

ards

and

Hum

an R

esou

rce

prin

cipl

es.

246

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

60 61

Ont

ario

Sunn

ybro

ok H

ealth

Sc

ienc

es C

entr

e

Dis

clos

ure

of A

dver

se M

edic

al E

vent

s and

U

nant

icip

ated

Out

com

es o

f Car

eIt

is S

unny

broo

k &

wom

en’s

pol

icy,

in k

eepi

ng w

ith o

ur m

issi

on, v

isio

n, v

alue

s and

phi

loso

phy

of c

are,

to

ensu

re th

at p

atie

nts a

nd/o

r the

ir su

bstit

ute

deci

sion

-mak

er, a

nd/o

r the

ir fa

mily

are

pro

perly

info

rmed

abo

ut

thei

r hea

lth c

are.

Thi

s inc

lude

s an

oblig

atio

n on

the

part

of a

ll ph

ysic

ians

and

hea

lth c

are

prac

titio

ners

to

info

rm p

atie

nts a

bout

sign

ifica

nt a

dver

se m

edic

al e

vent

s and

una

ntic

ipat

ed n

egat

ive

outc

omes

of c

are

that

m

ay a

ffect

thei

r wel

l-bei

ng.

DE

FIN

ITIO

NS:

Adv

erse

Med

ical

Eve

nts (

sign

ifica

nt):

Adv

erse

med

ical

eve

nts a

re n

egat

ive

patie

nt o

utco

mes

that

can

occ

ur a

s the

resu

lt of

hea

lth c

are

treat

men

t an

d no

t due

to th

e pa

tient

’s il

lnes

s. Th

ey a

re o

ften

unan

ticip

ated

and

une

xpec

ted

outc

omes

of h

ealth

car

e th

at d

o, o

r hav

e th

e po

tent

ial t

o, n

egat

ivel

y im

pact

a p

atie

nt’s

hea

lth a

nd q

ualit

y of

life

. The

y in

clud

e co

mpl

icat

ions

and

side

effe

cts o

f tre

atm

ent a

s wel

l as e

rror

s in

the

perf

orm

ance

of m

edic

al d

utie

s. A

dver

se

med

ical

eve

nts a

re n

ot n

eces

saril

y m

arke

rs o

f sub

stan

dard

car

e.

Non

-Sig

nific

ant E

vent

s:N

on-s

igni

fican

t med

ical

eve

nts a

re m

inor

inci

dent

s tha

t do

not h

ave

a ne

gativ

e im

pact

on

patie

nt o

utco

mes

, no

w o

r in

the

fore

seea

ble

futu

re. N

o ex

tra p

roce

dure

s affe

ctin

g th

e pa

tient

are

requ

ired

to p

reve

nt n

egat

ive

patie

nt o

utco

mes

. The

se e

vent

s are

not

sign

ifica

nt fr

om th

e pa

tient

’s p

ersp

ectiv

e an

d di

sclo

sure

to th

e pa

tient

an

d /o

r sub

stitu

te d

ecis

ion-

mak

er o

r fam

ily is

dis

cret

iona

ry.

Dis

clos

ure

Proc

ess

Dis

clos

ure

of si

gnifi

cant

adv

erse

med

ical

eve

nts i

s req

uire

d as

par

t of t

he g

ener

al p

rofe

ssio

nal d

uty

to

info

rm p

atie

nts a

bout

eve

nts t

hat h

ave

affe

cted

or m

ay a

ffect

thei

r hea

lth in

the

futu

re. I

t is t

he ti

mel

y an

d op

en re

spon

se to

such

diffi

cult

inci

dent

s by

trust

ed a

nd re

spon

sibl

e m

edic

al p

erso

nnel

that

can

pre

vent

di

ssat

isfa

ctio

n w

ith c

are

and

impr

ove

the

qual

ity o

f car

e pr

ovid

ed to

pat

ient

s in

the

futu

re. H

ealth

car

e pr

actit

ione

rs a

re e

ncou

rage

d to

seek

out

the

avai

labl

e ho

spita

l res

ourc

es to

hel

p th

em in

form

pat

ient

s abo

ut

an a

dver

se m

edic

al e

vent

. [Se

e App

endi

x I:

Freq

uent

ly A

sked

Que

stio

ns (F

AQ

’s),

whi

ch o

ffers

gui

delin

es fo

r di

sclo

sure

and

reso

urce

s to

enab

le p

ract

ition

ers t

o be

ope

n w

ith p

atie

nts a

bout

diffi

cult

inci

dent

s]

APP

EN

DIX

IFr

eque

ntly

Ask

ed Q

uest

ions

(FA

Qs)

Abo

ut D

iscl

osin

g A

dver

se M

edic

al E

vent

s & U

nant

icip

ated

Out

com

es o

fC

are

1. W

hat e

vent

s oug

ht to

be

disc

lose

d?*

Inci

dent

s cau

sing

pat

ient

s har

m o

r, in

som

e ca

ses,

havi

ng th

epo

tent

ial t

o do

so, o

r*

Inci

dent

s req

uirin

g ad

ditio

nal n

on-tr

ivia

l int

erve

ntio

ns to

pre

vent

Har

m.

Exa

mpl

es:

This

mig

ht in

clud

e ev

ents

such

as a

n un

expe

cted

adm

issi

on to

inte

nsiv

e ca

re d

ue to

a d

rug

reac

tion,

a

prol

onge

d ho

spita

l sta

y on

acc

ount

of c

ompl

icat

ions

aris

ing

from

trea

tmen

t, or

an

intra

oper

ativ

e ev

ent,

such

as

rupt

urin

g an

org

an o

r maj

or b

lood

ves

sel,

that

requ

ires u

nexp

ecte

d an

d si

gnifi

cant

inte

rven

tions

to c

orre

ct.

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

247

62

2. T

o w

hom

shou

ld d

iscl

osur

e be

mad

e?*

Dis

clos

ure

of th

e ev

ent s

houl

d be

mad

e to

the

patie

nt, o

r in

certa

in c

ircum

stan

ces,

the

patie

nt’s

subs

titut

e de

cisi

on-m

aker

and

/or f

amily

.

* ii.

If th

e pa

tient

is d

eem

ed in

capa

ble

of u

nder

stan

ding

a d

iscu

ssio

n of

this

nat

ure,

then

in a

ccor

danc

e w

ith

the

Hea

lth C

are

Con

sent

Act

(199

6), t

he p

atie

nt’s

subs

titut

e de

cisi

on-m

aker

shou

ld b

e in

form

ed.

Whe

n sh

ould

dis

clos

ure

take

pla

ce?

* D

iscl

osur

e of

the

even

t sho

uld

take

pla

ce a

s soo

n as

pra

ctic

ally

pos

sibl

e af

ter i

t has

occ

urre

d or

has

bee

n id

entifi

ed.

* D

iscl

osur

e to

the

patie

nt sh

ould

occ

ur w

hen

the

patie

nt’s

con

ditio

n is

stab

le a

nd/o

r the

pat

ient

is a

ble

to

com

preh

end

the

info

rmat

ion.

Dis

clos

ure

to th

e pa

tient

’s su

bstit

ute

deci

sion

-mak

er m

ay o

ccur

prio

r to

this

an

d w

ill d

epen

d on

the

seve

rity

of th

e ev

ent.

4. W

ho o

ught

to d

iscl

ose

even

ts to

pat

ient

s?*

If th

e ev

ent i

s mos

t ass

ocia

ted

with

phy

sici

an st

aff,

the

patie

nt’s

atte

ndin

g ph

ysic

ian,

whe

ther

or n

ot th

is

phys

icia

n w

as in

volv

ed in

the

even

t, w

ould

usu

ally

initi

ate

the

disc

ussi

on w

ith th

e pa

tient

. The

re m

ay b

e si

tuat

ions

whe

re a

noth

er st

aff p

hysi

cian

wou

ld ta

ke th

e le

ad, f

or e

xam

ple

whe

re th

e ev

ent o

ccur

red

in o

ne o

f th

e di

agno

stic

uni

ts.

