Medication Error Reporting Systems and Disclosing Medication Errors to Patients and Families

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Learning Objectives

Describe the differences between internal and external event reporting systemsDiscuss the multidisciplinary role of tracking medication errors and disclosing those trends to patientsList the barriers to disclosing medication events to patients

Medication Error Reporting Systems

Error reporting systems promote the goal of providing the best possible patient care in a safe, compassionate environment by helping those involved learn about:Potential risksActual errorsCauses of errors Prevention of recurrent eventsBoth internal and external systems for reporting and tracking errors are necessaryVoluntary and mandatory systems each have strengths and weaknesses

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Definitions

Adverse drug event (ADE) Any injury resulting from medical intervention related to a drugPreventable ADE ADE that results from an error or equipment failureError Failure of a planned action to be completed as intendedMedication error Any preventable event that may cause or lead to inappropriate medication use or to patient harm while the medication is in the control of the health care professional, patient, or consumerClose call or near miss Medication error that was detected and corrected before it reached the patientMedication error that reached the patient and did not cause harm because of chance

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Purpose of Reporting Systems

Strong error reporting systems are invaluable in highlighting hazards related to medication use, including ADEs, medication errors, close calls, and near misses1999 Institute of Medicine (IOM) report, To Err Is Human, describes two primary purposes of reporting programs:Hold providers accountable for performance and patient safetyProvide information that leads to new knowledge and improved patient safetySome hospitals resist the IOMs call to accountability for fear that ADEs may be publicly disclosedPurposes of internal error reporting systems:Improved management of individual patientsGetting timely medical adviceProviding a record of eventsObtaining immediate legal counsel

Kohn LT, et al., eds. To Err Is Human: Building a Safer Health System. Washington, DC: National Academies Press; 2000.

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Purpose of Reporting Systems (continued)

IdeallyAn error is reported internally, investigated, and error reduction strategies implemented Error reduction strategies are then reported to an external programPurposes of external error reporting systemsGenerate widespread alertsWidely disseminate new ways to prevent errorsUncover trends and hazards Recommend best practices for all health care stakeholders

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Responsibility for Reporting

The best person to report an event is the one who was involved or who found or witnessed the eventMost medication errors are reported by nurses or pharmacistsEveryone associated with health care could potentially make reports (e.g., pharmacists, physicians, nurses, dentists, techs, assistants, medical equipment vendors)Consumers may report suspected medication errors to:External voluntary error reporting programsAppropriate licensing boardsFacility in which error occurredPerson(s) making the errorThe facility should thoroughly investigate any reported medication error

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Reportable Events, Conditions, and Priorities

It is essential to use clear, consistent terminology when reporting eventsThe word event is used by many organizations because the word incident has the connotation of being a crisisEvent has a broad connotationClearly define the types of events and conditions to be reportedNot knowing what to report is a barrier to reportingThe categories of conditions and events reportable to error reporting systems are:Risk: hazardous conditions that could lead to an errorNear misses/close calls: errors that were intercepted and corrected before reaching the patientErrors, no harm: errors that reach the patient but do not cause harmErrors, harm: errors that reach the patient and cause harmSee textbook page 517 for more detailed information

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Reportable Events, Conditions, and Priorities (continued)

Provide staff members with examples of adverse occurrences to minimize confusion about what is desiredNear misses and conditions that could lead to errors or less serious errors all provide information about the underlying system-based causes of medication errorsAll of the above should be reported Allows systems to be proactive in identifying system failuresLess devastating to report events not causing harm than to have to report harmful occurrencesInstitutions should encourage personnel to report events and not to assume that the problem is already knownMore complete reporting enhances the ability to learn about errors and to implement appropriate safeguards

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Reporting Mechanisms

Staff must understand both formal and informal (alternative) methods of reporting events Informal lines of communication help to enhance trust and confidenceBoth formal and informal ways of accepting information should be part of the event reporting mechanismReports may be submitted by e-mail, especially for external reporting systemsThe organization that maintains the reporting system should track the effectiveness and usefulness of the various systems and make adjustments if necessaryEvent reporting forms with electronic formats are provided by both internal and external reporting programs

