The data elements in this profile contain narrative guidance (mappings) to specific columns in the “LOINC Mapping” tab contained in the LIVD Spreadsheet.

Although most at home test kits will have a single udiCarrier.deviceIdentifier for the “test kit” (all in one package of reagents, test card/device, etc.) it is possible for at home kits to have a resuable “reader device” which would need a distinct “equipment id”. In this case, the reader device would have an “equipment UID” that may be the same for multiple tests performed. For these cases use multiple Devices - one to represent the test kit (which would have the Test Kit Name ID recorded in Device.udiCarrier.deviceIdentifier) and one to represent the reader device (which would have the Equipment ID recorded in Device.udiCarrier.deviceIdentifier).

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

This structure is derived from Device

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	Item used in healthcare
udiCarrier	S	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
deviceIdentifier	S	1..1	string	LIVD Spreadsheet | LOINC Mapping.Testkit Name ID or LIVD Spreadsheet | LOINC Mapping.Testkit Equipment UID
issuer	S	0..1	uri	UDI Issuing Organization
manufacturer	S	0..1	string	LIVD Spreadsheet | LOINC Mapping.Manufacturer
manufactureDate	S	0..1	dateTime	Date when the device was made
expirationDate	S	0..1	dateTime	Expiration date of the test kit
lotNumber	S	0..1	string	Lot number of the test kit
serialNumber	S	0..1	string	Serial number of the test kit
Slices for deviceName		1..*	BackboneElement	The name of the device as given by the manufacturer Slice: Unordered, Open by value:type
deviceName:modelName		1..1	BackboneElement	LIVD Spreadsheet | LOINC Mapping.Model
name	S	1..1	string	The name of the device
type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Fixed Value: model-name
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	Item used in healthcare
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
udiCarrier	SΣ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
deviceIdentifier	SΣ	1..1	string	LIVD Spreadsheet | LOINC Mapping.Testkit Name ID or LIVD Spreadsheet | LOINC Mapping.Testkit Equipment UID
issuer	S	0..1	uri	UDI Issuing Organization
status	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
manufacturer	S	0..1	string	LIVD Spreadsheet | LOINC Mapping.Manufacturer
manufactureDate	S	0..1	dateTime	Date when the device was made
expirationDate	S	0..1	dateTime	Expiration date of the test kit
lotNumber	S	0..1	string	Lot number of the test kit
serialNumber	S	0..1	string	Serial number of the test kit
Slices for deviceName		1..*	BackboneElement	The name of the device as given by the manufacturer Slice: Unordered, Open by value:type
deviceName:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		1..1	string	The name of the device
type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by.
deviceName:modelName		1..1	BackboneElement	LIVD Spreadsheet | LOINC Mapping.Model
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name	S	1..1	string	The name of the device
type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by. Fixed Value: model-name
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Device.status	required	FHIRDeviceStatus
Device.deviceName.type	required	DeviceNameType
Device.deviceName:modelName.type	required	Fixed Value: model-name

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Device	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Device	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	Device	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	Device	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Device	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()