* If

the

even

t is m

ost a

ssoc

iate

d w

ith n

on-p

hysi

cian

staf

f/em

ploy

ees o

f the

hos

pita

l, su

ch a

s nur

sing

or

othe

r hea

lth c

are

prof

essi

onal

s, th

e m

anag

er o

r dire

ctor

of t

he a

rea

wou

ld u

sual

ly in

itiat

e th

e di

sclo

sure

in

con

sulta

tion

with

the

Dire

ctor

of Q

ualit

y an

d R

isk

Man

agem

ent o

r del

egat

e. T

he p

atie

nt’s

atte

ndin

g ph

ysic

ian

will

alw

ays b

e in

form

ed o

f the

eve

nt a

nd w

ill b

e gi

ven

the

optio

n of

bei

ng p

art o

f the

dis

cuss

ion

with

the

patie

nt.

5. A

re th

ere

even

ts w

here

dis

clos

ure

is n

ot re

quire

d?*

Dis

clos

ure

of n

on-s

igni

fican

t eve

nts (

ones

that

do

not h

arm

a p

atie

nt),

shou

ld b

e a

mat

ter f

or c

linic

al

judg

emen

t by

the

skill

ed p

ract

ition

er. S

uch

inci

dent

s do

not r

equi

re d

iscl

osur

e to

the

patie

nt b

ecau

se th

ey d

o no

t affe

ct th

e pa

tient

’s w

ell-b

eing

. Dis

clos

ure

is a

mat

ter o

f “pr

opor

tiona

lity”

: the

gre

ater

the

harm

or r

isk

of

harm

cau

sed

by a

n ev

ent,

the

grea

ter i

s the

dut

y of

the

heal

th p

ract

ition

er to

dis

clos

e th

is e

vent

to th

e pa

tient

an

d/or

to th

e pa

tient

’s su

bstit

ute

deci

sion

-mak

er.

Exa

mpl

es:

A m

inor

del

ay in

giv

ing

a pa

tient

a m

edic

atio

n m

ay b

e an

unw

ante

d ev

ent ,

but i

f the

re w

as n

o ha

rm to

the

patie

nt a

s a re

sult,

dis

clos

ure

wou

ld n

ot b

e re

quire

d. T

he d

iscl

osur

e of

cer

tain

intra

oper

ativ

e ev

ents

, suc

h as

ble

edin

g or

hyp

oten

sion

that

are

pro

mpt

ly tr

eate

d w

ith n

o co

nseq

uenc

e to

the

patie

nt, w

ould

als

o be

di

scre

tiona

ry.

248

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

62 63

6. W

hat m

echa

nism

will

be

in p

lace

to h

elp

with

dis

clos

ure?

* D

urin

g bu

sine

ss h

ours

, sta

ff in

volv

ed in

an

even

t who

are

em

ploy

ees o

f the

hos

pita

l will

imm

edia

tely

co

ntac

t the

Dire

ctor

of Q

ualit

y an

d R

isk

Man

agem

ent o

r del

egat

e to

revi

ew a

n ad

vers

e ev

ent.

The

role

of

Qua

lity

and

Ris

k M

anag

emen

t is t

o fa

cilit

ate

the

staf

f’s d

iscu

ssio

n ab

out t

he e

vent

and

to h

elp

plan

the

conv

ersa

tion

with

the

patie

nt o

r sub

stitu

te.

* A

fter h

ours

the

on-s

ite M

anag

er o

r Adm

inis

trato

r-on-

Cal

l is c

onta

cted

imm

edia

tely

.*

The

Dire

ctor

of Q

ualit

y an

d R

isk

Man

agem

ent o

r del

egat

e is

ava

ilabl

e up

on re

ques

t to

supp

ort p

hysi

cian

s in

the

disc

losu

re o

f adv

erse

eve

nts.

7. W

hat a

re th

e be

nefic

ial c

onse

quen

ces o

f dis

clos

ure?

* Pa

tient

s will

rece

ive

prom

pt a

nd th

orou

gh in

terv

entio

ns fo

r any

har

m su

ffere

d or

ant

icip

ated

.*

Patie

nts a

nd/o

r the

ir fa

mili

es w

ill h

ave

thei

r con

cern

s and

fear

s ope

nly

addr

esse

d an

d re

spec

ted.

* Pa

tient

s will

rece

ive

impo

rtant

info

rmat

ion

abou

t the

ir ca

re in

a ti

mel

y m

anne

r.*

Erro

rs a

nd a

dver

se e

vent

s, w

hile

unw

ante

d, a

re o

ppor

tuni

ties f

or p

ract

ition

ers a

nd in

stitu

tions

to le

arn

how

to

impr

ove

the

qual

ity o

f car

e an

d pa

tient

safe

ty.

8. W

hat i

s the

diff

eren

ce b

etw

een

an e

rror

and

an

adve

rse

even

t?*

Erro

rs a

nd a

dver

se e

vent

s ove

rlap

but a

re a

lso

diffe

rent

.*

Adv

erse

eve

nts a

nd e

rror

s are

alik

e in

that

they

are

unw

ante

d an

d of

ten

unan

ticip

ated

eve

nts o

r pro

cess

es

of c

are.

The

y oc

cur t

o ev

en th

e m

ost c

aref

ul p

ract

ition

er a

nd a

re n

ot m

arke

rs o

f neg

ligen

t car

e.*

Som

e ad

vers

e ev

ents

are

une

xpec

ted,

such

as a

n al

lerg

ic re

actio

n to

a fi

rst-t

ime

treat

men

t with

pen

icill

in.

* A

n er

ror i

s som

etim

es c

onsi

dere

d to

be

a “p

reve

ntab

le a

dver

se e

vent

,” su

ch a

s pre

scrib

ing

peni

cilli

n to

a

patie

nt w

ith a

his

tory

of p

enic

illin

alle

rgy.

It is

unl

ikel

y, h

owev

er, t

hat a

ll er

rors

are

“pr

even

tabl

e.”

* W

hat m

ay se

em li

ke a

n “e

rror

” af

ter t

he fa

ct m

ay si

mpl

y be

due

to d

iffer

ence

s in

prof

essi

onal

judg

emen

t. Pr

ofes

sion

al ju

dgem

ent t

oler

ates

a w

ide

varie

ty o

f app

roac

hes t

o pa

tient

situ

atio

ns. L

ess t

han

optim

al p

atie

nt

outc

omes

and

eve

n ad

vers

e ou

tcom

es m

ay b

e du

e to

legi

timat

e di

ffere

nces

in a

ppro

ach

rath

er th

an a

ny

“err

or”

per s

e.

* A

dver

se e

vent

s are

“ad

vers

e” b

ecau

se th

ey c

ause

, or t

hrea

ten

som

e ha

rm to

pat

ient

s. N

ot a

ll er

rors

are

ha

rmfu

l to

patie

nts i

f cau

ght i

n tim

e, su

ch a

s a p

harm

acis

t, w

ho, n

otin

g th

e pa

tient

has

a p

enic

illin

alle

rgy,

al

erts

the

pres

crib

ing

doct

or. S

uch

“har

mle

ss”

erro

rs a

re “

near

mis

ses”

that

shou

ld n

ot re

quire

dis

clos

ure

to

the

patie

nt.

9. W

hat a

ctio

ns a

re re

com

men

ded

for s

taff

to ta

ke w

hen

a si

gnifi

cant

eve

nt o

ccur

s or i

s ide

ntifi

ed?

Thes

e ac

tions

app

ly to

thos

e m

ost i

mm

edia

tely

resp

onsi

ble

for t

he c

are

of th

e pa

tient

.*

The

even

t sho

uld

be d

ocum

ente

d in

the

patie

nt’s

cha

rt in

an

obje

ctiv

e, fa

ctua

l and

nar

rativ

e w

ay. T

his

shou

ld b

e do

ne a

s soo

n as

pos

sibl

e af

ter t

he e

vent

has

occ

urre

d or

has

bee

n re

cogn

ized

.*

Staf

f who

are

em

ploy

ees o

f the

hos

pita

l will

invo

lve

thei

r man

ager

and

the

Dire

ctor

of Q

ualit

y an

d R

isk

Man

agem

ent o

r del

egat

e im

med

iate

ly. Q

ualit

y an

d R

isk

Man

agem

ent i

s ava

ilabl

e up

on re

ques

t to

supp

ort

phys

icia

ns w

ith d

iscl

osur

e on

requ

est.

* D

iscl

osur

e of

the

even

t to

the

patie

nt, s

ubst

itute

dec

isio

n-m

aker

, and

/ or

fam

ily sh

ould

take

pla

ce in

a

timel

y w

ay. T

he a

dver

se o

utco

me

may

be

obvi

ous;

wha

t may

requ

ire sp

ecia

l atte

ntio

n is

dis

clos

ure

of th

e ci

rcum

stan

ces l

eadi

ng u

p to

/ su

rrou

ndin

g th

e ev

ent.

