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Introduction

The Office of the National Coordinator (ONC) releases periodic proposed rules, and final rules, which reference the use of Consolidated CDA (C-CDA). The Companion Guide to Consolidated Clinical Document Architecture (C-CDA) provides supplemental guidance to the Health Level Seven (HL7) CDA® R2 IG: C-CDA Templates for Clinical Notes STU. The prior version of the companion guide is specific to a rule, the 2015 ONC Certification rule.

This project will update the companion guide to support C-CDA implementations in the US.

Updates may include new C-CDA templates and other revisions to meet industry requirements, for example changes in government requirements.  The set of updates for any release SHALL require approval by the Structured Documents Work Group and the US Realm Steering Committee.

Background Information

Previous Guidance:

Existing Specifications:

  • C-CDA (HL7 CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes - US Realm) including optional supplemental templates for updated Advance Directives Templates, Nutrition, and Pregnancy Status. The Consolidated CDA (C-CDA) implementation guide contains a library of CDA templates, incorporating and harmonizing previous efforts from Health Level Seven (HL7), Integrating the Healthcare Enterprise (IHE), and Health Information Technology Standards Panel (HITSP). It represents harmonization of the HL7 Health Story guides, HITSP C32, related components of IHE Patient Care Coordination (IHE PCC), and Continuity of Care (CCD). C-CDA Release 1 included all required CDA templates in Final Rules for Stage 1 Meaningful Use and 45 CFR Part 170 – Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule. This R2.1 guide was developed and produced by the HL7 Structured Documents Workgroup. It updates the C-CDA R2 (2014) guide to support “on-the-wire” compatibility with R1.1 systems C-CDA Release 2.1 implementation guide, in conjunction with the HL7 CDA Release 2 (CDA R2) standard, is to be used for implementing the following CDA documents and header constraints for clinical notes: Care Plan including Home Health Plan of Care (HHPoC), Consultation Note, Continuity of Care Document (CCD), Diagnostic Imaging Reports (DIR), Discharge Summary, History and Physical (H&P), Operative Note, Procedure Note, Progress Note, Referral Note, Transfer Summary, Unstructured Document, Patient Generated Document (US Realm Header). Note that the supplemental guide for Unique Device Identifier (UDI) for Implantable Medical Devices requires updates to address emerging issues. A team is working to address the issues. The material is presently still considered in scope for the Companion Guide Project, but it MAY go to ballot as less mature material than other guidance included in the Companion Guide.

Emerging Regulations:

  • USCDI v1 Summary of Data Classes and Data Elements (PDF) From ONC: As the country moves forward towards value-based care, data beyond those included in the Common Clinical Data Set (CCDS) is needed. We propose to remove the CCDS definition and its references from the 2015 Edition and replace it with the United States Core Data for Interoperability (USCDI) standard. This will increase the minimum baseline of data classes that must be commonly available for interoperable exchange. The USCDI Version 1 (USCDI v1) is proposed as a standard (§ 170.213). It reflects the same data classes referenced by the CCDS definition and includes new required data classes and data elements. If adopted, health IT developers will need to update their certified health IT to support the USCDI for all certification criteria affected by this change. Also see USCDI v1 Summary of Data Classes and Data Elements (website)
  • Section I: Vocabulary/Code Set/Terminology Standards and Implementation Specifications 2019 Interoperability Standards Advisory (ISA)

  • ONC Cures Act Proposed Rule: " In order to advance interoperability, we propose to remove the CCDS definition and its references from the 2015 Edition and replace it with the “United States Core Data for Interoperability.” We propose to adopt the USCDI as a standard, naming USCDI Version 1 (USCDI v1) in § 170.213 and incorporating it by reference in § 170.299. The USCDI standard, if adopted, would establish a set of data classes and constituent data elements that would be required to be exchanged in support of interoperability nationwide. "

Review sections:

B. Revised and New 2015 Edition Criteria

1. The United States Core Data for Interoperability Standard (USCDI)

a. USCDI 2015 Edition Certification Criteria
b. USCDI Standard - Data Classes Included
c. USCDI Standard – Relationship to Content Exchange Standards and Implementation Specifications 

Published C-CDA Implementer Community Guidance:

Emerging C-CDA Implementer Community Guidance



Task Force Conference Call Agenda/Minutes

Currently none scheduled.

