Consolidated CDA
3.0.0-ballot - ballot United States of America flag

This page is part of the CCDA: Consolidated CDA Release (v3.0.0-ballot: CCDA 3.0 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Logical Model: Brand Name Observation

Official URL: http://hl7.org/cda/us/ccda/StructureDefinition/BrandNameObservation Version: 3.0.0-ballot
Draft as of 2023-12-21 Computable Name: BrandNameObservation
Other Identifiers: id: urn:hl7ii:2.16.840.1.113883.10.20.22.4.301:2019-06-21

This template is intended to be used in addition to the Product Instance template to exchange the Brand Name. The UDI-DI of the medical device may be used to retrieve the Brand Name in accessGUDID, which should be considered the source of truth.

Usage:

  • This Logical Model is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

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

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C1..1ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, 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
Instances 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..*IISlice: Unordered, Open by value:root, value:extension
.... templateId:brand-name-obs 1..1II
..... @root 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.10.20.22.4.301
..... @extension 1..1stRequired Pattern: 2019-06-21
... code 1..1CDCode for "Device Brand Name"
.... @code 1..1csRequired Pattern: C71898
.... @codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... @codeSystemName 0..1stMAY be set to 'NCI Thesaurus'
.... @displayName 0..1stMAY be set to 'Brand Name'
... text 0..1EDSHOULD reference the portion of section narrative text corresponding to this entry
.... reference C0..1TELvalue-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative

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 & Constraintsdoco
.. Observation C1..1ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, 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
Instances 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..*IISlice: Unordered, Open by value:root, value:extension
.... templateId:brand-name-obs 1..1II
..... @root 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.10.20.22.4.301
..... @extension 1..1stRequired Pattern: 2019-06-21
... @classCode 1..1csBinding: ActClassObservation (2.0.0) (required)
... @moodCode 1..1csBinding: XActMoodDocumentObservation (2.0.0) (required)
.... @code 1..1csRequired Pattern: C71898
.... @codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... @codeSystemName 0..1stMAY be set to 'NCI Thesaurus'
.... @displayName 0..1stMAY be set to 'Brand Name'
... text 0..1EDSHOULD reference the portion of section narrative text corresponding to this entry
.... reference C0..1TELvalue-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative
... value 1..1ED

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.classCoderequiredActClassObservation
Observation.moodCoderequiredXActMoodDocumentObservation
Observation.codeexampleObservationType

