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1 CDA Overview

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2 Introduction to CDA Technical Artifacts

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3 CDA Document Exchange in HL7 Messages

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4 CDA Templating

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5 CDA Design

5.1 Clinical Document

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5.2 Header

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5.3 Body

5.3.1 Body Choice

The CDA body choice can be either a document body in a format other than XML, or the CDA structured body. Every CDA document has exactly one body, associated with the ClinicalDocument class through the component relationship.

5.3.1.1 component

The component class relates the ClinicalDocument header to the body choice; NonXMLBody or StructuredBody.

Table X: documentationOf Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	DOC	Fixed
contextConductionInd	BL	[0..1]

component.typeCode

The component.typeCode is fixed to "COMP", which indicates that the body is a component part of the StructuredDocument.

Table X: Fixed component.typeCode

Code	Display Name
COMP	has component
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

component.contextConductionInd

The component.contextConductionInd indicator is fixed to "true". Ancestor elements () which propagate, will conduct through this component class to the associated child element.

5.3.1.2 NonXMLBody

The NonXMLBody class represents a document body that is in some format other than XML. The NonXMLBody can be used to represent scanned document(s) or legacy document(s) needing to be transferred using the CDA standard.

Table X: NonXMLBody Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	DOCCLIN	Fixed
moodCode	CS	[0..1]	EVN	Fixed
text	ED	[1..1]
confidentialityCode	SET<CE>	[0..*]	V:x_BasicConfidentialityKind	Open
languageCode	CS	[0..1]	D:HumanLanguage	Closed

NonXMLBody.typeCode

The ClinicalDocument.classCode in the CDA model is fixed to "DOCCLIN".

Table X: Fixed NonXMLBody.classCode

Code	Display Name
DOCBODY	document body
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

NonXMLBody.moodCode

The NonXMLBody.moodCode is fixed to "EVN" or event mood to indicate that this is documentation of a past service.

Table X: Fixed NonXMLBody.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

NonXMLBody.text

NonXMLBody.text is used to reference data that is stored externally to the CDA document or to encode the data directly inline. Rendering a referenced non-XML body requires a software tool that recognizes the particular MIME media type for this type of body.

NonXMLBody.confidentialityCode

Confidentiality is a required contextual component of CDA, where the value expressed in the ClinicalDocument can be overridden for the NonXMLBody of the document.

Table X: Value set for NonXMLBody.confidentialityCode

X_BasicConfidentialityKind [2.16.840.1.113883.1.11.16926] (OPEN)
Code	Display Name		Code	Display Name
N	normal		R	restricted
V	very restricted
Code System: Confidentiality (HL7) Code System OID: 2.16.840.1.113883.5.25

‡ The codeSystem value is included here because confidentialityCode is of type CE, and therefore must carry both a code and a codeSystem.

NonXMLBody.languageCode

Specifies the human language of character data (whether they be in contents or attribute values). The values of the attribute are language identifiers as defined by the IETF (Internet Engineering Task Force) RFC 3066 for the Identification of Languages, ed. H. Alvestrand. 1995, which obsoletes RFC 1766. The HL7 code system for these values is "2.16.840.1.113883.6.121". Language is a contextual component of CDA, where the value expressed in the header holds true for the entire document, unless overridden by the NonXMLBody (see CDA Context (§ 5.4)).

5.3.1.3 StructuredBody

The StructuredBody class represents a CDA document body that is comprised of one or more document sections.

Table X: StructuredBody Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	DOCCLIN	Fixed
moodCode	CS	[0..1]	EVN	Fixed
confidentialityCode	SET<CE>	[0..*]	V:x_BasicConfidentialityKind	Open
languageCode	CS	[0..1]	D:HumanLanguage	Closed

StructuredBody.classCode

Table X: Fixed StructuredBody.classCode

Code	Display Name
DOCBODY	document body
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

StructuredBody.moodCode

Table X: Fixed StructuredBody.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

StructuredBody.confidentialityCode

Table X: Value set for StructuredBody.confidentialityCode

X_BasicConfidentialityKind [2.16.840.1.113883.1.11.16926] (OPEN)
Code	Display Name		Code	Display Name
N	normal		R	restricted
V	very restricted
Code System: Confidentiality (HL7) Code System OID: 2.16.840.1.113883.5.25

‡ The codeSystem value is included here because confidentialityCode is of type CE, and therefore must carry both a code and a codeSystem.

StructuredBody.languageCode

Specifies the human language of character data (whether they be in contents or attribute values). The values of the attribute are language identifiers as defined by the IETF (Internet Engineering Task Force) RFC 3066: Tags for the Identification of Languages, ed. H. Alvestrand. 1995 , which obsoletes RFC 1766. The HL7 code system for these values is "2.16.840.1.113883.6.121".

A value for StructuredBody.languageCode overrides the value propagated from the header (see CDA Context (§ 5.4) for more details).

5.3.1.3.1 component @a@

A component class is used to relate the body choice (NonXMLBody, StructuredBody) to it's component Section(s) (see component (§ 5.3.1.1) for modeling).

5.3.2 Section Attributes

Section

Document sections can nest, can override context propagated from the header, and can contain narrative and CDA entries (see CDA Context (§ 5.4)).

Table X: Section Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	DOCSECT	Fixed
moodCode	CS	[0..1]	EVN	Fixed
id	II	[0..1]
code	CE	[1..1]	D:DocumentSectionType	Open
title	ST	[0..1]
text	ED.STRUCTURED_TEXT	[0..1]
confidentialityCode	SET<CE>	[0..*]	V:x_BasicConfidentialityKind	Open
languageCode	CS	[0..1]	D:HumanLanguage	Closed

NOTE: XML ID Attribute added. For more information, see ID/IDREF discussion in Section Narrative Block (§ 5.3.5).

Section.classCode

The Section.classCode is fixed to "DOCSECT", which represents a context that subdivides the body of a document. Document sections are typically used for human navigation, to give a reader a clue as to the expected content. Document sections are used to organize and provide consistency to the contents of a document body. Document sections can contain document sections and can contain entries.

Table X: Fixed Section.classCode

Code	Display Name
DOCSECT	document section
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Section.moodCode

The Section.moodCode is fixed to "EVN" (event) which indicates the section is about a service that actually happens, may be an ongoing service or a documentation of a past service.

Table X: Fixed Section.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

Section.id

The unique instance identifier of a particular document section.

Section.code

The code specifying the particular kind of section (e.g. Chief Complaint, Review of Systems, Assessment). The value set is drawn from LOINC in the US Realm, but has an OPEN binding to enable other coding systems in other realms.

Section.title

Represents the label of a section. If valued, it is to be rendered as part of the narrative content of the clinical document body.

Section.text

Used to store narrative to be rendered. Also referred to as the CDA Narrative Block (see Section Narrative Block (§ 5.3.5) for details).

Section.confidentialityCode

A value for Section.confidentialityCode overrides the value propagated from StructuredBody (see CDA Context (§ 5.4) for more details.

Table X: Value set for Section.confidentialityCode

X_BasicConfidentialityKind [2.16.840.1.113883.1.11.16926] (OPEN)
Code	Display Name		Code	Display Name
N	normal		R	restricted
V	very restricted
Code System: Confidentiality (HL7) Code System OID: 2.16.840.1.113883.5.25

‡ The codeSystem value is included here because confidentialityCode is of type CE, and therefore must carry both a code and a codeSystem.

Section.languageCode

Specifies the human language of character data (whether they be in contents or attribute values). The values of the attribute are language identifiers as defined by the IETF (Internet Engineering Task Force) RFC 3066: Tags for the Identification of Languages, ed. H. Alvestrand. 1995 , which obsoletes RFC 1766. The HL7 code system for these values is "2.16.840.1.113883.6.121".

A value for Section.languageCode overrides the value propagated from StructuredBody (see CDA Context (§ 5.4) for more details).

5.3.3 Section Participants

5.3.3.1 author @a@

The author participant (see author (§ 5.2.2.2)), can be ascribed to a CDA section, where it overrides the value(s) propagated from the CDA header.

5.3.3.2 informant @a@

The informant participant (see informant (§ 5.2.2.6)), can be ascribed to a CDA section where it overrides the value(s) propagated from the CDA header.

5.3.3.3 subject

The subject participant represents the primary target of the entries recorded in the document. Most of the time the subject is the same as the recordTarget (see recordTarget (§ 5.2.2.11)), but need not be, for instance when the subject is a fetus observed in an obstetrical ultrasound.

The subject participant can be ascribed to a CDA section or a CDA entry. It propagates to nested components, unless overridden. The subject of a document is presumed to be the patient.

Table X: informant

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	INF	Fixed
contextControlCode	CS	[0..1]	OP	Fixed
awarenessCode	CE	[0..1]	D:TargetAwareness	Open

subject.typeCode

The subject.typeCode is fixed to "SBJ" to indicate that a participant that is the principle target (subject) of the service acts documented.

Table X: Fixed subject.typeCode

Code	Display Name
SBJ	subject
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

subject.contextControlCode

The subject.contextControlCode is fixed to "OP". Any subject(s) defined for a section will override the the Patient in recordTarget (an implicit subject) and propagate to the sub-sections and entries this section contains.

Table X: Fixed subject.contextControlCode

Code	Display Name
OP	overriding, propagating
Code System: ContextControl (HL7) Code System OID: 2.16.840.1.113883.5.1057

5.3.3.3.1 RelatedSubject

A subject is a person playing one of several possible roles (RelatedSubject class).

Table X: RelatedSubject

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	x_DocumentSubject	Closed
code	CE	[0..1]	D:PersonalRelationshipRoleType	Open
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]

RelatedSubject.classCode

The RelatedSubject.classCode can take two codes; "PAT" a Role of a LivingSubject (player) as a recipient of health care services from a healthcare provider (scoper) and "PRS" which links two people in a personal relationship. The character of the relationship must be defined by a PersonalRelationshipRoleType code.

Table X: Value set for RelatedSubject.classCode

v:x_DocumentSubject [2.16.840.1.113883.1.11.19368] (CLOSED)
Code	Display Name		Code	Display Name
PAT (Default)	patient		PRS	personal relationship
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

RelatedSubject.code

The RelatedSubject.code is bound to the PersonalRelationshipRoleType concept domain

RelatedSubject.addr

An optional postal address for the subject.

RelatedSubject.telecom

An optional phone number for the subject.

5.3.3.3.2 SubjectPerson

The entity playing in the role RelatedSubject, is a person (SubjectPerson class).

Table X: SubjectPerson

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	PSN	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
id	SET<II>	[0..*]
name	SET<PN>	[0..*]
desc	ED	[0..1]
administrativeGenderCode	CE	[0..1]	D:administrativeGender	Open
birthTime	TS	[0..1]
deceasedInd	BL	[0..1]
deceasedTime	TS	[0..1]
multipleBirthInd	BL	[0..1]
multipleBirthOrderNumber	INT	[0..1]
maritalStatusCode	CE	[0..1]	D:MaritalStatus	Open
religiousAffiliationCode	CE	[0..1]	D:ReligousAffiliation	Open
raceCode	SET<CE>	[0..*]	D:Race	Open
ethnicGroupCode	SET<CE>	[0..*]	D:Ethnicity	Open

SubjectPerson.classCode

The SubjectPerson.classCode is fixed to "PSN", indicating that the entity is a person.

Table X: Fixed SubjectPerson.classCode

Code	Display Name
PSN	person
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

SubjectPerson.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates a specific person is a SubjectPerson.

Table X: Fixed SubjectPerson.determinerCode

Code	Display Name
INSTANCE	specific
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

SubjectPerson.id

Optional identifier for the SubjectPerson.

SubjectPerson.name

The subject's name.

Note: The person name data type "PN" supports current, and historical names using validTime, and the specification of different use codes can indicate legal name, tribal name, stage name and others.

SubjectPerson.desc

A textual or multimedia depiction of the subject.

SubjectPerson.administrativeGenderCode

The gender (i.e., the behavioral, cultural, or psychological traits typically associated with one sex) of a living subject as defined for administrative purposes.

SubjectPerson.birthTime

The date and time of the subject's birth.

SubjectPerson.deceasedInd

An indication that the subject is dead.

SubjectPerson.deceasedTime

The date and time that the Subject's death occurred.

SubjectPerson.multipleBirthInd

An indication as to whether the subject was part of a multiple birth.

SubjectPerson.multipleBirthOrderNumber

The order within a multiple birth in which this subject was born.

SubjectPerson.maritalStatusCode

The domestic partnership status of the subject.

SubjectPerson.religiousAffiliationCode

The primary religious preference of the subject.

SubjectPerson.raceCode

The race of the subject.

Note: More than one race code is now supported in CDA R2.1.

SubjectPerson.ethnicGroupCode

The ethnic group of the subject.

Note: More than one ethnic group is now supported in CDA R2.1.

Note: See 2.7 Backwards and Forwards Compatibility, for discussion on sdtc: extensions defined for CDA R2.0 and CDA R2.1.

5.3.4 Section Relationships

5.3.4.1 component @b@

The "component" Act Relationship is used to nest a Section within a Section. Context propagates to nested sections (see CDA Context (§ 5.4)). Refer to component (§ 5.3.1.1) above for more information.

5.3.4.2 entry

The relationship between a section and its entries is encoded in the intervening "entry" Act Relationship.

The narrative of each Section, together with the multimedia content referenced in the narrative, comprises the complete authenticated content of the Section. This multimedia content consists of ObservationMedia and RegionOfInterest entries referenced by tags in the Section.text. This is the only case where the entries contain authenticated content that must be rendered with the narrative.

NOTE: See Referencing in and out of the narrative block (§ 5.3.5.12) for a discussion of referencing in and out of a section's narrative block.

Table X: entry Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	V:x_ActRelationshipEntry	Fixed
contextConductionInd	BL	[0..1]

entry.typeCode

In terms of the relationship between a section and its entries, CDA defines a default general case, and a more specific case that can be used when applicable.

The entry relationship is defaulted to "COMP" (component), for the general case where the only assertion is that the related entries are contained within the source section and no other semantics are implied. In this case, the narrative is the original authenticated content. The CDA entries are created by various techniques (e.g., natural language processing, a human coder, a structured data entry tool that outputs both entries and a text report). The method of entry creation may be indicated by the entry participants (e.g., by identifying the algorithm or person that generated them). Relationships between various entries (such as two Observations or an Observation and an ObservationMedia) are encoded using the relationship types defined in entryRelationship (§ 5.3.8.4).

A section may also have no narrative content in the case where the entries represent information that is not part of the clinical content of the document. A report may embed information referencing evidence data, reagents, calibration or other information that may be used for later processing but is not part of the clinical content. Such entries are also linked to the Section with ActRelationships possessing typeCode="COMP".

The entry relationship "DRIV" (is derived from) can be used in the special case where the narrative is fully derived from CDA Entries. When a report consisting entirely of structured entries is transformed into CDA, the encoding application must ensure that the authenticated content (narrative plus multimedia) is a faithful and complete rendering of the clinical content of the structured source data. This ensures that the narrative plus multimedia represents, as in all CDA documents, the complete authenticated content of the Section. In this case, narrative plus multimedia does not contain any clinical content that is not present in the Entries. An example of this case is a DICOM Structured Reporting document of obstetrical measurements made by ultrasound, rendered into a tabular report by a program converting it to CDA narrative block. If the typeCode of the ActRelationship linking these Entries to the Section was "DRIV", it would indicate to a receiving application: 1) the source of the narrative block is the Entries; 2) the contents of the two are equivalent.

The entries sourced from a Section may have a mix of ActRelationship typeCodes. In such a case, the union of the targets with a "DRIV" relationship are those used to generate the narrative block, and are those that, taken in total, are equivalent to the narrative block. Additional entries with "COMP" relationships are contained within the same section, with no implied semantics.

Table X: Value set for entry.typeCode

V:x_ActRelationshipEntry [2.16.840.1.113883.1.11.19446] (CLOSED)
Code	Display Name		Code	Display Name
COMP (Default)	has component		DRIV	is derived from
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

entry.contextConductionInd

The component.contextConductionInd indicator is fixed to "true". Ancestor elements () which propagate, will conduct through this component class to the associated child element.

5.3.5 Section Narrative Block

The Section.text field is used to store narrative to be rendered, as described above in CDA Conformance (§ 1.3), and is therefore referred to as the CDA Narrative Block.

The CDA Narrative Block schema can be found here.

The content model of the CDA Narrative Block schema is specially hand crafted to meet the requirements outlined above (see Human Readability and Rendering CDA Documents (§ 1.2.3)). The schema is registered as a MIME type (text/x-hl7-text+xml), which is the fixed media type for Section.text. Components of the schema are described in the sections that follow.

5.3.5.1 <content>

The CDA <content> element is used to wrap a string of text so that it can be explicitly referenced, or so that it can suggest rendering characteristics. The <content> element can nest recursively, which enables wrapping a string of plain text down to as small a chunk as desired.

The <content> element contains an optional identifier, that can serve as the target of a reference. All values of attributes of type XML ID must be unique within the document (per the W3C XML specification). The originalText component of a RIM attribute present in any CDA entry can make explicit reference to the identifier, thereby indicating the original text associated with the attribute in the CDA entry.

Note: The <content> element is not the only element which can serve as the target of a reference. All narrative elements (including <text>) contain an ID element which can be referenced by the originalText component in a CDA entry. <content> is simply a tool which can be used to reference only a portion of a longer string contained in another narrative element.

Example X

<section>
   <code code="10153-2" 
    codeSystem="2.16.840.1.113883.6.1" 
    codeSystemName="LOINC"/>
   <title>Past Medical History</title>
   <text>
    There is a history of <content ID="a1">Asthma</content>
   </text>
   <entry>
      <observation classCode="OBS" moodCode="EVN">
         <code code="195967001" 
          codeSystem="2.16.840.1.113883.6.96" 
          codeSystemName="SNOMED CT" 
          displayName="Asthma">
            <originalText>
               <reference value="#a1"/>
            </originalText>
         </code>
         <statusCode code="completed"/>
      </observation>
   </entry>
</section>

There is no requirement that CDA entries must reference into the CDA Narrative Block. The referencing mechanism can be used where it is important to represent the original text component of a coded CDA entry.

