NIST GCR 11-940

Continuity of Care (CCD) Standards Action Plan

Lantana Consulting Group 
NIST GCR 11-940

Continuity of Care (CCD) Standards Action Plan

Prepared for 

 National Institute of Standards and Technology

Gaithersburg Md 20899-8202

By

Lantana Consulting Group

June 2011 

U.S. Department of Commerce 

John E. Bryson, Secretary

National Institute of Standards and Technology 

Patrick D. Gallagher, Under Secretary for Standards and Technology and Director

This publication was produced as part of contract SB1341-10-CN-0085 with the National Institute of Standards and

Technology. The contents of this publication do not necessarily reflect the views or policies of the National Institute of

Standards and Technology or the US Government.
Continuity of Care (CCD) 

Standards Action Plan

June 2011

Prepared by Lantana Consulting Group

for

National Institute of Standards and Technology

© 2011 Lantana Consulting Group

All rights reserved.
Lantana Consulting Group

PO Box 177

East Thetford, VT 05043

www.lantanagroup.com

Liora Alschuler

Chief Executive Officer

liora.alschuler@lantanagroup.com

Bob Dolin, MD, FACP

President and Chief Medical Officer

bob.dolin@lantanagroup.com

Lauren Wood, Ph.D.

Senior Project Manager

lauren.wood@lantanagroup.com

Gaye Dolin, RN, MSN

Senior Nurse Informaticist

gaye.dolin@lantanagroup.com

Jingdong Li, MD

Chief Architect

jingdong.li@lantanagroup.com

Yan Heras

Senior Medical Informaticist

yan.heras@lantanagroup.com

Bob Yencha

Principal Consultant

bob.yencha@lantanagroup.com

Susan Hardy

Senior Technical Editor

susan.hardy@lantangroup.com

Lantana Consulting Group CCD Standards Action Plan June 2011

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Table of Contents

EXECUTIVE SUMMARY................................................................................................ 4

INTRODUCTION............................................................................................................. 5

RECOMMENDED ACTIONS.......................................................................................... 6

Testability.................................................................................................................................... 6

Testing and Validation................................................................................................................. 6

Error Handling............................................................................................................................ 7

Certification................................................................................................................................ 7

Documentation............................................................................................................................ 8

CONCLUSIONS............................................................................................................... 9

REFERENCES................................................................................................................ 10

ACRONYMS AND ABBREVIATIONS..........................................................................11

Lantana Consulting Group CCD Standards Action Plan June 2011

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Executive Summary

This document is the action plan to improve the suitability of Health Level Seven (HL7)

Continuity of Care Document (CCD) to support the Department of Health and Human Services’

Stage 1 Meaningful Use. Lantana Consulting Group prepared this report for the National

Institute of Standards and Technology (NIST) to accompany the related “CCD Suitability

Analysis”.

We believe that CCD addresses its intended purpose to provide a snapshot in time of a patient’s

pertinent clinical, demographic, and administrative data. We believe CCD—with its underlying,

stable HL7 Clinical Document Architecture (CDA) standard—will support the overall

Meaningful Use goal of achieving significant improvements in care. In our analysis, we identified

improvements in testability, testing and validation, error handling, and certification that can

enhance the adoption of CCD. In addition, improved documentation from the CDA Consolidation

project will mitigate some of the problems presented by layered C32 and IHE constraints. Here

we recommend actions to address these improvements.

We recognize that testability, testing and validation will benefit from the investment of software

development and policy decisions. There is work to be done to enrich an already strong standard

by improving tools and processes. If acted upon, these recommendations will improve CCD’s

ability to support Meaningful Use.

Lantana Consulting Group CCD Standards Action Plan June 2011

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Introduction

This document is the action plan to improve the suitability of Health Level Seven (HL7)

Continuity of Care Document (CCD) to support the Department of Health and Human Services’

Stage 1 Meaningful Use. Lantana Consulting Group prepared this report for the National Institute

of Standards and Technology (NIST) to accompany the related “CCD Suitability Analysis”1.

This plan contains recommended actions for all issues identified in the “CCD Suitability

Analysis”. We also consider the interdependence between the recommended actions. Resolution

of these issues will enrich an already strong standard by improving tools and processes to

encourage more widespread adoption of the CCD standard.

