At-Home In-Vitro Test Report
1.0.0 - STU 1 United States of America flag

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

Resource Profile: DiagnosticReport - At-Home In-Vitro Results

Official URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/DiagnosticReport-at-home-in-vitro-results Version: 1.0.0
Active as of 2023-03-25 Computable Name: DiagnosticReportAtHomeInVitroResult

This profile constrains the US Core Diagnostic Report for Laboratory Results profile to At-Home In-Vitro Tests.

This is a framework profile and can be the base of another profile that is further constrained to meet the requirements of a specific use case. See DiagnosticReport - At-Home In-Vitro Test Results - COVID-19 for an example of such a profile.

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

  • DiagnosticReport.code - value set containing the use case specific test types (consult LIVD to obtain the values to be used for each particular use case)
  • DiagnosticReport.result - Reference to an Observation - At-Home In-Vitro Test Result constrained to the specific use case

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from USCoreDiagnosticReportProfileLaboratoryReporting

NameFlagsCard.TypeDescription & Constraintsdoco
.. DiagnosticReport 0..*USCoreDiagnosticReportProfileLaboratoryReportingA Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
... id S0..1idLogical id of this artifact
... Extension-at-home-in-vitro-test-supporting-info S0..*(Complex)Extension - At-Home In-Vitro Test Supporting Information
URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-supporting-info
... identifier S0..*IdentifierBusiness identifier for report
... code S1..1CodeableConceptConsult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case.
... subject 1..1Reference(Patient - At Home In Vitro Test)The subject of the report - usually, but not always, the patient
... effective[x] S0..1dateTimeDiagnostically relevant time (typically the time of specimen collection)
... result S1..1Reference(Observation - At-Home In-Vitro Test Result)Observations
... media 0..*BackboneElementImages related to the test, such as a photo of the test result, images to support proctor interpretation of test results, etc.

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. DiagnosticReport C0..*USCoreDiagnosticReportProfileLaboratoryReportingA Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
... id SΣ0..1idLogical id of this artifact
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... Extension-at-home-in-vitro-test-supporting-info S0..*(Complex)Extension - At-Home In-Vitro Test Supporting Information
URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-supporting-info
... identifier SΣ0..*IdentifierBusiness identifier for report
... status ?!SΣC1..1coderegistered | partial | preliminary | final +
Binding: DiagnosticReportStatus (required)
Fixed Value: final
... Slices for category SΣ1..*CodeableConceptService category
Slice: Unordered, Open by pattern:$this
Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections.


.... category:LaboratorySlice SΣ1..1CodeableConceptService category
Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections.



Required Pattern: At least the following
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0074
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: LAB
... code SΣ1..1CodeableConceptConsult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case.
Binding: US Core Diagnostic Report Laboratory Codes (extensible): LOINC codes

... subject SΣ1..1Reference(Patient - At Home In Vitro Test)The subject of the report - usually, but not always, the patient
... effective[x] SΣC0..1dateTimeDiagnostically relevant time (typically the time of specimen collection)
... issued SΣC0..1instantWhen the report was released
... performer SΣ0..*Reference(US Core Practitioner Profile)Responsible Diagnostic Service
... result S1..1Reference(Observation - At-Home In-Vitro Test Result)Observations
... media Σ0..*BackboneElementImages related to the test, such as a photo of the test result, images to support proctor interpretation of test results, etc.
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... link Σ1..1Reference(Media)Reference to the image source

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
DiagnosticReport.statusrequiredFixed Value: final
DiagnosticReport.categoryexampleDiagnosticServiceSectionCodes
DiagnosticReport.category:LaboratorySliceexamplePattern: LAB
DiagnosticReport.codeextensibleUSCoreDiagnosticReportLabCodes

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDiagnosticReportIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDiagnosticReportIf 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-4errorDiagnosticReportIf 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-5errorDiagnosticReportIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDiagnosticReportA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
us-core-8errorDiagnosticReporteffective[x] SHALL be present if the status is 'partial', 'preliminary', 'final', 'amended', 'corrected' or 'appended'
: (status='partial' or status='preliminary' or status='final' or status='amended' or status='corrected' or status='appended' ) implies effective.exists()
us-core-9errorDiagnosticReportissued SHALL be present if the status is 'partial', 'preliminary', 'final', 'amended', 'corrected' or 'appended'
: (status='partial' or status='preliminary' or status='final' or status='amended' or status='corrected' or status='appended' ) implies issued.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. DiagnosticReport C0..*USCoreDiagnosticReportProfileLaboratoryReportingA Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
... id SΣ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Extension-at-home-in-vitro-test-supporting-info S0..*(Complex)Extension - At-Home In-Vitro Test Supporting Information
URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-supporting-info
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier SΣ0..*IdentifierBusiness identifier for report
... basedOn 0..*Reference(CarePlan | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)What was requested
... status ?!SΣC1..1coderegistered | partial | preliminary | final +
Binding: DiagnosticReportStatus (required)
Fixed Value: final
... Slices for category SΣ1..*CodeableConceptService category
Slice: Unordered, Open by pattern:$this
Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections.