The <content> element contains an optional "revised" attribute that can be valued with "insert" or "delete", which can be used to indicate narrative changes from the last version of a CDA document. The attribute is limited to a single generation, in that it only reflects the changes from the preceding version of a document. If applied, it needs to be used in conjunction with standard CDA revision tracking. Changes to a CDA document that has been released for patient care still require a formal versioning and revision, and the revised document can optionally carry the "revised" attribute to show the delta in the narrative. Receivers are required to interpret the "revised" attribute when rendering by visually distinguishing or suppressing deleted narrative.

5.3.5.2 <linkHtml>

The CDA <linkHtml> is a generic referencing mechanism, similar, but not identical, to the HTML anchor tag. It can be used to reference identifiers that are either internal or external to the document.

Multimedia that is integral to a document, and part of the attestable content of the document requires the use of the ObservationMedia CDA entry, which is referenced by the <renderMultiMedia> element (see <renderMultiMedia> (§ 5.3.5.6)). Multimedia that is simply referenced by the document and not an integral part of the document can use <linkHtml>.

The source of a link uses the linkHtml.href attribute. The target of an internal reference is an identifier of type XML ID, which can exist on other elements in the same or a different narrative block, or XML ID attributes that have been added to the <section>, <ObservationMedia>, or <renderMultiMedia> elements of the CDA Schema. The linkHtml.name attribute is deprecated, because attributes of type XML ID provide an alternative and more consistent target for referencing. Following the conventions of HTML, an internal link is prefaced with the pound sign, as shown in the following example.

Example X

<section ID="SECT001">
   <code code="10164-2" codeSystem="2.16.840.1.113883.6.1" 
    codeSystemName="LOINC"/>
   <title>History of Present Illness</title>
   <text>Mr. Smith is a 57 year old male presenting with 
    chest pain. He sustained a myocardial infarction 3 years 
    ago, ...
   </text>
</section>

 ...

<section ID="SECT003">
   <code code="10153-2" codeSystem="2.16.840.1.113883.6.1" 
    codeSystemName="LOINC"/>
   <title>Past Medical History</title>
   <text>History of coronary artery disease, as noted
    <linkHtml href="#SECT001">above</linkHtml>.</text>
</section>

CDA links do not convey shareable meaning. Shareable semantics are only achieved by the inclusion of CDA entries and their associated formalized relationships. There is no requirement that a receiver render an internal or external link, or the target of an external link.

5.3.5.3 <sub> and <sup>

The CDA <sub> and <sup> elements are used to indicate subscripts and superscripts, respectively.

Receivers are required to interpret these elements when rendering by visually distinguishing subscripted and superscripted characters.

5.3.5.4 <br>

The CDA <br/> element is used to indicate a hard line break. It differs from the CDA <paragraph> element in that the <br/> element has no content. Receivers are required to interpret this element when rendering so as to represent a line break.

5.3.5.5 <footnote> and <footnoteRef>

The CDA <footnote> element is used to indicate a footnote. The element contains the footnote, inline with the flow of text to which it is applied.

The <footnoteRef> element can reference an existing footnote in the same or different CDA Narrative Block of the same document. It can be used when the same footnote is being used multiple times. The value of the footnoteRef.IDREF must be an footnote.ID value in the same document.

Receivers are required to interpret these elements when rendering by visually distinguishing footnoted text. The exact rendition is at the discretion of the recipient, and might include a mark at the location of the footnote with a hyperlink to the footnoted text, a simple demarcation (such as "This is the text [this is the footnote] that is being footnoted"), etc.

5.3.5.6 <renderMultiMedia>

The CDA <renderMultiMedia> element references external multimedia that is integral to a document, and part of the attestable content of the document, and serves to show where the referenced multimedia is to be rendered.

The <renderMultiMedia> element has an optional <caption>, and contains a required referencedObject attribute (of type XML IDREFS), the values of which must equal the XML ID value(s) of ObservationMedia or RegionOfInterest CDA entries within the same document.

Example X

<section>
   <code code="8709-8" codeSystem="2.16.840.1.113883.6.1" 
    codeSystemName="LOINC"/>
   <title>Skin exam</title>
   <text>Erythematous rash, palmar surface, left index 
    finger.<renderMultiMedia referencedObject="MM1"/>
   </text>
   <entry>
      <observationMedia classCode="OBS" moodCode="EVN" ID="MM1">
         <id root="2.16.840.1.113883.19.2.1"/>
         <value xsi:type="ED" mediaType="image/jpeg">
            <reference value="left_hand_image.jpeg"/>
         </value>
      </observationMedia>
   </entry>
</section>

Multimedia that is simply referenced by the document and not an integral part of the document must use <linkHtml>.

The expected behavior is that the referenced multimedia should be rendered or referenced at the point of reference. Where a caption is present, it must also be rendered. <renderMultiMedia> can either reference a single ObservationMedia, or one or more RegionOfInterest. If <renderMultiMedia> references a single ObservationMedia, that ObservationMedia should be rendered or referenced at the point of reference. If <renderMultiMedia> references one or more RegionOfInterest, all RegionOfInterests should be rendered or referenced at the point of reference, atop the multimedia they are regions of. If <renderMultiMedia> references more than one RegionOfInterest, each RegionOfInterest must be a region on the same multimedia.

5.3.5.7 <paragraph>

A CDA <paragraph> is similar to the HTML paragraph, which allows blocks of narrative to be broken up into logically consistent structures. A CDA <paragraph> element contains an optional caption, which if present must come first before any other character data.

5.3.5.8 <list>

A CDA <list> is similar to the HTML list. A CDA <list> has an optional caption, and contains one or more <item> elements. A CDA <item> element contains an optional caption, which if present must come first before any other character data. The required listType attribute specifies whether the <list> is ordered or unordered (with unordered being the default). Unordered lists are typically rendered with bullets, whereas ordered lists are typically rendered with numbers, although this is not a requirement.

5.3.5.9 <table>

The CDA <table> is similar to the HTML table. The table markup is for presentation purposes only and, unlike a database table, does not possess meaningful field names. Remember to access the discrete data conveyed in a CDA document, process the RIM models contained within the <entry> element.

CDA modifies the strict XHTML table model by removing formatting tags and by setting the content model of cells to be similar to the contents of other elements in the CDA Narrative Block. A notable enhancement to the CDA R2.1 standard is the support of the <table> element within <td> & <th> elements. The support of tables within tables was not supported in CDA R2.0, but has been added for those implementation requiring complex table layouts. For definitions of the @align and @valign attributes see the W3C HTML 4.01 Specification section 11.3.2.

The table.border, table.cellspacing, and table.cellpadding attributes are deprecated, because the styleCode attribute (see styleCode attribute (§ 5.3.5.11)) provides a more consistent way for senders to suggest rendering characteristics.

5.3.5.10 <caption>

The CDA <caption> is a label for a paragraph, list, list item, table, or table cell. It can also be used within the <renderMultiMedia> element to indicate a label for referenced ObservationMedia and RegionOfInterest entries. A <caption> contains plain text and may contain links and footnotes.

5.3.5.11 styleCode attribute

The styleCode attribute is used within the CDA Narrative Block to give the instance author the ability to suggest rendering characteristics of the nested character data. Receivers are not required to render documents using the style hints provided and can present stylized text in accordance with their local style conventions.

The value set is drawn from the HL7 styleType vocabulary domain, and has a CWE coding strength.

Table X: Value set for styleCode (CWE)

Code	Definition
Font style (Defines font rendering characteristics.)
Bold	Render with a bold font.
Underline	Render with an underlines font.
Italics	Render italicized.
Emphasis	Render with some type of emphasis.
Table rule style (Defines table cell rendering characteristics.
Lrule	Render cell with left-sided rule.
Rrule	Render cell with right-sided rule.
Toprule	Render cell with rule on top.
Botrule	Render cell with rule on bottom.
Ordered list style (Defines rendering characteristics for ordered lists.)
Arabic	List is ordered using Arabic numerals: 1, 2, 3.
LittleRoman	List is ordered using little Roman numerals: i, ii, iii.
BigRoman	List is ordered using big Roman numerals: I, II, III.
LittleAlpha	List is ordered using little alpha characters: a, b, c.
BigAlpha	List is ordered using big alpha characters: A, B, C.
Unordered list style (Defines rendering characteristics for unordered lists.)
Disc	List bullets are simple solid discs.
Circle	List bullets are hollow discs.
Square	List bullets are solid squares.

Local extensions to the styleType vocabulary domain must follow the following convention: [x][A-Za-z][A-Za-z0-9]* (first character is "x", second character is an upper or lower case A-Z, remaining characters are any combination of upper and lower case letters or numbers).

The styleCode attribute can contain multiple values, separated by white space. Where an element containing a styleCode attribute is nested within another element containing a styleCode attribute, the style effects are additive, as in the following example:

Example X

<section>
   <text><content styleCode="Bold">This is rendered bold, 
    <content styleCode="Italics">this is rendered bold and 
    italicized,</content> this is rendered bold. </content>
    <content styleCode="Bold Italics">This is also rendered 
    bold and italicized.</content>
   </text>
</section>

5.3.5.12 Referencing in and out of the narrative block

NOTE: See entry (§ 5.3.4.2) for a discussion of the relationships between a section and its contained entries.

To summarize the mechanisms for referencing in and out of the CDA Narrative Block:

CDA entries can point in to the <content> element of the CDA Narrative Block (see <content> (§ 5.3.5.1)).

The <linkHtml> element of the CDA Narrative Block can reference targets that are either internal or external to the document (see <linkHtml> (§ 5.3.5.2)).

The <footnoteRef> element of the CDA Narrative Block can reference a <footnote> element in the same or different CDA Narrative Block of the same document (see <footnote> and <footnoteRef> (§ 5.3.5.5)).

The <renderMultiMedia> element of the CDA Narrative Block can point out to CDA ObservationMedia and RegionOfInterest entries of the same document (see <renderMultiMedia> (§ 5.3.5.6)).

5.3.6 Entry Acts

CDA entries represent the structured computer-processable components within a document section. Each section can contain zero to many entries.

Clinical documents contain a wide breadth of content, requiring much of the RIM to enable a full and complete encoding. The current set of CDA entries have been developed in response to identified requirements and scenarios that are in CDA's scope. Rather than creating specific entries for each scenario, similar requirements are merged to create broader entries, which can then be constrained within a particular realm or implementation. This approach is consistent with the approach taken by CEN, DICOM, and OpenEHR.

The model for CDA entries is derived from the shared HL7 Clinical Statement model, which is a collaborative project between several committees striving to provide a consistent representation of clinical observations and acts across various V3 specifications.

5.3.6.1 Act

A derivative of the RIM Act class, to be used when the other classes present in the CDA Clinical Statement choice pattern are not appropriate.

Table X: Act Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	V:x_ActClassDocumentEntryAct	Closed
moodCode	CS	[1..1]	V:x_DocumentActMood	Closed
id	SET <II>	[0..*]
code	CD	[1..1]	D:ActCode	Open
actionNegationInd	BL	[0..1]
negationInd (Deprecated)	BL	[0..1]
text	ED	[0..1]
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	IVL<TS>	[0..1]
activityTime	GTS	[0..1]
availabilityTime	TS	[0..1]
priorityCode	CE	[0..1]	D:ActPriority	Open
confidentialityCode	SET<CE>	[0..*]	D:Confidentiality	Open
uncertaintyCode	CE	[0..1]	D:ActUncertainty	Open
reasonCode	SET<CE>	[0..*]	D:ActReason	Open
languageCode	CS	[0..1]	D:HumanLanguage	Closed

Act.classCode

The major class of Acts to which an Act-instance belongs.

Table X: Value set for Act.classCode

x_ActClassDocumentEntryAct [2.16.840.1.113883.1.11.19599] (CLOSED)
Code	Display Name		Code	Display Name
ACT	Act		ACCM	accommodation
CONS	consent		CTTEVENT	clinical trial timepoint event
INC	incident		INFRM	inform
PCPR	care provision		REG	registration
SPCTRT	specimen treatment		TRNS	transportation
ACSN	accession		CONTREG	container registration
DISPACT	disciplinary action		EXPOS	exposure
AEXPOS	acquisition exposure		TEXPOS	transmission exposure
LIST	working list		MPROT	monitoring program
REV	review		STORE	storage
TRFR	transfer
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Act.moodCode

The intended use of the Act statement: as a report of fact, a command, a possibility, a goal, etc. Since the mood code is a determining factor for the meaning of an entire Act object, the mood must always be known. This means that whenever an act object is instantiated, the mood attribute SHALL be assigned to a valid code, and the mood assignment SHALL NOT change throughout the lifetime of the act object.

Table X: Value set for Act.moodCode

V:x_DocumentActMood [2.16.840.1.113883.1.11.19458] (CLOSED)
Code	Display Name		Code	Display Name
APT	appointment		ARQ	appointment request
EVN	event		DEF	definition
RQO	request		INT	intent
PRMS	promise		PRP	proposal
RSK	risk
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

Act.id

A unique identifier for the Act.

Act.code

The particular kind of Act that the Act-instance represents within its class. Act.code, if used, SHALL be a specialization of the Act.classCode. This attribute defines a specific sub-type of a given Act type (determined by the "classCode" attribute). It allows the use of rich terminologies such as LOINC and SNOMED to represent sub-types of the limited set of Act types defined by "classCode." The Act.code is bound to the ActCode concept domain.

Act.actionNegationInd

The Act.actionNegationInd works as a negative existence quantifier on the actual, intended or described Act event. In Event mood, it indicates the defined act did not occur. In Intent mood, it indicates the defined act is not intended/desired to occur. In Criterion mood, it indicates that the condition is based on the non-occurrence of the event. It is nonsensical to have a negationInd of true for acts with a mood of definition.

The actionNegationInd negates the Act as described by the descriptive properties which are: classCode, code, statusCode, effectiveTime, activityTime, priorityCode, reasonCode and any of their components.

The remaining properties represent the document characteristics, E.g. Act.id, Act.moodCode, Act.confidentialityCode, and particularly the Author-Participation are not negated. These document characteristic properties always have the same meaning: i.e., the author remains to be the author of the negative observation. Also, most ActRelationships (except for components) are not included in the negation. Refer to the attribute isDocumentCharacteristic property and the ActRelationshipType and ParticipationType code system isDocumentCharacteristic properties for specific guidance.

Act.negationInd

Act.negationInd, is deprecated in RIM 2.35, and CDA R2.1 retains it for backwards compatibility. CDA R2.1 compliant implementation guides should use actionNegationInd moving forward.

Act.text

A renderable textual or multimedia description (or reference to a description) of the complete information which would reasonably be expected to be displayed to a human reader conveyed by the Act. The Act.text attribute can reference the associated narrative content in the section using the XML ID attribute added to the Narrative Text elements.

Act.statusCode

The status reflects the state of the activity. The RIM based state machine diagram depicts the allowable state transitions that an Act.StatusCodes can take on.

Table X: Value set for Act.statusCode

V:ActStatus [2.16.840.1.113883.1.11.15933] (CLOSED)
Code	Display Name		Code	Display Name
normal	normal		aborted	aborted
active	active		cancelled	cancelled
completed	completed		held	held
new	new		suspended	suspended
nullified	nullified		obsolete	obsolete
Code System: ActStatus (HL7) Code System OID: 2.16.840.1.113883.5.14

Act.effectiveTime

Act.effectiveTime is used to indicate the clinically or operationally relevant time of an act, exclusive of administrative activity.

Act.activityTime

Act.activityTime is a time expression specifying when an act occurs, inclusive of administrative time E.g. times of component actions, such as preparation and clean-up. Depending on the mood code used, it represents the time the act occurred, is supposed to occur, is scheduled to occur, etc.

Act.availabilityTime

Act.availabilityTime is the point in time at which information about an act instance (regardless of mood) first became available to a system. The availabilityTime is metadata describing the recording of, not the act itself.

Act.priorityCode

The urgency under which the Act happened, can happen, is happening, is intended to happen, or is requested/demanded to happen. The Act.priorityCode is bound to the ActPriority concept domain.

Act.confidentialityCode

Constraints around appropriate disclosure of information about this Act, regardless of mood. The Act.confidentialityCode is bound to the Confidentiality concept domain.

Act.uncertaintyCode

An indication that the Act statement as a whole, with its subordinate components has been asserted to be uncertain in some way. The use of the uncertaintyCode is appropriate only if the entirety of the Act and its dependent Acts is questioned. The Act.uncertaintyCode is bound to the ActUncertainty concept domain.

Act.reasonCode

The motivation, cause, or rationale of an Act, when such rationale is not reasonably represented as an ActRelationship of type "has reason" linking to another Act. The Act.reasonCode is bound to the ActReason concept domain.

Most reasons for acts can be clearly expressed by linking the new Act to another prior Act record using an ActRelationship of type "has reason." This simply states that the prior Act is a reason for the new Act (see ActRelationship). The prior act can then be a specific existing act or a textual explanation. This works for most cases, and the more specific the reason data is, the more should this reason ActRelationship be used instead of the reasonCode.

The reasonCode remains as a place for common reasons that are not related to a prior Act or any other condition expressed in Acts. Indicators that something was required by law or was on the request of a patient may qualify. However, if that piece of legislation, regulation, or the contract or the patient request can be represented as an Act (and they usually can), such a representation is preferable to the reasonCode.

Act.languageCode

The primary language in which this Act statement is specified, particularly the language of the Act.text. The Act.languageCode is bound to the HumanLanguage concept domain.

5.3.6.2 Encounter

Encounter

A derivative of the RIM PatientEncounter class, used to represent related encounters, such as follow-up visits or referenced past encounters.

NOTE: The EncompassingEncounter class in the CDA Header (see Header Relationships (§ 5.2.3)) represents the setting of the clinical encounter during which the documented act occurred. The Encounter class in the CDA Body is used to represent other related encounters.

