Con$nuity of Care Document (CCD) Tony Weida Bre7 Marquard

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1 Con$nuity of Care Document (CCD) Tony Weida Bre7 Marquard

2 Outline Preview of Summary Document Clinical Document Architecture (CDA) Con$nuity of Care Document (CCD) HITSP C32 (with C83 and C80) CCD Implementa$on Guide CCD Body Templates Advanced Topics

3 CCD Sample

4 CCD Sample Forma7ed with XSL style sheet (CCD.xsl)

5 Outline Preview of Summary Document Clinical Document Architecture (CDA) Con$nuity of Care Document (CCD) HITSP C32 (with C83 and C80) CCD Implementa$on Guide CCD Body Templates Advanced Topics

6 Clinical Document Architecture (CDA) HL7 standard Specifies structure and seman$cs of clinical documents for the purpose of exchange Expressed with XML Based on HL7 version 3 RIM (Reference Informa$on Model) Basis for Con$nuity of Care Document (CCD)

7 Clinical Documents CDA Release 2, Sec$on 1.1: A clinical document... has the following characteris$cs: Persistence Stewardship Poten$al for authen$ca$on Context Wholeness Human readability CDA documents such as CCD are not: birth- to- death aggregate records electronic health records

8 CDA = header + body CDA Header Metadata required for document discovery, management, retrieval CDA Body Clinical report Discharge Summary Care Record Summary Progress Note H&P Public health report any content that carries a signature 8

9 9 <ClinicalDocument>... <structuredbody> <section> <text>...</text> <observation>...</observation> <substanceadministration> <supply>...</supply> </substanceadministration> <observation> <externalobservation>... </externalobservation> </observation> </section> <section> <section>...</section> </section> </structuredbody> </ClinicalDocument> D O C U M E N T B O D Y Header S E C T I O N S Narrative Block E N T R I E S External References Major Components of a CDA

10 CCD sample revisited Demo

11 Outline Preview of Summary Document Clinical Document Architecture (CDA) Con$nuity of Care Document (CCD) HITSP C32 (with C83 and C80) CCD Implementa$on Guide CCD Body Templates Advanced Topics

12 Con$nuity of Care Document (CCD) For exchanging pa$ent summary informa$on (administra$ve, demographic and clinical) Constrains CDA Specified as a CDA Implementa$on Guide Narra$ve blocks are mandatory (within a given sec$on); coded entries are op$onal

13 CCD Deriva$on CDA specified by HL7 Con$nuity of Care Record (CCR) specified by ASTM CCD jointly developed by HL7 and ASTM Implements CCR requirements in CDA framework

14 CCD and CDA CDA is a generic architecture for crea$ng clinical documents Individual document types can be created by constraining CDA for specific use cases CCD is a specific document type implemented using CDA In programming terms, think of CDA as a class, and CCD as a subclass CCD is not a replacement for CDA

15 CDA Schema CCD Template

16 Header Purpose Problems Procedures Family history Social history Payers Advance direc$ves Alerts CCD Templates Medica$ons Immuniza$ons Medical equipment Vital signs Func$onal stats Results Encounters Plan of care

17 What CCD is / is not CCD is A summary of an episode of care Useful for transfer of care scenarios CCD is not A complete longitudinal health record A replacement for more specific document types History and Physical Opera$ve Note Discharge Summary (specifically excluded from CCR/CCD)

18 Outline Preview of Summary Document Clinical Document Architecture (CDA) Con$nuity of Care Document (CCD) HITSP C32 (with C83 and C80) CCD Implementa$on Guide CCD Body Templates Advanced Topics

19 HITSP Selected CDA R2 as base standard for clinical documents as profiled by HL7 and IHE per use case requirements Specified vocabulary for clinical documents and messages (HITSP C80) Defined content models for CDA and CCD (HITSP C83) Described documents Summary document of a consumer's medical status for the purpose of informa$on exchange (HITSP C32) Various others

20 HITSP Dependencies C32 (Summary Documents Using CCD) C83 (CDA and CCD Content Modules) C80 (Clinical Document and Message Terminology)

21 HITSP C83 and C80 Interoperability is achieved below the document level Documents aggregate smaller content modules Modules are reusable in different contexts Establish appropriate levels of re- use for interoperability of templated CDA documents, sec$ons and entries (clinical statements) in support of current and proposed use cases

22 HITSP CDA R2- Based Constructs Mul$ple HITSP constructs specify profiles that constrain HL7 CDA R2 These constructs state addi$onal constraints, e.g., vocabularies and terminology sets to meet the contextual requirements of an Interoperability Specifica$on Document C32 C37 C38 C48 Document Descrip2on (Profile) Summary Documents Using HL7 Con$nuity of Care Document (CCD) Component Lab Report Document Component Pa$ent Level Quality Data Document Using IHE Medical Summary (XDS- MS) Component Encounter Document Using IHE Medical Summary (XDS- MS) Component

23 HITSP/C32 Summary Documents Using HL7 Con$nuity of Care Document (CCD) Component Describes constraints for the U.S. realm on: HL7 Implementa$on Guide: CDA Release 2 Con$nuity of Care Document (CCD), Release 1.0, April 01, 2007 with addi$onal clarifica$ons and specifica$ons as appropriate HITSP constraints derived from AHIC Use Cases Consumer Empowerment 2006 IS03 V1.0 (Consumer Update Registra$on and Medica$on) Emergency Responder Use Case 2007 IS04 V1.0 Consumer Access to Clinical Informa$on 2008 IS03 V3.0, IS05 V1.0

24 What C32 Does Defines Informa$on Modules that map to CCD required header elements, sec$ons and/or clinical statements. All CCD constraints must be met in addi$on to C32 in order to be a valid XML instance for U.S. realm A HITSP Interoperability Specifica$on may describe further constraints on C32 C32 should not be used as- is there are implementa$on- specific condi$ons for content depending on context of use See the example on the next slide

