reporting and responding to adverse events · of adverse events to patients seem to be better...

Quality improvement and accountability responses

contribute to an effective and safe health care system.

Reporting and responding to adverse events: A medical liability perspective

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PURPOSE

How to reference this document:

Reporting and responding to adverse events: A medical liability perspective.

Ottawa, ON: Canadian Medical Protective Association; 2009.

This paper addresses the medical liability issues associated withthe reporting of and response to adverse events, and proposesmeasures to strengthen the existing system. The documentprovides recommendations for policy makers, regulatoryauthorities, health institutions and physicians, which are aimedat enhancing patient safety and ensuring an equitableaccountability framework by which the actions of health careprofessionals may be considered. The paper re-affirms that bothquality improvement and accountability responses to an adverseevent are important in ensuring an effective and safe healthcare system in which Canadians can have confidence. Suchconfidence can be realized through the use of appropriatesystem-level policies and procedures.

This paper will be of interest to physicians as well as non-physicians, including those involved in the management of thehealth care and justice systems. It complements a CanadianMedical Protective Association (CMPA) publication entitledLearning from adverse events: Fostering a just culture of safetyin Canadian hospitals and health care institutions prepared forCMPA member physicians, including those in leadership andmanagement positions. That publication provides advice onreporting requirements for unexpected clinical outcomes,adverse events and close calls, and on how to conduct reviewsin institutions and hospitals. It may be helpful to consider thesetwo documents in tandem.

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THE CANADIAN MEDICAL PROTECTIVE ASSOCIATION

Health care providers always seek the best possibleclinical outcomes for their patients. However, evenwith the best of medical care, a patient’s outcomemay not be what was originally desired oranticipated. Unfortunately, despite the dedication,training and professionalism of the health careproviders, some unexpected outcomes are relatedto health care delivery itself. An adverse event isone which results in unintended harm to thepatient, and is related to the care and/or servicesprovided to the patient rather than to the patient'sunderlying medical condition.

Within the Canadian health care system, and as depictedin the diagram on page 4, there are generally threeprimary responses to an adverse event:

1. Once the immediate clinical needs of the patienthave been addressed, the first response is to disclosethe adverse event to the patient. Patients expect tobe informed about harm they have experienced,whatever the reason for it. Effective communicationwith patients and the health care team can improvepatient outcomes and satisfaction. Failure tocommunicate effectively may lead to patient harm,misunderstandings, complaints and lawsuits.

2. The second response focuses on learning from whathas happened to support quality improvements. Thedevelopment of a protected “learning environment”is vital to a just culture of safety in which health careproviders are able to report adverse events and closecalls, and review these events without fear ofinappropriate reprimand or punishment.

3. A third response involves consideration ofaccountability issues and may include investigationsand/or disciplinary proceedings within a hospital orregulatory authority (College). Where compensationis sought, the matter may proceed to civil litigation.Regardless of the type of proceeding, theaccountability response has well-establishedprotocols to ensure procedural fairness is accordedto all parties. Although this response may, whenappropriate, lead to sanctions, remediation andeducation are preferred.

Recently, the CMPA has focused its educational effortson the effective disclosure of adverse events to patients.The Association collaborated with the Canadian PatientSafety Institute on its Canadian Disclosure Guidelinesand has developed a comprehensive booklet ondisclosure. The Association has also supported theintroduction of effective apology legislation thatencourages the use of apologies by health careprofessionals by protecting expressions of regret frombeing used against the health care professional inproceedings and civil litigation.

While the roles and responsibilities related to disclosureof adverse events to patients seem to be betterunderstood, more work is required on qualityimprovement processes and accountability responses.The CMPA is committed to working collaboratively withstakeholders to ensure the creation of a just culture ofsafety that encourages learning from adverse events.Such work will ultimately help to strengthen the system,educate physicians and others to prevent similar eventsin the future, and hold individuals professionallyaccountable in a fair and balanced way.

BACKGROUND

The CMPA is committed to

working collaboratively

with stakeholders to ensure

the creation of a just

culture of safety that

encourages learning from

adverse events.

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It is important to achieve an appropriate balancebetween the protected nature of the learningenvironment and the public’s right to understandhow the safety of health care can be improved.