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When to Report

Best approach is to immediately report an event whether or not it may cause serious harmAdvantages to immediate reporting:

An ADE that may not seem serious may, in fact, be serious

The supervisor can ask questions while the event is fresh in the reporters mind

An immediate oral report to a supervisor may be more beneficial than a hastily written reportSend final reports to risk management within 1 week of the event unless additional time is requested in the reportReport to the external voluntary reporting system after all the information is gatheredThese systems have specific reporting time frames and all information may not be available

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What Information to Report

JUST THE FACTSinclude a factual description of what happened and the patient outcomeInclude names of products if the event involves a problem with labeling or packagingInclude any additional patient monitoring or testing performed or medications administered as a result of the eventInclude explanatory information that describes:How the event happenedWhat normally happens and how risk was managed before the eventWhy the event happenedAt-risk behaviorsHow to prevent similar events

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What Information to Report (continued)

Figure 19-1 in the textbook provides an event reporting form with questions designed to elicit causative factors for reportingSeparate the causative and prevention portions from the factual to better protect event analysis from discovery during a lawsuitNever include personal or professional opinions, conclusions, criticisms, accusations, admissions, or patients names in the report

JUST THE FACTS

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Categorizing Reports

Categorize reports according to the severity of patient outcome to help organizations monitor patient harm and prioritize their medication safety activitiesFigure 19-2 in the textbook shows an index for categorizing medication errors from the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)The NCC MERP index considers factors such as whether the patient was harmed, and if so, to what degreeAll event reports are useful for learning and for change even if there was no harm to the patientAll reports should be investigated and acted upon if appropriate

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Mandatory Reporting Programs

The IOM recommended both mandatory and voluntary reporting programsThe Institute for Safe Medication Practices (ISMP), the American Hospital Association, and the American Medical Association objected, saying mandatory reporting would stifle reporting because of heightened fear of damaged reputations and legal liabilityIn the United States today, both mandatory and voluntary reporting systems are in operationFundamentally, all reporting is voluntaryThreat of punishment will decrease likelihood of reportingThe lack of success may be less about the mandatory nature and more about the design of the reporting systems, the punitive culture, and the ineffective use of data submitted

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Limited Success of Mandatory Programs

Usually run by the state departments of health and the licensing boards that require reportingThere is potential to generate useful data Requirements for reporting are inconsistentAmount of useful information and the number of reports variesOrganizations may underreport to avoid penalties, punitive actions, and legal and public scrutinySome practitioners are reluctant to report errors to external mandatory programs, but will report errors internallyHealth systems cannot make it safe for staff to disclose errors to mandatory programs that hand down punishments The designated reporter is charged with minimizing the organizations exposure to liability and public distrustOutcome-based event analysis is especially prone to hindsight bias

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Mandatory State Programs

Less than half of the U.S. states require mandatory reporting States are not consistent in the types of events reported, the number of events, or the requirements for reportingMost investigate serious eventsThe only consistent reportable event is unanticipated deathHealth professionals and health systems rarely receive feedbackInformation about professionals sanctioned for errors are published by licensing boardsHealth departments typically make some findings public but insulate detailed information from legal discoveryNeed for research about whether safety changes are made by practitioners that would not otherwise have been made as a result of mandatory state reporting

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Patient Safety Centers

Six states (Florida, Maryland, Pennsylvania, Oregon, Massachusetts, and New York) have created patient safety centers The functions vary from state to state but they arose as a result of health issues such as affordability and malpractice reformSeek to educate providers about best safety practices for patientsHave governing boards and consumers in an advisory capacityMost of the centers operate under little or no state regulatory controlEach center submits mandatory periodic progress reports to a governing bodyMost disclose findings to the public, some utilizing the WebAll but Oregon have mandatory reporting systems for serious adverse eventsTable 19-1 in the textbook compares features of these patient safety centers

Six states is an accurate number at time of ISMP textbook printing, double check this number prior to presenting this information.

