Consolidated CDA (C-CDA)
4.0.0 - STU4 United States of America flag

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 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

Logical Model: Instruction Observation

Official URL: http://hl7.org/cda/us/ccda/StructureDefinition/InstructionObservation Version: 4.0.0
Draft as of 2025-10-02 Computable Name: InstructionObservation
Other Identifiers: urn:ietf:rfc:3986#Uniform Resource Identifier (URI)#urn:hl7ii:2.16.840.1.113883.10.20.22.4.515:2025-05-01

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.

Usages:

You can also check for usages in the FHIR IG Statistics

Changes since version 3.0.0:

  • New Content

    • Formal Views of Template Content

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

    This structure is derived from Observation

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Observation C 1..1 Observation XML Namespace: urn:hl7-org:v3
    Base for all types and resources
    Instance of this type are validated by templateId
    Logical Container: ClinicalDocument (CDA Class)
    Constraints: should-text-ref-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 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 Constraints: value-starts-octothorpe
    ... statusCode 1..1 CS
    .... @code 1..1 cs Fixed Value: completed
    ... effectiveTime C 0..1 IVL_TS Constraints: value-only
    .... @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

    doco Documentation for this format

    Terminology Bindings (Differential)

    Path Status Usage ValueSet Version Source
    Observation.code.translation Base preferred Patient Education . 📦20240606 VSAC v0.23

    Constraints

    Id Grade Path(s) Description Expression
    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('#')
    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Observation C 1..1 Observation XML Namespace: urn:hl7-org:v3
    Base for all types and resources
    Instance of this type are validated by templateId
    Logical Container: ClinicalDocument (CDA Class)
    Constraints: should-text-ref-value
    ... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ... realmCode 0..* CS
    ... typeId C 0..1 II Constraints: II-1
    .... @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 Constraints: value-starts-octothorpe
    .... 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 Constraints: value-only
    .... @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 C 0..1 II Constraints: II-1
    ..... @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)

    doco Documentation for this format

    Terminology Bindings

    Path Status Usage ValueSet Version Source
    Observation.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.templateId:instruction.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.classCode Base required CDAActClassObservation 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.moodCode Base required x_ActMoodDocumentObservation 📍2.0.0 THO v5.2
    Observation.code Base example ObservationType 📦3.0.0 THO v6.5
    Observation.code.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.code.translation Base preferred Patient Education . 📦20240606 VSAC v0.23
    Observation.text.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.text.compression Base required CDACompressionAlgorithm 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.text.integrityCheckAlgorithm Base required IntegrityCheckAlgorithm 📍2.0.0 THO v5.2
    Observation.text.mediaType Base example MediaType 📦3.0.0 THO v6.5
    Observation.text.representation Base required CDABinaryDataEncoding 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.statusCode Base required ActStatus 📦3.0.0 THO v6.5
    Observation.statusCode.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.effectiveTime.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.effectiveTime.​operator Base required CDASetOperator 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.priorityCode Base example ActPriority 📦3.0.0 THO v6.5
    Observation.languageCode Base required All Languages 📦5.0.0 FHIR Std.
    Observation.interpretationCode Base required CDAObservationInterpretation 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.methodCode Base example ObservationMethod 📦3.0.0 THO v6.5
    Observation.referenceRange.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.referenceRange.​typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.referenceRange.​typeCode Base required CDAActRelationshipType 📦2.0.1-sd Clinical Document Architecture v2.0

    Constraints

    Id Grade Path(s) Description Expression
    II-1 error Observation.typeId, Observation.referenceRange.typeId An II instance must have either a root or an nullFlavor. root.exists() or nullFlavor.exists()
    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('#')
    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Observation C 1..1 Observation XML Namespace: urn:hl7-org:v3
    Base for all types and resources
    Instance of this type are validated by templateId
    Logical Container: ClinicalDocument (CDA Class)
    Constraints: should-text-ref-value
    ... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ... realmCode 0..* CS
    ... typeId C 0..1 II Constraints: II-1
    .... @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 Constraints: value-starts-octothorpe
    .... 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 Constraints: value-only
    .... @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 C 0..1 II Constraints: II-1
    ..... @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)

    doco Documentation for this format

    Terminology Bindings

    Path Status Usage ValueSet Version Source
    Observation.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.templateId:instruction.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.classCode Base required CDAActClassObservation 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.moodCode Base required x_ActMoodDocumentObservation 📍2.0.0 THO v5.2
    Observation.code Base example ObservationType 📦3.0.0 THO v6.5
    Observation.code.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.code.translation Base preferred Patient Education . 📦20240606 VSAC v0.23
    Observation.text.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.text.compression Base required CDACompressionAlgorithm 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.text.integrityCheckAlgorithm Base required IntegrityCheckAlgorithm 📍2.0.0 THO v5.2
    Observation.text.mediaType Base example MediaType 📦3.0.0 THO v6.5
    Observation.text.representation Base required CDABinaryDataEncoding 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.statusCode Base required ActStatus 📦3.0.0 THO v6.5
    Observation.statusCode.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.effectiveTime.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.effectiveTime.​operator Base required CDASetOperator 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.priorityCode Base example ActPriority 📦3.0.0 THO v6.5
    Observation.languageCode Base required All Languages 📦5.0.0 FHIR Std.
    Observation.interpretationCode Base required CDAObservationInterpretation 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.methodCode Base example ObservationMethod 📦3.0.0 THO v6.5
    Observation.referenceRange.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.referenceRange.​typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.referenceRange.​typeCode Base required CDAActRelationshipType 📦2.0.1-sd Clinical Document Architecture v2.0

