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Risk Management in HealthcareRisk Management in Healthcare

Frank R. Painter, MS, CCEFrank R. Painter, MS, CCEClinical Engineering Internship Clinical Engineering Internship Program DirectorProgram DirectorUniversity of ConnecticutUniversity of ConnecticutHealthcare Technology ConsultantHealthcare Technology Consultant

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ACCEACCE

American College of Clinical American College of Clinical EngineeringEngineeringProfessional society of Clinical Professional society of Clinical EngineersEngineers

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Risk Versus SafetyRisk Versus Safety

Safety & Risk; opposite sides of the Safety & Risk; opposite sides of the same coinsame coin

If risk goes up, safety goes downIf risk goes up, safety goes down

If risk goes down, safety goes upIf risk goes down, safety goes up

Everyone likes safety; no one likes Everyone likes safety; no one likes riskrisk

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Risk Versus SafetyRisk Versus Safety

Risk management identifies risks, Risk management identifies risks, analyzes risk data and mitigates riskanalyzes risk data and mitigates riskSafety programs manage that risk Safety programs manage that risk through education, maintenance, through education, maintenance, design, and personal protective design, and personal protective equipmentequipment

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Understanding SafetyUnderstanding Safety

Safety = The level of risk you are Safety = The level of risk you are willing to acceptwilling to accept

SafetySafety is freedom from danger, is freedom from danger, risk or injuryrisk or injury

Safety is subjectiveSafety is subjective

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Understanding RiskUnderstanding Risk

RiskRisk is the possibility of suffering is the possibility of suffering harm or lossharm or loss

Probability of an eventProbability of an event

Severity of an eventSeverity of an event

Risk = Probability x SeverityRisk = Probability x Severity

Risk is measured in numbersRisk is measured in numbers

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Risk AcceptanceRisk Acceptance

Acceptableconsideringthe benefit

Probability

Severity

Generallyunacceptable

Generallyacceptable

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Managing RiskManaging Risk

Reduce the probabilityReduce the probability

Reduce the severityReduce the severity

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Healthcare RisksHealthcare Risks

Medication ErrorsMedication ErrorsWrong Site SurgeryWrong Site SurgeryHospital Acquired InfectionsHospital Acquired InfectionsManaging Multiple AlarmsManaging Multiple AlarmsPatient RestraintsPatient RestraintsElectromagnetic InterferenceElectromagnetic InterferencePatient FallsPatient FallsSurgical & ICU FiresSurgical & ICU FiresElectrosurgical BurnsElectrosurgical Burns

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Managing RiskManaging Risk

CONTROLtake actions toavoid/minimize

risks

EVALUATEcompute risk exposures anddetermine which risks posethe greatest threat, and how

they might be averted

ANALYZEestimate the likelihood

and loss of eachoutcome, under all

alternative choices ordecisions

PLAN ACTIONavoid/minimize risks

MONITORmonitor risk preventionactivities and modify as

needed

ASSESSRISK

identify, name andcategorize risks

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2007

Unusual Conditions in Unusual Conditions in Hospitals Increase RiskHospitals Increase Risk–– Functions 24 x 7Functions 24 x 7–– Multiple functions; patient care, cafeteria, clinical Multiple functions; patient care, cafeteria, clinical

lab, laundry, etclab, laundry, etc–– Hospital equipment varied and complex Hospital equipment varied and complex –– Hazards affect healthy staff as well as severely ill Hazards affect healthy staff as well as severely ill

& immobile patients& immobile patients–– ““HazardsHazards”” mean fires, infections, security issues, mean fires, infections, security issues,

chemicals and the likechemicals and the like–– Hazards vary with equipment and applicationsHazards vary with equipment and applications–– Hazards constantly changingHazards constantly changing

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Integrated Safety Integrated Safety Program Program (Tobey Clark)(Tobey Clark)

Environmental Safety

Employee Safety

Risk Management

Patient Safety

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Hospital Risk Management Hospital Risk Management ProgramsPrograms

One component of an overall quality One component of an overall quality control programcontrol programHistorically, treated as separate processHistorically, treated as separate processRecently integrated into quality Recently integrated into quality assurance and patient safety activitiesassurance and patient safety activitiesRisk managers, safety officers, quality Risk managers, safety officers, quality assurance, & patient safetyassurance, & patient safetyAll integrated at some levelAll integrated at some level

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Hospital Risk ManagementHospital Risk Management(continued)(continued)

Risk is an exposure to the chance of Risk is an exposure to the chance of injury or financial lossinjury or financial lossRisk Managers reduce liability & costs Risk Managers reduce liability & costs by managing risksby managing risksAccident data analysisAccident data analysisConstant systems improvements to Constant systems improvements to reduce riskreduce risk

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Risk ManagementRisk Management

Insurance policiesInsurance policies–– MalpracticeMalpractice–– LiabilityLiability–– Errors & OmissionsErrors & Omissions

Claims managementClaims managementRisk reduction strategiesRisk reduction strategiesIncident investigationIncident investigation

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Risk Management ToolsRisk Management Tools

Administrative supportAdministrative supportHazard identificationHazard identificationHazard evaluationHazard evaluationTrainingTrainingControlsControlsCommunicationsCommunicationsRecord keeping Record keeping Program review & improvementProgram review & improvementTotal involvementTotal involvement