.... category:LaboratorySlice SΣ1..1CodeableConceptService category
Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections.



Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0074
...... version0..1stringVersion of the system - if relevant
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: LAB
...... display0..1stringRepresentation defined by the system
...... userSelected0..1booleanIf this coding was chosen directly by the user
..... text0..1stringPlain text representation of the concept
... code SΣ1..1CodeableConceptConsult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case.
Binding: US Core Diagnostic Report Laboratory Codes (extensible): LOINC codes

... subject SΣ1..1Reference(Patient - At Home In Vitro Test)The subject of the report - usually, but not always, the patient
... encounter Σ0..1Reference(Encounter)Health care event when test ordered
... effective[x] SΣC0..1dateTimeDiagnostically relevant time (typically the time of specimen collection)
... issued SΣC0..1instantWhen the report was released
... performer SΣ0..*Reference(US Core Practitioner Profile S | US Core Organization Profile | US Core CareTeam Profile | US Core PractitionerRole Profile)Responsible Diagnostic Service
... resultsInterpreter Σ0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam)Primary result interpreter
... specimen 0..*Reference(Specimen)Specimens this report is based on
... result S1..1Reference(Observation - At-Home In-Vitro Test Result)Observations
... imagingStudy 0..*Reference(ImagingStudy)Reference to full details of imaging associated with the diagnostic report
... media Σ0..*BackboneElementImages related to the test, such as a photo of the test result, images to support proctor interpretation of test results, etc.
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... comment 0..1stringComment about the image (e.g. explanation)
.... link Σ1..1Reference(Media)Reference to the image source
... conclusion 0..1stringClinical conclusion (interpretation) of test results
... conclusionCode 0..*CodeableConceptCodes for the clinical conclusion of test results
Binding: SNOMEDCTClinicalFindings (example): Diagnosis codes provided as adjuncts to the report.


... presentedForm 0..*AttachmentEntire report as issued

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
DiagnosticReport.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
DiagnosticReport.statusrequiredFixed Value: final
DiagnosticReport.categoryexampleDiagnosticServiceSectionCodes
DiagnosticReport.category:LaboratorySliceexamplePattern: LAB
DiagnosticReport.codeextensibleUSCoreDiagnosticReportLabCodes
DiagnosticReport.conclusionCodeexampleSNOMEDCTClinicalFindings

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Differential View

This structure is derived from USCoreDiagnosticReportProfileLaboratoryReporting

NameFlagsCard.TypeDescription & Constraintsdoco
.. DiagnosticReport 0..*USCoreDiagnosticReportProfileLaboratoryReportingA Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
... id S0..1idLogical id of this artifact
... Extension-at-home-in-vitro-test-supporting-info S0..*(Complex)Extension - At-Home In-Vitro Test Supporting Information
URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-supporting-info
... identifier S0..*IdentifierBusiness identifier for report
... code S1..1CodeableConceptConsult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case.
... subject 1..1Reference(Patient - At Home In Vitro Test)The subject of the report - usually, but not always, the patient
... effective[x] S0..1dateTimeDiagnostically relevant time (typically the time of specimen collection)
... result S1..1Reference(Observation - At-Home In-Vitro Test Result)Observations
... media 0..*BackboneElementImages related to the test, such as a photo of the test result, images to support proctor interpretation of test results, etc.

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. DiagnosticReport C0..*USCoreDiagnosticReportProfileLaboratoryReportingA Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
... id SΣ0..1idLogical id of this artifact
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... Extension-at-home-in-vitro-test-supporting-info S0..*(Complex)Extension - At-Home In-Vitro Test Supporting Information
URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-supporting-info
... identifier SΣ0..*IdentifierBusiness identifier for report
... status ?!SΣC1..1coderegistered | partial | preliminary | final +
Binding: DiagnosticReportStatus (required)
Fixed Value: final
... Slices for category SΣ1..*CodeableConceptService category
Slice: Unordered, Open by pattern:$this
Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections.


.... category:LaboratorySlice SΣ1..1CodeableConceptService category
Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections.