Table X: Encounter Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	ENC	Fixed
moodCode	CS	[1..1]	V:x_DocumentEncounterMood	Closed
id	SET <II>	[0..*]
code	CD	[0..1]	D:ActCode	Open
actionNegationInd	BL	[0..1]
negationInd (Deprecated)	BL	[0..1]
text	ED	[0..1]
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	IVL<TS>	[0..1]
activityTime	GTS	[0..1]
availabilityTime	TS	[0..1]
priorityCode	CE	[0..1]	D:ActPriority	Open
confidentialityCode	SET<CE>	[0..*]	D:Confidentiality	Open
uncertaintyCode	CE	[0..1]	D:ActUncertainty	Open
reasonCode	SET<CE>	[0..*]	D:ActReason	Open
languageCode	CS	[0..1]	D:HumanLanguage	Closed
admissionReferralSourceCode	<CE>	[0..1]	D:EncounterReferralSource	Open
lengthOfStayQuantity	<PQ>.TIME	[0..1]
dischargeDispositionCode	<CE>	[0..1]	D:EncounterDischargeDisposition	Open
preAdmitTestInd	BL	[0..1]
specialCourtesiesCode	SET<CE>	[0..*]	D:EncounterSpecialCourtesy	Open
specialArrangementCode	SET<CE>	[0..*]	D:SpecialArrangement	Open

Encounter.classCode

The Encounter.classCode is fixed to "ENC" to represent an encounter. The encounter class is used to represent an interaction between a patient and healthcare participant(s) for the purpose of providing patient service(s) or assessing the health status of a patient.

Table X: Fixed Encounter.classCode

Code	Display Name
ENC (Fixed)	encounter
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Encounter.moodCode

The Encounter.moodCode is bound to the x_DocumentEncounterMood value set. This enables to the modeling of both past, present and planned future encounters.

Table X: Value set for Encounter.moodCode

V:x_DocumentEncounterMood [2.16.840.1.113883.1.11.19459] (CLOSED)
Code	Display Name		Code	Display Name
APT	appointment		ARQ	appointment request
EVN	event		DEF	definition
RQO	request		INT	intent
PRMS	promise		PRP	proposal
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

Encounter.id

The optional Encounter.id can be used to uniquely identify the encounter.

Encounter.code

The optional Encounter.code is bound to the ActEncounterCode value set.

Table X: Value set for EncompassingEncounter.code

V:ActEncounterCode [2.16.840.1.113883.1.11.13955] (OPEN)
Code	Display Name		Code	Display Name
AMB	ambulatory		EMER	emergency
FLD	field		HH	home health
IMP	inpatient encounter		ACUTE	inpatient acute
NONAC	virtual		SS	short stay
VR	inpatient non-acute
Code System: ActCode (HL7) Code System OID: 2.16.840.1.113883.5.4

Encounter.actionNegationInd

The Encounter.actionNegationInd works as a negative existence quantifier on the actual, intended or described Encounter event. In Event mood, it indicates the defined encounter did not occur. In Intent mood, it indicates the defined encounter is not intended/desired to occur. In Criterion mood, it indicates that the condition is based on the non-occurrence of the event. It is nonsensical to have a negationInd of true for acts with a mood of definition.

The actionNegationInd negates the Encounter as described by the descriptive properties which are: classCode, code, statusCode, effectiveTime, activityTime, priorityCode, reasonCode, admissionReferralSourceCode, lengthOfStayQuantity, dischargeDispositionCode, preAdmitTestInd, specialCourtesiesCode, specialArrangementCode and any of their components.

The remaining properties represent the document characteristics, E.g. Encounter.id, Encounter.moodCode, Encounter.confidentialityCode, and particularly the Author-Participation are not negated. These document characteristic properties always have the same meaning: i.e., the author remains to be the author of the negative encounter. Also, most ActRelationships (except for components) are not included in the negation. Refer to the attribute isDocumentCharacteristic property and the ActRelationshipType and ParticipationType code system isDocumentCharacteristic properties for specific guidance.

Encounter.text

A renderable textual or multimedia description (or reference to a description) of the complete information which would reasonably be expected to be displayed to a human reader conveyed by the Encounter. The Encounter.text attribute can reference the associated narrative content in the section using the XML ID attribute added to the Narrative Text elements.

Encounter.statusCode

The status reflects the state of the Encounter. The RIM based state machine diagram depicts the allowable state transitions that an Encounter.statusCode can take on.

Encounter.effectiveTime

For Encounters, the effectiveTime is the "administrative" time, i.e., the encounter start and end date as established by business rules. For inpatient encounters, the effectiveTime/low value is the admission date and time and the effectiveTime/high value is the discharge date and time. Note: If the encounter is still active at the time of document creation, the effectiveTime/high element can be omitted to indicate the encounter is on-going.

Encounter.activityTime

Encounter.activityTime is a time expression specifying when an Encounter occurs, inclusive of administrative time E.g. times of component actions, such as preparation and clean-up. Depending on the mood code used, it represents the time the Encounter occurred, is supposed to occur, is scheduled to occur, etc.

Encounter.availabilityTime

Encounter.availabilityTime is the point in time at which information about an Encounter instance (regardless of mood) first became available to a system. The availabilityTime is metadata describing the recording of, not the Encounter itself.

Encounter.priorityCode

The urgency under which the Encounter happened, can happen, is happening, is intended to happen, or is requested/demanded to happen. The Encounter.priorityCode is bound to the ActPriority concept domain.

Encounter.confidentialityCode

Constraints around appropriate disclosure of information about this Encounter, regardless of mood. The Encounter.confidentialityCode is bound to the Confidentiality concept domain.

Encounter.reasonCode

The motivation, cause, or rationale of an Encounter, when such rationale is not reasonably represented as an ActRelationship of type "has reason" linking to another Act. The Encounter.reasonCode is bound to the ActReason concept domain.

Encounter.languageCode

The primary language in which this Encounter statement is specified, particularly the language of the Encounter.text. The Encounter.languageCode is bound to the HumanLanguage concept domain.

Encounter.admissionReferralSourceCode

The optional EncompassingEncounter.admissionReferralSourceCode can be use to depict the type of place or organization responsible for the patient's care immediately prior to a patient encounter.

Encounter.lengthOfStayQuantity

The total quantity of time when the subject is expected to be or was resident at a facility as part of an encounter. Note, the actual days quantity cannot be simply calculated from the admission and discharge dates because of possible leaves of absence.

Encounter.dischargeDispositionCode

The optional EncompassingEncounter.dischargeDispositionCode can be used to depict the disposition of the patient at the time of hospital discharge (e.g., discharged to home, expired, against medical advice, etc.).

Encounter.preAdmitTestInd

An indication that pre-admission tests are required for this patient encounter.

Encounter.specialCourtesiesCode

Extraordinary considerations or services provided within the context of the Patient Encounter. Examples include: Professional courtesy, VIP courtesies, no courtesies

Encounter.specialArrangementCode

Extraordinary provisions required in the context of the patient encounter. For encounters in intention moods, this information can be used to identify special arrangements that will need to be made for the incoming patient.

5.3.6.3 Observation

Observation

A derivative of the Observation (§ RIM 2.35) class, it is intended to result in new information about a subject. The main difference between Observations and other Acts is that Observations have a value attribute. The code attribute of Observation and the value attribute of Observation must be considered in combination to determine the semantics of the observation.

Table X: Observation Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	<= OBS is V:ActClassObservation	Closed
moodCode	CS	[1..1]	V:x_ActMoodDocumentObservation	Closed
id	SET <II>	[0..*]
code	CD	[1..1]	D:ObservationType	Open
actionNegationInd	BL	[0..1]
negationInd (Deprecated)	BL	[0..1]
derivationExpr	ST	[0..1]
title	ED	[0..1]
text	ED	[0..1]
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	IVL<TS>	[0..1]
activityTime	GTS	[0..1]
availabilityTime	TS	[0..1]
priorityCode	CE	[0..1]	D:ActPriority	Open
confidentialityCode	SET<CE>	[0..*]	D:Confidentiality	Open
repeatNumber	IVL<INT>	[0..1]
uncertaintyCode	CE	[0..1]	D:ActUncertainty	Open
languageCode	CS	[0..1]	D:HumanLanguage	Closed
isCriterionInd	BL	[0..1]
value	SET<ANY>	[0..*]	D:ObservationValue	Open
valueNegationInd	BL	[0..1]
interpretationCode	SET<CE>	[0..*]	D:ObservationInterpretation	Open
methodCode	SET<CE>	[0..*]	D:ObservationMethod	Open
targetSiteCode	SET<CD>	[0..*]	D:ActSite	Open

Observation.classCode

The defines a specific sub-type of a given Observation type.

Table X: Value set for Observation.classCode

V:ActClassObservation [2.16.840.1.113883.1.11.11529] (CLOSED)
Code	Display Name		Code	Display Name
OBS	Observation		ALRT	detected issue
BATTERY	battery		CLNTRL	clinical trial
CONC	concern		COND	Condition
CASE	public health case		OUTB	outbreak
DGIMG	diagnostic image		GEN	genomic observation
DETPOL	determinant peptide		EXP	expression level
LOC	locus		PHN	phenotype
POL	polypeptide		SEQ	bio sequence
SEQVAR	bio sequence variation		INVSTG	investigation
OBSSER	observation series		OBSCOR	correlated observation sequences
POS	position		POSACC	position accuracy
POSCOORD	position coordinate		SPCOBS	specimen observation
VERIF	Verification		ROIBND	bounded ROI
ROIOVL	overlay ROI		LLD (Deprecated)	left lateral decubitus
PRN (Deprecated)	prone		RLD (Deprecated)	right lateral decubitus
SFWL (Deprecated)	Semi-Fowler's		SIT (Deprecated)	sitting
STN (Deprecated)	standing		SUP (Deprecated)	supine
RTRD (Deprecated)	reverse trendelenburg		TRD (Deprecated)	trendelenburg
CNOD (Deprecated)	Condition Node
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Observation.moodCode

The intended use of the Observation statement: as a report of fact, a command, a possibility, a goal, etc. Since the mood code is a determining factor for the meaning of an entire Observation object, the mood must always be known. This means that whenever an Observation is instantiated, the mood attribute SHALL be assigned to a valid code, and the mood assignment SHALL NOT change throughout the lifetime of the Observation.

Table X: Value set for Observation.moodCode

V:x_ActMoodDocumentObservation [2.16.840.1.113883.1.11.19644] (CLOSED)
Code	Display Name		Code	Display Name
APT	appointment		ARQ	appointment request
EVN	event		DEF	definition
GOL	goal		INT	intent
PRMS	promise		PRP	proposal
RSK	risk		RQO	request
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

Observation.id

A unique identifier for the Observation.

Observation.code

The particular kind of Observation that the Observation-instance represents within its class. Observation.code, if used, SHALL be a specialization of the Observation.classCode. This attribute defines a specific sub-type of a given Observation type (determined by the "classCode" attribute). The Observation.code is bound to the ActCode concept domain.

Observation.actionNegationInd

The Observation.actionNegationInd works as a negative existence quantifier on the actual, intended or described observation event. In Event mood, it indicates the defined observation did not occur. In Intent mood, it indicates the defined observation is not intended/desired to occur. In Criterion mood, it indicates that the condition is based on the non-occurrence of the event. It is nonsensical to have a negationInd of true for acts with a mood of definition.

The actionNegationInd negates the Observation as described by the descriptive properties which are: classCode, code, statusCode, effectiveTime, activityTime, priorityCode, derivationExpr, repeatNumber, isCriterionInd, value, valueNegationInd, interpretationCode, methodCode, targetSiteCode, and any of their components.

The remaining properties represent the document characteristics, E.g. Observatoin.id, Observation.moodCode, Observation.confidentialityCode, and particularly the Author-Participation are not negated. These document characteristic properties always have the same meaning: i.e., the author remains to be the author of the negative observation. Also, most ActRelationships (except for components) are not included in the negation. Refer to the attribute isDocumentCharacteristic property and the ActRelationshipType and ParticipationType code system isDocumentCharacteristic properties for specific guidance.

Observation.negationInd

Observation.negationInd, is deprecated in RIM 2.35, and CDA R2.1 retains it for backwards compatibility. It was deprecated as the type of negation required knowledge of template documentation to determine the actual type of negation I.e. value or action negation. CDA R2.1 compliant implementation guides should use actionNegationInd or valueNegationInd moving forward.

Observation.derivationExpr

A character string containing a formal language expression that specifies how the Observation's attributes are, should be, or have been derived from input parameters associated with derivation relationships. Derived observations can be defined through association with other observations using ActRelationships of type "derivation." For example, to define a derived observation for Mean Corpuscular Hemoglobin (MCH) one will associate the MCH observation with a Hemoglobin (HGB) observation and a Red Blood cell Count (RBC) observation: the derivation expression value encodes the formula: MCH = HGB / RBC.

Observation.title

A word or phrase by which a specific Observation may be known among people. This is not a formal identifier but rather a human-recognizable common name. However it is similar to the id attribute in that it refers to a specific Observation rather than a 'kind' of Observation. (For definition mood, the title refers to that specific definition, rather than to a broad category that might be conveyed with Observation.code.)

Observation.text

A renderable textual or multimedia description (or reference to a description) of the complete information which would reasonably be expected to be displayed to a human reader conveyed by the Observation. The Observation.text attribute can reference the associated narrative content in the section using the XML ID attribute added to the Narrative Text elements.

Observation.statusCode

The status reflects the state of the activity. In the case of an Observation, this is the status of the activity of observing (e.g., "new," "complete," "cancelled"), not the status of what is being observed (e.g., disease status, "Active" allergy to penicillin). To convey the status of the subject being observed, consider coordinating it into the code or value attribute of the Observation or using a related Observation. The RIM based state machine diagram depicts the allowable state transitions that an Observation.StatusCode can take on.

Table X: Value set for Observation.statusCode

V:ActStatus [2.16.840.1.113883.1.11.15933] (CLOSED)
Code	Display Name		Code	Display Name
normal	normal		aborted	aborted
active	active		cancelled	cancelled
completed	completed		held	held
new	new		suspended	suspended
nullified	nullified		obsolete	obsolete
Code System: ActStatus (HL7) Code System OID: 2.16.840.1.113883.5.14

Observation.effectiveTime

Observation.effectiveTime is used to indicate the clinically or operationally relevant time of an observation, exclusive of administrative activity. For example, in a Blood Gas Analysis (BGA), a result might not be available for several minutes after the specimen was taken. The effectiveTime is the time the specimen was taken, the availabilityTime would be the time the result was available for review. For clinical Observations, the effectiveTime represents the time at which the observation holds (is effective) for the patient. In V2 the effectiveTime was known as the biologically relevant time.

Observation.activityTime

Observation.activityTime is a time expression specifying when an Observation occurs, inclusive of administrative time E.g. times of component actions, such as preparation and clean-up. Depending on the mood code used, it represents the time the observation occurred, is supposed to occur, is scheduled to occur, etc. When an observation of a prior symptom is made, the activityTime describes the time the observation is made, as opposed to effectiveTime which is the time the symptom is reported to have occurred. Thus the activityTime may be entirely different from the effectiveTime for the same observation instance.

Observation.availabilityTime

Observation.availabilityTime is the point in time at which information about an observation instance (regardless of mood) first became available to a system. The availabilityTime is metadata describing the recording of, not the Observation itself. For CDA documents, the availabilityTime reported for its contents, would represent the time the observation first became available to a source system generating the CDA document.

Observation.priorityCode

The urgency under which the Act happened, can happen, is happening, is intended to happen, or is requested/demanded to happen. The Act.priorityCode is bound to the ActPriority concept domain.

Observation.confidentialityCode

Constraints around appropriate disclosure of information about this Observation, regardless of mood. The Observation.confidentialityCode is bound to the Confidentiality concept domain.

Observation.repeatNumber

An interval of integer numbers stating the minimal and maximal number of repetitions of the Observation.

Observation.uncertaintyCode

An indication that the Observation statement as a whole, with its subordinate components has been asserted to be uncertain in some way. The use of the uncertaintyCode is appropriate only if the entirety of the Observation and its dependent Acts is questioned. The Observation.uncertaintyCode is bound to the ActUncertainty concept domain. Note: Implementation Guides will need to provide explicit guidance on the proper evaluation and interpretation, as well as provide a default value assignment.

Observation.languageCode

The primary language in which this Observation statement is specified, particularly the language of the Observation.text. The Observation.languageCode is bound to the HumanLanguage concept domain.

Observation.isCriterionInd

Is defaulted to false, when set to true it indicates that the data conveyed by the act, including outbound associations, represent "criteria" for some other act, not a "real" act. I.e. If an Act exists with a classCode of ACT and a moodCode of RQO and isCriterionInd is true, it does not represent an order for an act. Rather, it represents a criteria that will match on all orders.

Observation.value

The result of the observation action. Extensive usage notes are available in the RIM, reference Value UsageNotes

Observation.valueNegationInd

Observation.valueNegationInd, indicates that when the observation event occurred, the finding communicated by the value attribute was NOT found. So, when we want to indicate the patient does not have asthma, we can negate a finding of asthma, using this indicator. Note: The RIM indicates that this attribute should only be used when the terminology used for Observation.value is not itself capable of expressing negated findings. (E.g. ICD9). Implementation experience may override the RIM definition and it's important to review template definitions and Value Set content and binding for consistent negation implementation. Existing CDA R2.0 implementations use negationInd in many C-CDA templates.

Observation.interpretationCode

A qualitative interpretation of the observation. These interpretation codes are sometimes called "abnormal flags," however, the judgment of normalcy is just one of the interpretations, and is often not relevant. For example, the susceptibility interpretations are not about "normalcy," and for any observation of a pathologic condition, it does not make sense to state the normalcy, since pathologic conditions are never considered "normal."

Observation.methodCode

The means or technique used to ascertain the observation. In all observations the method is already partially specified by the Observation.code. In this case, the methodCode NEED NOT be used at all. The methodCode MAY still be used to identify this method more clearly in addition to what is implied from the Observation.code. However, an information consumer system or process SHOULD NOT depend on this methodCode information for method detail that is implied by the Observation.code.

Observation.targetSiteCode

The anatomical site or system that is the focus of the observation. Most observation target sites are implied by the observation definition and Observation.code, or Observation.value. For example, "heart murmur" always has the heart as target. This attribute is used only when the observation target site needs to be refined, to distinguish right from left, etc. If the subject of the Observation is something other than a human patient or animal, the attribute is used analogously to specify a structural landmark of the thing where the Observation focuses. For example, if the subject is a lake, the site could be inflow and outflow, etc. If the subject is a lymphatic node, "hilus," "periphery," or other node sites would be valid target sites.

