Office of the National Coordinator for Health IT
Standards & Interoperability Framework
TOC Initiative Implementation Guidance
U.S. Health and Human Services
Office of the National Coordinator for Health IT
S&I
Framework
Standards & Interoperability Framework
Transitions of Care Initiative
CDA Consolidation Companion Guide
[Publish Date]
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Revision History
Date
Document Version
8/13/2011 0.05
11/4/2011 0.06
1.0
Document Revision Description
Initial draft of Transitions of Care Implementation Guidance,
intended to serve as an implementation primer for potential pilot
participants
Additional guidance added including:
 Alignment of CDA to TOC CEDD Version 1.0
 Designation of applicable value sets
 High level constraints applied to each CDA Section
 Additional split out of Care Transition Information
Exchanges into individual guidance documents
Official Draft developed by the TOC Implementation Guidance SubWorkgroup. Additional guidance added including:
 Alignment of C-CDA to TOC CEDD Version 2.0
 MDHT resources/guidance
 Clinical context for TOC document generation
 TOC document relationships to Meaningful Use
requirements
 Additional C-CDA guidance to supplement standard
publication
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Acknowledgements
The authors of this document wish to recognize the following participants who contributed their
time and expertise to the development of this guide.
List of Initiative participant names.
Copyrights
Include any standards referenced in the document here or other copyrighted material.
This is an example:
This material includes SNOMED Clinical Terms ® (SNOMED CT®) which is used by permission of the
International Health Terminology Standards Development Organization (IHTSDO). All rights reserved.
SNOMED CT was originally created by The College of American Pathologists. "SNOMED ®" and "SNOMED
CT ®" are registered trademarks of the IHTSDO.
This material contains content from LOINC® (http://loinc.org). The LOINC table, LOINC codes, and
LOINC panels and forms file are copyright (c) 1995-2011, Regenstrief Institute, Inc. and the Logical
Observation Identifiers Names and Codes (LOINC) Committee and available at no cost under the license
at http://loinc.org/terms-of-use.
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Table of Contents
................................................................................................................................................................ 1
................................................................................................................................................................ 1
1.
Introduction .................................................................................................................................. 5
1.1.
Purpose ................................................................................................................................. 5
1.2.
Scope ..................................................................................................................................... 7
1.2.1.
Use Case Scenarios............................................................................................................ 7
1.2.2.
Information Exchanges ...................................................... Error! Bookmark not defined.
1.3.
Audience ............................................................................................................................... 5
1.4.
Organization of this Guide .................................................................................................... 7
1.5.
ToC CEDD Overview .............................................................................................................. 8
1.6.
Templates.............................................................................................................................. 9
1.7.
Conformance......................................................................................................................... 9
1.8.
Conventions ........................................................................... Error! Bookmark not defined.
1.9.
Section Preamble .................................................................................................................. 9
1.9.1.
CDA Implementation Table ............................................................................................. 10
1.9.2.
Implementer Notes ......................................................................................................... 10
2.
Initiative Implementation Guidance ............................................................................................. 7
3.
Initiative CEDD .............................................................................................................................. 7
4.
Additional Guidance...................................................................................................................... 9
5.
Appendix A: Reference Documents ............................................................................................ 15
6.
Appendix B: Acronym List ........................................................................................................... 16
7.
Appendix C: Recommended Value Sets ...................................................................................... 17
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1. Introduction
In support of the national objectives for healthcare reform, the Office of the National Coordinator
for Health Information Technology (ONC) Standards and Interoperability (S&I) Framework has sponsored
the development of harmonized interoperability specifications. These specifications are designed to
support national health initiatives and healthcare priorities, including Meaningful Use, the Nationwide
Health Information Network, and the ongoing mission to improve health care delivery, advance care
coordination, and reduce costs to realize better population health.
The S&I Framework is comprised of several initiatives, each focusing on a single challenge with a set
of value-creating goals and outcomes to enhance the efficiency and effectiveness of healthcare delivery.
Among the first initiatives launched by the S&I Framework is the Transitions of Care (ToC) Initiative,
which focuses on empowering patients, engaging the clinician, and enabling health information
exchange in support of national health initiatives.
