LIVD on FHIR Draft Discussion

Concept Mapping Publication LIVDCatalogProfile (Composition) LIVD FHIR Resources Publication -- Equipment IVD Test Result Code LOINC Code LIVDCatalogProfile (Composition) LIVDCatalogEntryProfile (CatalogEntry - R4) DeviceDefinitionProfile (Device) Choices: “ActivityDefinition” codeable concept (one entry with multiple codes) “ActivityDefinition” multiple instances and mapped Catalog Entry mapping ConceptMap

FHIR Resources Only test device that it is performed on Does not take into account reagent – future scope perhaps IVD Test Code may not have a LOINC code (yet) Need to support nullflavor of “unknown” Need to support that an IVD Test Code can be represented by multiple LOINC codes. Where there are multiple LOINCs for one IVD Test Code, individual guidance etc. LIVDCatalogProfile Publication LIVDCatalog EntryProfile DeviceDefinitionProfile Equipment 1:* 1:1 IVD Test Code IVD Test Result LOINC Code 0:* Analyte Mapping 1:* 0:*

Publication: Catalog Publication LIVD FHIR Profile on Composition -- Publisher Publication Version ID LOINC Version ID LOINC Copyright Localization Region LIVDCatalogProfile Catalog.identifier (1..1) Catalog.name (0..1) Catalog.publisher (1..1) Catalog.version (1..1) format to be defined by publisher. Ask for Composition.version Catalog.LOINCVersionIdentifier (1..1) Consider ConceptMap Would yield a change in Catalog.identifier Catalog.LOINCCopyright (1..1) Text + URL to terms of use Catalog.language (1..1) RFC 5646 (doublecheck) Extension. Ask for one on Catalog Catalog.region (0..1) Ask for Composition.context

“Package” Composition Composition.status Composition.type - Could request a LOINC for LIVD Catalog, although we can make up our own. Composition.subject = LIVDCatalogProfile Composition.date Composition.author – Requires Organization to be an allowable reference. Composition.title – Name of the file? Composition.section.title = Perhaps: CatalogEntry, Device, ConceptMap, CodingSystem - We can have nested sections, so have some choices. Composition.section.entry = CatalogEntry instances, Device instances, ConceptMap instances, CodingSystem instances

Publication Line Item: Catalog Entry LIVD FHIR Resource – Proposal Pending -- CatalogEntry CatalogEntry.identifier Need to find out how far we can go with balloting without this being in R4. Is presence in a build o.k. for a Comment ballot? Need to manually create this one since FORGE is on R3 only.

Equipment: Device Equipment DeviceDefinitionProfile LIVD FHIR Resource Manufacturer Model UID (device identifier component) UID Type DeviceDefinitionProfile Device.manufacturer (1..1) Device.model (1..1) Device.udi.deviceIdentifier (0..1) Device.udi.issuer (0..1) Condition: if Device.udi.deviceIdentifier is present. While it looks like it is o.k. to have just one device identifier for a publication For other use cases it may be necessary to have multiple UDIs for one Device. To be Considered separately. Not in our scope for now.

What concept for mapping? ObservationDefinition Sounds reasonable, but need to be strictly definition of course How do you related observation A with observation B? Component construct? Concern that LOINC pre-coordinates various resources it is not great to use of those to represent this. ActivityDefinition To some this sounds more like process steps rather than core tests. For others it could cover tests as well. Still a problem how to map. Missing data for IVD Test codes and LOINC codes. ProcedureDefinition Could work, but similar challenges as Observation. Term is not used within Lab settings, so does not sound right. Perhaps on the order side. DataElement => StructureDefinition ConceptMap Neutral and has mapping. Does not appear to have everything need. Need to understand where what goes.