    Constraints

    Id Grade Path(s) Description Expression
    II-1 error Observation.typeId, Observation.referenceRange.typeId An II instance must have either a root or an nullFlavor. root.exists() or nullFlavor.exists()
    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

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Observation C 1..1 Observation XML Namespace: urn:hl7-org:v3
    Base for all types and resources
    Instance of this type are validated by templateId
    Logical Container: ClinicalDocument (CDA Class)
    Constraints: should-text-ref-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 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 Constraints: value-starts-octothorpe
    ... statusCode 1..1 CS
    .... @code 1..1 cs Fixed Value: completed
    ... effectiveTime C 0..1 IVL_TS Constraints: value-only
    .... @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

    doco Documentation for this format

    Terminology Bindings (Differential)

    Path Status Usage ValueSet Version Source
    Observation.code.translation Base preferred Patient Education . 📦20240606 VSAC v0.23

    Constraints

    Id Grade Path(s) Description Expression
    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

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Observation C 1..1 Observation XML Namespace: urn:hl7-org:v3
    Base for all types and resources
    Instance of this type are validated by templateId
    Logical Container: ClinicalDocument (CDA Class)
    Constraints: should-text-ref-value
    ... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ... realmCode 0..* CS
    ... typeId C 0..1 II Constraints: II-1
    .... @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 Constraints: value-starts-octothorpe
    .... 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 Constraints: value-only
    .... @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 C 0..1 II Constraints: II-1
    ..... @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)

    doco Documentation for this format

    Terminology Bindings

    Path Status Usage ValueSet Version Source
    Observation.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.templateId:instruction.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.classCode Base required CDAActClassObservation 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.moodCode Base required x_ActMoodDocumentObservation 📍2.0.0 THO v5.2
    Observation.code Base example ObservationType 📦3.0.0 THO v6.5
    Observation.code.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.code.translation Base preferred Patient Education . 📦20240606 VSAC v0.23
    Observation.text.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.text.compression Base required CDACompressionAlgorithm 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.text.integrityCheckAlgorithm Base required IntegrityCheckAlgorithm 📍2.0.0 THO v5.2
    Observation.text.mediaType Base example MediaType 📦3.0.0 THO v6.5
    Observation.text.representation Base required CDABinaryDataEncoding 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.statusCode Base required ActStatus 📦3.0.0 THO v6.5
    Observation.statusCode.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.effectiveTime.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.effectiveTime.​operator Base required CDASetOperator 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.priorityCode Base example ActPriority 📦3.0.0 THO v6.5
    Observation.languageCode Base required All Languages 📦5.0.0 FHIR Std.
    Observation.interpretationCode Base required CDAObservationInterpretation 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.methodCode Base example ObservationMethod 📦3.0.0 THO v6.5
    Observation.referenceRange.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.referenceRange.​typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.referenceRange.​typeCode Base required CDAActRelationshipType 📦2.0.1-sd Clinical Document Architecture v2.0

    Constraints

    Id Grade Path(s) Description Expression
    II-1 error Observation.typeId, Observation.referenceRange.typeId An II instance must have either a root or an nullFlavor. root.exists() or nullFlavor.exists()
    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

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Observation C 1..1 Observation XML Namespace: urn:hl7-org:v3
    Base for all types and resources
    Instance of this type are validated by templateId
    Logical Container: ClinicalDocument (CDA Class)
    Constraints: should-text-ref-value
    ... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ... realmCode 0..* CS
    ... typeId C 0..1 II Constraints: II-1
    .... @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 Constraints: value-starts-octothorpe
    .... 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 Constraints: value-only
    .... @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 C 0..1 II Constraints: II-1
    ..... @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)

    doco Documentation for this format

    Terminology Bindings

    Path Status Usage ValueSet Version Source
    Observation.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.templateId:instruction.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.classCode Base required CDAActClassObservation 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.moodCode Base required x_ActMoodDocumentObservation 📍2.0.0 THO v5.2
    Observation.code Base example ObservationType 📦3.0.0 THO v6.5
    Observation.code.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.code.translation Base preferred Patient Education . 📦20240606 VSAC v0.23
    Observation.text.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.text.compression Base required CDACompressionAlgorithm 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.text.integrityCheckAlgorithm Base required IntegrityCheckAlgorithm 📍2.0.0 THO v5.2
    Observation.text.mediaType Base example MediaType 📦3.0.0 THO v6.5
    Observation.text.representation Base required CDABinaryDataEncoding 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.statusCode Base required ActStatus 📦3.0.0 THO v6.5
    Observation.statusCode.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.effectiveTime.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.effectiveTime.​operator Base required CDASetOperator 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.priorityCode Base example ActPriority 📦3.0.0 THO v6.5
    Observation.languageCode Base required All Languages 📦5.0.0 FHIR Std.
    Observation.interpretationCode Base required CDAObservationInterpretation 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.methodCode Base example ObservationMethod 📦3.0.0 THO v6.5
    Observation.referenceRange.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.referenceRange.​typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    Observation.referenceRange.​typeCode Base required CDAActRelationshipType 📦2.0.1-sd Clinical Document Architecture v2.0

    Constraints

    Id Grade Path(s) Description Expression
    II-1 error Observation.typeId, Observation.referenceRange.typeId An II instance must have either a root or an nullFlavor. root.exists() or nullFlavor.exists()
    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