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: Specimen - At-Home In-Vitro Test

Official URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Specimen-at-home-in-vitro-test Version: 1.1.0
Active as of 2024-04-26 Computable Name: SpecimenAtHomeInVitroTest
Other Identifiers: OID:2.16.840.1.113883.4.642.40.32.42.15

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

This is a framework profile and can be the base of another profile that is further constrained to meet the requirements of a specific use case. See Specimen - At-Home In-Vitro Test - COVID-19 for an example of such a profile.

The following element is expected to be constrained to a use case specific value set:

  • Specimen.type - value set containing the use case specific specimen types (consult LIVD to obtain the values to be used for each particular use case)

Usage:

Formal Views of Profile Content

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

This structure is derived from USCoreSpecimenProfile

NameFlagsCard.TypeDescription & Constraintsdoco
.. Specimen USCoreSpecimenProfile
... identifier S 0..* Identifier At-Home Test Specimen identifier. {Unique ID assigned to every test by app manufacturer}Must be 100 characters or less. V2: SPM-2.2.1, SPM-2.2.3, SPM-2.2.4
... type 1..1 CodeableConcept At-Home Test Specimen type of tissue or material. Consult [LIVD](https://www.cdc.gov/csels/dls/livd-codes.html) to obtain the values to be used for each particular use case. V2: SPM-4.1, SPM-4.2, SPM-4.3, SPM-4.7
... subject 1..1 Reference(US Core Patient Profile) The subject is the person who took the at-home test.
.... collected[x] S 1..1 dateTime At-Home Test Specimen collected date. V2: SPM-17.1

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Specimen 0..* USCoreSpecimenProfile 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. {Unique ID assigned to every test by app manufacturer}Must be 100 characters or less. V2: SPM-2.2.1, SPM-2.2.3, SPM-2.2.4
... type SΣ 1..1 CodeableConcept At-Home Test Specimen type of tissue or material. Consult [LIVD](https://www.cdc.gov/csels/dls/livd-codes.html) to obtain the values to be used for each particular use case. V2: SPM-4.1, SPM-4.2, SPM-4.3, SPM-4.7
Binding: Specimen type . (extensible)
... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Specimen.statusrequiredSpecimenStatus
http://hl7.org/fhir/ValueSet/specimen-status|4.0.1
from the FHIR Standard
Specimen.typeextensibleSpecimenType .
http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.54
NameFlagsCard.TypeDescription & Constraintsdoco
.. Specimen 0..* USCoreSpecimenProfile 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
... 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. {Unique ID assigned to every test by app manufacturer}Must be 100 characters or less. V2: SPM-2.2.1, SPM-2.2.3, SPM-2.2.4
... 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 At-Home Test Specimen type of tissue or material. Consult [LIVD](https://www.cdc.gov/csels/dls/livd-codes.html) to obtain the values to be used for each particular use case. V2: SPM-4.1, SPM-4.2, SPM-4.3, SPM-4.7
Binding: Specimen type . (extensible)
... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Specimen.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Specimen.statusrequiredSpecimenStatus
http://hl7.org/fhir/ValueSet/specimen-status|4.0.1
from the FHIR Standard
Specimen.typeextensibleSpecimenType .
http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.54
Specimen.collection.methodexampleFHIRSpecimenCollectionMethod
http://hl7.org/fhir/ValueSet/specimen-collection-method
from the FHIR Standard
Specimen.collection.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Specimen.collection.fastingStatus[x]extensibleHl7VSRelevantClincialInformation
http://terminology.hl7.org/ValueSet/v2-0916
Specimen.processing.procedureexampleSpecimenProcessingProcedure
http://hl7.org/fhir/ValueSet/specimen-processing-procedure
from the FHIR Standard
Specimen.container.typeexampleSpecimenContainerType
http://hl7.org/fhir/ValueSet/specimen-container-type
from the FHIR Standard
Specimen.container.additive[x]exampleHl7VSAdditivePreservative
http://terminology.hl7.org/ValueSet/v2-0371
Specimen.conditionextensibleHl7VSSpecimenCondition
http://terminology.hl7.org/ValueSet/v2-0493

