At-Home In-Vitro Test Report
1.1.0 - STU 1.1 United States of America flag

At-Home In-Vitro Test Report, published by HL7 International / Orders and Observations. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/home-lab-report/ and changes regularly. See the Directory of published versions

Resource Profile: DeviceAtHomeInVitroTest - Mappings

Active as of 2024-04-26

Mappings for the Device-at-home-in-vitro-test resource profile.

Mappings for LIVD Spreadsheet (https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html)

DeviceAtHomeInVitroTest
Device
   udiCarrier
      deviceIdentifierLOINC Mapping.Testkit Name ID, LOINC Mapping.Equipment UID
   manufacturerLOINC Mapping.Manufacturer
   deviceName (modelName)LOINC Mapping.Model

Mappings for RIM Mapping (http://hl7.org/v3)

DeviceAtHomeInVitroTest
DeviceEntity. Role, or Act, Device
   textAct.text?
   containedN/A
   extensionN/A
   modifierExtensionN/A
   identifier.id
   udiCarrier.id and .code
      idn/a
      extensionn/a
      modifierExtensionN/A
      deviceIdentifierRole.id.extension
      issuerRole.id.root
      jurisdictionRole.scoper
      carrierAIDCRole.id.extension
      carrierHRFRole.id.extension
      entryTypeNA
   status.statusCode
   distinctIdentifier.lotNumberText
   manufacturer.playedRole[typeCode=MANU].scoper.name
   manufactureDate.existenceTime.low
   expirationDate.expirationTime
   lotNumber.lotNumberText
   serialNumber.playedRole[typeCode=MANU].id
   deviceName
      idn/a
      extensionn/a
      modifierExtensionN/A
      type.playedRole[typeCode=MANU].code
   deviceName (modelName)
      idn/a
      extensionn/a
      modifierExtensionN/A
      type.playedRole[typeCode=MANU].code
   modelNumber.softwareName (included as part)
   partNumber.playedRole[typeCode=MANU].id
   specialization
      idn/a
      extensionn/a
      modifierExtensionN/A
   version
      idn/a
      extensionn/a
      modifierExtensionN/A
   property
      idn/a
      extensionn/a
      modifierExtensionN/A
   patient.playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]
   owner.playedRole[typeCode=OWN].scoper
   contact.scopedRole[typeCode=CON].player
   location.playedRole[typeCode=LOCE].scoper
   url.telecom
   note.text
   safetyNA

Mappings for FiveWs Pattern Mapping (http://hl7.org/fhir/fivews)

DeviceAtHomeInVitroTest
Device
   identifierFiveWs.identifier
   udiCarrierFiveWs.identifier
      deviceIdentifierFiveWs.what[x]
   statusFiveWs.status
   statusReasonFiveWs.status
   distinctIdentifierFiveWs.what[x]
   manufacturerFiveWs.what[x]
   manufactureDateFiveWs.what[x]
   expirationDateFiveWs.what[x]
   lotNumberFiveWs.what[x]
   serialNumberFiveWs.what[x]
   deviceName
      typeFiveWs.what[x]
   deviceName (modelName)
      typeFiveWs.what[x]
   modelNumberFiveWs.what[x]
   partNumberFiveWs.what[x]
   specialization
      versionFiveWs.what[x]
   version
      componentFiveWs.what[x]
   patientFiveWs.subject[x], FiveWs.subject
   ownerFiveWs.source
   contactFiveWs.source
   locationFiveWs.where[x]
   urlFiveWs.where[x]

Mappings for UDI Mapping (http://fda.gov/UDI)

DeviceAtHomeInVitroTest
Device
   identifierThe serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
   udiCarrier
      deviceIdentifierThe device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
      issuerAll UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency. GS1 DIs: http://hl7.org/fhir/NamingSystem/gs1 HIBCC DIs: http://hl7.org/fhir/NamingSystem/hibcc ICCBBA DIs for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood ICCBA DIs for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other
      carrierAIDCA unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology.
      carrierHRFA unique device identifier (UDI) on a device label in plain text
   distinctIdentifierThe lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
   manufacturerN/A
   manufactureDateThe date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
   expirationDatethe expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
   lotNumberThe lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.