1.1. Transitions of Care Initiative Overview
The purpose of the Transitions of Care Initiative is to improve the exchange of core clinical
information among providers, patients and other authorized entities electronically in support of
meaningful use and IOM-identified needs for improvement in the quality of care. The ToC Initiative is
motivated by one very compelling question:
What if every care transition was accompanied by an
unambiguously-defined core set of high-quality clinical data?
Key Functions of the ToC Initiative:
 Focus on core clinical content that could inform complete reconciled medication, problem,
medication reaction, laboratory results, etc.;
 Build on existing standards to accelerate results;
 Work with community to lower the implementation burden; and
 Guide decision-making based on the requirements of meaningful use and IOM-identified needs
for improvement in the quality of care.
Key Outputs of the ToC Initiative:
 Unambiguous definition of the core clinical elements that should be included in care transitions
 Definition of four key clinical constructs that provide guidance on the exchange of information
in the event of a patient care transition
 Agreement on a single standard in support of meaningful use requirements, which minimizes
interoperability errors and streamlines patient care coordination
 Tools and resources to lower the barrier to implementation
The ToC CDA Consolidation Guide captures the efforts of the ToC Initiative to provide contextual
and purposeful implementation guidance for the health care community.
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1.2. Purpose
As part of an effort to align standards cited by national regulations, the S&I Framework launched the
CDA Consolidation Project and worked alongside of Health Level Seven (HL7), Integrating the Healthcare
Enterprise (IHE), and the Health Story Project to produce a single source for implementing CDA
documents defined by Final Rules for Stage 1 Meaningful Use and Final Rules for Health Information
Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology. The resulting HL7 Implementation Guide for CDA R2: IHE Health
Story Consolidation R1 is an implementation guide for CDA documents including the Clinical Care
Document (CCD), Consultation Notes, and Discharge Summary.
The Transitions of Care CDA Consolidation Companion Guide aims to supplement the HL7
Implementation Guide for CDA Release 2: IHE Health Story Consolidation, Release 1 through providing
additional clinical and functional context to assist the implementation community in their efforts to
provide practical guidance that is outside the scope of the HL7 balloted standards.
This companion guide enables the exchange of key clinical information among providers in the
instance of a transition of patient care. Adoption and implementation of transition of care specifications
provides the following benefits:
1. Establishes a common standard for the exchange of clinical information. By adherence to a
common semantic model, the standard provides semantically consistent information across
instances of exchange.
2. Implementation of the clinical constructs defined by the Transitions of Care Initiative ensures
compliance with the following Meaningful Use criteria: Electronic Copy of Health Information,
Electronic Copy of Discharge Instructions, and Clinical Summary for each Office Visit.
3. Facilitates the ease of adoption of Meaningful Use 1 and anticipated Stage 2, for which eligible
providers receive a monetary incentive.
1.3. Audience
The audience of this companion guide includes, but is not limited to, software developers, vendors,
the ToC Reference Implementation and Pilots Workgroup, and other HIT implementer parties. While this
guide includes informative content intended to educate the audience on recommended HL7 Clinical
Document Architecture, Release 2 (CDA R2) standard implementation specifications, the guide remains
a supplement to the HL7 Implementation Guide for CDA Release 2: IHE Health Story Consolidation,
Release 1 available through the HL7 Structured Documents WG page . The HL7 CDA R2 standard serves
as the authoritative source for the complete specification for implementation and development and
may be accessed through the HL7 site by HL7 members.
1.3.1. Requisite Knowledge
Readers of this guide are assumed to have functional knowledge of HL7 concepts including Clinical
Document Architecture (CDA) and Reference Information Model (RIM) terminology. Readers must have
knowledge of Extensible Markup Language (XML) and XPath syntax. Additionally, readers should have
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an understanding of user-controlled terminologies such as SNOMED CT, LOINC, CPT, ICD, and RxNorm.
Resources for these concepts are available in the Additional Guidance section of this document.