[See

#2,

“W

hen

Shou

ld d

Dsc

losu

re T

ake

Plac

e?”;

#6,

“W

hat M

echa

nism

Will

Be

in P

lace

to H

elp

with

Dis

clos

ure?

”; #

7, “

Wha

t are

the

Ben

efici

al C

onse

quen

ces

of D

iscl

osur

e?”] Ad

vers

e Ev

ent H

ealth

Man

agem

ent

Int

erna

tiona

l and

Can

adia

n Pr

actic

es

249

64

* D

iscu

ss th

e ev

ent w

ith m

embe

rs o

f the

pat

ient

’s c

are

team

and

, whe

re a

ppro

pria

te, t

he m

anag

er o

r de

partm

ent/d

ivis

ion

head

.

10. W

hat H

ospi

tal a

ctio

ns w

ill b

e ta

ken

whe

n a

sign

ifica

nt e

vent

occ

urs o

r is i

dent

ified

?*

The

hosp

ital e

ncou

rage

s rep

ortin

g of

adv

erse

eve

nts a

nd e

rror

s and

will

supp

ort s

taff

in th

is in

itiat

ive.

Pa

tient

safe

ty is

the

prim

ary

conc

ern

of th

e or

gani

zatio

n, n

ot d

isci

plin

ing

the

indi

vidu

als i

nvol

ved

in e

vent

s. Th

e ho

spita

l will

focu

s on

corr

ectin

g th

e fa

ctor

s tha

t allo

w e

vent

s to

occu

r and

wor

k w

ith st

aff a

ffect

ed to

pr

even

t the

recu

rren

ce o

f suc

h ev

ents

.*

Seco

ndar

y re

cord

s mad

e ab

out t

he e

vent

, e.g

., in

cide

nt re

ports

, int

ervi

ew n

otes

, will

be

fact

ual a

nd

obje

ctiv

e. T

hey

will

be

stor

ed in

a se

cure

are

a an

d w

ill b

e de

stro

yed

in k

eepi

ng w

ith R

eten

tion

Gui

delin

es.

Sum

mar

y re

ports

use

d fo

r qua

lity

impr

ovem

ent o

r to

mee

t the

requ

irem

ents

of

Sunn

ybro

ok’s

Acc

ount

abili

ty

Syst

em. S

econ

dary

reco

rds w

ill n

ot c

onta

in in

form

atio

n th

at w

ould

iden

tify

the

patie

nt o

r sta

ff.

11. W

hat a

re th

e re

com

men

datio

ns fo

r dis

clos

ure?

* Th

e at

tend

ing

phys

icia

n or

man

ager

(see

#4

abov

e) sh

ould

mee

t with

the

patie

nt /

subs

titut

e de

cisi

on m

aker

as

pro

mpt

ly a

s oth

er d

utie

s per

mit

and

as a

ppro

pria

te g

iven

the

patie

nt’s

clin

ical

con

ditio

n. T

he a

ssum

ptio

n is

that

mos

t pat

ient

s / fa

mili

es w

ould

wan

t to

know

wha

t has

hap

pene

d. H

owev

er, p

atie

nts h

ave

the

right

to

decl

ine

disc

losu

re. I

f in

doub

t, as

k be

fore

you

tell.

Wai

vers

of i

nfor

mat

ion

shou

ld b

e re

cord

ed in

the

patie

nt’s

ch

art.

* D

iscl

osur

e is

a p

roce

ss. P

ract

ition

ers s

houl

d av

oid

spec

ulat

ion,

focu

s on

wha

t is k

now

n ab

out t

he e

vent

at

the

time

of th

e di

scus

sion

, and

ans

wer

que

stio

ns fr

om th

e pa

tient

or s

ubst

itute

dec

isio

n-m

aker

to th

e be

st o

f th

eir a

bilit

y. U

nans

wer

ed q

uest

ions

oug

ht to

be

note

d, a

nd p

rom

pt a

nd th

orou

gh re

spon

ses s

ough

t.*

Avoi

d at

tribu

ting

blam

e to

spec

ific

indi

vidu

als o

r sim

ple

expl

anat

ions

as t

o “c

ause

”. M

ost s

erio

us e

vent

s ha

ve m

ultip

le c

ontri

butin

g fa

ctor

s tha

t may

not

alw

ays b

e ap

pare

nt a

t the

tim

e of

the

first

mee

ting

with

the

patie

nt/fa

mily

.*

A ti

mel

y an

d em

path

ic e

xpre

ssio

n of

sorr

ow o

r reg

ret a

nd c

ondo

lenc

es m

ay w

ell b

e ap

prop

riate

and

shou

ld

not b

e co

nstru

ed o

r tak

en to

be

an a

dmis

sion

of l

iabi

lity

or fa

ult.

(“Th

is m

ust b

e ve

ry d

ifficu

lt fo

r you

. I w

ish

thin

gs h

ad tu

rned

out

diff

eren

tly.”

) Doi

ng so

soon

afte

r an

adve

rse

outc

ome

can

help

pro

mot

e co

nfide

nce

in

hosp

ital s

taff

and

prev

ent u

nnec

essa

ry fe

elin

gs o

f dis

trust

.

250

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

64 65

Que

bec

McG

ill U

nive

rsity

Hea

lth

Cen

tre

MU

HC

Pol

icy

on S

entin

el E

vent

sTh

e M

UH

C is

com

mitt

ed to

taki

ng p

ositi

ve st

eps t

o re

duce

and

pre

vent

err

ors i

n or

der t

o im

prov

e pa

tient

ca

re. I

f a se

ntin

el e

vent

has

occ

urre

d, th

e M

UH

C is

com

mitt

ed to

und

erst

andi

ng th

e pr

oces

ses,

attit

udes

and

be

havi

or th

at u

nder

lie th

e ev

ent,

and

mak

ing

chan

ges i

n th

e sy

stem

s and

pro

cess

es, a

s wel

l as a

ttitu

des a

nd

beha

vior

, to

redu

ce th

e pr

obab

ility

of t

heir

reoc

curr

ence

.

This

pol

icy

is b

ased

on

the

belie

f tha

t, in

ord

er to

impr

ove

perf

orm

ance

, org

aniz

atio

ns n

eed

to c

ondu

ct

cred

ible

inve

stig

atio

ns o

f sen

tinel

eve

nts.

The

obje

ctiv

e is

not

to a

ssig

n bl

ame

but t

o im

prov

e pa

tient

car

e by

un

ders

tand

ing

the

proc

esse

s tha

t led

to a

mis

hap.

Sent

inel

Eve

ntA

sent

inel

eve

nt is

an

unex

pect

ed o

ccur

renc

e in

volv

ing

deat

h or

serio

us p

hysi

cal o

r psy

chol

ogic

al in

jury

, or

risk

ther

eof.

Serio

us in

jury

spec

ifica

lly in

clud

es lo

ss o

f lim

b or

func

tion.

The

phr

ase,

“or

risk

ther

eof”

in

clud

es a

ny p

roce

ss v

aria

tion

for w

hich

a re

curr

ence

wou

ld c

arry

a si

gnifi

cant

cha

nce

of a

serio

us a

dver

se

outc

ome.

Suc

h ev

ents

are

cal

led

“sen

tinel

” be

caus

e th

ey si

gnal

the

need

for i

mm

edia

te in

vest

igat

ion

and

resp

onse

.

Polic

yW

hen

a m

embe

r of t

he M

UH

C c

omm

unity

bec

omes

aw

are

that

a p

oten

tial s

entin

el e

vent

has

occ

urre

d at

the

MU

HC

, he/

she

mus

t not

ify th

e ap

prop

riate

indi

vidu

als w

ithin

the

orga

niza

tion.

The

fact

s will

be

revi

ewed

to

det

erm

ine

whe

ther

the

even

t sho

uld

be tr

eate

d as

a se

ntin

el e

vent

. Onc

e it

is d

eem

ed to

hav

e be

en a

se

ntin

el e

vent

, an

inve

stig

atio

n w

ill b

e un

derta

ken

to u

nder

stan

d th

e ca

uses

that

und

erlie

the

even

t and

to

mak

e ch

ange

s in

the

orga

niza

tion’

s sys

tem

s and

pro

cess

es a

s wel

l as a

ttitu

des a

nd b

ehav

iors

to re

duce

the

prob

abili

ty o

f suc

h an

eve

nt in

the

futu

re. T

he in

vest

igat

ion

is d

esig

ned

to id

entif

y th

e co

ntrib

utin

g fa

ctor

s, an

d th

e re

spon

se in

clud

es a

ctio

ns to

redu

ce th

e lik

elih

ood

of re

curr

ence

.

