1. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Overview of C-CDA Health eDecisions All Hands Community Meeting May 16, 2013 C. Beebe

2. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Presenter Calvin E. Beebe cbeebe@mayo.edu Technical Specialist Mayo Clinic, Rochester MN Co-editor - CDA R1, CDA R2 Author - CDA Certification Exam Co-chair - HL7 Structured Documents Member - HL7 Technical Steering Committee Treasure- HL7 Board of Directors

3. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Todays Topics Whats in the C-CDA Implementation Guide Review sample C-CDA document Identify HL7 & other useful resources Summary

4. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 01/01/2011 4

5. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Basic C-CDA 101 Technical Name: HL7 Implementation Guides for CDA Release 2: IHE Health Story Consolidation, DSTU Release 1.1 - US Realm Called: Consolidated CDA, C-CDA … The C-CDA contains a library of CDA templates. Updates 11 CDA document types, including CCD Harmonizes previous HL7, IHE, HITSP efforts It consolidated previous document templates into a single library, resolving conflicts, ambiguities as needed!

6. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7s CDA vs. C-CDA CDA The HL7 Clinical Document Architecture (CDA) is a document markup standard that specifies the structure and semantics of "clinical documents" for the purpose of exchange. C-CDA The HL7 Consolidated CDA is an implementation guide which specifies a library of templates and proscribes their use for a set of specific document types. defines a set of CDA documents! the schema for those documents!

7. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Consolidated CDA (C-CDA) C-CDA History and Physical Discharge Summary Consultation Notes Diagnostic Imaging Rpt Procedure Note Operative Note Progress Note Unstructured Documents HL7 Health Story Implementation Guides CCDCCD ONC - CEHRT HITSP - C32, C80, C83 IHE – PCC HL7 – CCD HL7 – CDA Continuity of Care Document

8. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Consolidated CDA The guide contains a library of CDA templates, incorporating and harmonizing previous efforts from: Health Level Seven (HL7) Integrating the Healthcare Enterprise (IHE) Health Information Technology Standards Panel (HITSP) It includes harmonized HL7 Health Story guides, HITSP C32, related components of IHE Patient Care Coordination, and the Continuity of Care (CCD). It includes all required CDA templates in Final Rules for Stage 1 Meaningful Use and can support Stage 2 Meaningful Use requirements.*

9. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Templated CDA: C-CDA, QRDA 01/01/2011 9 Figure1: Templated CDA A QRDA Category I report is an individual-patient-level quality report. Each report contains quality data for one patient for one or more quality measures. (126 Entry Templates)

10. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 C-CDA Implementation Guide Document Organization Introduction General Header Template Document-Level Templates Section-Level Templates Entry-Level Templates Appendix Template IDs, Code Systems, Value Sets, Extensions, …

11. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Consolidated CDA Documents H&P Diagnostic Imaging Consult Surgical Operation Progress Procedure Discharge Summary Unstructured (Non-XML Body) Unstructured (Non-XML Body) CCD 9 Document Types

12. 74 C-CDA Sections Advance Directives Section (entries optional) Advance Directives Section (entries required) Allergies Section (entries optional) Allergies Section (entries required) Anesthesia Section Assessment and Plan Section Assessment Section Chief Complaint and Reason for Visit Section Chief Complaint Section Complications Section DICOM Object Catalog Section - DCM 121181 Discharge Diet Section Encounters Section (entries optional) Encounters Section (entries required) Family History Section Fetus Subject Context Findings Section (DIR) Functional Status Section General Status Section History of Past Illness Section History of Present Illness Section Hospital Admission Diagnosis Section Hospital Admission Medications Section (entries optional) Hospital Consultations Section Hospital Course Section Hospital Discharge Diagnosis Section Hospital Discharge Instructions Section Hospital Discharge Medications Section (entries optional) Hospital Discharge Medications Section (entries required) Hospital Discharge Physical Section Hospital Discharge Studies Summary Section Immunizations Section (entries optional) Immunizations Section (entries required) Implants Section Instructions Section Interventions Section Medical (General) History Section Medical Equipment Section Medications Administered Section Medications Section (entries optional) Medications Section (entries required) Objective Section Observer Context Operative Note Fluids Section Operative Note Surgical Procedure Section Payers Section Physical Exam Section Plan of Care Section Planned Procedure Section Postoperative Diagnosis Section Postprocedure Diagnosis Section Preoperative Diagnosis Section Problem Section (entries optional) Problem Section (entries required) Procedure Description Section Procedure Disposition Section Procedure Estimated Blood Loss Section Procedure Findings Section Procedure Implants Section Procedure Indications Section Procedure Specimens Taken Section Procedures Section (entries optional) Procedures Section (entries required) Reason for Referral Section Reason for Visit Section Results Section (entries optional) Results Section (entries required) Review of Systems Section Social History Section Subjective Section Surgery Description Section Surgical Drains Section Vital Signs Section (entries optional) Vital Signs Section (entries required)

