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Implementation Guide for CDA Release 2 MDHT Example Project

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PROTOTYPE: FOR DISCUSSION AND DEMONSTRATION USE ONLY (Consolidated Developer Documentation)

| Introduction | 2

| Contents | 3

Contents
Acknowledgments............................................................................................................................ 5 Revision History.............................................................................................................................. 7 List of Figures..................................................................................................................................9

Chapter 1: INTRODUCTION...............................................................................11

Overview............................................................................................................................................................. 12 Approach............................................................................................................................................................. 12 Scope................................................................................................................................................................... 12 Audience..............................................................................................................................................................12 Organization of This Guide................................................................................................................................12 Templates.................................................................................................................................................12 Vocabulary and Value Sets..................................................................................................................... 12 Use of Templates................................................................................................................................................ 13 Originator Responsibilities..................................................................................................................... 13 Recipient Responsibilities.......................................................................................................................13 Conventions Used in This Guide....................................................................................................................... 13 Conformance Requirements....................................................................................................................13 Keywords.................................................................................................................................................14 XML Examples.......................................................................................................................................14

Chapter 2: DOCUMENT TEMPLATES............................................................. 17 Chapter 3: SECTION TEMPLATES................................................................... 25 Chapter 4: CLINICAL STATEMENT TEMPLATES........................................29

My Document..................................................................................................................................................... 18

My Section.......................................................................................................................................................... 26

My Observation.................................................................................................................................................. 30

Chapter 5: OTHER CLASSES............................................................................. 33 Chapter 6: VALUE SETS...................................................................................... 35

REFERENCES.............................................................................................................................. 37

My Problem Types............................................................................................................................................. 36 My Problem Values............................................................................................................................................ 36

| Contents | 4 .

This demonstration document contains informtion from the following sources: ©2010 ANSI. This material may be copied without permission from ANSI only if and to the extent that the text is not altered in any fashion and ANSI’s copyright is clearly noted. Inc. No part of the material may be copied or reproduced in any form outside of the Interoperability Specification documents. The LOINC table. and LOINC panels and forms file are copyright © 1995-2010. Inc. or HL7 Implementation Guide for CDA Release 2: Operative Notes with permission of Health Level Seven. therefore this version of the document is to be treated as CONFIDENTIAL by the project participants. using the OHT Model Driven Health Tools (MDHT).Acknowledgments This document contains an example of healthcare standards and specifications publication generated from UML models. SNOMED CT® is the registered trademark of the International Health Terminology Standard Development Organization (IHTSDO). . including an electronic retrieval system. HL7 Implementation Guide for CDA Release 2: History and Physical (H&P) Notes. This material contains content from LOINC® (http://loinc. or made available on the Internet without the prior written permission of Health Level Seven. Material drawn from these standards is credited where used.org/terms-of-use . HL7 Implementation Guide for CDA Release 2: Consult Notes. Inc. Certain materials contained in this Interoperability Specification are reproduced from Health Level Seven (HL7) HL7 Implementation Guide: CDA Release 2 – Continuity of Care Document (CCD). Inc. LOINC codes. Regenstrief Institute. Some portions of this document may not be publicly available but are included for demonstration purposes only. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and available at no cost under the license at http://loinc. Copies of standards included in this Interoperability Specification may be purchased from the Health Level Seven.org).

| Acknowledgments | 6 MDHT Example Project © 2011 Page 6 .

Revision History Rev New First draft for posting Date July 2010 December 2010 By Whom Dave Carlson Dave Carlson Updated model content and publication format Changes .

| Revision History | 8 MDHT Example Project © 2011 Page 8 .

......................................................................................................................13 Figure 2: Template-based conformance statements example.......| List of Figures | 9 List of Figures Figure 1: Template name and "conforms to" appearance.......................................... 14 Figure 4: ClinicalDocument example................................................................................... 14 Figure 3: CCD conformance statements example............................. 14 .........

| List of Figures | 10 .

Chapter 1 • • • • • • • INTRODUCTION Topics: Overview Approach Scope Audience Organization of This Guide Use of Templates Conventions Used in This Guide .

rules defined in Using SNOMED CT in HL7 Version 3 are adhered to. MDHT Example Project © 2011 Page 12 . In many cases. Taking this as an initial step ensures that the data set developers and standards community can reach consensus prior to the larger commitment of time that would be required to bring the full data set into standard format. See Templates by Containment for a listing of the higher level templates by containment. plus validation tools and Java libraries for implementers.org/documentcenter/public/membership/HL7_Governance_and_Operations_Manual. these vocabularies are further constrained into value sets for use within this guide. When SNOMED codes are used. Vocabulary and Value Sets Vocabularies recommended in this guide are from standard vocabularies. Organization of This Guide The requirements as laid out in the body of this document are subject to change per the policy on implementation guides (see section 13. This implementation guide (IG) specifies a standard for electronic submission of NCRs in a Clinical Document Architecture (CDA). The data specifications have been formalized into computational models expressed in UML.02" Draft Standard for Trial Use Documents" within the HL7 Governance and Operations Manual.| INTRODUCTION | 12 Overview This implementation guide is generated from UML models developed in the Open Health Tools (OHT) Model-Driven Health Tools (MDHT) project. These models are used by automated tooling to generate this publication. balloted through Health Level Seven (HL7) and/or recognized by the Health Information Technology Standards Panel (HITSP). templates are arranged hierarchically.hl7.. the appendix Templates Used in This Guide includes a table of all of the templates Organized Hierarchically. Within a section. Templates Templates are organized by document (see Document Templates). Approach Working with specifications generated from formal UML models provides the opportunity to work with the data from the perspective of the underlying model and electronic format and to explore many design issues thoroughly.. Scope TODO: scope of this implementation guide. by section (see Section Templates). Audience The audience for this document includes software developers and implementers who wish to develop. Value set names and OIDs are summarized in the table Summary of Value Sets. This project supports reusability and ease of data collection through a standard data representation harmonized with work developed through Health Information Technology Expert Panel (HITEP). Each named value set in this summary table is stored in a template database that will be maintained by CHCA. http://www. and by clinical statements (see Clinical Statement Templates). where a more specific template is nested under the more generic template that it conforms to.pdf ). Release 2 format.

