LOINC – IVD Test Code (LIVD) Mapping
1.0.0 - STU 1

LOINC – IVD Test Code (LIVD) Mapping, published by HL7 International / Orders and Observations. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/livd/ and changes regularly. See the Directory of published versions

## Resource Profile: LIVD DeviceDefinition

Official URL: http://hl7.org/fhir/uv/livd/StructureDefinition/devicedefinition-uv-livd | Version: 1.0.0
Standards status: Trial-use | Maturity Level: 2 | Computable Name: LIVDDeviceDefinition
Other Identifiers: OID:2.16.840.1.113883.4.642.40.51.42.4

Profile on the DeviceDefinition resource for representing the devices included in the LIVD catalog for which mappings are defined.

### Description

The LIVD DeviceDefinition is a profile on the DeviceDefinition resource for representing the devices included in the LIVD catalog for which mappings are defined.

Usages:

- Refer to this Profile: LIVD Device
- Examples for this Profile: DeviceDefinition/1faf1d64-df18-4d7a-b45d-3872ddd3f165

You can also check for usages in the FHIR IG Statistics

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
DeviceDefinition |  | 0..* | DeviceDefinition | LIVDDeviceDefinition
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
udiDeviceIdentifier | S | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | S | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
issuer | S | 1..1 | uri | UDI Issuing Organization
jurisdiction | S | 1..1 | uri | Regional UDI authority
manufacturer[x] | S | 1..1 | string | Name of device manufacturer
modelNumber | S | 1..1 | string | Model id assigned by the manufacturer
type | S | 0..1 | CodeableConcept | What kind of device or device system this is Binding: IVD device types for LIVD device definitions VS (extensible): IVD device types for LIVD device definitions (extensible).
capability | S | 1..* | BackboneElement | Device capabilities
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:DeviceDefinitionExtensionAnalyte | S | 1..* | Reference(LIVDObservationDefinition) | LIVD Test Analyte URL: http://hl7.org/fhir/uv/livd/StructureDefinition/ext-analyte
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S | 1..1 | CodeableConcept | Type of capability
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
DeviceDefinition.deviceName.type | required | DeviceNameType `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` From the FHIR Standard
DeviceDefinition.type | extensible | LivdDeviceTypeVS(a valid code from IVD device types for LIVD device definitions) `http://hl7.org/fhir/uv/livd/ValueSet/livd-device-type` From this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | DeviceDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from DeviceDefinition

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
DeviceDefinition |  | 0..* | DeviceDefinition | LIVDDeviceDefinition
identifier |  | 0..0 |  |
udiDeviceIdentifier | S | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string
deviceIdentifier | S | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
issuer | S | 1..1 | uri | UDI Issuing Organization
jurisdiction | S | 1..1 | uri | Regional UDI authority
manufacturer[x] | S | 1..1 | string | Name of device manufacturer
deviceName |  | 0..0 |  |
modelNumber | S | 1..1 | string | Model id assigned by the manufacturer
type | S | 0..1 | CodeableConcept | What kind of device or device system this is Binding: IVD device types for LIVD device definitions VS (extensible): IVD device types for LIVD device definitions (extensible).
specialization |  | 0..0 |  |
version |  | 0..0 |  |
safety |  | 0..0 |  |
shelfLifeStorage |  | 0..0 |  |
physicalCharacteristics |  | 0..0 |  |
languageCode |  | 0..0 |  |
capability | S | 1..* | BackboneElement | Device capabilities
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:DeviceDefinitionExtensionAnalyte | S | 1..* | Reference(LIVDObservationDefinition) | LIVD Test Analyte URL: http://hl7.org/fhir/uv/livd/StructureDefinition/ext-analyte
type | S | 1..1 | CodeableConcept | Type of capability
description |  | 0..0 |  |
property |  | 0..0 |  |
owner |  | 0..0 |  |
contact |  | 0..0 |  |
url |  | 0..0 |  |
onlineInformation |  | 0..0 |  |
note |  | 0..0 |  |
quantity |  | 0..0 |  |
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
DeviceDefinition.type | extensible | LivdDeviceTypeVS(a valid code from IVD device types for LIVD device definitions) `http://hl7.org/fhir/uv/livd/ValueSet/livd-device-type` From this IG

