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' vs '1.1.0' |
Information | StructureDefinition.date | Values for date differ: '2023-03-25T16:46:40+00:00' vs '2024-08-08T19:54:09+00:00' |
Information | StructureDefinition.publisher | Values for publisher differ: 'Orders and Observations' vs 'HL7 International / Orders and Observations' |
Information | StructureDefinition.short | Values for short differ: 'registered | preliminary | final | amended +' vs 'At-Home Test result status final. V2: OBR-25, OBX-11' |
Information | StructureDefinition.short | Values for short differ: 'Classification of type of observation' vs '(USCDI) Classification of type of observation' |
Information | StructureDefinition.short | Values for short differ: 'Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case.' vs 'Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for the COVID-19 use case.' |
Information | StructureDefinition.definition | Values for definition differ: 'The test that was performed. A LOINC **SHALL** be used if the concept is present in LOINC.' vs 'The name of the clinical test or procedure performed on a patient. A LOINC **SHALL** be used if the concept is present in LOINC.' |
Information | StructureDefinition.short | Values for short differ: 'Who and/or what the observation is about' vs '(USCDI) Who and/or what the observation is about' |
Information | StructureDefinition.short | Values for short differ: 'Clinically relevant time/time-period for observation' vs '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' |
Information | StructureDefinition.definition | Values for definition differ: 'For lab tests this is the specimen collection date. For Ask at Order Entry Questions (AOE)'s this is the date the question was asked.' vs 'The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the 'physiologically relevant time'. This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.' |
Information | StructureDefinition.short | Values for short differ: 'Test result date released' vs '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' |
Information | StructureDefinition.definition | Values for definition differ: '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.' vs 'The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.' |
Information | StructureDefinition.short | Values for short differ: 'Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case.' vs 'Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for the COVID-19 use case.' |
Information | StructureDefinition.short | Values for short differ: 'Why the result is missing' vs '(USCDI) Why the result is missing' |
Information | StructureDefinition.short | Values for short differ: 'The Specimen SHALL be from at-home Covid sample.' vs 'The Specimen SHALL be from at-home COVID-19 sample.' |
Information | StructureDefinition.definition | Values for definition differ: 'The referenced specifimen should contain a Specimen.identifier and a Specimen.identifier.assigner' vs 'The referenced specimen should contain a Specimen.identifier and a Specimen.identifier.assigner' |
Information | StructureDefinition.comment | Values for comment differ: 'The referenced specifimen should contain a Specimen.identifier and a Specimen.identifier.assigner' vs 'Should only be used if not implicit in code found in `Observation.code`. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).' |
Information | StructureDefinition.label | Values for label differ: 'At home Covid test device' vs 'At home test device' |
Information | StructureDefinition.short | Values for short differ: 'The referenced device SHALL be an home Covid test device.' vs 'The referenced device is an at-home COVID-19 test device.' |
Information | StructureDefinition.definition | Values for definition differ: 'The referenced device is an at home covid test device, The referenced device **SHALL** contain a Device.udiCarrier.deviceIdentifier. Please see GUDID data base: https://accessgudid.nlm.nih.gov/help/search/basic-search to find the device's UDI' vs 'The referenced device is an at-home COVID-19 test device, and should contain a Device.udiCarrier.deviceIdentifier. Please see GUDID data base: https://accessgudid.nlm.nih.gov/help/search/basic-search to find the device's UDI.' |
Name | Value | Comments | |
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abstract | false | ||
baseDefinition | http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Observation-at-home-in-vitro-test-result | ||
copyright | |||
date | 2023-03-25T16:46:40+00:00 | 2024-08-08T19:54:09+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 | HL7 International / 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 | 1.1.0 |
|
Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments | ||||||||
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Observation | C | 0..* | ObservationAtHomeInVitroTestResult | 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 | C | 0..* | ObservationAtHomeInVitroTestResult | 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 | SΣ | 1..1 | id | 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..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 | 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 | At-Home Test result status final. V2: OBR-25, OBX-11 Binding: ?? (required): Codes providing the status of an observation. Fixed Value: final | |||||||||
Slices for category | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ?? (preferred): Codes for high level observation categories. | S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ?? (preferred): Codes for high level observation categories. | |||||||||
code | 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 | SΣ | 1..1 | CodeableConcept | Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for the COVID-19 use case. Binding: ?? (extensible): Laboratory LOINC Codes | |||||||||
subject | SΣ | 1..1 | Reference(Patient - At Home In Vitro Test) | Who and/or what the observation is about | SΣ | 1..1 | Reference(Patient - At Home In Vitro Test) | (USCDI) 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 | 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 | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made | |||||||||
effective[x] | SΣC | 1..1 | dateTime | Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day. | SΣC | 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 | SΣ | 0..1 | instant | Test result date released | SΣ | 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 | 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(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] | 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. us-core-4: SHOULD use Snomed CT for coded Results us-core-3: SHALL use UCUM for coded quantity units. | SΣC | 1..1 | CodeableConcept S | Consult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for the COVID-19 use case. us-core-3: SHALL use UCUM for coded quantity units. us-core-4: SHOULD use Snomed CT for coded Results | |||||||||
dataAbsentReason | SC | 0..1 | CodeableConcept | Why the result is missing Binding: ?? (extensible) | SC | 0..1 | CodeableConcept | (USCDI) Why the 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. | |||||||||||
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-19 sample. | |||||||||
id | 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 |
| |||||||||||||
reference | 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). |
| ||||||||||||
identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known |
| ||||||||||||
display | 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 is an at-home COVID-19 test device. | |||||||||
id | 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 |
| |||||||||||||
reference | 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). |
| ||||||||||||
identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known |
| ||||||||||||
display | Σ | 0..1 | string | Text alternative for the resource |
| ||||||||||||
referenceRange | C | 0..* | BackboneElement | Provides guide for interpretation obs-3: Must have at least a low or a high or text | 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 | 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 - 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. | 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 | Σ | 0..* | BackboneElement | Component results | 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 | Σ | 1..1 | CodeableConcept | Type of component observation (code / type) 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] | Σ | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual component result | 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 |