1.4. Organization of this Guide
Guidance is provided as a walkthrough of the ToC Use Case Scenarios to offer contextual and
functional explanations to implementers. Please note that this companion guide does not replace the
HL7 CDA Release 2: IHE Health Story Consolidation Implementation Guide, but rather references the
guide where ToC functional priorities align with the standard specification. The companion guide is
organized to guide implementations of Final Rules for Stage 1 Meaningful Use and Final Rules for Health
IT compliant transitions of care documents as dictated by the ToC Use Case.
2. ToC Functional Requirements
The S&I Framework employs a use case methodology in order to transfer the business and
functional knowledge held by health information exchange stakeholders to the developers and
implementers of health information exchange solutions. The purpose of S&I Framework Use Cases is to
provide an explanation of what functions the solution must provide in order to satisfy the requirements.
At the highest level, use cases describe information exchange requirements in terms of a purpose or
objective.
The ToC Initiative Use Case is the foundation for subsequent Initiative activities including
identification of the clinical data elements necessary for clinical information exchange and
recommendation of a standard to promote adoption and interoperability. Ultimately, all ToC Initiative
outputs, including this companion guide, are drawn from the ToC Use Case.
Additional information on the final ToC Use Cases may be accessed through the S&I Framework
Wiki and downloaded from the S&I Framework Repository.
2.1. Scope
The scope of the transition of patient care is defined in the use case as two scenarios, both
supported by key outputs or constructs that contain specific patient information to facilitate the
exchange of information in the event of a care transition.
In Scope
 Clinical Summary information and its basic dataset(s) for the Transition of Care to include the
transfer of care and the exchange of clinical information between providers and patients, and
between providers
 Clinical Information necessary to support transitions from eligible providers, hospitals and critical
access hospitals as defined by Meaningful Use Stage 1 requirements
2.1.1. Use Case Scenarios
Scenario 1: The Transfer of Patient Information from One Provider to Another Actor: The transfer of
patient information from one provider to another actor occurs in two ways:
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1. The exchange of Discharge Instructions and Discharge Summary between a provider and patient
to support the transfer of a patient between care settings, or
2. The exchange of clinical summaries between providers and patients to support the closed-loop
transfer of a patient from one care setting to another consultation referral.
Scenario 2: The Transfer of Patient Information between Providers: The transfer of patient
information between providers occurs in three ways:
1. The exchange of information to support the transfer of patient information from one provider to
another,
2. A closed loop referral, or
3. A complex series of care transitions.
2.1.2. ToC Information Exchange Priorities
2.2. Application of the ToC CEDD
The four key information exchanges, or constructs, are supported by the Transition of Care Clinical
Element Data Dictionary (ToC CEDD). The ToC CEDD provides a concise and defined vocabulary for the
sharing of care transition information used to generate the constructs identified in the ToC Use Case
Scenarios. The ToC CEDD provides the reference vocabulary for consistent and reusable care transition
information exchanges. Specific guidance and references are provided at the section-level of each ToC
Construct.
The latest version of the ToC CEDD may be accessed through the S&I Framework Wiki and serves
as an informative document to expound on concepts presented within the companion guide to
orchestrate semantic interoperability beyond the ToC Consolidated CDA Recommended Standard.
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3. ToC Implementation Guidance
3.1. CDA Guidance
3.1.1. Templates
Template identifiers (template IDs) are assigned at the document, section, and entry level. When
valued in an instance, the template identifier signals the imposition of a set of template-defined
constraints. The value of this attribute provides a unique identifier for the template in question. Please
refer to the HL7 CDA Consolidation IG available through the HL7 Structured Documents WG page for
additional information on template identifiers and how they are used.
3.1.2. Conformance & Conventions
CDA implementers characterize conformance requirements in terms of three general levels that
correspond to three different, incremental types of conformance statements:
 Level 1 requirements impose constraints upon the CDA Header. The body of a Level 1 document
may be XML or an alternate allowed format. If XML, it must be CDA-conformant markup.
 Level 2 requirements specify constraints at the section level of a CDA XML document: most
critically, the section code and the cardinality of the sections themselves, whether optional or
required.
 Level 3 requirements specify constraints at the entry level within a section. A specification is
considered "Level 3" if it requires any entry-level templates.
