Consolidated CDA (C-CDA)
3.0.0 - STU3
Consolidated CDA (C-CDA)
3.0.0 - STU3
This page is part of the CCDA: Consolidated CDA Release (v3.0.0: CCDA 3.0) generated with FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. 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 | |||
| Draft as of 2024-05-18 | Computable Name: DeviceIdentifierObservation | |||
| Other Identifiers: urn:ietf:rfc:3986#Uniform Resource Identifier (URI)#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 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 Template, 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 Instance of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value |
  Slices for templateId |
1..* | II | Slice: Unordered, Open by value:root, value:extension | |
   templateId: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 Instance of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value |
| Slices for templateId |
1..* | II | Slice: Unordered, Open by value:root, value:extension | |
| templateId: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: CDAActClassObservation (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 | URI |
| Observation.classCode | required | CDAActClassObservationhttp://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation | |
| Observation.moodCode | required | XActMoodDocumentObservationhttp://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation|2.0.0 | |
| Observation.code | example | ObservationTypehttp://terminology.hl7.org/ValueSet/v3-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('#') |
| 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 Instance of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value |
| @nullFlavor |
0..1 | cs | Binding: CDANullFlavor (required) | |
| realmCode |
0..* | CS | ||
| typeId |
0..1 | II | ||
| @nullFlavor |
0..1 | cs | Binding: CDANullFlavor (required) | |
| @assigningAuthorityName |
0..1 | st | ||
| @displayable |
0..1 | bl | ||
| @root |
1..1 | oid, uuid, ruid | Fixed Value: 2.16.840.1.113883.1.3 | |
| @extension |
1..1 | st | ||
| Slices for templateId |
1..* | II | Slice: Unordered, Open by value:root, value:extension | |
| templateId:device-id-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: 2.16.840.1.113883.10.20.22.4.304 | |
| @extension |
1..1 | st | Required Pattern: 2022-06-01 | |
| @classCode |
1..1 | cs | Binding: CDAActClassObservation (required) | |
| @moodCode |
1..1 | cs | Binding: XActMoodDocumentObservation (2.0.0) (required) | |
| @negationInd |
0..1 | bl | ||
| id |
0..* | II | ||
| code |
1..1 | CD | Primary DI Number Code from NCIt Binding: ObservationType (example) | |
| @nullFlavor |
0..1 | cs | Binding: CDANullFlavor (required) | |
| @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' | |
| @codeSystemVersion |
0..1 | st | ||
| @displayName |
0..1 | st | MAY be set to 'Primary DI 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 | value-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative |
| thumbnail |
0..1 | ED | ||
| statusCode |
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 |
C | 1..1 | II | This value is assigned by the Manufacturer by using an FDA-accredited UDI-issuing agency should-extension: SHOULD contain extension |
| @nullFlavor |
0..1 | cs | Binding: CDANullFlavor (required) | |
| @assigningAuthorityName |
0..1 | st | ||
| @displayable |
1..1 | bl | Required Pattern: true | |
| @root |
1..1 | oid, uuid, ruid | ||
| @extension |
0..1 | st | ||
| interpretationCode |
0..* | CE | Binding: CDAObservationInterpretation (required) | |
| methodCode |
0..* | CE | Binding: ObservationMethod (example) | |
| targetSiteCode |
0..* | CD | ||
| subject |
0..1 | Subject | ||
| specimen |
0..* | Specimen | ||
| performer |
0..* | Performer2 | ||
| author |
0..* | Author | ||
| informant |
0..* | Informant | ||
| participant |
0..* | Participant2 | ||
| entryRelationship |
0..* | EntryRelationship | ||
| reference |
0..* | Reference | ||
| precondition |
0..* | Precondition | ||
| sdtcPrecondition2 |
0..* | Precondition2 | XML Namespace: urn:hl7-org:sdtc XML: precondition2 (urn:hl7-org:sdtc) | |
| referenceRange |
0..* | InfrastructureRoot | ||
| @nullFlavor |
0..1 | cs | Binding: CDANullFlavor (required) | |
| realmCode |
0..* | CS | ||
| typeId |
0..1 | II | ||
| @nullFlavor |
0..1 | cs | Binding: CDANullFlavor (required) | |
| @assigningAuthorityName |
0..1 | st | ||
| @displayable |
0..1 | bl | ||
| @root |
1..1 | oid, uuid, ruid | Fixed Value: 2.16.840.1.113883.1.3 | |
| @extension |
1..1 | st | ||
| templateId |