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Pennsylvanias Unique Program

The mandatory Pennsylvania Patient Safety Reporting System (PA-PSRS) requires the reporting of close calls, near misses, and serious adverse events by all licensed hospitals, birthing centers, and ambulatory surgical facilitiesThe Patient Safety Authority (PSA; an independent, nonregulatory state agency) is authorized by the PA-PSRSPSA analyzes reports for learning purposes, keeping the information confidential and not available to the publicWhistleblowers are protected and may report anonymouslyIndividual health care facilities can use PA-PSRS to monitor the progress to improve safety at their facilities

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Pennsylvanias Unique Program (continued)

Pennsylvania uses a program subcontracted to ISMP to analyze medication-related errors and adverse drug reactions reported to the system; suggests ways to avoid future errorsNew information about the sources and causes of medication errors is now available to ISMP and other safety expertsPatient Safety Advisory, published quarterly, is based on analysis of errors and near misses The 2004 data from Pennsylvania are consistent with national data, which show the following:Approximately one-fourth of reported medication errors involved one or more high-alert medicationsTwo out of three harmful events involved one or more high-alert medications

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Voluntary Reporting Programs

Voluntary systems are generally more successful than mandatory systems because: Reports come from frontline practitioners who can describe the conditions that led to the event and provide detailed informationConclusions can be drawn without waiting for numerous reportsInformation is immediately useful to help create a plan for improvementThere is trust between the reporters and the recipientsSystems are perceived as credible because they are independent of regulatory and accrediting bodiesA nonpunitive approach recognizes that human error is inevitableAnalysis is system or process oriented rather than outcome orientedError reduction efforts are not targeted at the individual but toward strengthening the system to lessen the possibility of errorTable 19-2 in the textbook lists elements identified by ISMP that encourage error reporting

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USP-ISMP Medication Errors Reporting Program

United States Pharmacopeia (USP) operates the medication errors reporting program (MERP) in cooperation with ISMP, which receives all MERP reports, analyzes reports and aggregate data, and disseminates the findingsUSP or MERP automatically passes error reports to FDAs MedWatch FDA focuses more on packaging, labeling, and nomenclature issues than with practice issues or health care system failuresProduct-related reports are sent to manufacturersReporting process of medication errors to USP-ISMP is described on page 529 of the textbook, including the phone, fax, e-mail, address, and Web siteReporters are often willing to answer questions and provide supplemental materials such as photos and redacted ordersReporters hope that their information will lead to changes for preventing future errors and patient harm

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USP-ISMP Medication Errors Reporting Program (continued)

MERP can:Objectively determine causes of errors and find solutions because it is independent of other agenciesAnalyze reports to provide information about the types, causes, and prevention of errorsPerform individual investigation and follow-up because it has a small number of reportsMERP cannot:Discipline, regulate, or mandate implementation of the recommendations that come from the analysisDetermine the prevalence of medication errorsProvide the names and locations of reporters

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Analysis of Reports to MERP

The goal at MERP is to learn from reported events or hazards, preventing them in the future, and extrapolating the system-based solutions to all health care settings2004 MERP data analyzing errors showed:57% of the submitted reports documented errors that reached the patient (see Table 19-3 for the categories of reported errors)13% of the errors caused temporary harm2% of the errors resulted in permanent harm1% of the errors resulted in death43% of the reports were from hazards that could lead to errorsMost of the errors reported to MERP in 2004 involved either the wrong drug, wrong dose, or prescribing errorsTable 19-4 in the textbook lists types of errors reported to MERP

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MERP Documented Errors

Reports Submitted to USP-ISMP Medication Errors Reporting Program in 2004

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Analysis of Reports to MERP (continued)

Table 19-6 in the textbook enumerates the leading products involved in harmful errors in 2004, including several pharmaceutical productsDrugs not currently considered high-alert medications were among the leading products on the 2004 list, including:Lipitor and ZocorPhenerganSeroquel and SerzoneClonidineDiflucanLithiumMetoprolol

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Impact of MERP

Early warning systemISMP immediately sends out electronic alerts, including subscription to free e-mail alerts, when MERP indicates serious hazardsLearningInformation about error prevention is shared through educational programs, newsletters, teleconferences, and the WebChangeSurveys and reports show information provided by ISMP is stimulating changes by individuals and organizationsStandardsInformation from MERP is often shared with agencies (e.g., The Joint Commission [TJC], FDA, and state health departments) and USPs standards and drug information database also has been impactedPublic policyISMP and USP use information from MERP to promote changes in public policy to enhance safetyAppendix A (pages 5469 in the textbook) lists examples of the nationwide impact of MERP