25 Example: Medica$ons Prescrip$on and Non- Prescrip$on Module Key specifica$ons in C32 that augment CCD for medica$ons: Route of Administra2on: value drawn from FDA route of administra$on Dose: unit a7ribute, if present, coded using Unified Code for Units of Measures (UCUM) Site: a value descending from the SNOMED CT Anatomical Structure ( ) hierarchy Product Form: from FDA dosage form source NCI Thesaurus Coded product name or brand name: using RxNorm, or NDC. When only the class of the drug is known, it shall be coded using NDF- RT. FDA Unique Ingredient Iden$fier codes (UNII) codes may be used when there are no suitable codes in the other vocabularies to iden$fy the medica$on. Indica2on: coded using the VA/KP Problem List Subset of SNOMED CT

26 Outline Preview of Summary Document Clinical Document Architecture (CDA) Con$nuity of Care Document (CCD) HITSP C32 (with C83 and C80) CCD Implementa$on Guide CCD Body Templates Advanced Topics

27 CCD Implementa$on Guide Introduc$on provides an overview and scope of the CCD specifica$on. CCR Header Representa$on defines constraints on CDA R2 corresponding to CCR Header components. CCR Body Representa$on defines constraints on CDA R2 corresponding to CCR Body components. CCR Footer Representa$on defines constraints on CDA R2 corresponding to CCR Footer components. General Constraints provides more detailed mappings and CDA R2 constraints for global CCR components, such as data types and iden$fiers. Appendix provides detailed and conformant sample CCR and CCD instances. Note: Since the order of CCR drives the organiza$on, some CCD body elements appear under the CCR header sec$on.

28 Conven$ons and Syntax Conformance statements Numbered conformance statements represent the prescrip$ve (norma$ve) content of the document. Everything else is descrip$ve elabora$on on the constraints. Conformance verbs Express the strength of a par$cular constraint. Are usually in all caps and bold. SHALL, SHALL NOT, SHOULD, SHOULD NOT, MAY, MAY NOT Example Advance direc$ves in the ASTM CCR correspond to CDA R2 Observa$ons in Event mood in that they assert findings (e.g. resuscita$on status is Full Code ) rather than orders. CONF- 82: An advance direc$ve observa$on (templateid ) SHALL be represented with Observa$on.

29 RMIM Diagrams Provides a graphical representa$on of those por$ons of the CDA R2 object model being constrained by conformance statements. Those parts of the CDA R2 object model not illustrated and not constrained are to be used in accordance with the base CDA R2 specifica$on.

30 Outline Preview of Summary Document Clinical Document Architecture (CDA) Con$nuity of Care Document (CCD) HITSP C32 (with C83 and C80) CCD Implementa$on Guide CCD Body Templates Advanced Topics

31 CCD Body The CCD body is broken up into sec$ons The sec$ons roughly match their equivalents in CCR No sec$ons are required Sec$ons can contain clinical statements Clinical statements contain computable data Sec$ons need not contain clinical statements. It is legal to have a text only CCD.

32 Social History Sec$on This sec$on contains data defining the pa$ent s occupa$onal, personal (e.g. lifestyle), social, and environmental history and health risk factors, as well as administra$ve data such as marital status, race, ethnicity and religious affilia$on. Social history can have significant influence on a pa$ent s physical, psychological and emo$onal health and wellbeing so should be considered in the development of a complete record.

33 Social History Sec$on - Details Component Details Template ID LOINC Sec$on Code Social history Clinical Statements Social History Observa$on Social History Status Observa$on Episode Observa$on

34 CCD Implementa$on Guide Excerpt

35 Alerts Sec$on This sec$on is used to list and describe any allergies, adverse reac$ons, and alerts that are per$nent to the pa$ent s current or past medical history. At a minimum, currently ac$ve and any relevant historical allergies and adverse reac$ons should be listed.

36 Alerts Sec$on - Details Component Details Template ID LOINC Sec$on Code Clinical Statements Allergies, adverse reac$ons, alerts Problem Act Alert Observa$on Alert Status Observa$on Reac$on Observa$on Severity Observa$on

37 Outline Preview of Summary Document Clinical Document Architecture (CDA) Con$nuity of Care Document (CCD) HITSP C32 (with C83 and C80) CCD Implementa$on Guide CCD Body Templates Advanced Topics

38 Valida$on CDA.xsd CDA XML Schema Every CCD Document must be a valid CDA document Will reject CCD extensions (transforma$on necessary) CCD.sch Schematron schema Only tests the constraints on CDA (i.e. not a complete schema) h7p://wiki.hl7.org/index.php? $tle=con$nuity_of_care_document_%28ccd%29

39 Reusing and Extending CCD Open templates Any CDA constructs not specifically prohibited are allowed Elements not defined by CCD may not be compa$ble with CCD Defining new templates Exis$ng CCD templates can be constrained further Example: Where CCD allows any vocabulary, a constraint may specify SNOMED This approach is compa$ble with all valid CCD tools New sec$on templates can be added to CCD documents However, they will not be recognized by CCD tools and may be ignored Custom extensions

40 Resources CCD Implementa$on Guide CCD Quick Start Guide CDA Validator h7p:// HL7 Structured Documents Wiki Page h7p://wiki.hl7.org/index.php?$tle=structured_documents_tc User: wiki, Password: wikiwiki NIST Validator (form and web service) and sample C32 documents h7p://xreg2.nist.gov/cda- valida$on/ HITSP C32 h7p://hitsp.org/constructset_details.aspx? &PrefixAlpha=4&PrefixNumeric=32

41 Questions? Thank you!

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