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 & Constraintsdoco
.. Observation C1..1ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, 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
Instances of this type are validated by templateId
Logical Container: ClinicalDocument (CDA Class)
should-text-ref-value: SHOULD contain text/reference/@value
... @nullFlavor 0..1csBinding: CDANullFlavor (required)
... realmCode 0..*CS
... typeId 0..1II
.... @nullFlavor 0..1csBinding: CDANullFlavor (required)
.... @assigningAuthorityName 0..1st
.... @displayable 0..1bl
.... @root 1..1oid, uuid, ruidFixed Value: 2.16.840.1.113883.1.3
.... @extension 1..1st
... Slices for templateId 1..*IISlice: Unordered, Open by value:root, value:extension
.... templateId:brand-name-obs 1..1II
..... @nullFlavor 0..1csBinding: CDANullFlavor (required)
..... @assigningAuthorityName 0..1st
..... @displayable 0..1bl
..... @root 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.10.20.22.4.301
..... @extension 1..1stRequired Pattern: 2019-06-21
... @classCode 1..1csBinding: ActClassObservation (2.0.0) (required)
... @moodCode 1..1csBinding: XActMoodDocumentObservation (2.0.0) (required)
... @negationInd 0..1bl
... id 0..*II
... code 1..1CDCode for "Device Brand Name"
Binding: ObservationType (example)
.... @nullFlavor 0..1csBinding: CDANullFlavor (required)
.... @code 1..1csRequired Pattern: C71898
.... @codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... @codeSystemName 0..1stMAY be set to 'NCI Thesaurus'
.... @codeSystemVersion 0..1st
.... @displayName 0..1stMAY be set to 'Brand Name'
.... @sdtcValueSet 0..1oidXML Namespace: urn:hl7-org:sdtc
XML: valueSet (urn:hl7-org:sdtc)
.... @sdtcValueSetVersion 0..1stXML Namespace: urn:hl7-org:sdtc
XML: valueSetVersion (urn:hl7-org:sdtc)
.... originalText 0..1ED
.... qualifier 0..*CR
.... translation 0..*CD
... derivationExpr 0..1ST
... text 0..1EDSHOULD reference the portion of section narrative text corresponding to this entry
.... @nullFlavor 0..1csBinding: CDANullFlavor (required)
.... @compression 0..1csBinding: CompressionAlgorithm (required)
.... @integrityCheck 0..1bin
.... @integrityCheckAlgorithm 0..1csBinding: IntegrityCheckAlgorithm (2.0.0) (required)
.... @language 0..1cs
.... @mediaType 0..1csBinding: MediaType (example)
.... @representation 0..1csBinding: Binary Data Encoding Value Set (required)
.... xmlText 0..1stAllows for mixed text content. If @representation='B64', this SHALL be a base64binary string.
.... reference C0..1TELvalue-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative
.... thumbnail 0..1ED
... statusCode 0..1CSBinding: ActStatus (required)
... effectiveTime 0..1IVL_TS
... priorityCode 0..1CEBinding: ActPriority (example)
... repeatNumber 0..1IVL_INT
... languageCode 0..1CSBinding: AllLanguages (required)
... value 1..1ED
... interpretationCode 0..*CEBinding: ObservationInterpretation (required)
... methodCode 0..*CEBinding: ObservationMethod (example)
... targetSiteCode 0..*CD
... subject 0..1Subject
... 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..*Precondition2XML Namespace: urn:hl7-org:sdtc
XML: precondition2 (urn:hl7-org:sdtc)
... referenceRange 0..*InfrastructureRoot
.... @nullFlavor 0..1csBinding: CDANullFlavor (required)
.... realmCode 0..*CS
.... typeId 0..1II
..... @nullFlavor 0..1csBinding: CDANullFlavor (required)
..... @assigningAuthorityName 0..1st
..... @displayable 0..1bl
..... @root 1..1oid, uuid, ruidFixed Value: 2.16.840.1.113883.1.3
..... @extension 1..1st
.... templateId 0..*II
.... @typeCode 0..1csBinding: ActRelationshipType (2.0.0) (required)
Fixed Value: REFV
.... observationRange 1..1ObservationRange
... sdtcInFulfillmentOf1 0..*InFulfillmentOf1XML Namespace: urn:hl7-org:sdtc
XML: inFulfillmentOf1 (urn:hl7-org:sdtc)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.nullFlavorrequiredCDANullFlavor
Observation.typeId.nullFlavorrequiredCDANullFlavor
Observation.templateId:brand-name-obs.nullFlavorrequiredCDANullFlavor
Observation.classCoderequiredActClassObservation
Observation.moodCoderequiredXActMoodDocumentObservation
Observation.codeexampleObservationType
Observation.code.nullFlavorrequiredCDANullFlavor
Observation.text.nullFlavorrequiredCDANullFlavor
Observation.text.compressionrequiredCDACompressionAlgorithm
Observation.text.integrityCheckAlgorithmrequiredIntegrityCheckAlgorithm
Observation.text.mediaTypeexampleMediaType
Observation.text.representationrequiredBinaryDataEncoding
Observation.statusCoderequiredActStatus
Observation.priorityCodeexampleActPriority
Observation.languageCoderequiredAllLanguages
Observation.interpretationCoderequiredObservationInterpretation
Observation.methodCodeexampleObservationMethod
Observation.referenceRange.nullFlavorrequiredCDANullFlavor
Observation.referenceRange.typeId.nullFlavorrequiredCDANullFlavor
Observation.referenceRange.typeCoderequiredFixed Value: REFV

