consolidated clinical document architecture (c-cda) for

1 Copyright©2017TheSequoiaProject.Allrightsreserved.

ConsolidatedClinicalDocumentArchitecture(C-CDA)forClinicalDataExchange

DidiDavisDirectorTestingPrograms

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ClinicalDocumentationBeforetheEHR

• CollectionofCommonlyuseddocumenttypesforvarioususecases– History&Physical– ConsultNote– OperativeNote/ProcedureNote– ProgressNote– DischargeSummary– Radiology/Imaging– OtherMisc.

• Focusedonnarrative• Semi-structured• Looselystandardizedcontent

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Convergence of Data

AdministrativeBilling & Claims

Clinical

Personal Health Record

ResearchBest

Practices

Patient-Centered

Care


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EHRandDataQualityChallengesandImpact• Howdoyouinterfacecomputersandhumansinthe

medicalenvironment?– Computers“think”structured andencodeddata– Humans“think”insentences,paragraphs,concepts

• DataQualitychallengesdirectlyrelatedtomanyaspectsofaclinicalworkflowandthesystemsused– DataCapture,DataStorage,DataExchange– TransitionsofCare(ToC)isacommonoccurrencethatif

improved,benefitsthepatientpopulation• ConsistentdatarepresentationandinterpretationisnecessaryforToC toimprovepatientoutcomes

• InteroperabilityExchangeofthedatacapturedandstored• C-CDAistheUS/ONCrecommendedmechanismforToC


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C-CDAProvidesSemanticBuildingBlocks!


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Thatwecanreconfigureforspecificpurposes


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TheC-CDAdocumentdefined1. Persistence: A clinical document continues to exist in an unaltered state

for a time period defined by local and regulatory requirements2. Stewardship: A clinical document is maintained by an organization

entrusted with its care3. Potential for authentication: A clinical document is an assemblage of

information that is intended to be legally authenticated4. Context: A clinical document establishes the default context for its

contents5. Wholeness: Authentication of a clinical document applies to the whole

and does not apply to portions of the document without the full context of the document

6. Human readability: A clinical document is human readable to support decision making

• therefore, CDA documents are not:– data fragments, unless signed– birth-to-death aggregate records– electronic health records

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C-CDA Design Principles• priority is patient care, facilitate sharing of data to

healthcare applications• minimize technical barriers to implementation• promote longevity of clinical records• scoped by exchange, independent of transfer or storage• enable policy-makers to control information requirements

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C-CDA US Realm Header: Metadata

• Identify– Patient– Provider– Document type...

• Sufficient for– Medical records management– Document management– Registry/repository– Record locator service– Store, query, retrieve

required

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C-CDA Body: Machine Processable• Model-based computable semantics:

– Observation– Procedure– Organizer– Supply– Encounter– Substance Administration– Observation Media– Region Of Interest– Act

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C-CDA: A Document Exchange Specification• This is a C-CDA• and this• and this• and this• and this• and this• and this

13

Aninitiativeof14 Copyright©2017TheSequoiaProject. Allrightsreserved.

US/ONC/MUConsolidationProject(C-CDA)

HITSPC32

HITSPC62

MU2011

HL7C-CDAv1.1

MU2014

HL7C-CDAv2.0

HL7C-CDAv2.1

MU2015

• 2011Edition/Stage1MU• 2014Edition/Stage2MU:

– HL7ImplementationGuideforCDA®Release2:IHEHealthStoryConsolidation,DSTURelease1.1(USRealm)DraftStandardforTrialUse

– HL7ImplementationGuide:S&IFrameworkTransitionsofCareCompanionGuidetoConsolidated-CDAforMeaningfulUseStage2,Release1– USRealm

• 2015Edition/Stage3MU:– HL7ImplementationGuideforCDA®Release2:Consolidated

CDATemplatesforClinicalNotes(USRealm)DraftStandardforTrialUseRelease2.1– Volume1– IntroductoryMaterial(August2015)

– HL7ImplementationGuideforCDA®Release2:ConsolidatedCDATemplatesforClinicalNotes(USRealm)DraftStandardforTrialUseRelease2.1- Volume2– TemplatesandSupportingMaterials(August2015)

