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: Implantable Device Status Observation

Official URL: http://hl7.org/cda/us/ccda/StructureDefinition/ImplantableDeviceStatusObservation | Version: 2.1
Draft as of 2023-09-29 | Computable Name: ImplantableDeviceStatusObservation
Other Identifiers: id: urn:hl7ii:2.16.840.1.113883.10.20.22.4.305:2019-06-21

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 augment the parsed data from the a Unique Device Identifier (UDI). This template is used to exchange the status of the patient’s implantable medical device. This status is only relevant to medical devices implanted in the patient’s body.

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: 2.16.840.1.113883.10.20.22.4.305
extension |  | 1..1 | st | Required Pattern: 2019-06-21
code |  | 1..1 | CD | Code for "Implantable Device Status"
code |  | 1..1 | cs | Required Pattern: C160939
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: Implantable Device Status
value |  | 1..1 | CD | Binding: Implantable Device Status (required)
code |  | 1..1 | cs |
codeSystem |  | 1..1 | oid, uuid, ruid |
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet
Observation.value | required | Implantable Device Status

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: 2.16.840.1.113883.10.20.22.4.305
@extension |  | 1..1 | st | Required Pattern: 2019-06-21
code |  | 1..1 | CD | Code for "Implantable Device Status" Binding: ObservationType (extensible)
@code |  | 1..1 | cs | Required Pattern: C160939
@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: Implantable Device Status
value |  | 1..1 | CD | Binding: Implantable Device Status (required)
@code |  | 1..1 | cs |
@codeSystem |  | 1..1 | oid, uuid, ruid |
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet
Observation.classCode | required | ActClassObservation
Observation.code | extensible | ObservationType
Observation.value | required | Implantable Device Status

#### 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: 2.16.840.1.113883.10.20.22.4.305
@extension |  | 1..1 | st | Required Pattern: 2019-06-21
id |  | 0..* | II |
code |  | 1..1 | CD | Code for "Implantable Device Status" Binding: ObservationType (extensible)
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@code |  | 1..1 | cs | Required Pattern: C160939
@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: Implantable Device Status
@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 | CD | Binding: Implantable Device Status (required)
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@code |  | 1..1 | cs |
@codeSystem |  | 1..1 | oid, uuid, ruid |
@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 |
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.value | required | Implantable Device Status
Observation.value.nullFlavor | required | NullFlavor
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: 8 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: 2.16.840.1.113883.10.20.22.4.305
extension |  | 1..1 | st | Required Pattern: 2019-06-21
code |  | 1..1 | CD | Code for "Implantable Device Status"
code |  | 1..1 | cs | Required Pattern: C160939
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: Implantable Device Status
value |  | 1..1 | CD | Binding: Implantable Device Status (required)
code |  | 1..1 | cs |
codeSystem |  | 1..1 | oid, uuid, ruid |
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet
Observation.value | required | Implantable Device Status

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: 2.16.840.1.113883.10.20.22.4.305
@extension |  | 1..1 | st | Required Pattern: 2019-06-21
code |  | 1..1 | CD | Code for "Implantable Device Status" Binding: ObservationType (extensible)
@code |  | 1..1 | cs | Required Pattern: C160939
@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: Implantable Device Status
value |  | 1..1 | CD | Binding: Implantable Device Status (required)
@code |  | 1..1 | cs |
@codeSystem |  | 1..1 | oid, uuid, ruid |
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet
Observation.classCode | required | ActClassObservation
Observation.code | extensible | ObservationType
Observation.value | required | Implantable Device Status

#### 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: 2.16.840.1.113883.10.20.22.4.305
@extension |  | 1..1 | st | Required Pattern: 2019-06-21
id |  | 0..* | II |
code |  | 1..1 | CD | Code for "Implantable Device Status" Binding: ObservationType (extensible)
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@code |  | 1..1 | cs | Required Pattern: C160939
@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: Implantable Device Status
@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 | CD | Binding: Implantable Device Status (required)
@nullFlavor |  | 0..1 | cs | Binding: NullFlavor (required)
@code |  | 1..1 | cs |
@codeSystem |  | 1..1 | oid, uuid, ruid |
@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 |
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.value | required | Implantable Device Status
Observation.value.nullFlavor | required | NullFlavor
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: 8 elements

Other representations of profile: CSV, Excel