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

## LIVD Data Mapping to FHIR

Page standards status: Informative

This guide is based on the HL7 FHIR standard and therefore uses terminology, notations and design principles that are specific to FHIR. Before continuing to read this implementation guide, it's important to be familiar with some of the basic principles of FHIR as well as general guidance on how to read FHIR specifications. Readers who are unfamiliar with FHIR are encouraged to read (or at least skim) the following prior to reading the rest of this implementation guide.

- FHIR overview
- Developer's introduction
- (or Clinical introduction)
- FHIR data types
- Using codes
- References between resources
- How to read resource & profile definitions
- Base resource

### Overview

The concepts described above are mapped to a number of FHIR resources that have been profiled to support the scope of the LIVD Publication. The diagram below shows the HL7 FHIR resources/profiles and their relationship:

- LIVD Bundle - Packages all relevant resources of the LIVD Catalog.
- LIVD Catalog Profile - This provides the information about the LIVD Publication. The profile is based on the Catalog profile that is based on the Composition resource. Note that, while the LIVD Catalog Profile does some organization of the resources, there is no need for representing the format of the data. The formatting and presentation is left to the client consuming these resources.
- LIVD Device Definition Profile - This profile reflects the equipment (device) that is represented in the publication.
  - (A) Each LIVD publication must include at least one device, and can cover many.
- LIVD Device Observation Definition - This profile reflects the IVD Test Performed that each device can produce.
  - (B) Each LIVD Device Definition has the capability to perform at least one observation, i.e., IVD Test Performed.
- LIVD Test Concept Map Profile - This profile supports the data necessary to document the actual mapping between the IVD Test for a device and the LOINC codes to consider.
  - (C) A LIVD Test Code Concept Map must be associated with at least one LIVD Device Definition. It may represent multiple LIVD Device Definitions where, e.g., different models performing the same tests could share the same map.
  - The ConceptMap.source reflects the IVD Test Performed and must exist (D) as a LIVD Device Observation Definition.
  - The ConceptMap.target and ConceptMap.group reflects the LOINC code or codes that the IVD Test Performed's code maps to, including context information to aid in the mapping such as result, specimen or other considerations.
  - The ConceptMap.traget references through (E) the value set where the LOINC codes used in the LIVD catalog are further defined.
  - An IVD Test Performed may not have a mapping (e.g., no LOINC code available yet), one, or more.

The LIVD Bundle Profile will enable packaging of the resources.

### Detailed Mapping

The following table provides the mapping of LIVD data of interest to FHIR resource attributes. Note that the use of FHIR introduces additional attributes that either are needed as required elements in FHIR or provide additional capabilities.

LIVD Attribute | FHIR | Comments
--- | --- | ---
| Bundle.type | This is set to "collection" as LIVD is modeled in FHIR to serve as a payload while it is not needed to be in the form of a document either, thus a well structured collection.
Publication
Publisher - the entity publishing the mapping information | Composition.author.display
Publication Version ID - human-readable information provided by the vendor that can be used to differentiate LIVD Publication versions | Composition.identifier.system Composition.identifier.value Composition.assigner.display
| Composition.type.coding.code Composition.type.coding.display Composition.type.coding.version Composition.type.coding.system | This represents only the LOINC Code representing this publication is a LIVD Catalog. It does not reflect the version of the LOINC code used in the detailed mapping.
LOINC Version ID - the version of LOINC that was used for the mapping | ValueSet.expansion.contains.system.version | Since a LIVD Catalog can include LOINC codes from different versions
LOINC Copyright - holds the required attribution statement | Composition.section.title Composition.section.code Composition.section.entry.reference | The relevant copyright text is in .section.entry.reference where the .section.title is "Copyrights" and the section.code is "copy-right".
Localization - the language used for this LIVD Publication | extension-Composition.language
Region - an optional vendor description for which geographic or administrative region this localization is valid. | extension-Composition.region
| Composition.extension-version
| Composition.status
| Composition.title
| extension-Composition.note
| Composition.section | This enables organization like information together, particularly the equipment, tests, and mappings. </tr>
Equipment
| DeviceDefinition.identifier
Manufacturer - the name of the manufacturer of the device. | DeviceDefinition.manufacturerString
Model - the model of the device as provided by the manufacturer | DeviceDefinition.modelNumber
Testkit UID - the unique device identifier, that may be the one used in the Unique Device Identifier (UDI) constructs | DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
Testkit UID Type - capable of supporting the unique device identification system to identify medical devices through their distribution and use. | DeviceDefinition.udiDeviceIdentifier.issuer
| DeviceDefinition.udiDeviceIdentifier.jurisdiction
| DeviceDefinition.capability.type extension-DeviceDefinition.capability.observationDefinition | This enables a linkage to the ObservationDefinition that represents the test that the device can perform.
| extension-DeviceDefinition.classification
| extension-DeviceDefinition.hasPart
IVD Test Performed,
Vendor Analyte Code - Vendor Transmission Code for automated tests or Vendor Analyte Identifier for manual tests. | ObservationDefinition.coding.code.system ObservationDefinition.coding.code.code
Vendor Analyte Name - human-readable text the vendor used to identify the analyte | ObservationDefinition.coding.code.display
Vendor Reference ID - an additional vendor identifier, such as an identifier that can be used to locate the associated assay insert published by the vendor. | ObservationDefinition.identifier.type ObservationDefinition.identifiervalue
| extension-ObservationDefinition.device | This enables a link to the device(s) that can perform this test
IVD Analyte Code - LOINC Mapping
LOINC Mapping Version | ConceptMap.group.element.target.version
| ConceptMap.identifier
Vendor Specimen Description - human-readable text that provides information about the specimen used for the test, such as “Serum or Plasma.” | ConceptMap.group.element.target.dependsOn:specimen.property ConceptMap.group.element.target.dependsOn:specimen.value
Vendor Result Description - human-readable text that provides information about the result that is produce Binary Ordinal Nominal | ConceptMap.group.element.target.dependsOn:result.property ConceptMap.group.element.target.dependsOn:result.value
Vendor Device Description</dt> | ConceptMap.group.element.target.dependsOn:device.property ConceptMap.group.element.target.dependsOn:device.value </tr>
Vendor Comment - human-readable text clarification, such as “This is a STAT (prioritized) version of the test”. | ConceptMap.group.element.target.dependsOn:other.property ConceptMap.group.element.target.dependsOn:other.value
| ConceptMap.status
| ConceptMap.source
| ConceptMap.target | This represents the target value set where the suggested LOINC codes are further defined.
| ConceptMap.group.target ConceptMap.group.targetVerion | This represents the LOINC code system and the version that was used for the mapping to the LOINC codes referenced.
| ConceptMap.group.element.code | This represents the test code used by the manufacturer for which a mapping to a LOINC is provided.
| ConceptMap.group.element.target.display
Test Code Value Set
| ValueSet.version
| ValueSet.status
Test Code Value Set
| ValueSet.version
| ValueSet.status
LOINC Code | ValueSet.expansion.contains.code
LOINC Long Name | ValueSet.expansion.contains.display
| ValueSet.expansion.contains.system
Component, Property, time Aspect, System, Scale Type, Method Type | extension-ValueSet.expansion.conctains.extR5-property.code ("COMPONENT", "PROPERTY", "TIME ASPCT", "SYSTEM", "SCALE TYPE", "METHOD") extension-ValueSet.expansion.conctains.extR5-property.valueCoding.code
</table>