Required Pattern: At least the following
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0074
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: LAB
... code SΣ1..1CodeableConceptConsult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case.
Binding: US Core Diagnostic Report Laboratory Codes (extensible): LOINC codes

... subject SΣ1..1Reference(Patient - At Home In Vitro Test)The subject of the report - usually, but not always, the patient
... effective[x] SΣC0..1dateTimeDiagnostically relevant time (typically the time of specimen collection)
... issued SΣC0..1instantWhen the report was released
... performer SΣ0..*Reference(US Core Practitioner Profile)Responsible Diagnostic Service
... result S1..1Reference(Observation - At-Home In-Vitro Test Result)Observations
... media Σ0..*BackboneElementImages related to the test, such as a photo of the test result, images to support proctor interpretation of test results, etc.
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... link Σ1..1Reference(Media)Reference to the image source

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
DiagnosticReport.statusrequiredFixed Value: final
DiagnosticReport.categoryexampleDiagnosticServiceSectionCodes
DiagnosticReport.category:LaboratorySliceexamplePattern: LAB
DiagnosticReport.codeextensibleUSCoreDiagnosticReportLabCodes

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDiagnosticReportIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDiagnosticReportIf 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-4errorDiagnosticReportIf 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-5errorDiagnosticReportIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDiagnosticReportA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
us-core-8errorDiagnosticReporteffective[x] SHALL be present if the status is 'partial', 'preliminary', 'final', 'amended', 'corrected' or 'appended'
: (status='partial' or status='preliminary' or status='final' or status='amended' or status='corrected' or status='appended' ) implies effective.exists()
us-core-9errorDiagnosticReportissued SHALL be present if the status is 'partial', 'preliminary', 'final', 'amended', 'corrected' or 'appended'
: (status='partial' or status='preliminary' or status='final' or status='amended' or status='corrected' or status='appended' ) implies issued.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. DiagnosticReport C0..*USCoreDiagnosticReportProfileLaboratoryReportingA Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
... id SΣ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Extension-at-home-in-vitro-test-supporting-info S0..*(Complex)Extension - At-Home In-Vitro Test Supporting Information
URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Extension-at-home-in-vitro-test-supporting-info
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier SΣ0..*IdentifierBusiness identifier for report
... basedOn 0..*Reference(CarePlan | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)What was requested
... status ?!SΣC1..1coderegistered | partial | preliminary | final +
Binding: DiagnosticReportStatus (required)
Fixed Value: final
... Slices for category SΣ1..*CodeableConceptService category
Slice: Unordered, Open by pattern:$this
Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections.


.... category:LaboratorySlice SΣ1..1CodeableConceptService category
Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections.



Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0074
...... version0..1stringVersion of the system - if relevant
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: LAB
...... display0..1stringRepresentation defined by the system
...... userSelected0..1booleanIf this coding was chosen directly by the user
..... text0..1stringPlain text representation of the concept
... code SΣ1..1CodeableConceptConsult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case.
Binding: US Core Diagnostic Report Laboratory Codes (extensible): LOINC codes

... subject SΣ1..1Reference(Patient - At Home In Vitro Test)The subject of the report - usually, but not always, the patient
... encounter Σ0..1Reference(Encounter)Health care event when test ordered
... effective[x] SΣC0..1dateTimeDiagnostically relevant time (typically the time of specimen collection)
... issued SΣC0..1instantWhen the report was released
... performer SΣ0..*Reference(US Core Practitioner Profile S | US Core Organization Profile | US Core CareTeam Profile | US Core PractitionerRole Profile)Responsible Diagnostic Service
... resultsInterpreter Σ0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam)Primary result interpreter
... specimen 0..*Reference(Specimen)Specimens this report is based on
... result S1..1Reference(Observation - At-Home In-Vitro Test Result)Observations
... imagingStudy 0..*Reference(ImagingStudy)Reference to full details of imaging associated with the diagnostic report
... media Σ0..*BackboneElementImages related to the test, such as a photo of the test result, images to support proctor interpretation of test results, etc.
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... comment 0..1stringComment about the image (e.g. explanation)
.... link Σ1..1Reference(Media)Reference to the image source
... conclusion 0..1stringClinical conclusion (interpretation) of test results
... conclusionCode 0..*CodeableConceptCodes for the clinical conclusion of test results
Binding: SNOMEDCTClinicalFindings (example): Diagnosis codes provided as adjuncts to the report.


... presentedForm 0..*AttachmentEntire report as issued

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
DiagnosticReport.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
DiagnosticReport.statusrequiredFixed Value: final
DiagnosticReport.categoryexampleDiagnosticServiceSectionCodes
DiagnosticReport.category:LaboratorySliceexamplePattern: LAB
DiagnosticReport.codeextensibleUSCoreDiagnosticReportLabCodes
DiagnosticReport.conclusionCodeexampleSNOMEDCTClinicalFindings

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

 

Other representations of profile: CSV, Excel, Schematron