This structure is derived from USCoreSpecimenProfile

Summary

Mandatory: 3 elements
Must-Support: 3 elements

Differential View

This structure is derived from USCoreSpecimenProfile

NameFlagsCard.TypeDescription & Constraintsdoco
.. Specimen USCoreSpecimenProfile
... identifier S 0..* Identifier At-Home Test Specimen identifier. {Unique ID assigned to every test by app manufacturer}Must be 100 characters or less. V2: SPM-2.2.1, SPM-2.2.3, SPM-2.2.4
... type 1..1 CodeableConcept At-Home Test Specimen type of tissue or material. Consult [LIVD](https://www.cdc.gov/csels/dls/livd-codes.html) to obtain the values to be used for each particular use case. V2: SPM-4.1, SPM-4.2, SPM-4.3, SPM-4.7
... subject 1..1 Reference(US Core Patient Profile) The subject is the person who took the at-home test.
.... collected[x] S 1..1 dateTime At-Home Test Specimen collected date. V2: SPM-17.1

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Specimen 0..* USCoreSpecimenProfile 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. {Unique ID assigned to every test by app manufacturer}Must be 100 characters or less. V2: SPM-2.2.1, SPM-2.2.3, SPM-2.2.4
... type SΣ 1..1 CodeableConcept At-Home Test Specimen type of tissue or material. Consult [LIVD](https://www.cdc.gov/csels/dls/livd-codes.html) to obtain the values to be used for each particular use case. V2: SPM-4.1, SPM-4.2, SPM-4.3, SPM-4.7
Binding: Specimen type . (extensible)
... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Specimen.statusrequiredSpecimenStatus
http://hl7.org/fhir/ValueSet/specimen-status|4.0.1
from the FHIR Standard
Specimen.typeextensibleSpecimenType .
http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.54

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Specimen 0..* USCoreSpecimenProfile 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
... 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. {Unique ID assigned to every test by app manufacturer}Must be 100 characters or less. V2: SPM-2.2.1, SPM-2.2.3, SPM-2.2.4
... 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 At-Home Test Specimen type of tissue or material. Consult [LIVD](https://www.cdc.gov/csels/dls/livd-codes.html) to obtain the values to be used for each particular use case. V2: SPM-4.1, SPM-4.2, SPM-4.3, SPM-4.7
Binding: Specimen type . (extensible)
... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Specimen.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Specimen.statusrequiredSpecimenStatus
http://hl7.org/fhir/ValueSet/specimen-status|4.0.1
from the FHIR Standard
Specimen.typeextensibleSpecimenType .
http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.54
Specimen.collection.methodexampleFHIRSpecimenCollectionMethod
http://hl7.org/fhir/ValueSet/specimen-collection-method
from the FHIR Standard
Specimen.collection.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Specimen.collection.fastingStatus[x]extensibleHl7VSRelevantClincialInformation
http://terminology.hl7.org/ValueSet/v2-0916
Specimen.processing.procedureexampleSpecimenProcessingProcedure
http://hl7.org/fhir/ValueSet/specimen-processing-procedure
from the FHIR Standard
Specimen.container.typeexampleSpecimenContainerType
http://hl7.org/fhir/ValueSet/specimen-container-type
from the FHIR Standard
Specimen.container.additive[x]exampleHl7VSAdditivePreservative
http://terminology.hl7.org/ValueSet/v2-0371
Specimen.conditionextensibleHl7VSSpecimenCondition
http://terminology.hl7.org/ValueSet/v2-0493

This structure is derived from USCoreSpecimenProfile

Summary

Mandatory: 3 elements
Must-Support: 3 elements

 

Other representations of profile: CSV, Excel, Schematron