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: Specimen - At-Home In-Vitro Test - COVID-19

This Specimen profile identifies and describes the specimen used in a COVID-19 At-Home In-Vitro Test.

Usage:

• Refer to this Resource Profile: Observation - At-Home In-Vitro Test Result - COVID-19
• Examples for this Resource Profile: Specimen/specimen-anterior-nares-swab-p-noelle and Specimen/specimen-swab-internal-nose-s-trevor

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

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

This structure is derived from SpecimenAtHomeInVitroTest

Name	Flags	Card.	Type	Description & Constraints
Specimen			SpecimenAtHomeInVitroTest
type		1..1	CodeableConcept	Type of tissue or material. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for the COVID-19 use case.
coding	S	1..*	Coding	The coded specimen type.
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Specimen		0..*	SpecimenAtHomeInVitroTest	Sample for analysis
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	At-Home Test Specimen identifier.
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
status	?!Σ	0..1	code	available | unavailable | unsatisfactory | entered-in-error Binding: SpecimenStatus (required): Codes providing the status/availability of a specimen.
type	SΣ	1..1	CodeableConcept	Type of tissue or material. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for the COVID-19 use case. Binding: Specimen type (extensible)
coding	SΣ	1..*	Coding	The coded specimen type.
subject	SΣ	1..1	Reference(US Core Patient Profile)	The subject is the person who took the at-home test.
collection	S	1..1	BackboneElement	Collection details
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
collected[x]	SΣ	1..1	dateTime	At-Home Test Specimen collected date. V2: SPM-17.1
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Specimen.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Specimen.status	required	SpecimenStatus http://hl7.org/fhir/ValueSet/specimen-status|4.0.1 from the FHIR Standard
Specimen.type	extensible	SpecimenType http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.54 from https://vsac.nlm.nih.gov

Name	Flags	Card.	Type	Description & Constraints
Specimen		0..*	SpecimenAtHomeInVitroTest	Sample for analysis
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	SΣ	0..*	Identifier	At-Home Test Specimen identifier.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	At-Home Test Specimen ID assigner ID type. 'ISO' V2: SPM-2.2.4 Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	0..1	uri	At-Home Specimen ID assigner ID type . See 'Obtaining App Specific Identifiers' (see Guidance->Getting Started for details). If converting FHIR to V2, must be 100 characters or less. V2: SPM-2.2.3 Example General: http://www.acme.com/identifiers/patient
value	Σ	0..1	string	At-Home Test Specimen identifier. {Unique ID assigned to every test by app manufacturer} If converting FHIR to V2, must be 100 characters or less. V2: SPM-2.2.1 Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
accessionIdentifier	Σ	0..1	Identifier	Identifier assigned by the lab
status	?!Σ	0..1	code	available | unavailable | unsatisfactory | entered-in-error Binding: SpecimenStatus (required): Codes providing the status/availability of a specimen.
type	SΣ	1..1	CodeableConcept	Type of tissue or material. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for the COVID-19 use case. Binding: Specimen type (extensible)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..*	Coding	The coded specimen type.
text	Σ	0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(US Core Patient Profile)	The subject is the person who took the at-home test.
receivedTime	Σ	0..1	dateTime	The time when specimen was received for processing
parent		0..*	Reference(Specimen)	Specimen from which this specimen originated
request		0..*	Reference(ServiceRequest)	Why the specimen was collected
collection	S	1..1	BackboneElement	Collection details
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
collector	Σ	0..1	Reference(Practitioner | PractitionerRole)	Who collected the specimen
collected[x]	SΣ	1..1	dateTime	At-Home Test Specimen collected date. V2: SPM-17.1
duration	Σ	0..1	Duration	How long it took to collect specimen
quantity		0..1	SimpleQuantity	The quantity of specimen collected
method		0..1	CodeableConcept	Technique used to perform collection Binding: FHIRSpecimenCollectionMethod (example): The technique that is used to perform the procedure.
bodySite		0..1	CodeableConcept	Anatomical collection site Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
fastingStatus[x]	Σ	0..1		Whether or how long patient abstained from food and/or drink Binding: hl7VS-relevantClincialInformation (extensible): Codes describing the fasting status of the patient.
fastingStatusCodeableConcept			CodeableConcept
fastingStatusDuration			Duration
processing		0..*	BackboneElement	Processing and processing step details
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
description		0..1	string	Textual description of procedure
procedure		0..1	CodeableConcept	Indicates the treatment step applied to the specimen Binding: SpecimenProcessingProcedure (example): Type indicating the technique used to process the specimen.
additive		0..*	Reference(Substance)	Material used in the processing step
time[x]		0..1		Date and time of specimen processing
timeDateTime			dateTime
timePeriod			Period
container		0..*	BackboneElement	Direct container of specimen (tube/slide, etc.)
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
identifier	Σ	0..*	Identifier	Id for the container
description		0..1	string	Textual description of the container
type		0..1	CodeableConcept	Kind of container directly associated with specimen Binding: SpecimenContainerType (example): Type of specimen container.
capacity		0..1	SimpleQuantity	Container volume or size
specimenQuantity		0..1	SimpleQuantity	Quantity of specimen within container
additive[x]		0..1		Additive associated with container Binding: hl7VS-additivePreservative (example): Substance added to specimen container.
additiveCodeableConcept			CodeableConcept
additiveReference			Reference(Substance)
condition	Σ	0..*	CodeableConcept	State of the specimen Binding: hl7VS-specimenCondition (extensible): Codes describing the state of the specimen.
note		0..*	Annotation	Comments
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Specimen.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Specimen.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Specimen.identifier.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Specimen.status	required	SpecimenStatus http://hl7.org/fhir/ValueSet/specimen-status|4.0.1 from the FHIR Standard
Specimen.type	extensible	SpecimenType http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.54 from https://vsac.nlm.nih.gov
Specimen.collection.method	example	FHIRSpecimenCollectionMethod http://hl7.org/fhir/ValueSet/specimen-collection-method from the FHIR Standard
Specimen.collection.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
Specimen.collection.fastingStatus[x]	extensible	Hl7VSRelevantClincialInformation http://terminology.hl7.org/ValueSet/v2-0916
Specimen.processing.procedure	example	SpecimenProcessingProcedure http://hl7.org/fhir/ValueSet/specimen-processing-procedure from the FHIR Standard
Specimen.container.type	example	SpecimenContainerType http://hl7.org/fhir/ValueSet/specimen-container-type from the FHIR Standard
Specimen.container.additive[x]	example	Hl7VSAdditivePreservative http://terminology.hl7.org/ValueSet/v2-0371
Specimen.condition	extensible	Hl7VSSpecimenCondition http://terminology.hl7.org/ValueSet/v2-0493