1 as zero to one present 1. 1. SHALL contain [1.. . a recipient looking to receive only CCD documents can reject an instance without the appropriate templateId). which specifies the element under constraint. whereas the cardinality indicator (0.*.XX. ClinicalDocument.. 2.1" both allow for a document to omit the particular component. A recipient may process objects in an instance document that do not contain a templateId (e. Template name [<type of template>: templateId <XXXX.g. observation)......1] @classCode = <AAA> <code display name> (CodeSystem: 123.789 <XXX> Class) STATIC (CONF:<number>).* as zero to many present MDHT Example Project © 2011 Page 13 . If a template is a specialization of another template. asserting the more specific template also implies conformance to the more general template.. Recipient Responsibilities A recipient may reject an instance that does not contain a particular templateId (e..2 as two must be present 1. its first constraint indicates the more general template. along with the templateId and the context of the template (e.g. SHOULD .. even if the entries do not have templateIds). Thus.1. section. Originator Responsibilities An originator can apply a templateId to assert conformance with a particular template.1" and " SHOULD contain 0.XXX.456.* as one or more present 0. 1.g.. In the most general forms of CDA exchange. The value of this attribute provides a unique identifier for the templates in question.1.. Figure 1: Template name and "conforms to" appearance The conformance verb keyword at the start of a constraint ( SHALL .. MAY. etc. The following cardinality indicators may be interpreted as follows: 0. Conventions Used in This Guide Conformance Requirements Conformance statements are grouped and identified by the name of the template..| INTRODUCTION | 13 Use of Templates When valued in an instance.XXX>] Description of the template will be here . 3... This implementation guide asserts when templateIds are required for conformance. a recipient can process entries that contain Observation acts within a Problems section. etc.. Conforms to <The template name> Template (templateId: XXXX<XX>XXX>YYY).. an originator need not apply a templateId for every template that an object in an instance document conforms to.1 as one and only one present 2.. the template identifier (templateId) signals the imposition of a set of templatedefined constraints.) specifies the allowable occurrences within an instance. but the latter is a stronger recommendation that the component be included if it is known. " MAY contain 0. 1. In all cases where a more specific template conforms to a more general template.... An example is shown below..) indicates business conformance..

the time the condition started. and NEED NOT in this document are to be interpreted as described in the HL7 Version 3 Publishing Facilitator's Guide: • • • • SHALL: an absolute requirement SHALL NOT: an absolute prohibition against inclusion SHOULD/SHOULD NOT: valid reasons to include or ignore a particular item.org/ index..16. </ClinicalDocument> Figure 4: ClinicalDocument example MDHT Example Project © 2011 Page 14 . (CONF: 816).. STATIC binding. 3.2. SHALL contain [1. 1..1] Patient data section .113883.10.840. (CONF: 814).php?title=CCD_Suggested_Enhancements The user name and password are: wiki/wikiwiki. MAY. Each constraint is uniquely identified (e..1] component/structuredBody (CONF:4082). (CONF: 817). CCD templates contained within this implementation guide are formatted WITHOUT typical KEYWORD and XML element styles. to indicate the biological timing of condition (e.16. etc. SHALL contain [1.2.840.20. SHOULD . These identifiers are not sequential as they are based on the order of creation of the constraint.g.1.113883.| INTRODUCTION | 14 Value set bindings adhere to HL7 Vocabulary Working Group best practices.1] component (CONF:4130) such that it a. in every case any HL7 "null" value such as other (OTH) or unknown (UNK) may be used.14 ActStatus STATIC.NCR (templateId:2. <ClinicalDocument xmlns=’urn:h17-org:v3’> .10.g.1) (CONF:4131). SHOULD..5... "CONF:605") by an identifier placed at or near the end of the constraint. A problem observation SHALL include exactly one Observation / statusCode.113883.5) (CONF:4133).1] Reporting Parameters section (templateId:2.5.840..1. This component/structuredBody SHOULD contain [0. 2.1] component (CONF:4132) such that it a.1. however.16.1001 ActMood STATIC. Figure 2: Template-based conformance statements example CCD templates are included within this implementation guide for ease of reference.113883.1. The use of SHALL requires that the component be valued with a member from the cited value set. The value for "Observation / @moodCode" in a problem observation SHALL be "EVN" 2. A problem observation SHOULD contain exactly one Observation / effectiveTime. 4. This component/structuredBody SHALL contain [1. the onset of the illness or symptom. (CONF: 815). SHOULD NOT.16. MAY.840. and include both a conformance verb ( SHALL . b. 1. the duration of a condition).20.hl7. marked by an ellipsis (…) as shown in the example below. A WIKI site is available if you would like to make a comment to be considered for the next release of CCD: http://wiki.17. can be included or omitted as the author decides with no implications XML Examples XML samples appear in various figures in this document in a fixed-width font. a.) and an indication of DYNAMIC vs. The value for "Observation / statusCode" in a problem observation SHALL be "completed" 2. Portions of the XML content may be omitted from the content for brevity. SHALL contain [1. but must be understood and carefully weighed MAY/NEED NOT: truly optional.17. You will need to create an account to edit the page and add your suggestion. SHALL NOT. Figure 3: CCD conformance statements example Keywords The keywords SHALL.

MDHT Example Project © 2011 Page 15 .| INTRODUCTION | 15 XPath expressions are used in the narrative and conformance requirements to identify elements because they are familiar to many XML implementers.

| INTRODUCTION | 16 MDHT Example Project © 2011 Page 16 .

