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Copyright 2004 Liora Alschuler Clinical Document Architecture CDA::CCR and the Continuity of Care Record MRI Conference August 2004, Boston Liora Alschuler.

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Presentation on theme: "Copyright 2004 Liora Alschuler Clinical Document Architecture CDA::CCR and the Continuity of Care Record MRI Conference August 2004, Boston Liora Alschuler."— Presentation transcript:

1 copyright 2004 Liora Alschuler Clinical Document Architecture CDA::CCR and the Continuity of Care Record MRI Conference August 2004, Boston Liora Alschuler

2 copyright 2004 Liora Alschuler 2 Liora Alschuler –alschuler.spinosa, consultants –Co-chair, HL7 Structured Documents TC –Co-chair, HL7 Marketing Committee –Co-editor, CDA –Single Source, principal –Manager, 2004 HL7 HIMSS Technical Demo

3 copyright 2004 Liora Alschuler 3 Outline Introduction to the CDA –What is the CDA & What Does It Do? –Key Design Decisions –Implementing CDA CDA and CCR Current & future

4 copyright 2004 Liora Alschuler 4 Clinical Document Architecture ANSI/HL7 CDA R first certified XML spec for healthcare first balloted portion of HL7s V3 first RIM-based specification created & maintained by HL7 Structured Documents Technical Committee (SDTC) CDA

5 copyright 2004 Liora Alschuler 5 Short history of CDA Jan. 1997: 1st meeting as HL7 SGML SIG July 1997: Operation Jumpstart at Kona Mansion Jan. 1998: Kona Editorial Group (KEG) Sept. 1998: Presentation of (renamed & RIM- based) Patient Record Architecture (PRA) Jan. 2000: First committee level ballot passes May 2000: Second committee level ballot passes Sept. 2000: Membership ballot passes unanimously Nov. 2000: ANSI/HL7 CDA R July 2003: First committee ballot CDA Release 2 August 2004: Third committee ballot now open

6 copyright 2004 Liora Alschuler 6 Clinical Document Architecture 3M Health Information Systems Akron General Medical Center Care Data Systems CareScience, Inc. Danica Biomedical AB Electronic Data Systems Corporation Epic Systems Corporation Figler Consulting Health Network Ventures Healtheon/WebMD Corporation HL7 Australia HL7 Canada HL7 Germany HL7 Japan HL7 United Kingdom IDX Systems Corporation Intermountain Health Care Kaiser Permanente, Inc. Lanier Worldwide, Inc. LifeGard Technologies Los Alamos National Laboratory Magnolia Technologies Mayo Foundation McKessonHBOC Medic Computer Systems, LLC Medical Center of Boston Intl Medical Informatics Project, UCSF Medical Manager Research & Development, Inc. MedicaLogic, Inc. Netfish Technologies, Inc. Oacis Healthcare Systems, Inc. Oracle Corporation Partners HealthCare System, Inc. PBM Micro, Inc. Per-Se Technologies, Inc. Pitt County Mem. Hospital /University Systems QuadraMed Corporation Queensland Health Saint Vincent Hospital and Health Center Shafarman Consulting Shared Medical Systems (SMS) St. Alphonsus Regional Medical Center SUNY Stony Brook Sutter Health the BREENs The Word Electric U.S. Department of Veterans Affairs University of California Arthur ASHE Student University of Chicago Hospitals & Health Systems Washoe Medical Center Release 1.0: 3 ballots; 108 votes; all negatives reconciled; unanimous final ballot

7 copyright 2004 Liora Alschuler 7 The HL7 Clinical Document Architecture priority is patient care, other applications facilitated 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

8 copyright 2004 Liora Alschuler 8 The scope of the CDA is the standardization of clinical documents for exchange. CDA: scope

9 copyright 2004 Liora Alschuler 9 CDA: A Document Exchange Specification This is a CDA and this

10 copyright 2004 Liora Alschuler 10 CDA: A Document Exchange Specification A CDA can be a –Discharge Summary –Referral –Progress Note –H&P –Public health report … any content that carries a signature

