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 - Patient Question Answer

Official URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Observation-patient-question-answer | Version: 1.1.0
Active as of 2024-08-08 | Computable Name: ObservationPatientQuestionAnswer
Other Identifiers: OID:2.16.840.1.113883.4.642.40.32.42.12

This profile constrains the FHIR Observation Resource to represent an answer given to a question asked of the patient by the app when recording or uploading their test results.

The following table shows the Observation.value to use with each of the Observation.code options:

Observation.code | Description | Observation.value
--- | --- | ---
65222-2 | Date and time of symptom onset | Date/time
95419-8 | Whether the patient has symptoms related to condition of interest | hl7VS-yes-no-Indicator
82810-3 | Pregnancy status | US Public Health Pregnancy Status

Usage:

- Refer to this Resource Profile: Extension - At-Home In-Vitro Test Supporting Info
- Examples for this Resource Profile: Observation/observation-patient-answer-congregate-s-trevor, Observation/observation-patient-answer-employed-healthcare-s-trevor, Observation/observation-patient-answer-first-test-s-trevor, Observation/observation-patient-answer-hospitalized-s-trevor... Show 4 more, Observation/observation-patient-answer-pregnancy-s-trevor, Observation/observation-patient-answer-symptom-onset-covid-p-noelle, Observation/observation-patient-answer-symptoms-present-covid-p-noelle and Observation/observation-patient-answer-symptoms-present-covid-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 USCoreObservationScreeningAssessmentProfile

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  | 0..* | USCoreObservationScreeningAssessmentProfile | Survey Observation
code |  | 1..1 | CodeableConcept | Questions asked of the patient by the app when recording or uploading their at-home in-vitro test results. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7 Binding: At Home In Vitro Patient Questions (extensible): Clinical Focus: This set of values contains concepts representing questions asked of the patient by the app when recording or uploading their at-home in-vitro test results.
value[x] |  | 1..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Answer given to a question asked of the patient by the app when recording or uploading their test results. V2: OBX-5
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
Observation.code | extensible | AtHomeInVitroPatientQuestions `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.55` from https://vsac.nlm.nih.gov

