At-Home In-Vitro Test Report
1.1.0 - STU 1.1 United States of America flag

This page is part of the At-Home In-Vitro Test Report (v1.1.0: STU 1) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: DiagnosticReportAtHomeInVitroResultsCovid - Detailed Descriptions

Active as of 2024-08-08

Definitions for the DiagnosticReport-at-home-in-vitro-results-covid resource profile.

Guidance on how to interpret the contents of this table can be found here

0. DiagnosticReport
2. DiagnosticReport.result
TypeReference(Observation - At-Home In-Vitro Test Result - COVID-19)

Guidance on how to interpret the contents of this table can be found here

0. DiagnosticReport
Definition

-


The findings and interpretation of diagnostic tests performed on patients, groups of patients, devices, and locations, and/or specimens derived from these. The report includes clinical context such as requesting and provider information, and some mix of atomic results, images, textual and coded interpretations, and formatted representation of diagnostic reports.

ShortA Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
Comments

-


This is intended to capture a single report and is not suitable for use in displaying summary information that covers multiple reports. For example, this resource has not been designed for laboratory cumulative reporting formats nor detailed structured reports for sequencing.

Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate NamesReport, Test, Result, Results, Labs, Laboratory, Lab Result, Lab Report
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
us-core-8: effective[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-9: issued 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())
2. DiagnosticReport.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ShortLogical id of this artifact
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Control0..1
Typeidstring
Is Modifierfalse
Must Supporttrue
Summarytrue
4. DiagnosticReport.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. DiagnosticReport.extension
Definition

Additional information supporting the diagnostic report.

ShortExtension - At-Home In-Vitro Test Supporting Information
Control0..*
This element is affected by the following invariants: ele-1
TypeExtension(Extension - At-Home In-Vitro Test Supporting Info) (Complex Extension)
Is Modifierfalse
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. DiagnosticReport.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
10. DiagnosticReport.identifier
Definition

Identifiers assigned to this report by the performer or other systems.

ShortBusiness identifier for report
Comments

Usually assigned by the Information System of the diagnostic service provider (filler id).

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Need to know what identifier to use when making queries about this report from the source laboratory, and for linking to the report outside FHIR context.

Alternate NamesReportID, Filler ID, Placer ID
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. DiagnosticReport.status
Definition

The status of the diagnostic report.

Short(USCDI) registered | partial | preliminary | final +registered | partial | preliminary | final +
Control1..1
This element is affected by the following invariants: us-core-8, us-core-9
BindingThe codes SHALL be taken from DiagnosticReportStatushttp://hl7.org/fhir/ValueSet/diagnostic-report-status|4.0.1
(required to http://hl7.org/fhir/ValueSet/diagnostic-report-status)
Typecode
Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

Diagnostic services routinely issue provisional/incomplete reports, and sometimes withdraw previously released reports.

Fixed Valuefinal
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. DiagnosticReport.category
Definition

A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.

Short(USCDI) Service categoryService category
Comments

Multiple categories are allowed using various categorization schemes. The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in DiagnosticReport.code.

Control10..*
BindingFor example codes, see DiagnosticServiceSectionCodeshttp://hl7.org/fhir/ValueSet/diagnostic-service-sections
(example to http://hl7.org/fhir/ValueSet/diagnostic-service-sections)

Codes for diagnostic service sections.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Alternate NamesDepartment, Sub-department, Service, Discipline
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on DiagnosticReport.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
  • 16. DiagnosticReport.category:LaboratorySlice
    Slice NameLaboratorySlice
    Definition

    A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.

    Short(USCDI) Service categoryService category
    Comments

    Multiple categories are allowed using various categorization schemes. The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in DiagnosticReport.code.

    Control10..1*
    BindingFor example codes, see DiagnosticServiceSectionCodeshttp://hl7.org/fhir/ValueSet/diagnostic-service-sections
    (example to http://hl7.org/fhir/ValueSet/diagnostic-service-sections)

    Codes for diagnostic service sections.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Alternate NamesDepartment, Sub-department, Service, Discipline
    Pattern Value{
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/v2-0074",
        "code" : "LAB"
      }]
    }
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. DiagnosticReport.code
    Definition

    The test, panel or battery that was ordered.


