Continuity of Care (CCD) Suitability Analysis
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NIST GCR 11-941 Continuity of Care (CCD) Suitability Analysis Lantana Consulting Group NIST GCR 11-941 Continuity of Care (CCD) Suitability Analysis Prepared for National Institute of Standards and Technology Gaithersburg Md 20899-8202 By Lantana Consulting Group May 2011 U.S. Department of Commerce Rebecca M. Blank, Acting Secretary National Institute of Standards and Technology Patrick D. Gallagher, Under Secretary for Standards and Technology and Director Certain commercial entities, equipment, or materials may be identified in this document in order to describe an experimental procedure or concept adequately. Such identification is not intended to imply recommendation or endorsement by the National Institute of Standards and Technology, nor is it intended to imply that the entities, materials, or equipment are necessarily the best available for the purpose. Continuity of Care Document (CCD) Suitability Analysis May 2011 Prepared by Lantana Consulting Group for National Institute of Standards and Technology © 2011 Lantana Consulting Group All rights reserved. Lantana Consulting Group P.O. Box 177 East Thetford, VT 05043 www . lantanagroup . com Bob Dolin, MD President and CMO bob . dolin @ lantanagroup . com Liora Alschuler Chief Executive Officer liora . alschuler @ lantanagroup . com Rick Geimer Chief Technology Officer rick . geimer @ lantanagroup . com Gaye Giannone Dolin Senior Nurse Informaticist gaye . dolin @ lantanagroup . com Kate Hamilton Senior Information Analyst kate . hamilton @ lantanagroup . com Susan Hardy Senior Technical Editor susan . hardy @ lantangroup . com Yan Heras Senior Medical Informaticist yan . heras @ lantanagroup . com Jingdong Li Chief Architect jingdong . li @ lantanagroup . com Brett Marquard Senior Interoperability Consultant brett . marquard @ lantangroup . com Sean McIlvenna Senior Software Architect sean . mcilvenna @ lantangroup . com Tim Stevens Technical Writer tim . stevens @ lantanagroup . com Lauren Wood Senior Project Manager lauren . wood @ lantanagroup . com Acknowledgments This analysis was produced and developed by Lantana Consulting Group for the National Institute of Standards and Technology (NIST) under contract number SB134110CN0039, CCD Definition. SNOMED CT® ( http :// www . ihtsdo . org / snomed - ct / ) is a registered trademark of the International Health Terminology Standard Development Organisation (IHTSDO). LOINC® ( http :// loinc . org ) codes, LOINC table, and LOINC panels and forms file are copyright © 1995-2010, Regenstrief Institute, Inc., and the Logical Observation Identifiers Names and Codes (LOINC) Committee and are available at no cost under the license at http :// loinc . org / terms - of - use. Table of Contents 1 Executive Summary 8 2 Introduction 9 2.1 Purpose 9 2.2 Audience9 2.3 Approach 9 2.4 Organization of This Document 10 3 Healthcare Conformance Requirements and Their Testability 11 3.1 Conformance Statements 11 3.1.1 Conformance Statements vs. Prose Guidance 11 3.1.2 Conformance Verbs 12 3.1.3 Types of Conformance Statements 12 3.1.3.1 Parent-to-child Constraints 12 3.1.3.2 Document Tree Conditional Constraints 13 3.1.3.3 Template-specific Vocabulary Constraints 13 3.1.3.4 Non-XML Syntax Constraints 13 3.1.3.5 Data Integrity Checks 14 3.1.3.6 Business Rules 14 3.1.3.7 Guidance on Data Recording and Accuracy 14 3.1.3.8 CDA Extensions 14 3.1.3.9 Compound Conformance Statements15 3.1.4 Templates 15 3.2 Base Standard Constraints 16 3.2.1 Data Types 16 3.2.2 Narrative Block 16 3.2.3 Identifiers 16 3.2.3.1 OIDs 16 3.2.3.2 UUIDs 17 3.2.4 Base Standard Vocabularies 17 3.2.5 XML Structure 18 3.2.5.1 Syntax Validation 18 3.2.5.2 Attributes and Elements 18 3.2.5.3 Cardinality and Conformance Verbs 18 3.2.5.4 Namespaces 19 3.2.5.5 XML Schema and XSI-Type 19 3.3 External Constraints 20 3.3.1 HITSP/C32 20 3.3.2 Meaningful Use 21 4 Test Technologies 22 4.1 Ranking Criteria 22 4.2 Currently Used Technologies 22 4.2.1 CDA.xsd XML Schema 22 4.2.2 Constrained Schemas 23 4.2.3 Schematron 24 4.2.4 XPath 25 4.2.5 Model-Driven Validation 26 4.2.6 Terminology Service Validation 28 4.2.7 Human Validation 29 4.3 Potential Technologies 29 4.3.1 RELAX NG 29 4.3.2 Web Ontology Language 30 4.3.3 Custom Validation Code 31 4.4 Test Technology Application 32 5 Conclusions and Recommendations 34 5.1 Recommendations for Standards Developers 34 5.2 Test Technology Recommendations 35 5.2.1 General Recommendations to NIST 35 5.2.2 Applicable Technologies for Constraint Types 35 6 References 37 Appendix A — Acronyms and Abbreviations 39 Appendix B — CCD Test Data Coverage 41 Table of Figures Figure 1: Parent-to-child cardinality constraint example 12 Figure 2: Document tree conditional constraint example 13 Figure 