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: Observation - At-Home In-Vitro Test Result

Official URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Observation-at-home-in-vitro-test-result | Version: 1.1.0
Active as of 2024-08-08 | Computable Name: ObservationAtHomeInVitroTestResult
Other Identifiers: OID:2.16.840.1.113883.4.642.40.32.42.11

This profile constrains the US Core Laboratory Result Observation to At-Home In-Vitro Sample Tests.

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 Observation - At-Home In-Vitro Test Result - COVID-19 for an example of such a profile.

The following elements are expected to be constrained to use case specific value sets:

- Observation.code - value set containing the use case specific test types (consult LIVD to obtain the values to be used for each particular use case)
- Observation.value - value set containing the use case specific test results (consult LIVD to obtain the values to be used for each particular use case)
- For Multiplex Assay tests that serve as a single test to diagnose infection caused by multiple viruses (e.g. CDC Flu SC2 Multiplex Assay for SARS-CoV-2, influenza A, and/or influenza B viruses) use Observation.hasMember to reference another Observation - At-Home In-Vitro Test Result.

Usage:

- Derived from this Resource Profile: Observation - At-Home In-Vitro Test Result - COVID-19
- Refer to this Resource Profile: DiagnosticReport - At-Home In-Vitro Results and Observation - At-Home In-Vitro Test Result

### 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 USCoreLaboratoryResultObservationProfile

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  |  | USCoreLaboratoryResultObservationProfile |
id | S | 1..1 | id | Logical id of this artifact
Extension-at-home-in-vitro-test-proctored-info |  | 0..1 | (Complex) | Extension - At-Home In-Vitro Test Proctored Information URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-proctored-info
status |  | 1..1 | code | At-Home Test result status final. V2: OBR-25, OBX-11 Fixed Value: final
code |  | 1..1 | CodeableConcept | At-Home Test performed code. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7
subject |  | 1..1 | Reference(Patient - At Home In Vitro Test) | (USCDI) Who and/or what the observation is about
effective[x] |  | 1..1 | dateTime | At-Home Test date of interpretation/result date. The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. NOTE: For multiplex tests, this field must match across all results. V2: OBX-7.1, OBX-19
issued | S | 0..1 | instant | At-Home Test result date released - when test item is done (in the at-home setting will mostly be the same as the Observation.effective[x], could be different when a proctor is involved - when the proctor releases the result). V2: OBR-22.1
performer | S | 0..* | Reference(US Core Practitioner Profile | US Core PractitionerRole Profile | US Core Organization Profile | US Core CareTeam Profile | Patient - At Home In Vitro Test | US Core RelatedPerson Profile) | If the performer is not the patient being tested, specify the person performing the test.
value[x] |  | 0..1 | CodeableConcept | At-Home Test Result value. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-5.1, OBX-5.2, OBX-5.3, OBX-5.7
specimen |  | 1..1 | Reference(Specimen - At-Home In-Vitro Test) | The Specimen SHALL be from at-home sample. The referenced specifimen should contain a Specimen.identifier and a Specimen.identifier.assigner.
device | S | 1..1 | Reference(Device - At-Home In-Vitro Test) | The referenced device SHALL be at-home test device.
hasMember |  | 0..* | Reference(Observation - At-Home In-Vitro Test Result) | Multiplex Assay tests that serve as a single test to diagnose infection caused by multiple viruses (e.g. CDC Flu SC2 Multiplex Assay for SARS-CoV-2, influenza A, and/or influenza B viruses) should be recorded using multiple Observation.hasMember elements.