We do not duplicate our analysis in this document, but do refer to it wherever applicable. This

report does not discuss assignment of responsibility for management of change process. 

Any mention of commercial products or organizations in this report is for information only; it

does not imply recommendation or endorsement by Lantana or NIST.

1

 Both CCD reports were prepared under contract SB134110CN0085.

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Recommended Actions

We recommend five categories of actions: testability, testing and validation, error handling,

certification, and documentation. Testability will be improved as model-driven Clinical

Document Architecture (CDA) development techniques, such as those described in “Templated

CDA: Key Concept for Interoperability,”

2

 evolve. Model-driven development will improve our

ability to generate schematron and other testing and validation artefacts. Improved error handling

processes will help ensure that errors are corrected at the source, such that revisions cascade to all

down-stream artefacts. Certification of implementers in CCD as well as CDA will improve the

consistency of technical implementations. Improved documentation, particularly the creation of

an implementation guide that flattens the multiple layers of indirection across multiple

documents, can dramatically lower the learning curve.

Testability

Testability of the CCD standard will be improved by refining its conformance statements as

recommended in the “CCD Coverage Report”3and by creating a template library as described in

“Templated CDA: Key Concept for Interoperability”. We recommend the following actions:

Re-write CCD conformance statements into multiple discrete conformance statements with

consistent style, each of which are individually testable.

Develop a standard style of prose guidance when discrete testable conformance statement(s)

require additional guidance for untestable real-world requirements.

Create a computable template library.

The CDA Consolidation Project4 is addressing issues with conformance and testability. If CCD

adopts this consistent approach, it will simplify the definition of what is testable and the

requirements for validation and run-time validation versus certification.

Templated CDA is a key technology underlying CCD and other HL7 CDA implementation

guides. Such template libraries support both standards development and implementation. A

template library will improve quality assurance, consistency, and schematron testing.

Testability and testing improvements will develop hand-in-hand when conformance statements

are written with discrete computable testable syntax.

Testing and Validation

Schematron validates syntax at several different levels of syntactic correctness. Implementers rely

on schematron to determine the correctness of a CCD instance generation. A better review

2

 Lantana Consulting Group. Templated CDA: Key Concept for Interoperability, May 2011. Related

document prepared for NIST.

3

 Lantana Consulting Group. CCD Coverage Report, May 2011. Related document prepared for NIST.

4 http://jira.siframework.org/wiki/display/SIF/CDA+Consolidation+Project

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process for schematron rule development and creation of a reference implementation will

improve testing and validation. We recommend the following actions:

Develop and publish schematron rules along with the CCD standard revisions. Any off-the-shelf

XML tool can then apply these schematron rules to validate CCD instances. 

Establish a healthcare information technology (HIT) community review and consensus process as

part of the development of schematron rules, so that they can be publicly vetted. 

Consider other testing technologies to improve instance testing as identified in the “CCD

Coverage Report” such as model-driven validation and RELAX NG. 

Create a CCD reference implementation. A reference implementation could be built to the

current specification; it should then be enhanced with subsequent CCD versions as part of testing

and validation of new or versioned templates.

Improve vocabulary validation. When a system receives a CCD instance, it must validate the

structural correctness of the instance and whether a correct code is received for a coded data

element. Codes from dynamic vocabulary bindings are difficult to validate and require interface

with terminology services. Health care often uses dynamic value sets to support new knowledge

and to supply missing terms. A terminology service such as one based on the HL7 Version 3

Standard: Common Terminology Services, DSTU Release 2)5 would mitigate this testing problem.

See the “CCD Coverage Report” for full discussion of this issue.

Error Handling

HL7 has a well-defined error-handling system. Errors for base CCD are handled within the HL7

community on errata pages and by the Structured Document Work Group meetings. We

recommend creation of a coordinated cross-organization error handling process for C32.

Certification

HL7 provides one type of certification for the professionals who work with the CDA, but there is

no certification for CCD. We recommend the following actions:

• Create a certification for proficiency in CCD/C32.

• Create several depths to the certification program so that it can be tailored to different

roles/job types.

