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: Lot or Batch Number Observation

Official URL: http://hl7.org/cda/us/ccda/StructureDefinition/LotOrBatchNumberObservation Version: 4.0.0
Draft as of 2025-06-17 Computable Name: LotOrBatchNumberObservation
Other Identifiers: urn:ietf:rfc:3986#Uniform Resource Identifier (URI)#urn:hl7ii:2.16.840.1.113883.10.20.22.4.315:2019-06-21

This template is intended to be used in addition to the Product Instance template to exchange the Lot or Batch Number of the device. The Lot or Batch Number is parsed from the UDI value, if present.

Usages:

Changes since version 3.0.0:

  • No changes

    • 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
    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)
    Constraints: should-text-ref-value
    ... Slices for templateId 1..* II Slice: Unordered, Open by value:root, value:extension
    .... templateId:lot-batch-obs 1..1 II
    ..... @root 1..1 oid, uuid, ruid Required Pattern: 2.16.840.1.113883.10.20.22.4.315
    ..... @extension 1..1 st Required Pattern: 2019-06-21
    ... code 1..1 CD Code for "Lot or Batch Number"
    .... @code 1..1 cs Required Pattern: C101672
    .... @codeSystem 1..1 oid, uuid, ruid Required Pattern: 2.16.840.1.113883.3.26.1.1
    .... @codeSystemName 0..1 st MAY be set to 'NCI Thesaurus'
    .... @displayName 0..1 st MAY be set to 'Lot or Batch Number'
    ... 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

    doco Documentation for this format

    Constraints

    IdGradePath(s)DetailsRequirements
    should-text-ref-valuewarningObservationSHOULD contain text/reference/@value
    : text.reference.value.exists()
    value-starts-octothorpeerrorObservation.text.referenceIf 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
    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)
    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:lot-batch-obs 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: 2.16.840.1.113883.10.20.22.4.315
    ..... @extension 1..1 st Required Pattern: 2019-06-21
    ... @classCode 1..1 cs Binding: CDAActClassObservation (required)
    ... @moodCode 1..1 cs Binding: XActMoodDocumentObservation (2.0.0) (required)
    ... @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 Code for "Lot or Batch Number"
    Binding: ObservationType (example)
    .... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    .... @code 1..1 cs Required Pattern: C101672
    .... @codeSystem 1..1 oid, uuid, ruid Required Pattern: 2.16.840.1.113883.3.26.1.1
    .... @codeSystemName 0..1 st MAY be set to 'NCI Thesaurus'
    .... @codeSystemVersion 0..1 st
    .... @displayName 0..1 st MAY be set to 'Lot or Batch Number'
    .... @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
    ... 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 0..1 CS Binding: ActStatus (required)
    ... effectiveTime 0..1 IVL_TS
    ... priorityCode 0..1 CE Binding: ActPriority (example)
    ... repeatNumber 0..1 IVL_INT
    ... languageCode 0..1 CS Binding: AllLanguages (required)
    ... value 1..1 ED
    ... 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

    PathConformanceValueSet / CodeURI
    Observation.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.templateId:lot-batch-obs.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.classCoderequiredCDAActClassObservation
    http://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation
    Observation.moodCoderequiredXActMoodDocumentObservation
    http://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation|2.0.0
    Observation.codeexampleObservationType
    http://terminology.hl7.org/ValueSet/v3-ObservationType
    Observation.code.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.text.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.text.compressionrequiredCDACompressionAlgorithm
    http://hl7.org/cda/stds/core/ValueSet/CDACompressionAlgorithm
    Observation.text.integrityCheckAlgorithmrequiredIntegrityCheckAlgorithm
    http://terminology.hl7.org/ValueSet/v3-IntegrityCheckAlgorithm|2.0.0
    Observation.text.mediaTypeexampleMediaType
    http://terminology.hl7.org/ValueSet/v3-MediaType
    Observation.text.representationrequiredBinaryDataEncoding
    http://hl7.org/cda/stds/core/ValueSet/BinaryDataEncoding
    Observation.statusCoderequiredActStatus
    http://terminology.hl7.org/ValueSet/v3-ActStatus
    Observation.priorityCodeexampleActPriority
    http://terminology.hl7.org/ValueSet/v3-ActPriority
    Observation.languageCoderequiredAllLanguages
    http://hl7.org/fhir/ValueSet/all-languages
    From the FHIR Standard
    Observation.interpretationCoderequiredCDAObservationInterpretation
    http://hl7.org/cda/stds/core/ValueSet/CDAObservationInterpretation
    Observation.methodCodeexampleObservationMethod
    http://terminology.hl7.org/ValueSet/v3-ObservationMethod
    Observation.referenceRange.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.referenceRange.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.referenceRange.typeCoderequiredFixed Value: REFV
    http://hl7.org/cda/stds/core/ValueSet/CDAActRelationshipType