.Chapter 2 • DOCUMENT TEMPLATES Topics: My Document This section contains the document level constraints for CDA documents that are compliant with this implementation guide.

c. SHALL contain exactly one [1. MAY contain zero or one [0. Such recordTargets SHALL contain exactly one [1. a..1] confidentialityCode.1] patient (CONF:5283) a..22.1] patientRole (CONF:5268) a.1. MAY contain zero or one [0..1] @root="1.16.1 DYNAMIC (CONF:6394) b.1] title (CONF:5254) 7.1] realmCode/@code="US" (CONF:16791) 3.*] telecom with data type TEL (CONF:5280) This patientRole SHALL contain exactly one [1..1] component. SHALL contain exactly one [1. when the document first came into being. This patientRole SHALL contain at least one [1..840.. where the @code SHALL be selected from ValueSet HL7 BasicConfidentialityKind 2. SHALL contain exactly one [1. This patient SHALL contain exactly one [1.113883.16.1] effectiveTime (CONF:5256) Signifies the document creation time.2. the ClinicalDocument.| DOCUMENT TEMPLATES | 18 My Document [ClinicalDocument: templateId 1.1] My Section (templateId: 1.1] languageCode. [explain how this CDA document is used]. Contains exactly one [1. SHALL conform to Consol General Header Constraints template (templateId: 2..1. SHALL conform to Consol General Header Constraints template (templateId: 2.1.*] id (CONF:5268) This patientRole SHALL contain at least one [1...1) 3.1] administrativeGenderCode..2.1.1) 2.840..20.. SHALL contain exactly one [1. SHALL contain exactly one [1.*] addr with data type US Realm Address (CONF:5271) This patientRole SHALL contain at least one [1.. SHALL contain exactly one [1.4. where the @code SHALL be selected from ValueSet Administrative Gender (HL7 V3) 2..1] typeId (CONF:5361) 4.1. Where the CDA document is a transform from an original document in some other format.1] templateId ( ) such that it a. This patient SHALL contain exactly one [1..3.1.1.1.11.11.16.113883. SHALL contain exactly one [1.10...11. SHALL contain exactly one [1...1] setId (CONF:5261) 11.1) 1. a. it must contain at least one patientRole element.effectiveTime is the time the original document is created.10.840. SHALL contain exactly one [1.20.1] Component2 13. Contains exactly one [1.3.113883. where its type is Component2 • a.. SHALL contain at least one [1.4" 2. Contains exactly one [1.11526 DYNAMIC (CONF:5372) 10.3.16..2..22.1] versionNumber (CONF:5264) 12.1] id (CONF:5363) 5.1. 1.. The time when the transform occurred is not currently represented in CDA (CONF:9995) 8...1] birthTime (CONF:5298) MDHT Example Project © 2011 Page 18 .*] recordTarget (CONF:5266) The recordTarget records the patient whose health information is described by the clinical document. SHALL contain exactly one [1.16.113883. b.16926 STATIC (CONF:5259) 9. d.1] code (CONF:5253) 6. SHALL contain exactly one [1.113883.840..1..840.4] My Document is used for X and Y. where the @code SHALL be selected from ValueSet Language 2.1] component (CONF-Example-3) • Template specifiations may include guidance documentation about how or when this section is used.

1] name with data type US Realm Patient Name (CONF:5284) f. This patient MAY contain zero or one [0.1. which SHALL be selected from ValueSet CountryValueSet 2.88.20.113883.*] sDTCRaceCode.1. This guardianPerson SHALL contain at least one [1.12.12.1] postalCode.1. This providerOrganization SHALL contain at least one [1.840.5.11.1] ethnicGroupCode.16.11.840.113883..1.12212 STATIC 1 e.80. This patient SHALL contain exactly one [1.. This place If country is US.11. where the @code SHALL be selected from ValueSet Language 2.840.19185 STATIC 1 h.113883.113883. where the @code SHALL be selected from ValueSet Race 2.| DOCUMENT TEMPLATES | 19 c.113883.10. which SHALL be selected from ValueSet PostalCodeValueSet 2.1.840.88.1] proficiencyLevelCode...1] languageCode..3.3.14914 STATIC 1 (CONF:7263) l.11.1...3..113883.*] languageCommunication (CONF:5406) a. This patient MAY contain zero or one [0...113883.114222. Such guardians SHOULD contain zero or more [0..1] addr (CONF:5397) b. Such guardians SHALL contain exactly one [1.1] maritalStatusCode (CONF:5303).22.. which SHALL be selected from ValueSet StateValueSet 2. This patient MAY contain zero or one [0. This patient SHOULD contain zero or more [0. where the @code SHALL be selected from ValueSet HL7 Marital Status 2. where the @code SHALL be selected from ValueSet Ethnicity Value Set 2.113883.1..1. This patient MAY contain zero or one [0. where the @code SHALL be selected from ValueSet HL7 Religious Affiliation 2...19563 STATIC 1 (CONF:5326) c.840.4. this addr SHALL contain exactly one [1.840. Such guardians MAY contain zero or more [0.1] country.1] code. This guardianPerson The content of name SHALL be a conformant US Realm Person Name (PTN.16.1] guardianPerson a.11..840.1.837 STATIC (CONF:5323) d.1.1.*] name b..1 DYNAMIC c.840.1] modeCode.11.12199 STATIC (CONF:9965) c.11. where the @code SHALL be selected from ValueSet Race 2. Such languageCommunications SHALL contain exactly one [1.16.63 DYNAMIC j.16. Such languageCommunications SHOULD contain zero or one [0.14914 STATIC 1 (CONF:5322) g.1] providerOrganization (CONF:5416) a.16. Such languageCommunications MAY contain zero or one [0.1) (CONF:10414) i. This place This addr MAY contain zero or one [0.113883.*] guardian (CONF:5325) a.1. Such languageCommunications MAY contain zero or one [0. Such guardians SHOULD contain zero or one [0..1] preferenceInd (CONF:5414) b.1] place (CONF:5396) a.. where the @code SHALL be selected from ValueSet HL7 LanguageAbilityMode 2.80.*] addr with data type US Realm Address (CONF:5422) MDHT Example Project © 2011 Page 19 . This patientRole MAY contain zero or one [0.840.FIELDED) (2. This patient MAY contain zero or more [0..11.840.. This place SHALL contain exactly one [1. where the @code SHALL be selected from ValueSet LanguageAbilityProficiency 2.16.16. This patient SHALL satisfy: BirthTime precise to year m.1.113883.1.16.1.2 DYNAMIC d.113883.16.11526 DYNAMIC (CONF:5407) k.1.16.1.1] birthplace (CONF:5395) a. This patient SHOULD satisfy: BirthTime precise to day e.1] raceCode.80.16. where the @code SHALL be selected from ValueSet Personal Relationship Role Type 2. This place This addr SHOULD contain zero or one [0.*] addr with data type US Realm Address b. This patient SHOULD contain zero or one [0...16.113883.12.11. This birthplace SHALL contain exactly one [1. This patient MAY contain zero or more [0.1.16.88..1.*] telecom with data type TEL d.840.1.840.1.1] religiousAffiliationCode (CONF:5317).US..12249 STATIC 1 (CONF:5409) d.1.1] state.840.

