8/9/2019 Call for Greater Oversight of Electronic Health Records

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COMMENTARY

SafeElectronicHealthRecordUseRequiresaComprehensive

Monitoring

andEvaluationFrameworkDeanF.Sittig,PhDDavidC.Classen,MD

RECENT PASSAGE OF THE AMERICAN REINVESTMENTandRecoveryAct(ARRA)increasespressureonhealthcarepractitionersandorganizationstoimple-mentcurrentlyavailableelectronichealthrecords

(EHRs).Researchandexperiencegainedtodateshowthatsuch implementationeffortsaredifficult,costly,timeconsuming,

and

fraught

with

many

unintended

conse-quences.1 Evaluationofthesesystemsafter implementa-

tionsuggeststhattheydonotroutinelymeetsafetystandardsofothersafetycriticalindustries.2 TheaggressivetimelineproposedintheARRAbillmeansthatalargenumberofprac-titionersandhealthcareorganizationswillsoonbeattempt-ingamonumentalfeatwithoutthetimeorabilitytocus-tomizethesesystemstotheirlocalworkflows.3

Inapreviousarticle,weproposed8dimensionsorrightsofEHRsafetythataddressedthecomplexsocial,technical,andpersonalissuesassociatedwithEHRuse.4 ThegoalofthisarticleistodescribeanapproachforacomprehensiveEHRmonitoringandevaluationframework(ie,theeighthdimensionofEHRsafety).Withoutsuchacomprehensiveframework,safeandeffectiveEHRusecannotbeensured.

Thisproposedframeworkhas5essentialcomponents:(1)abilityfor practitionersandorganizationsto reportpatientsafetyeventsorpotentialhazardsrelatedtoEHRuse5,6;(2)enhancedEHRcertificationthatincludesspecificassurancesthatgoodsoftwaredevelopmentprocedures7havebeenfollowedalongwithevidencethatpreviouslyreportedadverseeventsandhaz-ardshavebeenaddressed;(3)selfassessment,attestation,test-ing,andreportingbybothcliniciansandhealthcareorgani-zationsthatall8dimensionsofsafeEHRusehavebeenaddressed;(4)local,state,andnationaloversightintheformofanonsite,inpersonaccreditationofEHRsasimplementedandusedbycliniciansinthehealthcaresetting;and(5)anationalEHRrelatedadverseeventinvestigationboardthatreviewsincidentreportsandhastheauthoritytoinvestigate.ReportingEHRSafetyIssuesCurrently,thereisnoclearorganizationorotherentityforhealthcarepractitionerstoreportadverseeventsorpotenSeealsop452.450 JAMA,February3,2010Vol303,No.5(Reprinted)

tialsafetyhazards thatresult from inadequatedesign,development,implementation,oruseofEHRs.KoppelandKreda6 statethatmanyEHRvendorslegallylimittheabil-ityoftheirclientstopublicallyreportthesetypesofprob-lems. Such anationalEHR hazard reportingsystem,describedindetailbyWalkeretal,5 couldincreaseaware-nessofsafetyconcernsamongusersaswellashelpven-dorsidentifyitemsthatneedtheirattention.Thisreport-ingsystemmightbeoperationalizedthrough the newpatientsafetyorganizationstatuteandassociatedAgencyforHealthcareResearchandQuality(AHRQ)commonreportingformats.8EnhancedEHRCertificationTheorganizationsresponsibleforcertifyingEHRsshouldaddthefollowingtypesofcheckstotheircurrentcertifica-tioncriteria.AllEHRvendorsshouldhavetodemonstratethattheyfollowgoodsoftwareengineeringpractices,in-cludingperforminghazardanalysesoftheirproducts,de-signingforsafety,documentingthesedesigns,andverify-ingthattheirsystemsworkasdesigned.7Allsystemsshouldhavetheiruserinterfacestestedforusability.Allvendorsshouldbepreparedtodemonstratethattheyhavesuccess-fullyaddressedallcriticalsoftwareissuesidentifiedwithinthenationalhazardreportingandinvestigationsystemwithinthepreviousyearatanytime.Inaddition,eachEHRshouldbeloadtestedtosimulateitsresponsetimewhenmul-tipleusersareaccessingthesystemsimultaneously.More-over,eachvendorshouldberequiredtopresentdatacol-lected frommultiple implementationsdescribingtheirsystemsreliabilityandresponsetimeasimplemented.Insummary,EHRvendorsmustdemonstratethattheirappli-cationshavebeendesignedforsafety,developedcorrectly,workasdesigned,andhadalltheirdefectsfixed.Self-assessmentofEHRUseA