    Constraints

    IdGradePath(s)DetailsRequirements
    II-1errorObservation.typeId, Observation.referenceRange.typeIdAn II instance must have either a root or an nullFlavor.
    : root.exists() or nullFlavor.exists()
    should-text-ref-valuewarningObservationSHOULD contain text/reference/@value
    : text.reference.value.exists()
    value-starts-octothorpeerrorObservation.text.referenceIf 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
    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)
    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:lot-batch-obs 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: 2.16.840.1.113883.10.20.22.4.315
    ..... @extension 1..1 st Required Pattern: 2019-06-21
    ... @classCode 1..1 cs Binding: CDAActClassObservation (required)
    ... @moodCode 1..1 cs Binding: XActMoodDocumentObservation (2.0.0) (required)
    ... @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 Code for "Lot or Batch Number"
    Binding: ObservationType (example)
    .... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    .... @code 1..1 cs Required Pattern: C101672
    .... @codeSystem 1..1 oid, uuid, ruid Required Pattern: 2.16.840.1.113883.3.26.1.1
    .... @codeSystemName 0..1 st MAY be set to 'NCI Thesaurus'
    .... @codeSystemVersion 0..1 st
    .... @displayName 0..1 st MAY be set to 'Lot or Batch Number'
    .... @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
    ... 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 0..1 CS Binding: ActStatus (required)
    ... effectiveTime 0..1 IVL_TS
    ... priorityCode 0..1 CE Binding: ActPriority (example)
    ... repeatNumber 0..1 IVL_INT
    ... languageCode 0..1 CS Binding: AllLanguages (required)
    ... value 1..1 ED
    ... 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

    PathConformanceValueSet / CodeURI
    Observation.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.templateId:lot-batch-obs.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.classCoderequiredCDAActClassObservation
    http://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation
    Observation.moodCoderequiredXActMoodDocumentObservation
    http://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation|2.0.0
    Observation.codeexampleObservationType
    http://terminology.hl7.org/ValueSet/v3-ObservationType
    Observation.code.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.text.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.text.compressionrequiredCDACompressionAlgorithm
    http://hl7.org/cda/stds/core/ValueSet/CDACompressionAlgorithm
    Observation.text.integrityCheckAlgorithmrequiredIntegrityCheckAlgorithm
    http://terminology.hl7.org/ValueSet/v3-IntegrityCheckAlgorithm|2.0.0
    Observation.text.mediaTypeexampleMediaType
    http://terminology.hl7.org/ValueSet/v3-MediaType
    Observation.text.representationrequiredBinaryDataEncoding
    http://hl7.org/cda/stds/core/ValueSet/BinaryDataEncoding
    Observation.statusCoderequiredActStatus
    http://terminology.hl7.org/ValueSet/v3-ActStatus
    Observation.priorityCodeexampleActPriority
    http://terminology.hl7.org/ValueSet/v3-ActPriority
    Observation.languageCoderequiredAllLanguages
    http://hl7.org/fhir/ValueSet/all-languages
    From the FHIR Standard
    Observation.interpretationCoderequiredCDAObservationInterpretation
    http://hl7.org/cda/stds/core/ValueSet/CDAObservationInterpretation
    Observation.methodCodeexampleObservationMethod
    http://terminology.hl7.org/ValueSet/v3-ObservationMethod
    Observation.referenceRange.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.referenceRange.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.referenceRange.typeCoderequiredFixed Value: REFV
    http://hl7.org/cda/stds/core/ValueSet/CDAActRelationshipType