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('#')

This structure is derived from Observation

Summary

Mandatory: 7 elements

Slices

This structure defines the following Slices:

  • The element Observation.templateId is sliced based on the values of value:root, value:extension

Differential View

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C1..1ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, 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
Instances 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..*IISlice: Unordered, Open by value:root, value:extension
.... templateId:brand-name-obs 1..1II
..... @root 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.10.20.22.4.301
..... @extension 1..1stRequired Pattern: 2019-06-21
... code 1..1CDCode for "Device Brand Name"
.... @code 1..1csRequired Pattern: C71898
.... @codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... @codeSystemName 0..1stMAY be set to 'NCI Thesaurus'
.... @displayName 0..1stMAY be set to 'Brand Name'
... text 0..1EDSHOULD reference the portion of section narrative text corresponding to this entry
.... reference C0..1TELvalue-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative

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 & Constraintsdoco
.. Observation C1..1ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, 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
Instances 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..*IISlice: Unordered, Open by value:root, value:extension
.... templateId:brand-name-obs 1..1II
..... @root 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.10.20.22.4.301
..... @extension 1..1stRequired Pattern: 2019-06-21
... @classCode 1..1csBinding: ActClassObservation (2.0.0) (required)
... @moodCode 1..1csBinding: XActMoodDocumentObservation (2.0.0) (required)
.... @code 1..1csRequired Pattern: C71898
.... @codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... @codeSystemName 0..1stMAY be set to 'NCI Thesaurus'
.... @displayName 0..1stMAY be set to 'Brand Name'
... text 0..1EDSHOULD reference the portion of section narrative text corresponding to this entry
.... reference C0..1TELvalue-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative
... value 1..1ED

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.classCoderequiredActClassObservation
Observation.moodCoderequiredXActMoodDocumentObservation
Observation.codeexampleObservationType

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('#')

