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: UDI Organizer

Official URL: http://hl7.org/cda/us/ccda/StructureDefinition/UDIOrganizer | Version: 2.1
Draft as of 2023-09-29 | Computable Name: UDIOrganizer
Other Identifiers: id: urn:hl7ii:2.16.840.1.113883.10.20.22.4.311:2019-06-21

This template is nested in an entryRelationship/Procedure Activity Procedure to record all the UDI-related templates to exchange the parsed UDI data elements and associated data.

- Device Identifier urn:hl7ii:2.16.840.1.113883.10.20.22.4.304: 2019-06-21 NCIt: C101722 SHALL be included in UDI Organizer
- Lot or Batch Number urn:hl7ii:2.16.840.1.113883.10.20.22.4.315: 2019-06-21 NCIt:C101672 SHOULD be included in UDI Organizer if present in UDI
- Serial Number urn:hl7ii:2.16.840.1.113883.10.20.22.4.319: 2019-06-21 NCIt: C101671 SHOULD be included in UDI Organizer if present in UDI
- Manufacturing Date
  urn:hl7ii:2.16.840.1.113883.10.20.22.4.316: 2019-06-21 NCIt:C101669 SHOULD be included in UDI Organizer if present in UDI
- Expiration Date urn:hl7ii:2.16.840.1.113883.10.20.22.4.309: 2019-06-21 NCIt: C101670 SHOULD be included in UDI Organizer if present in UDI
- Distinct Identification Code urn:hl7ii:2.16.840.1.113883.10.20.22.4.308: 2019-06-21 NCIt: C113843 SHOULD be included in UDI Organizer if present in UDI
- Brand Name urn:hl7ii:2.16.840.1.113883.10.20.22.4.301: 2019-06-21 NCIt: C71898 MAY be included in the UDI Organizer if available
- Model Number urn:hl7ii:2.16.840.1.113883.10.20.22.4.317: 2019-06-21 NCIt: C99285 MAY be included in the UDI Organizer if available
- Catalog Number urn:hl7ii:2.16.840.1.113883.10.20.22.4.302: 2019-06-21 NCIt: C99286 MAY be included in the UDI Organizer if available
- Company Name urn:hl7ii:2.16.840.1.113883.10.20.22.4.303: 2019-06-21 NCIt: C54131 MAY be included in the UDI Organizer if available
- MRI Safety urn:hl7ii:2.16.840.1.113883.10.20.22.4.318: 2019-06-21 NCIt: C106044 MAY be included in the UDI Organizer if available
- Latex Safety urn:hl7ii:2.16.840.1.113883.10.20.22.4.314: 2019-06-21 NCIt: C160938 MAY be included in the UDI Organizer if available
- Implantable Device Status urn:hl7ii:2.16.840.1.113883.10.20.22.4.305 2019-06-21 NCIt: C160939 MAY be included in the UDI Organizer if available