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
DeviceDefinition |  | 0..* | DeviceDefinition | LIVDDeviceDefinition
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
udiDeviceIdentifier | S | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | S | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
issuer | S | 1..1 | uri | UDI Issuing Organization
jurisdiction | S | 1..1 | uri | Regional UDI authority
manufacturer[x] | S | 1..1 | string | Name of device manufacturer
modelNumber | S | 1..1 | string | Model id assigned by the manufacturer
type | S | 0..1 | CodeableConcept | What kind of device or device system this is Binding: IVD device types for LIVD device definitions VS (extensible): IVD device types for LIVD device definitions (extensible).
capability | S | 1..* | BackboneElement | Device capabilities
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:DeviceDefinitionExtensionAnalyte | S | 1..* | Reference(LIVDObservationDefinition) | LIVD Test Analyte URL: http://hl7.org/fhir/uv/livd/StructureDefinition/ext-analyte
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S | 1..1 | CodeableConcept | Type of capability
parentDevice | Σ | 0..1 | Reference(DeviceDefinition) | The parent device it can be part of
material |  | 0..* | BackboneElement | A substance used to create the material(s) of which the device is made
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
substance |  | 1..1 | CodeableConcept | The substance
alternate |  | 0..1 | boolean | Indicates an alternative material of the device
allergenicIndicator |  | 0..1 | boolean | Whether the substance is a known or suspected allergen
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
DeviceDefinition.language | preferred | CommonLanguages `http://hl7.org/fhir/ValueSet/languages|4.0.1` From the FHIR Standard
Additional Bindings | Purpose
AllLanguages | Max Binding
DeviceDefinition.deviceName.type | required | DeviceNameType `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` From the FHIR Standard
DeviceDefinition.type | extensible | LivdDeviceTypeVS(a valid code from IVD device types for LIVD device definitions) `http://hl7.org/fhir/uv/livd/ValueSet/livd-device-type` From this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | DeviceDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from DeviceDefinition

Summary

Mandatory: 5 elements
Must-Support: 10 elements
Prohibited: 16 elements

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/uv/livd/StructureDefinition/ext-analyte

Maturity: 2

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
DeviceDefinition |  | 0..* | DeviceDefinition | LIVDDeviceDefinition
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
udiDeviceIdentifier | S | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | S | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
issuer | S | 1..1 | uri | UDI Issuing Organization
jurisdiction | S | 1..1 | uri | Regional UDI authority
manufacturer[x] | S | 1..1 | string | Name of device manufacturer
modelNumber | S | 1..1 | string | Model id assigned by the manufacturer
type | S | 0..1 | CodeableConcept | What kind of device or device system this is Binding: IVD device types for LIVD device definitions VS (extensible): IVD device types for LIVD device definitions (extensible).
capability | S | 1..* | BackboneElement | Device capabilities
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:DeviceDefinitionExtensionAnalyte | S | 1..* | Reference(LIVDObservationDefinition) | LIVD Test Analyte URL: http://hl7.org/fhir/uv/livd/StructureDefinition/ext-analyte
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S | 1..1 | CodeableConcept | Type of capability
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
DeviceDefinition.deviceName.type | required | DeviceNameType `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` From the FHIR Standard
DeviceDefinition.type | extensible | LivdDeviceTypeVS(a valid code from IVD device types for LIVD device definitions) `http://hl7.org/fhir/uv/livd/ValueSet/livd-device-type` From this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | DeviceDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

