Consolidated Clinical Document Architecture (C-CDA) For .

Consolidated Clinical Document Architecture(C-CDA) for Clinical Data ExchangeDidi DavisDirector Testing Programs1Copyright 2017 The Sequoia Project. All rights reserved.

Clinical Documentation Before the EHR 2Collection of Commonly used document types for various use cases– History & Physical– Consult Note– Operative Note/Procedure Note– Progress Note– Discharge Summary– Radiology/Imaging– Other Misc.Focused on narrativeSemi-structuredLoosely standardized content 2017 Copyright The Sequoia Project. All Rights Reserved.An initiative of

Convergence of DataClinicalAdministrativeBilling pyright 2017 The Sequoia Project. All rights reserved.PersonalHealthRecord

EHR and Data Quality Challenges and Impact How do you interface computers and humans in themedical environment?– Computers “think” structured and encoded data– Humans “think” in sentences, paragraphs, concepts Data Quality challenges directly related to manyaspects of a clinical workflow and the systems used– Data Capture, Data Storage, Data Exchange– Transitions of Care (ToC) is a common occurrence that ifimproved, benefits the patient population Consistent data representation and interpretation is necessary forToC to improve patient outcomes Interoperability Exchange of the data captured and stored C-CDA is the US/ONC recommended mechanism for ToC4 2017 Copyright The Sequoia Project. All Rights Reserved.An initiative of

C-CDA Provides Semantic Building Blocks!5 2017 Copyright The Sequoia Project. All Rights Reserved.An initiative of

That we can reconfigure for specific purposes6 2017 Copyright The Sequoia Project. All Rights Reserved.An initiative of

The C-CDA document defined1. Persistence: A clinical document continues to exist in an unaltered statefor a time period defined by local and regulatory requirements2. Stewardship: A clinical document is maintained by an organizationentrusted with its care3. Potential for authentication: A clinical document is an assemblage ofinformation that is intended to be legally authenticated4. Context: A clinical document establishes the default context for itscontents5. Wholeness: Authentication of a clinical document applies to the wholeand does not apply to portions of the document without the full contextof the document6. Human readability: A clinical document is human readable to supportdecision making therefore, CDA documents are not:– data fragments, unless signed– birth-to-death aggregate records– electronic health records7 2017 Copyright The Sequoia Project. All Rights Reserved.An initiative of7

C-CDA Design Principles priority is patient care, facilitate sharing of data tohealthcare applicationsminimize technical barriers to implementationpromote longevity of clinical recordsscoped by exchange, independent of transfer or storageenable policy-makers to control information requirements

9 2017 Copyright The Sequoia Project. All Rights Reserved.An initiative of

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C-CDA US Realm Header: Metadata Identify Sufficient for– Patient– Provider– Document type.–––––requiredMedical records managementDocument managementRegistry/repositoryRecord locator serviceStore, query, retrieveAn initiative of

C-CDA Body: Machine Processable Model-based computable semantics:– Observation– Procedure– Organizer– Supply– Encounter– Substance Administration– Observation Media– Region Of Interest– ActAn initiative of

C-CDA: A Document Exchange Specification This is a C-CDAand thisand thisand thisand thisand thisand thisAn initiative of1313

US/ONC/MU Consolidation Project (C-CDA) 2011 Edition/Stage 1 MU2014 Edition/Stage 2 MU:– HL7 Implementation Guide for CDA Release 2: IHE HealthStory Consolidation, DSTU Release 1.1 (US Realm) DraftStandard for Trial Use– HL7 Implementation Guide: S&I Framework Transitions of CareCompanion Guide to Consolidated-CDA for Meaningful UseStage 2, Release 1 – US Realm2015 Edition/Stage3 MU:– HL7 Implementation Guide for CDA Release 2: ConsolidatedCDA Templates for Clinical Notes (US Realm) Draft Standard forTrial Use Release 2.1 – Volume 1 – IntroductoryMaterial(August 2015)– HL7 Implementation Guide for CDA Release 2: ConsolidatedCDA Templates for Clinical Notes (US Realm) Draft Standard forTrial Use Release 2.1- Volume 2 – Templates andSupportingMaterials(August 2015)– Companion Guide to HL7 Consolidated CDA R2.1 for ONC 2015Health IT Certification CriteriaHL7 Implementation Guide for CDA Release 2: Clinical Guidance on Relevant and Pertinent Data to Include AutomaticallyGenerated Patient Summaries HL7 Example Task Force Library Best Practices and Quantitative Scoring Criteria (Scorecard)14Copyright 2017 The Sequoia Project. All rights reserved.HITSPC32MU2015HITSPC62HL7 CCDAv2.1MU2011HL7 CCDAv2.0HL7 CCDAv1.1MU2014An initiative of

C-CDA R2.1 Document Types (12 Total) 15C-CDA R1.0/R1.1– Consultation Note– Continuity of Care Document(CCD)– Diagnostic Imaging Report– Discharge Summary– History and Physical– Operative Note– Procedure Note– Progress Note– Unstructured Document 2017 Copyright The Sequoia Project. All Rights Reserved. New as of C-CDA R2.0/R2.1– Care Plan– Referral Note– Transfer SummaryAn initiative of