The following is an example of how an author can record a patient that has no known allergies. It uses the new valueNegationInd with an "Allergy to substance" code in the value element.

Example X

<section>
    <templateId .../>
    <code code="48765-2" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/>
    <title>ALLERGIES AND ADVERSE REACTIONS</title>
    <text>No Known Allergies</text>
    <entry typeCode="DRIV">
        <!-- Allergy Concern Act -->
        <act classCode="ACT" moodCode="EVN">
            <templateId ... />
            <id root="36e3e930-7b14-11db-9fe1-0800200c9a66"/>
            <code code="CONC" codeSystem="2.16.840.1.113883.5.6"/>
            <statusCode code="active"/>
            <effectiveTime>
                <low value="20100103"/>
            </effectiveTime>
            <author> ... </author>
            <entryRelationship typeCode="SUBJ">
                <!-- No Known Allergies -->
                <!-- The <valueNegationInd value="true" /> negates the observation/value -->
                <observation classCode="OBS" moodCode="EVN">
                    <!-- allergy - intolerance observation template -->
                    <templateId ... />
                    <templateId ... />
                    <id ... />
                    <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4"/>
                    <statusCode code="completed"/>
                    <effectiveTime>
                        <low nullFlavor="NA"/>
                    </effectiveTime>
                    <value xsi:type="CD" code="419199007"
                        displayName="Allergy to substance (disorder)"
                        codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/>
                    <valueNegationInd value="true"/>
                    <author> ... </author>
                    <participant typeCode="CSM">
                        <participantRole classCode="MANU">
                            <playingEntity classCode="MMAT">
                                <code nullFlavor="NA"/>
                            </playingEntity>
                        </participantRole>
                    </participant>
                </observation>
            </entryRelationship>
        </act>
    </entry>
</section>
 

5.3.6.3.1 Reference Range

An Observation can have zero to many referenceRange relationships, which relate an Observation to the ObservationRange class.

referenceRange.typeCode

The referenceRange.typeCode has been fixed to "REFV", which indicates an association to a reference range.

Table X: Fixed referenceRange.typeCode

Code	Display Name
REFV	has reference values
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

5.3.6.3.2 ObservationRange

ObservationRange or reference ranges are essentially descriptors of a class of result values assumed to be "normal", "abnormal", or "critical." Those can vary by sex, age, or any other criterion.

Table X: ObservationRange Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	<= OBS is V:ActClassObservation	Closed w/ Default
moodCode	CS	[0..1]	ENV.CRT	Fixed
code	CD	[1..1]	D:ActCode	Open
text	ED	[0..1]
isCriterionInd	BL	[0..1]
value	SET<ANY>	[0..*]	D:ObservationValue	Open
valueNegationInd	BL	[0..1]
interpretationCode	SET<CE>	[0..*]	D:ObservationInterpretation	Open

ObservationRange.classCode

Table X: Value set for ObservationRange.classCode

V:ActClassObservation [2.16.840.1.113883.1.11.11529] (CLOSED)
Code	Display Name		Code	Display Name
OBS (Default)	Observation		ALRT	detected issue
BATTERY	battery		CLNTRL	clinical trial
CONC	concern		COND	Condition
CASE	public health case		OUTB	outbreak
DGIMG	diagnostic image		GEN	genomic observation
DETPOL	determinant peptide		EXP	expression level
LOC	locus		PHN	phenotype
POL	polypeptide		SEQ	bio sequence
SEQVAR	bio sequence variation		INVSTG	investigation
OBSSER	observation series		OBSCOR	correlated observation sequences
POS	position		POSACC	position accuracy
POSCOORD	position coordinate		SPCOBS	specimen observation
VERIF	Verification		ROIBND	bounded ROI
ROIOVL	overlay ROI		LLD (Deprecated)	left lateral decubitus
PRN (Deprecated)	prone		RLD (Deprecated)	right lateral decubitus
SFWL (Deprecated)	Semi-Fowler's		SIT (Deprecated)	sitting
STN (Deprecated)	standing		SUP (Deprecated)	supine
RTRD (Deprecated)	reverse trendelenburg		TRD (Deprecated)	trendelenburg
CNOD (Deprecated)	Condition Node
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

ObservationRange.moodCode

The ObservationRange.moodCode is fixed to the "EVN.CRT" (event criterion). The "EVN.CRT" is a criterion or condition over service events that must apply for an associated service to be considered.

Table X: Fixed ObservationRange.moodCode

Code	Display Name
EVN.CRT	event criterion
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

ObservationRange.code

The particular kind of Observation that the ObservationRange-instance represents within its class. ObservationRange.code, if used, SHALL be a specialization of the ObservationRange.classCode. This attribute defines a specific sub-type of a given Observation type (determined by the "classCode" attribute). The ObservationRange.code is bound to the ActCode concept domain.

ObservationRange.text

A renderable textual or multimedia description (or reference to a description) of the complete information which would reasonably be expected to be displayed to a human reader conveyed by the ObservationRange. The ObservationRange.text attribute can reference the associated narrative content in the section using the XML ID attribute added to the Narrative Text elements.

ObservationRange.isCriterionInd

Is set to true to indicate that the data conveyed by the ObservationRange, including outbound associations, represent "criteria" for some other act, not a "real" act. I.e. If an Act exists with a classCode of ACT and a moodCode of RQO and isCriterionInd is true, it does not represent an order for an act. Rather, it represents a criteria that will match on all orders.

ObservationRange.value

The result of the ObservationRange action. Extensive usage notes are available in the RIM, reference Value UsageNotes

ObservationRange.valueNegationInd

ObservationRange.valueNegationInd, indicates that when the ObservationRange event occurred, the finding communicated by the value attribute was NOT found. Note: This attribute should only be used when the terminology used for ObservationRange.value is not itself capable of expressing negated findings. (E.g. ICD9).

ObservationRange.interprerationCode

A qualitative interpretation of the ObservationRange. These interpretation codes are sometimes called "abnormal flags," however, the judgment of normalcy is just one of the interpretations, and is often not relevant. For example, the susceptibility interpretations are not about "normalcy," and for any observation of a pathologic condition, it does not make sense to state the normalcy, since pathologic conditions are never considered "normal."

5.3.6.4 ObservationMedia

Observation Media

A derivative of the RIM Observation class that represents multimedia that is logically part of the current document. This class is only for multimedia that is logically part of the attested content of the document. Rendering a referenced ObservationMedia requires a software tool that recognizes the particular MIME media type. The distinction between ObservationMedia and ExternalObservation is that ObservationMedia entries are part of the attested content of the document whereas ExternalObservations are not. For instance, when a clinician draws a picture as part of a progress note, that picture is represented as a CDA ObservationMedia. If that clinician is also describing a finding seen on a chest-x-ray, the referenced chest-x-ray is represented as a CDA ExternalObservation.

Table X: ObservationMedia Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	<= OBS is V:ActClassObservation	Closed
moodCode	CS	[1..1]	EVN	Fixed
id	SET <II>	[0..*]
languageCode	CS	[0..1]	D:HumanLanguage	Closed
value	ED	[1..1]

NOTE: XML ID Attribute added

An XML attribute "ID" of type XML ID, is added to ObservationMedia within the CDA Schema. This attribute serves as the target of a <renderMultiMedia> reference (see <renderMultiMedia> (§ 5.3.5.6)). All values of attributes of type XML ID must be unique within the document (per the W3C XML specification).

ObservationMedia.classCode

The ObservationMedia.classCode is defaulted to "OBS" for Observation, but can be set to any sub-type of Observation that may more accurately characterize the multi-media referenced via the ObservationMedia class.

Table X: Value set for ObservationMedia.classCode

V:ActClassObservation [2.16.840.1.113883.1.11.11529] (CLOSED)
Code	Display Name		Code	Display Name
OBS (Default)	Observation		ALRT	detected issue
BATTERY	battery		CLNTRL	clinical trial
CONC	concern		COND	Condition
CASE	public health case		OUTB	outbreak
DGIMG	diagnostic image		GEN	genomic observation
DETPOL	determinant peptide		EXP	expression level
LOC	locus		PHN	phenotype
POL	polypeptide		SEQ	bio sequence
SEQVAR	bio sequence variation		INVSTG	investigation
OBSSER	observation series		OBSCOR	correlated observation sequences
POS	position		POSACC	position accuracy
POSCOORD	position coordinate		SPCOBS	specimen observation
VERIF	Verification		ROIBND	bounded ROI
ROIOVL	overlay ROI		LLD (Deprecated)	left lateral decubitus
PRN (Deprecated)	prone		RLD (Deprecated)	right lateral decubitus
SFWL (Deprecated)	Semi-Fowler's		SIT (Deprecated)	sitting
STN (Deprecated)	standing		SUP (Deprecated)	supine
RTRD (Deprecated)	reverse trendelenburg		TRD (Deprecated)	trendelenburg
CNOD (Deprecated)	Condition Node
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

ObservationMedia.moodCode

The ObservationMedia.moodCode is fixed to "EVN" or event mood to indicate that this is ObservationMedia is from a past service.

Table X: Fixed ObservationMedia.moodCode

Code	Display Name
EVN	event (occurrence)
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

ObservationMedia.id

An optional identifier for the ObservationMedia instance.

ObservationMedia.languageCode

Specifies the human language of character data (whether they be in contents or attribute values).

ObservationMedia.value

The ObservationMedia.value is set to the xsi:type="ED" which enables the referencing of the multi-media object. Review the ED data type for more information about linking to files.

5.3.6.5 Organizer

Organizer

A derivative of the RIM Act class, which can be used to create arbitrary groupings of other CDA entries that share a common context. An Organizer can contain other Organizers and/or other CDA entries, by traversing the component relationship. An Organizer can refer to external acts by traversing the reference relationship. An Organizer cannot be the source of an entryRelationship relationship.

NOTE: CDA entries such as Observation can also contain other CDA entries by traversing the entryRelationship class. There is no requirement that the Organizer entry be used in order to group CDA entries.

Table X: Organizer Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	V:x_ActClassDocumentEntryOrganizer	Closed
moodCode	CS	[1..1]	EVN	Fixed
id	SET <II>	[0..*]
code	CD	[0..1]	D:ActCode	Open
text	ED	[0..1]
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	IVL<TS>	[0..1]
activityTime	GTS	[0..1]
availabilityTime	TS	[0..1]
priorityCode	CE	[0..1]	D:ActPriority	Open
confidentialityCode	SET<CE>	[0..*]	D:Confidentiality	Open

Organizer.classCode

The Organizer.classCode can take on one of two values, BATTERY or CLUSTER.

1. CLUSTER is an ACT that organizes a set of component acts into a semantic grouping that have a shared subject. The subject may be either a subject participation (SBJ), subject act relationship (SUBJ), or child participation/act relationship types.
2. The BATTERY is an observation that is composed of a set of observations. These observations typically have a logical or practical grouping for generally accepted clinical or functional purposes, such as observations that are run together because of automation. A battery can define required and optional component observations and, in some cases, will define complex rules that determine whether or not a particular observation is made. BATTERY is a constraint on the Observation class in that it is understood to always be composed of component observations.

Table X: Value set for Organizer.classCode

V:x_ActClassDocumentEntryOrganizer [2.16.840.1.113883.1.11.19598] (CLOSED)
Code	Display Name		Code	Display Name
BATTERY	battery		CLUSTER	Cluster
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Organizer.moodCode

The Organizer.moodCode is fixed to the "EVN" or event mood to indicate that the Organizer has been created with the contents specified.

Table X: Fixed Organizer.moodCode

Code	Display Name
EVN	event (occurrence)
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

Organizer.id

An optional identifier for the Organizer instance.

Organizer.code

The particular kind of Organizer that the Organizer-instance represents within its class. Organizer.code, if used, SHALL be a specialization of the Organizer.classCode. This attribute defines a specific sub-type of a given Organizer type (BATTERY or CLUSTER). The Organizer.code is bound to the ActCode concept domain.

Organizer.text

A renderable textual or multimedia description (or reference to a description) of the complete information which would reasonably be expected to be displayed to a human reader conveyed by the Organizer. The Organizer.text attribute can reference the associated narrative content in the section using the XML ID attribute added to the Narrative Text elements.

Organizer.statusCode

The status reflects the state of the activity. The RIM based state machine diagram depicts the allowable state transitions that an Organizer.StatusCode can take on.

Table X: Value set for Organizer.statusCode

V:ActStatus [2.16.840.1.113883.1.11.15933] (CLOSED)
Code	Display Name		Code	Display Name
normal	normal		aborted	aborted
active	active		cancelled	cancelled
completed	completed		held	held
new	new		suspended	suspended
nullified	nullified		obsolete	obsolete
Code System: ActStatus (HL7) Code System OID: 2.16.840.1.113883.5.14

Organizer.effectiveTime

The optional Organizer.effectiveTime is used to indicate the clinically or operationally relevant time of an Organizer's component items, exclusive of administrative activity. For example, in a Blood Gas Analysis (BGA), a result might not be available for several minutes after the specimen was taken. The effectiveTime is the time the specimen was taken, the availabilityTime would be the time the result was available for review.

Organizer.activityTime

The optional Organizer.activityTime is a time expression specifying when the activityTime of the Organizer's component items occurred, inclusive of administrative time E.g. times of component actions, such as preparation and clean-up. Depending on the mood code used, it represents the time the component Acts occurred, is supposed to occur, is scheduled to occur, etc.

Organizer.availabilityTime

The optional Observation.availabilityTime is the point in time at which information about the component Acts regardless of mood) first became available to a system. The availabilityTime is metadata describing the recording of, not the Organizer's component activities themselves.

Organizer.priorityCode

The optional priorityCode identifies the urgency under which the component Act's happened, can happen, is happening, is intended to happen, or is requested/demanded to happen. The Organizer.priorityCode is bound to the ActPriority concept domain.

Organizer.confidentialityCode

The optional confidentialityCode identifies any constraints around appropriate disclosure of information about this Organizer and it's component Acts, regardless of mood. The Organizer.confidentialityCode is bound to the Confidentiality concept domain.

5.3.6.6 Procedure

Procedure

A derivative of the RIM Procedure class, is represents an act whose immediate and primary outcome (post-condition) is the alteration of the physical condition of the subject.

Table X: Procedure Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	<= PROC is V:ActClassProcedure	Closed
moodCode	CS	[1..1]	V:x_DocumentProcedureMood	Closed
id	SET <II>	[0..*]
code	CD	[0..1]	D:ActProcedureCode	Open
actonNegationInd	BL	[0..1]
negationInd (Deprecated)	BL	[0..1]
text	ED	[0..1]
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	IVL<TS>	[0..1]
activityTime	GTS	[0..1]
availabilityTime	TS	[0..1]
priorityCode	CE	[0..1]	D:ActPriority	Open
confidentialityCode	SET<CE>	[0..*]	D:Confidentiality	Open
uncertaintyCode	CE	[0..1]	D:ActUncertainty	Open
languageCode	CS	[0..1]	D:HumanLanguage	Closed
isCriterionInd	BL	[0..1]
methodCode	CE	[0..*]	D:ProcedureMethod	Open
approachSiteCode	CE	[0..*]	D:ActSite	Open
targetSiteCode	CE	[0..*]	D:ActSite	Open

Procedure.classCode

The defines a specific sub-type of a given Procedure type. The Procedure.classCode is bound to the V:ActClassProcedure value set.

Table X: Value set for Procedure.classCode

V:ActClassProcedure [2.16.840.1.113883.1.11.19665] (CLOSED)
Code	Display Name		Code	Display Name
PROC (Default)	procedure		SBEXT	Substance Extraction
SPECCOLLECT	Specimen Collection
Note: Although SBADM is technically allowed, is best used with the SubstanceAdministration Entry Class
SBADM	substance administration
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Procedure.moodCode

The intended use of the Procedure statement: as a procedure report, a command, a possibility, a goal, etc. Since the mood code is a determining factor for the meaning of an entire Procedure object, the mood must always be known. This means that whenever an Procedure is instantiated, the mood attribute SHALL be assigned to a valid code, and the mood assignment SHALL NOT change throughout the lifetime of the Procedure.

Table X: Value set for Procedure.moodCode

V:x_DocumentProcedureMood [2.16.840.1.113883.1.11.19460] (CLOSED)
Code	Display Name		Code	Display Name
APT	appointment		ARQ	appointment request
EVN	event		DEF	definition
RQO	request		INT	intent
PRMS	promise		PRP	proposal
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

Procedure.id

A unique identifier for the Procedure.

Procedure.code

The particular kind of Procedure that the Procedure-instance represents within its class. Procedure.code, if used, SHALL be a specialization of the Procedure.classCode. This attribute defines a specific sub-type of a given Procedure type (determined by the "classCode" attribute). The Procedure.code is bound to the ActProcedureCode concept domain.

Procedure.actionNegationInd

The Procedure.actionNegationInd works as a negative existence quantifier on the actual, intended or described Procedure event. In Event mood, it indicates the defined procedure did not occur. In Intent mood, it indicates the defined procedure is not intended/desired to occur. In Criterion mood, it indicates that the condition is based on the non-occurrence of the event. It is nonsensical to have a negationInd of true for acts with a mood of definition.

The actionNegationInd negates the Act as described by the descriptive properties which are: classCode, code, statusCode, effectiveTime, activityTime, priorityCode, isCriterionInd, methodCode, approachSiteCode, targetSiteCode and any of their components.

The remaining properties represent the document characteristics, E.g. Procedure.id, Procedure.moodCode, Procedure.confidentialityCode, and particularly the Author-Participation are not negated. These document characteristic properties always have the same meaning: i.e., the author remains to be the author of the negative observation. Also, most ActRelationships (except for components) are not included in the negation. Refer to the attribute isDocumentCharacteristic property and the ActRelationshipType and ParticipationType code system isDocumentCharacteristic properties for specific guidance.