This structure is derived from SpecimenAtHomeInVitroTest

Summary

Mandatory: 1 element
Must-Support: 1 element

Differential View

This structure is derived from SpecimenAtHomeInVitroTest

Name	Flags	Card.	Type	Description & Constraints
Specimen			SpecimenAtHomeInVitroTest
type		1..1	CodeableConcept	Type of tissue or material. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for the COVID-19 use case.
coding	S	1..*	Coding	The coded specimen type.
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Specimen		0..*	SpecimenAtHomeInVitroTest	Sample for analysis
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	At-Home Test Specimen identifier.
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
status	?!Σ	0..1	code	available | unavailable | unsatisfactory | entered-in-error Binding: SpecimenStatus (required): Codes providing the status/availability of a specimen.
type	SΣ	1..1	CodeableConcept	Type of tissue or material. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for the COVID-19 use case. Binding: Specimen type (extensible)
coding	SΣ	1..*	Coding	The coded specimen type.
subject	SΣ	1..1	Reference(US Core Patient Profile)	The subject is the person who took the at-home test.
collection	S	1..1	BackboneElement	Collection details
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
collected[x]	SΣ	1..1	dateTime	At-Home Test Specimen collected date. V2: SPM-17.1
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Specimen.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Specimen.status	required	SpecimenStatus http://hl7.org/fhir/ValueSet/specimen-status|4.0.1 from the FHIR Standard
Specimen.type	extensible	SpecimenType http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.54 from https://vsac.nlm.nih.gov