0..* | II | ||
| @typeCode |
0..1 | cs | Binding: CDAActRelationshipType (required) Fixed Value: REFV | |
| observationRange |
1..1 | ObservationRange | ||
| sdtcInFulfillmentOf1 |
0..* | InFulfillmentOf1 | XML Namespace: urn:hl7-org:sdtc XML: inFulfillmentOf1 (urn:hl7-org:sdtc) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Observation.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.typeId.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.templateId:device-id-obs.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.classCode | required | CDAActClassObservationhttp://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation | |
| Observation.moodCode | required | XActMoodDocumentObservationhttp://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation|2.0.0 | |
| Observation.code | example | ObservationTypehttp://terminology.hl7.org/ValueSet/v3-ObservationType | |
| Observation.code.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.text.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.text.compression | required | CDACompressionAlgorithmhttp://hl7.org/cda/stds/core/ValueSet/CDACompressionAlgorithm | |
| Observation.text.integrityCheckAlgorithm | required | IntegrityCheckAlgorithmhttp://terminology.hl7.org/ValueSet/v3-IntegrityCheckAlgorithm|2.0.0 | |
| Observation.text.mediaType | example | MediaTypehttp://terminology.hl7.org/ValueSet/v3-MediaType | |
| Observation.text.representation | required | BinaryDataEncodinghttp://hl7.org/cda/stds/core/ValueSet/BinaryDataEncoding | |
| Observation.statusCode | required | ActStatushttp://terminology.hl7.org/ValueSet/v3-ActStatus | |
| Observation.priorityCode | example | ActPriorityhttp://terminology.hl7.org/ValueSet/v3-ActPriority | |
| Observation.languageCode | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languagesfrom the FHIR Standard | |
| Observation.value.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.interpretationCode | required | CDAObservationInterpretationhttp://hl7.org/cda/stds/core/ValueSet/CDAObservationInterpretation | |
| Observation.methodCode | example | ObservationMethodhttp://terminology.hl7.org/ValueSet/v3-ObservationMethod | |
| Observation.referenceRange.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.referenceRange.typeId.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.referenceRange.typeCode | required | Fixed Value: REFVhttp://hl7.org/cda/stds/core/ValueSet/CDAActRelationshipType |
| 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 Instance of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value |
| Slices for templateId |
1..* | II | Slice: Unordered, Open by value:root, value:extension | |
| templateId: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 Instance of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value |
| Slices for templateId |
1..* | II | Slice: Unordered, Open by value:root, value:extension | |
| templateId: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: CDAActClassObservation (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 | URI |
| Observation.classCode | required | CDAActClassObservationhttp://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation | |
| Observation.moodCode | required | XActMoodDocumentObservationhttp://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation|2.0.0 | |
| Observation.code | example | ObservationTypehttp://terminology.hl7.org/ValueSet/v3-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
| 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 Instance of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value |
| @nullFlavor |
0..1 | cs | Binding: CDANullFlavor (required) | |
| realmCode |
0..* | CS | ||
| typeId |
0..1 | II | ||
| @nullFlavor |
0..1 | cs | Binding: CDANullFlavor (required) | |
| @assigningAuthorityName |
0..1 | st | ||
| @displayable |
0..1 | bl | ||
| @root |
1..1 | oid, uuid, ruid | Fixed Value: 2.16.840.1.113883.1.3 | |
| @extension |
1..1 | st | ||
| Slices for templateId |
1..* | II | Slice: Unordered, Open by value:root, value:extension | |
| templateId:device-id-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: 2.16.840.1.113883.10.20.22.4.304 | |
| @extension |
1..1 | st | Required Pattern: 2022-06-01 | |
| @classCode |
1..1 | cs | Binding: CDAActClassObservation (required) | |
| @moodCode |
1..1 | cs | Binding: XActMoodDocumentObservation (2.0.0) (required) | |
| @negationInd |
0..1 | bl | ||
| id |
0..* | II | ||
| code |
1..1 | CD | Primary DI Number Code from NCIt Binding: ObservationType (example) | |
| @nullFlavor |