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation | C | 0..* | USCoreLaboratoryResultObservationProfile | Measurements and simple assertions obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
id | S Σ | 1..1 | id | Logical id of this artifact
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
Extension-at-home-in-vitro-test-proctored-info |  | 0..1 | (Complex) | Extension - At-Home In-Vitro Test Proctored Information URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-proctored-info
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
status | ?!S Σ | 1..1 | code | At-Home Test result status final. V2: OBR-25, OBX-11 Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: final
Slices for category | S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets Required Pattern: At least the following
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory
code | S Σ | 1..1 | CodeableConcept | At-Home Test performed code. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7 Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes
subject | S Σ | 1..1 | Reference(Patient - At Home In Vitro Test) | (USCDI) Who and/or what the observation is about
effective[x] | S Σ C | 1..1 | dateTime | At-Home Test date of interpretation/result date. The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. NOTE: For multiplex tests, this field must match across all results. V2: OBX-7.1, OBX-19 us-core-1: Datetime must be at least to day.
issued | S Σ | 0..1 | instant | At-Home Test result date released - when test item is done (in the at-home setting will mostly be the same as the Observation.effective[x], could be different when a proctor is involved - when the proctor releases the result). V2: OBR-22.1
performer | S Σ | 0..* | Reference(US Core Practitioner Profile | US Core PractitionerRole Profile | US Core Organization Profile | US Core CareTeam Profile | Patient - At Home In Vitro Test | US Core RelatedPerson Profile) | If the performer is not the patient being tested, specify the person performing the test.
value[x] | S Σ C | 0..1 | CodeableConcept | At-Home Test Result value. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-5.1, OBX-5.2, OBX-5.3, OBX-5.7 us-core-3: SHALL use UCUM for coded quantity units. us-core-4: SHOULD use Snomed CT for coded Results
dataAbsentReason | S C | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
specimen | S | 1..1 | Reference(Specimen - At-Home In-Vitro Test) | The Specimen SHALL be from at-home sample. The referenced specifimen should contain a Specimen.identifier and a Specimen.identifier.assigner.
device | S | 1..1 | Reference(Device - At-Home In-Vitro Test) | The referenced device SHALL be at-home test device.
hasMember | Σ | 0..* | Reference(Observation - At-Home In-Vitro Test Result) | Multiplex Assay tests that serve as a single test to diagnose infection caused by multiple viruses (e.g. CDC Flu SC2 Multiplex Assay for SARS-CoV-2, influenza A, and/or influenza B viruses) should be recorded using multiple Observation.hasMember elements.
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Observation.status | required | Fixed Value: final `http://hl7.org/fhir/ValueSet/observation-status|4.0.1` from the FHIR Standard
Observation.category | preferred | ObservationCategoryCodes `http://hl7.org/fhir/ValueSet/observation-category` from the FHIR Standard
Observation.category:us-core | required | Pattern: laboratory `http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category`
Observation.code | extensible | USCoreLaboratoryTestCodes `http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes`
Observation.dataAbsentReason | extensible | DataAbsentReason `http://hl7.org/fhir/ValueSet/data-absent-reason` from the FHIR Standard

