Consolidated CDA Release 2.1 StructureDefinition Publication
2.1 - CI Build

Consolidated CDA Release 2.1 StructureDefinition Publication, published by Health Level Seven. This is not an authorized publication; it is the continuous build for version 2.1). This version is based on the current content of https://github.com/HL7/CDA-ccda-2.1-sd/ and changes regularly. See the Directory of published versions

## Document Level Guidance

The C-CDA Companion Guide provides additional guidance aimed at increasing consistency in the way data in C- CDA document templates are represented and used across all implementations. The goal is to increase awareness about how to use the HL7 CDA and C-CDA standards to meet rising expectations and emerging regulations focused on expanding interoperability.

This chapter provides generalized document header guidance and additional guidance for specific types of C-CDA documents.

### Reusable, Nesting Templates

C-CDA establishes two document header templates. These header templates establish consistent rules for populating the data elements in a C-CDA document header. Document header elements create context for the information contained in the body of the document.

The US Realm General Header is used for documents that are authored by clinicians and systems supporting clinicians, and the US Realm Patient Generated Header is used for documents that are authored by patients and systems supporting patients.

Each document template defined in C-CDA R2.1 indicates the header template that the document is expected to conform to, and each MAY include additional header constraints that are relevant to the type of clinical note being represented in the document. [BP-028]

Additionally, document templates define the sections of content that SHALL, SHOULD, or MAY be present for exchanging clinical notes. Each section is identified with a code that tells the computer the type of information in the section.

Further, the sections define entry templates which SHALL, SHOULD, or MAY be used to represent the information in each section using even more discrete representations that aid further computer processing of the clinical information in the section.

#### Nested Content and Context Conduction

CDA context is set in the CDA header and applies to the entire document. Context can be overridden at the level of the section, and/or CDA entry. A document, in a sense, is a contextual wrapper for its contents. Assertions in the document header are typically applicable to statements made in the body of the document, unless overridden. For instance, the patient identified in the header is assumed to be the subject of observations described in the body of the document, unless a different subject is explicitly stated. The author identified in the header is assumed to be the author of the information in the sections and entries of the document, unless a different author is explicitly identified on a section or on individual entries. The objective of the CDA context rule is to make these practices explicit with relationship to the RIM, such that a computer will understand the context of a portion of a document the same way that a human interprets it.

CDA’s approach to context, and the propagation of that context to nested document components, follows these design principles :

- The CDA Header sets context for the entire document. A propagating value specified in the document header holds true throughout the document, unless explicitly overridden. This principal applies only to designated participations and attributes of the CDA Header that support propagating context conduction. Contextual header components (i.e., those that have propagating values) include:
  o Author
  o Confidentiality
  o Data enterer
  o Human language
  o Informant
  o Legal authenticator
  o Participant
  o Record target
- Context components that can be overridden at the level of the document body include:
  o Confidentiality
  o Human language

- Context components that can be overridden at the level of a document section include:
  o Author
  o Confidentiality
  o Human language
  o Informant
  o Subject

- Context components that can be overridden at the level of a CDA entry include:
  o Author
  o Confidentiality
  o Human language
  o Informant
  o Participant
  o Subject
- Context propagates from outer context to nested context. Context that is specified on an outer tag holds true for all nested tags, unless overridden on a nested tag. Context specified on a tag within the CDA body always overrides context propagated from an outer tag. For instance, the specification of authorship at a document section level overrides all authorship propagated from the header. The outer context for an entryRelationship component in an entry is the outer entry act. The outer context for an entry is the encompassing section. The outer context for a section is the document header.
- Context is sometimes known precisely, and is sometimes unknown, such as in the case where a document is comprised of a large unparsed narrative block that potentially includes statements that contradict outer context. Because CDA context always propagates unless overridden, the representation of unknown context is achieved by overriding with a null value.
- To override the Confidentiality at the entry level, an implementation must use Confidentiality Security Observation [Observation: templateId 2.16.840.1.113883.3.445.12] defined in “HL7 CDA® R2 Implementation Guide: Privacy Consent Directives, Release 1.”

Example 4: Section with narrative text and a nullFlavor for the author

This example explains explains that the author of the section is not known. Thus the author in the header does not conduct to be the author of the unparsed narrative information contained in the section.

    <section>
        <templateId root="1.3.6.1.4.1.19376.1.5.3.1.1.13.2.1"/>
        <code code="10154-3" displayName="Chief complaint Reported"
            codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/>
        <title>Chief Complaint Section</title>
        <text><content>No complaints, annual wellness exam</content>
            <content>Author of this section not known.</content>
        </text>
        <author nullFlavor="UNK">
            <time/>
            <assignedAuthor>
                <id/>
            </assignedAuthor>
        </author>
    </section>

Reference: For additional information on Context Conduction mechanisms in CDA documents, consult the HL7 CDA R2.0 specification.

Reference: The HL7 Data Security for Privacy and HL7 Privacy Consent Directives^56 implementation guides define how to override confidentiality context at the entry level.

Reference: Provenance, Unknown Data in Sections That Require Entries

### Structured Header

All CDA documents include a structured header regardless if the document is CDA document with a structured structuredBody element (a “structured document”) or a CDA document with a nonXMLBody element (an “unstructured document”). The structured header permits computer processing (parsing) to occur on its content.

#### Patient

The recordTarget represents the medical record that this document belongs to. In the uncommon case where a clinical document (such as a group encounter note) is placed into more than one patient chart, more than one recordTarget participants can be stated.^57 The recordTarget records the administrative and demographic data of the patient whose health information is described by the clinical document; each recordTarget must contain at least one patientRole element.^58

The recordTarget contains many elements that hold core data for interoperability. The table below summarizes data elements present in the recordTarget.

Patient matching continues to be one of the major challenges for interoperability due to the lack of a universal patient identifier, similar to a Social Security Number, but used for healthcare.

^57 HL7 CDA Web Edition 2010. Chapter 4.2.2.11. ^58 HL7 Consolidated CDA R2.1. Chapter 1.1.1.2.

Data Element | Data element xPath
--- | ---
First Name | /ClinicalDocument/recordTarget/patientRole/patient/name/given[1]
Last Name | /ClinicalDocument/recordTarget/patientRole/patient/name/family
Previous Name | /ClinicalDocument/recordTarget/patientRole/patient/name/family/@qualifier
Middle Name | /ClinicalDocument/recordTarget/patientRole/patient/name/given[2]
Suffix | /ClinicalDocument/recordTarget/patientRole/patient/name/suffix
Administrative Gender | /ClinicalDocument/recordTarget/patientRole/patient/administrativeGenderCode
Birth Sex | Reference: Birth Sex
Date of Birth | /ClinicalDocument/recordTarget/patientRole/patient/birthTime
Race | /ClinicalDocument/recordTarget/patientRole/patient/raceCode
Ethnicity | /ClinicalDocument/recordTarget/patientRole/patient/ethnicGroupCode
Preferred Language (requires preferenceInd=”true”) | /ClinicalDocument/recordTarget/patientRole/patient/languageCommunication /ClinicalDocument/recordTarget/patientRole/patient/languageCommunication/preferenceInd
Address | /ClinicalDocument/recordTarget/patientRole/addr
Phone Number | /ClinicalDocument/recordTarget/patientRole/telecom

Table 10: Patient Data Elements

C-CDA Content Creators SHOULD include identifiers that improve the accuracy of automated patient matching mechanisms. [BP-029] Note: Testability would require business decisions to be made about what type of identifiers improve automated matching.
C-CDA Content Creators SHALL include the patient’s administrative gender in the demographic information of the recordTarget. [CONF-030]
When C-CDA Content Creators include birth sex they SHALL use the Birth Sex Observation in the Social History Section. [CONF-031]
C-CDA Content Creators who choose to include a non-null patient address SHOULD follow the guidance in the Project US@ Technical Specification [BP-099] ^59

Example 5: recordTarget with demographic data

    <recordTarget>
        <patientRole>
            <!-- Here is a public id that has an external meaning based on a root OID that is
    publically identifiable. -->
            <!-- root="1.3.6.1.4.1.41179.2.4" is the assigningAuthorityName for
    DirectTrust's Patient/Consumer addresses "DT.org PATIENT" -->
            <id root="1.3.6.1.4.1.41179.2.4" extension="lisarnelson@direct.myphd.us"
                assigningAuthorityName="DT.org PATIENT"/>
            <!-- More ids may be used. -->
            <!-- Here is the patient's MRN at RVHS -->
            <id root="2.16.840.1.113883.1.111.12345" extension="12345-0828"
                assigningAuthorityName="River Valley Health Services local patient Medical
                Record Number" />
            <addr>
                <streetAddressLine>1 Happy Valley Road</streetAddressLine>
                <city>Westerly</city>
                <state>RI</state>
                <postalCode>02891</postalCode>
                <country nullFlavor="UNK"/>
            </addr>
            <telecom use="WP" value="tel:+1-4013482345"/>
            <telecom use="HP" value="tel:+1-4016412345"/>
            <telecom value="mailto:lisanelson@gmail.com"/>
            <telecom value="mailto:lisarnelson@direct.myphd.us"/>
            <patient>
                <name use="L">
                    <family>Nelson</family>
                    <given qualifier="CL">Lisa</given>
                </name>
                <administrativeGenderCode code="F" displayName="Female"
                    codeSystem="2.16.840.1.113883.5.1" codeSystemName="HL7
                    AdministrativeGender"/>
                <birthTime value="19620828"/>
                <maritalStatusCode code="M" displayName="Married"
                    codeSystem="2.16.840.1.113883.5.2"
                    codeSystemName="HL7 MaritalStatus"/>
                <raceCode code="2106-3" displayName="White"
                    codeSystem="2.16.840.1.113883.6.238"
                    codeSystemName="CDC Race and Ethnicity"/>
                <ethnicGroupCode code="2186-5" displayName="Not Hispanic or Latino"
                    codeSystem="2.16.840.1.113883.6.238" codeSystemName="CDC Race and
                    Ethnicity"/>
                <languageCommunication>
                    <templateId root="2.16.840.1.113883.3.88.11.32.2"/>
                    <languageCode code="eng"/>
                    <preferenceInd value="true"/>
                </languageCommunication>
            </patient>
            <providerOrganization>
                <!-- This is a public id where the root is registered to indicate the
    National Provider ID -->
                <id root="2.16.840.1.113883.4.6" extension="1417947383"
                    assigningAuthorityName="National Provider ID"/>
            </providerOrganization>
        </patientRole>
    </recordTarget>

