HL7 CDA R2 Implementation Guide: C-CDA

Companion Guide to HL7 Consolidated CDA R2.1CDAR2 IG CCDA COMPANION R2 STU 2019OCTHL7 CDA R2 Implementation Guide:C-CDA Templates for Clinical Notes R2.1Companion Guide,Release 2- US RealmOctober 2019HL7 Standard for Trial UseSponsored by:Structured Documents Work GroupPublication of this standard for trial use and comment has been approved by Health LevelSeven International (HL7). This standard is not an accredited American National Standard. Thecomment period for trial use of this standard shall end 24 months from the date of publication.Suggestions for revision should be submitted at g this 24 month evaluation period, this standard, revised as necessary, will besubmitted to a normative ballot in preparation for approval by ANSI as an American NationalStandard. Implementations of this trial use standard shall be viable throughout the normativeballot process and for up to six months after publication of the relevant normative standard.Copyright 2019 Health Level Seven International ALL RIGHTS RESERVED. The reproduction of this material in any formis strictly forbidden without the written permission of the publisher. HL7 and Health Level Seven are registered trademarks ofHealth Level Seven International. Reg. U.S. Pat & TM Off.Page 1HL7 CDA R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2 STU- US Realm 2019 Health Level Seven International. All rights reserved.October 2019

Companion Guide to HL7 Consolidated CDA R2.1IMPORTANT NOTES:HL7 licenses its standards and select IP free of charge. If you did not acquire a free license from HL7 for thisdocument, you are not authorized to access or make any use of it. To obtain a free license, please cfm.If you are the individual that obtained the license for this HL7 Standard, specification or other freely licensedwork (in each and every instance "Specified Material"), the following describes the permitted uses of the Material.A. HL7 INDIVIDUAL, STUDENT AND HEALTH PROFESSIONAL MEMBERS, who register and agree to the termsof HL7’s license, are authorized, without additional charge, to read, and to use Specified Material to develop and sellproducts and services that implement, but do not directly incorporate, the Specified Material in whole or in partwithout paying license fees to HL7.INDIVIDUAL, STUDENT AND HEALTH PROFESSIONAL MEMBERS wishing to incorporate additional items ofSpecial Material in whole or part, into products and services, or to enjoy additional authorizations granted to HL7ORGANIZATIONAL MEMBERS as noted below, must become ORGANIZATIONAL MEMBERS of HL7.B. HL7 ORGANIZATION MEMBERS, who register and agree to the terms of HL7's License, are authorized, withoutadditional charge, on a perpetual (except as provided for in the full license terms governing the Material), nonexclusive and worldwide basis, the right to (a) download, copy (for internal purposes only) and share this Materialwith your employees and consultants for study purposes, and (b) utilize the Material for the purpose of developing,making, having made, using, marketing, importing, offering to sell or license, and selling or licensing, and to otherwisedistribute, Compliant Products, in all cases subject to the conditions set forth in this Agreement and any relevantpatent and other intellectual property rights of third parties (which may include members of HL7). No other license,sublicense, or other rights of any kind are granted under this Agreement.C. NON-MEMBERS, who register and agree to the terms of HL7’s IP policy for Specified Material, are authorized,without additional charge, to read and use the Specified Material for evaluating whether to implement, or inimplementing, the Specified Material, and to use Specified Material to develop and sell products and services thatimplement, but do not directly incorporate, the Specified Material in whole or in part.NON-MEMBERS wishing to incorporate additional items of Specified Material in whole or part, into products andservices, or to enjoy the additional authorizations granted to HL7 ORGANIZATIONAL MEMBERS, as noted above,must become ORGANIZATIONAL MEMBERS of HL7.Please see http://www.HL7.org/legal/ippolicy.cfm for the full license terms governing the Material.Ownership. Licensee agrees and acknowledges that HL7 owns all right, title, and interest, in and to the Materials.Licensee shall take no action contrary to, or inconsistent with, the foregoing.Licensee agrees and acknowledges that HL7 may not own all right, title, and interest, in and to the Materialsand that the Materials may contain and/or reference intellectual property owned by third parties (“Third PartyIP”). Acceptance of these License Terms does not grant Licensee any rights with respect to Third Party IP.Licensee alone is responsible for identifying and obtaining any necessary licenses or authorizations toutilize Third Party IP in connection with the Materials or otherwise. Any actions, claims or suits brought by athird party resulting from a breach of any Third Party IP right by the Licensee remains the Licensee’s liability.Following is a non-exhaustive list of third-party terminologies that may require a separate license:TerminologyOwner/ContactCurrent Procedures TerminologyAmerican Medical Association(CPT) code t-licensingSNOMED CTSNOMED International http://www.snomed.org/snomed-ct/getsnomed-ct or info@ihtsdo.orgLogical Observation Identifiers NamesRegenstrief Institute& Codes (LOINC)International Classification of Diseases World Health Organization (WHO)(ICD) codesNUCC Health Care ProviderAmerican Medical Association. Please see www.nucc.org. AMATaxonomy code setlicensing contact: 312-464-5022 (AMA IP services)Page 2HL7 CDA R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2 STU- US Realm 2019 Health Level Seven International. All rights reserved.October 2019

