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MRI Conference August 2004, Boston Liora Alschuler

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1 MRI Conference August 2004, Boston Liora Alschuler
Clinical Document Architecture CDA::CCR and the Continuity of Care Record MRI Conference August 2004, Boston 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 Outline Introduction to the CDA CDA and CCR
What is the CDA & What Does It Do? Key Design Decisions Implementing CDA CDA and CCR Current & future

4 CDA Clinical Document Architecture ANSI/HL7 CDA R1.0-2000
first certified XML spec for healthcare first balloted portion of HL7’s “V3” first RIM-based specification created & maintained by HL7 Structured Documents Technical Committee (SDTC)

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 Clinical Document Architecture
Release 1.0: 3 ballots; 108 votes; all negatives reconciled; unanimous final ballot 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 Labtest.com, 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 scheduling.com 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

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 CDA: scope The scope of the CDA is the standardization of clinical documents for exchange.

9 CDA: A Document Exchange Specification
This is a CDA and this

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

12 Sample CDA: Ballot R1 2000

13 Sample CDA: HIMSS 2004

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 What can you do with a few tags?
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 The CDA document defined
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.” (material in blue is quoted from the Clinical Document Architecture Release 1.0)

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 CDA::Readability 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

19 XML-encoded info human readable machine processible
<Section> <code code="10123-x" codeSystem="LOINC">Allergies and Adverse Reactions</code> <text> <list> <item><content>Penicillin - Hives</content></item> </list> </text> <component> <Observation> <code code="G-1001" codeSystem="SNOMED" displayName="Prior dx"/> <value xsi:type="CD" code="DF-10074" codeSystem="SNOMED" displayName="Allergy to penicillin"/> <pertinentInformation typeCode="MFST"> <value xsi:type="CD" code="D " codeSystem="SNOMED" displayName="Hives"/> </Observation> human readable machine processible CDA Release 2.0: Draft

20 The CDA Document A CDA document is comprised of a header, referred to as the “CDA Header", and a body referred to as the “CDA Level One Body". Header Body

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 patient’s clinical documents into a lifetime electronic patient record (“uniquely identify a single patient”) From PRA 2.2: Formally, the PRA Level One DTD incorporates the PRA Header DTD, the PRA Level One Body DTD, and the HL7 Version 3 data type DTD. Thus, a PRA Level One document references the PRA Level One DTD which in turn references the PRA Header DTD and the RIM data types. Terminology note: The term "document type" is ambiguous. In XML, "document type" is typically equated with "DTD". In the RIM, "document type" is equated with the value of the clinical_document_header.service_cd attribute. This document will use "DTDs" when referring to XML document types and will use "document type codes" when referring to the RIM value, and will avoid the phrase "document type".

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

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

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 CDA: How to Display any way you like

26 XML data is accessible <section>Allergy List</section>
<para>…</para> <section>Medications List</section> automated table of contents creation, linked to content, through style sheet transformations

27 CDA: How to Display One document, many views Many documents, one view

28 CDA::HIMSS demo 2004 Document creation: Management/display:
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 CDA::HIMSS demo 2004 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

30 One CDA, many applications: pathology
Display or print (referring physician’s view Source CDA (pathologist, author’s view) Archival CDA XML Tumor Board, synopsis, meets CAP reporting guidelines

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 Relationship to HL7 messages
CDA documents are encapsulated as MIME packages within HL7 messages HL7 V2.x MSH|... EVN|... PID|... PV1|... TXA|... OBX|1|ED|... |... HL7 V3 <service_cd> <service_txt T="ED"> </service_txt> </service_cd> CDA CDA

33 Reference Information Model Hierarchical Description
HL7’s Development Framework Reference Information Model RMIM subset of RIM tighten constraints linearization additional constraints XML Schema algorithm <xs:element name="ClinicalDocument" type="CDA_MT ClinicalDocument" /> - <xs:group name="CDA_MT000017"> - <xs:sequence>   <xs:element name="ClinicalDocument" type="CDA_MT ClinicalDocument" /> Hierarchical Description