C-CDA: Exchanging the Patient’s Story Today, most of the clinical data exchanged by systems leverages ONLY the CCD Many documents are not created by a human but by a machine on demandwhen queried. Data should be exchanged using appropriate document -building-blocks-meaningful-exchange16 2017 Copyright The Sequoia Project. All Rights Reserved.An initiative of

Why is using the right type of document important? 17Each CDA Document is designed to address a specific purpose– Use Cases should be reviewed to determine appropriate documentsfor use to support optimal patient care– Documents need to fit the situation– Share information that is relevant and pertinentEstablish the right context for the information being shared– Information about multiple encounters– Information about a single encounter– Information about a service(s) within an encounter– Information that is related to a specific order– Patient generated information vs. Clinician or System generated data 2017 Copyright The Sequoia Project. All Rights Reserved.An initiative of

70 Document Sections in C-CDA uilding-blocks-meaningful-exchange18 2017 Copyright The Sequoia Project. All Rights Reserved.An initiative of

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What is the Sequoia Project Doing toImprove C-CDA Content Exchanged?24 2017 Copyright The Sequoia Project. All Rights Reserved.An initiative of

2016 - Content Testing Pilot/Program CompletedeHealth Exchange Content Testing Pilot April – July 2016– 20 Organizations Participated in the Pilot with10 different vendor architectures All 20 Organizations had one or more documents fail– 45 Sample Documents Received (9 C32s, 27 R1.1, 9 R2.1)– 5 testing tools were evaluated and scored– Testing Documentation published for 3rd round of public comment November 2015 April 2016 December 2016 2017 Copyright The Sequoia Project . All rights reserved.An initiative of

Industry-wide Content Pain PointsOptionality:Terminology:Specification AmbiguityComplexity:More than one way to do things andinconsistent implementations acrossvendorsInconsistent terminology usageThe C-CDA standard is difficult tounderstand and consume and islacking in clearly documentedexamplesAn initiative of

Data Quality Challenges and ImpactTerminology: Inconsistent terminology usage Coding issues ( 1,000,000 terms spread across multiplevocabularies (RxNorm, ICD-10, SNOMED, LOINC, CPT withoverlap between concepts) How to manage terminologies withconceptual overlap?– Differences around code system mappings, including somecreation of duplicates UCUM errors are common How to handle consistency of meta-information for class andtype codes? 2016 Copyright The Sequoia Project. All rights reserved.An initiative of

Data Quality Challenges and Impact Cont’dOptionality: More than one way to do things and inconsistentimplementations across vendors How to deal with unstructured or free-text informationwhen terminologies are not used? How to deal with missing information? What if there is content in one section but notthe other? When a query for a date range is used, whatsections in a summary of care should the rangebe applied against? 2016 Copyright The Sequoia Project. All rights reserved.An initiative of

Data Quality Challenges and Impact Cont’dComplexity: The C-CDA standard is difficult to understand andconsume; lack of clearly documented examples How to reconcile machine readable entries and the humanreadable portion when information conflicts? How does one package multiple documents that are related? otherdocuments might be a discharge summary, operative note,progress lab, labs? What is the minimal set of metadata that a Content Consumershould display from a query response to help providers havesufficient information to choose from the returned list? How do we handle versioning (C32, HL7 C-CDA R1.1 or R2.1) andconflicting guidance? 2016 Copyright The Sequoia Project. All rights reserved.An initiative of

Data Quality Challenges and Impact Cont’dSpecification Ambiguity Where to include clinical notes in a summary of caredocument - e.g., encounters, procedures, results sections? When a query is issued for a date range, what sections ina summary of care should the range be applied against? Lack of basic understanding and consistentimplementation on service start and stop (to/from) for aquery? Is a summary of care or continuity of care documentbased on a single encounter, multiple encounters,episodic of care? How are external references handled that may crosssecurity contexts? How is embedded formatting handled within textelements? 2016 Copyright The Sequoia Project. All rights reserved.An initiative of

Sequoia Project Content Testing ObjectivesDeveloptesting requirements to test andvalidate Health IT ModulesCreatereview and approve testingdocumentation, checklists and UseCasesDetermineinteroperability testingrequirements to enable robusttesting of information exchangeamong paces.com/Documentation for Comment31Copyright 2016 The Sequoia Project. All rights reserved.An initiative of

What is the Enhanced Content Testing Program? 32Focused on HITSP C32/CCD, HL7 Consolidated CDA (C-CDA) R1.1 and R2.1Enhanced Testable AssertionsMeaningful Use (MU) requirements/Transitions of CareEnhanced test cases and proceduresDesigned to enable interoperability and assure specification complianceImplementation-hardened by years of operations and documented painpoints that continue to be coordinated with HL7 for inclusion in futuredocumentation:– HL7 Implementation Guides/Companion Guides– Improved Scorecard Rubrics (Quantitative Scoring Criteria)– HL7 C-CDA Companion Guide for MU Guidance for R2.1– Relevant & Pertinent Documentation Publication– HL7 CDA Example SearchCopyright 2016 The Sequoia Project. All rights reserved.An initiative of

Process for Creating Consistent & Robust HL7 C-CDAsContentPriorities Clinicians Business Office Others33Copyright 2016 The Sequoia Project. All rights reserved.Data MappingC-CDA Creation SDO Requirements Vendor specific datamodel overlay SemanticInteroperabilityTransformation Identify Sources SystemConfiguration Value Sets Internal/ExternaltransformationAn initiative of