national,

vendorindependent,

federally

funded

and

man-agedEHRoversightorganizationshoulddevelopaself

AuthorAffiliations:UniversityofTexasatHoustonMemorialHermannCenterforHealthcareQualityandSafety,SchoolofHealthInformationScience,Univer-sityofTexasHealthScienceCenter,Houston(DrSittig);andDepartmentofIn-ternalMedicine,UniversityofUtahSchoolofMedicine,andCSC,SaltLakeCity(DrClassen).CorrespondingAuthor:DeanF.Sittig,PhD,UniversityofTexasatHoustonMemorialHermannCenterforHealthcareQualityandSafety,UniversityofTexasSchoolofHealthInformationSciences,6410FanninSt,UTPB1100.43,Houston,TX77030(dean.f.sittig@uth.tmc.edu).

2010AmericanMedicalAssociation.Allrightsreserved.

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8/9/2019 Call for Greater Oversight of Electronic Health Records

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COMMENTARYassessmentguideforallindividualEHRusersaswellastheorganizationsresponsibleforimplementingthem.Thisguideforusersshouldincludeataminimumapproximately25commonactionsthatausershouldbecapableofperform-ing(eg,lookupapatientbyname,medicalrecordnum-ber,orreviewthe3mostrecentlaboratorytestresults),theorganizations

EHR

downtime

and

reactivation

proce-dures,andanyEHRrelatedadverseeventsorpotentialhaz-

ardsthe userhasbeendirectly involved in. Thisselfassessmenttoolcouldbedevelopedand implementedsimilarlytothewaytheAHRQ/LeapFrogEHR/clinicalde-cisionsupportassessmenttoolhasbeen.9

Inaddition,eachorganizationshouldperformanddocu-mentamoreextensivereviewoftheirclinicalinformationsystemsonayearlybasis.Thisreviewshouldaddresseachofthe8dimensionsofsafeEHRusethatincludeshard-wareandsoftware,clinicalcontent,userinterfaces,usertrain-ingandauthorizationprocedures,clinicalworkflowandcom-munication, organizational policies andprocedures,compliancewithstateandfederalrulesandregulations,andperiodicmeasurementsofsystemactivity.

Theresultsoftheseself andorganizationalassessmentsshouldbesubmittedtoacentralclearinghousethatwouldfacilitatethecreationanddisseminationofnationalEHRsafetybenchmarks.OnsiteAccreditationofEHRSasImplementedandUsedAlthoughthefirst3proposalswillmostlikelyhelptosig-nificantlyimprovethesafetyandeffectivenessofEHRus-agenationwide,thereisstillnosubstituteforperiodic,un-announced,random,onsiteinspectionsofEHRsystems.Theseinspectionscouldbeconductedaspartofongoingorganizationwide,qualityandpatientsafetyaccreditationactivitiesbyorganizations,suchasTheJointCommissionorlocalstatedepartmentsofhealth.Onceagain,thesein-spectionswouldaddressall8dimensionsofsafeEHRuse.4Organizationscouldbegiven6monthstoaddressallofthereviewersconcernsorfacesignificantfinancialpenalties.NationalEHRAdverseEventInvestigationBoardAsEHRsbegintoplayanincreasinglyimportantroleinpa-tientcareonalargescale,communitywidebasis,theOf-ficeoftheNationalCoordinatorforHealthInformationTech-nology(ONC)couldcreateaNationalEHRAdverseEventInvestigationBoard,similartotheNationalTransporta-tion

Safety

Board

or

the

Commercial

Aviation

Safety

Team,

10toinvestigateseriousEHRrelatedadverseeventsorhaz-ardsthatinvolvecomplex,sociotechnicalinteractionsbe-tweencliniciansorpatientsandsoftwaresystems.Thefind-ingsoftheseinvestigationscouldbereportedtotheONCandmadepublicsothatpatients,othervendors,healthcareorganizations,andpractitionerscanlearnfromthem.Thisboardwouldbeprovidedwithunlimitedaccesstoallas-pectsoftheEHR,including,forexample,keysystemback-2010AmericanMedicalAssociation.Allrightsreserved.

