RISK ASSESSMENT FOR PHYSICS PLAN...

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RISKASSESSMENTFORPHYSICSPLANREVIEW

STEPHANIEA.PARKER,MS,DABR

NOVANT HEALTHGREATERWINSTON-SALEMMARKET,NORTHCAROLINA

CONFLICTSOFINTEREST

• None

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DISCLOSURES

•MemberofTG275

OBJECTIVES

• ToprovideanintroductionandoverviewofTG-275• Toshowhowphysics planandchartchecksrelatetoerrormanagement

• TodemonstratetheuseofTG-100Methodology toassess physicsplanandchartcheckprocesses

• ToshareTG-275members’experienceduringFMEAprocess

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OUTLINE• Background

• TheTeam• ChargeandScopeofTG-275• CrewResourceManagement

• TG-275InitialTasks• CurrentGuidelines

• TG-275RiskAssessment(FMEA)ExperiencetoDate• WorkinProgress• Summary

BACKGROUND

• TG-275:StrategiesforEffectivePhysicsPlanandChartReviewinRadiationTherapy

• September2014• EricFordstartedRecruitingMembers• PreliminaryMeeting

• December2014• Proposal Submitted• Kick-OffMeeting

• April2015• ApprovalbyTherapyPhysicsCommittee• ApprovalbyScienceCouncil• AssignedTGNumber

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THETEAM– TG275MEMBERS• EricFord,Chair

• UniversityofWashington

• LeiDong• ScrippsProtonTherapyCenter

• LuisFongdelos Santos• MayoClinic

• AnneGreener• EastOrangeVA

• JenniferJohnson• UTMDAndersonCancerCenter

• PerryJohnson• UniversityofMiami

• GraceGwe-Ya Kim• UniversityofCalifornia,SanDiego,Ca

• JamesMechalakos• MemorialSloan-KetteringCancerCenter

• BrianNapolitano• AAMDRepresentative,MGH

• Stephanie Parker• Novant Health,Winston-Salem,NC

• DeborahSchofield• SaintVincentHospital

• Koren Smith,• MaryBirdPerkinsCancerCenter

• MichelleWells• PiedmontHospital,Atlanta,Ga

• EllenYorke• MemorialSloan-KetteringCancerCenter

THETEAM– TG275MEMBERS• 14Members

• Cross-Section ofRadiationOncologyMedicalPhysics

• AcademicandNon-academicMembers

• GeographicallyDiverse• DiverseWork Experience

• RiskBasedAssessment Experience

• TG-100Member&OtherVeryExperiencedMembers

• FMEANewbies

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CHARGEOFTG-275

• Toreviewexistingdataandrecommendations• Surveyinformationoncurrentpractices• Providerisk-basedrecommendations• Providerecommendations tosoftwarevendors

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SCOPEOFTG-275

• TypesofChecks• InitialPlan/ChartChecks• Continuing (Weekly) PhysicsChecks

• EndofTreatmentChecks(EOT’s)

• TypesofProcedures• ExternalBeam• Photon andElectron

• Brachytherapy• Proton





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CREWRESOURCEMANAGEMENT

CREWRESOURCEMANAGEMENT(CRM)

• IntroducedinaNASAworkshop in1979• SetofTrainingProcedures• UsedinEnvironmentswhereHumanErrorcanhavedevastatingeffects• PrimarilyusedforImprovingAirSafety• Evolvedovertime- Several“Generations”• Hasbeenadaptedtoother fields

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5TH GENERATIONCREWRESOURCEMANAGEMENT• ~1990• InfluencedbyworkofJamesReason• UnderlyingPremisethatHumanError is:

•Ubiquitous• Inevitable• Valuablesourceofinformation

• SetofErrorCountermeasures• Threelinesofdefense• “ErrorTroika”

ERRORTROIKA

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ERRORTROIKA





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TG275INITIALTASKS

• ReviewofCurrentRecommendations• SurveyofCurrentPractices• RiskAssessmentStudy forExternalBeamRT

