Consolidated CDA (C-CDA), published by Health Level Seven. This guide is not an authorized publication; it is the continuous build for version 4.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/CDA-ccda/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples
• XML
• JSON

Logical Model: Instruction Observation

The Instruction observation template can be used in several ways, such as to record patient instructions within a Medication Activity or to record fill instructions within a supply order. Though not defined in this template, a Vaccine Information Statement (VIS) document could be referenced through observation/reference/externalDocument, and patient awareness of the instructions can be represented with the generic participant and the participant/awarenessCode.

The value element represents the actual instructions given to the patient. Typically recorded as a string or a narrative reference, the value may also be coded, though this template enforces no limits on the set of codes that can be used.

Usage:

• Use this Logical Model: Immunization Activity, Instructions Section, Intervention Act, Medication Activity... Show 9 more, Medication Supply Order, Non-Medicinal Supply Activity, Planned Immunization Activity, Planned Intervention Act, Planned Medication Activity, Planned Procedure, Planned Supply, Plan of Treatment Section and Procedure Activity Procedure

Formal Views of Template Content

Description of Template, Differentials, Snapshots and how the different presentations work.

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation	C	1..1	Observation	XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors:@nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, sdtcCategory, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, sdtcPrecondition2, referenceRange, sdtcInFulfillmentOf1 Base for all types and resources Instance of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value
Slices for templateId		1..*	II	Slice: Unordered, Open by value:root, value:extension
templateId:instruction		1..1	II
@root		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.22.4.515
@extension		1..1	st	Required Pattern: 2025-05-01
@classCode		1..1	cs	Fixed Value: OBS
@moodCode		1..1	cs	Fixed Value: EVN
code		1..1	CD	Instructions Provided
@code		1..1	cs	Required Pattern: 89187-7
@codeSystem		1..1	oid, uuid, ruid	LOINC Required Pattern: 2.16.840.1.113883.6.1
translation		0..*	CD	Can further classify the type of instructions provided Binding: Patient Education (preferred)
text		0..1	ED	SHOULD reference the portion of section narrative text corresponding to this entry
reference	C	0..1	TEL	value-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative
statusCode		1..1	CS
@code		1..1	cs	Fixed Value: completed
effectiveTime	C	0..1	IVL_TS	value-only: Interval fields SHALL NOT be present
@value		0..1	ts	value should be used instead of low/high
value		1..1		The actual instructions provided
value			ED
value			ST
value			CD
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.code.translation	preferred	PatientEducation http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.11.20.9.34 from https://vsac.nlm.nih.gov

Constraints

Id	Grade	Path(s)	Details	Requirements
should-text-ref-value	warning	Observation	SHOULD contain text/reference/@value : text.reference.value.exists()
value-only	error	Observation.effectiveTime	Interval fields SHALL NOT be present : (low | high | width | center).empty()
value-starts-octothorpe	error	Observation.text.reference	If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative : value.exists() implies value.startsWith('#')

Name	Flags	Card.	Type	Description & Constraints
Observation	C	1..1	Observation	XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors:@nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, sdtcCategory, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, sdtcPrecondition2, referenceRange, sdtcInFulfillmentOf1 Base for all types and resources Instance of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value
Slices for templateId		1..*	II	Slice: Unordered, Open by value:root, value:extension
templateId:instruction		1..1	II
@root		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.22.4.515
@extension		1..1	st	Required Pattern: 2025-05-01
@classCode		1..1	cs	Binding: CDAActClassObservation (required) Fixed Value: OBS
@moodCode		1..1	cs	Binding: XActMoodDocumentObservation (2.0.0) (required) Fixed Value: EVN
code		1..1	CD	Instructions Provided Binding: ObservationType (example)
@code		1..1	cs	Required Pattern: 89187-7
@codeSystem		1..1	oid, uuid, ruid	LOINC Required Pattern: 2.16.840.1.113883.6.1
translation		0..*	CD	Can further classify the type of instructions provided Binding: Patient Education (preferred)
text		0..1	ED	SHOULD reference the portion of section narrative text corresponding to this entry
reference	C	0..1	TEL	value-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative
statusCode		1..1	CS	Binding: ActStatus (required)
@code		1..1	cs	Fixed Value: completed
effectiveTime	C	0..1	IVL_TS	value-only: Interval fields SHALL NOT be present
@value		0..1	ts	value should be used instead of low/high Date Format: YYYYMMDDHHMMSS.UUUU[+|-ZZzz]
value		1..1		The actual instructions provided
value			ED
value			ST
value			CD
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.classCode	required	Fixed Value: OBS http://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation
Observation.moodCode	required	Fixed Value: EVN http://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation|2.0.0
Observation.code	example	ObservationType http://terminology.hl7.org/ValueSet/v3-ObservationType
Observation.code.translation	preferred	PatientEducation http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.11.20.9.34 from https://vsac.nlm.nih.gov
Observation.statusCode	required	ActStatus http://terminology.hl7.org/ValueSet/v3-ActStatus