Participants

Name

Email 

Role

Lisa Nelson Lnelson@max.mdProject Lead
Natasha KreisleNKreisle@max.mdProject Manager
Dave Hamilldhamill@hl7.orgProgram Manager
Matt RahnMatthew.Rahn@hhs.govSponsor Adviser
CDA Example Task Force
Assist with Content Development, Template Design, Editorial Review
SDWG
Inform about Content/Templates/Editorial changes; Accountable for Project Governance

Project Charter 

C-CDA Companion Guide Update 2019-06-24 PSS

Project Insight ID 1526

The C-CDA Companion Guide Update project mitigates risk regarding completion of a C-CDA R2.1 Update planned as an STU Update in September 2019. The C-CDA R2.1 Update (C-CDA R2.2) may not be reconciled and published in time to be considered in upcoming rule making.  The updated C-CDA R2.1 Companion Guide would be referenced in place of being able to point to a new version of C-CDA.

        

Key Project Objectives

  • Decoupled the guidance from being relevant only for 2015 EHR Certification
    • additional implementer guidance?
  • Improve implementer guidance on CCDS that will support the implementation of planned USCDI v1
    • Best practices on how to implement key data classes and data elements
    • current regulations in the US
  • Address critical gaps where insufficient implementer guidance exists currently


        Detailed Project Requirements

  1. Plan new Table of Contents, based on approved detailed scope
    1. Developing a mapping document that shows the prior Table of Contents with any updates in the new document
    2. Approach for managing incremental reviews
    3. Create the basis for a "What's New" chapter in the updated IG
  2. Address Schematron options with Lantana
    1. Add chapter to explain how the Schematron will work across multiple template IGs
  3. Decompose existing document into re-usable editable chunks
  4. Make editorial changes
    1. Replace/remove references to 2015 EHR Certification
  5. Draft new content
    1. Clarify use of Clinical Note Templates
    2. Clarify use of Section Time Range Template
    3. Clarify use of Medication Statement
    4. Bridging guidance between CCDS and USCDI
    5. Clarify what templateIDs to include in a document instance
  6. Develop new templates
    1. Care Team Section
    2. Care Team Entry
    3. Vital Sign for Oxygen Saturation Action Matthew Rahn  : (In or Out?)
  7. Update samples documents
  8. Validate sample documents


        Milestones


Date

Deliverable

Notes

Technical06.03.2019Submit initial materials to HL7Was not needed.

06.21.2019Submit final ballot package materials to HL7

Completed on 6/19/2019

Governance06.06.2019Review initial materials with SDWGCompleted on 6/6/2019

06.13.2019Submit for SDWG review with request to approve on 6/20Review completed on 6/13/2019

06.20.2019Request vote to approve materials to be submitted for ballotVote with CMG done on 6/19/2019, approval from SDWG on 6/20


July Ballot (Open June 21, 2019)  (Close July 22, 2019)

07.23.2019Ballot ReconciliationFinished on 10.10.2019

10.03.2019Block vote on the 10.03.2019 block of comments + deal with 162 Completed on 10.10.2019

10.10.2019Distribute final ballot reconciliation sheet, Block for on C25,186,187.Completed on 10.11.2019

10.17.2019SDWG vote to accept ballot reconciliation sheet as complete

10.17.2019SDWG meeting overview of updated Companion Guide materials

10.17.2019Post updated Companion Guide materials for member only review

PRERELEASE 20191014 copy posted for early review.