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	Item used in healthcare
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
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier		0..*	Identifier	Instance identifier
definition		0..1	Reference(DeviceDefinition)	The reference to the definition for the device
udiCarrier	SΣ	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	SΣ	1..1	string	LIVD Spreadsheet | LOINC Mapping.Testkit Name ID or LIVD Spreadsheet | LOINC Mapping.Testkit Equipment UID
issuer	S	0..1	uri	UDI Issuing Organization
jurisdiction		0..1	uri	Regional UDI authority
carrierAIDC	Σ	0..1	base64Binary	UDI Machine Readable Barcode String
carrierHRF	Σ	0..1	string	UDI Human Readable Barcode String
entryType		0..1	code	barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
status	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
statusReason		0..*	CodeableConcept	online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
distinctIdentifier		0..1	string	The distinct identification string
manufacturer	S	0..1	string	LIVD Spreadsheet | LOINC Mapping.Manufacturer
manufactureDate	S	0..1	dateTime	Date when the device was made
expirationDate	S	0..1	dateTime	Expiration date of the test kit
lotNumber	S	0..1	string	Lot number of the test kit
serialNumber	S	0..1	string	Serial number of the test kit
Slices for deviceName		1..*	BackboneElement	The name of the device as given by the manufacturer Slice: Unordered, Open by value:type
deviceName:All Slices				Content/Rules for all slices
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
name		1..1	string	The name of the device
type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by.
deviceName:modelName		1..1	BackboneElement	LIVD Spreadsheet | LOINC Mapping.Model
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
name	S	1..1	string	The name of the device
type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by. Fixed Value: model-name
modelNumber		0..1	string	The model number for the device
partNumber		0..1	string	The part number of the device
type		0..1	CodeableConcept	The kind or type of device Binding: DeviceType (example): Codes to identify medical devices.
specialization		0..*	BackboneElement	The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
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
systemType		1..1	CodeableConcept	The standard that is used to operate and communicate
version		0..1	string	The version of the standard that is used to operate and communicate
version		0..*	BackboneElement	The actual design of the device or software version running on the device
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
type		0..1	CodeableConcept	The type of the device version
component		0..1	Identifier	A single component of the device version
value		1..1	string	The version text
property		0..*	BackboneElement	The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
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
type		1..1	CodeableConcept	Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
valueQuantity		0..*	Quantity	Property value as a quantity
valueCode		0..*	CodeableConcept	Property value as a code, e.g., NTP4 (synced to NTP)
patient		0..1	Reference(Patient)	Patient to whom Device is affixed
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
location		0..1	Reference(Location)	Where the device is found
url		0..1	uri	Network address to contact device
note		0..*	Annotation	Device notes and comments
safety	Σ	0..*	CodeableConcept	Safety Characteristics of Device
parent		0..1	Reference(Device)	The parent device
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Device.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Device.udiCarrier.entryType	required	UDIEntryType
Device.status	required	FHIRDeviceStatus
Device.statusReason	extensible	FHIRDeviceStatusReason
Device.deviceName.type	required	DeviceNameType
Device.deviceName:modelName.type	required	Fixed Value: model-name
Device.type	example	DeviceType

Constraints

Id	Grade	Path(s)	Details	Requirements
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 Device

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	Item used in healthcare
udiCarrier	S	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
deviceIdentifier	S	1..1	string	LIVD Spreadsheet | LOINC Mapping.Testkit Name ID or LIVD Spreadsheet | LOINC Mapping.Testkit Equipment UID
issuer	S	0..1	uri	UDI Issuing Organization
manufacturer	S	0..1	string	LIVD Spreadsheet | LOINC Mapping.Manufacturer
manufactureDate	S	0..1	dateTime	Date when the device was made
expirationDate	S	0..1	dateTime	Expiration date of the test kit
lotNumber	S	0..1	string	Lot number of the test kit
serialNumber	S	0..1	string	Serial number of the test kit
Slices for deviceName		1..*	BackboneElement	The name of the device as given by the manufacturer Slice: Unordered, Open by value:type
deviceName:modelName		1..1	BackboneElement	LIVD Spreadsheet | LOINC Mapping.Model
name	S	1..1	string	The name of the device
type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Fixed Value: model-name
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	Item used in healthcare
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
udiCarrier	SΣ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
deviceIdentifier	SΣ	1..1	string	LIVD Spreadsheet | LOINC Mapping.Testkit Name ID or LIVD Spreadsheet | LOINC Mapping.Testkit Equipment UID
issuer	S	0..1	uri	UDI Issuing Organization
status	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
manufacturer	S	0..1	string	LIVD Spreadsheet | LOINC Mapping.Manufacturer
manufactureDate	S	0..1	dateTime	Date when the device was made
expirationDate	S	0..1	dateTime	Expiration date of the test kit
lotNumber	S	0..1	string	Lot number of the test kit
serialNumber	S	0..1	string	Serial number of the test kit
Slices for deviceName		1..*	BackboneElement	The name of the device as given by the manufacturer Slice: Unordered, Open by value:type
deviceName:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		1..1	string	The name of the device
type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by.
deviceName:modelName		1..1	BackboneElement	LIVD Spreadsheet | LOINC Mapping.Model
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name	S	1..1	string	The name of the device
type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by. Fixed Value: model-name
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Device.status	required	FHIRDeviceStatus
Device.deviceName.type	required	DeviceNameType
Device.deviceName:modelName.type	required	Fixed Value: model-name