Example 6: recordTarget including the provider organization context for the clinical documentation

    <recordTarget>
        <patientRole>
            <!-- Here is a public id that has an external meaning based on a root OID that is publicly identifiable. -->
            <!-- root="1.3.6.1.4.1.41179.2.4" is the assigningAuthorityName for
    DirectTrust's Patient/Consumer addresses "DT.org PATIENT" -->
            <id root="1.3.6.1.4.1.41179.2.4" extension="lisarnelson@direct.myphd.us"
                assigningAuthorityName="DT.org PATIENT"/>
            <!-- More ids may be used. -->
            <!-- Here is the patient's MRN at RVHS -->
            <id root="2.16.840.1.113883.1.111.12345" extension="12345-0828"
                assigningAuthorityName="River Valley Health Services local patient Medical Record Number" />
            <addr>
                <streetAddressLine>1 Happy Valley Road</streetAddressLine>
                <city>Westerly</city>
                <state>RI</state>
                <postalCode>02891</postalCode>
                <country nullFlavor="UNK"/>
            </addr>
            <telecom use="WP" value="tel:+1-4013482345"/>
            <telecom use="HP" value="tel:+1-4016412345"/>
            <telecom value="mailto:lisanelson@gmail.com"/>
            <telecom value="mailto:lisarnelson@direct.myphd.us"/>
            <patient>
                <name use="L">
                    <family>Nelson</family>
                    <given qualifier="CL">Lisa</given>
                </name>
                <administrativeGenderCode code="F" displayName="Female"
                    codeSystem="2.16.840.1.113883.5.1" codeSystemName="HL7 AdministrativeGender"/>
                <birthTime value="19620828"/>
                <maritalStatusCode code="M" displayName="Married" codeSystem="2.16.840.1.113883.5.2"
                    codeSystemName="HL7 MaritalStatus"/>
                <raceCode code="2106-3" displayName="White" codeSystem="2.16.840.1.113883.6.238"
                    codeSystemName="CDC Race and Ethnicity"/>
                <ethnicGroupCode code="2186-5" displayName="Not Hispanic or Latino"
                    codeSystem="2.16.840.1.113883.6.238" codeSystemName="CDC Race and Ethnicity"/>
                <languageCommunication>
                    <templateId root="2.16.840.1.113883.3.88.11.32.2"/>
                    <languageCode code="eng"/>
                    <preferenceInd value="true"/>
                </languageCommunication>
            </patient>
            <providerOrganization>
                <!-- This is a public id where the root is registered to indicate the National Provider ID -->
                <id root="2.16.840.1.113883.4.6" extension="1417947383"
                    assigningAuthorityName="National Provider ID"/>
                <!-- This is a public id where the root indicates this is a Provider Direct Address. -->
                <!-- root="1.3.6.1.4.1.41179.2.1" is the assigningAuthorityName for
    DirectTrust's Covered Entity addresses "DT.org CE" -->
                <id root="1.3.6.1.4.1.41179.2.1" extension="rvhs@rvhs.direct.md" assigningAuthorityName="DT.org CE (Covered Entity)"/>
                <!-- By including a root OID attribute for a healthcare organization, you can use this information to
    indicate a patient's MRN id at that organization.-->
                <id root="2.16.840.1.113883.1.111.12345"
                    assigningAuthorityName="River Valley Health Services local patient Medical Record Number" />
                <name>River Valley Health Services</name>
                <telecom use="WP" value="tel:+1-4015394321"/>
                <telecom use="WP" value="mailto:rvhs@rvhs.direct.md"/>
                <addr>
                    <streetAddressLine>823 Main Street</streetAddressLine>
                    <city>River Valley</city>
                    <state>RI</state>
                    <postalCode>028321</postalCode>
                    <country>US</country>
                </addr>
            </providerOrganization>
        </patientRole>
    </recordTarget>

The CDA Examples Search tool provides useful examples showing the Patient Demographic data elements represented in a C-CDA document. The examples below show how to include information about a patient’s prior name or prior address in a C-CDA document. The relevance and pertinence of including this type of information in an exchange document remains a business decision to be made by organizations engaged in sharing information.

^60 https://cdasearch.hl7.org/examples/view/Header/Patient%20Demographic%20Information

Example 7: How to represent Patient demographic Information^60

    <recordTarget>
        <patientRole>
            <!-- The @root OID below (which is fictional) would be specific to an institution's
    record identifier system. -->
            <id root="2.16.840.1.113883.3.6132" extension="345678912-0154"/>
            <!-- HP is "primary home" from valueSet 2.16.840.1.113883.1.11.10637 -->
            <addr use="HP">
                <!-- You can have multiple [1..4] streetAddressLine elements. Single shown below -->
                <streetAddressLine>1436 Jennyhill Ln.</streetAddressLine>
                <city>Hollywood</city>
                <!-- 5 or 9 digit zip codes from valueSet 2.16.840.1.113883.3.88.12.80.2-->
                <!-- PostalCode is required if the country is US. If country is not specified, it's
    assumed to be US. If country -->
                <!-- is something other than US, the postalCode MAY be present but MAY be bound to
    different vocabularies -->
                <postalCode>90068</postalCode>
                <!-- State is required if the country is US. If country is not specified, it's
    assumed to be US. -->
                <!-- If country is something other than US, the state MAY be present but MAY be bound
    to different vocabularies -->
                <!-- OR is "Oregon" from valueSet 2.16.840.1.113883.3.88.12.80.1 -->
                <state>CA</state>
                <!-- US is the two digit code for "United States" -->
                <country>US</country>
            </addr>
            <!-- MC is "mobile contact" from HL7 AddressUse 2.16.840.1.113883.5.1119 -->
            <telecom value="tel:+1(565)867-5309" use="MC"/>
            <!-- Multiple telecoms are possible -->
            <telecom value="mailto://adam@diameterhealth.com" use="WP"/>
            <patient>
                <name use="L">
                    <given>Adam</given>
                    <family>Everyman</family>
                </name>
                <!-- From CDA R2 on administrativeGender Code: This attribute does not include terms
    related to clinical gender.
    Gender is a complex physiological, genetic and sociological concept
    that requires multiple observations in order to be
    comprehensively described. The purpose of this attribute is to
    provide a high level classification that can additionally
    be used for the appropriate allocation of inpatient bed assignment.-->
                <!-- Sex at birth and gender identity may be specified in social history -->
                <administrativeGenderCode code="M" codeSystem="2.16.840.1.113883.5.1"
                    displayName="Male" codeSystemName="AdministrativeGender"/>
                <birthTime value="19621022"/>
                <maritalStatusCode code="M" displayName="Married" codeSystem="2.16.840.1.113883.5.2"
                    codeSystemName="MaritalStatus"/>
                <religiousAffiliationCode code="1013" displayName="Christian (non-Catholic, non-
                    specific)" codeSystem="2.16.840.1.113883.5.1076" codeSystemName="HL7 Religious Affiliation"/>
                <!-- CDC Race and Ethnicity code set contains the five minimum race and the two
    minimum ethnicity categories defined by OMB Standards -->
                <raceCode code="2106-3" displayName="White" codeSystem="2.16.840.1.113883.6.238"
                    codeSystemName="OMB Standards for Race and Ethnicity"/>
                <ethnicGroupCode code="2186-5" displayName="Not Hispanic or Latino"
                    codeSystem="2.16.840.1.113883.6.238" codeSystemName="OMB Standards for Race and Ethnicity"/>
                <languageCommunication>
                    <languageCode code="eng"/>
                    <!-- "eng" is ISO 639-2 alpha-3 code for "English" -->
                    <modeCode code="ESP" displayName="Expressed spoken"
                        codeSystem="2.16.840.1.113883.5.60" codeSystemName="LanguageAbilityMode"/>
                    <proficiencyLevelCode code="E" displayName="Excellent"
                        codeSystem="2.16.840.1.113883.5.61" codeSystemName="LanguageAbilityProficiency"/>
                    <preferenceInd value="true"/>
                </languageCommunication>
                <!-- Multiple languages are permitted. Only one should have a preferenceInd = true -->
                <languageCommunication>
                    <languageCode code="ita"/>
                    <!-- "ita" is ISO 639-2 alpha-3 code for "Italian" -->
                    <modeCode code="ESP" displayName="Expressed spoken"
                        codeSystem="2.16.840.1.113883.5.60" codeSystemName="LanguageAbilityMode"/>
                    <proficiencyLevelCode code="G" displayName="Good"
                        codeSystem="2.16.840.1.113883.5.61" codeSystemName="LanguageAbilityProficiency"/>
                    <!-- Patient's preferred language -->
                    <preferenceInd value="false"/>
                </languageCommunication>
            </patient>
        </patientRole>
    </recordTarget>