1] dataEnterer (CONF:5441) a.6" National Provider Identifier (CONF:9996) (CONF:16786) c. This assignedAuthoringDevice SHALL contain exactly one [1...FIELDED) (2..US.16. where the @code SHOULD be selected from (CodeSystem: 2..16..20.1] assignedEntity (CONF:5442) a.*] id (CONF:5443) d.1] assignedAuthoringDevice a.. This providerOrganization The id SHOULD include zero or one [0.113883. This encompassingEncounter SHALL contain at least one [1.16..*] id (CONF:5417) c.*] id (CONF:9959) 15. This encompassingEncounter SHALL contain exactly one [1.1] id where id/@root ="2.1.. This assignedAuthor This assignedAuthor SHALL contain exactly one [1. This assignedAuthoringDevice SHALL contain exactly one [1. This assignedEntity SHALL contain exactly one [1.4) (CONF:5446) 16.4.114222.4..1] @root ="2. This componentOf SHALL contain exactly one [1..1] time (CONF:5445) b.1.. Such authors SHALL contain exactly one [1...101 NUCC Health Care Provider Taxonomy) (CONF:9944) c...1066 DYNAMIC (CONF:16788) c.*] addr with data type US Realm Address (CONF:5452) b.840..840.HIPAA) 2..11.6" National Provider Identifier (CONF:16821) 17. This assignedAuthor SHALL contain at least one [1.1] encompassingEncounter (CONF:9956) a...4.1] code. This assignedAuthor SHALL contain at least one [1.*] telecom with data type TEL (CONF:5420) e.*] name (CONF:16789) g. This assignedAuthor SHOULD contain zero or one [0.| DOCUMENT TEMPLATES | 20 b.1.840. CONF:5519) a.16. This assignedAuthor SHOULD contain zero or one [0.1] componentOf (CONF:9955) a. This assignedEntity SHALL contain at least one [1.*] id (CONF:5449) d... where the @code SHOULD be selected from ValueSet Healthcare Provider Taxonomy (NUCC ..*] name f. MAY contain exactly one [1... This assignedEntity MAY contain zero or one [0.. This assignedEntity SHALL contain at least one [1.1] custodian (iv.*] author (CONF:5444) a.1] effectiveTime (CONF:9958) b.113883.*] addr with data type US Realm Address (CONF:5460) b.4. This assignedPerson SHALL contain at least one [1. SHALL contain exactly one [1.1. This assignedEntity id SHOULD include zero or one [0. This dataEnterer SHALL contain exactly one [1.1.6.1] code (CONF:16787).. Such authors SHALL contain exactly one [1.840.840.6" National Provider Identifier (CONF:9996) (CONF:9996) 14.113883..1] softwareName (CONF:16785) f. MAY contain zero or one [0. This providerOrganization SHALL contain at least one [1..1] US Realm Date and Time (DTM.1. This assignedAuthor The id SHALL contain exactly one root ="2.16. This assignedAuthor SHALL contain at least one [1.22. This assignedEntity SHALL contain at least one [1.1] assignedPerson or assignedAuthoringDevice (CONF:16790) h.1] assignedAuthor (CONF:5448) a..5....*] telecom with data type TEL (CONF:5466) e.113883.840.*] name (CONF:5419) d.1] assignedCustodian (CONF:5520) MDHT Example Project © 2011 Page 20 . This custodian SHALL contain exactly one [1. This assignedPerson SHALL contain at least one [1.*] telecom with data type TEL (CONF:5428) e. This assignedAuthor SHOULD contain zero or one [0. SHALL contain at least one [1.16.113883.1] assignedPerson a. Such authors This time SHALL contain exactly one [1.10. This providerOrganization SHALL contain at least one [1.1] manufacturerModelName (CONF:16784) b. This providerOrganization SHALL contain at least one [1..1] assignedPerson (CONF:5469) a..