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.Organizer

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Organizer |  | 1..1 | CDAR2.Organizer | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, realmCode, typeId, templateId, id, code, statusCode, effectiveTime, subject, specimen, performer, author, informant, participant, reference, precondition, component Base for all types and resources
classCode |  | 1..1 | cs | Fixed Value: CLUSTER
moodCode |  | 1..1 | cs |
Slices for templateId |  | 1..* | II | Slice: Unordered, Open by value:root, value:extension
templateId:templateId1 |  | 1..1 | II | templateId
root |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.311
extension |  | 1..1 | st | Required Pattern: 2019-06-21
id |  | 1..1 | II |
root |  | 1..1 | oid, uuid, ruid |
code |  | 0..1 | CD |
code |  | 0..1 | cs | Required Pattern: 74711-3
codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.6.1
statusCode |  | 1..1 | CS |
code |  | 1..1 | cs | Fixed Value: completed
component |  | 1..1 | OrganizerComponent |
observation |  | 1..1 | DeviceIdentifierObservation | Base for all types and resources
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Organizer |  | 1..1 | CDAR2.Organizer | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, realmCode, typeId, templateId, id, code, statusCode, effectiveTime, subject, specimen, performer, author, informant, participant, reference, precondition, component Base for all types and resources
@classCode |  | 1..1 | cs | Binding: ActClass (required) Fixed Value: CLUSTER
@moodCode |  | 1..1 | cs | Binding: ActMood (required) Fixed Value: EVN
Slices for templateId |  | 1..* | II | Slice: Unordered, Open by value:root, value:extension
templateId:templateId1 |  | 1..1 | II | templateId
@root |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.311
@extension |  | 1..1 | st | Required Pattern: 2019-06-21
id |  | 1..1 | II |
@root |  | 1..1 | oid, uuid, ruid |
code |  | 0..1 | CD | Binding: v3 Code System ActCode (extensible)
@code |  | 0..1 | cs | Required Pattern: 74711-3
@codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.6.1
statusCode |  | 1..1 | CS | Binding: ActStatus (required)
@code |  | 1..1 | cs | Fixed Value: completed
component |  | 1..1 | OrganizerComponent |
observation |  | 1..1 | DeviceIdentifierObservation | Base for all types and resources
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code
Organizer.classCode | required | Fixed Value: CLUSTER
Organizer.moodCode | required | Fixed Value: EVN
Organizer.code | extensible | ActCode
Organizer.statusCode | required | ActStatus

#### 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
--- | --- | --- | --- | ---
Organizer |  | 1..1 | CDAR2.Organizer | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, realmCode, typeId, templateId, id, code, statusCode, effectiveTime, subject, specimen, performer, author, informant, participant, reference, precondition, component Base for all types and resources
@classCode |  | 1..1 | cs | Binding: ActClass (required) Fixed Value: CLUSTER
@moodCode |  | 1..1 | cs | Binding: ActMood (required) Fixed Value: EVN
realmCode |  | 0..* | CS |
typeId |  | 0..1 | II |
Slices for templateId |  | 1..* | II | Slice: Unordered, Open by value:root, value:extension
templateId:templateId1 |  | 1..1 | II | templateId
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@assigningAuthorityName |  | 0..1 | st |
@displayable |  | 0..1 | bl |
@root |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.311
@extension |  | 1..1 | st | Required Pattern: 2019-06-21
id |  | 1..1 | II |
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@assigningAuthorityName |  | 0..1 | st |
@displayable |  | 0..1 | bl |
@root |  | 1..1 | oid, uuid, ruid |
@extension |  | 0..1 | st |
code |  | 0..1 | CD | Binding: v3 Code System ActCode (extensible)
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@code |  | 0..1 | cs | Required Pattern: 74711-3
@codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.6.1
@codeSystemName |  | 0..1 | st |
@codeSystemVersion |  | 0..1 | st |
@displayName |  | 0..1 | st |
@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 |
statusCode |  | 1..1 | CS | Binding: ActStatus (required)
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@code |  | 1..1 | cs | Fixed Value: completed
@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)
effectiveTime |  | 0..1 | IVL_TS |
subject |  | 0..1 | Subject |
specimen |  | 0..* | Specimen |
performer |  | 0..* | Performer2 |
author |  | 0..* | Author |
informant |  | 0..* | Informant |
participant |  | 0..* | Participant2 |
reference |  | 0..* | Reference |
precondition |  | 0..* | Precondition |
component |  | 1..1 | OrganizerComponent |
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
realmCode |  | 0..* | CS |
typeId |  | 0..1 | II |
templateId |  | 0..* | II |
@typeCode |  | 0..1 | cs | Binding: ActRelationshipHasComponent (required)
@contextConductionInd |  | 0..1 | bl | Fixed Value: true
sequenceNumber |  | 0..1 | INT |
priorityNumber |  | 0..1 | INT | XML Namespace: urn:hl7-org:sdtc XML Namespace: urn:hl7-org:sdtc
seperatableInd |  | 0..1 | BL |
act |  | 0..1 | Act |
encounter |  | 0..1 | Encounter |
observation |  | 1..1 | DeviceIdentifierObservation | Base for all types and resources
observationMedia |  | 0..1 | ObservationMedia |
organizer |  | 0..1 | Organizer |
procedure |  | 0..1 | Procedure |
regionOfInterest |  | 0..1 | RegionOfInterest |
substanceAdministration |  | 0..1 | SubstanceAdministration |
supply |  | 0..1 | Supply |
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code
Organizer.classCode | required | Fixed Value: CLUSTER
Organizer.moodCode | required | Fixed Value: EVN
Organizer.templateId:templateId1.nullFlavor | required | NullFlavor
Organizer.id.nullFlavor | required | NullFlavor
Organizer.code | extensible | ActCode
Organizer.code.nullFlavor | required | NullFlavor
Organizer.statusCode | required | ActStatus
Organizer.statusCode.nullFlavor | required | NullFlavor
Organizer.component.nullFlavor | required | NullFlavor
Organizer.component.typeCode | required | ActRelationshipHasComponent