DRAFT20191017 will be posted prior to review on 10/17/2019


10.17.2019SDWG Co-chairs send request to withdraw negative ballot votes

10.24.2019SDWG joint with CDA Management Group Vote to publish C-CDA R2.1 Companion Guide R2

10.24.2019Send request to publish C-CDA R2.1 Companion Guide R2 to TSC

10.31.2019

HL7 Publishes C-CDA R2.1 Companion Guide R2


   

   

Activities and Schedule

ActivityResponsibleDate ScheduledDate CompletedBallot Sheet for reviewComment Resolution Tracking
Review of initial material Structured Documents workgroup06.06.201906.06.2019

Review of ballot materialStructured Documents workgroup06.13.201906.13.2019

Approve ballot materialStructured Documents workgroup06.20.201906.20.2019

Ballot Analysis
07.25.201907.25.2019Overview of ballot comments received
Ballot Reconciliation Block Voting and Discussion as neededStructured Documents workgroup07.25.201907.25.2019amalgamated ballot sheet as of 7/23/2019398 comments to go
Ballot Reconciliation Block Voting and Discussion as neededStructured Documents workgroup08.01.201908.01.2019amalgamated ballot sheet as of 7/25/2019

156 addressed

242 comments to go

Ballot Reconciliation Block Voting and Discussion as neededStructured Documents workgroup08.08.201908.08.2019amalgamated ballot sheet as of 8/1/2019

54 addressed

188 comments to go

Ballot Reconciliation

Block Voting and Discussion as needed

Structured Documents workgroup08.15.201908.15.2019

17 addressed

171 comments to go

Ballot Reconciliation

Block Voting and Discussion as needed

Structured Documents workgroup08.22.201908.22.2019

16 comments addressed

4 comments added

159 comments to go

Ballot Reconciliation

Block Voting and Discussion as needed

Structured Documents workgroup08.29.201908.29.2019

47 comments addressed

112 comments to go

Ballot Reconciliation

Block Voting and Discussion as needed

Structured Documents workgroup09.05.201909.05.2019

56 comments addressed

56 comments to go

Ballot Reconciliation

Block Voting and Discussion as needed

Structured Documents workgroup09.12.201909.19.2019

29 comments addressed

about 27 comments to go

Ballot Reconciliation

Block Voting and Discussion as needed

Structured Documents workgroup10.03.201910.03.2019

34 comments addressed

6 comments remaining


Ballot Reconciliation

Block Voting and Discussion as needed

Structured Documents workgroup10.10.201910.10.2019

Amalgamated Ballot Sheet as of 10/03/2019

Comment 25 Proposed Disposition

Comment 25 Proposed Disposition - PC Input.docx

Comment 27 Proposed Disposition.docx

Companion Guide Comment #404 - (No change to the  Companion Guide, but it updates the values in the Note Types value set referenced from the Notes Section and Note Activity templates defined in Companion Guide where DYNAMIC bindings are used and conformance levels are SHOULD.) 

6 comments addressed

0 comments remaining


Also have SDWG Review C-CDA R2.1 STU Comment #1872 to mark it WITHDRAWN.

Ballot Reconciliation

Block Voting and Discussion as needed

Structured Documents workgroup10.10.201910.10.2019

Amalgamated Ballot Sheet as of 10/07/2019 

Comment 409 Proposed Disposition

Need to confirm if the correct template id is: 

Is the correct template ID and Extension urn:hl7ii:2.16.840.1.113883.10.20.22.4.305:2019-06-04 ?

Amalgamated Ballot Sheet as of 10/09/2019

1 comment addressed 

0 comments remaining 



Completed Ballot Reconciliation SheetStructured Documents workgroup10.10.2019
To be approved by SDWG on 10.17.2019
Fully Executed Ballot Reconciliation SheetStructured Documents workgroup10.14.2019
Fully executed ballot comments
Additional Technical Correction for Provenance - Author Participation version labelStructured Documents workgroup10.15.201910.17.2019Fully executed ballot comments with additional technical correction to add missing template version label for Provenance - Author ParticipationTo be uploaded to Ballot Desktop Tally area after approved by SDWG.
Completed Ballot Reconciliation Sheet including vote on 10.17.2019Structured Documents workgroup

Amalgamated Ballot Sheet as of 10/17/2019 Including vote on 10.17.2019 approved by SDWG on comment 410. 
Completed Ballot Reconciliation Sheet including vote on 10.18.2019 on 19 additional commentsStructured Documents workgroup

10.18.2019

10.18.2019FINAL Amalgamated Ballot Sheet as of 10/18/2019Includes vote on 10.18.2019 on 19 additional comments approved by SDWG
Completed Ballot Reconciliation Sheet filed as updated Ballot Reconciliation Package.Structured Documents workgroup10.21.201910.21.2019

FINAL Amalgamated Ballot Sheet as of  

Includes vote on  19 additional comments, and rows for people who added Negative ballot vote with comment referring to someone else's comment sheet approved by SDWG on 10/21/2019.