The conventions used in this document are intended to outline a set of tables for implementers to
use as guidance.
Refer to the CDA Consolidation IG for additional information regarding conventions including XPath
notation, XML examples, and sample documents as well as conformance requirements including levels
of constraint, conformance statements, conformance verbs, cardinality, vocabulary conformance, and
null flavor.
3.2. Section Preamble
A description of the CDA section is provided, within the context of a care transition. This preamble
includes the list of conformance statements required for the CDA section template, as well as underlying
entry-level templates that may apply. These conformance statements MAY be an addition to the
conformance statements contained within the CDA Consolidation guide. Some of these conformance
statements also specify the use of specific value sets for a care transition, which are drawn from existing
implementation guidance such as HITSP C80 and HITSP C83. A full listing of all conformance statements
can be drawn from the conformance statements links in the Implementer Notes of the section guidance.
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3.2.1. CDA Implementation Table
The CDA Implementation table immediately follows the section preamble and contains key
implementation details about the section.
Reference
Document
The source for
the section
template.





CDA Template ID
(Proposed)
The CDA Template ID
for the section. The
implementer SHALL
include the template ID
in each section to
declare conformance
to the CDA
Consolidation Guide.
Required/Optional
Indicates whether
the CDA Section is
required or
optional for the
care transition.
Consolidated CDA IG
Reference
Provides the specific
reference to the CDA
Consolidation
Implementation Guide
to determine
conformance
requirements and
optionality.
Code Set
Provides the
recommended
terminology to
be used for that
section.
Reference Document: For some sections, implementation guidance is provided both for
Consolidated CDA and HITSP C83. This is provided to ensure smooth transition planning for
those implementers who may already be using a C32 or CCD for a care transition information
exchange.
CDA Template ID (Proposed): A conformance statement that should be followed for each CDA
Section. In order to be conformant with the Consolidated CDA Guide, a CDA Document SHALL
declare conformance for the specific section by including a <templateID> element with the root
attribute set to the value.
Required/Optional: This indicates whether the CDA Section and/or Entry is required for the
particular information exchange or is optional.
Consolidated CDA IG Reference: This will indicate the specific location of the CDA Section
and/or Entry within the Consolidated CDA Guide. This reference allows an implementer to
quickly access the relevant conformance statements for the CDA Section and/or Entry.
Code Set: The recommended code set to be used for that CDA Section and/or Entry.
3.2.2. Implementer Notes
The implementer notes include the following:
 Links to conformance statements
 Links to XML samples of the CDA Section and/or Entry, where appropriate
These links are provided as an implementer resource and are derived from CDAtools.org made
available by Open Health Tools (OHT) for use in support of this implementation guidance. In many cases,
the current samples and conformance statements provided are linked to HITSP C32 and/or the CCD. The
HITSP C32 and/or CCD examples and conformance statements are fully useable in conjunction with
Consolidated CDA.
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Data Element
CDA XPath
Reference
R/O
CEDD
Reference
Null Values
Notes
Does the data
element allow
for a null
value or not?
Additional
implementation
notes, such as
required value
sets, required
XML entries, etc.
CDA FULL XPATH REFERENCE HERE
HITSP C83 data
element and
business name
listed for
implementer
reference






A link to the CDA
XPath specific to
this data element,
so implementers
know where a
specific data
element will go
Required
or
Optional
A reference to
the applicable
CEDD Object
and CEDD Data
Element
Data Element: The data element listed in this table is drawn from HITSP C154 and is provided to
give implementers a specific business name to reference when populating the relevant CDA
Section and/or Entry.
CDA XPath Reference: This XML expression outlines where the data element would be captured
within a CDA document.
R/O: Indicates whether the data element is required or optional within the specific CDA Section
and/or Entry.
Null Values: Outlines whether null values are allowed or not for this data element.
CEDD Reference: References the specific ToC CEDD data element.
Notes: Additional implementation notes, such as which value set to be used to encode an
element or where this data might also be represented within a CDA document.
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4. Additional Guidance
The following information is supplied as a starting point for information on the various tools and
information one may find useful (depending on their proficiency).