Example 8: How to represent Patient with Previous Name^61

    <recordTarget>
        <!-- Note: several other data elements (telecom, address, etc.) are required to meet C-CDA
    R2.1 requirements -->
        <patientRole>
            <id extension="444222222" root="2.16.840.1.113883.4.1"/>
            <patient>
                <!-- SDWG reviewed and approved approach for recording a birth name and legal name -->
                <name use="L">
                    <given>Alice</given>
                    <given>Jones</given>
                    <family>Newman</family>
                </name>
                <name>
                    <given qualifier="BR">Alicia</given> <!-- BR = Birth name-->
                    <given>Jones</given>
                    <family qualifier="BR">Newman</family> <!-- BR = Birth name-->
                    <!-- Optional valid time - best practice -->
                    <validTime>
                        <low value="20010505"/>
                        <high value="20010510"/>
                    </validTime>
                </name>
            </patient>
        </patientRole>
    </recordTarget>

^61 https://cdasearch.hl7.org/examples/view/Header/Patient%20Previous%20Name

Example 9: How to represent Patient with Prior Address^62

    <!-- recordTarget example from C-CDA-Examples/Header/Patient Demographic Information
    added multiple home addresses
    -->
    <recordTarget>
        <patientRole>
            <id root="2.16.840.1.113883.3.6132" extension="345678912-0154"/>
            <!-- HP is "primary home" from valueSet 2.16.840.1.113883.1.11.10637
    and in this instance represents patient's current address -->
            <addr use="HP">
                <streetAddressLine>152 Creek Lane</streetAddressLine>
                <city>Shelburne</city>
                <state>VT</state>
                <postalCode>05455</postalCode>
                <country>US</country>
                <useablePeriod xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
                    xsi:type="IVL_TS">
                    <low value="20110822"/>
                </useablePeriod>
                <!-- It is permissible to omit a low element to indicate current residence -->
                <!-- It is permissible to omit a high element or use nullFlavor='NA' -->
            </addr>
            <addr use="H">
                <streetAddressLine>191 S OAK AVE</streetAddressLine>
                <city>BURLINGTON</city>
                <state>VT</state>
                <postalCode>05422</postalCode>
                <country>US</country>
                <useablePeriod xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
                    xsi:type="IVL_TS">
                    <low value="20110131"/>
                    <high value="20110821"/>
                </useablePeriod>
            </addr>
            <addr use="H">
                <streetAddressLine>1141 W MAIN AVE</streetAddressLine>
                <city>CHICAGO</city>
                <state>IL</state>
                <postalCode>60613</postalCode>
                <country>US</country>
                <useablePeriod xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
                    xsi:type="IVL_TS">
                    <low value="20070513"/>
                    <high value="20110130"/>
                </useablePeriod>
            </addr>
            <telecom value="tel:+1(565)867-5309" use="MC"/>
            <telecom value="mailto://adam@diameterhealth.com" use="WP"/>
            <patient>
                <name use="L">
                    <given>Adam</given>
                    <family>Everyman</family>
                </name>
                <administrativeGenderCode code="M" codeSystem="2.16.840.1.113883.5.1"
                    displayName="Male" codeSystemName="AdministrativeGender"/>
                <birthTime value="19621022"/>
                <maritalStatusCode code="M" displayName="Married" codeSystem="2.16.840.1.113883.5.2"
                    codeSystemName="MaritalStatus"/>
                <religiousAffiliationCode code="1013" displayName="Christian (non-Catholic, non-
                    specific)" codeSystem="2.16.840.1.113883.5.1076" codeSystemName="HL7 Religious Affiliation"/>
                <raceCode code="2106-3" displayName="White" codeSystem="2.16.840.1.113883.6.238"
                    codeSystemName="OMB Standards for Race and Ethnicity"/>
                <ethnicGroupCode code="2186-5" displayName="Not Hispanic or Latino"
                    codeSystem="2.16.840.1.113883.6.238" codeSystemName="OMB Standards for Race and Ethnicity"/>
                <languageCommunication>
                    <languageCode code="eng"/>
                    <modeCode code="ESP" displayName="Expressed spoken"
                        codeSystem="2.16.840.1.113883.5.60" codeSystemName="LanguageAbilityMode"/>
                    <proficiencyLevelCode code="E" displayName="Excellent"
                        codeSystem="2.16.840.1.113883.5.61" codeSystemName="LanguageAbilityProficiency"/>
                    <preferenceInd value="true"/>
                </languageCommunication>
                <languageCommunication>
                    <languageCode code="ita"/>
                    <modeCode code="ESP" displayName="Expressed spoken"
                        codeSystem="2.16.840.1.113883.5.60" codeSystemName="LanguageAbilityMode"/>
                    <proficiencyLevelCode code="G" displayName="Good"
                        codeSystem="2.16.840.1.113883.5.61" codeSystemName="LanguageAbilityProficiency"/>
                    <preferenceInd value="false"/>
                </languageCommunication>
            </patient>
        </patientRole>
    </recordTarget>

^62 http://hl7-c-cda-examples.herokuapp.com/examples/view/Header/Patient%20With%20Prior%20Addresses

##### @use and @qualifier attributes for Patient name

The US Realm Patient Name template (2.16.840.1.113883.10.20.22.5.1) supports the @use attribute on the name tag. This template also supports the @qualifier attribute on the given and family tags.

These value sets are available in the C-CDA Value Set Release Package available from the Downloads page of the Value Set Authority Center.

Concepts available for use with the @use attribute of the name element SHALL be selected from the EntityNameUse value set (2.16.840.1.113883.1.11.15913 ). [CONF-032]
Concepts available for use with the @qualifier attribute of the name element SHALL be selected from the EntityPersonNamePartQualifier value set (2.16.840.1.113883.11.20.9.26 ). [CONF-033]

Example 10: Logical display order of name pieces

(i.e., such that a receiver which only extracts the text and ignores the markup around , , etc. would still display the name in a way a human would interpret correctly).

        <recordTarget>
            <!-- Examples of how systems send names and logical display order -->
            <!-- Note: This snippet omits other data elements required to meet C-CDA R2.1 requirements
    (telecom, address, etc.) -->
            <patientRole>
                <id nullFlavor="NI" />
                <patient>
                    <!-- This is okay; "Robin Taylor" is a logical display order -->
                    <name>
                        <given>Robin</given>
                        <family>Taylor</family>
                    </name>
                    <!-- This is okay; "Taylor, Robin" implies Lastname, Firstname ordering in the US -->
                    <name>
                        <family>Taylor</family>
                        <delimiter>, </delimiter>
                        <given>Robin</given>
                    </name>
                    <!-- This is okay; "Dr. Robin Taylor" is a logical display order -->
                    <name>
                        <prefix qualifier="AC TITLE">Dr. </prefix><!-- Space in element is intentional
    (see CDA R2.0 Section 2.23.4) -->
                        <given>Robin</given>
                        <family>Taylor</family>
                    </name>
                    <!-- This is okay; "Robin Taylor MD" is a logical display order -->
                    <name>
                        <given>Robin</given>
                        <family>Taylor</family>
                        <suffix qualifier="AC TITLE"> MD</suffix><!-- Space in element is intentional
    (see CDA R2.0 Section 2.23.4) -->
                    </name>
                    <!-- Don't do this; "Robin Taylor Dr." isn't a logical display order -->
                    <name>
                        <given>Robin</given>
                        <family>Taylor</family>
                        <prefix qualifier="AC TITLE">Dr. </prefix><!-- Space in element is intentional -->
    </name>
    <!-- Don't do this; "Taylor Robin" is confusing (is Taylor the given name?) -->
                        <name>
                            <family>Taylor</family>
                            <given>Robin</given>
                        </name>
                </patient>
            </patientRole>
        </recordTarget>

Some systems may collect a patient’s Social Security number but organizational business rules prohibit distribution of the full number and require that all but the final four digits of the identifier to be masked when distributing this information to data sharing partners.