System improvements can be achieved by examiningwhy adverse events happened and sharing the results ofthis examination with a view to preventing re-occurrence. However, this should happen in a mannerthat provides procedural fairness for all involved,including health care providers. This is necessary to

encourage health care providers to frankly discuss whathappened in a non-threatening environment – theyneed to know that quality improvement informationcollected as part of the learning process is protectedfrom being unfairly used against them in the context ofhospital or College proceedings or civil litigation.

The protection of quality improvement information isone of the cornerstones of an effective patient safetyprogram. The CMPA encourages its physicianmembers to fully participate in quality improvement

Provider accountability

Disclosure to patients

ADVERSE EVENTS*

Quality improvement

Improved health care

Reporting and prescribed procedures Protected discussion

In

fo

rm

at

io

n

Fi

re

wa

ll

Safer medicine• prevention• quality improvement• system improvement• education

CompensationRemediationand sanctions • professional• financial• education

Remediationand sanctions• professional• education

Remediationand sanctions

LitigationRegulatoryInstitutional Inquiries

Explanations to patients

Determination of accountability• preventability• responsibility• harm• standards• due process

Diagram A — The response to adverse events

* While all adverse events need to be disclosed to patients, not all adverse events require further review and analysis.

A BALANCED APPROACH

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activities, while ensuring that the informationgenerated by such activities will be protected from usein either accountability reviews (e.g., hospital orCollege proceedings) or civil litigation. Themaintenance of a protected “learning environment” inwhich those involved can freely examine the adverseevent and discuss the factors that may havecontributed to it is vital to the just culture of safety – aculture where health care providers are able to reportadverse events and close calls without fear ofinappropriate reprimand or punishment.

Erosion of the firewall The CMPA is concerned that the importance ofprotecting quality improvement information is not wellunderstood by decision makers. Some have taken theview that full and unfettered disclosure of qualityimprovement information is necessary to improvepatient safety. As a result, some institutions havesought to undertake quality improvement reviews thatare not constituted in a way that benefit from thelegislated protection against disclosure of qualityimprovement information.

At the same time, the CMPA recognizes the need for astrong accountability framework that holds health careproviders responsible for their actions. Accountability isreinforced through various means including regulatoryauthority investigations and, in certain instances,through civil litigation.

It is crucial, however, that an “information firewall”exists between quality improvement and accountabilitymechanisms and that they be treated as distinctprocesses. By separating the professional accountabilityprocess from the quality improvement process, healthprofessionals will be more likely to provide a qualityimprovement committee their opinions, and inappropriate instances, hypothesize as to how certainprocesses could be changed to improve the system.

Each of the responses to an adverse event requires itsown method of handling information. These separateflows are what make the system work – for thepatient, the health care providers involved and for thesystem as a whole. While the specific nature of thedisclosure, reporting and review will vary dependingupon the situation, they will comprise one or more ofthe following:

• Appropriate disclosure to the patient;

• Protected discussion in support of qualityimprovement and enhanced patient safety; and

• Prescribed reporting procedures and informationprotocols for accountability responses that are inkeeping with procedural fairness.

The CMPA recognizes that health care facilities andproviders are under increasing pressure to improveaccountability-related reporting; however, this shouldnot happen at the expense of the quality improvementprocess. The challenge is to find the right balancebetween improving health care and helping all providersprevent similar events in the future, while fairlyaddressing any issues of individual provider performanceand accountability.

The maintenance of aprotected “learningenvironment” in whichthose involved can freelyexamine the adverse eventand discuss the factorsthat may have contributedto it is vital to the justculture of safety.

The reporting of an adverse event is a crucialprerequisite to both quality improvement andaccountability responses. Adverse events arereported through various means, including:

• Direct reporting by providers involved in theadverse event or close call;

• Concerns and complaints brought forwardby patients and families, or health careproviders; and

• Audits (e.g., using trigger tools).

Reporting systems should focus on capturing onlyfactual information, recognizing that speculations oropinions may lead to misunderstandings and inaccurateconclusions. Incident/occurrence reports may not benefitfrom the legislation that generally protects the disclosureof quality improvement information from being used insubsequent legal, regulatory or other proceedings. Whilethis situation is appropriate, it reflects the need to focusincident/occurrence reporting on the facts, as they areknown at the time.