Crit

eria

for s

elec

ting

sent

inel

eve

nts i

s bas

ed o

n th

e C

CH

SA e

vent

type

s (su

rgic

al e

vent

s or i

nvas

ive

proc

edur

es, d

evic

e or

pro

duct

eve

nts,

patie

nt p

rote

ctio

n ev

ents

, env

ironm

enta

l eve

nts,

care

man

agem

ent

even

ts a

nd c

rimin

al e

vent

s).

The

MU

HC

Pol

icy

and

Proc

edur

e U

ser’s

Gui

de g

ives

ver

y sp

ecifi

c tim

elin

es a

nd re

quire

d ac

tions

. Th

is u

ser’s

gui

de c

an b

e ac

cess

ed a

t http

://w

ww.

mss

s.gou

v.qc

.ca/

min

iste

re/v

igila

nce/

dow

nloa

d.ph

p?id

=725

41,7

3,2

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

251

66

Nov

a Sc

otia

Cap

ital D

istr

ict H

ealth

A

utho

rity

(Hal

ifax)

Patie

nt S

afet

y Re

port

ing

–Eve

nt C

ateg

ory

and

Type

sTh

e C

apita

l Hea

lth P

atie

nt S

afet

y R

epor

ting

Syst

em u

ses a

n ev

ent c

ateg

ory

and

type

list

ing

as a

gui

delin

e fo

r the

repo

rting

of a

n ad

vers

e ev

ent a

cros

s the

regi

on. T

here

are

11

cate

gorie

s as l

iste

d be

low.

Exa

mpl

es a

re

prov

ided

for e

ach

cate

gory

.D

iagn

ostic

pro

cedu

re –

resu

lts re

porti

ng is

sue,

mis

sing

spec

imen

, spe

cim

en c

olle

ctio

n is

sue

and

1.

so o

n.M

edic

atio

n re

late

d –

med

icin

e in

cide

nts r

elat

ed to

pro

fess

iona

l pra

ctic

e, d

rug

prod

ucts

, 2.

pr

oced

ures

and

syst

ems.

May

incl

ude

pres

crib

ing,

ord

er c

omm

unic

atio

n, p

rodu

ct la

belin

g/pa

ckag

ing/

nom

encl

atur

e, c

ompo

undi

ng, d

ispe

nsin

g, d

istri

butio

n, a

dmin

istra

tion,

edu

catio

n,

mon

itorin

g an

d us

e.M

edic

atio

n A

dmin

istra

tion-

rela

ted

–adv

erse

dru

g re

actio

n, e

xtra

dos

e, in

corr

ect (

wro

ng) p

atie

nt,

3.

inco

rrec

t (w

rong

) rat

e, a

nd so

on.

Med

icat

ion

Ord

er-r

elat

ed –

illeg

ible

ord

er, i

ncor

rect

ord

er, i

ncor

rect

(wro

ng) p

atie

nt c

hart,

kno

wn

4.

alle

rgy,

and

so o

n.M

edic

atio

n D

ispe

nsin

g-re

late

d –

expi

red

drug

, inc

orre

ct (w

rong

) dru

g di

spen

sed,

inco

rrec

t 5.

pa

tient

, and

so o

n.Pa

tient

/Clie

nt B

ehav

ior –

acc

iden

tal i

njur

y, le

ft ag

ains

t med

ical

adv

ice,

refu

sal o

f tre

atm

ent,

self-

6.

infli

cted

inju

ry, s

uici

de, s

exua

l ass

ault,

and

so o

n.Pa

tient

Iden

tifica

tion

and

Doc

umen

tatio

n –m

isfil

ed re

ports

/reco

rds,

mis

sing

reco

rd, p

atie

nt

7.

arm

band

/iden

tifica

tion,

and

so o

n.Pa

tient

-rel

ated

equ

ipm

ent –

equi

pmen

t fai

lure

, equ

ipm

ent m

isus

e, in

appr

opria

te fo

r the

task

, and

8.

so

on.

Priv

acy

issu

es –

con

vers

atio

ns o

verh

eard

, rec

ords

uns

ecur

ed, r

elea

sed

patie

nt in

form

atio

n/9.

ho

spita

l doc

umen

ts w

ithou

t con

sent

, rel

ease

of p

atie

nt in

form

atio

n/ho

spita

l doc

umen

ts to

the

wro

ng p

arty

, and

so o

n.Fa

lls.

10.

A fa

ll is

defi

ned

as a

sudd

en, u

ncon

trolle

d, u

nint

entio

nal,

dow

nwar

d di

spla

cem

ent o

f the

bod

y to

the

grou

nd

or o

ther

obj

ect,

excl

udin

g fa

lls re

sulti

ng fr

om v

iole

nt b

low

s, ot

her p

urpo

sefu

l act

ions

, stro

kes,

fain

ting,

and

/or

seiz

ures

.A

nea

r-fa

ll is

a su

dden

loss

of b

alan

ce th

at d

oes n

ot re

sult

in a

fall

or o

ther

inju

ry. T

his c

an in

clud

e a

pers

on

who

slip

s, st

umbl

es, o

r trip

s but

is a

ble

to re

gain

con

trol p

rior t

o fa

lling

.A

n un

witn

esse

d fa

ll oc

curs

whe

n a

patie

nt is

foun

d on

the

floor

and

nei

ther

the

patie

nt n

or a

nyon

e el

se

know

s how

he

or sh

e go

t the

re.

http

://w

ww.

patie

ntsa

fety

.gov

/Top

ics/

falls

tool

kit/n

oteb

ook/

inde

x.ht

ml.

Ther

apeu

tic P

roce

dure

s – b

lood

type

issu

e, d

elay

in p

atie

nt m

anag

emen

t, in

fect

ion

cont

rol i

ssue

, 11

. pa

tient

iden

tifica

tion

issu

e, p

roce

dure

del

ayed

, pro

cedu

re c

ance

lled,

surg

ical

cou

nt is

sue,

reta

inin

g fo

reig

n bo

dy, a

nd so

on.

252

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

66 67

Patie

nt S

afet

y Im

pact

Cla

ssifi

catio

n C

apita

l Hea

lth u

tiliz

es a

Pat

ient

Saf

ety

Impa

ct C

lass

ifica

tion

Syst

em c

onsi

stin

g of

eig

ht le

vels

of h

arm

as

desc

ribed

bel

ow.

Leve

l 1 -

No

Har

m /

Det

ecta

ble

Har

m

Ther

e w

as n

o in

jury

or n

o ha

rmfu

l effe

ct to

the

patie

nt a

nd n

o po

tent

ial r

isk

iden

tified

. NE

AR

MIS

SLe

vel 2

– M

inim

al T

empo

rary

Har

m

Req

uire

s litt

le o

r no

inte

rven

tion.

Leve

l 3 –

Min

imal

Per

man

ent H

arm

R

equi

res i

nitia

l but

not

pro

long

ed in

terv

entio

n.Le

vel 4

– M

oder

ate

Tem

pora

ry H

arm

rR

equi

res i

nitia

l but

not

pro

long

ed h

ospi

taliz

atio

n.Le

vel 5

– M

oder

ate

Perm

anen

t Har

m

Req

uire

s int

ensi

ve b

ut n

ot p

rolo

nged

hos

pita

lizat

ion.

Leve

l 6 –

Sev

ere

Tem

pora

ry H

arm

R

equi

res i

nter

vent

ion

nece

ssar

y to

sust

ain

life

but m

ay a

lso

requ

ire p

rolo

nged

hos

pita

lizat

ion.

Leve

l 7 –

Sev

ere

Perm

anen

t Har

mR

equi

res i

nter

vent

ion

nece

ssar

y to

sust

ain

life

and

prol

onge

d ho

spita

lizat

ion,

long

-term

car

e or

hos

pice

.Le

vel 8

– D

eath

D

rast

ic o

utco

me

as a

resu

lt of

an

even

t.G

uide

to D

iscl

osur

e:C

linic

ian-

Patie

nt In

terv

iew

sC

hoos

e ap

prop

riate

phy

sica

l set

ting.

1.

Invo

lve

the

care

team

.2.