Procedure.negationInd

Procedure.negationInd, is deprecated in RIM 2.35, and CDA R2.1 retains it for backwards compatibility. CDA R2.1 compliant implementation guides should use actionNegationInd moving forward.

Procedure.text

A renderable textual or multimedia description (or reference to a description) of the complete information which would reasonably be expected to be displayed to a human reader conveyed by the Procedure. The Procedure.text attribute can reference the associated narrative content in the section using the XML ID attribute added to the Narrative Text elements.

Procedure.statusCode

The status reflects the state of the activity. The RIM based state machine diagram depicts the allowable state transitions that an Procedure.statusCode can take on.

Table X: Value set for Procedure.statusCode

V:ActStatus [2.16.840.1.113883.1.11.15933] (CLOSED)
Code	Display Name		Code	Display Name
normal	normal		aborted	aborted
active	active		cancelled	cancelled
completed	completed		held	held
new	new		suspended	suspended
nullified	nullified		obsolete	obsolete
Code System: ActStatus (HL7) Code System OID: 2.16.840.1.113883.5.14

Procedure.effectiveTime

Procedure.effectiveTime is used to indicate the clinically or operationally relevant time of a procedure, exclusive of administrative activity. For a surgical procedure (operation), the effectiveTime is the time relevant for the patient, i.e., between incision and last suture. For transportation acts, the effective time is the time the transported payload is en route.

Procedure.activityTime

Procedure.activityTime is a time expression specifying when a procedure occurs, inclusive of administrative time E.g. times of component actions, such as preparation and clean-up. Depending on the mood code used, it represents the time the procedure occurred, is supposed to occur, is scheduled to occur, etc. For Procedures the activityTime can provide a needed administrative function by providing a more inclusive time to be anticipated in scheduling.

Procedure.availabilityTime

Procedure.availabilityTime is the point in time at which information about a procedure instance (regardless of mood) first became available to a system. The availabilityTime is metadata describing the recording of, not the procedure itself.

Procedure.priorityCode

The urgency under which the Act happened, can happen, is happening, is intended to happen, or is requested/demanded to happen. The Procedure.priorityCode is bound to the ActPriority concept domain.

Procedure.confidentialityCode

Constraints around appropriate disclosure of information about this Procedure, regardless of mood. The Procedure.confidentialityCode is bound to the Confidentiality concept domain.

Procedure.uncertaintyCode

An indication that the Procedure statement as a whole, with its subordinate components has been asserted to be uncertain in some way. The use of the uncertaintyCode is appropriate only if the entirety of the Procedure and its dependent Acts is questioned. The Procedure.uncertaintyCode is bound to the ActUncertainty concept domain.

Procedure.languageCode

The primary language in which this Procedure statement is specified, particularly the language of the Procedure.text. The Procedure.languageCode is bound to the HumanLanguage concept domain.

Procedure.isCriterionInd

Is defaulted to false, when set to true it indicates that the data conveyed by the act, including outbound associations, represent "criteria" for some other act, not a "real" act. I.e. If an Act exists with a classCode of ACT and a moodCode of RQO and isCriterionInd is true, it does not represent an order for an act. Rather, it represents a criteria that will match on all orders.

Procedure.methodCode

The means or technique used to ascertain the observation. In some procedures the method is already partially specified by the Procedure.code. In this case, the methodCode NEED NOT be used at all. The methodCode MAY still be used to identify this method more clearly in addition to what is implied from the Procedure.code. However, an information consumer system or process SHOULD NOT depend on this methodCode information for method detail that is implied by the Procedure.code.

Procedure.approachSiteCode

The anatomical site or system through which the procedure reaches its target.

Procedure.targetSiteCode

The anatomical site or system that is the focus of the procedure. Most procedure target sites are implied by the procedure definition and Procedure.code, or Procedure.value. If the subject of the procedure is something other than a human patient or animal, the attribute is used analogously to specify a structural landmark of the thing where the Procedure occurred.

5.3.6.7 RegionOfInterest

Region of Interest

A derivative of the RIM Observation class that represents a region of interest on an image, using an overlay shape. RegionOfInterest is used to make reference to specific regions in images, e.g., to specify the site of a physical finding by "circling" a region in a schematic picture of a human body. The relationship between a RegionOfInterest and its referenced ObservationMedia or ExternalObservation is specified by traversing the entryRelationship or reference class, respectively, where typeCode equals "SUBJ". A RegionOfInterest must reference exactly one ObservationMedia or one ExternalObservation. If the RegionOfInterest is the target of a <renderMultimedia> reference, then it shall only reference an ObservationMedia and not an ExternalObservation.

Table X: RegionOfInterest Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	ROIOVL	Fixed
moodCode	CS	[1..1]	EVN	Fixed
id	SET <II>	[0..*]
code	CE	[0..1]	V:ROIOverlayShape	Closed
value	LIST<INT>	[1..*]

NOTE: XML ID Attribute added

An XML attribute "ID" of type XML ID, is added to RegionOfInterest within the CDA Schema. This attribute serves as the target of a <renderMultiMedia> reference (see <renderMultiMedia> (§ 5.3.5.6)). All values of attributes of type XML ID must be unique within the document (per the W3C XML specification).

RegionOfInterest.classCode

The RegionOfInterest.classCode is fixed to "ROIOVL" which is a Region of Interest (ROI) specified for an image using an overlay shape. Typically used to make reference to specific regions in images, e.g., to specify the location of a radiologic finding in an image or to specify the site of a physical finding by "circling" a region in a schematic picture of a human body. The units of the coordinate values are in pixels. The origin is in the upper left hand corner, with positive X values going to the right and positive Y values going down. The relationship between a ROI and its referenced Act is specified through an ActRelationship of type "subject" (SUBJ), which must always be present.

Table X: Fixed RegionOfInterest.classCode

Code	Display Name
ROIOVL	overlay ROI
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

RegionOfInterest.moodCode

The RegionOfInterest.moodCode is fixed to "EVN" or event mood to indicate that this is region of interest, was created.

Table X: Fixed RegionOfInterest.moodCode

Code	Display Name
EVN (Fixed)	event (occurrence)
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

RegionOfInterest.id

The optional RegionOfInterest.id allows for the unique identification of the region of interest.

RegionOfInterest.code

There are 4 types of regions that can be created, they are determined by the RegionOfInterest.code which can take on 1 of the following codes: circle, ellipse, point and polyline.

Table X: Value set for RegionOfInterest.code

V:ROIOverlayShape [2.16.840.1.113883.1.11.16117] (CLOSED)
Code	Display Name		Code	Display Name
CIRCLE	circle		ELLIPSE	ellipse
POINT	point		POLY	polyline
Code System: ActCode (HL7) Code System OID: 2.16.840.1.113883.5.4

RegionOfInterest.value

The RegionOfInterest.value units are pixels, expressed as a list of integers. The origin is in the upper left hand corner, with positive X values going to the right and positive Y values going down.

EXAMPLE

The following example illustrates one sample use of RegionOfInterest. In this case, the clinician has identified a rash upon physical examination of the skin, and indicates this by creating a region of interest atop a hand image taken from an image library. The narrative block references the RegionOfInterest via the <renderMultiMedia> tag, and the referenced RegionOfInterest references the hand image.

Example X

<section>
   <code code="8709-8" codeSystem="2.16.840.1.113883.6.1" 
    codeSystemName="LOINC"/>
   <title>Skin Exam</title>
   <text>Erythematous rash, palmar surface, left index 
    finger.<renderMultiMedia referencedObject="MM2"/>
   </text>
   <entry>
      <observation classCode="OBS" moodCode="EVN">
         <code code="271807003" 
          codeSystem="2.16.840.1.113883.6.96" 
          codeSystemName="SNOMED CT" 
          displayName="Rash"/>
         <statusCode code="completed"/>
         <targetSiteCode code="48856004" 
          codeSystem="2.16.840.1.113883.6.96" 
          codeSystemName="SNOMED CT" 
          displayName="Skin of palmer surface of index finger">
            <qualifier>
               <name code="78615007" 
                codeSystem="2.16.840.1.113883.6.96" 
                displayName="with laterality"/>
               <value code="7771000" 
                codeSystem="2.16.840.1.113883.6.96" 
                displayName="left"/>
            </qualifier>
         </targetSiteCode>
         <entryRelationship typeCode="SPRT">
            <regionOfInterest classCode="ROIOVL" moodCode="EVN" ID="MM2">
               <id root="2.16.840.1.113883.19.3.1"/>
               <code code="ELLIPSE"/>
               <value value="3"/>
               <value value="1"/>
               <value value="3"/>
               <value value="7"/>
               <value value="2"/>
               <value value="4"/>
               <value value="4"/>
               <value value="4"/>
               <entryRelationship typeCode="SUBJ">
                  <observationMedia classCode="OBS" moodCode="EVN">
                     <id root="2.16.840.1.113883.19.2.1"/>
                     <value mediaType="image/jpeg">
                        <reference value="lefthand.jpeg"/>
                     </value>
                  </observationMedia>
               </entryRelationship>
            </regionOfInterest>
         </entryRelationship>
      </observation>
   </entry>
</section>

5.3.6.8 SubstanceAdministration

Substance Administration

A derivative of the RIM SubstanceAdministration class, used for representing medication-related events such as medication history or planned medication administration orders.

Table X: SubstanceAdministration Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	SBADM	Fixed
moodCode	CS	[1..1]	V:x_DocumentSubstanceMood	Closed
id	SET <II>	[0..*]
code	CD	[0..1]	D:ActSubstanceAdministrationCode	Open
actonNegationInd	BL	[0..1]
negationInd (Deprecated)	BL	[0..1]
text	ED	[0..1]
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	GTS	[0..1]
activityTime	GTS	[0..1]
availabilityTime	TS	[0..1]
priorityCode	CE	[0..1]	D:ActPriority	Open
confidentialityCode	SET<CE>	[0..*]	D:Confidentiality	Open
repeatNumber	IVL<INT>	[0..1]
languageCode	CS	[0..1]	D:HumanLanguage	Closed
isCriterionInd	BL	[0..1]
routeCode	CE	[0..1]	D:RouteOfAdministration	Open
approachSiteCode	SET<CD>	[0..*]	D:ActSite	Open
doseQuantity	IVL<PQ>	[0..*]
rateQuantity	IVL<PQ>	[0..*]
doseCheckQuantity	SET<RTO<PQ,PQ.TIME>>	[0..*]
maxDoseQuantity	SET<RTO<PQ,PQ.TIME>>	[0..*]
administrationUnitCode	CE	[0..1]	D:AdministrableDrugForm	Open

SubstanceAdministration.classCode

The SubstanceAdministration.classCode is fixed to "SBADM" which indicates an act of introducing or otherwise applying a substance to the subject.

Table X: Fixed SubstanceAdministration.classCode

Code	Display Name
SBADM	substance administration
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

SubstanceAdministration.moodCode

SubstanceAdministration.moodCode has been bound to the x_DocumentSubstanceMood value set.

Table X: Fixed SubstanceAdministration.moodCode

V:x_DocumentSubstanceMood [2.16.840.1.113883.1.11.19461] (CLOSED)
Code	Display Name		Code	Display Name
EVN	event		DEF	definition
RQO	request		INT	intent
PRMS	promise		PRP	proposal
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

SubstanceAdministration.id

The optional SubstanceAdministration.id can be used to uniquely identify the substance administration.

SubstanceAdministration.code

The SubstanceAdministration.code has been bound to the ActSubstanceAdministrationCode concept domain.

SubstanceAdministration.actionNegationInd

The SubstanceAdministration.actionNegationInd works as a negative existence quantifier on the actual, intended or described substance administration event. In Event mood, it indicates the defined substance administration did not occur. In Intent mood, it indicates the defined substance administration is not intended/desired to occur. In Criterion mood, it indicates that the condition is based on the non-occurrence of the event. It is nonsensical to have a negationInd of true for acts with a mood of definition.

The actionNegationInd negates the SubstanceAdministration as described by the descriptive properties which are: classCode, code, statusCode, effectiveTime, activityTime, priorityCode, repeatNumber, isCriterionInd, routeCode, approachSiteCode, doseQuantity, rateQuantity, maxDoseQuantity, administrationUnitCode and any of their components.

The remaining properties represent the document characteristics, E.g. SubstanceAdministration.id, SubstanceAdministration.moodCode, SubstanceAdministration.confidentialityCode, and particularly the Author-Participation are not negated. These document characteristic properties always have the same meaning: i.e., the author remains to be the author of the negative observation. Also, most ActRelationships (except for components) are not included in the negation. Refer to the attribute isDocumentCharacteristic property and the ActRelationshipType and ParticipationType code system isDocumentCharacteristic properties for specific guidance.

SubstanceAdministration.negationInd

SubstanceAdministration.negationInd, is deprecated in RIM 2.35, and CDA R2.1 retains it for backwards compatibility. CDA R2.1 compliant implementation guides should use actionNegationInd moving forward.

SubstanceAdministration.text

A renderable textual or multimedia description (or reference to a description) of the complete information which would reasonably be expected to be displayed to a human reader conveyed by the SubstanceAdministration. The SubstanceAdministration.text attribute can reference the associated narrative content in the section using the XML ID attribute added to the Narrative Text elements.

SubstanceAdministration.statusCode

The status reflects the state of the activity. The RIM based state machine diagram depicts the allowable state transitions that an SubstanceAdministration.StatusCode can take on.

Table X: Value set for SubstanceAdministration.statusCode

V:ActStatus [2.16.840.1.113883.1.11.15933] (CLOSED)
Code	Display Name		Code	Display Name
normal	normal		aborted	aborted
active	active		cancelled	cancelled
completed	completed		held	held
new	new		suspended	suspended
nullified	nullified		obsolete	obsolete
Code System: ActStatus (HL7) Code System OID: 2.16.840.1.113883.5.14

SubstanceAdministration.effectiveTime

SubstanceAdministration.effectiveTime is the clinically relevant time of an substance administration act, exclusive of administrative activity. It is used to indicate the time over which the substance is to be administered, including the frequency of administration (e.g., TID for 10 days). SubstanceAdministration.effectiveTime is used to describe the timing of administration. It is modeled using the GTS data type to accommodate various dosing scenarios, as illustrated in the following example.

SubstanceAdministration.activityTime

SubstanceAdministration.activityTime is a time expression specifying when the substance administration activity occurs, inclusive of administrative time E.g. times of component actions, such as preparation and clean-up. The substance administration activityTime can provide a needed administrative function, by providing a more inclusive time to be anticipated in scheduling.

SubstanceAdministration.availabilityTime

SubstanceAdministration.availabilityTime is the point in time at which information about a substance administration instance (regardless of mood) first became available to a system. The availabilityTime is metadata describing the recording of, not the substance administration itself.

SubstanceAdministration.priorityCode

The urgency under which the SubstanceAdministration happened, can happen, is happening, is intended to happen, or is requested/demanded to happen. The SubstanceAdministration.priorityCode is bound to the ActPriority concept domain.

SubstanceAdministration.confidentialityCode

Constraints around appropriate disclosure of information about this SubstanceAdministration, regardless of mood. The SubstanceAdministration.confidentialityCode is bound to the Confidentiality concept domain.

SubstanceAdministration.repeatNumber

An interval of integer numbers stating the minimal and maximal number of repetitions of the SubstanceAdministration.

SubstanceAdministration.languageCode

The primary language in which this SubstanceAdministrationstatement is specified, particularly the language of the SubstanceAdministration.text. The SubstanceAdministration.languageCode is bound to the HumanLanguage concept domain.

SubstanceAdministration.isCriterionInd

Is defaulted to false, when set to true it indicates that the data conveyed by the act, including outbound associations, represent "criteria" for some other act, not a "real" act. I.e. If an Act exists with a classCode of ACT and a moodCode of RQO and isCriterionInd is true, it does not represent an order for an act. Rather, it represents a criteria that will match on all orders.

SubstanceAdministration.routeCode

The physiological path or route for introducing the therapeutic material into or onto the subject. Route, site of administration (administrationSiteCode), method of administration (methodCode) and the device used in administration are closely related. All four (if present) must be closely coordinated and in agreement. In some cases, the coding system used to specify one may pre-coordinate one or more of the others.

SubstanceAdministration.approachSiteCode

The anatomical site or system through which the procedure reaches its target.

SubstanceAdministration.doseQuantity

SubstanceAdministration.doseQuantity indicates how much medication is given per dose.

SubstanceAdministration.rateQuantity

SubstanceAdministration.rateQuantity can be used to indicate the rate at which the dose is to be administered (e.g., the flow rate for intravenous infusions).

SubstanceAdministration.doseCheckQuantity

The ratio of a quantity to be consumed over the period of time during which it expected to be consumed.

SubstanceAdministration.maxDoseQuantity

SubstanceAdministration.maxDoseQuantity is used to capture the maximum dose of the medication that can be given over a stated time interval (e.g., maximum daily dose of morphine, maximum lifetime dose of doxorubicin).

SubstanceAdministration.administrationUnitCode

A unit for the administered substance.

1. This attribute SHOULD be used if and only if the material specified as the player of the Role attaching to the consumable participation is not in itself the finished dose form to be administered but a larger whole, pack, etc.
2. If the material so specified is the proper administered dose form, such as a tablet, capsule, etc. then this attribute SHOULD be valued NULL (not applicable).
3. If the material so specified is an amorphous substance (liquid, gas, powder, etc.) to be measured as a volume, mass, etc., then this attribute SHOULD remain NULL (not applicable).
4. If the material so specified is a container, and the content is to be measured as a volume, mass, etc., then this attribute SHOULD be specified as "measured portion".

Example X

<section>
   <text>Take captopril 25mg PO every 12 hours, starting on 
    Jan 01, 2002, ending on Feb 01, 2002.
   </text>
   <entry>
      <substanceAdministration classCode="SBADM" moodCode="RQO">
         <effectiveTime xsi:type="IVL_TS">
            <low value="20020101"/>
            <high value="20020201"/>
         </effectiveTime>
         <effectiveTime xsi:type="PIVL_TS" operator="A">
            <period value="12" unit="h"/>
         </effectiveTime>
         <routeCode code="PO" 
          codeSystem="2.16.840.1.113883.5.112" 
          codeSystemName="RouteOfAdministration"/>
         <doseQuantity value="1"/>
         <consumable>
            <manufacturedProduct>
               <manufacturedLabeledDrug>
                  <code code="318821008" 
                   codeSystem="2.16.840.1.113883.6.96" 
                   codeSystemName="SNOMED CT" 
                   displayName="Captopril 25mg tablet"/>
               </manufacturedLabeledDrug>
            </manufacturedProduct>
         </consumable>
      </substanceAdministration>
   </entry>
</section>

5.3.6.8.1 consumable

The capture of medication-related information also involves the interrelationship of SubstanceAdministration with several other classes.

