CDAR2_IG_PACP_R1_DSTU1.0_2015NOV_
Vol1_Introductory_Material
Project Insight: 1204
HL7 Implementation Guide for CDA® Release 2:
Personal Advance Care Plan Document
(US Realm)
Draft Standard for Trial Use Release 1.0
Volume 1 — Introductory Material
November 2015
Publication of this draft standard for trial use and comment has been approved by Health Level Seven International (HL7). This draft standard is not an accredited American National Standard. The comment period for use of this draft standard shall end 24 months from the date of publication. Suggestions for revision should be submitted at http://www.hl7.org/dstucomments/index.cfm.
Following this 24 month evaluation period, this draft standard, revised as necessary, will be submitted to a normative ballot in preparation for approval by ANSI as an American National Standard. Implementations of this draft standard shall be viable throughout the normative ballot process and for up to six months after publication of the relevant normative standard.
Sponsored by:
Structured Documents Work Group
Patient Care Work Group
Copyright © 2015 Health Level Seven International ® ALL RIGHTS RESERVED. The reproduction of this material in any form is strictly forbidden without the written permission of the publisher. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. Pat TM Off.
Use of this material is governed by HL7's IP Compliance Policy.
Structure of This Guide
Two volumes comprise this HL7 Implementation Guide for CDA® Release 2: Personal Advance Care Plan. Volume 1 provides narrative introductory and background material pertinent to this implementation guide, including information on how to understand and use the templates documented in Volume 2. Volume 2 contains the normative Clinical Document Architecture (CDA) templates for this guide along with lists of all templates, code systems, value sets, and changes from the previous version.
Primary Editor / Lisa R. NelsonOrganizationLife Over Time Solutions
-mail / Co-Editor: / David Tao, D.Sc.
ICSA Labs
David Tao
Co-Chair: / Brett Marquard
River Rock Associates
rett Marquard / Co-Editor: / Brian Scheller, MBA
Healthwise, Incorporated
Brian Scheller
Co-Chair: / Calvin Beebe
Mayo Clinic
alvin Beebe / Co-Editor: / L. Scott Brown
MyDirectives
Scott Brown
Co-Chair: / Austin Kreisler
SAIC Consultant to CDC/NHSN
/ Co-Editor: / Monica Williams-Murphy, MD
Huntsville Hospital Emergency Physician and Medical Director for Advance Care Planning and End of Life Education
Monica Williams-Murphy
Co-Chair: / Mark Roche / Co-Editor: / M’Lynda Owens, PhD, RN-BC, CHDA
Cognosante, LLC
M’Lynda Owens
Co-Chair: / Gaye Dolin, MSN, RN
Intelligent Medical Objects, Inc.
/ Co-Editor:
Co-Chair: / Laura Herman / Co-Editor:
Co-Chair / Emma Jones RN-BC, MSN
Allscripts
/ Co-Editor:
Co-Chair / Stephen Chu / Co-Editor:
Co-Chair / Jay Lyle / Co-Editor:
OAdd names of other industry team participants:
Terrence A. O’Malley, MD
Partners HealthCare System, Inc
Judith R. Peres, LCSW-C
Social Work Hospice and Palliative Care Network
John F. Derr, RPh
Strategic Clinical Technology
JD & Associates Enterprises, Inc.
Acknowledgments
This R2.1 guide was developed and produced through the efforts of Health Level Seven (HL7).
The editors appreciate the support and sponsorship of the HL7 Structured Documents Working Group (SDWG), the HL7 Patient Care Work Group, and all volunteers and staff associated with the creation of this document.
This material contains content from SNOMED CT® (http://www.ihtsdo.org/snomed-ct/). SNOMED CT is a registered trademark of the International Health Terminology Standard Development Organization (IHTSDO).
This material contains content from the Logical Observation Identifiers Names and Codes (LOINC) organization (http://loinc.org). The LOINC table, LOINC codes, and LOINC panels and forms file are copyright © 1995-2014, Regenstrief Institute, Inc. and LOINC Committee, and available at no cost under the license at http://loinc.org/terms-of-use.
