Consolidated CDA Release 2.1 StructureDefinition Publication
2.1 - CI Build

Consolidated CDA Release 2.1 StructureDefinition Publication, published by Health Level Seven. This is not an authorized publication; it is the continuous build for version 2.1). This version is based on the current content of https://github.com/HL7/CDA-ccda-2.1-sd/ and changes regularly. See the Directory of published versions

## Logical Model: Distinct Identification Code Observation

Official URL: http://hl7.org/cda/us/ccda/StructureDefinition/DistinctIdentificationCodeObservation | Version: 2.1
Draft as of 2023-09-29 | Computable Name: DistinctIdentificationCodeObservation
Other Identifiers: id: urn:hl7ii:2.16.840.1.113883.10.20.22.4.308:2019-06-21

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 Distinct Identification Code for an HCT/P product regulated as a device as cited in 21 CFR 1271.290(c). The distinct identification code is parsed from the UDI value, if present.

The distinct identification code may be equivalent to the serial number, lot or batch number, or the donation identification number. The appropriate value should be provided as the distinct identification code.

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.

- Differential Table
- Key Elements Table
- Snapshot Table
- Statistics/References
- All

This structure is derived from CDAR2.Observation

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  | 1..1 | CDAR2.Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange Base for all types and resources
templateId |  | 1..1 | II |
root |  | 1..1 | oid, uuid, ruid | template oid Required Pattern: 2.16.840.1.113883.10.20.22.4.308
extension |  | 1..1 | st | Required Pattern: 2019-06-21
code |  | 1..1 | CD | Distinct Identification Code from NCIt
code |  | 1..1 | cs | Required Pattern: C113843
codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.3.26.1.1
codeSystemName |  | 0..1 | st | Required Pattern: NCI Thesaurus
displayName |  | 0..1 | st | Required Pattern: Distinct Identification Code
value |  | 1..1 | ED |
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  | 1..1 | CDAR2.Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange Base for all types and resources
@classCode |  | 1..1 | cs | Binding: ActClassObservation (required)
@moodCode |  | 1..1 | cs |
templateId |  | 1..1 | II |
@root |  | 1..1 | oid, uuid, ruid | template oid Required Pattern: 2.16.840.1.113883.10.20.22.4.308
@extension |  | 1..1 | st | Required Pattern: 2019-06-21
code |  | 1..1 | CD | Distinct Identification Code from NCIt Binding: ObservationType (extensible)
@code |  | 1..1 | cs | Required Pattern: C113843
@codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.3.26.1.1
@codeSystemName |  | 0..1 | st | Required Pattern: NCI Thesaurus
@displayName |  | 0..1 | st | Required Pattern: Distinct Identification Code
value |  | 1..1 | ED |
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet
Observation.classCode | required | ActClassObservation
Observation.code | extensible | ObservationType

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  | 1..1 | CDAR2.Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange Base for all types and resources
@classCode |  | 1..1 | cs | Binding: ActClassObservation (required)
@moodCode |  | 1..1 | cs |
@negationInd |  | 0..1 | bl |
realmCode |  | 0..* | CS |
typeId |  | 0..1 | II |
templateId |  | 1..1 | II |
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@assigningAuthorityName |  | 0..1 | st |
@displayable |  | 0..1 | bl |
@root |  | 1..1 | oid, uuid, ruid | template oid Required Pattern: 2.16.840.1.113883.10.20.22.4.308
@extension |  | 1..1 | st | Required Pattern: 2019-06-21
id |  | 0..* | II |
code |  | 1..1 | CD | Distinct Identification Code from NCIt Binding: ObservationType (extensible)
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@code |  | 1..1 | cs | Required Pattern: C113843
@codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.3.26.1.1
@codeSystemName |  | 0..1 | st | Required Pattern: NCI Thesaurus
@codeSystemVersion |  | 0..1 | st |
@displayName |  | 0..1 | st | Required Pattern: Distinct Identification Code
@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 |
statusCode |  | 0..1 | CS | Binding: ActStatus (required)
effectiveTime |  | 0..1 | IVL_TS |
priorityCode |  | 0..1 | CE | Binding: ActPriority (extensible)
repeatNumber |  | 0..1 | IVL_INT |
languageCode |  | 0..1 | CS | Binding: HumanLanguage (required)
value |  | 1..1 | ED |
interpretationCode |  | 0..* | CE | Binding: ObservationInterpretation (required)
methodCode |  | 0..* | CE | Binding: ObservationMethod (extensible)
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 |
referenceRange |  | 0..* | InfrastructureRoot |
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
realmCode |  | 0..* | CS |
typeId |  | 0..1 | II |
templateId |  | 0..* | II |
@typeCode |  | 0..1 | cs | Binding: ActRelationshipPertains (required) Fixed Value: REFV
observationRange |  | 1..1 | ObservationRange |
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code
Observation.classCode | required | ActClassObservation
Observation.templateId.nullFlavor | required | NullFlavor
Observation.code | extensible | ObservationType
Observation.code.nullFlavor | required | NullFlavor
Observation.statusCode | required | ActStatus
Observation.priorityCode | extensible | ActPriority
Observation.languageCode | required | HumanLanguage (a valid code from `http://terminology.hl7.org/CodeSystem/ietf3066`)
Observation.interpretationCode | required | ObservationInterpretation
Observation.methodCode | extensible | ObservationMethod
Observation.referenceRange.nullFlavor | required | NullFlavor
Observation.referenceRange.typeCode | required | Fixed Value: REFV