This receivedOrganization SHALL contain exactly one [1..16.4..5. This assignedEntity MAY contain zero or one [0..16. This representedCustodianOrganization SHALL contain at least one [1. This assignedPerson SHALL contain at least one [1.*] name (CONF:5598) f.1] time (CONF:5580) b. This legalAuthenticator Contains zero or one [0.113883.1] assignedEntity (CONF:5612) a.1066 DYNAMIC (CONF:16826) c.840.1] assignedEntity a. MAY contain zero or more [0.1] signatureCode/@code="S" (CodeSystem: 2.1] assignedPerson (CONF:5624) a.....113883. SHOULD contain zero or one [0.HIPAA) 2.11.5.. This assignedPerson SHALL contain at least one [1.1] code (CONF:17000)...*] name (CONF:5470) b.1. This intendedRecipient MAY contain zero or one [0. CONF:5584) c.1..1] @root ="2.113883.*] id (CONF:5613) d.*] name (CONF:5625) MDHT Example Project © 2011 Page 21 . where the @code SHOULD be selected from ValueSet Healthcare Provider Taxonomy (NUCC .1] code (CONF:16825).1.... This assignedCustodian SHALL contain zero or one [0.1] representedCustodianOrganization (CONF:5521) a.. This representedCustodianOrganization The id SHOULD include zero or one [0. This legalAuthenticator SHALL contain exactly one [1. MAY contain zero or more [0..*] addr with data type US Realm Address (CONF:5589) b.114222. Such authenticators SHALL contain exactly one [1.*] id (CONF:5586) d. This representedCustodianOrganization SHALL contain exactly one [1.1] informationRecipient (CONF:5568) a.. This assignedEntity SHALL contain at least one [1.6" National Provider Identifier (CONF:9996) (CONF:16823) 20.1] receivedOrganization (CONF:5577) a. This assignedEntity SHALL contain exactly one [1.16.*] addr with data type US Realm Address (CONF:5616) b.840.1] root ="2.HIPAA) 2.1. This assignedEntity The id MAY include zero or one [0. This assignedEntity SHALL contain at least one [1.1] assignedPerson (CONF:5597) a.89 Participationsignature) (CONF:5610) c.1] time (CONF:5608) b. This assignedEntity SHALL contain at least one [1.4.11. This representedCustodianOrganization SHALL contain at least one [1.*] informationRecipient (CONF:5565) a. This legalAuthenticator SHALL contain exactly one [1.113883.| DOCUMENT TEMPLATES | 21 a.6" National Provider Identifier (CONF:9996) 18.89 Participationsignature) (CONF:5583.. This assignedEntity SHALL contain exactly one [1. Such authenticators SHALL contain exactly one [1.1] name (CONF:5578) 19. This informationRecipient SHALL contain at least one [1.1] intendedRecipient (CONF:5566) a...16.. Such informationRecipients SHALL contain exactly one [1.840.1] telecom with data type TEL (CONF:5525) e.. This assignedEntity SHALL contain at least one [1.1] name (CONF:5524) d.1. where the @code SHOULD be selected from ValueSet Healthcare Provider Taxonomy (NUCC .1066 DYNAMIC c..4.840.*] authenticator (CONF:5607) a.1.4. This assignedEntity SHALL contain at least one [1.840..1] signatureCode/@code="S" (CodeSystem: 2..16.1] legalAuthenticator (CONF:5579) a.*] addr with data type US Realm Address (CONF:5559) b.*] telecom with data type TEL (CONF:5595) e. This assignedEntity MAY contain zero or one [0. This intendedRecipient MAY contain zero or one [0. This assignedEntity SHALL contain at least one [1..840..*] telecom with data type TEL (CONF:5622) e..16.. Such authenticators SHALL contain exactly one [1.114222.*] id (CONF:5522) c. This representedCustodianOrganization SHALL contain exactly one [1.....

840. 23.1] serviceEvent (CONF:14836) a.*] id (CONF:9954) 24. SHALL have an associatedPerson or scopingOrganization element under participant/associatedEntity.1..1] id where id/@root ="2. This informant MAY contain zero or one [0.*] name e.*] documentationOf (CONF:14835) a.| DOCUMENT TEMPLATES | 22 f.16.16. MAY contain zero or more [0..*] addr with data type US Realm Address (CONF:8220) b.20. Such performers SHALL contain exactly one [1.16.1.*] inFulfillmentOf (CONF:9952) a.9..1] low (CONF:14838) a. This assignedEntity SHOULD contain zero or more [0.840.11.33 STATIC 2011-09-30.6" National Provider Identifier (CONF:9996) 21.113883. This order SHALL contain at least one [1. Such participants Such participants.16.4.1...1] relatedPerson (CONF:8221) a.840.840.4. where the @code SHALL be selected from (CodeSystem: 2.840...16.840..5. when participant/ @typeCode is IND.1] informant (CONF:8001) a.1] time (CONF:10004) b.. This relatedEntity SHOULD contain zero or more [0. This relatedEntity SHALL contain zero or one [0.1] relatedEntity a. This informant MAY contain zero or one [0.4.1] root ="2..1..1] assignedEntity (CONF:14841) MDHT Example Project © 2011 Page 22 . where the @code SHOULD be selected from (CodeSystem: 2..1. This relatedPerson SHALL contain at least one [1.1] assignedPerson (CONF:8221) a.6" National Provider Identifier (CONF:9996) (CONF:14847) c.1] code (CONF:14842).. where the @code SHOULD be selected from (CodeSystem: 2..6.6. MAY contain zero or more [0.. MAY contain zero or more [0.*] addr with data type US Realm Address (CONF:8220) b..16.113883.1] effectiveTime (CONF:14837) b.1.113883.1] order (CONF:9953) a.*] name c. This informant SHALL satisfy: contain exactly one [1.....113883.1] assignedEntity OR exactly one [1. c.*] performer (CONF:14839) a. This serviceEvent effectiveTime SHALL contain exactly one [1. This assignedEntity The id SHOULD include zero or one [0. if present. Such participants Unless otherwise specified by the document specific header constraints. This serviceEvent SHALL contain exactly one [1..101 NUCC Health Care Provider Taxonomy) (CONF:14843) b.. This serviceEvent SHOULD contain zero or more [0. This assignedEntity The id SHOULD include zero or one [0.. This assignedEntity SHOULD contain zero or one [0.. Such participants MAY contain zero or one [0..*] id (CONF:14846) c. Such inFulfillmentOfs SHALL contain exactly one [1. associatedEntity/@classCode SHALL be selected from ValueSet INDRoleclassCodes 2..113883.1]root ="2.113883.1.101 NUCC Health Care Provider Taxonomy) (CONF:9947) c.1] @typeCode (CONF:14840) b. MAY contain zero or one [0.*] id (CONF:9945) d.1] code.1] functionCode (CONF:16818). This assignedEntity SHALL contain at least one [1.1] assignedEntity a.88 ParticipationFunction) (CONF:16819) c.16..1] relatedEntity (CONF:8002) 22.. This assignedPerson SHALL contain at least one [1.*] participant (CONF:10003) a.840.. This assignedEntity The id SHOULD include zero or one [0. This assignedEntity MAY contain zero or one [0. Such documentationOfs SHALL contain exactly one [1.. Such performers SHALL contain exactly one [1.6" National Provider Identifier (CONF:9996) b.. Such performers MAY contain zero or one [0.113883. This assignedEntity SHALL contain exactly one [1. This assignedEntity SHALL contain at least one [1.