Currently, the legal obligation for reporting adverseevents or close calls varies across Canadian jurisdictions.This represents an opportunity for considerable systemimprovement. A consistent approach to adverse eventreporting is needed — one in which health careprofessionals and/or health care institutions providefactual and timely reports of adverse events to therelevant authorities. Carefully developed standardizedreporting protocols will permit factual information to begathered (and possibly prevent the inclusion ofspeculation), as well as support system-wide datacollection and analysis, including meta-analysis ofincident/occurrence trends.

Health care institutions generally have policies guidingthe reporting of adverse events or close calls. Thesepolicies should specify a person or committee

responsible for receiving incident reports on adverseevents and such reports should be submitted only tothose individuals. However, such policies do not alwaysexist in non-institutional settings where an increasingamount of care is being delivered. This represents agrowing gap through which a considerable amount ofimportant information may be lost. Once a supportingquality improvement infrastructure is implemented,policy makers are encouraged to address how thisinformation can be appropriately captured. This willlikely require the establishment of reasonableparameters for the reporting of such events in non-institutional settings.

There should also be a mechanism to effectively collectand analyze the information provided, withoutidentifying individuals. The resulting information willprovide Canadians with a more accurate understandingof the safety of the health care delivery system, and willenable detailed analysis that supports the identificationand implementation of evidence-based systemimprovements. While a national incident/occurrencereport database would be the preferred approach, it isrecognized that varying degrees of progress at theprovincial level likely make such an outcomeunattainable in the short term. Provincial governmentsshould be encouraged to put in place the datacollection and analysis capabilities and make theappropriate information widely available to otherjurisdictions, health care institutions in their jurisdictionand to patient safety research.

A consistent approach toadverse event reporting isneeded — one in whichhealth care professionalsand/or health careinstitutions provide factualand timely reports ofadverse events to therelevant authorities.

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REPORTING ADVERSE EVENTS: IMPROVING QUALITY AND ACCOUNTABILITY

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While the reporting of adverse events is a necessaryfirst step, it alone is not sufficient. After a seriousunexpected clinical outcome or adverse event, areview should generally be considered. Building onthe information provided in the incident/occurrencereport, a preliminary collection of facts may be doneto develop an initial understanding of an event. This“triaging” effort will assist decision makers inunderstanding whether more detailed reviewsshould follow in the form of a quality improvementreview, an accountability review, or both.

Quality improvement responseThe focus of the quality improvement review is to identifyactions to improve the system of care for the benefit offuture patients. It is not a determination of responsibilityfor individual providers. The quality improvement reviewshould be conducted under the auspices of a properlyconstituted quality improvement committee. Qualityimprovement committees, depending on the province orterritory, may have different titles, for example: Quality ofCare, Critical Incident Review, Risk Management, etc.Legislation in each province/territory generally protectsthe information and documents prepared for, orgenerated by, a quality improvement committee frombeing used in subsequent legal, regulatory or otherproceedings, but does not protect the fact that thereview itself was conducted. The extent to which qualityimprovement information can currently be provided toothers, including what is disclosed to patients, variesamong the jurisdictions.

Generally, the relevant legislation reflects the publicpolicy objective of encouraging health care providers toparticipate in quality improvement processes. Meaningfulquality improvement reviews are characterized by acandid and forthright assessment by the health careproviders involved of the events that occurred. In additionto reviewing the facts, it may be helpful to consider whatcould have happened or what the participants wishedhad happened. While such speculation would be highlyinappropriate within an accountability review,

hypothesizing about system processes during a qualityimprovement review may be useful to identify the rootcause(s) and to develop strategies to help preventpossible re-occurrences.

For quality improvement reviews to be successful,participants must be confident that the informationgained through such reviews will not be used againstthem. Otherwise, they are likely to be unwilling toparticipate (or participate fully) in the quality improvementprocess, thereby greatly undermining its effectiveness as alearning opportunity. The likely outcome would be thatpatient safety would suffer.

Efforts to eliminate or reduce the legislated protectionsfor quality improvement information may in factjeopardize patient safety. Indeed, patients have themost to gain from a system that allows for rigorousexamination of an adverse event so that thecircumstances that led to it can be avoided in thefuture. Such an examination is most likely to beeffective only where the information gathered isappropriately protected.

While the information uncovered in the course of aquality improvement review should generally remainprotected, if serious concerns regarding a health careprovider’s competence or conduct are discovered, thequality improvement committee should suspend itsanalysis so these issues may be appropriately reviewed ina separate and independent accountability process.Importantly, the quality improvement protections are notmeant to shield the accountability of health careproviders. Quality improvement and accountabilityreviews have distinct purposes and can, if properlyconstituted, operate in parallel.