    Constraints

    IdGradePath(s)DetailsRequirements
    II-1errorObservation.typeId, Observation.referenceRange.typeIdAn II instance must have either a root or an nullFlavor.
    : root.exists() or nullFlavor.exists()
    should-text-ref-valuewarningObservationSHOULD contain text/reference/@value
    : text.reference.value.exists()
    value-starts-octothorpeerrorObservation.text.referenceIf 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: 7 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
    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)
    Constraints: should-text-ref-value
    ... Slices for templateId 1..* II Slice: Unordered, Open by value:root, value:extension
    .... templateId:lot-batch-obs 1..1 II
    ..... @root 1..1 oid, uuid, ruid Required Pattern: 2.16.840.1.113883.10.20.22.4.315
    ..... @extension 1..1 st Required Pattern: 2019-06-21
    ... code 1..1 CD Code for "Lot or Batch Number"
    .... @code 1..1 cs Required Pattern: C101672
    .... @codeSystem 1..1 oid, uuid, ruid Required Pattern: 2.16.840.1.113883.3.26.1.1
    .... @codeSystemName 0..1 st MAY be set to 'NCI Thesaurus'
    .... @displayName 0..1 st MAY be set to 'Lot or Batch Number'
    ... 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

    doco Documentation for this format

    Constraints

    IdGradePath(s)DetailsRequirements
    should-text-ref-valuewarningObservationSHOULD contain text/reference/@value
    : text.reference.value.exists()
    value-starts-octothorpeerrorObservation.text.referenceIf 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
    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)
    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:lot-batch-obs 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: 2.16.840.1.113883.10.20.22.4.315
    ..... @extension 1..1 st Required Pattern: 2019-06-21
    ... @classCode 1..1 cs Binding: CDAActClassObservation (required)
    ... @moodCode 1..1 cs Binding: XActMoodDocumentObservation (2.0.0) (required)
    ... @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 Code for "Lot or Batch Number"
    Binding: ObservationType (example)
    .... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    .... @code 1..1 cs Required Pattern: C101672
    .... @codeSystem 1..1 oid, uuid, ruid Required Pattern: 2.16.840.1.113883.3.26.1.1
    .... @codeSystemName 0..1 st MAY be set to 'NCI Thesaurus'
    .... @codeSystemVersion 0..1 st
    .... @displayName 0..1 st MAY be set to 'Lot or Batch Number'
    .... @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
    ... 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 0..1 CS Binding: ActStatus (required)
    ... effectiveTime 0..1 IVL_TS
    ... priorityCode 0..1 CE Binding: ActPriority (example)
    ... repeatNumber 0..1 IVL_INT
    ... languageCode 0..1 CS Binding: AllLanguages (required)
    ... value 1..1 ED
    ... 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

    PathConformanceValueSet / CodeURI
    Observation.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.templateId:lot-batch-obs.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.classCoderequiredCDAActClassObservation
    http://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation
    Observation.moodCoderequiredXActMoodDocumentObservation
    http://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation|2.0.0
    Observation.codeexampleObservationType
    http://terminology.hl7.org/ValueSet/v3-ObservationType
    Observation.code.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.text.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.text.compressionrequiredCDACompressionAlgorithm
    http://hl7.org/cda/stds/core/ValueSet/CDACompressionAlgorithm
    Observation.text.integrityCheckAlgorithmrequiredIntegrityCheckAlgorithm
    http://terminology.hl7.org/ValueSet/v3-IntegrityCheckAlgorithm|2.0.0
    Observation.text.mediaTypeexampleMediaType
    http://terminology.hl7.org/ValueSet/v3-MediaType
    Observation.text.representationrequiredBinaryDataEncoding
    http://hl7.org/cda/stds/core/ValueSet/BinaryDataEncoding
    Observation.statusCoderequiredActStatus
    http://terminology.hl7.org/ValueSet/v3-ActStatus
    Observation.priorityCodeexampleActPriority
    http://terminology.hl7.org/ValueSet/v3-ActPriority
    Observation.languageCoderequiredAllLanguages
    http://hl7.org/fhir/ValueSet/all-languages
    From the FHIR Standard
    Observation.interpretationCoderequiredCDAObservationInterpretation
    http://hl7.org/cda/stds/core/ValueSet/CDAObservationInterpretation
    Observation.methodCodeexampleObservationMethod
    http://terminology.hl7.org/ValueSet/v3-ObservationMethod
    Observation.referenceRange.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.referenceRange.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.referenceRange.typeCoderequiredFixed Value: REFV
    http://hl7.org/cda/stds/core/ValueSet/CDAActRelationshipType