Content Consumers SHALL NOT treat id elements that include a nullFlavor attribute as globally unique identifiers. [BP-034]

Example 11: How to represent a social security number (SSN) that has been masked to show only the last four digits

    <recordTarget>
        <patientRole>
            <!-- Example Social Security Number using the root for the Social Security Administration
    assigningAuthority. -->
            <id assigningAuthorityName="US Social Security Administration" root="2.16.840.1.113883.4.1"
                extension="414122222"/>
            <!-- SSN provided, but masked to include only the last 4 characters. -->
            <!-- Note: both examples are shows for comparison. It would not make sense to use both of
    these options in a real C-CDA Document. -->
            <!-- When recording SSN in the extension dashes (-) are permitted but not required" -->
            <!-- Receiving systems may decide whether to store the last 4 or discard -->
            <!-- an id with a nullFlavor SHALL NOT be used for matching or indexing -->
            <id assigningAuthorityName="US Social Security Administration" root="2.16.840.1.113883.4.1"
                extension="***-**- 2222" nullFlavor="MSK"/>
            <addr use="HP">
                <!-- HP is "primary home" from codeSystem 2.16.840.1.113883.5.1119 -->
                <streetAddressLine>1357 Amber Dr</streetAddressLine>
                <city>Beaverton</city>
                <state>OR</state>
                <postalCode>97006</postalCode>
                <country>US</country>
                <!-- US is "United States" from ISO 3166-1 Country Codes: 1.0.3166.1 -->
            </addr>
            <telecom value="tel:+1(555)- 777 - 1234" use="MC"/>
            <telecom value="tel:+1(555)- 723 - 1544" use="HP"/>
            <!-- HP is "primary home" from HL7 AddressUse 2.16.840.1.113883.5.1119 -->
            <patient> </patient>
            <providerOrganization> </providerOrganization>
        </patientRole>
    </recordTarget>

#### Representing Multiple Races or Multiple Ethnicities

The recordTarget utilizes two CDA R2 extensions for representing multiple races and multiple ethnicities.

The following guidance in available in Chapter 1.1 of the HL7 C-CDA R2.1 Implementation Guide^64:

This patient SHALL contain exactly one [1..1] raceCode, which SHALL be selected from ValueSet Race Category Excluding Nulls urn:oid:2.16.840.1.113883.3.2074.1.1.3 DYNAMIC [CONF:1198-5322].
This patient MAY contain zero or more [0..*] sdtc:raceCode, which SHALL be selected from ValueSet Race urn:oid:2.16.840.1.113883.1.11.14914 DYNAMIC (CONF:1198-7263). Note: The sdtc:raceCode is only used to record additional values when the patient has indicated multiple races or additional race detail beyond the five categories required for Meaningful Use Stage 2. The prefix sdtc: SHALL be bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension to CDA R2 for the use of the additional raceCode elements. a. If sdtc:raceCode is present, then the patient SHALL contain [1..1] raceCode [CONF:1198-31347].
This patient SHALL contain exactly one [1..1] ethnicGroupCode, which SHALL be selected from ValueSet Ethnicity urn:oid:2.16.840.1.114222.4.11.837 DYNAMIC [CONF:1198-5323].
This patient MAY contain zero or more [0..*] sdtc:ethnicGroupCode, which SHALL be selected from ValueSet Detailed Ethnicity urn:oid:2.16.840.1.114222.4.11.877 DYNAMIC (CONF:1198-32901).

#### Patient Identifiers

Patient identifiers are included in a C-CDA within the patientRole structure of the recordTarget. The @extension attribute of the id tag holds the identifier. The @root attribute holds an OID associated with the assigning authority of the identifier. The @assigningAuthorityName attribute holds the name of the assigning authority. Many organizations that assign trusted identifiers exist today and have registered OIDs to support exchange of the identifiers they assign. The table below includes some examples.

Assigning Authority Name | Assigning Authority OID identifier
--- | ---
U.S. Social Security Administration | 2.16.840.1.113883.4.1
Driver’s license issuing authority | 2.16.840.1.113883.12.333
DT.org PATIENT (DirectTrust assigned identity for Consumer entity) | 1.3.6.1.4.1.41179.2.4

Table 11: Patient Identifiers

Example 12: How to represent a patient’s social security number

    <recordTarget>
        <patientRole>
            <id assigningAuthorityName="EPI"
                extension="700000305" root="1.2.840.114350.1.13.6289.1.7.5.737384.14"/>
            <id assigningAuthorityName="US Social Security Administration"
                root="2.16.840.1.113883.4.1" extension="999-99- 9999"/>
            <id assigningAuthorityName="Driver’s license issuing authority"
                extension="43721-643" root="2.16.840.1.113883.4.3.24"/>
            <patient>
                <name use="L"><given>Barbara</given><family>Epic</family></name>
            </patient>
        </patientRole>
    </recordTarget>

#### recordTarget Provider Organization

While the recordTarget represents the medical record that this document belongs to, the providerOrganization within the recordTarget represents the provider organization to which the medical record belongs.

C-CDA Content Creators SHOULD populate the providerOrganization within the recordTarget when the document represents information from a provider’s medical record system. [CONF-035]
C-CDA Content Creators SHOULD include an identifier for the provider organization in the id/@extension attribute and SHOULD identify the assigning authority for the identifier using a globally unique identifier (GUID or OID) in the id/@root attribute. [CONF-036]

Reference: Example 5: recordTarget with demographic data , Example 6: recordTarget including the provider organization context for the clinical documentation

#### Authors Versus Performers

CDA includes structures to record the author of information, and separately, the performer of a service. It is important for implementers to avoid recording a performer as an author, if that performer was not the individual who authored content.

A performer participant represents a clinician who actually and principally carried out a service. A performer participation indicated at one location in a document does not conduct throughout the document and must be repeated at each entry to indicate involvement. For example, the performer indicated in the serviceEvent in the CDA header is not automatically implied to be the performer in procedures or medication activities represented by the entries in the document. An author represents the human or machine that authored content. Authors listed in the header are responsible for all content in the document, while authors recorded in a section or entry are only responsible for content within that structure and override the author in the header. Section authorship applies to the full content of a section, including both the narrative block and any entries. Entry authorship applies only to the specific entry.

One example where confusion between these roles might arise for implementers is related to quality measurement use cases, which require clinical documentation to indicate who diagnosed a patient’s condition and when a clinician made or re-confirmed the diagnosis. The provider who documents the diagnosis (data enterer or author) may not be the provider who makes the diagnosis (performer).

The Author Participation template (2.16.840.1.113883.10.20.22.4.119) is used to explicitly indicate an Author in a section or entry. The template provides conformance rules for representing the author and author.time elements associated with individual entries. The HL7 Basic Provenance project^65 also developed additional guidance on sharing the Author in the Provenance - Author Participation template in Appendix A.

The C-CDA R2.1 specification requires the following:

1. SHALL contain exactly one [1..1] templateId (CONF:1098-32017) such that it a. SHALL contain exactly one ["..1] @root="2.16.840.1.113883.10”20.22.4.119" (CONF:1098- 32018). 2. SHALL contain exactly one [1..1] time (CONF:1098-31471). 3. SHALL contain exactly one [1..1] assignedAuthor (CONF:1098-31472). a. This assignedAuthor SHALL contain at least one [1..*] id (CONF:1098-31473). Note: This id may be set equal to (a pointer to) an id on a participant elsewhere in the document (header or entries) or a new author participant can be described here. If the id is pointing to a participant already described elsewhere in the document, assignedAuthor/id is sufficient to identify this participant and none of the remaining details of assignedAuthor are required to be set. Application Software must be responsible for resolving the identifier back to its original object and then rendering the information in the correct place in the containing section's narrative text. This id must be a pointer to another author participant. If’ the ID isn't referencing an author described elsewhere in the document, then the author components required in US Realm Header are required here as well (CONF:1098-32628). This assignedAuthor SHOULD contain zero or one [0..1] code, which SHOULD be selected from ValueSet Healthcare Provider Taxonomy (HIPAA) urn:oid:2.16.840.1.114222.4.11.1066 DYNAMIC (CONF:1098-31671). i. If the content is patient authored the code SHOULD be selected from Personal And Legal Relationship Role Type (2.16.840.1.113883.11.20.12.1) (CONF:1098-32315). i. The representedOrganization, if present, MAY contain zero or more [0..*] id (CONF:1098-31478). ii. The representedOrganization, if present, MAY contain zero or more [0..*] name (CONF:1098-31479). The representedOrganization, if present, MAY contain zero or more [0..*] telecom (CONF:1098-31480). The representedOrganization, if present, MAY contain zero or more [0..*] addr (CONF:1098-31481).

Figure 4: Author Participation

Inclusion of an entry-level author is allowed in open entry templates in C-CDA where use of entry-level authors has not explicitly been prohibited. Its use is required on only one entry template, the Handoff Communication Participants template 2.16.840.1.113883.10.20.22.4.141.

^65 https://confluence.hl7.org/display/SEC/Basic+Provenance+Implementation+Guide ^66 http://www.hl7.org/ccdasearch/templates/2.16.840.1.113883.10.20.22.4.119.html.

C-CDA Content Creators MAY explicitly indicate the performer for observations and acts, not just the author who documents those activities. [BP-038]

#### Identifying Practitioners

The example below shows how to identify a practitioner playing the role of author, performer or other roles such at authenticator, legal authenticator. It shows how to represent the provider’s National Provider Identifier (NPI) number and his or her Direct Address. It also shows how to represent a provider Organization’s NPI number and Direct Address. It includes how to indicate the preferred telecom addresses for various forms of communication.