ups,changelogs,andminutesfromthelocalEHRsafetyover-sightcommittees.ThisboardwouldhavetheauthoritytoinvestigateallseriousEHRrelatedadverseeventsornearmisses.ConclusionsIn

conclusion,

President

Obama

has

taken

an

important

step

towardimprovingtheclinicalcomputinginfrastructureoftheUShealthcaredeliverysystembystatingthegoalofallcitizenshavingaccesstoanEHR.However,theextremelyaggressivetimelineintheARRAstimuluspackageplacesenormouspressureonhealthcarepractitionersandtheirorganizationstorapidlyimplementEHRs.Suchrapidimple-mentationscouldleadtosignificantpatientsafetyevents.Tohelpensurethattheseimplementationsareassafeandeffectiveaspossible,this5stageproposaltocreateacom-prehensiveEHRmonitoringandevaluationframeworkshouldbeconsidered.Usingsuchaframework,theONC,oranotherdesignatednationalbody,couldbegintopro-videtheoversightneededtoensurethatallEHRimplemen-tationsaresafeandeffectiveandtoprovidethemecha-nismstohelphealthcareorganizationsusingthesesystemstodeliverthehighestquality,lowestcost,andsafesthealthcarepossible.FinancialDisclosures:DrClassenisanemployeeandstockholderofCSC(SaltLakeCity,Utah),atechnologyservicescompany.DrSittigreportednofinancialdisclo-sures.Funding/Support:DrSittigissupportedinpartbygrantR01LM006942fromtheNationalLibraryofMedicine.RoleoftheSponsor:TheNationalLibraryofMedicinehadnoroleintheprepa-ration,review,orapprovalofthemanuscript.AdditionalContributions:HardeepSingh,MD,MPH(VAHSR&DCenterofEx-cellence,MichaelE.DeBakeyVeteransAffairsMedicalCenter,andBaylorCol-legeofMedicine,Houston,Texas);andEricJ.Thomas,MD,MPH(UniversityofTexasatHoustonMemorialHermannCenterforHealthcareQualityandSafetyandDepartmentofMedicine,UniversityofTexasMedicalSchool,Houston),pro-videdtheirvaluablecommentsonanearlierversionofthemanuscript,forwhichtheyreceivednocompensation.

REFERENCES1. SittigDF, Ash JS. Clinical InformationSystems:OvercomingAdverseConsequences.Sudbury,MA:Jones&Bartlett;2009.2. BhansaliPV.Universalsoftwaresafetystandard:ACMSIGSOFTSoftwareEn-gineeringNotes.http://doi.acm.org/10.1145/1095430.1095440.AccessedJanu-ary6,2010.3. SittigDF,AshJS,Zhang J,OsheroffJA,ShabotMM.Lessonsfromunex-pectedincreasedmortalityafterimplementationofacommerciallysoldcomput-erizedphysicianorderentrysystem.Pediatrics.2006;118(2):797801.4. SittigDF,SinghH.Eightrightsofsafeelectronichealthrecorduse.JAMA.2009;302(10):11111113. 5. WalkerJM,CarayonP,LevesonN,etal.EHRsafety:thewayforwardtosafeandeffectivesystems.JAmMedInformAssoc.2008;15(3):272277.6. KoppelR,KredaD.Healthcareinformationtechnologyvendorsholdharm-lessclause:implicationsforpatientsandclinicians.JAMA.2009;301(12):1276-1278.7. LevesonN.Safeware:SystemSafetyandComputers.Indianapolis,IN:AddisonWesleyProfessional;1995.8. SanghviAA.Patientsafetyandqualityimprovementactfinalized.JMedAs-socGa.2009;98(1):5354.9. KilbridgePM,WelebobEM,ClassenDC.DevelopmentoftheLeapfrogmeth-odologyforevaluatinghospitalimplementedinpatientcomputerizedphysicianor-derentrysystems.QualSafHealthCare.2006;15(2):8184.10. PronovostPJ,GoeschelCA,OlsenKL,etal.Reducinghealthcarehazards:lessonsfromtheCommercialAviationSafetyTeam.HealthAff(Millwood).2009;28(3):w479w489.

(Reprinted)JAMA,February3,2010Vol303,No.5 451

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