Contents
1 Introduction 8
1.1 Purpose 8
1.2 Audience 8
1.3 Approach 8
1.4 Organization of the Guide 10
1.4.1 Volume 1 Introductory Material 10
1.4.2 Volume 2 CDA Templates and Supporting Material 11
1.5 Contents of the Package 11
2 Background 13
2.1 What is the Personal Advance Care Plan document? 14
2.2 Why is digital information exchange for personal advance care plans needed? 14
2.3 What are the envisioned Use Cases? 15
3 Design Considerations 22
3.1 Functional requirements for Personal Advance Care Plan Document Content 22
3.2 Levels of Machine Readability to Support Interoperability 23
3.2.1 Benefits of Level-1 CDA Document Exchange 24
3.2.2 Benefits of Level-2 CDA Document Exchange 25
3.2.3 Benefits of Level-3 CDA Document Exchange. 25
3.3 Considerations for Human Readable Narrative Text 26
3.4 Compatibility with other C-CDA Information Exchange Artifacts 28
3.4.1 Coded Content Crosswalk 31
3.5 Machine Readable Entries 32
3.6 Overview of Header Data Elements 33
4 Using This Implementation Guide 37
4.1 Conformance Conventions Used in This Guide 37
4.1.1 Templates and Conformance Statements 37
4.1.2 Template Versioning 39
4.1.3 Open and Closed Templates 40
4.1.4 Conformance Verbs (Keywords) 41
4.1.5 Cardinality 42
4.1.6 Optional and Required with Cardinality 42
4.1.7 Containment Relationships 43
4.1.8 Vocabulary Conformance 43
4.1.9 Data Types 45
4.1.10 Document-Level Templates "Properties" Heading 45
4.2 XML Conventions Used in This Guide 46
4.2.1 XPath Notation 46
4.2.2 XML Examples and Sample Documents 46
4.3 DSTU Comment Process: Errata and Enhancements 46
5 References 48
Appendix A — Acronyms and Abbreviations 52
Appendix B — High-Level Change Log 56
Volume 1 Summary of Changes 56
Volume 2 Summary of Changes 56
Appendix C — Extensions to CDA R2 57
Appendix D — Care Plan Relationships 58
Care Plan Relationships and HL7 RIM Terms 58
Care Plan Relationships Story Board Example 59
Appendix E — Coded Content Crosswalk 61
Figures
Figure 1: Level 2 PACP 21
Figure 2: Constraint Conformance Including "such that it" Syntax Example 33
Figure 3: Versioned Template Change Log Example 34
Figure 4: Constraints Format – only one allowed 36
Figure 5: Constraints Format – only one like this allowed 37
Figure 6: Binding to a Single Code 38
Figure 7: XML Expression of a Single-Code Binding 38
Figure 8: Translation Code Example 39
Figure 9: XML Document Example 41
Figure 10: XPath Expression Example 41
Figure 11: DSTU Comment Example 41
Figure 12: Care Plan Relationship Diagram 50
Figure 13: Care Plan Relationship Diagram - Instantiated 51
Tables
Table 1: New Guidance or Guidance Further Constraining C-CDA Implementation Guidance 9
Table 2: Contents of the Review Package 11
Table 3: Contexts Table Example—Allergy Concern Act (V2) 32
Table 4: Constraints Overview Example—Allergy Concern Act (V2) 32
Table 5: Example Value Set Table (Referral Types) 40
Table 6: Sample High-Level Change Log 47
Table 7: moodCodes 49
Table 8: actRelationship TypeCodes 50
1 Introduction
1.1 Purpose
This two-volume implementation guide (IG) establishes the Personal Advance Care Plan Document standard. It describes the document design and its envisioned use in information exchange (Volume 1). It contains a library of CDA templates applicable to the US Realm which can be applied to the HL7 CDA R2 standard to facilitate creation, validation, and consumption of information in this format (Volume 2).
This version of the Personal Advance Care Plan Document standard is being balloted as a Draft Standard for Trial Use (DSTU).
The working name for this standard is Personal Advance Care Plan Document. The terms in the name have been selected to communicate five key characteristics about this type of information exchange artifact:
1. Document – The information follows the document metaphor and document principles established by the HL7 Clinical Document Architecture standard.
2. Plan – The information that the document presents is a plan in that it addresses a course of action to be carried out or goals to be accomplished in the future.
3. Care – The information expresses the individual’s plan for his or her care and medical treatments. It includes information that is relevant and pertinent for care planning.
4. Advance – The information is prospective. It is generated in advance of when it may be needed under certain emergency, critical or terminal illness circumstances.
5. Personal – While most other information in a care plan may be prepared by clinicians, this information is authored by the individual. It expresses his or her personal goals, preferences and priorities for medical treatments.
1.2 Audience
The audience for this implementation guide includes architects and developers of healthcare information technology (HIT) systems in the US Realm that exchange patient clinical and non-clinical data. Business analysts and policy managers can also benefit from a basic understanding of the use of CDA templates across multiple implementation use cases.
1.3 Approach
Implementation Guidance for creation of a personal advance care plan document has been developed to align with and be consistent with guidance and CDA templates established within the HL7 Consolidated CDA release 2.1 implementation guide.
Some of the content in this implementation guide is similar to information in C-CDA, but has been further constrained. Other information has been created specifically for this implementaion guide. Material in the following sections that is new or revised from C-CDA may be altered through the HL7 ballot and DSTU Comment process associated with this implementation guide.
When making comments against this DSTU, commenters are requested to use Chapter references and to confirm that the chapter being addressed includes new or constrained content specific to this Personal Advance Care Plan Document implementation guide.