Li

sten

& d

eal w

ith e

mot

ions

.3.

Fa

ctua

l exp

lana

tion.

4.

Com

mun

icat

e a

stra

tegy

.5.

C

losu

re a

nd fo

llow

-up.

Defi

nitio

n of

adv

erse

eve

nt: a

n un

expe

cted

and

und

esire

d in

cide

nt d

irect

ly a

ssoc

iate

d w

ith th

e ca

re p

rovi

ded

to th

e pa

tient

, or t

he e

nviro

nmen

t in

whi

ch c

are

was

pro

vide

d, w

hich

doe

s, or

can

be

reas

onab

ly e

xpec

ted

to,

harm

the

patie

nt (n

egat

ivel

y af

fect

the

patie

nt’s

phy

sica

l and

/or p

sych

olog

ical

hea

lth a

nd/o

r qua

lity

of li

fe).

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

253

68

Nov

a Sc

otia

Hea

lth(p

rovi

ncia

l pol

icy)

Dis

clos

ure

of A

dver

se E

vent

s Pol

icy

All

desi

gnat

ed o

rgan

izat

ions

pro

vidi

ng h

ealth

car

e in

Nov

a Sc

otia

that

rece

ive

publ

ic fu

nds,

are

requ

ired

to

have

a p

roce

ss in

pla

ce to

pro

mpt

ly in

form

clie

nts o

f per

tinen

t fac

ts a

ssoc

iate

d w

ith a

dver

se e

vent

s. Th

is

proc

ess r

equi

res m

aint

aini

ng a

writ

ten

polic

y th

at o

utlin

es th

e as

soci

ated

resp

onsi

bilit

ies,

proc

edur

es a

nd

supp

ort.

The

prov

inci

al p

olic

y on

hea

lth c

are

disc

losu

re o

f adv

erse

eve

nts a

ims t

o as

sist

org

aniz

atio

ns to

pr

ovid

e an

env

ironm

ent w

here

clie

nts r

ecei

ve th

e in

form

atio

n th

ey n

eed

to u

nder

stan

d w

hat h

appe

ned

and

to m

ake

info

rmed

dec

isio

ns a

bout

thei

r car

e an

d cr

eate

an

envi

ronm

ent w

here

clie

nts,

care

pro

vide

rs a

nd

man

ager

s all

feel

supp

orte

d w

hen

adve

rse

even

ts o

ccur

.

This

pol

icy

appl

ies t

o th

e N

ova

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epar

tmen

t of H

ealth

(DoH

) and

to N

ova

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re

ceiv

ing

publ

ic fu

nds t

o pr

ovid

e he

alth

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ch a

s dis

trict

hea

lth a

utho

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e IW

K H

ealth

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tre, a

nd

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. DoH

con

tract

ors p

rovi

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th se

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an u

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d un

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inci

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dire

ctly

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with

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care

or s

ervi

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rovi

ded

to th

e cl

ient

or t

he e

nviro

nmen

t in

whi

ch th

e ca

re is

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vide

d.N

ear

Mis

s - a

n ev

ent o

r circ

umst

ance

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ch h

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ot a

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e cl

ient

nor

cau

sed

harm

but

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l for

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rm e

xist

s. Th

is n

ear m

iss “

alm

ost h

appe

ned”

but

may

not

hav

e re

ache

d th

e cl

ient

due

to c

hanc

e, c

orre

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e ac

tion,

and

/or t

imel

y in

terv

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n.

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polic

y ou

tline

s the

con

ditio

ns th

at re

quire

dis

clos

ure.

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inim

um, t

he fa

cts o

f the

eve

nt a

nd it

s im

pact

on

the

clie

nt a

nd o

n th

e ca

re m

ust b

e di

sclo

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whe

n an

adv

erse

eve

nt o

ccur

s dur

ing

the

proc

ess o

f pro

vidi

ng

heal

th c

are

and

resu

lts in

clie

nt in

jury

, dea

th o

r neg

ativ

ely

impa

cts h

ealth

(rea

l or p

erce

ived

).

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mpl

e or

gani

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thic

s dec

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akin

g fr

amew

ork

for d

iscl

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ifica

nt a

dver

se e

vent

s is

prov

ided

as a

gui

delin

e fo

r the

hea

lth re

gion

s.

254

Task

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Eve

nts B

ackg

roun

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ocum

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Vol

ume

II: A

dditi

onal

Rep

orts

68 69

Hea

lth C

anad

aC

anad

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Adve

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Dru

g Re

actio

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onito

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Pro

gram

Gui

delin

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actio

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essi

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s and

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sum

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Adv

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(AR

s) to

Can

adia

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heal

th p

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incl

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g pr

escr

iptio

n, n

on-p

resc

riptio

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biol

ogic

(inc

ludi

ng fr

actio

nate

d bl

ood

prod

ucts

, as w

ell a

s the

rape

utic

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dia

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, nat

ural

he

alth

and

radi

opha

rmac

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re c

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by

the

Can

ada

Vig

ilanc

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n ad

vers

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actio

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R) i

s a h

arm

ful a

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nint

ende

d re

spon

se to

a h

ealth

pro

duct

. Thi

s inc

lude

s any

und

esira

ble

patie

nt e

ffect

su

spec

ted

to b

e as

soci

ated

with

hea

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se. U

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rdos

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ract

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ug-d

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tera

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nd u

nusu

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ck o

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rape

utic

effi

cacy

are

all

cons

ider

ed to

be

repo

rtabl

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s. To

repo

rt a

susp

ecte

d A

R fo

r hea

lth p

rodu

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[pha

rmac

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als,

biol

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clud

ing

frac

tiona

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dpr

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s wel

l as t

hera

peut

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nd d

iagn

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atur

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phar

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eutic

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mar

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Can

ada,

– h

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iona

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sum

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pref

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ly in

con

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with

thei

r hea

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ofes

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o th

at in

form

atio

n ab

out m

edic

al h

isto

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an b

e in

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ed in

ord

er to

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e re

ports

mor

eco

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and

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houl

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a co

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Can

ada

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epor

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Form

Rep

ort o

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pect

ed A

dver

se R

eact

ion

Due

to H

ealth

Pro

duct

s Mar

kete

d in

Can

ada

(HC

/SC

401

6):

This

form

may

be

obta

ined

from

the

Inte

rnet

at:

http

://w

ww.

hc-s

c.gc

.ca/

dhp-

mps

/med

eff/r

epor

tdec

lara

tion/

ar-e

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l, fr

om y

our C

anad

a V

igila

nce

Reg

iona

l Offi

ce, a

nd is

als

o av

aila

ble

in th

e ap

pend

ices

of

the

Com

pend

ium

of P

harm

aceu

tical

s and

Spe

cial

ities

.

To re

port

an A

dver

se E

vent

Fol

low

ing

an Im

mun

izat

ion

(AEF

I) fo

r a v

acci

ne u

sed

in th

e pr

even

tion

of

infe

ctio

us d

isea

ses,

the

sam

e cr

iteria

as s

tate

d in

thes

e gu

idel

ines

are

use

d. H

ealth

pro

fess

iona

ls sh

ould

co

mpl

ete

a co

py o

f an

Adv

erse

Eve

nt F

ollo

win

g Im

mun

izat

ion

Rep

ortin

g Fo

rm. T

his f

orm

is a

vaila

ble

on

the

inte

rnet

at h

ttp://

ww

w.ph

ac-a

spc.

gc.c

a/im

/aefi

-for

m_e

.htm

l or i

n th

e ap

pend

ices

of t

he C

PS. F

orm

s als

o ex

ist a

s cus

tom

ized

pro

vinc

ial/t

errit

oria

l adv

erse

eve

nt fo

rms w

hich

can

be

obta

ined

eith

er fr

om lo

cal p

ublic

he

alth

dep

artm

ents

or f

rom

the

prov

inci

al/te

rrito

rial h

ealth

aut

horit

ies.

Any

info

rmat

ion

rela

ted

to th

e id

entit

y of

the

patie

nt a

nd/o

r the

repo

rter o

f the

AR

will

be

prot

ecte

d as

per

th

e Pr

ivac

y A

ct. Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

255

70

Sources cited in this Table:

Calgary Health Region, AlbertaReporting Harm, Close Calls and Hazards. Reference Number 1626Disclosing Harm to Patients. Reference Number 1627Just and Trusting Culture. Reference Number 1628Informing Principal Health Partners & Stakeholders – Safety Hazards, Failures, Fixes. Reference Number 1629

Alberta Health Quality Council, AlbertaDisclosure of Harm to Patients and Families, Provincial Framework, July 2006.