    A code or name that describes this diagnostic report.

    ShortConsult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case.Name/Code for this diagnostic report
    Comments

    UsageNote= The typical patterns for codes are: 1) a LOINC code either as a translation from a "local" code or as a primary code, or 2) a local code only if no suitable LOINC exists, or 3) both the local and the LOINC translation. Systems SHALL be capable of sending the local code if one exists.

    Control1..1
    BindingUnless not suitable, these codes SHALL be taken from The codes SHOULD be taken from US Core Laboratory Test Codeshttp://hl7.org/fhir/ValueSet/report-codes
    (extensible to http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes)

    LOINC codes


    Codes that describe Diagnostic Reports.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Alternate NamesType
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. DiagnosticReport.subject
    Definition

    The subject of the report. Usually, but not always, this is a patient. However, diagnostic services also perform analyses on specimens collected from a variety of other sources.

    Short(USCDI) The subject of the report - usually, but not always, the patientThe subject of the report - usually, but not always, the patient
    Control10..1
    TypeReference(Patient - At Home In Vitro Test, Patient, Group, Device, Location)
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    SHALL know the subject context.

    Alternate NamesPatient
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    22. DiagnosticReport.effective[x]
    Definition

    The time or time-period the observed values are related to. When the subject of the report is a patient, this is usually either the time of the procedure or of specimen collection(s), but very often the source of the date/time is not known, only the date/time itself.

    Short(USCDI) Diagnostically relevant time (typically the time of specimen collection)Clinically relevant time/time-period for report
    Comments

    If the diagnostic procedure was performed on the patient, this is the time it was performed. If there are specimens, the diagnostically relevant time can be derived from the specimen collection times, but the specimen information is not always available, and the exact relationship between the specimens and the diagnostically relevant time is not always automatic.

    Control0..1
    This element is affected by the following invariants: us-core-8
    TypedateTime, Period
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Must Support TypesdateTime
    Summarytrue
    Requirements

    Need to know where in the patient history to file/present this report.

    Alternate NamesObservation time, Effective Time, Occurrence
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    24. DiagnosticReport.issued
    Definition

    The date and time that this version of the report was made available to providers, typically after the report was reviewed and verified.

    Short(USCDI) When the report was releasedDateTime this version was made
    Comments

    May be different from the update time of the resource itself, because that is the status of the record (potentially a secondary copy), not the actual release time of the report.

    Control0..1
    This element is affected by the following invariants: us-core-9
    Typeinstant
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Requirements

    Clinicians need to be able to check the date that the report was released.

    Alternate NamesDate published, Date Issued, Date Verified
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. DiagnosticReport.performer
    Definition

    The diagnostic service that is responsible for issuing the report.

    Short(USCDI) Responsible Diagnostic ServiceResponsible Diagnostic Service
    Comments

    This is not necessarily the source of the atomic data items or the entity that interpreted the results. It is the entity that takes responsibility for the clinical report.

    Control0..*
    TypeReference(US Core Practitioner Profile, US Core Organization Profile, US Core CareTeam Profile, US Core PractitionerRole Profile, Practitioner, PractitionerRole, Organization, CareTeam)
    Is Modifierfalse
    Must Supporttrue
    Must Support TypesReference(US Core Practitioner Profile)
    Summarytrue
    Requirements

    Need to know whom to contact if there are queries about the results. Also may need to track the source of reports for secondary data analysis.

    Alternate NamesLaboratory, Service, Practitioner, Department, Company, Authorized by, Director
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    28. DiagnosticReport.result
    Definition

    Observations that are part of this diagnostic report.

    ShortObservation representing the result of the at-home in-vitro test.Observations
    Comments

    Observations can contain observations.

    Control10..1*
    TypeReference(Observation - At-Home In-Vitro Test Result - COVID-19, Observation)
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Requirements

    Need to support individual results, or groups of results, where the result grouping is arbitrary, but meaningful.