Table X: consumable

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	CSM	consumable
contextControlCode	CS	[0..1]	OP	Fixed

consumable.typeCode

The consumable.typeCode is fixed to "CSM" to represent a consumable participation.

Table X: Fixed consumable.typeCode

Code	Display Name
CSM	consumable
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

consumable.contextControlCode

The consumable.contextControlCode is fixed to "OP". It means that the consumable identified will replace the set of consumables that have propagated from ancestor Acts, and will itself be the only consumable to propagate to any child Acts that allow context to be propagated.

5.3.6.8.2 ManufacturedProduct

The consumable participation is used to bring in the LabeledDrug or Material entity that describes the administered substance via the ManufacturedProduct role class.

ManufacturedProduct.classCode

The ManufacturedProduct.typeCode is fixed to "MANU" to represent the role of manufactured. The playing role is what was manufactured and the scoping role identifies the manufacturer.

Table X: Fixed ManufacturedProduct.classCode

Code	Display Name
MANU	manufactured
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

ManufacturedProduct.id

An optional unique identifier assigned by the manufacturer.

5.3.6.8.3 LabeledDrug

The LabeledDrug class, which is an Entity class playing the Role of Manufactured Product, identifies the drug that is consumed in the substance administration. The medication is identified by means of the LabeledDrug.code or the LabeledDrug.name.

LabeledDrug.classCode

The LabeledDrug.classCode is fixed to "MMAT" which indicates the substance administered was manufactured.

Table X: Fixed LabeledDrug.classCode

Code	Display Name
MMAT	A manufactured material.
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

LabeledDrug.determinerCode

The determinerCode is fixed to "KIND", which indicates that the LabeledDrug referenced, represents a kind or class of Labeled drug.

Table X: Fixed LabeledDrug.determinerCode

Code	Display Name
KIND	described
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

LabeledDrug.code

The LabeledDrug.code is bound to the DrugEntity concept domain, which identifies a substance whose therapeutic effect is produced by chemical action within the body.

LabeledDrug.name'

An optional non-unique textual identifier or moniker for the LabeledDrug.

5.3.6.8.4 Material

The Material entity can be used to identify non-drug administered substances such as vaccines and blood products and drugs.

Material.classCode

The Material.classCode is fixed to "MMAT" which indicates the material administered was manufactured.

Table X: Fixed Material.classCode

Code	Display Name
MMAT	A manufactured material.
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

Material.determinerCode

The determinerCode is fixed to "KIND", which indicates that the Material referenced, represents a kind or class of Material.

Table X: Fixed Material.determinerCode

Code	Display Name
KIND	described
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

Material.code

The Material.code is bound to the MaterialEntityClassType concept domain, which identifies types of materials.

Material.name

An optional non-unique textual identifier or moniker for the Material.

Material.desc

A textual or multimedia depiction of the Material.

Material.formCode

The physical state and nature of the material.

Material.lotNumberText

An identifier for a particular batch of manufactured material.

5.3.6.9 Supply

Supply

The Supply class represents dispensing, whereas the SubstanceAdministration class represents administration. Prescriptions are complex activities that involve both an administration request to the patient (e.g. take digoxin 0.125mg by mouth once per day) and a supply request to the pharmacy (e.g. dispense 30 tablets, with 5 refills). This should be represented in CDA by a SubstanceAdministration entry that has a component Supply entry. The nested Supply entry can have Supply.independentInd set to "false" to signal that the Supply cannot stand alone, without it's containing SubstanceAdministration. The following example illustrates a prescription representation in CDA.

Table X: Supply Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	SPLY	Fixed
moodCode	CS	[1..1]	V:x_DocumentSubstanceMood	Closed
id	SET <II>	[0..*]
code	CD	[0..1]	D:ActSupplyType	Open
actionNegationInd	BL	[0..1]
text	ED	[0..1]
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	GTS	[0..1]
activityTime	GTS	[0..1]
availabilityTime	TS	[0..1]
priorityCode	CE	[0..*]	D:ActPriority	Open
confidentialityCode	SET<CE>	[0..*]	D:Confidentiality	Open
repeatNumber	IVL<INT>	[0..1]
independentInd	BL	[0..1]
languageCode	CS	[0..1]	D:HumanLanguage	Closed
isCriterionInd	BL	[0..1]
quantity	PQ	[0..1]
expectedUseTime	IVL<TS>	[0..1]

Supply.classCode

The Supply.classCode is fixed to "SPLY" which is used to represent a Supply. Supply orders and deliveries are simple Acts that focus on the delivered product. The product is associated with the Supply Act via Participation.typeCode="product". With general Supply Acts, the precise identification of the Material (manufacturer, serial numbers, etc.) is important. Most of the detailed information about the Supply should be represented using the Material class.

Table X: Fixed Supply.classCode

Code	Display Name
SPLY	supply
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Supply.moodCode

The Supply.moodCode is bound to the x_ClinicalStatementSubstanceMood value set.

Table X: Value set for Supply.moodCode

V:x_ClinicalStatementSubstanceMood [2.16.840.1.113883.1.11.19645] (CLOSED)
Code	Display Name		Code	Display Name
EVN	event		DEF	definition
RQO	request		INT	intent
PRMS	promise		PRP	proposal
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

Supply.id

The optional Supply.id is used to uniquely identify the supply activity.

Supply.code

The optional Supply.code is bound to the ActSupplyType concept domain, which is used to further define the type of supply for order or distribution. Examples:

• central supply
• materials management
• nurse station supply

Supply.actionNegationInd

The Supply.actionNegationInd works as a negative existence quantifier on the actual, intended or described Supply event. In Event mood, it indicates the defined supply act did not occur. In Intent mood, it indicates the defined supply act is not intended/desired to occur. In Criterion mood, it indicates that the condition is based on the non-occurrence of the event. It is nonsensical to have a negationInd of true for acts with a mood of definition.

The actionNegationInd negates the Supply act as described by the descriptive properties which are: classCode, code, statusCode, effectiveTime, activityTime, priorityCode, repeatNumber, independentInd, isCriterionInd, quantity, expectedUseTime and any of their components.

The remaining properties represent the document characteristics, E.g. Supply.id, Supply.moodCode, Supply.confidentialityCode, and particularly the Author-Participation are not negated. These document characteristic properties always have the same meaning: i.e., the author remains to be the author of the negative observation. Also, most ActRelationships (except for components) are not included in the negation. Refer to the attribute isDocumentCharacteristic property and the ActRelationshipType and ParticipationType code system isDocumentCharacteristic properties for specific guidance.

Supply.text

A renderable textual or multimedia description (or reference to a description) of the complete information which would reasonably be expected to be displayed to a human reader conveyed by the Supply activity.

Supply.statusCode

The status reflects the state of the activity. The RIM based state machine diagram depicts the allowable state transitions that an Supply.StatusCodes can take on.

Table X: Value set for Supply.statusCode

V:ActStatus [2.16.840.1.113883.1.11.15933] (CLOSED)
Code	Display Name		Code	Display Name
normal	normal		aborted	aborted
active	active		cancelled	cancelled
completed	completed		held	held
new	new		suspended	suspended
nullified	nullified		obsolete	obsolete
Code System: ActStatus (HL7) Code System OID: 2.16.840.1.113883.5.14

Supply.effectiveTime

Supply.effectiveTime is used to indicate the clinically or operationally relevant time of a supply, exclusive of administrative activity.

Supply.activityTime

Supply.activityTime is a time expression specifying when a supply occurs, inclusive of administrative time E.g. times of component actions, such as preparation and clean-up. Depending on the mood code used, it represents the time the Supply activity occurred, is supposed to occur, is scheduled to occur, etc.

Supply.availabilityTime

Supply.availabilityTime is the point in time at which information about an Supply instance (regardless of mood) first became available to a system. The availabilityTime is metadata describing the recording of, not the Supply itself.

Supply.priorityCode

The urgency under which the Supply activity happened, can happen, is happening, is intended to happen, or is requested/demanded to happen. The Supply.priorityCode is bound to the ActPriority concept domain.

Supply.confidentialityCode

Constraints around appropriate disclosure of information about this Supply activity, regardless of mood. The Supply.confidentialityCode is bound to the Confidentiality concept domain.

Supply.repeatNumber

An interval of integer numbers stating the minimal and maximal number of repetitions of the Supply activity.

Supply.independentInd

An indicator specifying whether the Act can be manipulated independently of other Acts or only through a super-ordinate composite Act that has this Act as a component. By default the independentInd should be true. An Act definition is sometimes marked with independentInd=false if the business rules would not allow this act to be ordered without ordering the containing act group.

Supply.languageCode

The primary language in which this Supply statement is specified, particularly the language of the Supply.text. The Supply.languageCode is bound to the HumanLanguage concept domain.

Supply.isCriterionInd

Is defaulted to false, when set to true it indicates that the data conveyed by the act, including outbound associations, represent "criteria" for some other act, not a "real" act. I.e. If an Act exists with a classCode of ACT and a moodCode of RQO and isCriterionInd is true, it does not represent an order for an act. Rather, it represents a criteria that will match on all orders.

Supply.quantity

The optional Supply.quantity is used to represent the amount of material that was or is to be supplied.

Supply.expectedUseTime

Th optional Supply.expectedUseTime is used to identify the period time over which the supplied product is expected to be used.

5.3.6.9.1 Product

The dispensed product is associated with the Supply act via a product participant, which connects to the same ManufacturedProduct role used for SubstanceAdministration.

Product.typeCode

The Product.typeCode is fixed to "PRD" which represents a product participation.

Table X: Fixed product.typeCode

Code	Display Name
PRD	product
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

5.3.6.9.2 ManufacturedProduct @a@

See ManufacturedProduct (§ 5.3.6.8.2) above.

Example X

<section>
   <text>Digoxin 0.125mg, 1 PO qDay, #30, 5 refills.</text>
   <entry>
      <substanceAdministration classCode="SBADM" moodCode="RQO">
         <effectiveTime xsi:type="PIVL_TS">
            <period value="24" unit="h"/>
         </effectiveTime>
         <routeCode code="PO" 
          codeSystem="2.16.840.1.113883.5.112" 
          codeSystemName="RouteOfAdministration"/>
         <doseQuantity value="1"/>
         <consumable>
            <manufacturedProduct>
               <manufacturedLabeledDrug>
                  <code code="317896006" 
                   codeSystem="2.16.840.1.113883.6.96" 
                   codeSystemName="SNOMED CT" 
                   displayName="Digoxin 125micrograms tablet"/>
               </manufacturedLabeledDrug>
            </manufacturedProduct>
         </consumable>
         <entryRelationship typeCode="COMP">
            <supply classCode="SPLY" moodCode="RQO">
               <repeatNumber>
                  <low value="0"/>
                  <high value="5"/>
               </repeatNumber>
               <independentInd value="false"/>
               <quantity value="30"/>
            </supply>
         </entryRelationship>
      </substanceAdministration>
   </entry>
</section>

5.3.7 Entry Participants

CDA structures and entries can have various participants, some of which are also defined in the CDA header. As described in the discussion of CDA context (see CDA Context (§ 5.4)), participants propagated from the header can be overridden within the body.

Entry Participants

5.3.7.1 author @b@

The author participant (described above, see author (§ 5.2.2.2)), can be ascribed to a CDA section where it overrides the value(s) propagated from the CDA header, or can be ascribed to a CDA entry, where it overrides the value(s) propagated from a CDA section and propagates to nested entries.

5.3.7.2 consumable

The consumable participant is described above (see Consumable (§ 5.3.6.8.1)).

5.3.7.3 informant @a@

The informant participant is described above (see informant (§ 5.2.2.6)). The informant can be ascribed to a CDA section where it overrides the value(s) propagated from the CDA header, or can be ascribed to a CDA entry, where it overrides the value(s) propagated from a CDA section and propagates to nested entries.

5.3.7.4 participant @a@

Participant

Can be used to represent any other participant that cannot be represented with one of the more specific participants. The participant can be ascribed to a CDA entry, and propagates to nested CDA entries, unless overridden.

Table X: informant

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	INF	Fixed
functionCode	CE	[0..1]	D:ParticipationFunction	Open
contextControlCode	CS	[0..1]	OP	Fixed
time	IVL<TS>	[0..1]
awarenessCode	CE	[0..1]	D:TargetAwareness	Open

participant.typeCode

The participant.typeCode is bound to the v:ParticipationType value set. This enables a wide range of participation types to be selected. Note: Where an existing participation exists, it should be used in preference to the generic participation, failure to do so, will result in needlessly additional complexity for implementations.

Table X: Value set for participant.typeCode

v:ParticipationType [2.16.840.1.113883.1.11.10901] (CLOSED)
Code	Display Name		Code	Display Name
PART	Participation		ADM	admitter
ATND	attender		AUTHEN	authenticator
CALLBCK	callback contact		CON	consultant
DIS	discharger		ESC	escort
REF	referrer		TRANS	Transcriber
ENT	data entry person		WIT	witness
CST	custodian		DIR	direct target
BBY	baby		DEV	device
NRD	non-reuseable device		RDV	reusable device
EXPAGNT	ExposureAgent		EXPART	ExposureParticipation
EXPTRGT	ExposureTarget		EXSRC	ExposureSource
IND	indirect target		BEN	beneficiary
CAGNT	causative agent		COV	coverage target
GUAR	guarantor party		HLD	holder
DON	donor		RCV	receiver
IRCP	information recipient		NOT	ugent notification contact
PRCP	primary information recipient		REFB	Referred By
REFT	Referred to		TRC	tracker
LOC	location		DST	destination
ELOC	entry location		ORG	origin
RML	remote		VIA	via
RESP	responsible party		VRF	verifier
Use the following participations, only if the other participations provided in CDA will not work
RCT	record target		AUT	author (originator)
INF	informant		CSM	consumable
PRD	product		SBJ	subject
SPC	specimen		PRF	performer
DIST	distributor		PPRF	primary performer
SPRF	secondary performer		LA	legal authenticator
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

participant.functionCode

The participant.functionCode is bound to the concept domain ParticipationFunction, which is used to specify the exact function an actor had in a service in all necessary detail. This domain may include local extensions (Open).

participant.contextControlCode

The participant.contextControlCode is fixed to "OP". Any participant(s) defined in a clinical entry, will override the participants with the same typeCode propagating from ancestor elements, in the header, body or sections.

Table X: Fixed participant.contextControlCode

Code	Display Name
OP	overriding, propagating
Code System: ContextControl (HL7) Code System OID: 2.16.840.1.113883.5.1057

participant.time

The time during which the participant is involved in the act through this Participation.

participant.awarenessCode

The extent to which the Entity playing the participating Role is aware of the associated Act. For diagnostic observations, the patient, family member or other participant may not be aware of the patient's terminal illness. Because this attribute typically indicates that awareness is in question, it normally describes a target Participation (e.g., that of a patient). If the awareness, denial, unconsciousness, etc. is the subject of medical considerations (e.g., part of the problem list), explicit observations should be employed: this simple attribute in the Participation cannot represent information sufficient to support medical decision-making.

5.3.7.4.1 ParticipantRole

A participant is an entity playing one of several possible roles (ParticipantRole class). The entity playing the role is a device (Device class) or other entity (PlayingEntity class).

Table X: ParticipantRole

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	V:RoleClassRoot	Fixed
id	SET<II>	[0..*]
code	CE	[0..1]	D:RoleCode	Open
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]

ParticipantRole.classCode

The ParticipantRole.classCode can be any role defined in the V:RoleClassRoot value set, not already provided for the Clinical Statement choice pattern.

Table X: Value set for ParticipantRole.classCode

V:RoleClassRoot [2.16.840.1.113883.1.11.13940] (CLOSED)
Code	Display Name		Code	Display Name
ROL (Default)	role		AFFL	affiliate
AGNT	agent		ASSIGNED	assigned entity
COMPAR	commissioning party		SGNOFF	signing authority or officer
CON	contact		ECON	emergency contact
NOK	next of kin		GUARD	guardian
CIT	citizen		COVPTY	covered party
CLAIM	claimant		NAMED	named insured
DEPEN	dependent		INDIV	individual
SUBSCR	subscriber		PROG	program eligible
CRINV	clinical research investigator		CRSPNSR	clinical research sponsor
EMP	employee		MIL	military person
GUAR	guarantor		INVSBJ	Investigation Subject
CASEBJ	Case Subject		RESBJ	research subject
LIC	licensed entity		NOT	notary public
PROV	healthcare provider		PAT	patient
PAYEE	payee		PAYOR	invoice payor
POLHOLD	policy holder		QUAL	qualified entity
SPNSR	underwriter		STD	student
UNDWRT	coverage sponsor		CAREGIVER	caregiver
PRS	personal relationship		ACCESS	access
ADMM	Administerable Material		BIRTHPL	birthplace
DEATHPLC	place of death		DST	distributed material
RET	retailed material		EXPR	exposed entity
HLD	held entity		HLTHCHRT	health chart
IDENT	identified entity		MANU	manufactured product
THER	therapeutic agent		MNT	maintained entity
OWN	owned entity		RGPR	regulated product
SDLOC	service delivery location		DSDLOC	dedicated service delivery location, health care facility
ISDLOC	incidental service delivery location		TERR	territory of authority
USED	used entity		WRTE	warranted product
EQUIV	equivalent entity		SAME	same
SUBY	subsumed by		GEN	has generalization
GRIC	has generic		INST	instance
SUBS	subsumer		CONT	content
EXPAGTCAR	exposure agent carrier		EXPVECTOR	exposure vector
FOMITE	fomite		INGR	ingredient
ACTI	active ingredient		ACTIB	active ingredient - basis of strength
ACTIM	active ingredient - moiety is basis of strength		ACTIR	active ingredient - reference substance is basis of strength
ADTV	additive		BASE	base
IACT	inactive ingredient		COLR	color additive, color
FLVR	flavor additive, flavor		PRSV	preservative
STBL	stabilizer		LOCE	located entity
STOR	stored entity		MBR	member
PART	part		ACTM	active moiety
SPEC	specimen		ALQT	aliquot
ISLT	isolate
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

ParticipantRole.id

The optional participantRole.id is a unique identifier for the player Entity in this Role.