#### 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.Organizer

Summary

Mandatory: 9 elements (1 nested mandatory element)
Fixed Value: 2 elements

Structures

This structure refers to these other structures:

- Device Identifier Observation (http://hl7.org/cda/us/ccda/StructureDefinition/DeviceIdentifierObservation)

Slices

This structure defines the following Slices:

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

Differential View

This structure is derived from CDAR2.Organizer

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Organizer |  | 1..1 | CDAR2.Organizer | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, realmCode, typeId, templateId, id, code, statusCode, effectiveTime, subject, specimen, performer, author, informant, participant, reference, precondition, component Base for all types and resources
classCode |  | 1..1 | cs | Fixed Value: CLUSTER
moodCode |  | 1..1 | cs |
Slices for templateId |  | 1..* | II | Slice: Unordered, Open by value:root, value:extension
templateId:templateId1 |  | 1..1 | II | templateId
root |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.311
extension |  | 1..1 | st | Required Pattern: 2019-06-21
id |  | 1..1 | II |
root |  | 1..1 | oid, uuid, ruid |
code |  | 0..1 | CD |
code |  | 0..1 | cs | Required Pattern: 74711-3
codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.6.1
statusCode |  | 1..1 | CS |
code |  | 1..1 | cs | Fixed Value: completed
component |  | 1..1 | OrganizerComponent |
observation |  | 1..1 | DeviceIdentifierObservation | Base for all types and resources
Documentation for this format

Key Elements View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Organizer |  | 1..1 | CDAR2.Organizer | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, realmCode, typeId, templateId, id, code, statusCode, effectiveTime, subject, specimen, performer, author, informant, participant, reference, precondition, component Base for all types and resources
@classCode |  | 1..1 | cs | Binding: ActClass (required) Fixed Value: CLUSTER
@moodCode |  | 1..1 | cs | Binding: ActMood (required) Fixed Value: EVN
Slices for templateId |  | 1..* | II | Slice: Unordered, Open by value:root, value:extension
templateId:templateId1 |  | 1..1 | II | templateId
@root |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.311
@extension |  | 1..1 | st | Required Pattern: 2019-06-21
id |  | 1..1 | II |
@root |  | 1..1 | oid, uuid, ruid |
code |  | 0..1 | CD | Binding: v3 Code System ActCode (extensible)
@code |  | 0..1 | cs | Required Pattern: 74711-3
@codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.6.1
statusCode |  | 1..1 | CS | Binding: ActStatus (required)
@code |  | 1..1 | cs | Fixed Value: completed
component |  | 1..1 | OrganizerComponent |
observation |  | 1..1 | DeviceIdentifierObservation | Base for all types and resources
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code
Organizer.classCode | required | Fixed Value: CLUSTER
Organizer.moodCode | required | Fixed Value: EVN
Organizer.code | extensible | ActCode
Organizer.statusCode | required | ActStatus