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation | C | 0..* | USCoreLaboratoryResultObservationProfile | Measurements and simple assertions obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
id | S Σ | 1..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-at-home-in-vitro-test-proctored-info |  | 0..1 | (Complex) | Extension - At-Home In-Vitro Test Proctored Information URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-proctored-info
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier | Σ | 0..* | Identifier | Business Identifier for observation
basedOn | Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order
partOf | Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event
status | ?!S Σ | 1..1 | code | At-Home Test result status final. V2: OBR-25, OBX-11 Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: final
Slices for category | S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory
display |  | 0..1 | string | Representation defined by the system
userSelected |  | 0..1 | boolean | If this coding was chosen directly by the user
text |  | 0..1 | string | Plain text representation of the concept
code | S Σ | 1..1 | CodeableConcept | At-Home Test performed code. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7 Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes
subject | S Σ | 1..1 | Reference(Patient - At Home In Vitro Test) | (USCDI) Who and/or what the observation is about
focus | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record
encounter | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made
effective[x] | S Σ C | 1..1 | dateTime S | At-Home Test date of interpretation/result date. The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. NOTE: For multiplex tests, this field must match across all results. V2: OBX-7.1, OBX-19 us-core-1: Datetime must be at least to day.
issued | S Σ | 0..1 | instant | At-Home Test result date released - when test item is done (in the at-home setting will mostly be the same as the Observation.effective[x], could be different when a proctor is involved - when the proctor releases the result). V2: OBR-22.1
performer | S Σ | 0..* | Reference(US Core Practitioner Profile | US Core PractitionerRole Profile | US Core Organization Profile | US Core CareTeam Profile | Patient - At Home In Vitro Test | US Core RelatedPerson Profile) | If the performer is not the patient being tested, specify the person performing the test.
value[x] | S Σ C | 0..1 | CodeableConcept S | At-Home Test Result value. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-5.1, OBX-5.2, OBX-5.3, OBX-5.7 us-core-3: SHALL use UCUM for coded quantity units. us-core-4: SHOULD use Snomed CT for coded Results
dataAbsentReason | S C | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note |  | 0..* | Annotation | Comments about the observation
bodySite |  | 0..1 | CodeableConcept | Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method |  | 0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen | S | 1..1 | Reference(Specimen - At-Home In-Vitro Test) | The Specimen SHALL be from at-home sample. The referenced specifimen should contain a Specimen.identifier and a Specimen.identifier.assigner.
device | S | 1..1 | Reference(Device - At-Home In-Vitro Test) | The referenced device SHALL be at-home test device.
referenceRange | C | 0..* | BackboneElement | Provides guide for interpretation obs-3: Must have at least a low or a high or text
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
low | C | 0..1 | SimpleQuantity | Low Range, if relevant
high | C | 0..1 | SimpleQuantity | High Range, if relevant
type |  | 0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo |  | 0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age |  | 0..1 | Range | Applicable age range, if relevant
text |  | 0..1 | string | Text based reference range in an observation
hasMember | Σ | 0..* | Reference(Observation - At-Home In-Vitro Test Result) | Multiplex Assay tests that serve as a single test to diagnose infection caused by multiple viruses (e.g. CDC Flu SC2 Multiplex Assay for SARS-CoV-2, influenza A, and/or influenza B viruses) should be recorded using multiple Observation.hasMember elements.
derivedFrom | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from
component | Σ | 0..* | BackboneElement | Component results
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
code | Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x] | Σ | 0..1 |  | Actual component result
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange |  | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Observation.language | preferred | CommonLanguages
Additional Bindings | Purpose
AllLanguages | Max Binding
`http://hl7.org/fhir/ValueSet/languages` from the FHIR Standard
Observation.status | required | Fixed Value: final `http://hl7.org/fhir/ValueSet/observation-status|4.0.1` from the FHIR Standard
Observation.category | preferred | ObservationCategoryCodes `http://hl7.org/fhir/ValueSet/observation-category` from the FHIR Standard
Observation.category:us-core | required | Pattern: laboratory `http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category`
Observation.code | extensible | USCoreLaboratoryTestCodes `http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes`
Observation.dataAbsentReason | extensible | DataAbsentReason `http://hl7.org/fhir/ValueSet/data-absent-reason` from the FHIR Standard
Observation.interpretation | extensible | ObservationInterpretationCodes `http://hl7.org/fhir/ValueSet/observation-interpretation` from the FHIR Standard
Observation.bodySite | example | SNOMEDCTBodyStructures `http://hl7.org/fhir/ValueSet/body-site` from the FHIR Standard
Observation.method | example | ObservationMethods `http://hl7.org/fhir/ValueSet/observation-methods` from the FHIR Standard
Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodes `http://hl7.org/fhir/ValueSet/referencerange-meaning` from the FHIR Standard
Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodes `http://hl7.org/fhir/ValueSet/referencerange-appliesto` from the FHIR Standard
Observation.component.code | example | LOINCCodes (a valid code from LOINC) `http://hl7.org/fhir/ValueSet/observation-codes` from the FHIR Standard
Observation.component.dataAbsentReason | extensible | DataAbsentReason `http://hl7.org/fhir/ValueSet/data-absent-reason` from the FHIR Standard
Observation.component.interpretation | extensible | ObservationInterpretationCodes `http://hl7.org/fhir/ValueSet/observation-interpretation` from the FHIR Standard