Publication Package Deliverables

  1. IG word documents ready for publication
    1. Main file
    2. Appendix A (Templates Defined in C-CDA R2.1 Companion Guide)
    3. Appendix B (UDI Templates)
    4. Appendix C (Provenance - Author Participation Template)
  2. Sample C-CDA Files
  3. Schematron files for Templates Defined in C-CDA R2.1 Companion Guide
  4. Schematron files for C-CDA R2.1 
  5. Sample C-CDA Style Sheet

How to provide Pre-Release Publication Review feedback:

If you are doing final publication review, please download the package that is ready for review, use Track Changes to make edits or add comments. Please return the updated document to lnelson@max.md. 

Alternatively, there is a form you can use to capture comments that need to be addressed prior to publication. 

Scope of review should focus on formatting problems, broken links, minor type-o's or changes that are not consistent with approved ballot comment dispositions.


Edit

Name

Date

Current Incorrect Wording

Recommended Fixed Wording

Location in Guide

Change Accepted

Date of Correction

Andrew Statler Oct 23, 2019 sdrowkcab backwords page 32 No



Draft Final Publication Files

Files are all posted to the Members Only Area of SDWG page on HL7.org: Click Here 

NameStatusAdditional Notes
Pre-Release Package as of October 14, 2019

Pre-release Draft Version 20191014


This is a "Pre-Release" draft  package that people can use to review the execution of approved ballot comment dispositions.  Many technical issues are still being worked out, especially with new templates introduced in the appendices.  A stable package is expected by 10/17, as planned.  
DRAFT FINAL Package as of October 17, 2019Draft FINAL version 20191017This is a draft package of the FINAL materials that will be published for the HL7 C-CDA R2.1 Companion Guide R2. Please report any technical issues with these materials using the feedback form below. 
FINAL Publication Package as of October 23, 2019FINAL version 20191023This is the final publication package of the FINAL materials that will be published for the HL7 C-CDA R2.1 Companion Guide R2. 

Working Sample Files as of Oct 17, 2019 - Available from new C-CDA Sample Document Registry

Name

(click to open in Confluence)

Status
CCD Patient SummaryFINAL DRAFT - published in package and current version available on-line

Discharge Summary

FINAL DRAFT - published in package and current version available on-line
Referral NoteFINAL DRAFT - published in package and current version available on-line
Progress NoteFINAL DRAFT - published in package and current version available on-line
Care PlanFINAL DRAFT - published in package and current version available on-line
Unstructured DocumentFINAL DRAFT - published in package and current version available on-line
Legal Authenticator-signedFINAL DRAFT - published in package and current version available on-line
Authenticator -signedFINAL DRAFT - published in package and current version available on-line
New SectionsFINAL DRAFT - published in package and current version available on-line

Working Schematron Files as of June 19, 2019

NameStatusAdditional Notes
C-CDA R2.1 Companion Guide R2 SchematronFINAL DRAFTpublished in package 
Consolidated CDA Templates for Clinical Notes (US Realm) DSTUR2.1 SchematronFINALpublished in package - Source is the Schematron for C-CDA R2.1 JUN ERRATA package 

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1 Comment

  1. From GDolin: After hearing at the May 2019 HL7 WGM about challenges some vendors have with knowing how to handle user selected terms, their concerns about the proposed rubric around displayName (when present) and how they sometimes place(d) the user selected terms in observation/code/displayName instead of the reference codeSystem appropriate display name, despite the companion guide guidance. I would like to add some guidance in 4.1.9 and/or 4.1.9.1, similar to, but CDA scoped, that FHIR provides wrt user selected terms: "A typical use of CodeableConcept is to send the local code that the concept was coded with, and also one or more translations to publicly defined code systems such as LOINC or SNOMED CT. Sending local codes is useful and important for the purposes of debugging and integrity auditing." (https://www.hl7.org/fhir/datatypes.html#CodeableConcept) I will draft the text, including how and providing examples.