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FDA MedWatch

A voluntary reporting program that receives reports from health care professionals and consumers involving:ADEs, product use errors, biologics, medical devices, nutritional products, and cosmeticsDoes not accept reports involving vaccinesNew products are monitored through the FDA and the pharmaceutical industryReporter does not need proof, only suspicion, to submit an event reportContact information for MedWatch:Fax: 1-800-FDA-0178Phone: 1-800-FDA-1088Internet: www.fda.gov/medwatch/report/hcp.htm

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FDA MedWatch (continued)

FDA reviews product-related errors, but not practice-related errors, reported to MERPNames of reporters divulged only with permission from reporterISMP can review reports submitted to MedWatch, but can interview the reporter only through a third party within FDANarrative reports submitted are not available electronicallyThe Adverse Event Reporting System combines required reports from manufacturers and voluntary reports from MedWatch thus creating an even broader safety program5% of the reported events to the FDA in 2004 were voluntary, the rest came from manufacturers FDAs Division of Medication Errors and Technical Support (DMETS) analyzes reports and provides feedbackDMETS investigates causes and contributing factors and offers recommendations for label or packaging revisions

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The Joint Commission Sentinel Event Reporting Program

TJC asked accredited health care organizations in 1996 to identify and voluntarily report all sentinel events within the facilityA sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereofThe phrase or the risk thereof refers to any process variation whose recurrence would carry a significant chance of a serious adverse outcomeThe sentinel event policy requires organizations to:Investigate root causes within 45 days of becoming aware of a sentinel eventImplement strategies to prevent recurrenceMonitor the effectiveness of implemented strategies

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The Joint Commission Sentinel Event Reporting Program (continued)

The reporting program is not entirely voluntaryIf TJC learns about an event that the health system has failed to report, the health system must conduct a root cause analysis within the specified time frame or risk being placed on accreditation watch status with public disclosuresNo matter how the event comes to the attention of TJC, the response, time frame, and review procedure are the sameTJC provides expertise in the analysis of an event and validates that system-based changes have been madeThe amount of knowledge gained from an event is lessened and the disclosure of errors is inhibited when the reporting program has the authority to mandate actions

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The Joint Commission Sentinel Event Reporting Program (continued)

19952005: the sentinel events reported to TJC included patient suicides, wrong-site surgery, operative or postoperative complications, and medication errors19952004: most common root causes of medication-related sentinel events were communication failures, inadequate orientation or training of staff, inaccurate patient assessment, staffing issues, and unavailable informationFigure 19-3 in the textbook shows the breakdown of root causes of medication errors for 19952005Figure 19-4 graphs an example of one such sentinel event

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USP MEDMARX

Internet-based system launched in 1998 Subscribers upload data from internal reports, track the data, and learn about errors reported by other facilitiesReporting is anonymous and standardizedAllows for data to be aggregated for comparison with demographically similar facilitiesBy 2005, about 800 facilities paid a fee and subscribed USPs Center for the Advancement of Patient Safety (CAPS) analyzes the data for the purpose of creating educational programs and products that focus on error analysis and preventionAppendix B (pages 54950 in the textbook) includes topics featured in the MEDMARX annual reports

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Veterans Affairs Patient Safety Reporting System

Veterans Affairs (VA) staff can voluntarily report events or concerns on a standardized form by mail to the VAs external Patient Safety Reporting System (PSRS; an independent complementary system, established in 2002)Does not replace the VAs internal reporting system; PSRS is a reporting system some staff may be more comfortable usingPSRS was jointly developed with NASA, making use of NASAs 30 years of experience with the Aviation Safety Reporting SystemPSRS guiding principlesVoluntary participationConfidentiality protectionNonpunitive reporting

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Veterans Affairs Patient Safety Reporting System (continued)