Companion Guide to HL7 Consolidated CDA R2.1Revision Initial Draft – Reviewed with SDWG and posted to Confluence for communityreview.2.110/24/2019FinalThe Companion Guide has been developed by MaxMD under the management of HL7 as part ofa grant awarded to HL7 by the Office of the National Coordinator for Health InformationTechnology (ONC). The MaxMD team included Lisa Nelson and Natasha Kreisle. The guidancein the Companion Guide reflects implementation experience and input from healthcarecommunity stakeholders, and feedback from surveys and in-person “Implementation-a-thons”conducted by HL7.It has been developed through a detailed analysis and review of the current regulations,reviews with HL7 Working Groups, and reviews by experienced implementers and“Implementation-a-thons” participants.The project team wishes to extend its thanks to members of the HL7 Structured DocumentsWork Group, HL7 C-CDA Implementation-A-Thon participants and those who contributed to thedevelopment and review of guidance noted in this document:Structured Documents Work Group LeadershipCalvin BeebeGay DolinBenjamin FlessnerAustin KreislerSean McIlvennaAndrew StatlerC-CDA Companion Guide R2 Content Contributors and ReviewersCalvin BeebeLaura BryanMichael CliftonJohn D’AmoreDidi DavisGeorge DixonGay DolinEd DonaldsonJohn DonnellyBen FlessnerLindsey HoggleEmma JonesNatasha KreisleBrett MarquardRob McClureLinda MichaelsenJoseph QuinnMatt RahnStuart WardMartha VelezisIoana SingureanuStephen ChuJay LyleMichael PadulaC-CDA Companion Guide R1 Content Contributors and ReviewersCalvin BeebeCathrin BrittonGeorge ColeDidi DavisBob DieterleeGeorge DixonBenjamin FlessnerEvelyn GallegoBrett MarquardLisa NelsonMatt RahnPage 3HL7 CDA R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2 STU- US Realm 2019 Health Level Seven International. All rights reserved.October 2019

Companion Guide to HL7 Consolidated CDA R2.1CopyrightThis material includes content copyrighted by Health Level Seven International and is used withpermission of Health Level Seven International. ALL RIGHTS RESERVED. HL7, Health Level Seven andCDA are registered trademarks of Health Level Seven International. Reg U.S. Pat & TM office.This material includes SNOMED Clinical Terms (SNOMED CT ) which is used by permission of theInternational Health Terminology Standards Development Organization (IHTSDO). All rights reserved.SNOMED CT was originally created by The College of American Pathologists. "SNOMED " and "SNOMEDCT " are registered trademarks of the IHTSDO.Page 4HL7 CDA R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2 STU- US Realm 2019 Health Level Seven International. All rights reserved.October 2019

Companion Guide to HL7 Consolidated CDA R2.1Table of Contents1Introduction . 121.1Purpose: Essential Guidance for Advancing Interoperability . 121.2The Genesis and Evolution of C-CDA. 131.3Semantic Interoperability: C-CDA Value Set Management . 171.4Audience . 191.5Requisite Knowledge . 191.6Contents of this Guide . 201.2.11.2.21.2.32Understanding C-CDA and the C-CDA Companion Guide . 212.1Layered Constraints, Rising Expectations . 212.2CDA R2 Schema and Schema Validation . 232.3C-CDA Templates and Schematron Validation . 272.4C-CDA Companion Guide and C-CDA Rubric Rules . 292.5Fundamental Concepts for Document-Based Exchange . 322.6General Guidance on Document-Based Exchange . 372.7Clinical Notes. 452.8Options for Temporarily Unavailable Data. .12.6.22.7.13The Maturation Process for C-CDA .13C-CDA Errata Process .15C-CDA STU Updates.15CDA R2 Schema Extensions Used by C-CDA R2.1 .23Declaring Template Conformance .29Best Practice Guidance for Higher Levels of Interoperability.30Guidance Language and Expectations .30Best Practice Rubric and Validation .31CDA and C-CDA Templates .32Structured Versus Unstructured Documents .34Open Versus Closed Templates .35Encounter Summary Versus Patient Summary .36Content Creator Responsibilities .38Content Consumer Responsibilities.41LOINC Coding for Clinical Notes .47Document Level Guidance . 513.1Reusable, Nesting Templates . 513.2Structured Header. 543.1.13.2.13.2.23.2.33.2.43.2.53.2.6Nested Content and Context Conduction .52Patient .54Authors Versus Performers .64Custodian .68Care Team Members .68sdtc:signatureText in Authenticator and legalAuthenticator.70Context of Care .71Page 5HL7 CDA R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2 STU- US Realm 2019 Health Level Seven International. All rights reserved.October 2019