FHIR Resources LIVDBundleProfile LABObservationDefinition LABDeviceProfile LIVDCatalogProfile Bundle or Composition or both? Publication 1:* LIVDDeviceMetricProfile LIVDDeviceObservationDefinition.performer/source/originator/generator (Ref: Device, etc.) 1..1 = Abbott 1200 1:* 1:1 LIVDEntryDefinitionProfile LIVDDeviceDefinitionProfile LIVDDeviceObservationDefinition ObservationDefinition = IVD Test Code Equipment 1:* 1:1 Device.model=Abbott 1200 1:1 IVD Test Code LIVDIVDTestCodeSystemProfile informs CodeSystem.nnn=Abbott 1200 LIVDConceptMapProfile Analyte Mapping LIVDEntryDefinitionProfile Source: IVD Test Code Target: LOINC Code 1:* LIVDLOINCCodeSystemProfile LOINC Code CodeSystem.nnn=LOINC IVD Test Code ConceptMap.source=Abbott 1200 ConceptMap.group.element.code=ObservationDefinition.code

LIVDDeviceDefinitionProfile 1..* LIVDBundleProfile LIVDCatalogProfile LIVDDeviceDefinitionProfile 1..* Device.model=Acme 1200 1..* 1..* LIVDLOINCCodeSystemProfile LIVDConceptMapProfile 1..1 LIVDDeviceObservationDefinition Source: IVD Test Code Target: LOINC Code LIVDLOINCValueSetProfile 1..1 1..1 0..* ObservationDefinition.code = IVD Test Code ObservationDefinition.performer = Acme 1200 1..* ValueSet.code = LOINC Code ConceptMap.source = Acme 1200 ConceptMap.group.element.code = ObservationDefinition.code (IVD Test Code) ConceptMap.group.element.target.code = CodeSystem.concept.code (LOINC Code)

X LIVDBundleProfile LIVDCatalogProfile LIVDDeviceDefinitionProfile 1..* 1..* LIVDLOINCCodeSystemProfile …. Device.model=Acme 1200 1..* LIVDConceptMapProfile 1..1 LIVDDeviceObservationDefinition Source: IVD Test Code Target: LOINC Code LIVDLOINCValueSetProfile …. 1..1 1..1 0..* 1..* X LIVDLOINCAnswerCodeSystemProfile LIVDSNOMEDCodeSystemProfile …. N..1 LIVDValueSetProfile Source: IVD Test Result Values Target: SNOMED/LOINC Answer Value 1..1 1..1 Obs – OpioidTest ResVal – positive:positive ResVal – negative:negative ResVal – clear, cloudy, etc. ResVal – reactive, non-reactive, grey 0..* LIVDLOINCAnswerValueSetProfile LIVDSNOMEDValueSetProfile …. 1..1 1..* No dependency

Mapping Options – Device - ConceptMap An IVD Test Code can be unique just within a Device or across Devices. Up to manufacturer. The level of granularity of a Device is up to the manufacturer However we map Device to ConceptMap, needs to support that and not make it more difficult.

Mapping Options – Device - ConceptMap Device link to ConceptMap ConceptMap to Device Include extension in Device to link to ConceptMap Include Device identifier in ConceptMap using an extension 1..1 1..*

Mapping Options – Device - ConceptMap Using Code System link Using ObservationDefinition Link Device = Abbott Architect I200 Code System = XYZ Device = Abbott Architect 1200 ConceptMap Group.source=XYZ IVD Test A : LOINC 1, or 2, or 3 IVD Test B : LOINC 4, 5, 6 IVD Test C Ask Dan

Mapping Options – Device - ConceptMap EntryDefinition Concatenated Device Code Create an Entry for DeviceDefinition Create an Entry for ConceptMap Link Entry to Entry “IVD Test Code” = Device + IVD Test Code

Observation Definitions Identifier Code (codesystem) Who/what can perform this (Ref: Device, Practitioner, Organization) Device What can it perform (Ref:ObservationDefinition,Proce dureDefinition)

LOINC Attributes may help with that as well. Map Data Model IVD Test Code LOINC 0:N Vendor Specimen Description Vendor Result Description Vendor Comment LOINC Code – VS/CS LOINC Long Name – VS and/or CS Component - CS Property - CS Time - CS System - CS Scale - CS Method - CS Vendor Analyte Code Vendor Analyte Name Vendor Reference ID Consider using either ObservationDefinition like attributes to put into ConceptMap OR perhaps be able to link a “full” ObservationDefinition resource into the ConceptMap to further aid automating the definition of ObservationDefinitions. LOINC Attributes may help with that as well. FUTURE SCOPE