This structure is derived from USCoreLaboratoryResultObservationProfile

Summary

Mandatory: 4 elements
Must-Support: 4 elements
Fixed: 1 element

Structures

This structure refers to these other structures:

- Patient - At Home In Vitro Test (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Patient-at-home-in-vitro-test)
- US Core Practitioner Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner)
- US Core PractitionerRole Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitionerrole)
- US Core Organization Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-organization)
- US Core CareTeam Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-careteam)
- US Core RelatedPerson Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-relatedperson)
- Specimen - At-Home In-Vitro Test (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Specimen-at-home-in-vitro-test)
- Device - At-Home In-Vitro Test (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Device-at-home-in-vitro-test)
- Observation - At-Home In-Vitro Test Result (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Observation-at-home-in-vitro-test-result)

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-proctored-info

Differential View

This structure is derived from USCoreLaboratoryResultObservationProfile

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  |  | USCoreLaboratoryResultObservationProfile |
id | S | 1..1 | id | Logical id of this artifact
Extension-at-home-in-vitro-test-proctored-info |  | 0..1 | (Complex) | Extension - At-Home In-Vitro Test Proctored Information URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-proctored-info
status |  | 1..1 | code | At-Home Test result status final. V2: OBR-25, OBX-11 Fixed Value: final
code |  | 1..1 | CodeableConcept | At-Home Test performed code. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7
subject |  | 1..1 | Reference(Patient - At Home In Vitro Test) | (USCDI) Who and/or what the observation is about
effective[x] |  | 1..1 | dateTime | At-Home Test date of interpretation/result date. The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. NOTE: For multiplex tests, this field must match across all results. V2: OBX-7.1, OBX-19
issued | S | 0..1 | instant | At-Home Test result date released - when test item is done (in the at-home setting will mostly be the same as the Observation.effective[x], could be different when a proctor is involved - when the proctor releases the result). V2: OBR-22.1
performer | S | 0..* | Reference(US Core Practitioner Profile | US Core PractitionerRole Profile | US Core Organization Profile | US Core CareTeam Profile | Patient - At Home In Vitro Test | US Core RelatedPerson Profile) | If the performer is not the patient being tested, specify the person performing the test.
value[x] |  | 0..1 | CodeableConcept | At-Home Test Result value. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-5.1, OBX-5.2, OBX-5.3, OBX-5.7
specimen |  | 1..1 | Reference(Specimen - At-Home In-Vitro Test) | The Specimen SHALL be from at-home sample. The referenced specifimen should contain a Specimen.identifier and a Specimen.identifier.assigner.
device | S | 1..1 | Reference(Device - At-Home In-Vitro Test) | The referenced device SHALL be at-home test device.
hasMember |  | 0..* | Reference(Observation - At-Home In-Vitro Test Result) | Multiplex Assay tests that serve as a single test to diagnose infection caused by multiple viruses (e.g. CDC Flu SC2 Multiplex Assay for SARS-CoV-2, influenza A, and/or influenza B viruses) should be recorded using multiple Observation.hasMember elements.
Documentation for this format