Example 13: How to represent a provider and the provider’s organization in the role of author

This representation pattern is applicable for other roles such as performer, authenticator, legal authenticator, etc. The example shows how to represent NPI information for the provider and for the provider organization. It also shows how to represent Direct address information and how to indicate the preferred telecom address to use.</br>

    <!-- an appropriate participation such as author/assignedAuthor -->
    <author>
        <time value="20180801095245-0400"/>
        <assignedAuthor>
            <!-- This is a public id where the root is registered to indicate the National Provider ID -->
    <id root="2.16.840.1.113883.4.6" extension="1417947383"
    assigningAuthorityName="National Provider ID"/>
    <!-- This is a public id where the root indicates this is a Provider Direct Address. -->
            <!-- root="1.3.6.1.4.1.41179.2.1" is the assigningAuthorityName for
    Direct Trust's Covered Entity addresses "DT.org CE" -->
            <id root="1.3.6.1.4.1.41179.2.1" extension="rvhs@rvhs.direct.md"
                assigningAuthorityName="DT.org CE (Covered Entity)"/>
            <addr>
                <streetAddressLine>823 Main Street</streetAddressLine>
                <city>River Valley</city>
                <state>RI</state>
                <postalCode>028321</postalCode>
                <country>US</country>
            </addr>
            <telecom use="WP" value="tel:+1-(401)539-4321"/>
            <!-- The provider's preferred Direct Address is the address identified with his practice. See
    below.-->
            <telecom use="WP" value="mailto:rvhs@rvhs.direct.md"/>
            <assignedPerson>
                <name>
                    <given>Terry</given>
                    <given>A</given>
                    <family>Manning</family>
                    <delimeter>, </delimeter>
                        <suffix>MD</suffix>
                </name>
            </assignedPerson>
            <representedOrganization>
                <id extension="334" root="1.3.6.1.4.1.22812.4.222.334"/>
                <!-- This is a public id where the root is registered to indicate the National Provider
    ID -->
                <!-- Based on context, this is the NPI of the organization -->
                <id root="2.16.840.1.113883.4.6" extension="9999999999"
                    assigningAuthorityName="National Provider ID"/>
                <!-- This is a public id where the root indicates this is a Provider Direct Address. -->
                <!-- root="1.3.6.1.4.1.41179.2.1" is the assigningAuthorityName for
    Direct Trust's Covered Entity addresses "DT.org CE" -->
                <id root="1.3.6.1.4.1.41179.2.1" extension="rvhs@rvhs.direct.md"
                    assigningAuthorityName="DT.org CE (Covered Entity)"/>
                <name>River View Health Services</name>
                <telecom use="WP" value="tel:+1-(401)539-4321"/>
                <telecom use="WP" value="mailto:rvhs@rvhs.direct.md"/>
                <addr>
                    <streetAddressLine>823 Main Street</streetAddressLine>
                    <city>River Valley</city>
                    <state>RI</state>
                    <postalCode>028321</postalCode>
                    <country>US</country>
                </addr>
            </representedOrganization>
        </assignedAuthor>
    </author>
    <!-- end of the appropriate role block -->

If a provider’s NPI number is not known, it can be represented using a nullFlavor of UNK. However, is it important to note the id’s populated with a nullFlavor cannot me used as a globally unique identifier.

Example 14: Provider with an unknown NPI number.

    <assignedAuthor>
        <!-- This is a public id where the root is registered to indicate the National Provider ID -->
    <!-- Use nullFlavor UNK if the provider’s NPI number is not known. -->
        <id root="2.16.840.1.113883.4.6" nullFlavor="UNK"
            assigningAuthorityName="National Provider ID"/>
        <!-- This is a public id where the root indicates this is a Provider Direct Address. -->
        <!-- root="1.3.6.1.4.1.41179.2.1" is the assigningAuthorityName for
    Direct Trust's Covered Entity addresses "DT.org CE" -->
        <id root="1.3.6.1.4.1.41179.2.1" extension="rvhs@rvhs.direct.md"
            assigningAuthorityName="DT.org CE (Covered Entity)"/>
        <addr>
            <streetAddressLine>823 Main Street</streetAddressLine>
            <city>River Valley</city>
            <state>RI</state>
            <postalCode>028321</postalCode>
            <country>US</country>
        </addr>
        <telecom use="WP" value="tel:+1-(401)539-4321"/>
        <!-- The provider's preferred Direct Address is the address identified with his practice. See
    below.-->
        <telecom use="WP" value="mailto:rvhs@rvhs.direct.md"/>
        <assignedPerson>
            <name>
                <given>Terry</given>
                <given>A</given>
                <family>Manning</family>
                <delimeter>, </delimeter>
                    <suffix>MD</suffix>
            </name>
        </assignedPerson>
    </assignedAuthor>

#### Custodian

Every CDA document has exactly one custodian. The custodian represents the organization who is in charge of maintaining the document. The custodian is the steward that is entrusted with the care of the document. The custodian participation satisfies the CDA definition of Stewardship.

#### Care Team Members

Recommendations for care team member representation in the header of documents are included below. This guidance aims to explain the options available for representation of care team members and clarify which care team members belong in the available header structures. Industry consensus has not been reached in this area.

However, implementers can help reduce variability in the representation of care team members by adopting these recommendations.

This guide also includes representation of care team members in a care team section template with structured entries. The care team section documents care team members involved in support of care provision and coordination for the patient. Business rules are used to determine which care team members are involved in the encounter or services represented and documented in the header. Care team members established in the header should be included in the care team section template as well as any others who are relevant to the patient’s care.

Reference: Care Team

Because of the variability of how care team members are represented in the header, and because there is a lack of normative guidance on which header items must be rendered, it is recommended that receiving systems should render ALL the participants in the header, rather than only rendering participants of a particular type. The CDA R2.1 Stylesheet supports complete participant rendering.^67

The term “care team member” encompasses any participant in the care of a patient. A patient’s care team may include individuals providing support to the patient, such as family members or caregivers, as well as physician providers and non-physician providers, including nurses, social workers, behavioral health specialists, community- based providers, technicians, and assistants. In fact, a patient may have more than one care team. Different care teams exist for different purposes and at different times.

When exchanging information about a care team member, it is recommended to capture the name, identification number, and contact information, along with codes to indicate the type of provider and the role he or she plays on the patient’s care team. These details help to distinguish care team members from different care settings and helps clarify who is involved in the patient’s care and in what ways.

Within CDA, care team members are represented as participants in elements of the document header and may be associated with the patient (i.e. guardian), the clinical encounter, and/or service event(s) detailed in the document, and the document itself. Applicable header elements for documenting care team members from Chapter 1.1 of the C- CDA Implementation Guide are described in the following table.

^67 HL7 CDA R2.1 Stylesheet. https://hl7.org/permalink/?CDAStyleSheet GitHub Project Folder.

Participant | Description
--- | ---
documentationOf/ serviceEvent/ performer | Care team member who performs the service event detailed in the document. Examples: PCP, surgeon, consulting physician
encompassingEncounter/ responsibleParty | Care team member who is responsible for the patient encounter described in the document. Examples: PCP, surgeon, consulting physician, home health nurse
recordTarget | The patient, his or herself, is considered a member of the Care team.
author | Care team member who documents events included in the documentation of the encounter or documentation of the provision of care over time. Example: PCP, surgeon, consulting physician, home health nurse
custodian | The steward of the document is likely an organization with a role on the patient’s care team, although not necessarily. Example: PCP practice, Hospital, home health agency, HIE
legalAuthenticator | Care team member who authenticates content contained in the document and accepts legal responsibility. Examples: PCP, consulting physician, attending physician
authenticator | Care team member who authenticates content contained in the document. Examples: PCP, consulting physician, attending physician
informationRecipient | Care team member who the document is intended for. Examples: PCP, caregiver, consulting physician
participant | Other supporting care team members associated with the patient. Examples: Caregiver, family member, emergency contact

Table 12: Header Elements for Care Team Members

In the header of an Encounter Summary, a care team member may be documented as fulfilling more than one responsibility. For example, a consulting physician who sees a patient in a clinical encounter may be:

1. the author of the Consultation Note,
2. the responsible party for the Encounter (rendering physician), or
3. the authenticator (physician attesting to the human readable content in the document).

The physician also may be the person who legally authenticates the information contained in the document. In this example, the consulting physician is participating as the encompassingEncounter/responsibleParty, the author, the authenticator and the legalAuthenticator.

In the header of a Patient Summary, it is most common to see care team members identified in the documentationOf/serviceEvent as performers who were involved in the provision of care for the patient during the range of time covered by the summary. Again, depending on the use case behind how the Patient Summary is generated, care team members also may be documented in other roles such as the author, the authenticator and the legalAuthenticator.

Semantically, the actRelationships hold the key data elements for documenting Care Team members in the header. These are the data elements that tell who was responsible for the patient encounter and who was responsible for performing care services.

For Encounter Summary documents, C-CDA Content Creators SHALL document the provider who is responsible for the encounter in the componentOf/encompassingEncounter/responsibleParty. [BP-039]
For Patient Summary documents, C-CDA Content Creators SHALL document providers who played the role of Primary Care Provider for the patient during the range of time covered in the summary using the documentationOf/serviceEvent/performer. [BP-040]
C-CDA Content Creators SHALL populate the functionCode element with the provider’s or person’s role on the patient’s care team. Coded concepts for the functionCode SHALL be selected from the Care Team Member Function value set (2.16.840.1.113762.1.4.1099.30). [BP-041]

Reference: Care Team

#### sdtc:signatureText in Authenticator and legalAuthenticator

Sharing clinical documents with payers is an emerging use case for C-CDA. To meet the needs of this use case, document authentication and signing of C-CDA documents needs to be addressed.