Constraints

Id	Grade	Path(s)	Details	Requirements
should-text-ref-value	warning	Observation	SHOULD contain text/reference/@value : text.reference.value.exists()
value-only	error	Observation.effectiveTime	Interval fields SHALL NOT be present : (low | high | width | center).empty()
value-starts-octothorpe	error	Observation.text.reference	If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative : value.exists() implies value.startsWith('#')

Name	Flags	Card.	Type	Description & Constraints
Observation	C	1..1	Observation	XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors:@nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, sdtcCategory, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, sdtcPrecondition2, referenceRange, sdtcInFulfillmentOf1 Base for all types and resources Instance of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
Slices for templateId		1..*	II	Slice: Unordered, Open by value:root, value:extension
templateId:instruction		1..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.22.4.515
@extension		1..1	st	Required Pattern: 2025-05-01
@classCode		1..1	cs	Binding: CDAActClassObservation (required) Fixed Value: OBS
@moodCode		1..1	cs	Binding: XActMoodDocumentObservation (2.0.0) (required) Fixed Value: EVN
@negationInd		0..1	bl
id		0..*	II
sdtcCategory		0..*	CD	XML Namespace: urn:hl7-org:sdtc XML: category (urn:hl7-org:sdtc)
code		1..1	CD	Instructions Provided Binding: ObservationType (example)
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@code		1..1	cs	Required Pattern: 89187-7
@codeSystem		1..1	oid, uuid, ruid	LOINC Required Pattern: 2.16.840.1.113883.6.1
@codeSystemName		0..1	st
@codeSystemVersion		0..1	st
@displayName		0..1	st
@sdtcValueSet		0..1	oid	XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion		0..1	st	XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
originalText		0..1	ED
qualifier		0..*	CR
translation		0..*	CD	Can further classify the type of instructions provided Binding: Patient Education (preferred)
derivationExpr		0..1	ST
text		0..1	ED	SHOULD reference the portion of section narrative text corresponding to this entry
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@compression		0..1	cs	Binding: CDACompressionAlgorithm (required)
@integrityCheck		0..1	bin
@integrityCheckAlgorithm		0..1	cs	Binding: IntegrityCheckAlgorithm (2.0.0) (required)
@language		0..1	cs
@mediaType		0..1	cs	Binding: MediaType (example)
@representation		0..1	cs	Binding: CDABinaryDataEncoding (required)
xmlText		0..1	st	Allows for mixed text content. If @representation='B64', this SHALL be a base64binary string.
reference	C	0..1	TEL	value-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative
thumbnail		0..1	ED
statusCode		1..1	CS	Binding: ActStatus (required)
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@code		1..1	cs	Fixed Value: completed
@sdtcValueSet		0..1	oid	XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion		0..1	st	XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
effectiveTime	C	0..1	IVL_TS	value-only: Interval fields SHALL NOT be present
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@value		0..1	ts	value should be used instead of low/high Date Format: YYYYMMDDHHMMSS.UUUU[+|-ZZzz]
@operator		0..1	cs	Binding: CDASetOperator (required)
low		0..1	IVXB_TS
center		0..1	TS
width		0..1	PQ
high		0..1	IVXB_TS
priorityCode		0..1	CE	Binding: ActPriority (example)
repeatNumber		0..1	IVL_INT
languageCode		0..1	CS	Binding: AllLanguages (required)
value		1..1		The actual instructions provided
value			ED
value			ST
value			CD
interpretationCode		0..*	CE	Binding: CDAObservationInterpretation (required)
methodCode		0..*	CE	Binding: ObservationMethod (example)
targetSiteCode		0..*	CD
subject		0..1	Subject
specimen		0..*	Specimen
performer		0..*	Performer2
author		0..*	Author
informant		0..*	Informant
participant		0..*	Participant2
entryRelationship		0..*	EntryRelationship
reference		0..*	Reference
precondition		0..*	Precondition
sdtcPrecondition2		0..*	Precondition2	XML Namespace: urn:hl7-org:sdtc XML: precondition2 (urn:hl7-org:sdtc)
referenceRange		0..*	InfrastructureRoot
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@typeCode		0..1	cs	Binding: CDAActRelationshipType (required) Fixed Value: REFV
observationRange		1..1	ObservationRange
sdtcInFulfillmentOf1		0..*	InFulfillmentOf1	XML Namespace: urn:hl7-org:sdtc XML: inFulfillmentOf1 (urn:hl7-org:sdtc)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.typeId.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.templateId:instruction.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.classCode	required	Fixed Value: OBS http://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation
Observation.moodCode	required	Fixed Value: EVN http://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation|2.0.0
Observation.code	example	ObservationType http://terminology.hl7.org/ValueSet/v3-ObservationType
Observation.code.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.code.translation	preferred	PatientEducation http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.11.20.9.34 from https://vsac.nlm.nih.gov
Observation.text.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.text.compression	required	CDACompressionAlgorithm http://hl7.org/cda/stds/core/ValueSet/CDACompressionAlgorithm
Observation.text.integrityCheckAlgorithm	required	IntegrityCheckAlgorithm http://terminology.hl7.org/ValueSet/v3-IntegrityCheckAlgorithm|2.0.0
Observation.text.mediaType	example	MediaType http://terminology.hl7.org/ValueSet/v3-MediaType
Observation.text.representation	required	BinaryDataEncoding http://hl7.org/cda/stds/core/ValueSet/BinaryDataEncoding
Observation.statusCode	required	ActStatus http://terminology.hl7.org/ValueSet/v3-ActStatus
Observation.statusCode.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.effectiveTime.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.effectiveTime.operator	required	CDASetOperator http://hl7.org/cda/stds/core/ValueSet/CDASetOperator
Observation.priorityCode	example	ActPriority http://terminology.hl7.org/ValueSet/v3-ActPriority
Observation.languageCode	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages from the FHIR Standard
Observation.interpretationCode	required	CDAObservationInterpretation http://hl7.org/cda/stds/core/ValueSet/CDAObservationInterpretation
Observation.methodCode	example	ObservationMethod http://terminology.hl7.org/ValueSet/v3-ObservationMethod
Observation.referenceRange.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.referenceRange.typeId.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.referenceRange.typeCode	required	Fixed Value: REFV http://hl7.org/cda/stds/core/ValueSet/CDAActRelationshipType