Saskatoon Health Region, SaskatchewanSaskatoon Health Region Critical Incident Reporting Policy. (2007). Saskatoon Health Region Disclosure of Adverse/Unanticipated Events Policy. (2007). Saskatoon Health Region Multidisciplinary Care Review: A coordinated approach to managing risk (September, 2004).

Winnipeg Regional Health Authority, ManitobaWinnipeg Regional Health Authority. Critical incident and management learning policy. Retrieved June 4, 2008 from http://www.wrha.mb.ca/about/files/policy/10.50.040.pdfWinnipeg Regional Health Authority. Critical incident and management learning policy. Retrieved June 4, 2008 from http://www.wrha.mb.ca/about/files/policy/10.50.040.pdf

Sunnybrook Health Sciences Centre, OntarioSunnybrook Health Sciences Centre Disclosure of Adverse Medical Events and Unanticipated Outcomes of care Policy. Retrieved June 4, 2008 from

http://www.jointcentreforbioethics.ca/research/documents/sunnybrook_policy.pdfEtchells, E., Lester R., Morgan, B., & Johnson B. (2005). Striking a balance: Who is accountable for patient safety? Health Care Quarterly, 8(Special Issue), 146-150.

McGill University Health Centre, QuebecMcGill University Health Centre Policy on Sentinel Events. Accessed June 4, 2008 from http://www.msss.gouv.qc.ca/ministere/vigilance/download.php?id=72541,73,2

Capital Health Halifax, Nova ScotiaCapital Regional Health (Halifax) Patient Safety Impact Classification. (2006).Capital Regional Health (Halifax) Patient Safety Reporting System –Event

256

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

70 71

Category and Types. (Version 2007/05/30).Capital Regional Health (Halifax) Disclosure of Adverse Events Policy # CH 70-008. (2005).

Health Canada, Federal AgencyCanadian Adverse Drug Reaction Monitoring Program Guidelines for the Voluntary Reporting of Suspected Adverse Reactions to Health Professionals and Consumers. http://www.napra.org/pdfs/provinces/mb/drugreaction.pdf

Guidelines for the Voluntary Reporting of Suspected Adverse Reactions to Health Products by Health Professionals and Consumers. Retrieved June 04, 2008 from http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/medeff/ar-ei_guide-ldir-eng.pdf

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

257

72 73

References

1 Baker, G.R., Norton, P.G., Flintoft, W., Blais, R., Brown, A., Cox, J., et al. (2004). The Canadian Adverse Events Study: The incidence of adverse events among hospital patients in Canada. CMAJ, 170 (11), 1678-1686.

2 Wilson, R.M., Runciman W.B., Gibberd R.W., Harrison, B.T., Newby, L., & Hamilton, J.D. (1995). The Quality in Australian Health Care Study. The Medical Journal of Australia, 163 (9), 458-471.

3 Vincent, C., Neale, G., & Woloshynowych, M. (2001). Adverse events in British Hospitals: Preliminary retrospective record review. British Medical Journal, 322 (7285), 517-519.

4 Leape, L., Brennan T., Laird, N., Lawthers, A., Localio, A., Barnes B., et al. (1991). The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II. N Eng J Med 324; 377-384.

5 Silversides, A. (2007). Slouching towards disclosure. National Guidelines in the offing. [Editorial] CMAJ, 177 (11):1343.

6 Baker, G.R., Norton, P.G., Flintoft, W., Blais, R., Brown, A., Cox, J., et al. (2004). The Canadian Adverse Events Study: The incidence of adverse events among hospital patients in Canada. CMAJ, 170 (11), 1678-1686.

7 Wilson, R.M., Runciman W.B., Gibberd R.W., Harrison, B.T., Newby, L., & Hamilton, J.D. (1995). The Quality in Australian Health Care Study. The Medical Journal of Australia, 163 (9), 458-471.

8 Vincent, C., Neale, G., & Woloshynowych, M. (2001). Adverse events in British Hospitals: Preliminary retrospective record review. British Medical Journal, 322 (7285), 517-519.

9 Leape, L., Brennan T., Laird, N., Lawthers, A., Localio, A., Barnes B., et al. (1991). The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II. N Eng J Med 324; 377-384.

10 National Steering Committee on Patient Safety. Building a safer system: a national integrated strategy for improving patient safety in Canadian Health Care. Ottawa: Royal College of Physicians and Surgeons of Canada: (2002). Retrieved June 04, 2008 from http://www.rcpsc.medical.org/publications/building_a_safer_system_e.pdf

11 Baker, G.R., Norton, P.G., Flintoft, W., Blais, R., Brown, A., Cox, J., et al. (2004). The Canadian Adverse Events Study: The incidence of adverse events among hospital patients in Canada. CMAJ, 170 (11), 1678-1686.

258

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

72 73

12 Canadian Council on Health Services Accreditation (CCHSA). (2003). CCHSA Patient Safety Strategy – A Vision for a Safe Health Care System. Retrieved June 4, 2008 from http://www.cchsa-ccass.ca/upload/files/pdf/Patient%20Safety/CCHSAPatientSafetyStrategy.pdf

13 Canadian Council on Health Services Accreditation (CCHSA). Guide for Sentinel Events. Retrieved June 4, 2008 from http://www.cchsa-ccass.ca/upload/files/pdf/Patient%20Safety/GuideForSentinelEvents_e.pdf

14 Canadian Council on Health Services Accreditation (CCHSA). Guide for Near Misses. Retrieved June 4, 2008 from http://www.cchsa-ccass.ca/upload/files/pdf/Patient%20Safety/GuideForNearMisses_e.pdf

15 Canadian Council on Health Services Accreditation (CCHSA). (2007). CCHSA Patient/Client Safety Goals and Required Organizational Practices (ROP). Evaluation of Implementation and Evidence of Compliance. Version 2.1 for use with 2007 Standards (January 2007). Retrieved June 4, 2008 from http://www.cchsa-ccass.ca/upload/files/pdf/Patient%20Safety/PS%20ROP%20version%202%201%20for%202007%20E.pdf

16 Canadian Council on Health Services Accreditation (CCHSA). (2007). CCHSA Patient Safety Strategy – Phase 2, Strengthening Capacity and Connecting the Dots 2007-2010. Retrieved June 4, 2008 from http://www.cchsa-ccass.ca/upload/files/pdf/Patient%20Safety/PS_Strategy_Phase_2ENG.pdf.

17 Health Council of Canada. (2007). Health Care Renewal in Canada: Measuring up? Annual Report to Canadians, 2006. Toronto: Canada. Retrieved June 04, 2008 from http://www.healthcouncilcanada.ca/docs/rpts/2007/HCC_MeasuringUp_2007ENG.pdf

18 Health Council of Canada. (2008). Rethinking reform. Health Care Renewal in Canada 2003-2008. Retrieved June 19, 2008 from http://www.healthcouncilcanada.ca/docs/rpts/2008/HCC%205YRPLAN%20(WEB)_FA.pdf

19 National Steering Committee on Patient Safety. Building a safer system: a national integrated strategy for improving patient safety in Canadian Health Care. Ottawa: Royal College of Physicians and Surgeons of Canada: (2002). Retrieved June 04, 2008 from http://www.rcpsc.medical.org/publications/building_a_safer_system_e.pdf

20 Canadian Patient Safety Institute. Canadian Disclosure Guidelines. (2008). Retrieved June 4, 2008 from http://www.patientsafetyinstitute.ca/uploadedFiles/Resources/Canadian%20Disclosure%20Guidelines-%20Feb%202008.pdf

21 CPSI launches first-ever Canadian Disclosure Guidelines. (March 18, 2008 News Release). Retrieved June 4, 2008 from http://www.patientsafetyinstitute.ca/news/disclosureLaunch.html

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

259

74 75

22 Canadian Patient Safety Institute. (2008). Building a Safer System: The Canadian Adverse Event Reporting and Learning System. Consultation Paper.

23 Canadian Patient Safety Institute. Canadian Root Cause Analysis Framework. A tool for identifying and addressing the root causes of critical incidents in health care. (2006). Retrieved June 4, 2008 from http://www.patientsafetyinstitute.ca/uploadedFiles/Resources/RCA_March06.pdf.