The HL7 CDA R2 Attachment IG: Exchange of C-CDA Based Documents, R1 – US Realm explains, “The legalAuthenticator is recorded in ClinicalDocument.legalAuthenticator, and represents a participant who has legally authenticated the document. Authenticators are recorded in ClinicalDocument.authenticator, and each authenticator represents a participant who has attested to the accuracy of the document, but who does not have privileges to legally authenticate the document. An example would be a resident physician who sees a patient and dictates a note, then later signs it.”^68

It further includes these conformance requirements^69:

All documents SHALL have a legalAuthenticator. In the case of generated summary documents, institutions may meet the requirement for a Legal Authenticator by extending the practice of maintaining a “Signature on File”. The person, entity, organization, role, etc. indicated is responsible for the contents of the note where it is understood that this Legal Authenticator is not an author of the document. Policy for determining who is responsible for legal authentication of the summary document rests with the originating organization. In real-world exchange, organizations and roles are being used as legalAuthenticators; this is consistent with the CDA base standard. [AIGEX-HD4]
All documents that contain sdtc:signatureText, SHALL conform to the HL7 Digital Signatures and Delegation of Rights Implementation Guide R1. [AIGEX-HD7]

The HL7 Digital Signatures and Delegation of Rights Implementation Guide R1 defines the standards for digitally signing C-CDA documents.

C-CDA Content Creators MAY include the sdtc:signatureText extension for Authenticators and LegalAuthenticators. [BP-042]
C-CDA Content Consumers MAY render certificate information associated with digital signed C-CDA Documents when rendering the document. [BP-043]

#### Context of Care

As focus has shifted from using C-CDA to exchange Patient Summary documents to using C-CDA to exchange Encounter Summaries, new guidance is needed to clarify expectations for populating the actRelationships present

in the header. In a Patient Summary, the documentationOf/serviceEvent holds the key information about the range of time covered by the document and the key providers involved in the provision of the summarized care.

In an Encounter Summary, the header needs to capture the context of care for a particular encounter.

#### Encompassing Encounter

In an Encounter Summary, C-CDA Content Creators SHALL populate the encompassingEncounter/effectiveTime and the encompassingEncounter/location/healthCareFacility/serviceProviderOrganization and the encompassingEncounter/responsibleParty/assignedEntity. [CONF-044]

#### Service Events

In an Encounter Summary, C-CDA Content Creators MAY populate the documentationOf/serviceEvent, including the serviceEvent/effectiveTime, serviceEvent/code, and serviceEvent/performer(s). [BP-045]
In a Patient Summary, C-CDA Content Creators SHALL populate the documentationOf/serviceEvent based on conformance requirements of the C-CDA R2.1 specification for CCD documents. [CONF-046]

#### Orders Fulfilled

If an Encounter occurred as a result of a previously placed order (e.g., a visit to perform an MRI), the id of that order should be provided as context for the Encounter.

In an Encounter Summary, C-CDA Content Creators SHOULD populate the infulfillmentOf/order and the infulfillmentOf/order/id element where the order/id references the id of a previously placed order. [BP-047]
The Order Fulfilled area of the header MAY carry information about fulfilled orders, rereferrals or other requests that have been fulfilled. [BP-048]

#### Related Parent Document

The ParentDocument represents the source of a document revision, addendum, or transformation. The relatedDocument/parentDocument/id element is a mechanism used to link a revised, addendum, or transformed document to its original source document. There are many situations where a document may be updated. For example, a pending laboratory result or a missing note may trigger an update. The base CDA standard provides this mechanism to replace or append a previously sent document through the parentDocument relationship.

C- CDA Content Creators cannot know with certainty what documents a Content Consumer has previously stored. Therefore, it always is preferable for Content Creators to send a complete document that replaces a prior document rather than sending an addendum to a prior document. Indicate the parent document is being replaced by using a replace relationship (typeCode=”RPLC”).

C-CDA Content Creators SHOULD populate the ClinicalDocument/relatedDocument using @typeCode="RPLC" when a document replaces a prior document. [BP-049]

Example 15: Replacement Discharge Summary Document with Hospital Course Added

    <ClinicalDocument> <realmCode code="US">
        <typeId root="2.16.840.1.113883.1.3" extension="POCD_HD000040"/>
        <templateId root="2.16.840.1.113883.10.20.22.1.1" extension="2015-08- 01" >
            <templateId root="2.16.840.1.113883.10.20.22.1.8" extension="2015-08- 01" >
                <id root="2.16.840.1.113883.19.5.99999.1" extension="20160414145050">
                    <code codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" code="18842-5"
                        displayName="Discharge Summary" />
                    <title>Health Summary</title>
                    <effectiveTime value="20160414145050-0500">
                        <confidentialityCode codeSystem="2.16.840.1.113883.5.25" code="N">
                            <languageCode code="en-US">
                                <setId extension="20160414014447" root="2.16.840.1.113883.19.5.99999.19" I>
                                    <versionNumber value="2">
                                        <relatedDocument typeCode="RPLC"›
                                            <parentDocument> <id root="2.16.840.1.113883.19.5.99999.1" extension="20160414014447">
                                                <code codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" code="18842-5"
                                                    displayName="Discharge Summary" I>
                                                    <setId extension="20160414014447" root="2.16.840.1.113883.19.5.99999.19">
                                                        <versionNumber value="1"> </parentDocument>
                                        </relatedDocument>
                                        <section>
                                            <templateId root="1.3.6.1.4.1.19376.1.5.3.1.3.5"/>
                                            <code code="8648-8" displayName="HOSPITAL COURSE" codeSystem="2.16.840.1.113883.6.1"
                                                codeSystemName="LOINC"/>
                                            <title>Hospital Course</title>
                                            <text>The patient was admitted
                                            </text>

Reference: Content Creator Responsibilities

#### C-CDA R2.1 Document Templates

While all C-CDA documents share a common US Realm Header template, the C-CDA R2.1 implementation guide defines distinct types of document templates for exchanging different types of clinical notes.

Document-level templates describe the purpose and rules for constructing a conforming CDA document. Document templates include constraints on the CDA header and indicate contained section-level templates.

Each document-level template contains the following information:

- Scope and intended use of the document type.
- Description and explanatory narrative.
- Template metadata ( e.g., templateId).
- Header constraints ( e.g. , document type, template id, participants)
- Required and optional section-level templates.

Templates for structured documents (those that include a structuredBody) also define required and optional section-level templates.

All section-level templates include human readable narrative that conveys the information in that section. CDA calls this the Narrative Block. Each section-level template also includes:

- Scope and intended use within a document.
- Description and explanatory narrative.
- Template metadata ( e.g., templateId).

Page 65 HL7 CDA® R2 IG: C-CDA Templates for Clinical Notes STU Companion Guide, Release 4 - US Realm

The section may also define required and optional entry-level templates. Entry-level templates are structures for representing the information in the Narrative Block using machine representations that facilitates computerized information processing.

The table below describes the various document types defined by C-CDA R2.1 for use in representing clinical notes as structured documents that facilitate digital information exchange.

Document-Level Templates for Representing Clinical Notes as Structured Documents^73 | Description
--- | ---
Care Plan | A Care Plan (including Home Health Plan of Care [HHPoC]) is a consensus-driven dynamic plan that represents a patient’s and Care Team Members’ prioritized concerns, goals, and planned interventions. The CDA Care Plan represents an instance of this dynamic Care Plan at a point in time. The CDA document itself is NOT dynamic.
Consultation Note | The Consultation Note is generated by a request from a clinician for an opinion or advice from another clinician.
Continuity of Care Document (CCD) | The Continuity of Care Document (CCD) represents a core data set of the most relevant administrative, demographic, and clinical information facts about a patient’s healthcare, covering one or more healthcare encounters. It provides a means for one healthcare practitioner, system, or setting to aggregate all of the pertinent data about a patient and forward it to another to support the continuity of care.
Diagnostic Imaging Report | A Diagnostic Imaging Report (DIR) is a document that contains a consulting specialist’s interpretation of image data. It conveys the interpretation to the referring (ordering) physician and becomes part of the patient’s medical record. It is for use in Radiology, Endoscopy, Cardiology, and other imaging specialties.
Discharge Summary | The Discharge Summary is a document which synopsizes a patient’s admission to a hospital, LTPAC provider, or other setting. It provides information for the continuation of care following discharge.
History and Physical | A History and Physical (H&P) Note is a medical report that documents the current and past conditions of the patient. It contains essential information that helps determine an individual’s health status.
Operative Note | The Operative Note is a frequently used type of procedure note with specific requirements set forth by regulatory agencies. The Operative Note is created immediately following a surgical or other high-risk procedure. It records the pre- and post-surgical diagnosis, pertinent events of the procedure, as well as the condition of the patient following the procedure.
Progress Note | This template represents a patient’s clinical status during a hospitalization, outpatient visit, treatment with a LTPAC provider, or other healthcare encounter.
Procedure Note | This template encompasses many types of non-operative procedures including interventional cardiology, gastrointestinal endoscopy, osteopathic manipulation, and many other specialty fields. Procedure Notes are differentiated from Operative Notes because they do not involve incision or excision as the primary act.
Referral Note | A Referral Note communicates pertinent information from a provider who is requesting services of another provider of clinical or non-clinical services.
Transfer Summary | The Transfer Summary standardizes critical information for exchange of information between providers of care when a patient moves between health care settings.