Table 1: New Guidance or Guidance Further Constraining C-CDA Implementation Guidance
Chapter / Title1.1 / Purpose
1.4 / Organization of the Guide
1.4.1 / Volume 1 Introductory Material
1.4.2 / Volume 2 CDA Templates and Supporting Material
1.5 / Contents of the Package
2 / BACKGROUND
2.1 / Definition of a Personal Advance Care Plan Document
2.2 / Purpose for Personal Advance Care Plan Documents
2.3 / Use Cases for Personal Advance Care Plan Documents
3 / DESIGN CONSIDERATIONS
3.1 / Functional Requirements for the Content in a Personal Advance Care Plan Document
3.2 / Levels of Machine Readability Constraints to Support Interoperability
3.2.1 / Benefits of Level-1 CDA Document Exchange
3.2.2 / Benefits of Level-2 CDA Document Exchange
3.2.3 / Benefits of Level-3 CDA Document Exchange
3.3 / Considerations for Human Readable Text
3.4 / Compatibility with Other C-CDA Information Artifacts
3.4.1 / Coded Content Crosswalk
3.5 / Machine Readable Entries
3.65 / Overview of Header Elements
4 / USING THIS IMPLEMENTATION GUIDE
4.1.1 / Templates and Conformance Statements
4.3 / DSTU Comment Process for Errata and Enhancements
5 / REFERENCES
Appendix A / Accronyms and Abbreviations have additions marked as “NEW”.
Appendix B / High-Level Change Log
Volume 1 / Summary of Changes
Volume 2 / Summary of Changes
Appendix D / Care Plan Relationships
Appendix E / Coded Content Crosswalk
1.4 Organization of the Guide
This implementation guide is organized into two volumes. Volume 1 contains primarily narrative text describing the context for creation and use of a personal advance care plan document, and Volume 2 contains normative CDA template definitions.
1.4.1 Volume 1 Introductory Material
Volume 1, provides overview and background information that forms a context for understanding the purpose of a personal advance care plan document.
· Chapter 1—Introduction
· Chapter 2—Background. This section contains background information about the information exchange needs and requirements addressed by the Personal Advance Care Plan document.
· Chapter 3—Design Considerations. This section includes design considerations that are addressed by the Personal Advance Care Plan document templates. It includes additional information and narrative guidance about how to use the templates defined in Volume 2 of this implementation guide.
· Chapter 4—Using This Implementation Guide. This section describes the rules and formalisms used to constrain the CDA R2 standard. It describes the formal representation of CDA templates, the mechanism by which templates are bound to vocabulary, and additional information necessary to understand and correctly implement the normative content found in Volume 2 of this implementation guide.
· Appendices. The Appendices include a list of key acronyms, a high-level change log, a summary of extensions to CDA R2, a reference copy of the appendix for the Care Plan explanatory material from the C-CDA Guide, and a crosswalk between the coding specified for content in the Personal Advance Care Plan document and the coding defined in C-CDA R2.1 for summarizing different types of advance directive and emergency, critical and advance care plan content that a person may have documented.
1.4.2 Volume 2 CDA Templates and Supporting Material
Volume 2 includes CDA templates and prescribes their use for a set of specific document types. The main chapters are as follows:
· Chapter 1—Document-Level Templates. This chapter defines the US Realm Document and Header template for the Personal Advance Care Plan document.
· Chapter 2—Section-Level Templates. This chapter defines the section templates referenced within the document template. Sections are atomic units, and can be reused by future specifications.
· Chapter 3—Entry-Level Templates. This chapter defines entry-level templates referenced within the section templates of this document. Entry-level templates are called clinical statements. They are used to encode information from a section of the document as machine processable data. Entry-level templates are always contained in section-level templates, and section-level templates are always contained in a document. Entry templates are complex but atomic units, and can be reused by future specifications. An entry template may contain other template patterns within its design.
· Chapter 4—Participation and Other Templates. This chapter defines templates for CDA participants (e.g., author, performer) and other fielded items (e.g., address, name) that cannot stand on their own without being nested in another template.
· Chapter 5—Template Ids in this implementation guide
· Chapter 6—Value Sets in this implementation guide
· Chapter 7—Code Systems in this implementation guide
1.5 Contents of the Package
The following files comprise this implementation guide package:
Table 2: Contents of the Review Package
Filename / Description / Standards ApplicabilityCDAR2_IG_NEED NAME CCDA_CLINNOTES_R1_DSTU2.1_2015AUG_Vol1_Introductory_Material.docx
Appendices, if not normative, need to be declared to be non-normative. / Implementation Guide Introductory Material / Normative
CDAR2_IG_NEED NAME _Vol2_Templates_and_Supporting_Material.docx / Implementation Guide Template Library and Supporting Material / Normative
Level1 example.xml / PACP_Level1.xml / Informative
Level 2 example.xml / PACP_Level2.xml / Informative
Level 3 example.xml / PACP_Level3.xml / Informative
Header Data Element Index / Name.xls / Informative
Link to SDWG SVN for other technical artifacts / Informative
2 Background
According to the Centers for Disease Control and Prevention, there are approximately 136.3million emergency department visits every year in the United States. Many of the individuals visiting emergency departments are unable to communicate when they arrive due to their injuries or illness. In addition, a full 40% of adult medical inpatients are incapable of making medical treatment decisions. 44-69% of nursing home residents cannot make their own medical treatment decisions. The vast majority of critically ill patients people cannot participate directly in decision-making. Each of these situations would be an appropriate use case for documents that help the person in question to express his or her goals, preferences and priorities for medical treatments.