Given their typically speculative nature, qualityimprovement working documents should not bereleased. With a view to ensuring public confidence inthe health care system and to demonstrate an ongoingcommitment to improving the safety of care,

RESPONDING TO ADVERSE EVENTS:QUALITY IMPROVEMENT

continued . . .

RESPONDING TO ADVERSE EVENTS:ACCOUNTABILITY RESPONSE

While the quality improvement response may best becharacterized by its focus on learning, theaccountability framework requires the application ofprocedural fairness, prescribed protocols forinformation handling and the assessment of anindividual’s actions. Reviews that focus on the actionsof an individual (rather than on the system) should beconsidered part of the accountability response andguided by the legal and procedural protections thatexist within that domain. Regardless of theaccountability mechanism used (hospital review,regulatory authority investigation, civil litigation, etc.),in almost all cases, there are currently clearly prescribedprocesses in place that protect the interests of allinvolved: the patient, the provider and the public.

Recognizing that peer review is a term used with variedmeaning, when the intent of the review is to assess theclinical competency of an individual, such a reviewshould be considered under a properly constitutedaccountability framework. This type of review is

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consideration should be given to releasing therecommendations of quality improvement reviews,under the following conditions:

• The applicable legislation that protects qualityimprovement information permits the disclosure ofthese recommendations. As the legislation in somejurisdictions currently prohibits the disclosure of anyquality improvement information to persons outsidethe quality improvement committee, policy makersmay consider amending the legislation to permit thedisclosure of quality improvement recommendations,while still extending the protection to the otherinformation collected during the review.

• Information collected during the review, including

that gathered from the health care professionalsinvolved, should remain protected by the provisions ofthe relevant legislation. This information should notbe available to those reviewing a provider’sperformance from an accountability perspective.

• The obligation to make the actual systemrecommendations more widely available resides withthe institution, the regional health authority or, incertain instances, the provincial territorial ministry. Itwould not be appropriate for this release to emanatefrom the quality improvement committee itself. Anynew facts related to a patient’s care that werediscovered during the review and are not alreadycontained in the medical record of an individualpatient should be disclosed to the patient.

RESPONDING TO ADVERSE EVENTS: QUALITY IMPROVEMENT continued

The sound practice of medicine, along with naturaljustice imperatives, requires health careprofessionals to be accountable for their actions. Anaccountability review focuses on an individualprovider’s performance, although system failuresmay also be identified. This type of review isrequired whenever there are concerns about anindividual provider’s performance and it is anecessary element in ensuring quality of care andthe public’s ongoing confidence. This response may,when appropriate, lead to sanctions, althoughremediation and education are preferred. Examplesof possible sanctions include the withdrawal ofpractice privileges in hospitals or restrictions on orrevocation of licensing. The initiation of civillitigation also represents a form of accountabilityresponse, aimed at addressing appropriatecompensation for the patient who suffered harmfrom negligent care. A strong accountabilityframework is a necessary component of the healthcare system.

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generally described as a retrospective review by peers, orsubject matter experts, of an individual or groups ofindividuals looking at specific indicators of quality ofcare. The goal is to identify, within a confidentialprocess, areas for practice improvement. In this context,peer reviews should be constituted as part of anaccountability framework.

In a hospital/institutional setting, procedures should bedeveloped that would enable those who discover issueswith a provider’s performance during a qualityimprovement review to report the performance issues toleadership/management. The report should allow for anaccountability investigation to be commenced, whilemaintaining the protection for information gathered inthe quality improvement review. Those conducting theaccountability investigation should collect their owninformation in accordance with the establishedprocedures and protections. As a minimum, there mustbe an “information firewall” that prevents qualityimprovement information from being used inaccountability reviews. If that “firewall” is breached, it islikely health care providers will lose confidence in thequality improvement process and, fearing reprisals basedon information gained without procedural safeguards,may diminish their participation in this patient safety-oriented learning effort.

