Consolidated CDA
3.0.0-ballot - ballot
Consolidated CDA
3.0.0-ballot - ballot
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
| Official URL: http://hl7.org/cda/us/ccda/StructureDefinition/DeviceIdentifierObservation | Version: 3.0.0-ballot | |||
| Draft as of 2023-12-21 | Computable Name: DeviceIdentifierObservation | |||
| Other Identifiers: id: urn:hl7ii:2.16.840.1.113883.10.20.22.4.304:2022-06-01 | ||||
This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the Device Identifier (also known as the “Primary DI Number”) for a medical device marketed in the US. The device identifier is parsed from the UDI value.
The Device Identifier number can be used as a key to look-up device identification information in the publicly available version of the US FDA Global UDI Database (GUDID) - the AccessGUDID: https://accessgudid.nlm.nih.gov/resources/home
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Observation
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Observation | C | 1..1 | Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, 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..* | II | Slice: Unordered, Open by value:root, value:extension | |
   templateId:device-id-obs | 1..1 | II | ||
  @root | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.304 | |
  @extension | 1..1 | st | Required Pattern: 2022-06-01 | |
| code | 1..1 | CD | Primary DI Number Code from NCIt | |
 @code | 1..1 | cs | Required Pattern: C101722 | |
| @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 'Primary DI Number' | |
| text | 0..1 | ED | SHOULD reference the portion of section narrative text corresponding to this entry | |
| reference | C | 0..1 | TEL | value-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative |
  value | C | 1..1 | II | This value is assigned by the Manufacturer by using an FDA-accredited UDI-issuing agency should-extension: SHOULD contain extension |
| @displayable | 1..1 | bl | Required Pattern: true | |
| @root | 1..1 | oid, uuid, ruid | ||
| @extension | 0..1 | st | ||
| Documentation for this format | ||||
| Id | Grade | Path(s) | Details | Requirements |
| should-extension | warning | Observation.value | SHOULD contain extension : extension.exists() | |
| should-text-ref-value | warning | Observation | SHOULD contain text/reference/@value : text.reference.value.exists() | |
| value-starts-octothorpe | error | Observation.text.reference | If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative : value.exists() implies value.startsWith('#') |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | C | 1..1 | Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, 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..* | II | Slice: Unordered, Open by value:root, value:extension | |
| templateId:device-id-obs | 1..1 | II | ||
 @root | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.304 | |
| @extension | 1..1 | st | Required Pattern: 2022-06-01 | |
| @classCode | 1..1 | cs | Binding: ActClassObservation (2.0.0) (required) | |
| @moodCode | 1..1 | cs | Binding: XActMoodDocumentObservation (2.0.0) (required) | |
| code | 1..1 | CD | Primary DI Number Code from NCIt Binding: ObservationType (example) | |
| @code | 1..1 | cs | Required Pattern: C101722 | |
| @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 'Primary DI Number' | |
| text | 0..1 | ED | SHOULD reference the portion of section narrative text corresponding to this entry | |
| reference | C | 0..1 | TEL | value-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative |
| value | C | 1..1 | II | This value is assigned by the Manufacturer by using an FDA-accredited UDI-issuing agency should-extension: SHOULD contain extension |
| @displayable | 1..1 | bl | Required Pattern: true | |
| @root | 1..1 | oid, uuid, ruid | ||
| @extension | 0..1 | st | ||
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| Observation.classCode | required | ActClassObservation |
| Observation.moodCode | required | XActMoodDocumentObservation |
| Observation.code | example | ObservationType |
| Id | Grade | Path(s) | Details | Requirements |
| should-extension | warning | Observation.value | SHOULD contain extension : extension.exists() | |
| should-text-ref-value | warning | Observation | SHOULD contain text/reference/@value : text.reference.value.exists() | |
| 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('#') |
| Path | Conformance | ValueSet / Code |
| Observation.nullFlavor | required | CDANullFlavor |
| Observation.typeId.nullFlavor | required | CDANullFlavor |
| Observation.templateId:device-id-obs.nullFlavor | required | CDANullFlavor |
| Observation.classCode | required | ActClassObservation |
| Observation.moodCode | required | XActMoodDocumentObservation |
| Observation.code | example | ObservationType |
| Observation.code.nullFlavor | required | CDANullFlavor |
| Observation.text.nullFlavor | required | CDANullFlavor |
| Observation.text.compression | required | CDACompressionAlgorithm |
| Observation.text.integrityCheckAlgorithm | required | IntegrityCheckAlgorithm |
| Observation.text.mediaType | example | MediaType |
| Observation.text.representation | required | BinaryDataEncoding |
| Observation.statusCode | required | ActStatus |
| Observation.priorityCode | example | ActPriority |
| Observation.languageCode | required | AllLanguages |
| Observation.value.nullFlavor | required | CDANullFlavor |
| Observation.interpretationCode | required | ObservationInterpretation |
| Observation.methodCode | example | ObservationMethod |
| Observation.referenceRange.nullFlavor | required | CDANullFlavor |
| Observation.referenceRange.typeId.nullFlavor | required | CDANullFlavor |
| Observation.referenceRange.typeCode | required | Fixed Value: REFV |