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Specimen		0..*	SpecimenAtHomeInVitroTest	Sample for analysis
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	SΣ	0..*	Identifier	At-Home Test Specimen identifier.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	At-Home Test Specimen ID assigner ID type. 'ISO' V2: SPM-2.2.4 Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	0..1	uri	At-Home Specimen ID assigner ID type . See 'Obtaining App Specific Identifiers' (see Guidance->Getting Started for details). If converting FHIR to V2, must be 100 characters or less. V2: SPM-2.2.3 Example General: http://www.acme.com/identifiers/patient
value	Σ	0..1	string	At-Home Test Specimen identifier. {Unique ID assigned to every test by app manufacturer} If converting FHIR to V2, must be 100 characters or less. V2: SPM-2.2.1 Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
accessionIdentifier	Σ	0..1	Identifier	Identifier assigned by the lab
status	?!Σ	0..1	code	available | unavailable | unsatisfactory | entered-in-error Binding: SpecimenStatus (required): Codes providing the status/availability of a specimen.
type	SΣ	1..1	CodeableConcept	Type of tissue or material. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for the COVID-19 use case. Binding: Specimen type (extensible)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..*	Coding	The coded specimen type.
text	Σ	0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(US Core Patient Profile)	The subject is the person who took the at-home test.
receivedTime	Σ	0..1	dateTime	The time when specimen was received for processing
parent		0..*	Reference(Specimen)	Specimen from which this specimen originated
request		0..*	Reference(ServiceRequest)	Why the specimen was collected
collection	S	1..1	BackboneElement	Collection details
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
collector	Σ	0..1	Reference(Practitioner | PractitionerRole)	Who collected the specimen
collected[x]	SΣ	1..1	dateTime	At-Home Test Specimen collected date. V2: SPM-17.1
duration	Σ	0..1	Duration	How long it took to collect specimen
quantity		0..1	SimpleQuantity	The quantity of specimen collected
method		0..1	CodeableConcept	Technique used to perform collection Binding: FHIRSpecimenCollectionMethod (example): The technique that is used to perform the procedure.
bodySite		0..1	CodeableConcept	Anatomical collection site Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
fastingStatus[x]	Σ	0..1		Whether or how long patient abstained from food and/or drink Binding: hl7VS-relevantClincialInformation (extensible): Codes describing the fasting status of the patient.
fastingStatusCodeableConcept			CodeableConcept
fastingStatusDuration			Duration
processing		0..*	BackboneElement	Processing and processing step details
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
description		0..1	string	Textual description of procedure
procedure		0..1	CodeableConcept	Indicates the treatment step applied to the specimen Binding: SpecimenProcessingProcedure (example): Type indicating the technique used to process the specimen.
additive		0..*	Reference(Substance)	Material used in the processing step
time[x]		0..1		Date and time of specimen processing
timeDateTime			dateTime
timePeriod			Period
container		0..*	BackboneElement	Direct container of specimen (tube/slide, etc.)
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
identifier	Σ	0..*	Identifier	Id for the container
description		0..1	string	Textual description of the container
type		0..1	CodeableConcept	Kind of container directly associated with specimen Binding: SpecimenContainerType (example): Type of specimen container.
capacity		0..1	SimpleQuantity	Container volume or size
specimenQuantity		0..1	SimpleQuantity	Quantity of specimen within container
additive[x]		0..1		Additive associated with container Binding: hl7VS-additivePreservative (example): Substance added to specimen container.
additiveCodeableConcept			CodeableConcept
additiveReference			Reference(Substance)
condition	Σ	0..*	CodeableConcept	State of the specimen Binding: hl7VS-specimenCondition (extensible): Codes describing the state of the specimen.
note		0..*	Annotation	Comments
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Specimen.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Specimen.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Specimen.identifier.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Specimen.status	required	SpecimenStatus http://hl7.org/fhir/ValueSet/specimen-status|4.0.1 from the FHIR Standard
Specimen.type	extensible	SpecimenType http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.54 from https://vsac.nlm.nih.gov
Specimen.collection.method	example	FHIRSpecimenCollectionMethod http://hl7.org/fhir/ValueSet/specimen-collection-method from the FHIR Standard
Specimen.collection.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
Specimen.collection.fastingStatus[x]	extensible	Hl7VSRelevantClincialInformation http://terminology.hl7.org/ValueSet/v2-0916
Specimen.processing.procedure	example	SpecimenProcessingProcedure http://hl7.org/fhir/ValueSet/specimen-processing-procedure from the FHIR Standard
Specimen.container.type	example	SpecimenContainerType http://hl7.org/fhir/ValueSet/specimen-container-type from the FHIR Standard
Specimen.container.additive[x]	example	Hl7VSAdditivePreservative http://terminology.hl7.org/ValueSet/v2-0371
Specimen.condition	extensible	Hl7VSSpecimenCondition http://terminology.hl7.org/ValueSet/v2-0493

This structure is derived from SpecimenAtHomeInVitroTest

Summary

Mandatory: 1 element
Must-Support: 1 element

Other representations of profile: CSV, Excel, Schematron