While the information generated within theaccountability review may not be protected by legislation,it should still be treated as confidential. Each of thevarious accountability responses has its own set ofinformation procedures; for example, the information

protocols guiding hospital reviews are different fromthose used by regulatory authorities while civil litigationalso has its own procedures. Regardless of theaccountability mechanism, authorities are encouraged toensure full clarity of the procedures, and physicians andother health care professionals are advised to understandthe procedures that apply to them. Health care providersshould be informed as to how and to what extent theinformation generated may be shared with others. Inmany jurisdictions, if privileges are restricted, cancelled orsuspended as a result of any review into competency, thehospital/institution may be required by law to report thisinformation to the regulatory authority. Similarly,regulatory authorities are increasingly required to providepublic access to findings that indicate the physician didnot meet the standard of care.

In those instances in which it has been determinedthrough fair processes that unprofessional conduct by ahealth care professional has occurred, the CMPAsupports this information being made available. Indeed,to deny such availability would undermine the public’sconfidence in the profession. However, this should occuronly under carefully defined procedures and when it isviewed to be in the public’s interest. Information sharedshould generally be limited to the findings andrecommendations and, unless it is already in the publicdomain (e.g., through civil litigation), the supportinginformation should remain protected.

While the quality

improvement response may

best be characterized by its

focus on learning, the

accountability framework

requires the application of

procedural fairness, prescribed

protocols for information

handling and the assessment

of an individual’s actions.

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Governments, regulatory authorities, healthauthorities, institutions, physicians and otherhealth care providers all have important roles toplay in establishing the legislation, policies andprocedures necessary to ensure the effectivecollection, analysis, distribution and, whereappropriate, protection of information related to

unexpected clinical outcomes, adverse events, andclose calls. Achieving the appropriate balancebetween quality improvement and theaccountability responses will require policy makersto more clearly delineate the responsibilities foreach of these responses.

RECOMMENDATIONS

What should policy makers do?

Governments and other policy making bodies are keyplayers in achieving the right balance betweenimproving systems of care, while fairly addressing anyissues of provider performance and accountability. Toachieve this they should consider the following:

� Implement legislation that mandatesincident/occurrence reporting and policies that clearlyspecify the conditions under which such reporting isto take place. It is noteworthy that to date, Québec,Manitoba and Saskatchewan have all enacted suchlegislation for institutions as part of their efforts toimprove the quality of care.

�At the appropriate time, and once supporting qualityimprovement infrastructure is in place andreasonable parameters are established, considerextending reporting requirements to non-institutional settings.

�Develop a common coding system so that data can becollected, aggregated to preserve anonymity, analyzedand shared within and among jurisdictions.

�Re-affirm and, if required, strengthen the existingprotections for information collected as part of thequality improvement reviews. Particular attentionshould be directed to ensuring an effective“information firewall” between quality improvementand accountability reviews.

� Implement policies that require the sharing of therecommendations of quality improvementreviews, and identifying those recommendations tobe implemented.

�Adopt policies that more clearly specify and supporta more consistent approach to the disclosure of theresults from accountability reviews. Such policiesmust take into account and balance the interest of allparties involved, including patients, health careproviders and the public, and must ensure that,except in specific circumstances, the informationgenerated will be treated as confidential.

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Regional and local health authorities and institutionssuch as hospitals and clinics should provide the supportand infrastructure necessary to encourage the creationof a just culture of safety that supports learning fromadverse events and holds individuals professionallyaccountable in a fair and balanced way. This can beaccomplished, in part, through the following actions:

�Develop policies and procedures to support qualityimprovement, including the reporting of adverseevents and close calls and ensure that these areunderstood by providers and followed byleadership/management. These policies should alignwith provincially mandated requirements forincident/occurrence reporting.

� Implement policies and procedures that separatethe systems-oriented quality improvement reviewsfrom examinations that focus on the performanceof individual health care professionals.

�Accept appropriate responsibility and accountability.Individuals should not be held accountable for systemfailures over which they have little or no control.

�Ensure that the initial responses to the adverseevent, as well as any subsequent analyses andproceedings, will be conducted with fairness, withinthe applicable legal frameworks, and in accordancewith established policies.

�Establish procedures for the release of the systemimprovements recommendations of qualityimprovement reviews, while ensuring continuedprotection for the other information collected in thecourse of these reviews. Adhere to procedureswhereby reviews of the performance of individualhealth care providers are completed in accordancewith the provisions of the accountability framework.This would apply to hospital reviews and regulatoryauthority investigations, among other types of reviews.

�Educate health care professionals on the qualityimprovement process to:

• encourage participation in properly establishedquality improvement reviews that protect theinformation collected;

• recognize the procedural fairness and relatedprotections available within the accountabilityframework.