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation | C | 0..* | USCoreObservationScreeningAssessmentProfile | Survey Observation 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 us-core-3: SHALL use UCUM for coded quantity units.
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
status | ?!S Σ | 1..1 | code | (USCDI) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
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:survey | S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. 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: survey
category:screening-assessment | S | 0..* | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Screening Assessment Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code | S Σ | 1..1 | CodeableConcept | Questions asked of the patient by the app when recording or uploading their at-home in-vitro test results. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7 Binding: At Home In Vitro Patient Questions (extensible): Clinical Focus: This set of values contains concepts representing questions asked of the patient by the app when recording or uploading their at-home in-vitro test results.
subject | S Σ | 1..1 | Reference(US Core Patient Profile) | (USCDI) Who and/or what the observation is about
effective[x] | S Σ C | 0..1 |  | (USCDI) Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day.
effectiveDateTime |  |  | dateTime |
performer | S Σ | 0..* | Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) | (USCDI) Who is responsible for the observation
value[x] | S Σ C | 1..1 |  | Answer given to a question asked of the patient by the app when recording or uploading their test results. V2: OBX-5
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
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.
hasMember | S Σ | 0..* | Reference(US Core Observation Screening Assessment Profile) | (USCDI) Reference to panel members or multi-select responses or multi-select responses
derivedFrom | S Σ | 0..* | Reference(US Core Observation Screening Assessment Profile | US Core QuestionnaireResponse Profile) | (USCDI) Related Observation(s) or other resource the observation is made from
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Observation.status | required | ObservationStatus `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:survey | preferred | Pattern: survey `http://hl7.org/fhir/ValueSet/observation-category` from the FHIR Standard
Observation.category:screening-assessment | required | USCoreScreeningAssessmentObservationCategory `http://hl7.org/fhir/us/core/ValueSet/us-core-screening-assessment-observation-category`
Observation.code | extensible | AtHomeInVitroPatientQuestions `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.55` from https://vsac.nlm.nih.gov
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..* | USCoreObservationScreeningAssessmentProfile | Survey Observation 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 us-core-3: SHALL use UCUM for coded quantity units.
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 | 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 | (USCDI) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
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:survey | S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. 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: survey
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
category:screening-assessment | S | 0..* | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Screening Assessment Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code | S Σ | 1..1 | CodeableConcept | Questions asked of the patient by the app when recording or uploading their at-home in-vitro test results. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7 Binding: At Home In Vitro Patient Questions (extensible): Clinical Focus: This set of values contains concepts representing questions asked of the patient by the app when recording or uploading their at-home in-vitro test results.
subject | S Σ | 1..1 | Reference(US Core Patient Profile) | (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 | 0..1 |  | (USCDI) Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day.
effectiveDateTime |  |  | dateTime S |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
issued | Σ | 0..1 | instant | Date/Time this version was made available
performer | S Σ | 0..* | Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) | (USCDI) Who is responsible for the observation
value[x] | S Σ C | 1..1 |  | Answer given to a question asked of the patient by the app when recording or uploading their test results. V2: OBX-5
valueQuantity |  |  | Quantity S |
valueCodeableConcept |  |  | CodeableConcept S |
valueString |  |  | string S |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
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 |  | 0..1 | Reference(Specimen) | Specimen used for this observation
device |  | 0..1 | Reference(Device | DeviceMetric) | (Measurement) 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 | S Σ | 0..* | Reference(US Core Observation Screening Assessment Profile S | QuestionnaireResponse | MolecularSequence) | (USCDI) Reference to panel members or multi-select responses or multi-select responses
derivedFrom | S Σ | 0..* | Reference(US Core Observation Screening Assessment Profile S | US Core QuestionnaireResponse Profile S | US Core DocumentReference Profile | ImagingStudy | Media | MolecularSequence) | (USCDI) Related Observation(s) or other resource 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 | ObservationStatus `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:survey | preferred | Pattern: survey `http://hl7.org/fhir/ValueSet/observation-category` from the FHIR Standard
Observation.category:screening-assessment | required | USCoreScreeningAssessmentObservationCategory `http://hl7.org/fhir/us/core/ValueSet/us-core-screening-assessment-observation-category`
Observation.code | extensible | AtHomeInVitroPatientQuestions `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.55` from https://vsac.nlm.nih.gov
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 USCoreObservationScreeningAssessmentProfile

Summary

Mandatory: 1 element

Differential View

This structure is derived from USCoreObservationScreeningAssessmentProfile

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation |  | 0..* | USCoreObservationScreeningAssessmentProfile | Survey Observation
code |  | 1..1 | CodeableConcept | Questions asked of the patient by the app when recording or uploading their at-home in-vitro test results. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7 Binding: At Home In Vitro Patient Questions (extensible): Clinical Focus: This set of values contains concepts representing questions asked of the patient by the app when recording or uploading their at-home in-vitro test results.
value[x] |  | 1..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Answer given to a question asked of the patient by the app when recording or uploading their test results. V2: OBX-5
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
Observation.code | extensible | AtHomeInVitroPatientQuestions `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.55` from https://vsac.nlm.nih.gov