– CompanionGuidetoHL7ConsolidatedCDAR2.1forONC2015HealthITCertificationCriteriaHL7ImplementationGuideforCDARelease2:Clinical

• GuidanceonRelevantandPertinentDatatoIncludeAutomaticallyGeneratedPatientSummaries

• HL7ExampleTaskForceLibrary

• BestPracticesandQuantitativeScoringCriteria(Scorecard)

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C-CDAR2.1DocumentTypes(12Total)

• C-CDAR1.0/R1.1– ConsultationNote– ContinuityofCareDocument

(CCD)– DiagnosticImagingReport– DischargeSummary– HistoryandPhysical– OperativeNote– ProcedureNote– ProgressNote– UnstructuredDocument

• NewasofC-CDAR2.0/R2.1– CarePlan– ReferralNote– TransferSummary


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C-CDA:ExchangingthePatient’sStory


http://www.himss.org/library/c-cda-documents-building-blocks-meaningful-exchange

• Today,mostoftheclinicaldataexchangedbysystemsleveragesONLYtheCCD• Manydocumentsarenotcreatedbyahumanbutbyamachineondemand

whenqueried.Datashouldbeexchangedusingappropriatedocumenttypes.

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Whyisusingtherighttypeofdocumentimportant?

• EachCDADocumentisdesignedtoaddressaspecificpurpose– UseCasesshouldbereviewedtodetermineappropriatedocuments

forusetosupportoptimalpatientcare– Documentsneedtofitthesituation– Shareinformationthatisrelevantandpertinent

• Establishtherightcontextfortheinformationbeingshared– Informationaboutmultipleencounters– Informationaboutasingleencounter– Informationaboutaservice(s)withinanencounter– Informationthatisrelatedtoaspecificorder– Patientgeneratedinformationvs.ClinicianorSystemgenerateddata


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70DocumentSectionsinC-CDAR2.1



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WhatistheSequoiaProjectDoingtoImproveC-CDAContentExchanged?


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2016- ContentTestingPilot/ProgramCompleted

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eHealthExchangeContentTestingPilotApril– July2016– 20OrganizationsParticipatedinthePilotwith

10differentvendorarchitectures• All20Organizationshadoneormoredocumentsfail

– 45SampleDocumentsReceived(9C32s,27R1.1,9R2.1)– 5testingtoolswereevaluatedandscored– TestingDocumentationpublishedfor3rd roundofpubliccomment

• November2015• April2016• December2016

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Industry-wideContentPainPoints

Terminology:Inconsistentterminologyusage

Optionality:Morethanonewaytodothingsandinconsistentimplementationsacrossvendors

Complexity:TheC-CDAstandardisdifficulttounderstandandconsumeandislackinginclearlydocumentedexamples

SpecificationAmbiguity

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DataQualityChallengesandImpact

Terminology:Inconsistentterminologyusage• Codingissues(>1,000,000termsspreadacrossmultiple

vocabularies(RxNorm,ICD-10,SNOMED,LOINC,CPTwithoverlapbetweenconcepts)

• Howtomanageterminologieswithconceptualoverlap?– Differencesaroundcodesystemmappings,includingsome

creationofduplicates• UCUMerrorsarecommon• Howtohandleconsistencyofmeta-informationforclassand

typecodes?

©2016CopyrightTheSequoiaProject.Allrightsreserved.

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DataQualityChallengesandImpactCont’dOptionality:Morethanonewaytodothingsandinconsistentimplementationsacrossvendors• Howtodealwithunstructuredorfree-textinformation

whenterminologiesarenotused?• Howtodealwithmissinginformation?• Whatifthereiscontentinonesectionbutnot

theother?• Whenaqueryforadaterangeisused,what

sectionsinasummaryofcareshouldtherangebeappliedagainst?