| Id | Grade | Path(s) | Details | Requirements |
| should-extension | warning | Observation.value | SHOULD contain extension : extension.exists() | |
| should-text-ref-value | warning | Observation | SHOULD contain text/reference/@value : text.reference.value.exists() | |
| 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
Slices
This structure defines the following Slices:
Differential View
This structure is derived from Observation
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | C | 1..1 | Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, 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..* | II | Slice: Unordered, Open by value:root, value:extension | |
| templateId:device-id-obs | 1..1 | II | ||
| @root | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.304 | |
| @extension | 1..1 | st | Required Pattern: 2022-06-01 | |
| code | 1..1 | CD | Primary DI Number Code from NCIt | |
| @code | 1..1 | cs | Required Pattern: C101722 | |
| @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 'Primary DI Number' | |
| text | 0..1 | ED | SHOULD reference the portion of section narrative text corresponding to this entry | |
| reference | C | 0..1 | TEL | value-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative |
| value | C | 1..1 | II | This value is assigned by the Manufacturer by using an FDA-accredited UDI-issuing agency should-extension: SHOULD contain extension |
| @displayable | 1..1 | bl | Required Pattern: true | |
| @root | 1..1 | oid, uuid, ruid | ||
| @extension | 0..1 | st | ||
| Documentation for this format | ||||
| Id | Grade | Path(s) | Details | Requirements |
| should-extension | warning | Observation.value | SHOULD contain extension : extension.exists() | |
| should-text-ref-value | warning | Observation | SHOULD contain text/reference/@value : text.reference.value.exists() | |
| value-starts-octothorpe | error | Observation.text.reference | If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative : value.exists() implies value.startsWith('#') |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | C | 1..1 | Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, 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..* | II | Slice: Unordered, Open by value:root, value:extension | |
| templateId:device-id-obs | 1..1 | II | ||
| @root | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.304 | |
| @extension | 1..1 | st | Required Pattern: 2022-06-01 | |
| @classCode | 1..1 | cs | Binding: ActClassObservation (2.0.0) (required) | |
| @moodCode | 1..1 | cs | Binding: XActMoodDocumentObservation (2.0.0) (required) | |
| code | 1..1 | CD | Primary DI Number Code from NCIt Binding: ObservationType (example) | |
| @code | 1..1 | cs | Required Pattern: C101722 | |
| @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 'Primary DI Number' | |
| text | 0..1 | ED | SHOULD reference the portion of section narrative text corresponding to this entry | |
| reference | C | 0..1 | TEL | value-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative |
| value | C | 1..1 | II | This value is assigned by the Manufacturer by using an FDA-accredited UDI-issuing agency should-extension: SHOULD contain extension |
| @displayable | 1..1 | bl | Required Pattern: true | |
| @root | 1..1 | oid, uuid, ruid | ||
| @extension | 0..1 | st | ||
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| Observation.classCode | required | ActClassObservation |
| Observation.moodCode | required | XActMoodDocumentObservation |
| Observation.code | example | ObservationType |
| Id | Grade | Path(s) | Details | Requirements |
| should-extension | warning | Observation.value | SHOULD contain extension : extension.exists() | |
| should-text-ref-value | warning | Observation | SHOULD contain text/reference/@value : text.reference.value.exists() | |
| 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
| Path | Conformance | ValueSet / Code |
| Observation.nullFlavor | required | CDANullFlavor |
| Observation.typeId.nullFlavor | required | CDANullFlavor |
| Observation.templateId:device-id-obs.nullFlavor | required | CDANullFlavor |
| Observation.classCode | required | ActClassObservation |
| Observation.moodCode | required | XActMoodDocumentObservation |
| Observation.code | example | ObservationType |
| Observation.code.nullFlavor | required | CDANullFlavor |
| Observation.text.nullFlavor | required | CDANullFlavor |
| Observation.text.compression | required | CDACompressionAlgorithm |
| Observation.text.integrityCheckAlgorithm | required | IntegrityCheckAlgorithm |
| Observation.text.mediaType | example | MediaType |
| Observation.text.representation | required | BinaryDataEncoding |
| Observation.statusCode | required | ActStatus |
| Observation.priorityCode | example | ActPriority |
| Observation.languageCode | required | AllLanguages |
| Observation.value.nullFlavor | required | CDANullFlavor |
| Observation.interpretationCode | required | ObservationInterpretation |
| Observation.methodCode | example | ObservationMethod |
| Observation.referenceRange.nullFlavor | required | CDANullFlavor |
| Observation.referenceRange.typeId.nullFlavor | required | CDANullFlavor |
| Observation.referenceRange.typeCode | required | Fixed Value: REFV |
| Id | Grade | Path(s) | Details | Requirements |
| should-extension | warning | Observation.value | SHOULD contain extension : extension.exists() | |
| should-text-ref-value | warning | Observation | SHOULD contain text/reference/@value : text.reference.value.exists() | |
| 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
Slices
This structure defines the following Slices:
IG © 2019+ Health Level Seven. Package hl7.cda.us.ccda#3.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-21
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