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C1..1ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, 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
Instances of this type are validated by templateId
Logical Container: ClinicalDocument (CDA Class)
should-text-ref-value: SHOULD contain text/reference/@value
... @nullFlavor 0..1csBinding: CDANullFlavor (required)
... realmCode 0..*CS
... typeId 0..1II
.... @nullFlavor 0..1csBinding: CDANullFlavor (required)
.... @assigningAuthorityName 0..1st
.... @displayable 0..1bl
.... @root 1..1oid, uuid, ruidFixed Value: 2.16.840.1.113883.1.3
.... @extension 1..1st
... Slices for templateId 1..*IISlice: Unordered, Open by value:root, value:extension
.... templateId:brand-name-obs 1..1II
..... @nullFlavor 0..1csBinding: CDANullFlavor (required)
..... @assigningAuthorityName 0..1st
..... @displayable 0..1bl
..... @root 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.10.20.22.4.301
..... @extension 1..1stRequired Pattern: 2019-06-21
... @classCode 1..1csBinding: ActClassObservation (2.0.0) (required)
... @moodCode 1..1csBinding: XActMoodDocumentObservation (2.0.0) (required)
... @negationInd 0..1bl
... id 0..*II
... code 1..1CDCode for "Device Brand Name"
Binding: ObservationType (example)
.... @nullFlavor 0..1csBinding: CDANullFlavor (required)
.... @code 1..1csRequired Pattern: C71898
.... @codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... @codeSystemName 0..1stMAY be set to 'NCI Thesaurus'
.... @codeSystemVersion 0..1st
.... @displayName 0..1stMAY be set to 'Brand Name'
.... @sdtcValueSet 0..1oidXML Namespace: urn:hl7-org:sdtc
XML: valueSet (urn:hl7-org:sdtc)
.... @sdtcValueSetVersion 0..1stXML Namespace: urn:hl7-org:sdtc
XML: valueSetVersion (urn:hl7-org:sdtc)
.... originalText 0..1ED
.... qualifier 0..*CR
.... translation 0..*CD
... derivationExpr 0..1ST
... text 0..1EDSHOULD reference the portion of section narrative text corresponding to this entry
.... @nullFlavor 0..1csBinding: CDANullFlavor (required)
.... @compression 0..1csBinding: CompressionAlgorithm (required)
.... @integrityCheck 0..1bin
.... @integrityCheckAlgorithm 0..1csBinding: IntegrityCheckAlgorithm (2.0.0) (required)
.... @language 0..1cs
.... @mediaType 0..1csBinding: MediaType (example)
.... @representation 0..1csBinding: Binary Data Encoding Value Set (required)
.... xmlText 0..1stAllows for mixed text content. If @representation='B64', this SHALL be a base64binary string.
.... reference C0..1TELvalue-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative
.... thumbnail 0..1ED
... statusCode 0..1CSBinding: ActStatus (required)
... effectiveTime 0..1IVL_TS
... priorityCode 0..1CEBinding: ActPriority (example)
... repeatNumber 0..1IVL_INT
... languageCode 0..1CSBinding: AllLanguages (required)
... value 1..1ED
... interpretationCode 0..*CEBinding: ObservationInterpretation (required)
... methodCode 0..*CEBinding: ObservationMethod (example)
... targetSiteCode 0..*CD
... subject 0..1Subject
... 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..*Precondition2XML Namespace: urn:hl7-org:sdtc
XML: precondition2 (urn:hl7-org:sdtc)
... referenceRange 0..*InfrastructureRoot
.... @nullFlavor 0..1csBinding: CDANullFlavor (required)
.... realmCode 0..*CS
.... typeId 0..1II
..... @nullFlavor 0..1csBinding: CDANullFlavor (required)
..... @assigningAuthorityName 0..1st
..... @displayable 0..1bl
..... @root 1..1oid, uuid, ruidFixed Value: 2.16.840.1.113883.1.3
..... @extension 1..1st
.... templateId 0..*II
.... @typeCode 0..1csBinding: ActRelationshipType (2.0.0) (required)
Fixed Value: REFV
.... observationRange 1..1ObservationRange
... sdtcInFulfillmentOf1 0..*InFulfillmentOf1XML Namespace: urn:hl7-org:sdtc
XML: inFulfillmentOf1 (urn:hl7-org:sdtc)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.nullFlavorrequiredCDANullFlavor
Observation.typeId.nullFlavorrequiredCDANullFlavor
Observation.templateId:brand-name-obs.nullFlavorrequiredCDANullFlavor
Observation.classCoderequiredActClassObservation
Observation.moodCoderequiredXActMoodDocumentObservation
Observation.codeexampleObservationType
Observation.code.nullFlavorrequiredCDANullFlavor
Observation.text.nullFlavorrequiredCDANullFlavor
Observation.text.compressionrequiredCDACompressionAlgorithm
Observation.text.integrityCheckAlgorithmrequiredIntegrityCheckAlgorithm
Observation.text.mediaTypeexampleMediaType
Observation.text.representationrequiredBinaryDataEncoding
Observation.statusCoderequiredActStatus
Observation.priorityCodeexampleActPriority
Observation.languageCoderequiredAllLanguages
Observation.interpretationCoderequiredObservationInterpretation
Observation.methodCodeexampleObservationMethod
Observation.referenceRange.nullFlavorrequiredCDANullFlavor
Observation.referenceRange.typeId.nullFlavorrequiredCDANullFlavor
Observation.referenceRange.typeCoderequiredFixed Value: REFV

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('#')

This structure is derived from Observation

Summary

Mandatory: 7 elements

Slices

This structure defines the following Slices:

  • The element Observation.templateId is sliced based on the values of value:root, value:extension

 

Other representations of profile: CSV, Excel