#### 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
--- | --- | --- | --- | ---
Organizer |  | 1..1 | CDAR2.Organizer | XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @classCode, @moodCode, realmCode, typeId, templateId, id, code, statusCode, effectiveTime, subject, specimen, performer, author, informant, participant, reference, precondition, component Base for all types and resources
@classCode |  | 1..1 | cs | Binding: ActClass (required) Fixed Value: CLUSTER
@moodCode |  | 1..1 | cs | Binding: ActMood (required) Fixed Value: EVN
realmCode |  | 0..* | CS |
typeId |  | 0..1 | II |
Slices for templateId |  | 1..* | II | Slice: Unordered, Open by value:root, value:extension
templateId:templateId1 |  | 1..1 | II | templateId
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@assigningAuthorityName |  | 0..1 | st |
@displayable |  | 0..1 | bl |
@root |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.10.20.22.4.311
@extension |  | 1..1 | st | Required Pattern: 2019-06-21
id |  | 1..1 | II |
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@assigningAuthorityName |  | 0..1 | st |
@displayable |  | 0..1 | bl |
@root |  | 1..1 | oid, uuid, ruid |
@extension |  | 0..1 | st |
code |  | 0..1 | CD | Binding: v3 Code System ActCode (extensible)
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@code |  | 0..1 | cs | Required Pattern: 74711-3
@codeSystem |  | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.6.1
@codeSystemName |  | 0..1 | st |
@codeSystemVersion |  | 0..1 | st |
@displayName |  | 0..1 | st |
@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 |
statusCode |  | 1..1 | CS | Binding: ActStatus (required)
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@code |  | 1..1 | cs | Fixed Value: completed
@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)
effectiveTime |  | 0..1 | IVL_TS |
subject |  | 0..1 | Subject |
specimen |  | 0..* | Specimen |
performer |  | 0..* | Performer2 |
author |  | 0..* | Author |
informant |  | 0..* | Informant |
participant |  | 0..* | Participant2 |
reference |  | 0..* | Reference |
precondition |  | 0..* | Precondition |
component |  | 1..1 | OrganizerComponent |
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
realmCode |  | 0..* | CS |
typeId |  | 0..1 | II |
templateId |  | 0..* | II |
@typeCode |  | 0..1 | cs | Binding: ActRelationshipHasComponent (required)
@contextConductionInd |  | 0..1 | bl | Fixed Value: true
sequenceNumber |  | 0..1 | INT |
priorityNumber |  | 0..1 | INT | XML Namespace: urn:hl7-org:sdtc XML Namespace: urn:hl7-org:sdtc
seperatableInd |  | 0..1 | BL |
act |  | 0..1 | Act |
encounter |  | 0..1 | Encounter |
observation |  | 1..1 | DeviceIdentifierObservation | Base for all types and resources
observationMedia |  | 0..1 | ObservationMedia |
organizer |  | 0..1 | Organizer |
procedure |  | 0..1 | Procedure |
regionOfInterest |  | 0..1 | RegionOfInterest |
substanceAdministration |  | 0..1 | SubstanceAdministration |
supply |  | 0..1 | Supply |
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code
Organizer.classCode | required | Fixed Value: CLUSTER
Organizer.moodCode | required | Fixed Value: EVN
Organizer.templateId:templateId1.nullFlavor | required | NullFlavor
Organizer.id.nullFlavor | required | NullFlavor
Organizer.code | extensible | ActCode
Organizer.code.nullFlavor | required | NullFlavor
Organizer.statusCode | required | ActStatus
Organizer.statusCode.nullFlavor | required | NullFlavor
Organizer.component.nullFlavor | required | NullFlavor
Organizer.component.typeCode | required | ActRelationshipHasComponent

#### 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.Organizer

Summary

Mandatory: 9 elements (1 nested mandatory element)
Fixed Value: 2 elements

Structures

This structure refers to these other structures:

- Device Identifier Observation (http://hl7.org/cda/us/ccda/StructureDefinition/DeviceIdentifierObservation)

Slices

This structure defines the following Slices:

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

Other representations of profile: CSV, Excel