11 copyright 2004 Liora Alschuler 11 Clinical Document Architecture on One Leg (Relatively) simple XML specification for exchange of clinical documents The rest is commentary

12 copyright 2004 Liora Alschuler 12 Sample CDA: Ballot R1 2000

13 copyright 2004 Liora Alschuler 13 Sample CDA: HIMSS 2004

14 copyright 2004 Liora Alschuler 14 Why ? Lack of usable and re-usable electronic data: Numbers moving slowly upward, if at all Need to get information to the point of care, as-needed, when needed Need to leverage investment in information through re-use for decision support, claims, clinical trials…

15 copyright 2004 Liora Alschuler 15 Applications of the CDA…or What can you do with a few tags? access/portability/exchange –query/locate by patient, provider, practioner, setting, encounter, date –access distributed information through common metadata integration –multiple transcription systems –with EHR records re-use/derivative data –summaries, reports –decision support

16 copyright 2004 Liora Alschuler 16 The CDA document defined (material in blue is quoted from the Clinical Document Architecture Release 1.0) CDA Release 2 (draft), section 2.1: A clinical document... has the following characteristics: Persistence Stewardship Potential for authentication Context Wholeness Human readability Context - Contents of a clinical document share a common context unless all or part of that context is overridden or nullified.

17 copyright 2004 Liora Alschuler 17 Other Key Aspects of CDA CDA documents are encoded in XML CDA documents derive their meaning from the HL7 Reference Information Model (RIM) and use the HL7 Version 3 data types The CDA specification is generic to all clinical content CDA documents can be constrained to meet the requirements of specific document types

18 copyright 2004 Liora Alschuler 18 CDA documents are human readable = –This principle means that CDA documents are human readable using: a) widely-available and commonly deployed XML- aware browsers and print drivers and b) a generic CDA style sheet written in a standard style sheet language. CDA documents are also machine processable to the degree that markup has been added –required markup provides initial functionality –optional markup can augment processing CDA::Readability

19 copyright 2004 Liora Alschuler 19 XML-encoded info Allergies and Adverse Reactions Penicillin - Hives CDA Release 2.0: Draft human readable machine processible

21 copyright 2004 Liora Alschuler 21 The CDA Header: Purpose The CDA Header is constant across all CDA documents. Its purpose is to: –Enable clinical document exchange across and within institutions –Facilitate clinical document management –Facilitate compilation of an individual patients clinical documents into a lifetime electronic patient record (uniquely identify a single patient)

22 copyright 2004 Liora Alschuler 22 CDA Level One Body The body consists of either nested containers (sections, paragraphs, lists, tables) or a non-XML blob

23 copyright 2004 Liora Alschuler 23 CDA "structures" CDA "entries" A section can contain "structures", nested section's, and codes. CDA structures contain "entries".

24 copyright 2004 Liora Alschuler 24 CDA: How to Create creating CDA documents –eForms –transcription –EHR –knowledge base –dynamic query –HL7 message conversion (V2 & V3) –DICOM Structured Report transform

25 copyright 2004 Liora Alschuler 25 any way you like CDA: How to Display

26 copyright 2004 Liora Alschuler 26 XML data is accessible Allergy List … Medications List automated table of contents creation, linked to content, through style sheet transformations

27 copyright 2004 Liora Alschuler 27 One document, many views Many documents, one view CDA: How to Display

28 copyright 2004 Liora Alschuler 28 CDA::HIMSS demo 2004 Document creation: –Epic –Microsoft InfoPath (2) –Dictaphone –Adobe –Microsoft BizTalk Server –GE Management/display: –NIST ebXML registry/repository (open source): model for NHII –Siemens –MS BizTalk, Sharepoint –Raining Data –Kryptiq –Digital Infuzion –CommerceNet –Simi Document types: –Clinical documentation: surgical note, imaging report, discharge summary –Claims attachments (HIPAA) –Continuity of Care/Referral (Massachusetts Medical Society) –Public health reporting (CA Dept of PH Botulism Case Report) –Tumor registry report (College of American Pathologists) –Structured Product Label (SPL)