34 Table 17. Vocabulary domain for <function_cd> (CWE)

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 What you can do with simple CDA documents: the registry hub
4. Retrieve “what imaging reports are available from the last episode?” 1. Create documents 2. Register 3. Discover 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 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 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 Investing in Information
cost x 80/20? benefit

40 Why do we need a CDA? A document specification that hits the 80/20 sweet spot: Jim Klein, Gartner Group, on HL7’s 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 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 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 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 …but wait, there’s 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 HL7 Templates Constraints on HL7 specifications
What is a “constraint”? <section> called “ROS” must contain <section> on “vital signs” <document> called “H&P” must contain <section> called “ROS” CDA schema says “documents have sections” CCR template says: “CDA CCR documents have ASTM-specified required sections”

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

48 CDA CCR compatibility Questions that need resolution:
Levels of machine processibility, reuse, interoperability Levels of generality, constraint, validation

49 CDA::CCR processibility
<Section> <code code="10123-x" codeSystem="LOINC">Allergies and Adverse Reactions</code> <text> <list> <item><content>Penicillin - Hives</content></item> </list> </text> <component> <Observation> <code code="G-1001" codeSystem="SNOMED" displayName="Prior dx"/> <value xsi:type="CD" code="DF-10074" codeSystem="SNOMED" displayName="Allergy to penicillin"/> <pertinentInformation typeCode="MFST"> <value xsi:type="CD" code="D " codeSystem="SNOMED" displayName="Hives"/> </Observation> CCR: clinical content all optional required: human readable optional: machine processible CDA Release 2.0: Draft

50 CDA::CCR processibility
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

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 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 CCR—more specific than CDA
CDA: sections not specified CCR: Specifies sections, all optional CDA+CCR template: fine-level constraints with validation

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

55 First: human readable

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 Next: series of related statements

57 Getting from the RIM to CDA . .

58

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

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 SCIPHOX, Germany Kai Heitmann

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

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

66 International Conference on the CDA
Berlin, Germany, October 7-9, 2002 80+ participants 20 countries 22 presentations tutorials 10 case studies original research CEN/GEHR alignment http//www.hl7.de/cda2002/progoverz.html

67 Coming soon…. 2nd 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 Getting involved Join HL7 & vote on current ballot Listservs
SDTC & Templates, see CDA teleconferences: weekly or bi-weekly HL7 meeting schedule, see

69 Current references CDA Release 2 Committee Level Ballot 3: hl7.org, Structured Documents Technical Committee web page Regulatory Initiatives in HL7 Using XML and Structured Documents: Alschuler_DIA2003.zip First International Conference on the CDA -- abstracts: abstracts%2Epdf CDA in Context: CDA%5Fin%5Fcontext%5Fwithpics%2Ezip

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. 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 Thank you! any questions?

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

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

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 Outpatient encounter and chest xray
Continuity of Care Imaging Integration, Tumor Reporting, Claims Processing HL7 Standards aECG Arden CCOW CDA ODM LDM RIM SDM SPL V2 V3 IHE Profiles CT EUA PIX PSA RID SWF 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 Imaging RIS Workstation Server Repository PCP Registry Server relays copy of image to repository. Repository forwards document information to registry. 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 Outpatient encounter and chest xray Scheduled workflow; report stored as CDA

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 Patient referred for surgery
Continuity of Care Imaging Integration, Tumor Reporting, Claims Processing HL7 Standards aECG Arden CCOW CDA ODM LDM RIM SDM SPL V2 V3 IHE Profiles CT EUA PIX PSA RID SWF 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 Imaging RIS Workstation Server Broker Repository EMR PCP eForms Registry Clinic queries community radiology server for availability of x-rays Server/WS 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 EMR EMR Hospital Surgery Patient referred for surgery EMR & eForms CCR sent through brokers to hospital, surgery

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 A single data REPRESENTATION standard
facilitates multiple document PRESENTATION standards !

80 CAP/ACoS standards compliant, template-driven data entry
Pathologist view: CAP/ACoS standards compliant, template-driven data entry

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

82 Traditional format, print/electronic delivery
South Hospital Clinician view: Traditional format, print/electronic delivery

83 Irrelevant items filtered, stage computed automatically
South Hospital Tumor registrar view: Irrelevant items filtered, stage computed automatically


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