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |

This structure is derived from CDAR2.Observation

Summary

Mandatory: 6 elements

Differential View

This structure is derived from CDAR2.Observation

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  | 1..1 | CDAR2.Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange Base for all types and resources
templateId |  | 1..1 | II |
root |  | 1..1 | oid, uuid, ruid | template oid Required Pattern: 2.16.840.1.113883.10.20.22.4.308
extension |  | 1..1 | st | Required Pattern: 2019-06-21
code |  | 1..1 | CD | Distinct Identification Code from NCIt
code |  | 1..1 | cs | Required Pattern: C113843
codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.3.26.1.1
codeSystemName |  | 0..1 | st | Required Pattern: NCI Thesaurus
displayName |  | 0..1 | st | Required Pattern: Distinct Identification Code
value |  | 1..1 | ED |
Documentation for this format

Key Elements View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  | 1..1 | CDAR2.Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange Base for all types and resources
@classCode |  | 1..1 | cs | Binding: ActClassObservation (required)
@moodCode |  | 1..1 | cs |
templateId |  | 1..1 | II |
@root |  | 1..1 | oid, uuid, ruid | template oid Required Pattern: 2.16.840.1.113883.10.20.22.4.308
@extension |  | 1..1 | st | Required Pattern: 2019-06-21
code |  | 1..1 | CD | Distinct Identification Code from NCIt Binding: ObservationType (extensible)
@code |  | 1..1 | cs | Required Pattern: C113843
@codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.3.26.1.1
@codeSystemName |  | 0..1 | st | Required Pattern: NCI Thesaurus
@displayName |  | 0..1 | st | Required Pattern: Distinct Identification Code
value |  | 1..1 | ED |
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet
Observation.classCode | required | ActClassObservation
Observation.code | extensible | ObservationType

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  | 1..1 | CDAR2.Observation | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange Base for all types and resources
@classCode |  | 1..1 | cs | Binding: ActClassObservation (required)
@moodCode |  | 1..1 | cs |
@negationInd |  | 0..1 | bl |
realmCode |  | 0..* | CS |
typeId |  | 0..1 | II |
templateId |  | 1..1 | II |
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@assigningAuthorityName |  | 0..1 | st |
@displayable |  | 0..1 | bl |
@root |  | 1..1 | oid, uuid, ruid | template oid Required Pattern: 2.16.840.1.113883.10.20.22.4.308
@extension |  | 1..1 | st | Required Pattern: 2019-06-21
id |  | 0..* | II |
code |  | 1..1 | CD | Distinct Identification Code from NCIt Binding: ObservationType (extensible)
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@code |  | 1..1 | cs | Required Pattern: C113843
@codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.3.26.1.1
@codeSystemName |  | 0..1 | st | Required Pattern: NCI Thesaurus
@codeSystemVersion |  | 0..1 | st |
@displayName |  | 0..1 | st | Required Pattern: Distinct Identification Code
@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 |
statusCode |  | 0..1 | CS | Binding: ActStatus (required)
effectiveTime |  | 0..1 | IVL_TS |
priorityCode |  | 0..1 | CE | Binding: ActPriority (extensible)
repeatNumber |  | 0..1 | IVL_INT |
languageCode |  | 0..1 | CS | Binding: HumanLanguage (required)
value |  | 1..1 | ED |
interpretationCode |  | 0..* | CE | Binding: ObservationInterpretation (required)
methodCode |  | 0..* | CE | Binding: ObservationMethod (extensible)
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 |
referenceRange |  | 0..* | InfrastructureRoot |
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
realmCode |  | 0..* | CS |
typeId |  | 0..1 | II |
templateId |  | 0..* | II |
@typeCode |  | 0..1 | cs | Binding: ActRelationshipPertains (required) Fixed Value: REFV
observationRange |  | 1..1 | ObservationRange |
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code
Observation.classCode | required | ActClassObservation
Observation.templateId.nullFlavor | required | NullFlavor
Observation.code | extensible | ObservationType
Observation.code.nullFlavor | required | NullFlavor
Observation.statusCode | required | ActStatus
Observation.priorityCode | extensible | ActPriority
Observation.languageCode | required | HumanLanguage (a valid code from `http://terminology.hl7.org/CodeSystem/ietf3066`)
Observation.interpretationCode | required | ObservationInterpretation
Observation.methodCode | extensible | ObservationMethod
Observation.referenceRange.nullFlavor | required | NullFlavor
Observation.referenceRange.typeCode | required | Fixed Value: REFV

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |

This structure is derived from CDAR2.Observation

Summary

Mandatory: 6 elements

Other representations of profile: CSV, Excel