24 Canadian Patient Safety Institute. Safety Competencies Framework. Retrieved June 4, 2008 from http://www.patientsafetyinstitute.ca/education/safetycompetencies.html

25 World Alliance for Patient Safety. (2005). WHO draft guidelines on adverse event reporting and learning systems. Geneva: World Health Organization. Retrieved June 4, 2008 from http://www.who.int/patientsafety/events/05/Reporting_Guidelines.pdf

26 World Alliance for Patient Safety. (2005). WHO draft guidelines on adverse event reporting and learning systems. Geneva: World Health Organization. Retrieved June 4, 2008 from http://www.who.int/patientsafety/events/05/Reporting_Guidelines.pdf

27 Donaldson, L.J. & Fletcher M.G. (2006). The WHO World Alliance for Patient Safety: towards the years of living less dangerously. Medical Journal of Australia, 184 (10): S69-S72.

28 World Alliance for Patient Safety. (2005). WHO draft guidelines on adverse event reporting and learning systems. Geneva: World Health Organization. Retrieved June 4, 2008 from http://www.who.int/patientsafety/events/05/Reporting_Guidelines.pdf

29 Kohn, L.T., Corrigan, J.M., Donaldson, M.S., and the Committee on Quality of Health Care in America. (2000). To Err is Human: Building a Safer Health System. Washington: D.C., National Academy Press..

30 Weissman, J.S., Annas, C.L., Epstein A.M., et al., (2005). Error reporting and disclosure systems- Views from hospital leaders. JAMA, 31(1), 13-20.

31 Beard, P. (2006). A coordinated approach to reporting and learning from adverse events in Canada. Patient Safety Matters: Legal and Regulatory Affairs. Canadian patient Safety Institute

32 Donaldson, L. (2000). An organization with a memory. Report of an expert group on learning from adverse events in the NHS. Department of Health, United Kingdom. London: The Stationary Office. Retrieved June 4, 2008 from http://www.dh.gov.uk/assetRoot/04/06/50/86/04065086.pdf

260

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

74 75

33 Department of Health. (2001). Building a safer NHS for patients – implementing an organization with a memory. London: Department of Health. Retrieved June 04, 2008 from http://www.dh.gov.uk/assetRoot/04/05/80/94/04058094.pdf

34 Your NRLS: Improving the National Reporting and Learning System. National Patient Safety Agency. PowerPoint Presentation February 2008. Retrieved June 4, 2008 from http://www.npsa.nhs.uk/patientsafety/reporting

35 Canadian Institute for Health Information. (2007). Patient Safety in Canada: An Update. Analysis in Brief. Retrieved June 4, 2008 from http://secure.cihi.ca/cihiweb/en/downloads/Patient_Safety_AIB_EN_070814.pdf

36 Canadian Medication Incident Reporting and Prevention System (CMIRPS). http://www.ismp-canada.org/cmirps.htm

37 White, J.L. (2007). Adverse event reporting and learning systems: A review of the relevant literature. A report prepared for the Canadian Patient Safety Institute.

38 White, J.L. (2007). Adverse event reporting and learning systems: A review of the relevant literature. A report prepared for the Canadian Patient Safety Institute.

39 Baker, G.R., Grosso, F., Heinz, C., Sharpe, G., Beardwood, J., Fabiano, D., Jeffs, L., McIvor, P., & Parsons, D. (2007). Review of provincial, territorial and federal legislation and policy related to the reporting and review of adverse events in health care in Canada. A report prepared for the Canadian Patient Safety Institute. Edmonton: Alberta.

40 Baker, G.R., Grosso, F., Heinz, C., Sharpe, G., Beardwood, J., Fabiano, D., Jeffs, L., McIvor, P., & Parsons, D. (2007). Review of provincial, territorial and federal legislation and policy related to the reporting and review of adverse events in health care in Canada. A report prepared for the Canadian Patient Safety Institute. Edmonton: Alberta.

41 CPSI Annual Report. Patient Safety: New Heights, Higher Standards. (2007). Edmonton: Alberta. Retrieved June 4, 2008 from http://www.patientsafetyinstitute.ca/uploadedFiles/About_CPSI/CPSI%20Annual%20Report%20English-2007.pdf

42 Taylor, A. (2006). BC Incident Reporting Information System (IRIS) Project. Retrieved June 4, 2008 from http://www.whin.org/Documents/2006-Taylor.ppt

43 DATIX (June 23, 2008). British Columbia moves ahead with DATIX. Health Authorities in British Columbia choose DATIX for province-wide patient safety reporting. Retrieved June 29, 2008 from http://www.datix.co.uk/index.php?id=NEWS&nid=187

44 DATIX .Accessed August 2008 at http://www.datix.co.uk/index.php?id=OUR_CLIENTS.

Adve

rse

Even

t Hea

lth M

anag

emen

t I

nter

natio

nal a

nd C

anad

ian

Prac

tices

261

76 77

45 Williams, R. & Dodge, S. (September, 2006). ROSE – Regional Occurrence System Enhanced. Canada Health Infoway Innovation and Adoption Program: Project proposal.

46 Elliott, P. (June, 2008). ROSE Evaluation Workshop: Preliminary Evaluation Plan.

47 Kiley, B., Bracey, K., & Ross, M. (2007). On-line Reporting of Patient Safety Issues: Introducing the Patient Safety Reporting System (PSRS) and Just Culture. [Poster Presentation]

48 Bird, D. & Milligan, F. (2003). Adverse health care events: Part 2. Incident reporting systems. Professional Nurse 18(10), 572-575.

49 Carruthers, I. & Philip, P. (2006). Safety First –A report for patients, clinicians and health care managers. London: Department of Health.

50 Wagner, L.M. & Rust, T.B. (2008). Safety in Long Term Care: Broadening the patient safety agenda to include home care services. A report prepared for the Canadian Patient Safety Institute. Retrieved June 4, 208 from http://www.patientsafetyinstitute.ca/uploadedFiles/LTC_paper.pdf

51 Lang, A., & Edwards, N. (2006). Safety in Home Care: Broadening the patient safety agenda to include home care services. A report prepared for the Canadian Patient Safety Institute Retrieved June 4, 208 from http://www.patientsafetyinstitute.ca/uploadedFiles/Research/Safety%20in%20Home%20Care%20-%20Apr%202006.pdf

52 Health Council of Canada. (2007). Health Care Renewal in Canada: Measuring up? Annual Report to Canadians, 2006. Toronto: Canada. Retrieved June 04, 2008 from http://www.healthcouncilcanada.ca/docs/rpts/2007/HCC_MeasuringUp_2007ENG.pdf

53 Canadian Medical Protective Association. (2008). Communicating with your patient about harm: Disclosure of adverse events. Retrieved June 4, 2008 from http://www.cmpa-acpm.ca/cmpapd03/cmpa_docs/disclosure/pdf/com_disclosure_toolkit-e.pdf

54 Baker, G.R., Grosso, F., Heinz, C., Sharpe, G., Beardwood, J., Fabiano, D., Jeffs, L., McIvor, P., & Parsons, D. (2007). Review of provincial, territorial and federal legislation and policy related to the reporting and review of adverse events in health care in Canada. A report prepared for the Canadian Patient Safety Institute. Edmonton: Alberta.

55 Saskatchewan Health Critical Incident Reporting Guideline. (2004). Retrieved June 4, 2008 from http://www.health.gov.sk.ca/adx/aspx/adxGetMedia.aspx?DocID=2325,94,88,Documents&MediaID=1543&Filename=critical-incident-guidelines-2004.pdf

262

Task

For

ce o

n Ad

vers

e H

ealth

Eve

nts B

ackg

roun

d D

ocum

ents

Vol

ume

II: A

dditi

onal

Rep

orts

76 77

56 Saskatchewan Health Critical Incident Reporting Guideline. (2004). Retrieved June 4, 2008 from http://www.health.gov.sk.ca/adx/aspx/adxGetMedia.aspx?DocID=2325,94,88,Documents&MediaID=1543&Filename=critical-incident-guidelines-2004.pdf

57 The National Quality Forum. (2002). Serious Reportable Events in Health Care: A Consensus Report. National Forum for Health Care Quality Measurement and Reporting.