Table 13: C-CDA R2.1 Document-Level Templates for Representing Clinical Notes as Structured Documents

Reference: Section Level Guidance, Representation of Discrete Data

The table below describes the document template defined by C-CDA R2.1 for use in representing clinical notes as an unstructured document that facilitates digital information exchange.

Document Templates for Unstructured Clinical Notes | Description
--- | ---
Unstructured Document | An Unstructured Document (UD) document type can (1) include unstructured content, such as a graphic, directly in a text element with a mediaType attribute, or (2) reference a single document file, such as a word-processing document using a text/reference element.

Table 14: Document Templates of Unstructured Clinical Notes

The C-CDA R2.1 Unstructured Document template defines a C-CDA document with a structured header and a non- XML body. This template is used to convey information as an embedded object or referenced file. It may be appropriate for use cases where the exchange of clinical information does not require structured representation of the content. Simply having the structured header information may be beneficial for information exchange.

When the content to be exchanged does not have structured document templates defined in C-CDA, such as for Laboratory Report Narrative or Pathology Report Narrative, the Unstructured Document template can be used to represent the clinical note information.

C-CDA Content Creators MAY support the Unstructured Document template for representing clinical note types when the type of clinical note to be exchanged does not have an appropriate structured document template or when it is not possible for the C-CDA Content Creator to represent the clinical note information using a structured document template. [BP-050]

#### Further Constraints on C-CDA Documents

#### Nutrition-focused Constraints on C-CDA Documents

The table below identifies a supplemental document template defined to further constrain the C-CDA Care Plan document template when exchanging nutrition care plan information.^74

Care Plan Summary Documents | Description
--- | ---
Care Plan (Nutrition) 2.16.840.1.113883.10.20.22.1.16:2017-12-01 | This template is for supplemental use in a C-CDA Care Plan document. The Care Plan (Nutrition) standardizes documentation of information gathered and developed through the process of the Nutrition Care Process (NCP). The four steps in the NCP align with sections in a Care Plan (Nutrition) document. This template further constrains the C-CDA R2.1 Care Plan document-level template.

Table 15: Care Plan (Nutrition)

### Section Structure by Document Type

The following tables describe the required and optional section templates for each document type defined in C- CDA.^75 They include sections that support best practices for representing emerging data for exchange such as Patient Goals and Health Concerns.

Transition of Care C-CDA Documents SHALL include a Health Concerns section and a Goals Section. [CONF-051]

#### Care Plan: Document Template

A Care Plan (including Home Health Plan of Care (HHPoC)) is a consensus-driven dynamic plan that represents a patient’s and Care Team Members’ prioritized concerns, goals, and planned interventions. It serves as a blueprint shared by all Care Team Members (including the patient, their caregivers and providers), to guide the patient’s care. A Care Plan integrates multiple interventions proposed by multiple providers and disciplines for multiple conditions.

A Care Plan represents one or more Plan(s) of Care and serves to reconcile and resolve conflicts between the various Plans of Care developed for a specific patient by different providers. While both a plan of care and a care plan include the patient’s life goals and require Care Team Members (including patients) to prioritize goals and interventions, the reconciliation process becomes more complex as the number of plans of care increases. The Care Plan also serves to enable longitudinal coordination of care.

The CDA Care Plan represents an instance of this dynamic Care Plan at a point in time. The CDA document itself is NOT dynamic.

This document template enables Care Plan information to be shared in a way that includes:

- The ability to identify patient and provider priorities with each act.
- A header participant to indicate occurrences of Care Plan review.

A Care Plan document can include entry references from the information in these sections to the information (entries) in other sections. Volume 1 of the C-CDA R2.1 implementation guide includes of a Care Plan Relationship diagram and a story board to explain its use.

#### Structured Sections

The table below describes the required and optional sections in a Care Plan document template: Care Plan [ClinicalDocument: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.1.15:2015-08-01 (open)]

Document Type | Required Sections | Optional Sections
--- | --- | ---
Care Plan | Health Concerns Section Goals Section | Activities Section Health Status Evaluations and Outcomes Section
Sample | CarePlan.xml Sample | Included with this Companion Guide

Table 16: Care Plan: Document Template.

#### Consultation Note: Document Template

The Consultation Note is generated by a request from a clinician for an opinion or advice from another clinician. Consultations may involve face-to-face time with the patient or may fall under the auspices of telemedicine visits. Consultations may occur while the patient is inpatient or ambulatory. The Consultation Note should also be used to summarize an Emergency Room or Urgent Care encounter. A Consultation Note includes the reason for the referral, history of present illness, physical examination, and decision-making components (Assessment and Plan).

#### Structured Sections

The table below describes the required and optional sections in a Consultation Note document template: Consultation Note[ClinicalDocument: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.1.4:2015- 08 -01 (open)]

Document Type | Required Sections | Optional Sections
--- | --- | ---
Consultation Note | History of Present Illness Section Allergies and Intolerances Section Problem Section | Assessment Section Assessment and Plan Section Plan of Treatment Section Reason for Visit Section Physical Exam Section Chief Complaint Section Chief Complaint and Reason for Visit Section Family History Section General Status Section Past Medical History Immunizations Section Medications Section Procedures Section Results Section Social History Section Vital Signs Section Functional Status Section Review of Systems Section Medical Equipment Section

Table 17: Consultation Note: Document Template.

#### Continuity of Care Document (CCD): Document Template

The Continuity of Care Document (CCD) was originally based on the Continuity of Care Document (CCD) Release 1.1 which itself was derived from HITSP C32 and CCD Release 1.0. The Continuity of Care Document (CCD) represents a core data set of the most relevant administrative, demographic, and clinical information facts about a patient’s healthcare, covering one or more healthcare encounters. It provides a means for one healthcare practitioner, system, or setting to aggregate all of the pertinent data about a patient and forward it to another to support the continuity of care. The primary use case for the CCD is to provide a snapshot in time containing the germane clinical, demographic, and administrative data for a specific patient. The key characteristic of a CCD is that the ServiceEvent is constrained to “PCPR” “care provision.” This means that the contents of the document reflect the care that was actually provided within the time range indicated in serviceEvent.effectiveTime range. It reports on care that has already been provided. The CCD provides a historical tally of the care over a range of time and is not a record of new services delivered. More specific use cases, such as a Discharge Summary, Transfer Summary, Referral Note, Consultation Note, or Progress Note, are available as alternative documents in this guide.

#### Structured Sections

The table below describes the required and optional sections in a Continuity of Care Document document template: Continuity of Care Document (CCD) [ClinicalDocument: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.1.2:2015- 08 -01 (open)]

Document Type | Required Sections | Optional Sections
--- | --- | ---
Continuity of Care Document (CCD) | Allergies and Intolerances Section Medications Section Problem Section Results Section Social History Section Vital Signs Section | Procedures Section Encounters Section Family History Section Functional Status Section Immunizations Section Medical Equipment Section Payers Section Plan of Treatment Section Mental Status Section Nutrition Section Advance Directives Section Goals Section Health Concerns Section

Table 18: Continuity of Care Document: Document Template.

#### Discharge Summary: Document Template

The Discharge Summary is a document which synopsizes a patient’s admission to a hospital, LTPAC provider, or other setting. It provides information for the continuation of care following discharge. The Joint Commission requires the following information to be included in the Discharge Summary:

- Reason for hospitalization (the admission)
- Procedures performed, as applicable
- Care, treatment, and services provided
- Patient’s condition and disposition at discharge
- Information provided to the patient and family
- Provisions for follow-up care

The best practice for a Discharge Summary is to include the discharge disposition in the display of the header.

#### Structured Sections

The table below describes the required and optional sections in a Discharge Summary document template: Discharge Summary[ClinicalDocument: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.1.8:2015- 08 -01 (open)]

Document Type | Required Sections | Optional Sections
--- | --- | ---
Discharge Summary | Allergies and Intolerances SectionHospital Course Section Discharge Diagnosis Section Plan of Treatment Section (DIR) | Discharge Medications Section Chief Complaint Section Chief Complaint and Reason for Visit Section Nutrition Section Family History Section Functional Status Section Past Medical History History of Present Illness Section Admission Diagnosis Section Admission Medications Section Hospital Consultations Section Hospital Discharge Instructions Section Hospital Discharge Studies Summary Section Immunizations Section Procedures Section Reason for Visit Section Review of Systems Section Social History Section Vital Signs Section Discharge Medications Section Goals Section Health Concerns Section
Example | DischargeSummary.xml Sample | Included with this Companion Guide

Table 20: Discharge Summary: Document Template.

#### History and Physical: Document Template

A History and Physical (H&P) Note is a medical report that documents the current and past conditions of the patient. It contains essential information that helps determine an individual’s health status. The first portion of the report is a current collection of organized information unique to an individual. This is typically supplied by the patient or the caregiver, concerning the current medical problem or the reason for the patient encounter. This information is followed by a description of any past or ongoing medical issues, including current medications and allergies. Information is also obtained about the patient’s lifestyle, habits, and diseases among family members. The next portion of the report contains information obtained by physically examining the patient and gathering diagnostic information in the form of laboratory tests, imaging, or other diagnostic procedures. The report ends with the clinician’s assessment of the patient’s situation and the intended plan to address those issues. A History and Physical Examination is required upon hospital admission as well as before operative procedures. An initial evaluation in an ambulatory setting is often documented in the form of an H&P Note.