Key Elements View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation | C | 0..* | USCoreLaboratoryResultObservationProfile | Measurements and simple assertions obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
id | S Σ | 1..1 | id | Logical id of this artifact
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
Extension-at-home-in-vitro-test-proctored-info |  | 0..1 | (Complex) | Extension - At-Home In-Vitro Test Proctored Information URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-proctored-info
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
status | ?!S Σ | 1..1 | code | At-Home Test result status final. V2: OBR-25, OBX-11 Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: final
Slices for category | S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets Required Pattern: At least the following
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory
code | S Σ | 1..1 | CodeableConcept | At-Home Test performed code. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7 Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes
subject | S Σ | 1..1 | Reference(Patient - At Home In Vitro Test) | (USCDI) Who and/or what the observation is about
effective[x] | S Σ C | 1..1 | dateTime | At-Home Test date of interpretation/result date. The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. NOTE: For multiplex tests, this field must match across all results. V2: OBX-7.1, OBX-19 us-core-1: Datetime must be at least to day.
issued | S Σ | 0..1 | instant | At-Home Test result date released - when test item is done (in the at-home setting will mostly be the same as the Observation.effective[x], could be different when a proctor is involved - when the proctor releases the result). V2: OBR-22.1
performer | S Σ | 0..* | Reference(US Core Practitioner Profile | US Core PractitionerRole Profile | US Core Organization Profile | US Core CareTeam Profile | Patient - At Home In Vitro Test | US Core RelatedPerson Profile) | If the performer is not the patient being tested, specify the person performing the test.
value[x] | S Σ C | 0..1 | CodeableConcept | At-Home Test Result value. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-5.1, OBX-5.2, OBX-5.3, OBX-5.7 us-core-3: SHALL use UCUM for coded quantity units. us-core-4: SHOULD use Snomed CT for coded Results
dataAbsentReason | S C | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
specimen | S | 1..1 | Reference(Specimen - At-Home In-Vitro Test) | The Specimen SHALL be from at-home sample. The referenced specifimen should contain a Specimen.identifier and a Specimen.identifier.assigner.
device | S | 1..1 | Reference(Device - At-Home In-Vitro Test) | The referenced device SHALL be at-home test device.
hasMember | Σ | 0..* | Reference(Observation - At-Home In-Vitro Test Result) | Multiplex Assay tests that serve as a single test to diagnose infection caused by multiple viruses (e.g. CDC Flu SC2 Multiplex Assay for SARS-CoV-2, influenza A, and/or influenza B viruses) should be recorded using multiple Observation.hasMember elements.
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Observation.status | required | Fixed Value: final `http://hl7.org/fhir/ValueSet/observation-status|4.0.1` from the FHIR Standard
Observation.category | preferred | ObservationCategoryCodes `http://hl7.org/fhir/ValueSet/observation-category` from the FHIR Standard
Observation.category:us-core | required | Pattern: laboratory `http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category`
Observation.code | extensible | USCoreLaboratoryTestCodes `http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes`
Observation.dataAbsentReason | extensible | DataAbsentReason `http://hl7.org/fhir/ValueSet/data-absent-reason` from the FHIR Standard