Reports of events involving criminal actions, purposefully unsafe acts, and alleged or suspected patient abuse are not accepted by PSRSThese actions are not protected informationReporters are encouraged to include identifying information so they may be contacted if clarification is needed All identifying elements are removed once the report is declared complete, including all names and locationsOnly 400 reports were received in the first 2 years, while the internal VA system received 14,000 reports VA facilities are immediately alerted if an alarming safety trend is identifiedThe source of the problem is not identified

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Disclosure of Error Reports: Public Disclosure

Thoughts on public disclosure vary, including:Making it mandatory for health care practitioners to divulge informationPublic disclosure is necessary to encourage improvementsDisclosure of adverse events will cause error reporting to go underground, weakening the effort to ensure patient safetyThe public has rights regarding disclosure of patient safety issues such as:The right to expect steps are taken by health care organizations to deal with safety hazardsThe right to be informed about unsafe conditionsThe right to expect companies that make any health care products to do their part to ensure error-proof health careThe right to expect companies and providers to be held accountable for implementing safety strategies

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Disclosure of Error Reports: Public Disclosure (continued)

The public wants evidence that health care providers value patient safety above allSafety recommendations should be evaluated by regulatory, federal, and accrediting agencies as well as by health care purchasing groupsThe reporting system should not have the power to mandate the implementation of recommendations, but they should be adopted if the efficacy and cost benefit are favorablePublic disclosure should be considered if the agencies and groups do not adopt the recommendationsTo help make informed decisions, consumers can review:An organizations compliance with safety standardsAn annual report summarizing events and actions

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Disclosure of Error Reports: Legal Disclosure

Most states have some legal protection for information submitted to internal reporting programs operated for quality improvement purposesThe offer of confidentiality and evidentiary protection for the information submitted is one of the best incentives for reportingLacking federal protection of reporting information is a reason many external reporting systems and safety experts do not receive informationProtection under state law may be waived if the information is shared externallyISMP and many other safety experts subscribe to the belief that information from external reporting systems should be privileged for purposes of governmental judicial proceedings

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Disclosure of Error Reports: Legal Disclosure (continued)

Congress enacted the Patient Safety and Quality Improvement Act of 2005 to encourage more participation in external error reporting systems Calls for independent patient safety organizations (PSOs) that receive, analyze, and disseminate confidential dataThe PSOs are to be certified The information PSOs receive cannot be used in civil or administrative legal proceedings, thus lessening the threat of litigation while protecting patients rights to legal remedies

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Practitioners Perspectives on Reporting

A 2002 ISMP survey found that the majority of staff-level clinicians surveyed feel more effort is needed to promote voluntary reporting, both internally and externallyThose responding more often reported safety issues to internal rather than external programsTable 19-7 in the textbook shows frequency of reporting medication errors or safety issuesMedication errors that caused no harm, whether or not they reached the patient, were most often reported internallyHazards that could cause errors were not often reported internally, but were the issues most often reported to MERPErrors associated with harm were more often reported internally The survey found that at least half of the respondents had reported one harmful error internally, but only one in ten had reported a harmful error to MERP or MedWatch

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Practitioners Perspectives on Reporting (continued)

Adverse drug reactions were reported frequently to internal programs and less frequently to MedWatchMedWatch database may be lacking in critically important postmarketing surveillance dataTable 19-8 in the textbook lists motivations for reporting medication errors and safety issuesSurvey indicated that key motivations for reporting to both internal and external programs were to enhance patient safety and avoid needless tragediesThose surveyed felt more rewarded reporting to MERP than to MedWatch or internal programs, suggesting that more needs to be done to reward voluntary reporting

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Practitioners Perspectives on Reporting (continued)

Table 19-9 in the textbook indicates more promotion of internal over external programsThe least promoted external program was MedWatchResults show that stakeholders in patient safety must take more time to encourage frontline practitioners to report issues, both internally and externallyPotential reasons for lack of voluntary reportingLegal impedimentsLimited knowledge of voluntary external reporting programs2006 IOM report recommendationsMore aggressive error reporting by all stakeholdersUse of a national taxonomy for data storage and analysisUse of aggregated information to shape national health policy

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Disclosing Medication Errors to Patients and Families

Disclosing Medication Errors to Patients and Families

The public is increasingly aware of the frequency and consequences of medical errorsThere is general agreement that disclosure of outcomes and errors to the patients is the ethical thing to doDisclosure is an emotional experience for all involvedThere may be a hesitancy on the part of health care organizations and practitioners to move toward a process for full disclosure to patients and families

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What Constitutes Successful Disclosure?