Comparison and conversion tools to migrate from the existing CDA standard to new
Consolidated CDA
CCR-Consolidated CDA conversion tool for vendors who previously implemented CCR*
Openly available data modeling tools, reference implementation code, and test suite**, to aid
to lower implementation time and costs
Educational resources
4.1. Tools
The Transitions of Care Initiative has worked to enable the availability of multiple tools and
educational resources needed in support of using technology to improve care transitions. These tools
are designed to provide the level of automated tooling needed in support of Consolidated CDA.
4.1.1. OHT/MDHT
The implementation guidance used for Transitions of Care is designed to be generated directly from
MDHT. The MDHT-generated guidance includes the appropriate level of specification and detail needed
to implement a care transition information exchange, including API’s, code documentation, and models
needed for implementation.
MDHT allows the creation of computable models of the templates in UML. These models can be
used to produce:




Template Specifications (DITA, XHTML, PDF, Other)
Conformance/Validation Tools
Model Driven Code Generation
Schematron
The project has built models from the following specifications:





HL7 Continuity of Care Document
HITSP C83 Sections and Entries
IHE Patient Care Coordination Technical Framework
HL7 Common Document Types
Consolidated CDA
MDHT is available for download at: https://www.projects.openhealthtools.org/sf/projects/mdht/
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4.1.2. Trifolia
Tooling support is also provided by Lantana Group and their Trifolia Workbench, which supports
standards authors, developers and implementers in capturing, storing and managing HL7 Clinical
Document Architecture (CDA) templates.
Trifolia is available for download from: http://www.lantanagroup.com/resources/tools/
4.1.3. NIST Validation/MU testing sites
This site organizes key resources (e.g. HITSP, CCHIT, standards and testing tools) in a central place to
provide a resource for implementation and interoperability testing activities.
http://hit-testing.nist.gov/
http://xreg2.nist.gov/hit-testing/
4.1.4. TOC Quickstart Site
The Transitions of Care (TOC) Quickstart site is a central source to view and download Transitions of
Care Initiative guides, work products and models.
http://wiki.siframework.org/Transitions+of+Care+Quickstart+Page
4.1.5. myCDA
This wiki page serves as a central source for educational and training resources in support of
Consolidated CDA. With links to samples, FAQs, and guidance on implementing care transition
information exchanges. Sample XML and XSL code is also available to help implementers get started
with the use of CDA.
The myCDA site is under development and will be available in the next release of this guidance.
4.2. Educational Resources
4.2.1. Clinical Document Architecture (CDA)
The full Clinical Document Architecture Normative Edition is available for purchase from
www.HL7.org, this package includes additional publications such as Datatypes, HL7 Value Sets, and
other detailed information required for proper implementation of CDA.
The following links are provided for those who wish to further their understanding of the HL7 CDA
and the ASTM/HL7 Continuity of Care Document Implementation Guide. The former is the “base
standard” selected by S&I Transitions of Care Initiative for all healthcare documents.
 CDA Quick Start Guide (v1.5) This Quick Start Guide supports implementers working with simple
CDA documents. It covers required elements in the CDA header and body and explains
fundamental concepts including the CDA approach to identifiers, vocabulary and data types.
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 CCD Quick Start Guide (v1.0) This Quick Start Guide is for implementers working with the
Continuity of Care Document (CCD) which is the basis of the HITSP/C32. Readers should be
familiar with the underlying Clinical Document Architecture Release 2.0 (CDA R2) standard, (see
the CDA Quick Start Guide).
4.2.1.1.
HL7 Structured Documents Technical Committee Wiki
 This Wiki site is a subset of the full HL7 Wiki site (wiki.hl7.org)
 Login is not required for browsing pages:
http://wiki.hl7.org/index.php?title=Structured_Documents
 There are a number of sub-categories available from this page relative to the use of CDA, items
of particular interest may be: CDA Suggested Enhancements and the associated Formal
Proposals, Continuity of Care Document and CCD Errata
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5. Appendix A: Reference Documents
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6. Appendix B: Acronym List
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7. Appendix C: Recommended Value Sets
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