This page is part of the At-Home In-Vitro Test Report (v1.1.0: STU 1) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

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Resource Profile: DeviceAtHomeInVitroTest - Mappings

Active as of 2024-08-08

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

Mappings for HL7 V2 At-Home In-Vitro Test Report (https://www.nibib.nih.gov/covid-19/radx-tech-program/mars/HL7v2-implementation-guide)

DeviceAtHomeInVitroTest
Device
udiCarrier
deviceIdentifier	OBX-17.1

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

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

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

DeviceAtHomeInVitroTest
Device	Entity. Role, or Act, Device
text	Act.text?
contained	N/A
extension	N/A
modifierExtension	N/A
identifier	.id
udiCarrier	.id and .code
id	n/a
extension	n/a
modifierExtension	N/A
deviceIdentifier	Role.id.extension
issuer	Role.id.root
jurisdiction	Role.scoper
carrierAIDC	Role.id.extension
carrierHRF	Role.id.extension
entryType	NA
status	.statusCode
distinctIdentifier	.lotNumberText
manufacturer	.playedRole[typeCode=MANU].scoper.name
manufactureDate	.existenceTime.low
expirationDate	.expirationTime
lotNumber	.lotNumberText
serialNumber	.playedRole[typeCode=MANU].id
deviceName
id	n/a
extension	n/a
modifierExtension	N/A
type	.playedRole[typeCode=MANU].code
deviceName (modelName)
id	n/a
extension	n/a
modifierExtension	N/A
type	.playedRole[typeCode=MANU].code
modelNumber	.softwareName (included as part)
partNumber	.playedRole[typeCode=MANU].id
specialization
id	n/a
extension	n/a
modifierExtension	N/A
version
id	n/a
extension	n/a
modifierExtension	N/A
property
id	n/a
extension	n/a
modifierExtension	N/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
safety	NA

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

DeviceAtHomeInVitroTest
Device
identifier	FiveWs.identifier
udiCarrier	FiveWs.identifier
deviceIdentifier	FiveWs.what[x]
status	FiveWs.status
statusReason	FiveWs.status
distinctIdentifier	FiveWs.what[x]
manufacturer	FiveWs.what[x]
manufactureDate	FiveWs.what[x]
expirationDate	FiveWs.what[x]
lotNumber	FiveWs.what[x]
serialNumber	FiveWs.what[x]
deviceName
type	FiveWs.what[x]
deviceName (modelName)
type	FiveWs.what[x]
modelNumber	FiveWs.what[x]
partNumber	FiveWs.what[x]
specialization
version	FiveWs.what[x]
version
component	FiveWs.what[x]
patient	FiveWs.subject[x], FiveWs.subject
owner	FiveWs.source
contact	FiveWs.source
location	FiveWs.where[x]
url	FiveWs.where[x]

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

DeviceAtHomeInVitroTest
Device
identifier	The 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
deviceIdentifier	The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
issuer	All 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
carrierAIDC	A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology.
carrierHRF	A unique device identifier (UDI) on a device label in plain text
distinctIdentifier	The 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.
manufacturer	N/A
manufactureDate	The 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”.
expirationDate	the 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”.
lotNumber	The 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.