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JCAHOJCAHO

Environment of Care StandardsEnvironment of Care Standards–– Safety ManagementSafety Management–– Security ManagementSecurity Management–– Hazardous Materials & Waste ManagementHazardous Materials & Waste Management–– Emergency ManagementEmergency Management–– Life Safety (Fire Safety) ManagementLife Safety (Fire Safety) Management–– Medical Equipment ManagementMedical Equipment Management–– Utility Systems ManagementUtility Systems Management–– Safety Committee & Safety OfficerSafety Committee & Safety Officer

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JCAHOJCAHO

Patient Safety StandardsPatient Safety Standards

–– Annual FMEA (Failure Mode Annual FMEA (Failure Mode and Effect Analysis)and Effect Analysis)

–– Sentinel Events Sentinel Events –– RCA (RootRCA (RootCause Analysis)Cause Analysis)

–– National Patient Safety GoalsNational Patient Safety Goals

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Clinical Engineers as Risk Clinical Engineers as Risk ManagersManagers

By definition, clinical engineers By definition, clinical engineers ““apply apply engineering and managerial skills to engineering and managerial skills to the advancement of health care.the advancement of health care.””

Engineering educationEngineering education–– Scientific method (cause and effect)Scientific method (cause and effect)–– Analysis of systems and processes Analysis of systems and processes

(identify root causes)(identify root causes)

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Clinical Engineers as Risk Clinical Engineers as Risk ManagersManagers

Knowledge:Knowledge:–– How technology worksHow technology works–– How hospitals workHow hospitals work–– How the human body worksHow the human body works–– How the human mind worksHow the human mind works–– How to investigate an accidentHow to investigate an accident–– How to work with peopleHow to work with people–– How to write technical reportsHow to write technical reports

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Engineering & Risk Engineering & Risk ReductionReduction

Contributions to risk reduction and Contributions to risk reduction and patient safety:patient safety:–– Medical equipment planningMedical equipment planning

–– Medical equipment inspectionMedical equipment inspection

–– Medical equipment maintenanceMedical equipment maintenance

–– Training medical equipment usersTraining medical equipment users

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Engineering & Risk Engineering & Risk ReductionReduction

Management of recalls & hazard alertsManagement of recalls & hazard alerts

Analysis of maintenance recordsAnalysis of maintenance records

Review of Review of ““near missnear miss”” eventsevents

Incident investigationIncident investigation

User TrainingUser Training

Quality ImprovementQuality Improvement

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Systems Approach to Systems Approach to Reducing Medical Device RiskReducing Medical Device Risk

Assure safety of systems & processesAssure safety of systems & processesModify systems & processes as Modify systems & processes as recommended by the teamrecommended by the teamInvestigate failuresInvestigate failures–– Identify root causesIdentify root causes–– Modify the Modify the systemssystems to prevent future to prevent future

failures failures –– Benefit from past failuresBenefit from past failures

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ManufacturersManufacturers

Know their devicesKnow their devicesUse FMEA in designUse FMEA in designUse human factors Use human factors engineering and usability engineering and usability testing in designtesting in designKeep a complaint fileKeep a complaint fileListen to feedback and Listen to feedback and improve the design improve the design

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Healthcare WorkersHealthcare Workers

Device trainingDevice training–– How it worksHow it works–– What can go wrongWhat can go wrong–– What happens when it goes wrongWhat happens when it goes wrong

Report problems without fear of Report problems without fear of punishment or ridicule.punishment or ridicule.Competency assessmentCompetency assessment

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Patients and FamilyPatients and Family

Device TrainingDevice Training

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Clinical EngineersClinical Engineers

Device TrainingDevice TrainingService and inspectionService and inspectionInvestigate problemsInvestigate problemsProvide feedback to healthcare Provide feedback to healthcare workersworkersAdvise administrationAdvise administration

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AdministrationAdministration

Know devices in generalKnow devices in general–– Costs, risks, supplies, maintenanceCosts, risks, supplies, maintenance……Support training and improvementSupport training and improvementSupport nonSupport non--punitive problem punitive problem reportingreportingProvide record keepingProvide record keepingShare informationShare informationHave a planHave a plan

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GovernmentGovernment

Regulate medical device qualityRegulate medical device qualityCreate systems to share informationCreate systems to share informationFacilitate open communicationsFacilitate open communicationsPublicize trendsPublicize trendsEncourage quality healthcare systemsEncourage quality healthcare systemsAcknowledge good performanceAcknowledge good performance

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Risk Management Risk Management SummarySummary

Safety must begin at the topSafety must begin at the top------Ministry Ministry of Health, Local Health Authoritiesof Health, Local Health Authorities , , and hospital administratorsand hospital administrators------but must but must be implemented by motivated staff be implemented by motivated staff membersmembers

Risk management must be fully Risk management must be fully integrated into our health care culture, integrated into our health care culture, systems and processessystems and processes

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Risk Management Risk Management Summary Summary (continued)(continued)

Investigation of accidents, incidents and Investigation of accidents, incidents and ““near hitsnear hits”” can provide information that will can provide information that will allow improvements in systems and allow improvements in systems and processesprocesses

Clinical Engineers are valuable team Clinical Engineers are valuable team members members –– Educated, trained and experienced in accident Educated, trained and experienced in accident

investigation, they can provide the identification investigation, they can provide the identification of the root causes of failed systemsof the root causes of failed systems

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2007 perguntas

comentários

&