ConceptMap - LIVD ConceptMap.identifier ConceptMap.status ConceptMap.source ConceptMap.target ConceptMap.group.source ConceptMap.group.sourceVersion ConceptMap.group.target ConceptMap.group.targetVersion ConceptMap.group.element.code ConceptMap.group.element.target.code EXT:ConceptMap.group.element.target.dependsOn.criterionT ype EXT:ConceptMap.group.element.target.dependsOn.criterion Not necessary at the moment, maybe future. Set to active. Not necessary at the moment since it is contained for the foreseeable future. Maybe in the future. URI to the code system that contains the vendor’s IVD Test Codes Version of the vendor’s code system URI to the LOINC code system Version of LOINC Vendor Analyte Code LOINC Code Values: Vendor Specimen Description, Vendor Result Description, Vendor Comment The actual value Related to Device

ConceptMap…dependsOn.code/value https://gforge.hl7.org/gf/project/fhir/tracker/?action=TrackerItemEdi t&tracker_item_id=15604&start=0 submitted. Ideally before getting it before final May deadline.

Code System IVD Analyte CodeSystem.uri CodeSystem.version CodeSystem….Various others perhaps CodeSystem.concept.code = Vendor Analyte Code CodeSystem.concept.display = Vendor Analyte Name CodeSystem.concept.designation.use = “Vendor Reference ID” CodeSystem.concept.designation.valu e = the value of the vendor reference ID LOINC (Get this from elsewhere as probably already done – just need to profile if down further) CodeSystem.uri CodeSystem.version CodeSystem…Various others perhaps CodeSystem.concept.code = LOINC Code CodeSystem.concept.display = LOINC Long Name CodeSystem.concept.property (this likely already is profiled for LOINC) Component Property Time System Scale Method http://build.fhir.org/loinc.html

Profile Considerations Apply constraints from whitepaper where 0..1 or 0..* become “RE”. Bind ActivityDefinition.mappingReference (ActivityDefinition.identifier) to LOINC Do we need a bundle/composition/something to tie the entire “catalog” together?

Implementation Guide Considerations

Other Slides not used for now

IVD Test Result IVD Test Result ActivityDefinition LIVD FHIR Resource Vendor Analyte Code Vendor Analyte Name Vendor Specimen Description Vendor Result Description Vendor Reference ID Vendor Comment ActivityDefinition ActivityDefinition.identifier ActivityDefinition.name ActivityDefinition.specimenDefiniti onReference(SpecimenDefinition. description) ActivityDefinition.description ActivityDefinition.relatedArtifact ActivityDefinition.mappingReferen ce(ActivityDefinition)

LOINC Codes LOINC ActivityDefinition LIVD FHIR Resource - Proposed LOINC Long Name Component Property Time System Scale Method ActivityDefinition ActivityDefinition.identifier ActivityDefinition.LOINC.longName ActivityDefinition.LOINC.component ActivityDefinition.LOINC.Property ActivityDefinition.LOINC.Time ActivityDefinition.LOINC.System ActivityDefinition.LOINC.Scale ActivityDefinition.LOINC.Method ActivityDefinition.mappingReference( ActivityDefinition)

IVD Test Result IVD Test Result ConceptMap LIVD FHIR Resource Vendor Analyte Code Vendor Analyte Name Vendor Specimen Description Vendor Result Description Vendor Reference ID Vendor Comment ConceptMap

LOINC Codes ConceptMap LOINC LIVD FHIR Resource - Proposed LOINC Code LOINC Long Name Component Property Time System Scale Method ConceptMap

Bundle Bundle.type = document Bundle.entry.resource – The resource instances Seems to terse and no opportunity to organize the instances into section, nor give the overall package a title. Check with Rick Geimer what is the minimum used when including Composition.

Vendor Analyte Code 0..* 0..* LIVD LOINC Local LOINC Maps (RELMA, Web) Local LOINC Maps Informs Human Mapper creates LOINC Code LIS Test Result Code 0..1