ParticipantRole.code

The optional ParticipantRole.code is bound the the EntityCode concept domain.

ParticipantRole.addr

The optional ParticipantRole.addr is the postal address for the Entity while in the Role.

ParticipantRole.telecom

The optional ParticipantRole.telecom is the telecommunication address (phone number) for the Entity while in the Role.

5.3.7.4.2 Device

Scoping the ParticipantRole is an entity (Entity class).

Table X: Device

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	DEV	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
code	CE	[0..1]	D:EntityCode
manufacturerModelName	SC	[0..1]	D:ManufacturerModelName
softwareName	SC	[0..1]	D:SoftwareName

Device.classCode

The Device.classCode is defaulted to "DEV", but can take on any value defined in the EntityClassDevice value set.

Table X: Value set for Device.classCode

V:EntityClassDevice [2.16.840.1.113883.1.11.11623] (CLOSED)
Code	Display Name		Code	Display Name
DEV (Default)	role		CER	certificate representation
MODDV	imaging modality, ImagingModalityEntity
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

Device.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates we are referencing a specific device.

Table X: Fixed Device.determinerCode

Code	Display Name
INSTANCE	specific
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

Device.code

The optional Device.code is bound to the EntityCode domain.

Device.manufacturerModelName

The optional Device.manufacturerModelName is used to convey a coded name for the device.

Device.softwareName

The optional Device.softwareName is used to convey a coded name for the software used to author content.

5.3.7.4.3 PlayingEntity

Table X: PlayingEntity

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	DEV	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
code	CE	[0..1]	D:EntityCode
quantity	SET<PQ>	[0..*]
name	SET<PN>	[0..*]
desc	ED	[0..1]

Note: Support for more than one quantity element in PlayingEntity has been deprecated in CDA R2.1. The CDA R2.1 schema will continue to support multiple quantities for backwards compatibility with CDA R2, but implementers of new templates and document instances are encouraged to support only [0..1] instances.

PlayingEntity.classCode

The PlayingEntity.classCode is bound to the V:EntityClassRoot value set.

Table X: Value set for PlayingEntity.classCode

V:EntityClassRoot [2.16.840.1.113883.1.11.13922] (CLOSED)
Code	Display Name		Code	Display Name
ENT (Default)	entity		HCE	health chart entity
LIV	living subject		NLIV	non-person living subject
ANM	animal		MIC	microorganism
PLNT	plant		PSN	person
MAT	material		CHEM	chemical substance
FOOD	food		MMAT	manufactured material
CONT	container		HOLD	holder
DEV	device		CER	certificate representation
MODDV	imaging modality, ImagingModalityEntity		ORG	organization
PUB	public institution		STATE	state
NAT	Nation		PLC	place
CITY	city or town		COUNTRY	country
COUNTY	county or parish		PROVINCE	state or province
RGRP	group
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

PlayingEntity.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates we are referencing a specific entity.

Table X: Fixed PlayingEntity.determinerCode

Code	Display Name
INSTANCE	specific
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

PlayingEntity.code

The optional PlayingEntity.code is bound to the EntityCode domain. For each Entity, the value for this attribute is drawn from one of several coding systems as suggested by the Entity.classCode, such as living subject (animal and plant taxonomies), chemical substance (e.g., IUPAC code), organization (e.g., CMS provider number), etc. It is possible that Entity.code may be so fine grained that it represents a single instance. An example is the CDC vaccine manufacturer code, modeled as a concept vocabulary, when in fact each concept refers to a single instance. The boundary cases distinguishing codes and identifiers are controversial: this specification allows a certain amount of flexibility.

PlayingEntity.quantity

The optional PlayingEntity.quantity defines the a physical quantity specifying the amount of the physical thing represented by the Entity object, either as a count of the members of a group, or as some other physical quantity. In order to explicitly identify a group of like entities, a static model design should constrain the PQ data type of this attribute to INT, thus providing a count of the entities in the group.

Note: Support for more than one quantity element in PlayingEntity has been deprecated in CDA R2.1. The CDA R2.1 schema will continue to support multiple quantities for backwards compatibility with CDA R2, but implementers of new templates and document instances are encouraged to support only [0..1] instances.

PlayingEntity.name

Most entities have a commonly used name that can be used to differentiate them from other Entities, but that does not provide a necessarily unique identifier.

PlayingEntity.desc

A textual or multimedia depiction of the Entity.

5.3.7.4.4 Entity

A physical thing, group of physical things or an organization capable of participating in Acts while in a role.

Table X: Entity

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	ENT	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
id	SET<II>	[0..*]
code	CE	[0..1]	D:EntityCode
desc	ED	[0..1]

Entity.classCode

The Entity.classCode is bound to the V:EntityClassRoot value set.

Table X: Value set for Entity.classCode

V:EntityClassRoot [2.16.840.1.113883.1.11.13922] (CLOSED)
Code	Display Name		Code	Display Name
ENT (Default)	entity		HCE	health chart entity
LIV	living subject		NLIV	non-person living subject
ANM	animal		MIC	microorganism
PLNT	plant		PSN	person
MAT	material		CHEM	chemical substance
FOOD	food		MMAT	manufactured material
CONT	container		HOLD	holder
DEV	device		CER	certificate representation
MODDV	imaging modality, ImagingModalityEntity		ORG	organization
PUB	public institution		STATE	state
NAT	Nation		PLC	place
CITY	city or town		COUNTRY	country
COUNTY	county or parish		PROVINCE	state or province
RGRP	group
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

Entity.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates we are referencing a specific entity.

Table X: Fixed Entity.determinerCode

Code	Display Name
INSTANCE	specific
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

Entity.id

The optional Entity.id is used to uniquely identify the Entity.

Entity.code

The optional Entity.code is bound to the EntityCode domain.

Entity.desc

The optional Entity.desc is a textual or multimedia depiction of the Entity.

5.3.7.5 performer @a@

Performer

The performer is a person who carries out or will carry out a particular act. The performer need not be the principal responsible participant, e.g. a surgery resident operating under supervision of attending surgeon is a performer.

Table X: performer

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	PRF	Fixed
functionCode	CE	[0..1]	D:ParticipationFunction	Open
time	IVL<TS>	[0..1]
modeCode	CE	[0..1]	D:ParticipationMode	Fixed

performer.typeCode

The performer.typeCode is fixed to "PRF" which indicates a person, or organization that actually and principally carries out the action. Need not be the principal responsible actor.

Table X: Fixed performer.typeCode

Code	Display Name
PRF	performer
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

performer.functionCode

The performer.functionCode is bound to the concept domain ParticipationFunction, which is used to specify the exact function an actor had in a service in all necessary detail. This domain may include local extensions (Open).

performer.time

An optional interval of time which indicating the performer's participation in the associated Act.

performer.modeCode

The modality by which the Entity playing the Role is participating in the Act.

5.3.7.5.1 AssignedEntity @g@

A performer is an entity in the role of assigned entity (see AssignedEntity (§ 5.2.2.1.1)).

5.3.7.5.2 Person @i@

An assigned entity is a person assigned to the role by the scoping organization. The entity playing the role is a person (see Person (§ 5.2.2.2.2)).

5.3.7.5.3 Organization @j@

The entity scoping the role is an organization (see Organization (§ 5.2.2.1.3)).

5.3.7.6 product @a@

The product participant is described above (see product (§ 5.3.6.9.1)).

5.3.7.7 specimen

Specimen

A specimen is a part of some entity, typically the subject, that is the target of focused laboratory, radiology or other observations. In many clinical observations, such as physical examination of a patient, the patient is the subject of the observation, and there is no specimen. The specimen participant is only used when observations are made against some substance or object that is taken or derived from the subject.

Table X: informant

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	SPC	Fixed

specimen.typeCode

The specimen.typeCode is fixed to "SPC" to indicate the subject of non-clinical (e.g. laboratory) observation services is a specimen.

Table X: Fixed specimen.typeCode

Code	Display Name
SPC	specimen
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

5.3.7.7.1 SpecimenRole

A role played by a material entity that is a specimen for an act.

Table X: AssignedAuthor

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	SPEC	Fixed
id	SET<II>	[0..*]

SpecimenRole.classCode

The SpecimenRole.classCode is fixed to "SPEC".

Table X: Fixed SpecimenRole.classCode

Code	Display Name
SPEC	specimen
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

SpecimenRole.id

An optional SpecimenRole.id can be used to uniquely identify the specimen.

5.3.7.7.2 PlayingEntity @a@

A specimen is an PlayingEntity in the role of SpecimenRole (PlayingEntity (§ 5.3.7.4.3)).

5.3.7.8 subject @a@

The subject participant (described above, see subject (§ 5.3.3.3)), can be ascribed to a CDA section, or it can be ascribed to a CDA entry, where it overrides the value(s) propagated from a CDA section and propagates to nested entries.

5.3.8 Entry Relationships

5.3.8.1 component @c@

The component relationship has a source of Organizer (see Organizer (§ 5.3.6.5)), and a target that is another CDA entry, and is used to create groupings of CDA entries within an Organizer.

Table X: documentationOf Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	COMP	Fixed
contextConductionInd	BL	[0..1]
sequenceNumber	INT	[0..1]
seperatableInd	BL	[0..1]

component.typeCode

The component.typeCode is fixed to "COMP", which indicates that the associated Clinical Statement choice is a component part of the Organizer.

Table X: Fixed component.typeCode

Code	Display Name
COMP (FIXED)	has component
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

component.contextConductionInd

The component.contextConductionInd indicator is fixed to "true". Ancestor elements () which propagate, will conduct through this component class to the associated child element.

component.sequenceNumber

The optional component.sequenceNumber is an integer specifying the relative sequential ordering of this relationship among other like-types relationships having the same source Act.

component.seperatableInd

The optional component.seperatableInd is an indication that the source Act is intended to be interpreted independently of the target Act. The default value is true.

5.3.8.2 precondition

The precondition class, derived from the ActRelationship class, is used along with the Criterion class to express a condition that must hold true before some over activity occurs.

Table X: precondition Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	PRCN	Fixed

precondition.typeCode

The precondition.typeCode is fixed to PRCN which indicates a requirement to be true before a service is performed. The target can be any service in criterion mood. For multiple pre-conditions a conjunction attribute (AND, OR, XOR) is applicable.

Table X: Fixed precondition.typeCode

Code	Display Name
PRCN	has pre-condition
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

5.3.8.2.1 Criterion

Criterion class is used to express a condition that must hold true before some over activity occurs.

Table X: Criterion Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	<= OBS is V:ActClassObservation	Closed w/ Default
moodCode	CS	[0..1]	ENV.CRT	Fixed
code	CD	[1..1]	D:ActCode	Open
actonNegationInd	BL	[0..1]
text	ED	[0..1]
isCriterionInd	BL	[0..1]
value	SET<ANY>	[0..*]	D:ObservationValue	Open
valueNegationInd	BL	[0..1]
interpretationCode	SET<CE>	[0..*]	D:ObservationInterpretation	Open

Criterion.classCode

The Criterion.classCode is defaulted to "OBS" which represents an observation, but can take only any value defined in the ActClassObservation value set.

Table X: Value set for Criterion.classCode

V:ActClassObservation [2.16.840.1.113883.1.11.11529] (CLOSED)
Code	Display Name		Code	Display Name
OBS (Default)	Observation		ALRT	detected issue
BATTERY	battery		CLNTRL	clinical trial
CONC	concern		COND	Condition
CASE	public health case		OUTB	outbreak
DGIMG	diagnostic image		GEN	genomic observation
DETPOL	determinant peptide		EXP	expression level
LOC	locus		PHN	phenotype
POL	polypeptide		SEQ	bio sequence
SEQVAR	bio sequence variation		INVSTG	investigation
OBSSER	observation series		OBSCOR	correlated observation sequences
POS	position		POSACC	position accuracy
POSCOORD	position coordinate		SPCOBS	specimen observation
VERIF	Verification		ROIBND	bounded ROI
ROIOVL	overlay ROI		LLD (Deprecated)	left lateral decubitus
PRN (Deprecated)	prone		RLD (Deprecated)	right lateral decubitus
SFWL (Deprecated)	Semi-Fowler's		SIT (Deprecated)	sitting
STN (Deprecated)	standing		SUP (Deprecated)	supine
RTRD (Deprecated)	reverse trendelenburg		TRD (Deprecated)	trendelenburg
CNOD (Deprecated)	Condition Node
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Criterion.moodCode

The Criterion.moodCode is fixed to "EVN.CRT" which indicates a criterion or condition over service events that must apply for an associated service to be considered.

Table X: Fixed Criterion.moodCode

Code	Display Name
EVN.CRT	event criterion
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

Criterion.code

The particular kind of Criterion that the Criterion-instance represents. Criterion.code, if used, SHALL be a specialization of the Criterion.classCode. This attribute defines a specific sub-type of a given Criterion type. It allows the use of rich terminologies such as LOINC and SNOMED to represent sub-types of the Criterion. The Criterion.code is bound to the ActCode concept domain.

Criterion.actionNegationInd

The Criterion.actionNegationInd indicates that the condition is based on the non-occurrence of the event.

The actionNegationInd negates the Criterion as described by the descriptive properties which are: classCode, code, isCriterionInd, value, valueNegationInd, interpretationCode and any of their components.

The remaining properties represent the document characteristics, E.g. Criterion.moodCode, Criterion.text are not negated. Refer to the attribute isDocumentCharacteristic property and the ActRelationshipType and ParticipationType code system isDocumentCharacteristic properties for specific guidance.

Criterion.text

A renderable textual or multimedia description (or reference to a description) of the complete information which would reasonably be expected to be displayed to a human reader conveyed by the Criterion. The Criterion.text attribute can reference the associated narrative content in the section using the XML ID attribute added to the Narrative Text elements.

Criterion.isCriterionInd

Is defaulted to false, when set to true it indicates that the data conveyed by the act, including outbound associations, represent "criteria" for some other act, not a "real" act. I.e. If an Act exists with a classCode of ACT and a moodCode of RQO and isCriterionInd is true, it does not represent an order for an act. Rather, it represents a criteria that will match on all orders.

Criterion.value

The result of the observation action. Extensive usage notes are available in the RIM, reference Value UsageNotes

Criterion.valueNegationInd

Criterion.valueNegationInd, indicates that the Criterion, as defined in in this Criterion class is NOT true. Note: This attribute should only be used when the terminology used for Criterion.value is not itself capable of expressing negated findings. (E.g. ICD9).

Criterion.interpretationCode

A qualitative interpretation of the Criterion. These interpretation codes are sometimes called "abnormal flags," however, the judgment of normalcy is just one of the interpretations, and is often not relevant. For example, the susceptibility interpretations are not about "normalcy," and for any observation of a pathologic condition, it does not make sense to state the normalcy, since pathologic conditions are never considered "normal."

5.3.8.3 referenceRange

The referenceRange relationship (see Observation (§ 5.3.6.3)), has a source of Observation, and a target of ObservationRange.

5.3.8.4 entryRelationship

Entry Relationship

CDA has identified and modeled various link and reference scenarios. These scenarios enable CDA entries to be semantically linked to entries that exist within the same document (by traversing the entryRelationship class) or to objects external to it (by traversing the reference class).

Table X: entryRelationship Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	V:ActRelationshipType	Closed
inversionInd	BL	[0..1]
contextConductionInd	BL	[0..1]
sequenceNumber	INT	[0..1]
negationInd	BL	[0..1]
seperatableInd	BL	[0..1]

In CDA R2.0, the following entryRelationships scenarios were provided as informative content:

Table X: Examples of typical entryRelationships

ActRelationship Type	Reasonable Source and Target entries	Comments
CAUS (is etiology for)	(Act | Observation | Procedure | SubstanceAdministration) CAUS (Observation)	Used to show that the source caused the target observation (for instance, source "diabetes mellitus" is the cause of target "kidney disease").
COMP (has component)	(Act | Observation | Procedure | SubstanceAdministration | Supply) COMP (Act | Observation | Procedure | SubstanceAdministration | Suppply)	Used to show that the target is a component of the source (for instance "hemoglobin measurement" is a component of a "complete blood count").
GEVL (evaluates (goal))	(Observation) GEVL (Observation)	Used to link an observation (intent or actual) to a goal to indicate that the observation evaluates the goal (for instance, a source observation of "walking distance" evaluates a target goal of "adequate walking distance").
MFST (is manifestation of)	(Observation) MFST (Observation)	Used to say that the source is a manifestation of the target (for instance, source "hives" is a manifestation of target "penicillin allergy").
REFR (refers to)	(Act | Observation | Procedure | SubstanceAdministration | Supply) REFR (Act | Observation | ObservationMedia | Procedure | RegionOfInterest | SubstanceAdministration | Supply)	Used to show a general relationship between the source and the target, when the more specific semantics of the relationship isn't known.
RSON (has reason)	(Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply) RSON (Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply)	Used to show the reason or rational for a service (for instance source "treadmill test" has reason "chest pain").
SAS (starts after start)	(Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply) SAS (Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply)	The source Act starts after the start of the target Act (for instance source "diaphoresis" starts after the start of target "chest pain").
SPRT (has support)	(Observation) SPRT (Observation | ObservationMedia | RegionOfInterest)	Used to show that the target provides supporting evidence for the source (for instance source "possible lung tumor" has support target "mass seen on chest-x-ray").
SUBJ (has subject)	(Observation | RegionOfInterest) SUBJ (Observation | ObservationMedia)	Used to relate a source region of interest to a target image, or to relate an observation to its subject observation (for instance, source "moderate severity" has subject target "chest pain").