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation | C | 0..* | USCoreLaboratoryResultObservationProfile | Measurements and simple assertions obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
id | S Σ | 1..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-at-home-in-vitro-test-proctored-info |  | 0..1 | (Complex) | Extension - At-Home In-Vitro Test Proctored Information URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-proctored-info
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier | Σ | 0..* | Identifier | Business Identifier for observation
basedOn | Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order
partOf | Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event
status | ?!S Σ | 1..1 | code | At-Home Test result status final. V2: OBR-25, OBX-11 Binding: ObservationStatus (required): Codes providing the status of an observation. Fixed Value: final
Slices for category | S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:us-core | S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
coding |  | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex)
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory
display |  | 0..1 | string | Representation defined by the system
userSelected |  | 0..1 | boolean | If this coding was chosen directly by the user
text |  | 0..1 | string | Plain text representation of the concept
code | S Σ | 1..1 | CodeableConcept | At-Home Test performed code. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7 Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes
subject | S Σ | 1..1 | Reference(Patient - At Home In Vitro Test) | (USCDI) Who and/or what the observation is about
focus | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record
encounter | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made
effective[x] | S Σ C | 1..1 | dateTime S | At-Home Test date of interpretation/result date. The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset. NOTE: For multiplex tests, this field must match across all results. V2: OBX-7.1, OBX-19 us-core-1: Datetime must be at least to day.
issued | S Σ | 0..1 | instant | At-Home Test result date released - when test item is done (in the at-home setting will mostly be the same as the Observation.effective[x], could be different when a proctor is involved - when the proctor releases the result). V2: OBR-22.1
performer | S Σ | 0..* | Reference(US Core Practitioner Profile | US Core PractitionerRole Profile | US Core Organization Profile | US Core CareTeam Profile | Patient - At Home In Vitro Test | US Core RelatedPerson Profile) | If the performer is not the patient being tested, specify the person performing the test.
value[x] | S Σ C | 0..1 | CodeableConcept S | At-Home Test Result value. Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. V2: OBX-5.1, OBX-5.2, OBX-5.3, OBX-5.7 us-core-3: SHALL use UCUM for coded quantity units. us-core-4: SHOULD use Snomed CT for coded Results
dataAbsentReason | S C | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note |  | 0..* | Annotation | Comments about the observation
bodySite |  | 0..1 | CodeableConcept | Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method |  | 0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen | S | 1..1 | Reference(Specimen - At-Home In-Vitro Test) | The Specimen SHALL be from at-home sample. The referenced specifimen should contain a Specimen.identifier and a Specimen.identifier.assigner.
device | S | 1..1 | Reference(Device - At-Home In-Vitro Test) | The referenced device SHALL be at-home test device.
referenceRange | C | 0..* | BackboneElement | Provides guide for interpretation obs-3: Must have at least a low or a high or text
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
low | C | 0..1 | SimpleQuantity | Low Range, if relevant
high | C | 0..1 | SimpleQuantity | High Range, if relevant
type |  | 0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo |  | 0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age |  | 0..1 | Range | Applicable age range, if relevant
text |  | 0..1 | string | Text based reference range in an observation
hasMember | Σ | 0..* | Reference(Observation - At-Home In-Vitro Test Result) | Multiplex Assay tests that serve as a single test to diagnose infection caused by multiple viruses (e.g. CDC Flu SC2 Multiplex Assay for SARS-CoV-2, influenza A, and/or influenza B viruses) should be recorded using multiple Observation.hasMember elements.
derivedFrom | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from
component | Σ | 0..* | BackboneElement | Component results
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
code | Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x] | Σ | 0..1 |  | Actual component result
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange |  | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Observation.language | preferred | CommonLanguages
Additional Bindings | Purpose
AllLanguages | Max Binding
`http://hl7.org/fhir/ValueSet/languages` from the FHIR Standard
Observation.status | required | Fixed Value: final `http://hl7.org/fhir/ValueSet/observation-status|4.0.1` from the FHIR Standard
Observation.category | preferred | ObservationCategoryCodes `http://hl7.org/fhir/ValueSet/observation-category` from the FHIR Standard
Observation.category:us-core | required | Pattern: laboratory `http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category`
Observation.code | extensible | USCoreLaboratoryTestCodes `http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes`
Observation.dataAbsentReason | extensible | DataAbsentReason `http://hl7.org/fhir/ValueSet/data-absent-reason` from the FHIR Standard
Observation.interpretation | extensible | ObservationInterpretationCodes `http://hl7.org/fhir/ValueSet/observation-interpretation` from the FHIR Standard
Observation.bodySite | example | SNOMEDCTBodyStructures `http://hl7.org/fhir/ValueSet/body-site` from the FHIR Standard
Observation.method | example | ObservationMethods `http://hl7.org/fhir/ValueSet/observation-methods` from the FHIR Standard
Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodes `http://hl7.org/fhir/ValueSet/referencerange-meaning` from the FHIR Standard
Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodes `http://hl7.org/fhir/ValueSet/referencerange-appliesto` from the FHIR Standard
Observation.component.code | example | LOINCCodes (a valid code from LOINC) `http://hl7.org/fhir/ValueSet/observation-codes` from the FHIR Standard
Observation.component.dataAbsentReason | extensible | DataAbsentReason `http://hl7.org/fhir/ValueSet/data-absent-reason` from the FHIR Standard
Observation.component.interpretation | extensible | ObservationInterpretationCodes `http://hl7.org/fhir/ValueSet/observation-interpretation` from the FHIR Standard

This structure is derived from USCoreLaboratoryResultObservationProfile

Summary

Mandatory: 4 elements
Must-Support: 4 elements
Fixed: 1 element

Structures

This structure refers to these other structures:

- Patient - At Home In Vitro Test (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Patient-at-home-in-vitro-test)
- US Core Practitioner Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner)
- US Core PractitionerRole Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitionerrole)
- US Core Organization Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-organization)
- US Core CareTeam Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-careteam)
- US Core RelatedPerson Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-relatedperson)
- Specimen - At-Home In-Vitro Test (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Specimen-at-home-in-vitro-test)
- Device - At-Home In-Vitro Test (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Device-at-home-in-vitro-test)
- Observation - At-Home In-Vitro Test Result (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Observation-at-home-in-vitro-test-result)

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-proctored-info

Other representations of profile: CSV, Excel, Schematron