�Reassure providers that quality improvementinformation is protected and participation in theprocess will not make them unduly vulnerable toreprisal in legal, regulatory or other proceedings.

�Develop recommendations and implement systemchanges based on the outcome of qualityimprovement processes.

What should health care authorities and institutions do?

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In addressing adverse events, physicians and otherregulated health care professionals are faced with arange of requirements related to their legal, professionaland ethical responsibilities. In order to meet theserequirements, they should consider undertaking thefollowing actions:

�Regardless of their practice setting (hospital, clinic,office, etc.), fully understand and follow thelegislation, policies and procedures regarding thereporting of adverse events and close calls. Thisunderstanding should extend to knowing the likelyapproach to analysis, and to what extent, if any,information related to this analysis will be disclosedto patients, health care and regulatory authorities orthe public.

�Provide only factual information in incident/occurrence reporting and refrain from statements ofblame, speculation, opinion or other commentary asto the reasons for what happened. Incident/occurrence reports are unlikely to benefit fromlegislative protection in legal, regulatory orother proceedings.

� Inquire as to whether the institution’s qualityimprovement committee is properly constituted underthe relevant legislation and seek assurances thatquality improvement reviews will be conducted in aconfidential manner.

�Promote the use of properly constituted qualityimprovement committees so that informationcollected and produced by such committees willbe protected.

�Fully participate in systems-oriented qualityimprovement reviews. Participation by providers inquality improvement reviews may be mandated bylaw in some provinces/territories or by hospitalbylaws.

�Understand the differences between a qualityimprovement review and an accountability review, interms of their different purposes, procedures,information protections and consequences.

�Seek advice from the CMPA when necessary.

What should physicians and other health care providers do?

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The majority of unexpected outcomes result fromthe progression of the underlying medicalcondition of a patient. Most adverse events resultfrom the risks inherent in investigations ortreatments, while others result from failures inthe organization or processes of the systems ofcare. A minority of adverse events may beattributable to an individual provider’sperformance. An appropriate analysis of adverseevents holds the promise of revealing informationthat may prevent a similar occurrence at sometime in the future. It is this promise ofimprovement, in either system or individualperformance, which must be the imperative forpolicy makers, regulatory authorities, healthinstitutions, physicians and other health careproviders to substantively address the reportingof and response to adverse events.

Improving the quality of care and ensuring a robustframework that holds individuals accountable for theiractions starts with an effective reporting process.While some jurisdictions have made progress in thisarea, there remains a great deal more to be done, suchas standardizing procedures that support the analysisof incident/occurrence reports. Governments andothers must move quickly to address the shortfalls inreporting requirements and to establish themechanisms that facilitate learning from (and notmerely collecting) information.

Effective quality improvement review processes areessential for improving the safety of health care.Effectiveness rests, in part, on health care professionalsunderstanding that the information they provide will beprotected from disclosure or from use in possibleaccountability actions. At present, these protections arebeing weakened, threatening the effectiveness ofcurrent and past patient safety efforts and progress.

The public’s confidence in the quality of health caredepends on an understanding that quality improvementreviews do indeed generate recommendations that leadto actual system improvements. Therefore the needexists to make available the recommendations of suchreviews and the actions being taken to implementthose recommendations.

At the same time, these patient safety efforts must beaccompanied by a robust accountability framework thatinvestigates and deals appropriately with instanceswherein the standard of care was not met or acceptablepractices were not followed. A “firewall” that preventsthe flow of information from the protected qualityimprovement domain into the accountability domain iscrucial. Regardless of the accountability mechanismbeing employed, procedures that help ensure fairnessand protect the interests of patients, providers and thepublic is vital.

The CMPA believes that the Canadian health caresystem has reached an important juncture in the area ofimprovements to quality of care. The path that wouldresult in the widespread disclosure of qualityimprovement information threatens to underminedecades of efforts to improve care. The other path seeksto achieve an appropriate balance between the patientsafety and the accountability responses, recognizes theneed for both types of responses, and enables each typeto contribute to a more effective and safer health caresystem. The Association urges decision makers topromote legislation that achieves the right balancebetween safety and accountability and reflects theinterests of the Canadian public, including futurepatients whose quality of care will depend upon thedecisions being made today.

CONCLUSION

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For consistency, the CMPA encourages the use of the following definitions.