TJC standards state that a successful disclosure ensures both patients and families are informed about the outcomes of medical care, especially the unanticipated outcomesElements of successful disclosure of unanticipated events may include:Absence of litigationUnderstanding by the patient and family that mistakes are unavoidableCalming of the patients and familys anger after an adverse outcomeAbsence of media coverageEnsuring the organization and practitioners are positively portrayed if there is media coverageThe true goal is to learn from all adverse events and to use them as opportunities for improvement

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Patients Perspective

The National Patient Safety Foundation (NPSF) recommends:Prompt explanation of how an injury occurred and the effects of the injuryThe explanation should be truthful and compassionateThe explanation should include remedies available Lack of trust in the physician makes disclosure more difficultPatients and families know errors occur and they want the following to happen:Systems should be developed for avoiding medical errorsGive a detailed explanation and a sincere apology if an error happensPractitioners often distance themselves from patients and families

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Patients Perspective (continued)

2004 survey of consumers regarding medical errors found:92%: reporting should be required88%: physicians should be required to tell them if a preventable error resulting in serious harm happened in their own care63%: hospital reports of serious medical errors should be made public34%: had experienced medical errors28% of these respondents had been told about the error54%: believe the physician would be very or somewhat likely to tell them about a preventable error that resulted in serious harm 79%: giving physicians more time to spend with patients could reduce errors72%: require hospitals to develop systems for avoiding errors72%: better trained health professionals could reduce errors21%: malpractice lawsuits would help reduce medical errors

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Health Care Providers Perspective

Physician responses varied, from always disclose complications to disclose those that cause harm, unless the harm is trivial or the patient is unable to understand the errorNear misses should not be disclosed, preferring to handle them as the physicians problem

Risk managers surveyed:More than half always disclose death or serious injury due to errorLess likely to disclose preventable harm than unpreventable harmThose who felt disclosure increased the risk of litigation were more likely to disclose unpreventable harm over preventable harm

Physician definition of error: Deviation from the accepted standard of carePatient definition of error: All unpreventable adverse events, as well as poor service quality and low interpersonal skills on the part of the practitioner

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Experience With a Full Disclosure Policy

The Lexington, Kentucky, VA Medical Center had lost $1.5 million in malpractice judgmentsIn 1987, this facility adopted a full disclosure policy with equitable compensation for actual losses due to errorsCenter notifies patients and families as quickly as possible Settlements are numerous, including some that might not have been filed without the honest disclosureHospital even assists in the filing of claimsAttorneys are provided with clinical informationAttorneys may negotiate a settlement on the basis of monetary losses rather than seeking a more punitive judgmentAll of these actions lessen patients anger and desire for retributionResult was not an overwhelming number of lawsuits Payments for claims were moderate with the economic outcomes remaining positive more than 10 years later

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Experience With a Full Disclosure Policy (continued)

Full disclosure to patients and families is now mandatory at all VA facilities, including:A face-to-face meeting with the VA chief of staff, the quality manager, the quality management nurse, and the facility directorAll details of the event, including names, are givenThe facility emphasizes their regret and the actions being taken to prevent similar eventsThe VA system is uniqueit is a closed system and can offer restitution such as:Universal health coverageFree corrective treatmentMonthly disability payments to patientsVA practitioners pay no malpractice premiums and are protected from liability

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Legal Concerns

Legal liability is the reason most often given as the reason for avoidance of full disclosure of errorHealth care organizations fear the information could be used to pursue litigationResearch and anecdotal evidence show that this fear may be exaggeratedMost lawsuits are motivated by:Poor communication between patients and their caregiversBreakdown in trust between providers and patientsSuspicion of a cover-upDesire for revenge when an event is not immediately disclosed but later discoveredA feeling of betrayal

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Legal Concerns (continued)

