Left: | Observation - At-Home In-Vitro Test Result - COVID-19 (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Observation-at-home-in-vitro-test-result-covid) |
Right: | Observation - At-Home In-Vitro Test Result - COVID-19 (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Observation-at-home-in-vitro-test-result-covid) |
Error | StructureDefinition.version | Values for version differ: '1.0.0-ballot' vs '1.0.0' |
Information | StructureDefinition.date | Values for date differ: '2022-08-05T13:22:46+00:00' vs '2023-03-25T16:46:40+00:00' |
Warning | Observation.extension | Elements differ in short: 'Additional content defined by implementations' vs 'Extension - At-Home In-Vitro Test Proctored Information' |
Warning | Observation.extension | Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'Information about whether or not the test was proctored and who the proctor was.' |
Information | Observation.extension | Element maximum cardinalities differ: '2147483647' vs '1' |
Warning | Observation.code | Elements differ in short: 'Covid At Home Tests' vs 'Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case.' |
Warning | Observation.code | Elements differ in description: 'This set of values contains COVID-19 LOINC concepts that are appropriate for at-home in-vitro tests' vs 'LOINC codes' |
Warning | Observation.code | Elements differ in description: 'This set of values contains COVID-19 LOINC concepts that are appropriate for at-home in-vitro tests' vs 'LOINC codes' |
Warning | Observation.effective[x] | Elements differ in short: 'The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset' vs 'Clinically relevant time/time-period for observation' |
Warning | Observation.issued | Elements differ in definition: 'The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.' vs 'Test result date released: This should be populated with the test result date released, which, in the at-home setting, will mostly be the same as the Observation.effective[x], however, it could be different when a proctor is involved and releases the result. It is mapped to HL7 V2 OBR 22 because it is the required field in the message.' |
Warning | Observation.value[x] | Elements differ in label: 'At Home Covid Test Result Values' vs 'At-Home Test Result Value' |
Warning | Observation.value[x] | Elements differ in short: 'At Home Covid Test Result Values' vs 'Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case.' |
Warning | Observation.device.id | Elements differ in short: 'The referenced device SHALL contain a Device.udiCarrier.deviceIdentifier. The initial project will use the Quidel QuickVue UDI see: (https://accessgudid.nlm.nih.gov/devices/30014613339373) To find other at home device UDIs, please see GUDID data base: https://accessgudid.nlm.nih.gov/help/search/basic-search' vs 'The referenced device SHALL contain a Device.udiCarrier.deviceIdentifier. To find at-home in-vitro test device UDIs, please see GUDID data base: https://accessgudid.nlm.nih.gov/help/search/basic-search' |
Warning | Observation.hasMember | Elements differ in short: 'Related resource that belongs to the Observation group' vs '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.' |
Warning | Observation.component | Elements differ in short: '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.component elements.' vs 'Component results' |
Warning | Observation.component | Elements differ in definition for mustSupport: 'true' vs 'false' |
Warning | Observation.component.code | Elements differ in short: 'At Home Tests' vs 'Type of component observation (code / type)' |
Warning | Observation.component.code | Elements differ in definition for mustSupport: 'true' vs 'false' |
Warning | Observation.component.value[x] | Elements differ in short: 'At-Home Test Result Value' vs 'Actual component result' |
Warning | Observation.component.value[x] | Elements differ in definition for mustSupport: 'true' vs 'false' |
Information | Observation.component.value[x] | Element minimum cardinalities differ: '1' vs '0' |
Name | Value | Comments | |
---|---|---|---|
abstract | false | ||
baseDefinition | http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Observation-at-home-in-vitro-test-result | ||
copyright | |||
date | 2022-08-05T13:22:46+00:00 | 2023-03-25T16:46:40+00:00 |
|
description | This profile constrains the Observation - At-Home In-Vitro Test Result profile to COVID-19 At-Home In-Vitro Tests. | ||
experimental | |||
fhirVersion | 4.0.1 | ||
jurisdiction | |||
jurisdiction[0] | urn:iso:std:iso:3166#US | ||
kind | resource | ||
name | ObservationAtHomeInVitroTestResultCovid | ||
publisher | Orders and Observations | ||
purpose | |||
status | active | ||
title | Observation - At-Home In-Vitro Test Result - COVID-19 | ||
type | Observation | ||
url | http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Observation-at-home-in-vitro-test-result-covid | ||
version | 1.0.0-ballot | 1.0.0 |
|
Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | L Type | L Description & Constraints | Comments | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Observation | C | 0..* | ObservationAtHomeInVitroTestResult | Measurements and simple assertions | C | 0..* | ObservationAtHomeInVitroTestResult | Measurements and simple assertions | |||||||||
id | SΣ | 1..1 | string | Logical id of this artifact | SΣ | 1..1 | id | Logical id of this artifact | |||||||||
meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created | |||||||||
language | 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| |||||||||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||||||
contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
Extension-at-home-in-vitro-test-proctored-info | 0..* | Extension | Additional content defined by implementations | 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 | ?! | 0..* | Extension | Extensions that cannot be ignored | |||||||||
identifier | Σ | 0..* | Identifier | Business Identifier for observation | Σ | 0..* | Identifier | Business Identifier for observation | |||||||||
basedOn | Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order | 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 | Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event | |||||||||
status | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ?? (required) Fixed Value: final | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ?? (required) Fixed Value: final | |||||||||
Slices for category | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ?? (preferred): Codes for high level observation categories. | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ?? (preferred): Codes for high level observation categories. | |||||||||
code | SΣ | 1..1 | CodeableConcept | Covid At Home Tests Binding: ?? (extensible): This set of values contains COVID-19 LOINC concepts that are appropriate for at-home in-vitro tests | SΣ | 1..1 | CodeableConcept | Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. Binding: ?? (extensible): LOINC codes |
| ||||||||
subject | SΣ | 1..1 | Reference(US Core Patient Profile) | Who and/or what the observation is about | SΣ | 1..1 | Reference(Patient - At Home In Vitro Test) | Who and/or what the observation is about | |||||||||
focus | ΣTU | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | ΣTU | 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 | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made | |||||||||
effective[x] | SΣC | 1..1 | dateTime | The effectiveTime SHALL be precise to at least the minute and SHALL include a time zone offset | SΣC | 1..1 | dateTime | Clinically relevant time/time-period for observation |
| ||||||||
issued | SΣ | 0..1 | instant | Test result date released | SΣ | 0..1 | instant | Test result date released |
| ||||||||
performer | SΣ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | If the performer is not the patient being tested, specify the person performing the test. | SΣ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | If the performer is not the patient being tested, specify the person performing the test. | |||||||||
value[x] | SΣC | 1..1 | CodeableConcept | At Home Covid Test Result Values Binding: ?? (required): This set of values contains SNOMED CT concepts suitable for at-home in-vitro COVID-19 test results | SΣC | 1..1 | CodeableConcept | Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case. |
| ||||||||
dataAbsentReason | SC | 0..1 | CodeableConcept | Why the result is missing Binding: ?? (extensible) | SC | 0..1 | CodeableConcept | Why the result is missing Binding: ?? (extensible) | |||||||||
interpretation | 0..* | CodeableConcept | High, low, normal, etc. Binding: ?? (extensible): Codes identifying interpretations of observations. | 0..* | CodeableConcept | High, low, normal, etc. Binding: ?? (extensible): Codes identifying interpretations of observations. | |||||||||||
note | 0..* | Annotation | Comments about the observation | 0..* | Annotation | Comments about the observation | |||||||||||
bodySite | 0..1 | CodeableConcept | Observed body part Binding: ?? (example): Codes describing anatomical locations. May include laterality. | 0..1 | CodeableConcept | Observed body part Binding: ?? (example): Codes describing anatomical locations. May include laterality. | |||||||||||
method | 0..1 | CodeableConcept | How it was done Binding: ?? (example): Methods for simple observations. | 0..1 | CodeableConcept | How it was done Binding: ?? (example): Methods for simple observations. | |||||||||||
specimen | S | 1..1 | Reference(Specimen - At-Home In-Vitro Test - COVID-19) | The Specimen SHALL be from at-home Covid sample. | S | 1..1 | Reference(Specimen - At-Home In-Vitro Test - COVID-19) | The Specimen SHALL be from at-home Covid sample. | |||||||||
id | S | 1..1 | string | The referenced specimen SHALL contain a Specimen.identifier and a Specimen.identifier.assigner | S | 1..1 | string | The referenced specimen SHALL contain a Specimen.identifier and a Specimen.identifier.assigner | |||||||||