Constraints

Id	Grade	Path(s)	Details	Requirements
should-text-ref-value	warning	Observation	SHOULD contain text/reference/@value : text.reference.value.exists()
value-only	error	Observation.effectiveTime	Interval fields SHALL NOT be present : (low | high | width | center).empty()
value-starts-octothorpe	error	Observation.text.reference	If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative : value.exists() implies value.startsWith('#')

This structure is derived from Observation

Summary

Mandatory: 9 elements
Fixed: 3 elements

Slices

This structure defines the following Slices:

• The element 2 is sliced based on the values of Observation.templateId

Differential View

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation	C	1..1	Observation	XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors:@nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, sdtcCategory, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, sdtcPrecondition2, referenceRange, sdtcInFulfillmentOf1 Base for all types and resources Instance of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value
Slices for templateId		1..*	II	Slice: Unordered, Open by value:root, value:extension
templateId:instruction		1..1	II
@root		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.22.4.515
@extension		1..1	st	Required Pattern: 2025-05-01
@classCode		1..1	cs	Fixed Value: OBS
@moodCode		1..1	cs	Fixed Value: EVN
code		1..1	CD	Instructions Provided
@code		1..1	cs	Required Pattern: 89187-7
@codeSystem		1..1	oid, uuid, ruid	LOINC Required Pattern: 2.16.840.1.113883.6.1
translation		0..*	CD	Can further classify the type of instructions provided Binding: Patient Education (preferred)
text		0..1	ED	SHOULD reference the portion of section narrative text corresponding to this entry
reference	C	0..1	TEL	value-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative
statusCode		1..1	CS
@code		1..1	cs	Fixed Value: completed
effectiveTime	C	0..1	IVL_TS	value-only: Interval fields SHALL NOT be present
@value		0..1	ts	value should be used instead of low/high
value		1..1		The actual instructions provided
value			ED
value			ST
value			CD
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.code.translation	preferred	PatientEducation http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.11.20.9.34 from https://vsac.nlm.nih.gov

Constraints

Id	Grade	Path(s)	Details	Requirements
should-text-ref-value	warning	Observation	SHOULD contain text/reference/@value : text.reference.value.exists()
value-only	error	Observation.effectiveTime	Interval fields SHALL NOT be present : (low | high | width | center).empty()
value-starts-octothorpe	error	Observation.text.reference	If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative : value.exists() implies value.startsWith('#')