29 copyright 2004 Liora Alschuler 29 Continuity of Care scenario –Developed by physicians at Massachusetts Medical Society, Duke University Medical Center, Northwestern (Chicago) –Document types: MMS/ASTM Continuity of Care (CCR) implemented as a R2 CDA R1 from dictation with voice recognition and NLP R2 Pathology report R2 Discharge Summary R2 Imaging report transformed from DICOM SR CDA::HIMSS demo 2004

30 copyright 2004 Liora Alschuler 30 One CDA, many applications: pathology Source CDA (pathologist, authors view) Display or print (referring physicians view Archival CDA XML Tumor Board, synopsis, meets CAP reporting guidelines

31 copyright 2004 Liora Alschuler 31 Relationship to HL7 messages CDA complements HL7 messaging specs A CDA document is a defined and complete information object that can exist outside of a messaging context A CDA document can be a MIME- encoded payload within an HL7 message

32 copyright 2004 Liora Alschuler 32 HL7 V3 HL7 V2.x MSH|... EVN|... PID|... PV1|... TXA|... OBX|1|ED|... |... CDA documents are encapsulated as MIME packages within HL7 messages CDA Relationship to HL7 messages

33 copyright 2004 Liora Alschuler 33 HL7s Development Framework Reference Information Model RMIM Hierarchical Description - XML Schema subset of RIM tighten constraints linearization additional constraints algorithm

34 copyright 2004 Liora Alschuler 34 Table 17. Vocabulary domain for (CWE)

35 copyright 2004 Liora Alschuler 35 Low End Applications for CDA Persistant, accessible, human- readable documents Requirements: –CDA header –Release One or Two body Narrative block Non-semantic markup (HTML-like) Options: –More complex markup can be inserted, to be used or ignored

36 copyright 2004 Liora Alschuler 36 What you can do with simple CDA documents: the registry hub what imaging reports are available from the last episode? 1. Create documents2. Register3. Discover 4. Retrieve Ubiquitous access to distributed information –By class of document, patient, provider, encounter (CDA header metadata) –Documents remain under local control –Document creation technology evolves under local control –Registry (hub) for access control, identifier xRef

37 copyright 2004 Liora Alschuler 37 Investing in Information CDA XML can be simple CDA XML can be complex Simple encoding relatively inexpensive Complex encoding costs more You get what you pay for: –like charging a battery, –the more detailed the encoding –the greater the potential for reuse

38 copyright 2004 Liora Alschuler 38 CDA: Return on Investment –Low end: Access to documents please send referral letter to… please get me the discharge summary… what imaging reports are available from the last episode? –High end: Reuse Send synopsis to tumor board Attach to claim for automated adjudication of payment Extract data for clinical research

39 copyright 2004 Liora Alschuler 39 Investing in Information cost benefit 80/20?

40 copyright 2004 Liora Alschuler 40 Why do we need a CDA? A document specification that hits the 80/20 sweet spot: Jim Klein, Gartner Group, on HL7s CDA, April, 2001 RU: HL7's Clinical Document Architecture (CDA) defines a new target for clinical information exchange that is substantially easier to hit than one based on standards for discrete data while delivering 80 percent of the value of the latter approach.

41 copyright 2004 Liora Alschuler 41 So, how does this relate to the CCR? History: –Meetings initiated one year ago –Massachusetts Medical Society taking lead in coordination effort –Series of joint meetings, teleconferences –Combined with international effort on referrals (show spreadsheet) –Proof of concept at HIMSS 2004

42 copyright 2004 Liora Alschuler 42 ASTM/HL7 MOU ASTM has just adopted a standard set of core data elements for a Continuity of Care Record (CCR) and is in the process of developing an implementation guide for same, and HL7 has adopted a standard for Clinical Document Architecture (CDA) and a standard for the functionality of an Electronic Health Record (EHR) system. Since both SDOs want implementations based on these standards to be semantically interoperable, we agree to cooperate in the process of harmonizing the definitions of the data elements and the methods for representing instances of the data elements in XML….

