At-Home In-Vitro Test Report
1.1.0 - STU 1.1

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 - COVID-19

Official URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Specimen-at-home-in-vitro-test-covid | Version: 1.1.0
Active as of 2024-08-08 | Computable Name: SpecimenAtHomeInVitroTestCovid
Other Identifiers: OID:2.16.840.1.113883.4.642.40.32.42.14

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

This is an example of a profile that is based on a framework profile and futher constrained to meet the requirements of the COVID-19 use case. It is based on the Specimen - At-Home In-Vitro Test profile.

It constrains the following element to a COVID-19 specific value set:

- Specimen.type - consult LIVD to obtain the values to be used for each particular use case

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 | S Σ | 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 | S Σ | 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 | S Σ | 1..* | Coding | The coded specimen type.
subject | S Σ | 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] | S Σ | 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 | S Σ | 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 | S Σ | 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 | S Σ | 1..* | Coding | The coded specimen type.
text | Σ | 0..1 | string | Plain text representation of the concept
subject | S Σ | 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] | S Σ | 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 | S Σ | 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 | S Σ | 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 | S Σ | 1..* | Coding | The coded specimen type.
subject | S Σ | 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] | S Σ | 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 | S Σ | 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 | S Σ | 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 | S Σ | 1..* | Coding | The coded specimen type.
text | Σ | 0..1 | string | Plain text representation of the concept
subject | S Σ | 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] | S Σ | 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