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	1..1	Observation	XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors:@nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, sdtcCategory, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, sdtcPrecondition2, referenceRange, sdtcInFulfillmentOf1 Base for all types and resources Instance of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value
Slices for templateId		1..*	II	Slice: Unordered, Open by value:root, value:extension
templateId:instruction		1..1	II
@root		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.22.4.515
@extension		1..1	st	Required Pattern: 2025-05-01
@classCode		1..1	cs	Binding: CDAActClassObservation (required) Fixed Value: OBS
@moodCode		1..1	cs	Binding: XActMoodDocumentObservation (2.0.0) (required) Fixed Value: EVN
code		1..1	CD	Instructions Provided Binding: ObservationType (example)
@code		1..1	cs	Required Pattern: 89187-7
@codeSystem		1..1	oid, uuid, ruid	LOINC Required Pattern: 2.16.840.1.113883.6.1
translation		0..*	CD	Can further classify the type of instructions provided Binding: Patient Education (preferred)
text		0..1	ED	SHOULD reference the portion of section narrative text corresponding to this entry
reference	C	0..1	TEL	value-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative
statusCode		1..1	CS	Binding: ActStatus (required)
@code		1..1	cs	Fixed Value: completed
effectiveTime	C	0..1	IVL_TS	value-only: Interval fields SHALL NOT be present
@value		0..1	ts	value should be used instead of low/high Date Format: YYYYMMDDHHMMSS.UUUU[+|-ZZzz]
value		1..1		The actual instructions provided
value			ED
value			ST
value			CD
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.classCode	required	Fixed Value: OBS http://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation
Observation.moodCode	required	Fixed Value: EVN http://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation|2.0.0
Observation.code	example	ObservationType http://terminology.hl7.org/ValueSet/v3-ObservationType
Observation.code.translation	preferred	PatientEducation http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.11.20.9.34 from https://vsac.nlm.nih.gov
Observation.statusCode	required	ActStatus http://terminology.hl7.org/ValueSet/v3-ActStatus

Constraints

Id	Grade	Path(s)	Details	Requirements
should-text-ref-value	warning	Observation	SHOULD contain text/reference/@value : text.reference.value.exists()
value-only	error	Observation.effectiveTime	Interval fields SHALL NOT be present : (low | high | width | center).empty()
value-starts-octothorpe	error	Observation.text.reference	If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative : value.exists() implies value.startsWith('#')