43 copyright 2004 Liora Alschuler 43 HL7/ASTM MOU …We agree that compatibility will be enhanced by using the HL7 Reference Information Model (RIM) as a common basis for such harmonization and that the CCR standard, the EHR standard(s), the CDA standard, and the RIM are all open to appropriate modifications (with appropriate ballot cycles for approve of same for each SDO) to enable such harmonization.

44 copyright 2004 Liora Alschuler 44 …but wait, theres more Mapping of data elements is good We will establish a canonical method of implementing CCR as a template layered on top of CDA Benefits: –Interoperability with HL7 Reference Information Model –Compatibility with HIPAA, NHII document standard –Compatible with international approach to interoperability –EHR compatibility –Drive decision support, advanced processing applications –Public health, clinic trials tie-ins –Automated validation of specific, local requirements

45 copyright 2004 Liora Alschuler 45 HL7 Templates Constraints on HL7 specifications What is a constraint? – called ROS must contain on vital signs – called H&P must contain called ROS CDA schema says documents have sections CCR template says: CDA CCR documents have ASTM-specified required sections

46 copyright 2004 Liora Alschuler 46 HL7 Templates A template can constrain: –sections of a CDA document –set of laboratory observation result codes –coding scheme for a coded element –data type subcomponent

47 copyright 2004 Liora Alschuler 47 HL7 Templates Who creates HL7 Templates? –domain experts –standards groups (e.g., ASTM) –regulatory agencies Where are templates used? –within CDA documents –within HL7 V3 messages

48 copyright 2004 Liora Alschuler 48 CDA CCR compatibility Questions that need resolution: –Levels of machine processibility, reuse, interoperability –Levels of generality, constraint, validation

49 copyright 2004 Liora Alschuler 49 Allergies and Adverse Reactions Penicillin - Hives CDA Release 2.0: Draft required: human readable optional: machine processible CDA::CCR processibility CCR: clinical content all optional

50 copyright 2004 Liora Alschuler 50 CDA: single-styesheet rendering favors simple exchange for point of care review CDA CCR: will integrate required semantics for additional machine processing, reuse, RIM-based interoperability, retaining single- stylesheet rendering CDA::CCR processibility

51 copyright 2004 Liora Alschuler 51 CDA::CCR compatibility Existing levels of generality –CDA is generic to any document type –CCR is specific to referral-type scenarios, but general to requirements of any single implementation Ideal: CCR-compliant CDA with template for automated validation of local requirements

52 copyright 2004 Liora Alschuler 52 CDA::CCR compatibility CDA schema + ASTM CCR template –Valid according to ASTM implementation guide CDA schema + ASTM CCR template + local template –Machine validation of full local requirements –Interoperable with full spectrum of HL7 version 3, RIM-compliant messages & documents

53 copyright 2004 Liora Alschuler 53 CCRmore specific than CDA CDA: sections not specified CCR: Specifies sections, all optional CDA+CCR template: fine- level constraints with validation

54 copyright 2004 Liora Alschuler 54 Dr. Dolin asserts that Henry Levin manifests hives as a previously-diagnosed allergic reaction to penicillin hives: SNOMED CT What does all this buy you?

55 copyright 2004 Liora Alschuler 55 First: human readable

56 copyright 2004 Liora Alschuler 56 Next: series of related statements Allergy to penicillin Observation: RIM-defined Prior dx: SNOMED Allergy to penicillin: SNOMED Hives Prior dx: SNOMED Hives: SNOMED Hives is a manifestation of a reaction to penicillin Relationship: RIM-defined

57 copyright 2004 Liora Alschuler 57 Getting from the RIM to CDA..

