At-Home In-Vitro Test Report
1.0.0 - STU 1
At-Home In-Vitro Test Report
1.0.0 - STU 1
This page is part of the At-Home In-Vitro Test Report (v1.0.0: STU 1) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions 
| Official URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Observation-at-home-in-vitro-test-result-covid | Version: 1.0.0 | |||
| Active as of 2023-03-25 | Computable Name: ObservationAtHomeInVitroTestResultCovid | |||
This profile constrains the Observation - At-Home In-Vitro Test Result profile to COVID-19 At-Home In-Vitro Tests.
This is an example of a profile that is based on a framework profile and futher constrained to meet the requirements of the COVID-19 use case. It is based on the Observation - At-Home In-Vitro Test Result profile.
It constrains the following elements to COVID-19 specific value sets:
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ObservationAtHomeInVitroTestResult
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Observation | 0..* | ObservationAtHomeInVitroTestResult | Measurements and simple assertions | |
  code | 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. | |
 value[x] | S | 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. |
  specimen | 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 |
 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. To find at-home in-vitro test device UDIs, please see GUDID data base: https://accessgudid.nlm.nih.gov/help/search/basic-search |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | C | 0..* | ObservationAtHomeInVitroTestResult | Measurements and simple assertions |
 id | SΣ | 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 | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required) Fixed Value: final |
 Slices for category | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. |
  category:Laboratory | S | 1..1 | CodeableConcept | 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: laboratory | |
| 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: LOINCCodes (extensible): LOINC codes |
| subject | SΣ | 1..1 | Reference(Patient - At Home In Vitro Test) | Who and/or what the observation is about |
| effective[x] | SΣC | 1..1 | dateTime | Clinically relevant time/time-period for observation |
| issued | 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. |
| 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. |
| dataAbsentReason | SC | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible) |
| specimen | 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 |
| 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. To find at-home in-vitro test device UDIs, please see GUDID data base: https://accessgudid.nlm.nih.gov/help/search/basic-search |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| Observation.status | required | Fixed Value: final |
| Observation.category | preferred | ObservationCategoryCodes |
| Observation.category:Laboratory | preferred | Pattern: laboratory |
| Observation.code | extensible | LOINCCodes (a valid code from LOINC) |
| Observation.dataAbsentReason | extensible | DataAbsentReason |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Observation | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty() | |
| obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() | |
| us-core-1 | error | Observation.effective[x] | Datetime must be at least to day. : $this is DateTime implies $this.toString().length() >= 10 | |
| us-core-2 | error | Observation | If there is no component or hasMember element then either a value[x] or a data absent reason must be present : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()) | |
| us-core-3 | error | Observation.value[x] | SHALL use UCUM for coded quantity units. : valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org' | |
| us-core-4 | best practice | Observation.value[x] | SHOULD use Snomed CT for coded Results : valueCodeableConcept.coding.system.empty() or valueCodeableConcept.coding.system = 'http://snomed.info/sct' |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Observation | C | 0..* | ObservationAtHomeInVitroTestResult | Measurements and simple assertions | ||||
| id | SΣ | 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.
| |||||
| 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 | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required) Fixed Value: final | ||||
| Slices for category | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | ||||
| category:Laboratory | S | 1..1 | CodeableConcept | 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: 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 | 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: LOINCCodes (extensible): LOINC codes | ||||
| subject | 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 | ||||
| encounter | 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 | ||||
| issued | 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. | ||||
| 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. | ||||
| dataAbsentReason | SC | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible) | ||||
| 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 - 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 | ||||
 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: ResourceType (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. | ||||
| 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 | ||||
| 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: ResourceType (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 | ||||
| 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 | ||||||||
| Path | Conformance | ValueSet / Code | ||||
| Observation.language | preferred | CommonLanguages
| ||||
| Observation.status | required | Fixed Value: final | ||||
| Observation.category | preferred | ObservationCategoryCodes | ||||
| Observation.category:Laboratory | preferred | Pattern: laboratory | ||||
| Observation.code | extensible | LOINCCodes (a valid code from LOINC) | ||||
| Observation.dataAbsentReason | extensible | DataAbsentReason | ||||
| Observation.interpretation | extensible | ObservationInterpretationCodes | ||||
| Observation.bodySite | example | SNOMEDCTBodyStructures | ||||
| Observation.method | example | ObservationMethods | ||||
| Observation.specimen.type | extensible | ResourceType | ||||
| Observation.device.type | extensible | ResourceType | ||||
| Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodes | ||||
| Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodes | ||||
| Observation.component.code | example | LOINCCodes (a valid code from LOINC) | ||||
| Observation.component.dataAbsentReason | extensible | DataAbsentReason | ||||
| Observation.component.interpretation | extensible | ObservationInterpretationCodes |
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text : low.exists() or high.exists() or text.exists() | |
| us-core-1 | error | Observation.effective[x] | Datetime must be at least to day. : $this is DateTime implies $this.toString().length() >= 10 | |
| us-core-3 | error | Observation.value[x] | SHALL use UCUM for coded quantity units. : valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org' | |