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	1..1	Observation	XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors:@nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, sdtcCategory, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, sdtcPrecondition2, referenceRange, sdtcInFulfillmentOf1 Base for all types and resources Instance of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
Slices for templateId		1..*	II	Slice: Unordered, Open by value:root, value:extension
templateId:instruction		1..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.22.4.515
@extension		1..1	st	Required Pattern: 2025-05-01
@classCode		1..1	cs	Binding: CDAActClassObservation (required) Fixed Value: OBS
@moodCode		1..1	cs	Binding: XActMoodDocumentObservation (2.0.0) (required) Fixed Value: EVN
@negationInd		0..1	bl
id		0..*	II
sdtcCategory		0..*	CD	XML Namespace: urn:hl7-org:sdtc XML: category (urn:hl7-org:sdtc)
code		1..1	CD	Instructions Provided Binding: ObservationType (example)
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@code		1..1	cs	Required Pattern: 89187-7
@codeSystem		1..1	oid, uuid, ruid	LOINC Required Pattern: 2.16.840.1.113883.6.1
@codeSystemName		0..1	st
@codeSystemVersion		0..1	st
@displayName		0..1	st
@sdtcValueSet		0..1	oid	XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion		0..1	st	XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
originalText		0..1	ED
qualifier		0..*	CR
translation		0..*	CD	Can further classify the type of instructions provided Binding: Patient Education (preferred)
derivationExpr		0..1	ST
text		0..1	ED	SHOULD reference the portion of section narrative text corresponding to this entry
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@compression		0..1	cs	Binding: CDACompressionAlgorithm (required)
@integrityCheck		0..1	bin
@integrityCheckAlgorithm		0..1	cs	Binding: IntegrityCheckAlgorithm (2.0.0) (required)
@language		0..1	cs
@mediaType		0..1	cs	Binding: MediaType (example)
@representation		0..1	cs	Binding: CDABinaryDataEncoding (required)
xmlText		0..1	st	Allows for mixed text content. If @representation='B64', this SHALL be a base64binary string.
reference	C	0..1	TEL	value-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative
thumbnail		0..1	ED
statusCode		1..1	CS	Binding: ActStatus (required)
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@code		1..1	cs	Fixed Value: completed
@sdtcValueSet		0..1	oid	XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion		0..1	st	XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
effectiveTime	C	0..1	IVL_TS	value-only: Interval fields SHALL NOT be present
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@value		0..1	ts	value should be used instead of low/high Date Format: YYYYMMDDHHMMSS.UUUU[+|-ZZzz]
@operator		0..1	cs	Binding: CDASetOperator (required)
low		0..1	IVXB_TS
center		0..1	TS
width		0..1	PQ
high		0..1	IVXB_TS
priorityCode		0..1	CE	Binding: ActPriority (example)
repeatNumber		0..1	IVL_INT
languageCode		0..1	CS	Binding: AllLanguages (required)
value		1..1		The actual instructions provided
value			ED
value			ST
value			CD
interpretationCode		0..*	CE	Binding: CDAObservationInterpretation (required)
methodCode		0..*	CE	Binding: ObservationMethod (example)
targetSiteCode		0..*	CD
subject		0..1	Subject
specimen		0..*	Specimen
performer		0..*	Performer2
author		0..*	Author
informant		0..*	Informant
participant		0..*	Participant2
entryRelationship		0..*	EntryRelationship
reference		0..*	Reference
precondition		0..*	Precondition
sdtcPrecondition2		0..*	Precondition2	XML Namespace: urn:hl7-org:sdtc XML: precondition2 (urn:hl7-org:sdtc)
referenceRange		0..*	InfrastructureRoot
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@typeCode		0..1	cs	Binding: CDAActRelationshipType (required) Fixed Value: REFV
observationRange		1..1	ObservationRange
sdtcInFulfillmentOf1		0..*	InFulfillmentOf1	XML Namespace: urn:hl7-org:sdtc XML: inFulfillmentOf1 (urn:hl7-org:sdtc)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.typeId.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.templateId:instruction.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.classCode	required	Fixed Value: OBS http://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation
Observation.moodCode	required	Fixed Value: EVN http://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation|2.0.0
Observation.code	example	ObservationType http://terminology.hl7.org/ValueSet/v3-ObservationType
Observation.code.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.code.translation	preferred	PatientEducation http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.11.20.9.34 from https://vsac.nlm.nih.gov
Observation.text.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.text.compression	required	CDACompressionAlgorithm http://hl7.org/cda/stds/core/ValueSet/CDACompressionAlgorithm
Observation.text.integrityCheckAlgorithm	required	IntegrityCheckAlgorithm http://terminology.hl7.org/ValueSet/v3-IntegrityCheckAlgorithm|2.0.0
Observation.text.mediaType	example	MediaType http://terminology.hl7.org/ValueSet/v3-MediaType
Observation.text.representation	required	BinaryDataEncoding http://hl7.org/cda/stds/core/ValueSet/BinaryDataEncoding
Observation.statusCode	required	ActStatus http://terminology.hl7.org/ValueSet/v3-ActStatus
Observation.statusCode.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.effectiveTime.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.effectiveTime.operator	required	CDASetOperator http://hl7.org/cda/stds/core/ValueSet/CDASetOperator
Observation.priorityCode	example	ActPriority http://terminology.hl7.org/ValueSet/v3-ActPriority
Observation.languageCode	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages from the FHIR Standard
Observation.interpretationCode	required	CDAObservationInterpretation http://hl7.org/cda/stds/core/ValueSet/CDAObservationInterpretation
Observation.methodCode	example	ObservationMethod http://terminology.hl7.org/ValueSet/v3-ObservationMethod
Observation.referenceRange.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.referenceRange.typeId.nullFlavor	required	CDANullFlavor http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
Observation.referenceRange.typeCode	required	Fixed Value: REFV http://hl7.org/cda/stds/core/ValueSet/CDAActRelationshipType

Constraints

Id	Grade	Path(s)	Details	Requirements
should-text-ref-value	warning	Observation	SHOULD contain text/reference/@value : text.reference.value.exists()
value-only	error	Observation.effectiveTime	Interval fields SHALL NOT be present : (low | high | width | center).empty()
value-starts-octothorpe	error	Observation.text.reference	If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative : value.exists() implies value.startsWith('#')

This structure is derived from Observation

Summary

Mandatory: 9 elements
Fixed: 3 elements

Slices

This structure defines the following Slices:

• The element 2 is sliced based on the values of Observation.templateId

Other representations of profile: CSV, Excel