#### Structured Sections

The table below describes the required and optional sections in a History and Physical document template: History and Physical[ClinicalDocument: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.1.3:2015- 08 -01 (open)]

Document Type | Required Sections | Optional Sections
--- | --- | ---
History and Physical | Allergies and Intolerances SectionFamily History Section General Status Section Past Medical History Medications Section Physical Exam Section Results Section Review of Systems Section Social History Section Vital Signs Section | Assessment Section Plan of Treatment Section Assessment and Plan Section Chief Complaint Section Chief Complaint and Reason for Visit Section History of Present Illness Section Immunizations Section Instructions Section Problem Section Procedures Section Reason for Visit Section

Table 21: History and Physical: Document Template.

#### Operative Note: Document Template

The Operative Note is a frequently used type of procedure note with specific requirements set forth by regulatory agencies. The Operative Note is created immediately following a surgical or other high-risk procedure. It records the pre- and post-surgical diagnosis, pertinent events of the procedure, as well as the condition of the patient following the procedure. The report should be sufficiently detailed to support the diagnoses, justify the treatment, document the course of the procedure, and provide continuity of care.

#### Structured Sections

The table below describes the required and optional sections in an Operative Note document template: Operative Note[ClinicalDocument: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.1.7:2015- 08 -01 (open)]

Document Type | Required Sections | Optional Sections
--- | --- | ---
Operative Note | Anesthesia SectionComplications Section Preoperative Diagnosis Section Procedure Estimated Blood Loss Section Procedure Findings Section Procedure Specimens Taken Section Procedure Description Section Postoperative Diagnosis Section | Procedure Implants Section Operative Note Fluids Section Operative Note Surgical Procedure Section Plan of Treatment Section Planned Procedure Section Procedure Disposition Section Procedure Indications Section Surgical Drains Section

Table 22 Operative Note: Document Template.

#### Procedure Note: Document Template

A Procedure Note encompasses many types of non-operative procedures including interventional cardiology, gastrointestinal endoscopy, osteopathic manipulation, and many other specialty fields. Procedure Notes are differentiated from Operative Notes because they do not involve incision or excision as the primary act. The Procedure Note is created immediately following a non-operative procedure. It records the indications for the procedure and, when applicable, post-procedure diagnosis, pertinent events of the procedure, and the patient’s tolerance for the procedure. It should be detailed enough to justify the procedure, describe the course of the procedure, and provide continuity of care.

#### Structured Sections

The table below describes the required and optional sections in a Procedure Note document template: Procedure Note[ClinicalDocument: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.1.6:2015- 08 -01 (open)]

Document Type | Required Sections | Optional Sections
--- | --- | ---
Procedure Note | Complications Section Procedure Description Section Procedure Indications Section Postprocedure Diagnosis Section | Assessment Section Assessment and Plan Section Plan of Treatment Section Allergies and Intolerances Section Anesthesia Section Chief Complaint Section Chief Complaint and Reason for Visit Section Family History Section Past Medical History History of Present Illness Section Medical (General) History Section Medications Section Medications Administered Section Physical Exam Section Planned Procedure Section Procedure Disposition Section Procedure Estimated Blood Loss Section Procedure Findings Section Procedure Implants Section Procedure Specimens Taken Section Procedures Section Reason for Visit Section Review of Systems Section Social History Section

Table 23: Procedure Note: Document Template.

#### Progress Note: Document Template

The Progress Note represents a patient’s clinical status during a hospitalization, outpatient visit, treatment with a LTPAC provider, or other healthcare encounter. Taber’s medical dictionary defines a Progress Note as “An ongoing record of a patient’s illness and treatment. Physicians, nurses, consultants, and therapists record their notes concerning the progress or lack of progress made by the patient between the time of the previous note and the most recent note.” Mosby’s medical dictionary defines a Progress Note as “Notes made by a nurse, physician, social worker, physical therapist, and other health care professionals that describe the patient’s condition and the treatment given or planned.”^78 A Progress Note is not a re-evaluation note. A Progress Note is not intended to be a Progress Report for Medicare. Medicare B Section 1833(e) defines the requirements of a Medicare Progress Report.

#### Structured Sections

The table below describes the required and optional sections in a Progress Note document template: Progress Note[ClinicalDocument: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.1.9:2015- 08 -01 (open)]

Document Type | Required Sections | Optional Sections
--- | --- | ---
Progress Note |  | Assessment Section Plan of Treatment Section Assessment and Plan Section Allergies and Intolerances Section Chief Complaint Section Activities Section Instructions Section Medications Section Objective Section Physical Exam Section Problem Section Results Section Review of Systems Section Subjective Section Vital Signs Section Nutrition Section
Example | ProgressNote.xml Sample | Included with this Companion Guide

Table 24 Progress Note: Document Template.

^78 Mosby’s Medical Dictionary. 9th ed. St. Louis, MO: Mosby Elsevier, 2013. Print.

#### Referral Note: Document Template

A Referral Note communicates pertinent information from a provider who is requesting services of another provider of clinical or non-clinical services which includes the reason for the referral and additional information that would augment decision making and care delivery. Examples of referral situations include when a patient is:

- Referred from a family physician to a cardiologist for cardiac evaluation.
- Sent by a cardiologist to an emergency department for angina.
- Referred by a nurse practitioner to an audiologist for hearing screening.
- Referred by a hospitalist to social services.

#### Structured Sections

The table below describes the required and optional sections in a Referral Note document template: Referral Note [ClinicalDocument: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.1.14:2015- 08 -01 (open)]

Document Type | Required Sections | Optional Sections
--- | --- | ---
Referral Note | Problem Section Allergies and Intolerances Section Medications Section Reason for Referral Section | Plan of Treatment Section History of Present Illness Section Family History Section Immunizations Section Procedures Section Results Section Review of Systems Section Social History Section Vital Signs SectionFunctional Status Section Physical Exam Section Nutrition Section Mental Status Section Medical Equipment Section Assessment Section Assessment and Plan Section Past Medical History General Status Section Advance Directives Section Health Concerns Section Goals Section
Example | ReferralNote.xml Sample | Included with this Companion Guide

Table 25: Referral Note: Document Template.

#### Transfer Summary: Document Template

The Transfer Summary template describes constraints on the Clinical Document Architecture (CDA) header and body elements for a Transfer Summary. The Transfer Summary standardizes critical information for exchange of information between providers of care when a patient moves between health care settings. Standardization of information used in this form will promote interoperability; create information suitable for reuse in quality measurement, public health, research, and for reimbursement.

#### Structured Sections

The table below describes the required and optional sections in a Transfer Summary document template Transfer Summary[ClinicalDocument: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.1.13:2015-08-01 (open)]

Document Type | Required Sections | Optional Sections
--- | --- | ---
Transfer Summary | Allergies and Intolerances Section Medications Section Problem Section Results Section Vital Signs Section Reason for Referral Section | Physical Exam Section Encounters Section Family History Section Functional Status Section Discharge Diagnosis Section Immunizations Section Medical Equipment Section Payers Section Plan of Treatment Section Procedures Section Social History Section Mental Status Section General Status Section Review of Systems Section Nutrition Section Past Medical History History of Present Illness Section Assessment and Plan Section Assessment Section Admission Medications Section Admission Diagnosis Section Course of Care Section

Table 26: Transfer Summary: Document Template.

#### Other Section-Level Templates Available for Use in C-CDA Documents

As the library of available CDA templates grows and implementers become more experienced using the standard, implementers may use templates developed in other CDA implementation guides which are compatible with C- CDA. Employing additional C-CDA compatible templates within existing document types will expand the range of interoperable information available for exchange and help address emerging use cases for data exchange.

C-CDA Content Creators MAY include in existing C-CDA documents, other C-CDA compatible section- level templates defined in other implementation guides. [BP-052]

A C-CDA compatible template is a template that further constrains a template defined in C- CDA R2.1 or a template that does not conflict with templates defined in C-CDA. Determining if a template is C-CDA compliant may require human discernment and consensus building within the C-CDA implementer community. A particularly important collection of C-CDA compatible templates is the Supplemental Implementation Guides, which define new template versions and templates for additional use cases. These Supplemental Implementation Guides are published alongside the main C-CDA specification: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=492

The Joint Document Content Work Group recommends all sections include the Section Time Range Observation to describe the range of time used to limit the range of information contained in a section.^79

Reference: Declaring Business Rules that Limit Section Content; Specifying Time Intervals for Sections with Limits;

The Joint Document Content Work Group also recommends use of the Progress Note document template to represent an encounter summary for a non-inpatient setting.^80 The Progress Note document template does not include any required sections and the open nature of the template enables Content Creators to include the right sections to express the source data or the needed sections to satisfy the requirements of Content Consumers.

C-CDA Content Creators MAY support further constraints on the document templates defined in C-CDA R2.1. [BP-053]

^79 Joint Content Workgroup IG. Chapter 2.1.1 Section Time Range Observation. ^80 Joint Content Workgroup IG. Chapter 2.2 Outpatient/Ambulatory Summary (Progress Note Document)