58 The Regional Health Authorities Amendment and Manitoba Evidence Amendment Act. SM 2005, C.24. Retrieved June 4, 2008 from http://web2.gov.mb.ca/laws/statutes/2005/c02405e.php

59 Manitoba Evidence Act, R.S.M. 1987, c.E150, ss.9, 10 (C.C.S.M., c.E150). Retrieved June 4, 2008 from http://www.web2.gov.mb.ca/laws/statutes/index.php

60 An Act to amend the act respecting health services and social services as regards to the safe provision of health and social services, RSQ 2002, Bill 113, c 71. Retrieved June 4, 2008 from http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=5&file=2002C71A.PDF

61 An Act to amend the act respecting health services and social services as regards to the safe provision of health and social services, RSQ 2002, Bill 113, c 71. Retrieved June 4, 2008 from http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=5&file=2002C71A.PDF

62 Ste-Marie, M. (2005). Patient Safety: Le Groupe Vigilance pour la Sécurité des Soins: A Québec Perspective. Health Care Quarterly, 8 (Special Issue), 119-121.

63 Ontario Medical Association. Disclosure of critical incidents. Accessed June 4, 2008 from http://www.oma.org/Health/Reports/08hpr.asp

64 Ontario Regulation 423/07 Public Hospitals Act, Amending Reg. 965 of R.R.O. 1990. Retrieved June 25, 2008 from http://www.e-laws.gov.on.ca/html/source/regs/english/2007/elaws_src_regs_r07423_e.htm

65 Canadian Patient Safety Institute. (2006). Background Paper for the Development of National Guidelines for the Disclosure of Adverse Events. Retrieved June 4, 2008 from http://www.patientsafetyinstitute.ca/news/bkgrdrDisclosure.html

66 Australian Commission on Safety and Quality in Health Care. (2007). Open disclosure: A review of the literature. Retrieved June 4, 2008 from http://www.health.gov.au/internet/safety/publishing.nsf/Content/703C98BF37524DFDCA25729600128BD2/$File/Open%20Disclosure%20literature%20review.pdf

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Prac

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263

78 79

67 Australian Council for Safety and Quality in Health Care. (2003). Open disclosure standard: A national standard for open communication in public and private hospitals, following an adverse event in health care. Standards Australia. Retrieved June 4, 2008 from http://www.safetyandquality.org/internet/safety/publishing.nsf/Content/3D5F114646CEF93DCA2571D5000BFEB7/$File/OpenDisclosure_web.pdf

68 National Patient Safety Agency (UK). Being open: Communicating patient safety incidents with patients and their carers. Retrieved June 4, 2008 from www.hcsu.org.uk/index.php?option=com_docman&task=doc_download&gid=450

69 Harvard Hospitals. When things go wrong: responding to adverse events, a consensus statement of the Harvard Hospitals. Massachusetts Coalition for the Prevention of Medical Errors. (2006). Retrieved June 04, 2008 from http://www.ihi.org/NR/rdonlyres/A4CE6C77-F65C-4F34-B323-20AA4E41DC79/0/RespondingAdverseEvents.pdf

70 Canadian Patient Safety Institute. Canadian Disclosure Guidelines. (2008). Retrieved June 4, 2008 from http://www.patientsafetyinstitute.ca/uploadedFiles/Resources/Canadian%20Disclosure%20Guidelines-%20Feb%202008.pdf

71 Canadian Patient Safety Institute. Canadian Disclosure Guidelines. (2008). Retrieved June 4, 2008 from http://www.patientsafetyinstitute.ca/uploadedFiles/Resources/Canadian%20Disclosure%20Guidelines-%20Feb%202008.pdf

72 Commission of Inquiry on Hormone Receptor Testing (Part II). (2008). St. John’s: Newfoundland and Labrador, Canada. Retrieved June 4, 2008 from http://www.cihrt.nl.ca/partIIoftheinquiry.html

73 Silversides, A. (2007). Slouching towards disclosure. National Guidelines in the offing. [Editorial] CMAJ, 177 (11):1343.

74 Bonney, E., & Baker, G.R. (2004). Current strategies to improve patient safety in Canada: An overview of federal and provincial initiatives. Health Care Quarterly, 7 (2), 36-41.

75 Winnipeg Regional Health Authority. Regional Integrated Patient Safety Strategy. Retrieved June 4, 2008 from http://www.wrha.mb.ca/healthinfo/patientsafety/ripss.php

76 Winnipeg Regional Health Authority. Critical incident and management learning policy. Retrieved June 4, 2008 from http://www.wrha.mb.ca/about/files/policy/10.50.040.pdf

77 Winnipeg Regional Health Authority. Disclosure of information related to care and treatment. Retrieved June 4, 2008 from http://www.wrha.mb.ca/about/files/policy/10.50.030.pdf

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78 Robson, R., & Pelletier, E. (2008). Giving the pen back: Disclosure, apology and early compensation discussions after harm in the health care setting. Health Care Quarterly, 11(Special Issue):85-90.

79 Derwin, G.A. (2007). Apology laws: Protecting wrongdoers. Retrieved July 2, 2008 from http://www.derwin.ca/Apology%20Laws%20Protecting%20Wrongdoers%202007%20George%20Derwin.htm

80 Derwin, G.A. (2007).Legislative protection for apologies. Retrieved July 2, 2008 from http://www.derwin.ca/Legislative%20Protection%20of%20Apologies.htm

81 Gallagher, T.H. (2008). Disclosing unanticipated outcomes to Patients: International Trends.

82 Apology Act. S.M. 2007, C 25. Retrieved June 4, 2008 from http://web2.gov.mb.ca/laws/statutes/2007/c02507e.php

83 Uniform Apology Act, Uniform Law Conference of Canada, Civil Section, Charlottetown, PEI, September 2007 Retrieved June 4, 2008 from http://www.ulcc.ca/en/poam2/Uniform_Apology_Act_Policy_Paper_En.pdf

84 Apology Act. RSBC 2006, Bill 16. Retrieved June 4, 2008 from www.leg.bc.ca/38th2nd/amend/gov16-2.htm

85 Saskatchewan Evidence Act. Retrieved June 4, 2008 from http://www.qp.gov.sk.ca/documents/english/Statutes/Statutes/e11-2.pdf

86 Apology Act. RSBC 2006, Bill 16. Retrieved June 4, 2008 from www.leg.bc.ca/38th2nd/amend/gov16-2.htm

87 British Columbia Ministry of Attorney General . (2006). Discussion paper on apology legislation. Accessed June 4, 2008 from http://www.ag.gov.bc.ca/dro/publications/other/Discussion_Apology_Legislation.pdf

88 Apology Act. RSBC 2006, Bill 16. Retrieved June 4, 2008 from www.leg.bc.ca/38th2nd/amend/gov16-2.htm

89 Apology Act. S.M. 2007, C 25. Retrieved June 4, 2008 from http://web2.gov.mb.ca/laws/statutes/2007/c02507e.php

90 Yukon Apology Act. (2008). Retrieved July 2, 2008 from http://www.legassembly.gov.yk.ca/pdf/op/op74_32.pdf

91 Ontario Medical Association. Bill 59 —Apology Act. Accessed on June 4, 2008 from http://www.oma.org/Health/Reports/08hpr.asp

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92 Ontario Medical Association. Bill 59 —Apology Act. Accessed on June 4, 2008 from http://www.oma.org/Health/Reports/08hpr.asp

93 Uniform Apology Act, Uniform Law Conference of Canada, Civil Section, Charlottetown, PEI, September 2007 Retrieved June 4, 2008 from http://www.ulcc.ca/en/poam2/Uniform_Apology_Act_Policy_Paper_En.pdf

94 Canadian Council on Health Services Accreditation (CCHSA). (2007). CCHSA Patient/Client Safety Goals and Required Organizational Practices (ROP). Evaluation of Implementation and Evidence of Compliance. Version 2.1 for use with 2007 Standards (January 2007). Retrieved June 4, 2008 from http://www.cchsa-ccass.ca/upload/files/pdf/Patient%20Safety/PS%20ROP%20version%202%201%20for%202007%20E.pdf

95 Canadian Patient Safety Institute. Canadian Disclosure Guidelines. (2008). Retrieved June 4, 2008 from http://www.patientsafetyinstitute.ca/uploadedFiles/Resources/Canadian%20Disclosure%20Guidelines-%20Feb%202008.pdf

96 Baker, G.R., Grosso, F., Heinz, C., Sharpe, G., Beardwood, J., Fabiano, D., Jeffs, L., McIvor, P., & Parsons, D. (2007). Review of provincial, territorial and federal legislation and policy related to the reporting and review of adverse events in health care in Canada. A report prepared for the Canadian Patient Safety Institute. Edmonton: Alberta.

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