13. 65 C-CDA Entries Admission Medication Advance Directive Observation Age Observation Allergy Observation Allergy Problem Act Allergy Status Observation Boundary Observation Code Observations Comment Activity Coverage Activity Discharge Medication Drug Vehicle Encounter Activities Estimated Date of Delivery Family History Death Observation Family History Observation Family History Organizer Health Status Observation Hospital Admission Diagnosis Hospital Discharge Diagnosis Immunization Activity Immunization Medication Information Immunization Refusal Reason Indication Instructions Medication Activity Medication Dispense Medication Information Medication Supply Order Medication Use - None Known (deprecated) Non-Medicinal Supply Activity Plan of Care Activity Act Plan of Care Activity Encounter Plan of Care Activity Observation Plan of Care Activity Procedure Plan of Care Activity Substance Administration Plan of Care Activity Supply Policy Activity Postprocedure Diagnosis Precondition for Substance Administration Pregnancy Observation Preoperative Diagnosis Problem Concern Act (Condition) Problem Observation Problem Status Procedure Activity Act Procedure Activity Observation Procedure Activity Procedure Procedure Context Product Instance Purpose of Reference Observation Quantity Measurement Observation Reaction Observation Referenced Frames Observation Result Observation Result Organizer Series Act Service Delivery Location Severity Observation Social History Observation Sop Instance Observation Study Act Text Observation Vital Sign Observation Vital Signs Organizer

14. 38 C-CDA Code Systems ISO 3166-1 Country Codes DCM Internet Society Language Vaccines administered (CVX) Adminstrative Gender ActMood Religious Affiliation RoleClass RoleCode AddressUse ActStatus MaritalStatus LOINC NUCC Health Care Provider Taxonomy ICD9 CM Procedures CPT-4 Confidentiality Code National Cancer Institute (NCI) Thesaurus US Postal Codes Race and Ethnicity - CDC HealthcareServiceLocation ActCode EntityNamePartQualifier EntityNameUse ASC X12 LanguageAbilityMode LanguageAbilityProficiency NDF-RT ActPriority Unique Ingredient Identifier (UNII) ActReason ObservationInterpretation ParticipationFunction Participationsignature Unified Code for Units of Measure (UCUM) RXNorm FIPS 5-2 (State) SNOMED CT S&I Companion Guide references (links) on CEHRT Vocabularies: CDT – Dental Codes ICD – 10 CM / PCS CPT – AMA Procedure Codes ISO 639-2 Language Codes HCPCS – Procedure Codes LOINC – Lab Codes CVX – HL7 table 0292 OMB Race / Ethnicity Codes RxNorm – Medication Codes SNOMED CT – via UMLS

15. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. C-CDA Header Constraints It describes constraints that apply to the header for all documents within the scope of this implementation guide. Header constraints specific to each document type are described in the appropriate document-specific section below. SHALL contain: realmCode typeId templateId id code title effectiveTime confidentialityCode languageCode recordTarget w/ 1 patient name in US realm format administrativeGenderCode birthtime (precise to the year) serviceEvent effectiveTime performer author custodian ethnicity preferred Language race encompassing Encounter healthcareFacility responsibleParty encounterParticipant addr name

16. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. MU 2 - Document Types With respect to the Consolidated CDA, certification will not focus on a specific document-level template… Surprise! Rather, certification will focus on an EHR technologys ability to properly implement the US Realm header and the associated section-level templates necessary to support each certification criterion in which the Consolidated CDA is referenced and for the appropriate data specified in each of those certification criteria. Where vocabularies are specified in § 170.207 the accompanying section-template must be implemented using structured data, i.e. coded entries required. Unstructured Document template is not permitted.

17. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Document Types S&I performed a goodness of fitness assessment and deemed the C-CDA CCD best fit. 01/01/2011 17 However… MU3 advocates that the visit document should not simply be EMR extracts (need exact language!) You may want to start thinking about generating clinical notes based on C-CDA MU2 requirements. I.e. H&P Notes, Consult Notes, Diagnostic Imaging Notes, Surgical Notes, Progress Notes, Discharge Summary Notes. All said, for MU2 – the CCD seems like the likely target.

18. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Continuity of Care Document

19. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Continuity of Care Document

20. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Consolidated CDA Sections MU2 Data RequirementsConsolidated CDA SectionCCD Advance Directives (entries optional)O Medication allergiesAllergies (entries required)R Encounters (entries optional)O Family HistoryO Functional Status; Cognitive StatusFunctional StatusO Discharge instructions (Inpatient setting)Hospital Discharge Instructions ImmunizationsImmunizations (entries optional)O Clinical instructions; Recommended patient decision aidsInstructions Medical EquipmentO MedicationsMedications (entries required)R PayersO Care plan, including goals and instructions; Future appointments; Future scheduled tests; Referrals to other providers; Diagnostic tests pending Plan of Care or Assessment and PlanO ProblemsProblem (entries required)R ProceduresProcedures (entries required)O Reason for Referral Reason(s) for visit or Reason(s) for hospitalization (Inpatient setting) Reason for Visit or Chief Complaint or Chief Complaint and Reason for Visit Laboratory Tests; Values/results of laboratory testsResults (entries required)R Smoking statusSocial HistoryO Vital signsVital Signs (entries optional)O Well take peek a the Problem section

21. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Problem Section & Entries This section lists and describes all relevant clinical problems at the time the document is generated. At a minimum, all pertinent current and historical problems should be listed.

22. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Problem Section & Entries

23. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Problem Section with Coded Entries Required Two types of Problem sections are supported, MU2 requires the use of coded entries.

24. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Problem Section example

25. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Problem Act Concern

26. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Problem Act Concern

27. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Problem Act Concern

28. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Problem Act Concern

29. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Problem Concern Act example

30. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Problem Observation

31. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Problem Observation

32. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Problem Observation

33. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Problem Observation

34. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Problem Observation

35. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Problem observation example

36. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. at the C-CDA sample We will look at the sample C-CDA 01/01/2011 36

37. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Validation of C-CDA documents Two alternative techniques have been established to validate C-CDA documents. MDHT – JAVA validation code solution Available on the Open Health Tools Web Site Trifolia – Schematron (xPath) solution Available on the HL7 Web Site

38. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Tools & Pending NIST testing The National Institute of Standards and Technology (NIST) provides a list of available validation tooling sites for interoperability specifications. NIST also provides tools for testing MU2 implementations. Validation: http://xreg2.nist.gov/hit-testing/ http://xreg2.nist.gov/hit-testing/ Testing: http://healthcare.nist.gov/use_testing/tools.html http://healthcare.nist.gov/use_testing/tools.html

39. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Technique 1 - Schematron.xml CDA IG CCD.xsd XPath validation of Implementation Guide requirements Validates against generic CDA schema <Section code=Plan>.xPath,.xsl, Schematron Trifolia Workbench

40. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Technique 2 – MDHT Validation Domain Model MDHT Model Driven Health Tools MDHT Model Driven Health Tools Add Custom Validations & Constraints Java API (Source Code) Java API (Source Code) Validation Code Generation Validation Code Generation Implementation Guide(s) The JAVA code can parse, validate and provides an code able object model !

41. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Identify useful resources ToC Quickstart: http://wiki.siframework.org/Transitions+of+Care+Quickstar t+Page http://wiki.siframework.org/Transitions+of+Care+Quickstar t+Page CDA R2 Product Brief: http://www.hl7.org/implement/standards/product_brief.cfm ?product_id=7 http://www.hl7.org/implement/standards/product_brief.cfm ?product_id=7 Consolidated CDA Product Brief: http://www.hl7.org/implement/standards/ product_brief.cfm?product_id=258 http://www.hl7.org/implement/standards/ product_brief.cfm?product_id=258 HL7 FAQs: http://www.hl7.org/about/FAQs/index.cfmhttp://www.hl7.org/about/FAQs/index.cfm

42. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Additional Tutorials Available at HL7 Or consider a future HL7 Ed Summit or On-site Training. Contact Mary Ann (maryann@HL7.org) to learn more about on-site trainingmaryann@HL7.org or to schedule on-site training for your organization.

43. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. For More Information…. Contact us! cbeebe@mayo.edu HL7 C-CCD Implementation Guide HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, Release 1 - US Realm S&I Framework – C-CDA Companion Guide http://wiki.siframework.org/Companion+Guide+to+Consolidated+CDA+for+MU2 Open Health CDA Tools: http://cdatools.org/ http://cdatools.org/ MDHT: https://www.projects.openhealthtools.org/sf/projects/mdht/ https://www.projects.openhealthtools.org/sf/projects/mdht/ Validation: http://xreg2.nist.gov/hit-testing/http://xreg2.nist.gov/hit-testing/ Testing: http://healthcare.nist.gov/use_testing/tools.htmlhttp://healthcare.nist.gov/use_testing/tools.html Trifolia Workbench: http://www.lantanagroup.com/resources/products/ http://www.lantanagroup.com/resources/products/ Validation & CDA XSL Stylesheets: http://www.lantanagroup.com/resources/free-tools/http://www.lantanagroup.com/resources/free-tools/

44. © 2013 Calvin Beebe and Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Q & A Session 01/01/2011 44