0..1 | cs | Binding: CDANullFlavor (required) | |
| @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' | |
| @codeSystemVersion |
0..1 | st | ||
| @displayName |
0..1 | st | MAY be set to 'Primary DI 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 | value-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative |
| thumbnail |
0..1 | ED | ||
| statusCode |
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 |
C | 1..1 | II | This value is assigned by the Manufacturer by using an FDA-accredited UDI-issuing agency should-extension: SHOULD contain extension |
| @nullFlavor |
0..1 | cs | Binding: CDANullFlavor (required) | |
| @assigningAuthorityName |
0..1 | st | ||
| @displayable |
1..1 | bl | Required Pattern: true | |
| @root |
1..1 | oid, uuid, ruid | ||
| @extension |
0..1 | st | ||
| interpretationCode |
0..* | CE | Binding: CDAObservationInterpretation (required) | |
| methodCode |
0..* | CE | Binding: ObservationMethod (example) | |
| targetSiteCode |
0..* | CD | ||
| subject |
0..1 | Subject | ||
| specimen |
0..* | Specimen | ||
| performer |
0..* | Performer2 | ||
| author |
0..* | Author | ||
| informant |
0..* | Informant | ||
| participant |
0..* | Participant2 | ||
| entryRelationship |
0..* | EntryRelationship | ||
| reference |
0..* | Reference | ||
| precondition |
0..* | Precondition | ||
| sdtcPrecondition2 |
0..* | Precondition2 | XML Namespace: urn:hl7-org:sdtc XML: precondition2 (urn:hl7-org:sdtc) | |
| referenceRange |
0..* | InfrastructureRoot | ||
| @nullFlavor |
0..1 | cs | Binding: CDANullFlavor (required) | |
| realmCode |
0..* | CS | ||
| typeId |
0..1 | II | ||
| @nullFlavor |
0..1 | cs | Binding: CDANullFlavor (required) | |
| @assigningAuthorityName |
0..1 | st | ||
| @displayable |
0..1 | bl | ||
| @root |
1..1 | oid, uuid, ruid | Fixed Value: 2.16.840.1.113883.1.3 | |
| @extension |
1..1 | st | ||
| templateId |
0..* | II | ||
| @typeCode |
0..1 | cs | Binding: CDAActRelationshipType (required) Fixed Value: REFV | |
| observationRange |
1..1 | ObservationRange | ||
| sdtcInFulfillmentOf1 |
0..* | InFulfillmentOf1 | XML Namespace: urn:hl7-org:sdtc XML: inFulfillmentOf1 (urn:hl7-org:sdtc) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Observation.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.typeId.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.templateId:device-id-obs.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.classCode | required | CDAActClassObservationhttp://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation | |
| Observation.moodCode | required | XActMoodDocumentObservationhttp://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation|2.0.0 | |
| Observation.code | example | ObservationTypehttp://terminology.hl7.org/ValueSet/v3-ObservationType | |
| Observation.code.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.text.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.text.compression | required | CDACompressionAlgorithmhttp://hl7.org/cda/stds/core/ValueSet/CDACompressionAlgorithm | |
| Observation.text.integrityCheckAlgorithm | required | IntegrityCheckAlgorithmhttp://terminology.hl7.org/ValueSet/v3-IntegrityCheckAlgorithm|2.0.0 | |
| Observation.text.mediaType | example | MediaTypehttp://terminology.hl7.org/ValueSet/v3-MediaType | |
| Observation.text.representation | required | BinaryDataEncodinghttp://hl7.org/cda/stds/core/ValueSet/BinaryDataEncoding | |
| Observation.statusCode | required | ActStatushttp://terminology.hl7.org/ValueSet/v3-ActStatus | |
| Observation.priorityCode | example | ActPriorityhttp://terminology.hl7.org/ValueSet/v3-ActPriority | |
| Observation.languageCode | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languagesfrom the FHIR Standard | |
| Observation.value.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.interpretationCode | required | CDAObservationInterpretationhttp://hl7.org/cda/stds/core/ValueSet/CDAObservationInterpretation | |
| Observation.methodCode | example | ObservationMethodhttp://terminology.hl7.org/ValueSet/v3-ObservationMethod | |
| Observation.referenceRange.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.referenceRange.typeId.nullFlavor | required | CDANullFlavorhttp://hl7.org/cda/stds/core/ValueSet/CDANullFlavor | |
| Observation.referenceRange.typeCode | required | Fixed Value: REFVhttp://hl7.org/cda/stds/core/ValueSet/CDAActRelationshipType |
| 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 based on FHIR 5.0.0. Generated 2024-05-18
Links: Table of Contents |
QA Report
| Version History 
|
|
Propose a change