.113883.g.| DOCUMENT TEMPLATES | 23 25. If no time zone offset is provided.16.25" codeSystemName="ConfidentialityCode"/> <setId root="MDHT" extension="51ba5976-3165-4dcb-a14e-e58db5ef6808"/> <versionNumber value="1"/> <recordTarget> <typeId root="2. you can make no assumption about time.*] authorization (CONF:16792) a.4"/> <templateId root="2.xsd"> <realmCode code="US"/> <typeId root="2..1.. SHALL satisfy: The US Realm Clinical Document Date and Time datatype flavor records date and time information.1.1.3.g. you can make no assumption about time.3..3" (CONF:5250) 30.840.1.2.1] @root="2.3"/> <time/> <assignedAuthor/> </author> <custodian/> <component> MDHT Example Project © 2011 Page 23 .6 HL7ActClass) (CONF:16798) 26.4. If no time zone offset is provided.16.1"/> <id root="MDHT" extension="1724486731"/> <code code="1183589833"/> <title>TEXT FOR TITLE</title> <effectiveTime/> <confidentialityCode codeSystem="2.1] My Section (templateId: 1. This consent SHALL contain exactly one [1.FIELDED).w3.0" encoding="UTF-8"?> <ClinicalDocument xmlns:xsi="http://www.1] @extension="POCD_HD000040" (CONF:5251) 31. a consent to perform the related serviceEvent) is conveyed in consent/code (CONF:16796).113883. Progress Note). If setId is present versionNumber SHALL be present (CONF:6380) 34.1] statusCode (CONF:16797)/@code="completed" Completed (CodeSystem: 2.1. 29.840.1) • Template specifiations may include guidance documentation about how or when this section is used. MAY contain zero or more [0. typeId SHALL contain exactly one [1.US..1.2.org/2001/XMLSchema-instance" xmlns="urn:hl7-org:v3" xsi:schemaLocation="urn:hl7-org:v3 CDA. If versionNumber is present setId SHALL be present (CONF:6387) My Document example <?xml version="1. SHALL satisfy: The US Realm Clinical Document Date and Time datatype flavor records date and time information.113883.1.1] consent (CONF:16793) a.1.840.16..113883. but is used with the effectiveTime element.20.3"/> <templateId root="1. unless you have made a local exchange agreement.1..16. SHALL contain exactly one [1. code SHALL specify the particular kind of document (e.16.1] code (CONF:16795) The type of consent (e.US.840.*] id (CONF:16794) c.1. History and Physical.16.840. typeId SHALL contain exactly one [1.1.840..10.16.FIELDED).113883. unless you have made a local exchange agreement. This data type uses the same rules as US Realm Date and Time (DTM.. 28..1.5.3"/> <patientRole/> </recordTarget> <author> <typeId root="2.113883. id SHALL be a globally unique identifier for the document (CONF:9991) 32.5. Contains exactly one [1.22. This consent MAY contain zero or one [0. This consent MAY contain zero or more [0. b. (CONF:9992) 33. 27. This data type uses the same rules as US Realm Date and Time (DTM.113883. but is used with the effectiveTime element.840.1] component (CONF-Example-3) a. Such authorizations SHALL contain exactly one [1. Discharge Summary.

16.4.1.6.1"/> <id root="MDHT" extension="508376606"/> <code code="48764-5" codeSystem="2.22.113883.20.1" codeSystemName="LOINC" displayName="Summary Purpose"/> <title>TEXT FOR TITLE</title> <entry> <observation classCode="OBS" moodCode="EVN"> <typeId root="2.3"/> <templateId root="1.1.3"/> <templateId root="1.2.1.113883.1.113883.16.16.| DOCUMENT TEMPLATES | 24 <structuredBody> <component> <section> <typeId root="2.1.840.2"/> <templateId root="2.840.16.4"/> <id root="MDHT" extension="899442625"/> <code codeSystem="2.96" codeSystemName="SNOMEDCT"/> <statusCode code="completed"/> <effectiveTime> <low value="2013"/> <high value="2013"/> </effectiveTime> </observation> </entry> <entry> <substanceAdministration classCode="SBADM"/> </entry> <entry> <encounter/> </entry> </section> </component> </structuredBody> </component> </ClinicalDocument> MDHT Example Project © 2011 Page 24 .10.1.840.840.1.4.3.840.6.16.3.2.113883.4.113883.

Chapter 3 • SECTION TEMPLATES Topics: My Section .