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Device	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Device	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	Device	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	Device	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Device	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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	Item used in healthcare
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
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier		0..*	Identifier	Instance identifier
definition		0..1	Reference(DeviceDefinition)	The reference to the definition for the device
udiCarrier	SΣ	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	SΣ	1..1	string	LIVD Spreadsheet | LOINC Mapping.Testkit Name ID or LIVD Spreadsheet | LOINC Mapping.Testkit Equipment UID
issuer	S	0..1	uri	UDI Issuing Organization
jurisdiction		0..1	uri	Regional UDI authority
carrierAIDC	Σ	0..1	base64Binary	UDI Machine Readable Barcode String
carrierHRF	Σ	0..1	string	UDI Human Readable Barcode String
entryType		0..1	code	barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
status	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
statusReason		0..*	CodeableConcept	online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
distinctIdentifier		0..1	string	The distinct identification string
manufacturer	S	0..1	string	LIVD Spreadsheet | LOINC Mapping.Manufacturer
manufactureDate	S	0..1	dateTime	Date when the device was made
expirationDate	S	0..1	dateTime	Expiration date of the test kit
lotNumber	S	0..1	string	Lot number of the test kit
serialNumber	S	0..1	string	Serial number of the test kit
Slices for deviceName		1..*	BackboneElement	The name of the device as given by the manufacturer Slice: Unordered, Open by value:type
deviceName:All Slices				Content/Rules for all slices
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
name		1..1	string	The name of the device
type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by.
deviceName:modelName		1..1	BackboneElement	LIVD Spreadsheet | LOINC Mapping.Model
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
name	S	1..1	string	The name of the device
type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by. Fixed Value: model-name
modelNumber		0..1	string	The model number for the device
partNumber		0..1	string	The part number of the device
type		0..1	CodeableConcept	The kind or type of device Binding: DeviceType (example): Codes to identify medical devices.
specialization		0..*	BackboneElement	The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
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
systemType		1..1	CodeableConcept	The standard that is used to operate and communicate
version		0..1	string	The version of the standard that is used to operate and communicate
version		0..*	BackboneElement	The actual design of the device or software version running on the device
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
type		0..1	CodeableConcept	The type of the device version
component		0..1	Identifier	A single component of the device version
value		1..1	string	The version text
property		0..*	BackboneElement	The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
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
type		1..1	CodeableConcept	Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
valueQuantity		0..*	Quantity	Property value as a quantity
valueCode		0..*	CodeableConcept	Property value as a code, e.g., NTP4 (synced to NTP)
patient		0..1	Reference(Patient)	Patient to whom Device is affixed
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
location		0..1	Reference(Location)	Where the device is found
url		0..1	uri	Network address to contact device
note		0..*	Annotation	Device notes and comments
safety	Σ	0..*	CodeableConcept	Safety Characteristics of Device
parent		0..1	Reference(Device)	The parent device
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Device.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Device.udiCarrier.entryType	required	UDIEntryType
Device.status	required	FHIRDeviceStatus
Device.statusReason	extensible	FHIRDeviceStatusReason
Device.deviceName.type	required	DeviceNameType
Device.deviceName:modelName.type	required	Fixed Value: model-name
Device.type	example	DeviceType

Constraints

Id	Grade	Path(s)	Details	Requirements
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 Device

Summary

Mandatory: 2 elements (1 nested mandatory element)
Must-Support: 9 elements
Fixed Value: 1 element

Slices

This structure defines the following Slices:

• The element Device.deviceName is sliced based on the value of value:type