3: Static value set example 13 Figure 4: Dynamic value set example 13 Figure 5: Syntax constraint example 13 Figure 6: Data integrity check example 14 Figure 7: Business-rule constraint example 14 Figure 8: Data recording constraint example 14 Figure 9: CDA extension example 15 Figure 10: Compound conformance statement example 15 Figure 11: CCD template example 15 Figure 12: C32 template example 15 Figure 13: Namespace declaration example 19 Figure 14: xsi:type example 19 Table of Tables Table 1: Use of Conformance Verbs 12 Table 2: CDA.xsd XML Schema Analysis 23 Table 3: Constrained Schemas Analysis 24 Table 4: Schematron Analysis 25 Table 5: Model-driven Validation Analysis 27 Table 6: Terminology Service Validation Analysis 28 Table 7: Human Validation Analysis 29 Table 8: RELAX NG Validation Analysis 30 Table 9: Test Technology Application Examples 32 Table 10: Applicable Technologies for Validation 36 Table 11: CCD Conformance Statement Coverage 42 1. Executive Summary The advent of widespread dependence on electronic exchange of health information has highlighted the importance of interoperability standards and the testability of those standards. Several established and effective test tools and methods are in use; however, the relative merits and, more critically, limitations of different test methods have not been anlaysed or defined. This paper explores test methods for the Health Level Seven (HL7) Continuity of Care Document (CCD); some of our findings and recommendations apply generally to the testing and validation of HL7 Clinical Document Architecture (CDA) instances of all types. The paper reviews the expression of conformance requirements for Meaningful Use of CCD, categorizes these, and then catalogs the CCD conformance statements. We assess ten methods ranging from fully automated to human inspection for their ability to validate the different categories of conformance requirements. The analysis indicates that the methods in use are reasonably effective, where combined with a cleaner definition of conformance requirements and descriptions on the limits of each method. Thus, the paper contains recommendations to standards developers on the expression of conformance requirements that could improve the clarity of current test methods and tools. We give most attention to those methods currently in use: XML Schema, Schematron, and model- driven validation. We also examine potentially useful technologies not widely used for CDA validation at this time, such as RELAX NG and OWL (Web Ontology Language). 2. Introduction 1. Purpose This document analyzes Health Level Seven’s (HL7) Continuity of Care Document (CCD) specification from the perspective of validation, looking at the limits of automated testing and assessing the differential impact of various approaches to it. This document describes common concepts, structures, and data types within the specification and the extent to which they can be tested through automated processes. It assesses the relevance of testing technologies to CCD and recommends those technologies deemed appropriate for CCD validation. It provides an audit of CCD conformance statements, identifying which test technologies apply. Finally, this document provides recommendations for fully and semi- automated processes to generate test files. Note that this assessment also provides recommendations to the standards community on construction of conformance requirements to make them more manageable for automated testing; however, the emphasis here is on evaluation of test technologies against an established set of conformance requirements. Ultimately, this document clearly defines what portions of the HL7 CCD specification are testable and to what extent they will be included in the test data deliverable for this contract. This report contains the names of commercial products and organizations. Any mention of commercial products or organizations is for information only; it does not imply recommendation or endorsement by Lantana or NIST. 2. Audience The audience for this document includes NIST staff, standards developers interacting with CCD, and implementers interested in the available means to validate their documents. 3. Approach Our approach to analyzing CCD coverage consisted of these components: 1. Review of formal conformance requirements 2. Review of validation methods 3. Assessment of validation methods for different types of conformance requirements 4. Analysis of results We reviewed conformance requirements by describing how these requirements are conveyed and by developing categories of conformance requirements. We then cataloged and categorized all 549 CCD conformance requirements. This review encompassed the conformance requirements of the base standard, CDA, the CCD itself, and the layered constraints added by Integrating