1] templateId ( ) such that it a. SHALL contain exactly one [1.3.1] entry a.1. SHALL contain exactly one [1.20..*] entry (CONF-Example-9) a.4.. Contains exactly one [1.6.2.1. 1.4.49) 1.10...2"/> <templateId root="2. SHALL contain exactly one [1.840.2) 5..3.6.. 4.4.96" codeSystemName="SNOMEDCT"/> <statusCode code="completed"/> <effectiveTime> <low value="2013"/> <high value="2013"/> MDHT Example Project © 2011 Page 26 .3.20.1] Consol Encounter Activities (templateId: 2. SHALL contain exactly one [1. Contains exactly one [1.4.4.4.1] code/@code="48764-5" Summary Purpose (CodeSystem: 2.1..10.1] confidentialityCode (CONF-Example-11) 4.16.1] My Observation (templateId: 1.1] entry a.2.16) 7... SHALL contain at least one [1.840.113883.1] title (CONF-Example-12) SHALL contain exactly one [1.113883.22. SHALL contain exactly one [1.3.1 LOINC) (CONF-Example-10) 2.16.1"/> <id root="MDHT" extension="1267784622"/> <code code="48764-5" codeSystem="2.1] @root="1.1] code/@code="48764-5" Summary Purpose (CodeSystem: 2.4.1" 2.840.1] title (CONF-Example-12) 3..1] Consol Encounter Activities (templateId: 2.2.1] entry a.2.6.10.16.1.1. Contains exactly one [1.2.113883.6.840.4.1" codeSystemName="LOINC" displayName="Summary Purpose"/> <title>TEXT FOR TITLE</title> <confidentialityCode code="1679636193"/> <entry> <observation classCode="OBS" moodCode="EVN"> <templateId root="1..3.16.| SECTION TEMPLATES | 26 My Section [Section: templateId 1.1.113883. a.2) SHALL contain exactly one [1.113883.4"/> <id root="MDHT" extension="1743060016"/> <code codeSystem="2..840.1] entry a.16.16... 5..113883.1] Consol Medication Activity (templateId: 2.113883.4.1.16. Contains exactly one [1.. [explain purpose of this CDA section]..840.4.1] confidentialityCode (CONF-Example-11) SHALL contain exactly one [1.840.10.2. SHOULD contain exactly one [1..22.1] My Observation (templateId: 1.113883..20.16) 6. SHALL contain exactly one [1. Contains exactly one [1.1] My Section contain one or more My Problems.20.113883..1] Consol Medication Activity (templateId: 2. Contains exactly one [1.840.16.22.1..840.3.*] entry (CONF-Example-9) 3.16. SHALL contain exactly one [1.4.20.22. SHALL contain at least one [1.22..49) My Section example <section xmlns="urn:hl7-org:v3"> <templateId root="1.10.1 LOINC) (CONF-Example-10) SHOULD contain exactly one [1.1. 6.

| SECTION TEMPLATES | 27 </effectiveTime> </observation> </entry> <entry> <substanceAdministration/> </entry> <entry> <encounter/> </entry> </section> MDHT Example Project © 2011 Page 27 .

| SECTION TEMPLATES | 28 MDHT Example Project © 2011 Page 28 .

Chapter 4 • CLINICAL STATEMENT TEMPLATES Topics: My Observation This section of the Implementation Guide details the clinical statement entries referenced in the document section templates. The clinical statement entry templates are arranged alphabetically. .

22.1. MAY contain zero or one [0..3.840.100.6 HL7ActClass) (CONF-Example-4) 3. SHALL contain exactly one [1.10.16.5. MAY contain zero or one [0..1.2" SHALL conform to Consol Problem Observation template (templateId: 2. but this attribute is included in template with documentation that is published in the implementation guide.31) 13.1] @moodCode="EVN" Event (CodeSystem: 2.2.3.6 HL7ActClass) (CONF-Example-4) SHALL contain exactly one [1.113883. MAY contain zero or more [0.3. 5.113883..... CONF:15590) a.840.1] statusCode/@code="completed" Completed (CodeSystem: 2.840.| CLINICAL STATEMENT TEMPLATES | 30 My Observation [Observation: templateId 1. where the @code SHALL be selected from ValueSet My Problem Types 1..840.113883.1] Age Observation (templateId: 2.1. SHALL contain at least one [1.2 STATIC (CONF-Example-8) • 1.2.10.840.. a.14 ActStatus) (CONF:9049) SHALL contain exactly one [1.1] code.113883. Contains exactly one [1.16..2.. 7.840.20.. where the @code SHALL be selected from ValueSet My Problem Values 1. 9.*] value with data type CE. No additional constraint. SHALL contain exactly one [1.16. SHALL conform to Consol Problem Observation template (templateId: 2.3.4.22. 4.3. but this attribute is included in template with documentation that is published in the implementation guide...*] id Explain how or when the id should be used. SHALL contain exactly one [1. 6.*] targetSiteCode (CONF-Example-7) 12. SHALL contain exactly one [1..1] @root="1.1] @classCode="OBS" Observation (CodeSystem: 2. where the @code SHALL be selected from ValueSet My Problem Values 1.4.4.2.22.5.1] effectiveTime (CONF-Example-6) • Explain what the time is intended to represent for this problem observation...1.100.3.4. • Explain what the time is intended to represent for this problem observation.5. where the @code SHALL be selected from ValueSet My Problem Types 1.16. SHALL contain exactly one [1.1] code.4. SHALL contain at least one [1.4. CONF:9060.16.2] My Observations are used to represent problems about . 3. CONF:9068..1] entryRelationship (CONF:9063.2..4. Contains @typeCode="REFR" REFR MDHT Example Project © 2011 Page 30 .1] templateId ( ) such that it 2. No additional constraint.*] value with data type CE.1] @negationInd (CONF:10139) • Use negationInd="true" to indicate that the problem was not observed (CONF:16880) 5. MAY contain zero or one [0.5.1] text (CONF:9185) SHALL contain exactly one [1..4. Contains @typeCode="SUBJ" SUBJ b. Contains zero or more [0.4) SHALL contain exactly one [1.2.1] entryRelationship (CONF:9059.100.10.1] effectiveTime (CONF-Example-6) • 6.1.1] @classCode="OBS" Observation (CodeSystem: 2. [explain the purpose of this template] 1.*] id Explain how or when the id should be used..113883. 7.1 STATIC (CONF-Example-5) SHOULD contain zero or one [0.16.1.20.1..2 STATIC (CONF-Example-8) 11. 8.*] targetSiteCode (CONF-Example-7) 8.. MAY contain zero or more [0...100.4.840. CONF:15591) a.1 STATIC (CONF-Example-5) SHALL contain exactly one [1.4) 2.16.113883.113883. Contains zero or more [0. 10.20.1001 HL7ActMood) (CONF:9042) 4.