58 copyright 2004 Liora Alschuler 58

59 copyright 2004 Liora Alschuler 59 Extl Refs CDA Entries CDA Header CDA Body, Section, and Narrative Block CDA RMIM How are these concepts, relationships defined?

60 copyright 2004 Liora Alschuler 60 CDA: Major Implementations PICNIC (European Union) SCIPHOX (Germany) HYGEIAnet/WebOnColl (Greece) NHS South Staffordshire (United Kingdom) Aluetietojärjestelmä (Finland) Health Information Summaries (New Zealand) Referrals (Australia) MERIT-9 (Japan) e-Claims Supporting Document Architecture (Canada) Mayo Clinic (USA) Buenos Aires HMO project (Argentina) Dalhousie U, QEII Health Sci Ctr (Canada) Plus projects in Italy, Russia, Ireland, Mexico, …

61 copyright 2004 Liora Alschuler 61 SCIPHOX, Germany Kai Heitmann

62 copyright 2004 Liora Alschuler 62 Seamless Care and CDA, Finland Aluetietojärjestelmä 40% of Finnish population covered including Helsinki

63 copyright 2004 Liora Alschuler 63 CDA in the USA CDA Implementation: USA –Mayo Clinic (50,000 notes/week) –Kaiser –Columbia Presbyterian –VA –Duke Clinical Research Institute (Single Source Proof of Concept: integrating patient records and clinical trial case report forms ) Proposed for HIPAA Claims Attachments Cited by DHHS as document standard for NHII

64 copyright 2004 Liora Alschuler 64 Vendors Transcription: Dictaphone, MedQuist, MD Productivity, Cquence Medical, any EMR: IDX (Mayo), Epic Systems (Kaiser), Siemens (HIMSS) New: –VertiSoft's QuickDelivery for clinical documents –ChartIndex (a project at Stanford U. School of Medicine) In development: many (Mmodal, Guidant, SierraSystems…) Non-healthcare-specific: Microsoft InfoPath, Adobe Acrobat, Arbortext, Software AG, Oracle (any XML) Not a comprehensive list

65 copyright 2004 Liora Alschuler 65 Current Activities Release 2: 2nd ballot successful –Updated to current RIM (2.02) –addition of CDA entries –separation of human-readable & machine processible components 3 rd Committee-level ballot: open now! –CDA functionality driven by articulated user requirements –And implementation experience

66 copyright 2004 Liora Alschuler 66 International Conference on the CDA Berlin, Germany, October 7-9, participants 20 countries 22 presentations –tutorials –10 case studies –original research –CEN/GEHR alignment http// /progoverz.html

67 copyright 2004 Liora Alschuler 67 Coming soon…. 2 nd International Conference on the Clinical Document Architecture Acapulco, Mexico October 20-22, 2004 Hosted by HL7 Mexico in conjunction with the HL7 International Affiliates, HL7 Canada, HL7 Germany and the Structured Documents TC

68 copyright 2004 Liora Alschuler 68 Getting involved Join HL7 & vote on current ballot Listservs –SDTC & Templates, see CDA teleconferences: weekly or bi- weekly HL7 meeting schedule, see

69 copyright 2004 Liora Alschuler 69 Current references CDA Release 2 Committee Level Ballot 3:, Structured Documents Technical Committee web page Regulatory Initiatives in HL7 Using XML and Structured Documents: First International Conference on the CDA -- abstracts: abstracts%2Epdf CDA in Context: CDA%5Fin%5Fcontext%5Fwithpics%2Ezip