Differential View

This structure is derived from DeviceDefinition

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
DeviceDefinition |  | 0..* | DeviceDefinition | LIVDDeviceDefinition
identifier |  | 0..0 |  |
udiDeviceIdentifier | S | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string
deviceIdentifier | S | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
issuer | S | 1..1 | uri | UDI Issuing Organization
jurisdiction | S | 1..1 | uri | Regional UDI authority
manufacturer[x] | S | 1..1 | string | Name of device manufacturer
deviceName |  | 0..0 |  |
modelNumber | S | 1..1 | string | Model id assigned by the manufacturer
type | S | 0..1 | CodeableConcept | What kind of device or device system this is Binding: IVD device types for LIVD device definitions VS (extensible): IVD device types for LIVD device definitions (extensible).
specialization |  | 0..0 |  |
version |  | 0..0 |  |
safety |  | 0..0 |  |
shelfLifeStorage |  | 0..0 |  |
physicalCharacteristics |  | 0..0 |  |
languageCode |  | 0..0 |  |
capability | S | 1..* | BackboneElement | Device capabilities
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:DeviceDefinitionExtensionAnalyte | S | 1..* | Reference(LIVDObservationDefinition) | LIVD Test Analyte URL: http://hl7.org/fhir/uv/livd/StructureDefinition/ext-analyte
type | S | 1..1 | CodeableConcept | Type of capability
description |  | 0..0 |  |
property |  | 0..0 |  |
owner |  | 0..0 |  |
contact |  | 0..0 |  |
url |  | 0..0 |  |
onlineInformation |  | 0..0 |  |
note |  | 0..0 |  |
quantity |  | 0..0 |  |
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
DeviceDefinition.type | extensible | LivdDeviceTypeVS(a valid code from IVD device types for LIVD device definitions) `http://hl7.org/fhir/uv/livd/ValueSet/livd-device-type` From this IG

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
DeviceDefinition |  | 0..* | DeviceDefinition | LIVDDeviceDefinition
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
udiDeviceIdentifier | S | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | S | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
issuer | S | 1..1 | uri | UDI Issuing Organization
jurisdiction | S | 1..1 | uri | Regional UDI authority
manufacturer[x] | S | 1..1 | string | Name of device manufacturer
modelNumber | S | 1..1 | string | Model id assigned by the manufacturer
type | S | 0..1 | CodeableConcept | What kind of device or device system this is Binding: IVD device types for LIVD device definitions VS (extensible): IVD device types for LIVD device definitions (extensible).
capability | S | 1..* | BackboneElement | Device capabilities
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
extension:DeviceDefinitionExtensionAnalyte | S | 1..* | Reference(LIVDObservationDefinition) | LIVD Test Analyte URL: http://hl7.org/fhir/uv/livd/StructureDefinition/ext-analyte
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S | 1..1 | CodeableConcept | Type of capability
parentDevice | Σ | 0..1 | Reference(DeviceDefinition) | The parent device it can be part of
material |  | 0..* | BackboneElement | A substance used to create the material(s) of which the device is made
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
substance |  | 1..1 | CodeableConcept | The substance
alternate |  | 0..1 | boolean | Indicates an alternative material of the device
allergenicIndicator |  | 0..1 | boolean | Whether the substance is a known or suspected allergen
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
DeviceDefinition.language | preferred | CommonLanguages `http://hl7.org/fhir/ValueSet/languages|4.0.1` From the FHIR Standard
Additional Bindings | Purpose
AllLanguages | Max Binding
DeviceDefinition.deviceName.type | required | DeviceNameType `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` From the FHIR Standard
DeviceDefinition.type | extensible | LivdDeviceTypeVS(a valid code from IVD device types for LIVD device definitions) `http://hl7.org/fhir/uv/livd/ValueSet/livd-device-type` From this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | DeviceDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from DeviceDefinition

Summary

Mandatory: 5 elements
Must-Support: 10 elements
Prohibited: 16 elements

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/uv/livd/StructureDefinition/ext-analyte

Maturity: 2

Other representations of profile: CSV, Excel, Schematron