    Constraints

    IdGradePath(s)DetailsRequirements
    II-1errorObservation.typeId, Observation.referenceRange.typeIdAn II instance must have either a root or an nullFlavor.
    : root.exists() or nullFlavor.exists()
    should-text-ref-valuewarningObservationSHOULD contain text/reference/@value
    : text.reference.value.exists()
    value-starts-octothorpeerrorObservation.text.referenceIf 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
    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)
    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:lot-batch-obs 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: 2.16.840.1.113883.10.20.22.4.315
    ..... @extension 1..1 st Required Pattern: 2019-06-21
    ... @classCode 1..1 cs Binding: CDAActClassObservation (required)
    ... @moodCode 1..1 cs Binding: XActMoodDocumentObservation (2.0.0) (required)
    ... @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 Code for "Lot or Batch Number"
    Binding: ObservationType (example)
    .... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    .... @code 1..1 cs Required Pattern: C101672
    .... @codeSystem 1..1 oid, uuid, ruid Required Pattern: 2.16.840.1.113883.3.26.1.1
    .... @codeSystemName 0..1 st MAY be set to 'NCI Thesaurus'
    .... @codeSystemVersion 0..1 st
    .... @displayName 0..1 st MAY be set to 'Lot or Batch Number'
    .... @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
    ... 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 0..1 CS Binding: ActStatus (required)
    ... effectiveTime 0..1 IVL_TS
    ... priorityCode 0..1 CE Binding: ActPriority (example)
    ... repeatNumber 0..1 IVL_INT
    ... languageCode 0..1 CS Binding: AllLanguages (required)
    ... value 1..1 ED
    ... 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

    PathConformanceValueSet / CodeURI
    Observation.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.templateId:lot-batch-obs.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.classCoderequiredCDAActClassObservation
    http://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation
    Observation.moodCoderequiredXActMoodDocumentObservation
    http://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation|2.0.0
    Observation.codeexampleObservationType
    http://terminology.hl7.org/ValueSet/v3-ObservationType
    Observation.code.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.text.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.text.compressionrequiredCDACompressionAlgorithm
    http://hl7.org/cda/stds/core/ValueSet/CDACompressionAlgorithm
    Observation.text.integrityCheckAlgorithmrequiredIntegrityCheckAlgorithm
    http://terminology.hl7.org/ValueSet/v3-IntegrityCheckAlgorithm|2.0.0
    Observation.text.mediaTypeexampleMediaType
    http://terminology.hl7.org/ValueSet/v3-MediaType
    Observation.text.representationrequiredBinaryDataEncoding
    http://hl7.org/cda/stds/core/ValueSet/BinaryDataEncoding
    Observation.statusCoderequiredActStatus
    http://terminology.hl7.org/ValueSet/v3-ActStatus
    Observation.priorityCodeexampleActPriority
    http://terminology.hl7.org/ValueSet/v3-ActPriority
    Observation.languageCoderequiredAllLanguages
    http://hl7.org/fhir/ValueSet/all-languages
    From the FHIR Standard
    Observation.interpretationCoderequiredCDAObservationInterpretation
    http://hl7.org/cda/stds/core/ValueSet/CDAObservationInterpretation
    Observation.methodCodeexampleObservationMethod
    http://terminology.hl7.org/ValueSet/v3-ObservationMethod
    Observation.referenceRange.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.referenceRange.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    Observation.referenceRange.typeCoderequiredFixed Value: REFV
    http://hl7.org/cda/stds/core/ValueSet/CDAActRelationshipType

    Constraints

    IdGradePath(s)DetailsRequirements
    II-1errorObservation.typeId, Observation.referenceRange.typeIdAn II instance must have either a root or an nullFlavor.
    : root.exists() or nullFlavor.exists()
    should-text-ref-valuewarningObservationSHOULD contain text/reference/@value
    : text.reference.value.exists()
    value-starts-octothorpeerrorObservation.text.referenceIf 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: 7 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