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
reference | ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | |||||||||
type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ?? (extensible): Aa resource (or, for logical models, the URI of the logical model). | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ?? (extensible): Aa resource (or, for logical models, the URI of the logical model). | |||||||||
identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | |||||||||
display | Σ | 0..1 | string | Text alternative for the resource | Σ | 0..1 | string | Text alternative for the resource | |||||||||
device | S | 1..1 | Reference(Device - At-Home In-Vitro Test) | The referenced device SHALL be an home Covid test device. | S | 1..1 | Reference(Device - At-Home In-Vitro Test) | The referenced device SHALL be an home Covid test device. | |||||||||
id | S | 1..1 | string | The referenced device SHALL contain a Device.udiCarrier.deviceIdentifier. The initial project will use the Quidel QuickVue UDI see: (https://accessgudid.nlm.nih.gov/devices/30014613339373) To find other at home device UDIs, please see GUDID data base: https://accessgudid.nlm.nih.gov/help/search/basic-search | S | 1..1 | string | The referenced device SHALL contain a Device.udiCarrier.deviceIdentifier. To find at-home in-vitro test device UDIs, please see GUDID data base: https://accessgudid.nlm.nih.gov/help/search/basic-search |
| ||||||||
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
reference | ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | |||||||||
type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ?? (extensible): Aa resource (or, for logical models, the URI of the logical model). | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ?? (extensible): Aa resource (or, for logical models, the URI of the logical model). | |||||||||
identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | |||||||||
display | Σ | 0..1 | string | Text alternative for the resource | Σ | 0..1 | string | Text alternative for the resource | |||||||||
referenceRange | C | 0..* | BackboneElement | Provides guide for interpretation | C | 0..* | BackboneElement | Provides guide for interpretation | |||||||||
id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
low | C | 0..1 | ?? | Low Range, if relevant | C | 0..1 | ?? | Low Range, if relevant | |||||||||
high | C | 0..1 | ?? | High Range, if relevant | C | 0..1 | ?? | High Range, if relevant | |||||||||
type | 0..1 | CodeableConcept | Reference range qualifier Binding: ?? (preferred): Code for the meaning of a reference range. | 0..1 | CodeableConcept | Reference range qualifier Binding: ?? (preferred): Code for the meaning of a reference range. | |||||||||||
appliesTo | 0..* | CodeableConcept | Reference range population Binding: ?? (example): Codes identifying the population the reference range applies to. | 0..* | CodeableConcept | Reference range population Binding: ?? (example): Codes identifying the population the reference range applies to. | |||||||||||
age | 0..1 | Range | Applicable age range, if relevant | 0..1 | Range | Applicable age range, if relevant | |||||||||||
text | 0..1 | string | Text based reference range in an observation | 0..1 | string | Text based reference range in an observation | |||||||||||
hasMember | Σ | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Related resource that belongs to the Observation group | 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 | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | |||||||||
component | SΣ | 0..* | BackboneElement | 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.component elements. | Σ | 0..* | BackboneElement | Component results |
| ||||||||
id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
code | SΣ | 1..1 | CodeableConcept | At Home Tests Binding: ?? (example): Codes identifying names of simple observations. | Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: ?? (example): Codes identifying names of simple observations. |
| ||||||||
value[x] | SΣ | 1..1 | CodeableConcept | At-Home Test Result Value | Σ | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual component result |
| ||||||||
dataAbsentReason | C | 0..1 | CodeableConcept | Why the component result is missing Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. | C | 0..1 | CodeableConcept | Why the component result is missing Binding: ?? (extensible): Codes specifying why the result (Observation.value[x]) is missing. | |||||||||
interpretation | 0..* | CodeableConcept | High, low, normal, etc. Binding: ?? (extensible): Codes identifying interpretations of observations. | 0..* | CodeableConcept | High, low, normal, etc. Binding: ?? (extensible): Codes identifying interpretations of observations. | |||||||||||
referenceRange | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | |||||||||||
Documentation for this format |