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DataQualityChallengesandImpactCont’dComplexity:TheC-CDAstandardisdifficulttounderstandandconsume;lackofclearlydocumentedexamples• Howtoreconcilemachinereadableentriesandthehuman

readableportionwheninformationconflicts?• Howdoesonepackagemultipledocumentsthatarerelated?other

documentsmightbeadischargesummary,operativenote,progresslab,labs?

• WhatistheminimalsetofmetadatathataContentConsumershoulddisplayfromaqueryresponsetohelpprovidershavesufficientinformationtochoosefromthereturnedlist?

• Howdowehandleversioning(C32,HL7C-CDAR1.1orR2.1)andconflictingguidance?


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DataQualityChallengesandImpactCont’d

SpecificationAmbiguity• Wheretoincludeclinicalnotesinasummaryofcaredocument- e.g.,encounters,procedures,resultssections?

• Whenaqueryisissuedforadaterange,whatsectionsinasummaryofcareshouldtherangebeappliedagainst?

• Lackofbasicunderstandingandconsistentimplementationonservicestartandstop(to/from)foraquery?

• Isasummaryofcareorcontinuityofcaredocumentbasedonasingleencounter,multipleencounters,episodicofcare?

• Howareexternalreferenceshandledthatmaycrosssecuritycontexts?

• Howisembeddedformattinghandledwithintextelements?


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SequoiaProjectContentTestingObjectives

https://ehealth-exchange-testing.wikispaces.com/Documentation+for+Comment


DeveloptestingrequirementstotestandvalidateHealthITModules

Createreviewandapprovetestingdocumentation,checklistsandUseCases

Determineinteroperabilitytestingrequirementstoenablerobusttestingofinformationexchangeamongparticipants

Aninitiativeof32 Copyright©2016TheSequoiaProject.Allrightsreserved.

WhatistheEnhancedContentTestingProgram?

• FocusedonHITSPC32/CCD,HL7ConsolidatedCDA(C-CDA)R1.1andR2.1• EnhancedTestableAssertions• MeaningfulUse(MU)requirements/TransitionsofCare• Enhancedtestcasesandprocedures• Designedtoenableinteroperabilityandassurespecificationcompliance• Implementation-hardenedbyyearsofoperationsanddocumentedpain

pointsthatcontinuetobecoordinatedwithHL7forinclusioninfuturedocumentation:– HL7ImplementationGuides/CompanionGuides– ImprovedScorecardRubrics

• (QuantitativeScoringCriteria)– HL7C-CDACompanionGuideforMUGuidanceforR2.1– Relevant&PertinentDocumentationPublication– HL7CDAExampleSearch

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ProcessforCreatingConsistent&RobustHL7C-CDAs

ContentPriorities• Clinicians• BusinessOffice• Others

DataMapping• SDORequirements• Vendorspecificdatamodeloverlay

• SemanticInteroperabilityTransformation

C-CDACreation• IdentifySources• SystemConfiguration

• Value Sets• Internal/Externaltransformation


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EnhancedContentTesting- Milestones


MilestoneDescriptions TargetDate Status

PresenttoCCforReview/approval 11/15/16 Completed

ParticipantInput(PostdrafttoeHealthExchangeWiki)

11/15/16 Completed

Participant InputInformational Call(Reviewdocumentation)

12/02/16 Completed

30daynoticetoParticipants 12/02/16 Completed

30+dayObjectionPeriodEnds 01/09/17 Completed

TargetEffectiveDate 01/10/2017 Completed

eHealthExchangeToolingImplementation/Training Q2/2017 NotStarted

TestingWorkgroupFeedback toHL7/ONC Ongoing Ongoing

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ContentTestingFutureTimeline


• PublicCommentofUpdatedDocumentationthroughDecember2016• TestingToolingchosenforProductionContentTestingbyFebruary2017• ProductionContentTestingtobeginQ2/2017

– AllNewparticipantswillberequiredtotestContent– ExistingProductionParticipantswillhave12monthstotestcontent– ErrorsEncounteredwithInitialtestingwillhavetobecorrectedwithin

18monthsofinitialtestingreport• Enablecontinuousimprovementstoclinicalcontentexchanged• OngoingFeedbacktoHL7fromindustrytoimprovestandards