TGMembersDividedintoThreeGroupstoFocusonSpecificTasks





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CURRENTRECOMMENDATIONS&GUIDELINES

PRIMARYGUIDELINE– TG-40- 1994

TG-275willapplyTG-100Methodology toProvideanUpdatetoTG-40PartVISectionsB&C

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WORKFLOWFORTG275RISKASSESSMENTSTUDY

1. CreateProcessMap2. DevelopOnlineFMEAToolonAAPMWebsite3. CreateDatabaseofFailureModes4. EnterFailureModesandCauses intoOnline Tool5. ScoreFM’s usingAbbreviatedScale6. AnalyzeResultsof3PointScaleFMEA

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WORKFLOWFORTG275RISKASSESSMENTSTUDY

7. RemoveLowScoringFM’s&CombineCauses forRemainingFM’s8. ScoreFM’s usingStandard10PointScale9. IdentifyFM’swithScoreaboveThreshold10.DeterminewhichHighScoringFM’sCould bePreventedorMitigated

withPlanChecks11.DevelopRecommendationsbasedonFMEAResults

1.HIGHLEVELPROCESSMAP

PatientAssessment Simulation Treatment

Planning

Pre-Tx Reviewand

VerificationTreatmentDelivery

On-TreatmentQuality

Management

Post-Treatment

Completion

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2.DEVELOPONLINEFMEATOOLONAAPMWEBSITE

• EricFord’sVision• PrototypeCreatedusingMicrosoftAccess• WorkedwithAAPMITStafftoCreateWebVersion

• Demo’d forFMEAgroupat2015AAPMMeeting

3.CREATEDATABASEOFFAILUREMODES• ExperienceofTG-275Members

• IndividualListsGeneratedbyEachTGMember• ExcelWorkbookwithWorksheetforEachProcessStep

• SAFRON• 51EventIdentified• Potentialtobedetectedonphysicsreview• ListcomparedtoCurrentLists

• 38FM/CauseCombinationsAdded toDatabase

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3.CREATEDATABASEOFFAILUREMODES

• AllListsCompiledintoOneWorkbook•Duplicateentriesremoved

• TGMembersDividedintoSmallGroups•EachGroupReviewedListforOneProcessStep•AddedAdditionalFM’s•RemovedAllFM’sthatWouldOccurAfterInitialPlan/ChartCheck


• ValidationofDatabaseAgainstRO-ILS• 113EventsRelatedtoPhysicsChecks IdentifiedbyEricFord• ListComparedtoDatabaseGeneratedbyTaskGroup

• Excellentagreement• 97of113eventsalreadyincludedindatabase• 10oftheeventsresultedinnewcauses• 6eventsresultedinnewfailuremodes• 4of6ofminorimportanceandexcluded

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• FinalDatabase• 192FailureModes• CausesforeachFMrangedfrom1to21• Totalof594FM/CauseCombinations

4.ENTERFAILUREMODESANDCAUSESINTOONLINETOOL

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4.ENTERFAILUREMODESANDCAUSESINTOONLINETOOL

5.INITIALSCORINGUSINGABBREVIATEDSCALE

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5.INITIALSCORINGUSINGABBREVIATEDSCALE• ScoringInstructions• Enterscoresbasedonexperienceatyourinstitution• Detectabilityscore:

• ScorethiswiththeviewofwhatisdetectablePRIORtotheinitialphysicsplanandchartreview.