Practitioners are reluctant to talk openly about the event, and even more reluctant to apologize, fearing an admission could lead to litigationAn apology diffuses the situationAn apology is not necessarily an admission An apology is not costly and is rewardingSome states protect benevolent gestures from use as evidence of culpability in legal casesOutright admission of error is admissible in courtThe disclosure team should discuss the risks and benefits of saying, Im sorry this happened to you, versus Im sorry we did this to you.Disclosure does not protect practitioners and facilities, but it may diffuse the emotional feelings that would trigger litigationOffering a fair settlement may avoid a costly trial, or at least influence a jury to consider reducing the award since there was a gesture of compensation for injury

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Personal Barriers

Clinician barriers to successful disclosure of errors:A sense of failureDamage to reputationFear or retribution from patients or colleagues Fear of conducting the conversation poorlyFear of having to handle emotions, the recipients and their ownBelief that disclosure is unnecessaryUnfounded belief that they had no direct involvement in the eventUnfounded belief that the event would have happened anywayPractitioners should receive emotional support during the whole process

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What to Disclose?

Barron and Kuczewski suggest criteria for determining disclosability:The outcome would not be included in a reasonable informed consent process, would not be expected during usual treatment, or bothIt is not possible to exclude error, human or system, from the cause of the outcomeNear misses do not fit the criteria for disclosureTwo arguments regarding near misses:Disclose if patient is aware of near missDo not disclose because it may create anxiety and is not needed for patient to make treatment choicesA benign error that reached the patient, but caused no harm: May disclose if additional monitoring, observation, or treatment is needed to detect, reduce, or eliminate the risk of harmMay choose not to disclose if no treatment or precautionary measures are necessary and if harm from the error is not a possibility

Barron WM, et al. Jt Comm J Qual Saf. 2003;29:5515.

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Who Should Disclose the Error?

Those involved in disclosure of error to patients can vary according to the circumstancesThe attending physician may or may not be the best communicator but should be presentRisk managers should also be involved even though physicians think they are not always in favor of disclosing errors to patientsPhysicians, other practitioners, and risk managers should collaborate to create a disclosure policy and method of communication that will work best for their facility

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Models of Disclosure

The American Society for Healthcare Risk Management offers these models based on facility sizeSmall: one designated person, trained to have effective disclosure communication skillsSmall to medium-sized with sufficient staff: create a team trained in effective disclosure skills and communication of the policiesMedium to large organizations, especially to establish physician buy-in: a train-the-trainer model with a large group of practitioners and others who undergo disclosure training and in turn become trainers and role models for staffOrganizations with a mature culture of patient safety and widespread clinician buy-in: clinician at the site, who has a relationship with the patient, discloses the error, with guidance from an in-house coach who meets with the clinician just before the meeting with the patientOrganization must follow all state, federal, and TJC standards

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Available Tools

The Minnesota Hospital and Healthcare Partnerships offers a communication policy framework for discussionsExpression of regret and apologyTime, place, and circumstances of the accidentThe proximate cause, if knownActions taken to treat any consequences of the accidentWho will oversee the ongoing care of the patientPlans for investigation or review of the incidentOther parties informed of the eventActions taken to identify systems-related causes and preventive effortsWho will oversee ongoing communication with the patientContact information of agencies with which the patient or representative can communicate about the eventHow the patient can obtain support and counseling from the facility and from outside the facilityProcess for discussing compensation for harm

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Available Tools (continued)

The Institute for Healthcare Improvement Web site has a sample serious event disclosure policyThe ISMP Medication Safety Alert! described on page 558 of the textbook provides an outline for preparing for a damaging medication error

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Staff Education and Support

Staff education should include:The use of appropriate terms, defined in positive language Active learning about the barriers to medical error communicationDebriefing sessions and private support counseling for staff members involved in an errorA culture of safety must be created by leaders who support error reportingThe pledge to disclose has proven to be challenging because individual practitioners are still cautious about disclosing errors to colleagues or superiors, regardless of anonymity

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References

Barron WM, Kuczewski MG. Unanticipated harm to patients: deciding when to disclose outcomes. Jt Comm J Qual Saf. 2003;29:5515.

Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System. Washington, DC: National Academies Press; 2000.

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Six states is an accurate number at time of ISMP textbook printing, double check this number prior to presenting this information.

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