70 copyright 2004 Liora Alschuler 70 Selected References Dolin RH, Alschuler L, Beebe C, Biron PV, Boyer S, Essin D, Kimber E, Lincoln T, Mattison JE. The HL7 Clinical Document Architecture. J Am Med Inform Assoc. 2001;8: Chronaki CE, Lelis P, Demou C, Tsiknakis M, Orphanoudakis SC. An HL7/CDA Framework for the Design and Deployment of Telemedicine Services. Proceedings of EMBC 2001, 23rd Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Oct. 2001, Istanbul, Turkey. 01.htm Paterson GI, Shepherd M, Wang X, Watters C, Zitner D. Using the XML-based Clinical Document Architecture for Exchange of Structured Discharge Summaries. Proceedings of the 35th Hawaii International Conference on System Sciences , /02. IEEE Computer Society. [Available: Paterson GI, Wang X, Shepherd M, Watters C, Zitner D. Electronic Exchange of Structured Interim Discharge Summaries Using the XML-based Clinical Document Architecture, e- Health 2001: The Future of Health Care Proceedings May 2001, Toronto, Ontario. COACH Conference. CD-ROM. [Available:

71 copyright 2004 Liora Alschuler 71 Thank you! any questions?

72 copyright 2004 Liora Alschuler Continuity of Care virtual tour HL7-IHE Demonstration HIMSS 2004

73 copyright 2004 Liora Alschuler 73 Presented by John Madden, MD, PhD, Duke University Medical Center, Department of Pathology Liora Alschuler, HL7

74 copyright 2004 Liora Alschuler 74 Continuity of Care Patient scenario John is a 70-year old man with a 100- pack-year smoking history He recently developed persistent cough with blood-streaked sputum He visits Dr. Sullivan, his Primary Care Provider (PCP) Dr. Sullivan sends John to a nearby radiology practice for a chest x-ray

75 copyright 2004 Liora Alschuler 75 Adobe Berdy Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS Outpatient encounter and chest xray Scheduled workflow; report stored as CDA PCP Continuity of Care Imaging Integration, Tumor Reporting, Claims Processing Repository RIS Server Workstation Registry Imaging HL7 Standards aECG Arden CCOW CDA ODM LDM RIM SDM SPL V2 V3 IHE Profiles CT EUA PIX PSA RID SWF PCP sends order to radiology office Radiology information system queries scheduling server Imaging modality queries scheduling server for demographics Imaging system uploads completed image to server Server relays copy of image to repository. Repository forwards document information to registry.

76 copyright 2004 Liora Alschuler 76 Continuity of Care Patient scenario Chest x-ray shows a 3 cm right upper lobe mass Radiologists communicate result to Dr. Sullivan the same day She refers John to Dr. Blade, a chest surgeon at the South Hospital Medical Center

77 copyright 2004 Liora Alschuler 77 Patient referred for surgery EMR & eForms CCR sent through brokers to hospital, surgery PCP Continuity of Care Imaging Integration, Tumor Reporting, Claims Processing EMR Broker Hospital Repository eForms Surgery RIS Server Imaging Workstation Registry Server/WS EMR Adobe Berdy Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS HL7 Standards aECG Arden CCOW CDA ODM LDM RIM SDM SPL V2 V3 IHE Profiles CT EUA PIX PSA RID SWF PCP enters referral request via eForms application Broker forwards referral to South Med Center and to repository/registry Hospital EMR distributes referral request and schedules patient visit Clinic queries community radiology server for availability of x-rays

78 copyright 2004 Liora Alschuler 78 Continuity of Care Patient scenario Dr. Blade performs wedge resection of RUL with node sampling Specimen is examined by pathology; the diagnosis is large cell carcinoma with negative nodes Pathology report is sent to Dr. Blade, hospital Tumor Registry A copy is sent to the PCP, Dr. Sullivan

79 copyright 2004 Liora Alschuler A single data REPRESENTATION standard facilitates multiple document PRESENTATION standards !

80 copyright 2004 Liora Alschuler 80 Pathologist view: CAP/ACoS standards compliant, template- driven data entry

81 copyright 2004 Liora Alschuler 81 Repository view: HL7-CDA standard XML with XQuery-ready, context-linked SNOMED encodings

82 copyright 2004 Liora Alschuler 82 South Hospital Clinician view: Traditional format, print/electronic delivery

83 copyright 2004 Liora Alschuler 83 South Hospital Tumor registrar view: Irrelevant items filtered, stage computed automatically

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