• Severityscore.• Scoreasifthefailuregoesallthewaythroughtothepatient.• Scoreforthemostreasonablylikelyscenario

• i.e.nottheworst-casescenario• canalmostalwaysimageascenariowhereafailure modepropagatesinacertainwayastobecomeaseverityof10


• IndividualsEnteredScoresontheAAPMWebsite• ScoringOpenfromApril15toMay92016• TimeConsuming EvenWith3PointScale• ~3.5hours

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6.ANALYSISOF3POINTSCALEFMEA

• RPNScores:1to13.94• SeverityScores:1to3

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HighVariabilityinDetectability


HighestRankingSeverityS=3

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HighestRankingFM

RPN=13.94

6.ANALYSISOF3POINTSCALEFMEA

1

1.2

1.4

1.6

1.8

2

2.2

2.4

2.6

2.8

3

1 3 5 7 9 11 13 15 17 19 21 23 25 27

Severity

RPN

RangeofPotentialValues

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7.REMOVELOWSCORINGFM’S

• NeededtoDetermineThresholdforEliminationofLowScores• DecidedtoKeeptop40%ofbothRPNandSScores• KeptFM’swithRPN≥ 5.5andS≥ 2


1

1.2

1.4

1.6

1.8

2

2.2

2.4

2.6

2.8

3

1 3 5 7 9 11 13 15

Severity

RPN

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1

1.2

1.4

1.6

1.8

2

2.2

2.4

2.6

2.8

3

1 3 5 7 9 11 13 15

Severity

RPN

RPNValues≥ 5.5


1

1.2

1.4

1.6

1.8

2

2.2

2.4

2.6

2.8

3

1 3 5 7 9 11 13 15

Severity

RPN

RPNValues≥ 5.5

S≥ 2

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1

1.2

1.4

1.6

1.8

2

2.2

2.4

2.6

2.8

3

1 3 5 7 9 11 13 15

Severity

RPN

Eliminated258FM’s

7. REMOVELOWSCORINGFM’S

• Startedwith594FailureMode/CauseCombinations• Eliminated258thatFellBelowtheThreshold• 336Remaining- Stilltoomany• CombinedCauses forManyFM’s• FinalResultfor10PointScaleScoring– 118FM/CauseCombinations

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8.SCOREFM’SUSINGSTANDARD10POINTSCALE

• ScoringOpenJune27- July11,2016• 1to1.5Hours toCompleteScoring

INPROGRESS

7. IdentifyFM’swithScoreaboveThreshold8. DeterminewhichHighScoringFM’sCouldbePrevented

orMitigatedwithPlanChecks9. DevelopRecommendationsbasedonFMEAResults

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ALSOINPROGRESS

• WeeklyandEOTChartCheckFMEA• BrachytherapyFMEA• ProtonTherapyFMEA

SUMMARY• TG-275hascompletedmostoftheExternalBeamInitialPhysicsPlan/ChartCheckFMEA• Currentlyanalyzingdatafromthe10PointScaleScoring• UniquefeaturesofTG-275FMEA• Multi-institutional experienceconsidered• UsedanOnline FMEATool• InitiallyUsed3PointScaleScoring• Scoredbasedonmostlikelyscenarioinsteadofworstcasescenario

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THEEND

• Thankyouforyourtimeandattention!

REFERENCES

• ACR–AAPMTECHNICALSTANDARDFORTHEPERFORMANCEOFRADIATIONONCOLOGYPHYSICSFOREXTERNALBEAMTHERAPY

• Ford,EricC.etal.(2009).EvaluationofSafetyinaRadiationOncologySettingUsingFailureModeandEffectsAnalysis.Int.J.RadiationOncologyBiol.Phys,74(3),852– 858.

• Helmreich,R.L.,Merritt,A.C.,&Wilhelm,J.A.(1999).TheevolutionofCrewResourceManagementtrainingincommercialaviation.InternationalJournalofAviationPsychology,9(1),19-32.

• Huq etal. (2016)ThereportofTaskGroup100oftheAAPM:Applicationofriskanalysismethodstoradiationtherapyqualitymanagement.Med.Phys. 43(7),4209– 4262.

• Kutcheretal.(1994).ComprehensiveQAforradiationoncology:ReportofAAPMRadiationTherapyCommitteeTaskGroup40.Med.Phys.,21(4),598-599,609-611.

• Rath,Frank.(2008).ToolsforDevelopingaQualityManagementProgram:ProactiveTools.Int.J.RadiationOncologyBiol.Phys.,71(1),S187–S190

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