NOTE: The preceding table provides examples of reasonable relationships between CDA entries, but does not represent a conformance constraint.

The ActRelationshipType "has subject" is similar to the ParticipationType "subject". Entries that primarily operate on physical subjects use the Participation, whereas entries that primarily operate on other entries use the ActRelationship.

XCRPT (is excerpt of) (Act | Observation) XCRPT (Act | Observation | Procedure | SubstanceAdministration | Supply) Used to show that the source is excerpted from the target (for instance source "hemoglobin value of 12" is an excerpt of target "complete blood count").

The distinction between an excerpt and an informant participant can be blurry — such as in the case of recording a patient's medication history where the clinician may obtain the information from an informant or may excerpt the information from another computer system. An informant (or source of information) is a person who provides relevant information. An informant class is in the header, and can be overridden in the body. An excerpt is a sub portion of some other act.

entryRelationship.typeCode

In CDA R2.1 any entry (excluding Organizer), may be related to another entry, using the entryRelationship class. In the entryRelationship class, the typeCode attribute is used to define the semantic relationship that exists between the source or parent entry and the destination or child entry. The value set binding on typeCode was been significantly enhanced in CDA R2.1, and now any code present in the HL7 entryRelationship code system (RIM 2.35) may be used.

Table X: Value set for entryRelationship.typeCode

V:ActRelationshipType [2.16.840.1.113883.1.11.10317] (CLOSED)
Code	Display Name		Code	Display Name
CIND	has contra-indication		PRCN	has pre-condition
RSON	has reason		BLOCK	Blocks
CURE	curative indication		CURE.ADJ	adjunct curative indication
DIAG	diagnosis		MITGT	mitigates
RCVY	Recovery		MTGT.ADJ	adjunct mitigation
SYMP	symptomatic relief		TRIG	has trigger
COMP	has component		ARR	arrival
CTRLV	has control variable		DEP	departure
OUTC	has outcome		OBJC	has continuing objective
OBJF	has final objective		GOAL	has goal
RISK	has risk		PERT	has pertinent information
SAE	starts after end of		SAS	starts after start of
CHRG	has charge		COST	has cost
CREDIT	has credit		DEBIT	has debit
AUTH	authorized by		CAUS	is etiology for
COVBY	covered by		DRIV	is derived from
ELNK	episodeLink		EVID	provides evidence for
EXACBY	exacerbated by		EXPL	has explanation
ITEMSLOC	items located		LIMIT	limited by
MFST	is manifestation of		NAME	assigns name
PREV	has previous instance		REFR	refers to
REFV	has reference values		RELVBY	relieved by
SPRT	has support		SPRTBND	has bounded support
SUBJ	has subject		SUMM	summarized by
SEQL	is sequel		APND	is appendage
COMPLY	Update		DOC	documents
FLFS	fulfills		OCCR	occurrence
OREF	references order		SCH	schedules request
GEN	has generalization		GEVL	evaluates (goal)
INST	instantiates (master)		MOD	modifies
MTCH	matches (trigger)		OPTN	has option
RCHAL	re-challenge		REV	reverses
RPLC	replaces		SUCC	succeeds
UPDT	updates (condition)		XCRPT	Excerpts
VRXCRPT	Excerpt verbatim		XFRM	transformation
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

Note: Implementation Guide ("IG") authors will need to exercise caution and ensure they fully understand the semantics of the relationship defined by the term they have selected. In addition, IG authors will need to understand the impact of both inversionInd and negationInd flags, as these attributes can materially impact those semantics when machine processing.

entryRelationship.inversionInd

The entryRelationship.inversionInd can be set to "true" to indicate that the relationship should be interpreted as if the roles of the source and target entries were reversed. As in the example provided in CDA R2.0, "treadmill test" RSON (has reason) "chest pain". Inverted, this would have "chest pain" as the source and "treadmill test" as the target: "chest pain" RSON (inverted) "treadmill test". Inversion can be useful when the current context is describing the target of an act relationship that needs to be related back to the source.

The entryRelationship.negationInd can be set to "true" to indicate that the meaning of the link is negated. Examples where this might be useful:

• If the relationship without negation specifies that Act A has Act B as a component, then the negation indicator specifies that Act A does not have Act B as a component.
• If B is a reason for A, then negation means that B is not a reason for A.
• If B is a pre-condition for A, then negation means that B is not a precondition for A.

entryRelationship.contextConductionInd

The entryRelationship.contextConductionInd differs from the otherwise common use of this attribute (see CDA Context (§ 5.4)) in that in all other cases where this attribute is used, the value is fixed at "true", whereas here the value is defaulted to "true", and can be changed to "false" when referencing an entry in the same document. Setting the context conduction to false when referencing an entry in the same document keeps clear the fact that the referenced object retains its original context.

entryRelationship.sequenceNumber

An integer specifying the relative sequential ordering of this relationship among other like-types relationships having the same source Act.

entryRelationship.negationInd

An indicator that asserts that the meaning of the link is negated.

entryRelationship.seperatableInd

An indication that the source Act is intended to be interpreted independently of the target Act. The value is defaulted to true.

5.3.8.5 reference

External

CDA entries can reference external objects such as external images and prior reports. These external objects are not part of the authenticated document content. They contain sufficient attributes to enable an explicit reference rather than duplicating the entire referenced object. The CDA entry that wraps the external reference can be used to encode the specific portions of the external reference that are addressed in the narrative block.

Each object allows for an identifier and a code, and contains the RIM Act.text attribute, which can be used to store the URL and MIME type of the object. External objects always have a fixed moodCode of "EVN".

Table X: reference Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	V:ActRelationshipExternalReference	Fixed
seperatableInd	BL	[0..1]

reference.typeCode

A description of allowable reference.typeCode values are shown in the following table.

Table X: Value set for reference.typeCode

V:ActRelationshipType [2.16.840.1.113883.1.11.10317] (CLOSED)
Code	Display Name		Code	Display Name
ELNK	episodeLink		REFR	refers to
SPRT	has support		RPLC	replaces
XCRPT	Excerpts		SUBJ	has subject
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

reference.seperatableInd

The reference class contains the attribute reference.seperatableInd, which indicates whether or not the source is intended to be interpreted independently of the target. The indicator cannot prevent an individual or application from separating the source and target, but indicates the author's desire and willingness to attest to the content of the source if separated from the target. Typically, where seperatableInd is "false", the exchanged package should include the target of the reference so that the recipient can render it.

As in the table above (CDA entryRelationship Types), the following table is a guideline for reasonable relationships between CDA entries and external objects, and is not a conformance constraint.

Table X: EXAMPLE entryRelationship Types

ActRelationship Type	Reasonable Source and Target classes	Comments
ELNK (episode link)	(Observation) ELNK (ExternalObservation)	Used to show that the source and the target are part of the same episode (for instance, a diagnosis of "pneumonia" can be linked to an external problem list entry of "pneumonia" to show that the current diagnosis is part of the ongoing episode of pneumonia).
REFR (refers to)	(Act | Observation | Procedure | SubstanceAdministration | Supply) REFR (ExternalAct | ExternalDocument | ExternalObservation | ExternalProcedure)	Used to show a general relationship between the source and the target, when the more specific semantics of the relationship isn't known.
RPLC (replace)	(Act | Encounter | Observation | ObservationMedia | Organizer | Procedure | SubstanceAdministration | Supply) RPLC (ExternalAct | ExternalDocument | ExternalObservation | ExternalProcedure)	Used to indicate that the source entry is a replacement for the target external act.
SPRT (has support)	(Observation) SPRT (ExternalDocument | ExternalObservation)	Used to show that the target provides supporting evidence for the source.
SUBJ (has subject)	(Observation | RegionOfInterest) SUBJ (ExternalObservation)	Used to relate a source region of interest to a target image, or to relate an observation to its subject observation.
XCRPT (is excerpt of)	(Act | Observation) XCRPT (ExternalAct | ExternalDocument | ExternalObservation | ExternalProcedure)	Used to show that the source is excerpted from the target (for instance "the hemoglobin is 10.7" is an excerpt of an externally referenced "complete blood count").

Target classes of the reference relationship include ExternalAct, ExternalDocument, ExternalObservation, and External Procedure.

5.3.8.5.1 ExternalAct

The ExternalAct is a derivative of the RIM Act class, to be used when the other more specific classes are not appropriate.

Table X: ExternalAct Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	<= ACT is V:ActClassRoot	Closed w/ Default
moodCode	CS	[0..1]	EVN	Fixed
id	II	[1..*]
code	CD	[0..1]	D:ActCode	Open
text	ED	[0..1]

ExternalAct.classCode

The ExternalAct.classCode is bound to the ActClassRoot value set.

Table X: Value set for ExternalAct.classCode

V:ActClassRoot [2.16.840.1.113883.1.11.13856] (CLOSED)
Code	Display Name		Code	Display Name
ACT (Default)	act		COMPOSITION	composition, Attestable unit
DOC	document		DOCCLIN	clinical document
CDALVLONE	CDA Level One clinical document		CONTAINER	record container
CATEGORY	category		DOCBODY	document body
CATEGORY	document section, Section		TOPIC	topic
EXTRACT	extract		EHR	electronic health record
FOLDER	folder		GROUPER	grouper
CLUSTER	Cluster		ACCM	accommodation
ACCT	account		ACSN	accession
ADJUD	financial adjudication, financial adjudication results		CACT	control act
ACTN	action		INFO	information
STC	state transition control		CNTRCT	contract
FCNTRCT	financial contract		COV	coverage
CONS	consent		CONTREG	container registration
CTTEVENT	clinical trial timepoint event		DISPACT	disciplinary action
EXPOS	exposure		AEXPOS	acquisition exposure
TEXPOS	transmission exposure		INC	incident
INFRM	inform		INVE	invoice element
LIST	working list		MPROT	monitoring program
OBS	Observation		ALRT	detected issue
BATTERY	battery		CLNTRL	clinical trial
CONC	concern		COND	Condition
CASE	public health case		OUTB	outbreak
DGIMG	diagnostic image		GEN	genomic observation
DETPOL	determinant peptide		EXP	expression level
LOC	locus		PHN	phenotype
POL	polypeptide		SEQ	bio sequence
SEQVAR	bio sequence variation		INVSTG	investigation
OBSSER	observation series		OBSCOR	correlated observation sequences
POS	position		POSACC	position accuracy
POSCOORD	position coordinate		SPCOBS	specimen observation
VERIF	Verification		ROIBND	bounded ROI
ROIOVL	overlay ROI		PCPR	care provision
ENC	encounter		POLICY	policy
JURISPOL	jurisdictional policy		ORGPOL	organizational policy
SCOPOL	scope of practice policy		STDPOL	standard of practice policy
PROC	procedure		SBEXT	Substance Extraction
SPECCOLLECT	Specimen Collection		SBADM	substance administration
REG	registration		REV	review
SPCTRT	specimen treatment		SPLY	supply
DIET	diet		STORE	storage
SUBST	Substitution		TRFR	transfer
TRNS	transportation		XACT	financial transaction
CNOD (Deprecated)	Condition Node		LLD (Deprecated)	left lateral decubitus
PRN (Deprecated)	prone		RLD (Deprecated)	right lateral decubitus
SFWL (Deprecated)	Semi-Fowler's		SIT (Deprecated)	sitting
STN (Deprecated)	standing		SUP (Deprecated)	supine
RTRD (Deprecated)	reverse trendelenburg		TRD (Deprecated)	trendelenburg
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

ExternalAct.moodCode

The ExternalAct.moodCode is fixed to "EVN" which represents the event mood. Indicating that the act has taken place and this is information about that act.

Table X: Fixed ExternalAct.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

ExternalAct.id

The unique instance identifier for the ExternalAct.

ExternalAct.code

The particular kind of Act that the Act-instance represents within its class. ExternalAct.code, if used, SHALL be a specialization of the ExternalAct.classCode. This attribute defines a specific sub-type of a given Act type (determined by the "classCode" attribute). It allows the use of rich terminologies such as LOINC and SNOMED to represent sub-types of the limited set of Act types defined by "classCode." The ExternalAct.code is bound to the ActCode concept domain.

ExternalAct.text

A reference to a renderable textual or multimedia description of the complete information which would reasonably be expected to be displayed to a human reader conveyed by the ExternalAct.

5.3.8.5.2 ExternalDocument

The ExternalDocument is a derivative of the RIM Document class, used for representing external documents. ExternalDocument.text is modeled as an ED data type - allowing for the expression of the MIME type of the external document.

Table X: ExternalDocument Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	<=DOC is V:ActClassDocument	Closed w/ Default
moodCode	CS	[0..1]	EVN	Fixed
typeId	II	[1..1]
id	II	[1..*]
code	CE	[1..1]	D:DocumentType	Open
text	ED	[0..1]
setId	II	[0..1]
versionNumber	ST	[0..1]

ExternalDocument.classCode

The ExternalDocument.classCode is fixed to "DOCCLIN"

Table X: Fixed ExternalDocument.classCode

V:ActClassDocument [2.16.840.1.113883.1.11.18938] (CLOSED)
Code	Display Name		Code	Display Name
DOC(Default)	document		DOCCLIN||clinical document
CDALVLONE	CDA Level One clinical document
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

ExternalDocument..moodCode

The ExternalDocument.moodCode is fixed to "EVN" which represents the event mood. Indicating that the document has been created and is available.

Table X: Fixed ExternalDocument.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

ExternalDocument.id

The unique instance identifier for the ExternalDocument.

ExternalDocument.code

The ExternalDocument.code is bound to the DocumentType concept domain.

ExternalDocument.text

A reference to the external document.

ExternalDocument.setId

The ExternalDocument.setId is an optional identifier that does not change with revisions to a document.

ExternalDocument.versionNumber

A string used to represent the version of the document. For CDA R2.1 we use the ST data type as defined in the r2b datatypes. We have adopted, for all versionNumber references in CDA R2.1, this data type because it supports an @value attribute, and can support wire format compatibility with the versionNumber in CDA R2.0.

5.3.8.5.3 ExternalObservation

The ExternalObservation is a derivative of the RIM Observation class, used for representing external coded and other observations.

Table X: ExternalObservation Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	<= OBS is V:ActClassObservation	Closed w/ Default
moodCode	CS	[0..1]	EVN	Fixed
id	II	[1..*]
code	CD	[0..1]	D:ActCode	Open
text	ED	[0..1]

ExternalObservation.classCode

The ExternalObservation.classCode is defaulted to "OBS" in indicate an observation, but be be set to any code in the ActCode concept domain.

Table X: Value set for ExternalObservation.classCode

V:ActClassObservation [2.16.840.1.113883.1.11.11529] (CLOSED)
Code	Display Name		Code	Display Name
OBS (Default)	Observation		ALRT	detected issue
BATTERY	battery		CLNTRL	clinical trial
CONC	concern		COND	Condition
CASE	public health case		OUTB	outbreak
DGIMG	diagnostic image		GEN	genomic observation
DETPOL	determinant peptide		EXP	expression level
LOC	locus		PHN	phenotype
POL	polypeptide		SEQ	bio sequence
SEQVAR	bio sequence variation		INVSTG	investigation
OBSSER	observation series		OBSCOR	correlated observation sequences
POS	position		POSACC	position accuracy
POSCOORD	position coordinate		SPCOBS	specimen observation
VERIF	Verification		ROIBND	bounded ROI
ROIOVL	overlay ROI		LLD (Deprecated)	left lateral decubitus
PRN (Deprecated)	prone		RLD (Deprecated)	right lateral decubitus
SFWL (Deprecated)	Semi-Fowler's		SIT (Deprecated)	sitting
STN (Deprecated)	standing		SUP (Deprecated)	supine
RTRD (Deprecated)	reverse trendelenburg		TRD (Deprecated)	trendelenburg
CNOD (Deprecated)	Condition Node
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

ExternalObservation.moodCode

The ExternalObservation.moodCode is fixed to "EVN" which represents the event mood. Indicating that the observation has taken place and this is information about that observation.

Table X: Fixed ExternalObservation.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

ExternalObservation.id

The unique instance identifier for the ExternalObservation.

ExternalObservation.code

The particular kind of observation that the observation-instance represents within its class. ExternalObservation.code, if used, SHALL be a specialization of the ExternalObservation.classCode. This attribute defines a specific sub-type of a given Observation type (determined by the "classCode" attribute). It allows the use of rich terminologies such as LOINC and SNOMED to represent sub-types of the limited set of observation types defined by "classCode." The ExternalObservation.code is bound to the ActCode concept domain.

ExternalObservation.text

A reference to a renderable textual or multimedia description of the complete information which would reasonably be expected to be displayed to a human reader conveyed by the ExternalObservation.

5.3.8.5.4 ExternalProcedure

The ExternalProcedure is a derivative of the RIM Procedure class, used for representing external procedures.

Table X: ExternalProcedure Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	PROC	Fixed
moodCode	CS	[0..1]	EVN	Fixed
id	II	[1..*]
code	CD	[0..1]	D:ActCode	Open
text	ED	[0..1]

ExternalProcedure.classCode

The ExternalProcedure.classCode is fixed to "PROC".

Table X: Fixed ExternalProcedure.classCode

Code	Display Name
PROC	procedure
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

ExternalProcedure.moodCode

The ExternalProcedure.moodCode is fixed to "EVN" which represents the event mood. Indicating that the procedure has taken place and this is information about that procedure.

Table X: Fixed ExternalProcedure.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

ExternalProcedure.id

The unique instance identifier for the ExternalProcedure.

ExternalProcedure.code

The particular kind of procedure that the procedure-instance represents within its class. ExternalProcedure.code, if used, SHALL be a specialization of the ExternalProcedure.classCode. This attribute defines a specific sub-type of a given Procedure type (determined by the "classCode" attribute). It allows the use of rich terminologies such as LOINC and SNOMED to represent sub-types of the limited set of Procedure types defined by "classCode." The ExternalProcedure.code is bound to the ActCode concept domain.

ExternalProcedure.text

A reference to a renderable textual or multimedia description of the complete information which would reasonably be expected to be displayed to a human reader conveyed by the ExternalProcedure.

6 CDA Hierarchical Description

(content on separate page)

7 CDA XML Implementation

(content on separate page)

8 Appendix

(content on separate page)