| us-core-4 | best practice | Observation.value[x] | SHOULD use Snomed CT for coded Results : valueCodeableConcept.coding.system.empty() or valueCodeableConcept.coding.system = 'http://snomed.info/sct' |
This structure is derived from ObservationAtHomeInVitroTestResult
Differential View
This structure is derived from ObservationAtHomeInVitroTestResult
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | 0..* | ObservationAtHomeInVitroTestResult | Measurements and simple assertions | |
| code | 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. | |
| value[x] | S | 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. |
| specimen | 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 |
| 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. To find at-home in-vitro test device UDIs, please see GUDID data base: https://accessgudid.nlm.nih.gov/help/search/basic-search |
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Observation | C | 0..* | ObservationAtHomeInVitroTestResult | Measurements and simple assertions |
| id | SΣ | 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 | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required) Fixed Value: final |
| Slices for category | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. |
| category:Laboratory | S | 1..1 | CodeableConcept | 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: laboratory | |
| 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: LOINCCodes (extensible): LOINC codes |
| subject | SΣ | 1..1 | Reference(Patient - At Home In Vitro Test) | Who and/or what the observation is about |
| effective[x] | SΣC | 1..1 | dateTime | Clinically relevant time/time-period for observation |
| issued | 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. |
| 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. |
| dataAbsentReason | SC | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible) |
| specimen | 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 |
| 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. To find at-home in-vitro test device UDIs, please see GUDID data base: https://accessgudid.nlm.nih.gov/help/search/basic-search |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| Observation.status | required | Fixed Value: final |
| Observation.category | preferred | ObservationCategoryCodes |
| Observation.category:Laboratory | preferred | Pattern: laboratory |
| Observation.code | extensible | LOINCCodes (a valid code from LOINC) |
| Observation.dataAbsentReason | extensible | DataAbsentReason |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Observation | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty() | |
| obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() | |
| us-core-1 | error | Observation.effective[x] | Datetime must be at least to day. : $this is DateTime implies $this.toString().length() >= 10 | |
| us-core-2 | error | Observation | If there is no component or hasMember element then either a value[x] or a data absent reason must be present : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()) | |
| us-core-3 | error | Observation.value[x] | SHALL use UCUM for coded quantity units. : valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org' | |
| us-core-4 | best practice | Observation.value[x] | SHOULD use Snomed CT for coded Results : valueCodeableConcept.coding.system.empty() or valueCodeableConcept.coding.system = 'http://snomed.info/sct' |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Observation | C | 0..* | ObservationAtHomeInVitroTestResult | Measurements and simple assertions | ||||
| id | SΣ | 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.
| |||||
| 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 | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required) Fixed Value: final | ||||
| Slices for category | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | ||||
| category:Laboratory | S | 1..1 | CodeableConcept | 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: 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 | 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: LOINCCodes (extensible): LOINC codes | ||||
| subject | 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 | ||||
| encounter | 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 | ||||
| issued | 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. | ||||
| 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. | ||||
| dataAbsentReason | SC | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible) | ||||
| 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 - 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 | ||||
| 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: ResourceType (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. | ||||
| 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 | ||||
| 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: ResourceType (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 | ||||
| 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 | ||||||||
| Path | Conformance | ValueSet / Code | ||||
| Observation.language | preferred | CommonLanguages
| ||||
| Observation.status | required | Fixed Value: final | ||||
| Observation.category | preferred | ObservationCategoryCodes | ||||
| Observation.category:Laboratory | preferred | Pattern: laboratory | ||||
| Observation.code | extensible | LOINCCodes (a valid code from LOINC) | ||||
| Observation.dataAbsentReason | extensible | DataAbsentReason | ||||
| Observation.interpretation | extensible | ObservationInterpretationCodes | ||||
| Observation.bodySite | example | SNOMEDCTBodyStructures | ||||
| Observation.method | example | ObservationMethods | ||||
| Observation.specimen.type | extensible | ResourceType | ||||
| Observation.device.type | extensible | ResourceType | ||||
| Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodes | ||||
| Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodes | ||||
| Observation.component.code | example | LOINCCodes (a valid code from LOINC) | ||||
| Observation.component.dataAbsentReason | extensible | DataAbsentReason | ||||
| Observation.component.interpretation | extensible | ObservationInterpretationCodes |
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text : low.exists() or high.exists() or text.exists() | |
| us-core-1 | error | Observation.effective[x] | Datetime must be at least to day. : $this is DateTime implies $this.toString().length() >= 10 | |
| us-core-3 | error | Observation.value[x] | SHALL use UCUM for coded quantity units. : valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org' | |
| us-core-4 | best practice | Observation.value[x] | SHOULD use Snomed CT for coded Results : valueCodeableConcept.coding.system.empty() or valueCodeableConcept.coding.system = 'http://snomed.info/sct' |
This structure is derived from ObservationAtHomeInVitroTestResult
Other representations of profile: CSV, Excel, Schematron
IG © 2020+ Orders and Observations. Package hl7.fhir.us.home-lab-report#1.0.0 based on FHIR 4.0.1. Generated 2023-03-25
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