16. value MAY contain zero or more [0. value MAY contain zero or one [0.1] entryRelationship (CONF:9067.6.113883.w3.20.. The text.16. reference. The effectiveTime element . SHALL contain exactly one [1..1] high (CONF:15604) 20.org/2001/XMLSchema-instance" xmlns="urn:hl7-org:v3" classCode="OBS" moodCode="EVN"> <templateId root="1.1] @value (CONF:15588) 17.22..840. and the nullFlavor attribute SHALL be set to 'UNK'.1) (CONF:15589) 18. the existence of an high element within a problem does indicate that the problem has been resolved (CONF:16881) 21. SHOULD contain zero or one [0.840.3.1] reference (CONF:15587) 16..10..16. If the problem is known to be resolved. If the code is something other than SNOMED.3) (CONF:16750) My Observation example <observation xmlns:xsi="http://www.10.16. Contains @typeCode="REFR" REFR b. MAY contain zero or one [0.113883. if present. Contains exactly one [1.1] @inversionInd="true" True (CONF:9069) 24.113883.5) 15.5.113883.1.1.4. SHOULD contain zero or one [0. Therefore.4.1] Health Status Observation (templateId: 2.22. if present.20.840.. CONF:15592) a.840.113883.4"/> <id root="MDHT" extension="2002806740"/> <code codeSystem="2.6) 14. @nullFlavor SHOULD be OTH and the other code SHOULD be placed in the translation element (CONF:10142) 23. reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2. effectiveTime.1] @nullFlavor (CONF:10141) 22.20.1. Contains exactly one [1.1. if present.840.1] @code (CodeSystem: ICD10 2.96" codeSystemName="SNOMEDCT"/> <text>Text Value</text> <statusCode code="completed"/> <effectiveTime> <low value="2013"/> <high value="2013"/> </effectiveTime> <value xsi:type="CE" code="1271002991"/> <targetSiteCode code="919417652"/> </observation> MDHT Example Project © 2011 Page 31 . if present. section 4. SHALL contain exactly one [1.1] Problem Status (templateId: 2.22.2. CONF:9064. if present. entryRelationship with target entry Age Observation SHALL contain exactly one [1. translation.4..4.6.16.2"/> <templateId root="2.1. MAY contain zero or one [0.| CLINICAL STATEMENT TEMPLATES | 31 b.1] low (CONF:15603) 19..*] translation (CONF:16749) 25.3. If the diagnosis is unknown or the SNOMED code is unknown. but the date of resolution is not known then the high element SHALL be present. @nullFlavor SHOULD be UNK....10.

| CLINICAL STATEMENT TEMPLATES | 32 MDHT Example Project © 2011 Page 32 .

.Chapter 5 OTHER CLASSES This section of the Implementation Guide describes other classes that are not CDA Clinical Documents. Sections. or Clinical Statements.

| OTHER CLASSES | 34 MDHT Example Project © 2011 Page 34 .

Chapter 6 • • VALUE SETS Topics: My Problem Types My Problem Values The following tables summarize the value sets used in this Implementation Guide. .

3. dental. social.100.3.4.100.1. symptoms.2 SNOMEDCT .16.840.2. Code System SNOMEDCT SNOMEDCT SNOMEDCT SNOMEDCT SNOMEDCT SNOMEDCT SNOMEDCT Print Name Finding Complaint Diagnosis Condition Functional limitation Symptom Problem Code 404684003 409586006 282291009 64572001 248536006 418799008 55607006 My Problem Values Value Set Code System Source Source URL Definition My Problem Values .113883.1 SNOMEDCT .nci.| VALUE SETS | 36 My Problem Types Value Set Code System Definition My Problem Types .840.4.1.2.1.96 Veterans Administration/Kaiser Permanente (VA/KP) http://evs.6. preventative and psychiatric events and issues that are relevant to that patient s healthcare (e. Diagnosis/Problem List is broadly defined as a series of brief statements that catalog a patient s medical. nursing.6. signs.g. and defined conditions).gov/ftp1/FDA/ProblemList/ This describes the problem. MDHT Example Project © 2011 Page 36 .2.16.113883.2.96 The SNOMED CT has been limited to a value set that indicates the level of medical judgment used to determine the existence of a problem.1.nih..

www. ANSI-approved HL7 Standard. Available through HL7 . LOINC® : Logical Observation Identifiers Names and Codes. Implementation Guide. Inc. Using SNOMED CT in HL7 Version 3. Behlen FM. Extensible Markup Language.jamia. Alschuler L. 2006. HL7 Clinical Document Architecture. (Editors). 2007 available through HL7 . SNOMED CT® : SNOMED Clinical Terms SNOMED International Organization. HL7 Implementation Guide for CDA Release 2 Quality Reporting Document Architecture (QRDA) Draft Standard for Trial Use March 2009. Shabo A.0. Boyer S. Boyer S. Available through HL7 or if an HL7 member with the following link: Using SNOMED CT in HL7 Version 3 . Beebe C. Behlen FM.w3. Ann Arbor. Release 2 Draft Standard for Trial Use January 2009 Available at: NHSN Healthcare Associated Infection (HAI) Reports Dolin RH. Release 2. Mich. Biron PV. Shabo A.org/XML . Release 2. HL7 Implementation Guide for CDA Release 2: NHSN Healthcare Associated Infection (HAI) Reports.5.: Health Level Seven.org/cgi/reprint/13/1/30 . Regenstrief Institute. May 2005. Release 1. Available at: Quality Reporting Document Architecture (QRDA) HL7 Implementation Guide for CDA Release 2 CDA for Public Health Case Reports (PHCR) Informative Standard October 2009. Alschuler L. Available through HL7 or if an HL7 member with the following link: CDA Release 2 Normative Web Edition. Available at: http://www. Biron PV. J Am Med Inform Assoc. Beebe C.. HL7 Clinical Document Architecture.13:30-39.REFERENCES • • • • • • • • • • 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. Dolin RH.

| REFERENCES | 38 MDHT Example Project © 2011 Page 38 .