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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
endi
x C
L
egis
latio
n R
efer
ence
Tab
le
Legi
slat
ion
Ref
eren
ce T
able
Evi
denc
eH
ealth
Info
rmat
ion
Priv
acy/
Free
dom
of I
nfor
mat
ion
and
Gen
eral
Pri
vacy
Adv
erse
Eve
nt/C
ritic
al In
cide
nt
AB
Albe
rta
Evid
ence
Act
, R.S
.A. 2
000,
c.
A-1
8.H
ealth
Info
rmat
ion
Act,
R.S
.A. 2
000,
c. H
-5.
Free
dom
of I
nfor
mat
ion
and
Prot
ectio
n of
Pri
vacy
Act
, R.S
..A 2
000,
Cf-2
5.N
/A
BC
Evid
ence
Act
, R.S
.B.C
, c. 1
24.
Free
dom
of I
nfor
mat
ion
and
Prot
ectio
n of
Pri
vacy
Act
, R.S
.B.C
. 199
6, c
. 165
.N
/A
MB
The
Man
itoba
Evi
denc
e Ac
t, C
.C.S
.M. c
. F5
2. E
150.
The
Pers
onal
Hea
lth In
form
atio
n Ac
t, C
.C.S
.M. e
. P33
.5.
Free
dom
of I
nfor
mat
ion
and
Prot
ectio
n of
Pri
vacy
Act
, C.C
.S.M
. c. F
175.
The
Regi
onal
Hea
lth A
utho
ritie
s Act
, C.C
.S.M
, c.
R.3
4.C
ritic
al In
cide
nts R
egul
atio
n,
Man
. Reg
. 21
1/20
06.
NB
Evid
ence
Act
, R.S
.N.B
. 197
3, c
. E-1
1.
Prot
ectio
n of
Per
sona
l Inf
orm
atio
n Ac
t, S.
N.B
. 199
8, c
. P-1
9.1.
N/A
NL
Evid
ence
Act
, R.S
.N.L
. 199
0, e
. E-1
6.Ac
cess
to In
form
atio
n an
d Pr
otec
tion
of P
riva
cy A
ct, S
.N.L
. 200
2, c
. A-1
.1.
N/A
NT1
Evid
ence
Act
, R.S
.N.W
.T. 1
988,
c. E
-8.
Acce
ss to
Info
rmat
ion
and
Prot
ectio
n of
Pri
vacy
Act
, S.N
.W.T
..199
4, c
.20.
N/A
NS
Evid
ence
Act
, R.N
.S. 1
989,
a 1
54.
Free
dom
of I
nfor
mat
ion
and
Prot
ectio
n of
Pri
vacy
Act
, S.N
.S. 1
993,
c. 5
.N
/A
ON
Qua
lity
of C
are
Info
rmat
ion
Prot
ectio
n Ac
t, S.
O.2
004,
C. 3
, Sch
. A.
Pers
onal
Hea
lth In
form
atio
n Pr
otec
tion
Act
2004
, S.O
.200
4, C
. 3, S
ch. A
.Q
ualit
y of
Car
e In
form
atio
n Pr
otec
tion
Act,
2004
, S.O
.200
4, c
. 3, S
ch. B
.Fr
eedo
m o
f Inf
orm
atio
n an
d Pr
otec
tion
of P
rivac
y A
ct, R
.S.0
.199
0, c
. F.3
1.
N/A
PEH
ealth
Ser
vice
s Act
, R.S
.P.E
.I. 1
988,
e.
H-1
.5Fr
eedo
m o
f Inf
orm
atio
n an
d Pr
otec
tion
of P
riva
cy A
ct, R
.S.P
.E.I.
198
8, c
. F-
15.0
1.N
/A
QC
An A
ct R
espe
ctin
g H
ealth
Ser
vice
s Soc
ial
Serv
ices
, R.S
.Q.,
c. S
-4.2
.An
Act
Res
pect
ing
Acce
ss to
Doc
umen
ts H
eld
by P
ublic
Bod
ies a
nd th
e Pr
otec
tion
of P
erso
nal I
nfor
mat
ion,
R.S
.Q.,
c. A
-2.1
.An
Act
Res
pect
ing
Hea
lth S
ervi
ces S
ocia
l Ser
vice
s, R.
S.Q
., c.
S-4
.2.
SKTh
e Ev
iden
ce A
ct, S
.S. 2
006,
c. E
-I 1
.2.
The
Hea
lth In
form
atio
n Pr
otec
tion
Act,
S.S.
199
9, c
H-0
.021
.Fr
eedo
m o
f Inf
orm
atio
n an
d Pr
otec
tion
of P
riva
cy A
ct, S
.S.1
990-
91, c
. F-2
2.01
The
Regi
onal
Hea
lth S
ervi
ces A
ct, S
.S. 2
002,
C.
R-8
.2.
The
Cri
tical
Inci
dent
Reg
ulat
ions
, R.R
.S. 2
000,
c.
R-8
.2,
Reg
3.