Key Elements View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation | C | 0..* | USCoreObservationScreeningAssessmentProfile | Survey Observation 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 us-core-3: SHALL use UCUM for coded quantity units.
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
status | ?!S Σ | 1..1 | code | (USCDI) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
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:survey | S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. 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: survey
category:screening-assessment | S | 0..* | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Screening Assessment Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code | S Σ | 1..1 | CodeableConcept | Questions asked of the patient by the app when recording or uploading their at-home in-vitro test results. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7 Binding: At Home In Vitro Patient Questions (extensible): Clinical Focus: This set of values contains concepts representing questions asked of the patient by the app when recording or uploading their at-home in-vitro test results.
subject | S Σ | 1..1 | Reference(US Core Patient Profile) | (USCDI) Who and/or what the observation is about
effective[x] | S Σ C | 0..1 |  | (USCDI) Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day.
effectiveDateTime |  |  | dateTime |
performer | S Σ | 0..* | Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) | (USCDI) Who is responsible for the observation
value[x] | S Σ C | 1..1 |  | Answer given to a question asked of the patient by the app when recording or uploading their test results. V2: OBX-5
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
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.
hasMember | S Σ | 0..* | Reference(US Core Observation Screening Assessment Profile) | (USCDI) Reference to panel members or multi-select responses or multi-select responses
derivedFrom | S Σ | 0..* | Reference(US Core Observation Screening Assessment Profile | US Core QuestionnaireResponse Profile) | (USCDI) Related Observation(s) or other resource the observation is made from
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Observation.status | required | ObservationStatus `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:survey | preferred | Pattern: survey `http://hl7.org/fhir/ValueSet/observation-category` from the FHIR Standard
Observation.category:screening-assessment | required | USCoreScreeningAssessmentObservationCategory `http://hl7.org/fhir/us/core/ValueSet/us-core-screening-assessment-observation-category`
Observation.code | extensible | AtHomeInVitroPatientQuestions `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.55` from https://vsac.nlm.nih.gov
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..* | USCoreObservationScreeningAssessmentProfile | Survey Observation 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 us-core-3: SHALL use UCUM for coded quantity units.
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 | 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 | (USCDI) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
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:survey | S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. 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: survey
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
category:screening-assessment | S | 0..* | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Screening Assessment Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code | S Σ | 1..1 | CodeableConcept | Questions asked of the patient by the app when recording or uploading their at-home in-vitro test results. V2: OBX-3.1, OBX-3.2, OBX-3.3, OBX-3.7 Binding: At Home In Vitro Patient Questions (extensible): Clinical Focus: This set of values contains concepts representing questions asked of the patient by the app when recording or uploading their at-home in-vitro test results.
subject | S Σ | 1..1 | Reference(US Core Patient Profile) | (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 | 0..1 |  | (USCDI) Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day.
effectiveDateTime |  |  | dateTime S |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
issued | Σ | 0..1 | instant | Date/Time this version was made available
performer | S Σ | 0..* | Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) | (USCDI) Who is responsible for the observation
value[x] | S Σ C | 1..1 |  | Answer given to a question asked of the patient by the app when recording or uploading their test results. V2: OBX-5
valueQuantity |  |  | Quantity S |
valueCodeableConcept |  |  | CodeableConcept S |
valueString |  |  | string S |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
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 |  | 0..1 | Reference(Specimen) | Specimen used for this observation
device |  | 0..1 | Reference(Device | DeviceMetric) | (Measurement) 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 | S Σ | 0..* | Reference(US Core Observation Screening Assessment Profile S | QuestionnaireResponse | MolecularSequence) | (USCDI) Reference to panel members or multi-select responses or multi-select responses
derivedFrom | S Σ | 0..* | Reference(US Core Observation Screening Assessment Profile S | US Core QuestionnaireResponse Profile S | US Core DocumentReference Profile | ImagingStudy | Media | MolecularSequence) | (USCDI) Related Observation(s) or other resource 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 | ObservationStatus `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:survey | preferred | Pattern: survey `http://hl7.org/fhir/ValueSet/observation-category` from the FHIR Standard
Observation.category:screening-assessment | required | USCoreScreeningAssessmentObservationCategory `http://hl7.org/fhir/us/core/ValueSet/us-core-screening-assessment-observation-category`
Observation.code | extensible | AtHomeInVitroPatientQuestions `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.55` from https://vsac.nlm.nih.gov
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 USCoreObservationScreeningAssessmentProfile

Summary

Mandatory: 1 element

Other representations of profile: CSV, Excel, Schematron