GLOSSARY

Adverse event An event which results in unintended harm to the patient, and is related to the careand/or services provided to the patient rather than to the patient's underlyingmedical condition.

(Disclosure Working Group. Canadian Disclosure Guidelines.

Edmonton, AB: Canadian Patient Safety Institute; 2008)

Close call An event with the potential for harm that did not result in harm because it didnot reach the patient due to timely intervention or good fortune (sometimescalled a near miss).



Disclosure The process by which an adverse event is communicated to the patient by healthcare providers.



Harm An outcome that negatively affects the patient’s health and/or quality of life.



Incident/occurrencereport

A report of an adverse event or close call. The information contained therein maynot be protected from disclosure. (CMPA)

Just cultureof safety

A health care approach in which the provision of safe care is a core value of theorganization. The culture encourages and develops the knowledge, skills andcommitment of all leaders, management, health care providers, staff, and patientsfor the provision of safe patient care. Opportunities to proactively improve the safetyof care are constantly identified and acted on. Providers and patients areappropriately and adequately supported in the pursuit of safe care. The cultureencourages learning from adverse events and close calls to strengthen the system,and where appropriate, supports and educates health care providers and patients tohelp prevent similar events in the future. There is a shared commitment across theorganization to implement improvements and to share the lessons learned. Justice isan important element. All are aware of what is expected, and when analyzingadverse events any professional accountability of health care providers is determinedfairly. The interests of both patients and providers are protected. (CMPA)

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Negligence/fault A legal concept. In all provinces/territories of Canada except Québec, to establishnegligence by a physician, a plaintiff patient must prove to the satisfaction of acourt that harm to the patient was caused by the failure to exercise a reasonablestandard of care by the physician. In the courts, the medical standard of care todetermine negligence is not one of perfection but rather the standard of care thatmight reasonably have been applied by a colleague in similar circumstances.

In Québec, the concept of fault is at the heart of civil liability. Every person has aduty to abide by certain rules of conduct or standards, and if a person does not, heor she has committed a fault. The plaintiff must demonstrate the physiciancommitted a fault, that is, did not act as a reasonably prudent physician of similartraining and experience would have under the circumstances. The plaintiff mustalso have suffered an injury as a result of the fault committed, and the plaintiffmust establish the fault caused the injury. (CMPA)

(For more on negligence/fault, see CMPA Education online at www.cmpa-acpm.ca.)

Procedural fairness The legal concept that administrative proceedings should be conducted in amanner that is fair to the parties involved. While the extent of fairness varieswith the nature of the proceedings, at minimum, affected parties should begiven a fair opportunity to participate in the proceedings. This includes providingparties with notice of the proceedings and the ability to respond to anyprejudicial argument or evidence.

Qualityimprovement

review

The analysis by health care organizations (usually by a quality improvementcommittee) of patient outcomes, clinical practices, and systems of care in order torecommend improvements. (CMPA)

Quality improvement committees, as part of an ongoing program to improvepatient care, should be structured under the relevant provincial/territoriallegislation and include formal terms of reference. Quality improvementcommittees, depending on the province or territory, may have different titles, forexample: Quality of Care, Critical Incident Review, Risk Management.

Reporting The communication of information about an adverse event or close call by healthcare providers, through appropriate channels inside or outside of health careorganizations, for the purpose of reducing the risk of reoccurrence of adverseevents in the future.



Mailing Address: P.O. Box 8225, Station T, Ottawa ON K1G 3H7 Adresse postale : C.P. 8225, Succursale T, Ottawa ON K1G 3H7Street Address: 875 Carling Ave., Ottawa ON K1S 5P1 Adresse civique : 875, av. Carling, Ottawa ON K1S 5P1Telephone: 613 725-2000, 1 800 267-6522 Téléphone : 613 725-2000, 1 800 267-6522Facsimile: 1 877 763-1300 Website: www.cmpa-acpm.ca Télécopieur : 1 877 763-1300 Site Web : www.cmpa-acpm.ca

ABOUT THE CMPAThe Canadian Medical Protective Association provides advice, legal assistance,

and risk management education to 76,000 member physicians. As the principal

provider of medical liability protection in the country, the Association is

governed by an elected Council of physicians. A valuable contributor to the

health care system since 1901, the CMPA is firmly committed to protecting the

integrity of physicians and promoting safer medical care.

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