YT
Evid
ence
Act
, R.S
.Y. 2
002,
c. 7
8.Ac
cess
to In
form
atio
n an
d Pr
otec
tion
o Pr
ivac
y Ac
t, R.
S.Y.
200
2, C
.1.
N/A
1 A
ll st
atut
es a
lso
as e
nact
ed fo
r Nun
avut
, pur
suan
t to
the
Nun
avut
Act
, S.C
. 199
3, c
.28.
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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
Scot
ia D
epar
tmen
t of H
ealth
(DoH
) and
to N
ova
Scot
ia o
rgan
izat
ions
re
ceiv
ing
publ
ic fu
nds t
o pr
ovid
e he
alth
car
e, su
ch a
s dis
trict
hea
lth a
utho
ritie
s, th
e IW
K H
ealth
Cen
tre, a
nd
N.S
. DoH
con
tract
ors p
rovi
ding
em
erge
ncy
heal
th se
rvic
es.
Adv
erse
Eve
nt–
an u
nexp
ecte
d an
d un
desi
red
inci
dent
dire
ctly
ass
ocia
ted
with
the
care
or s
ervi
ces p
rovi
ded
to th
e cl
ient
or t
he e
nviro
nmen
t in
whi
ch th
e ca
re is
pro
vide
d.N
ear
Mis
s - a
n ev
ent o
r circ
umst
ance
whi
ch h
as n
ot a
ffect
ed th
e cl
ient
nor
cau
sed
harm
but
the
pote
ntia
l for
ha
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
ctiv
e ac
tion,
and
/or t
imel
y in
terv
entio
n.
The
polic
y ou
tline
s the
con
ditio
ns th
at re
quire
dis
clos
ure.
At m
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
sed
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
).
A sa
mpl
e or
gani
zatio
nal e
thic
s dec
isio
n-m
akin
g fr
amew
ork
for d
iscl
osur
e of
sign
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
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
68 69
Hea
lth C
anad
aC
anad
ian
Adve
rse
Dru
g Re
actio
n M
onito
ring
Pro
gram
Gui
delin
es fo
r the
Vol
unta
ry R
epor
ting
of
Susp
ecte
d Ad
vers
e Re
actio
ns to
Hea
lth
Prof
essi
onal
s and
Con
sum
ers
Adv
erse
reac
tions
(AR
s) to
Can
adia
n m
arke
ted
heal
th p
rodu
cts,
incl
udin
g pr
escr
iptio
n, n
on-p
resc
riptio
n,
biol
ogic
(inc
ludi
ng fr
actio
nate
d bl
ood
prod
ucts
, as w
ell a
s the
rape
utic
and
dia
gnos
tic v
acci
nes)
, nat
ural
he
alth
and
radi
opha
rmac
eutic
al p
rodu
cts a
re c
olle
cted
by
the
Can
ada
Vig
ilanc
e Pr
ogra
m. A
n ad
vers
e re
actio
n (A
R) i
s a h
arm
ful a
nd u
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
lth p
rodu
ct u
se. U
nint
ende
d ef
fect
, hea
lth p
rodu
ct a
buse
, ove
rdos
e,
inte
ract
ion
(incl
udin
g dr
ug-d
rug,
and
dru
g-fo
od in
tera
ctio
ns) a
nd u
nusu
al la
ck o
f the
rape
utic
effi
cacy
are
all
cons
ider
ed to
be
repo
rtabl
e AR
s. To
repo
rt a
susp
ecte
d A
R fo
r hea
lth p
rodu
cts –
[pha
rmac
eutic
als,
biol
ogic
s (in
clud
ing
frac
tiona
ted
bloo
dpr
oduc
ts, a
s wel
l as t
hera
peut
ic a
nd d
iagn
ostic
vac
cine
s), n
atur
al h
ealth
pro
duct
s or r
adio
phar
mac
eutic
als]
mar
kete
d in
Can
ada,
– h
ealth
pro
fess
iona
ls o
r con
sum
ers (
pref
erab
ly in
con
junc
tion
with
thei
r hea
lthpr
ofes
sion
al, s
o th
at in
form
atio
n ab
out m
edic
al h
isto
ry c
an b
e in
clud
ed in
ord
er to
mak
e th
e re
ports
mor
eco
mpl
ete
and
scie
ntifi
cally
val
id) s
houl
d co
mpl
ete
a co
py o
f the
Can
ada
Vig
ilanc
e R
epor
ting
Form
Rep
ort o
f Sus
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
i_fo
rm_e
.htm
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
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ume
II: A
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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
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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.
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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
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nal a
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ian
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tices
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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
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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.
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rse
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t Hea
lth M
anag
emen
t I
nter
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nal a
nd C
anad
ian
Prac
tices
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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
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onal
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orts
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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/$File/Open%20Disclosure%20literature%20review.pdf
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67 Australian Council for Safety and Quality in Health Care. (2003). Open disclosure standard: A national standard for open communication in public and private hospitals, following an adverse event in health care. Standards Australia. Retrieved June 4, 2008 from http://www.safetyandquality.org/internet/safety/publishing.nsf/Content/3D5F114646CEF93DCA2571D5000BFEB7/$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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