Certification overlaps with all recommendations in that updates in the CCD standard and related

tools will have to be reflected in any certification programs.

5

 HL7 Version 3 Standard: Common Terminology Services, DSTU Release 2

http://www.hl7.org/documentcenter/public/standards/dstu/2009may/V3_CTS_R2_DSTU_2009OCT.pdf

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Documentation

CCD/C32 places multiple layers of constraints on top of CCD and presents a barrier to adoption.

We recommend flattening that stack and improving its documentation to present a single resource

for implementers of CCD/C32:

Reconcile (resolve ballot comments) and publish the HL7 CDA Consolidated Implementation

Guide (currently in ballot).

Harmonize discrepancies across HL7, IHE, and Healthcare Information Technology Standards

Panel (HITSP) and ballot the remaining CCD/C32 and applicable C83 modules in version 2 of

the HL7 CDA Consolidated Implementation Guide.

Ensure template changes are tracked and noted so implementers can quickly locate where

changes need to be made in existing CCD/C32 implementations.

Augment the HL7/IHE Health Story Consolidation Project with new templates supporting new

use cases and common document types.

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Conclusions

The CCD standard fulfills its purpose and satisfies the criteria we defined for suitability for

Meaningful Use. CCD is robust because of the underlying well-accepted HL7 CDA standard and

the ability to represent data elements in a consistent manner through vetted templates. The areas

identified in this action plan, if acted upon, will further strengthen the standard, increase the rate

of implementation and prepare it for the future. 

Testability, testing, and validation will require an investment of software development and policy

decisions. Authoring and testing tools are in development, but need to be enhanced and to mature

to meet all of the HIT standards industry needs for CCD and other CDA implementation guides.

Development of a single CCD/C32 resource for implementers is in progress; it requires

participation and support of stakeholders to see the project through to completion. A process for

error handling inclusive of C32 requires cross-organization policy and process coordination.

In summary, these steps can enrich an already strong standard by improving tools and processes

to increase its validity and reliability in communicating patient information in a uniform,

consistent manner between healthcare organizations. 

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References

CDA Consolidation Project.

http://jira.siframework.org/wiki/display/SIF/CDA+Consolidation+Project

HL7 Version 3 Standard: Common Terminology Services, DSTU Release 2

http://www.hl7.org/documentcenter/public/standards/dstu/2009may/V3_CTS_R2_DSTU_2009O

CT.pdf

Department of Health and Human Services. Health Information Technology: Initial Set of

Standards, Implementation Specifications, and Certification Criteria for Electronic Health

Record Technology; Final Rule, 45 CFR Part 170. http://edocket.access.gpo.gov/2010/pdf/2010-

17210.pdf

Department of Health and Human Services. Medicare and Medicaid Programs; Electronic

Health Record Incentive Program; Final Rule – Stage 1 Meaningful Use Objectives, 42 CFR

Parts 412, 413, 422 et al. http://edocket.access.gpo.gov/2010/pdf/2010-17207.pdf

HL7 Implementation Guide: CDA Release 2 – Continuity of Care Document (CCD): A CDA

implementation of ASTM E2369-05 Standard Specification for Continuity of Care Record©

(CCR) April 01, 2007 available through HL7: http://www.hl7.org

Lantana Consulting Group. CCD Coverage Report, May 2011. Related document prepared for

NIST.

Lantana Consulting Group. Continuity of Care Document (CCD) Suitability Analysis, May 2011.

Related document prepared for NIST.

Lantana Consulting Group. Templated CDA: Key Concept for Interoperability, May 2011.

Related document prepared for NIST.

The S&I Framework Initiative: CDA Consolidation Project.

http://wiki.siframework.org/CDA+Harmonization+WG

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Acronyms and Abbreviations

CCD Continuity of Care Document

CCR Continuity of Care Record 

CDA Clinical Document Architecture

HIT Healthcare Information Technology 

HITSP Healthcare Information Technology Standards Panel

HL7 Health Level Seven

IHE Integrating the Healthcare Environment

IT Information Technology

MU Meaningful Use

NIST National Institute of Standards and Technology

SDO Standards Development Organization

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