    Alternate NamesData, Atomic Value, Result, Atomic result, Data, Test, Analyte, Battery, Organizer
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

    Guidance on how to interpret the contents of this table can be found here

    0. DiagnosticReport
    Definition

    -

    ShortA Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
    Comments

    -

    Control0..*
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Alternate NamesReport, Test, Result, Results, Labs, Laboratory, Lab Result, Lab Report
    Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
    dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
    dom-6: A resource should have narrative for robust management (text.`div`.exists())
    us-core-8: effective[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-9: issued 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())
    2. DiagnosticReport.id
    Definition

    The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

    ShortLogical id of this artifact
    Comments

    The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

    Control0..1
    Typeid
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    4. DiagnosticReport.meta
    Definition

    The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

    ShortMetadata about the resource
    Control0..1
    TypeMeta
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    6. DiagnosticReport.implicitRules
    Definition

    A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

    ShortA set of rules under which this content was created
    Comments

    Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

    Control0..1
    Typeuri
    Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    8. DiagnosticReport.language
    Definition

    The base language in which the resource is written.

    ShortLanguage of the resource content
    Comments

    Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

    Control0..1
    BindingThe codes SHOULD be taken from CommonLanguages
    (preferred to http://hl7.org/fhir/ValueSet/languages)

    A human language.

    Additional BindingsPurpose
    AllLanguagesMax Binding
    Typecode
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    10. DiagnosticReport.text
    Definition

    A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

    ShortText summary of the resource, for human interpretation
    Comments

    Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

    Control0..1
    TypeNarrative
    Is Modifierfalse
    Summaryfalse
    Alternate Namesnarrative, html, xhtml, display
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. DiagnosticReport.contained
    Definition

    These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

    ShortContained, inline Resources
    Comments

    This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

    Control0..*
    TypeResource
    Is Modifierfalse
    Summaryfalse
    Alternate Namesinline resources, anonymous resources, contained resources
    14. DiagnosticReport.extension
    Definition

    Additional information supporting the diagnostic report.

    ShortExtension - At-Home In-Vitro Test Supporting Information
    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(Extension - At-Home In-Vitro Test Supporting Info) (Complex Extension)
    Is Modifierfalse
    Must Supporttrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    16. DiagnosticReport.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    ShortExtensions that cannot be ignored
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
    Summaryfalse
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    18. DiagnosticReport.identifier
    Definition

    Identifiers assigned to this report by the performer or other systems.

    ShortBusiness identifier for report
    Comments

    Usually assigned by the Information System of the diagnostic service provider (filler id).

    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control0..*
    TypeIdentifier
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Need to know what identifier to use when making queries about this report from the source laboratory, and for linking to the report outside FHIR context.

    Alternate NamesReportID, Filler ID, Placer ID
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. DiagnosticReport.basedOn
    Definition

    Details concerning a service requested.

    ShortWhat was requested
    Comments

    Note: Usually there is one test request for each result, however in some circumstances multiple test requests may be represented using a single test result resource. Note that there are also cases where one request leads to multiple reports.

    Control0..*
    TypeReference(CarePlan, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
    Is Modifierfalse
    Summaryfalse
    Requirements

    This allows tracing of authorization for the report and tracking whether proposals/recommendations were acted upon.

    Alternate NamesRequest
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    22. DiagnosticReport.status
    Definition

    The status of the diagnostic report.

    Short(USCDI) registered | partial | preliminary | final +
    Control1..1
    This element is affected by the following invariants: us-core-8, us-core-9
    BindingThe codes SHALL be taken from DiagnosticReportStatus
    (required to http://hl7.org/fhir/ValueSet/diagnostic-report-status)
    Typecode
    Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Requirements

    Diagnostic services routinely issue provisional/incomplete reports, and sometimes withdraw previously released reports.

    Fixed Valuefinal
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    24. DiagnosticReport.category
    Definition

    A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.

    Short(USCDI) Service category
    Comments

    Multiple categories are allowed using various categorization schemes. The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in DiagnosticReport.code.

    Control1..*
    BindingFor example codes, see DiagnosticServiceSectionCodes
    (example to http://hl7.org/fhir/ValueSet/diagnostic-service-sections)

    Codes for diagnostic service sections.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Alternate NamesDepartment, Sub-department, Service, Discipline
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    SlicingThis element introduces a set of slices on DiagnosticReport.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • pattern @ $this
    • 26. DiagnosticReport.category:LaboratorySlice
      Slice NameLaboratorySlice
      Definition

      A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes.

      Short(USCDI) Service category
      Comments

      Multiple categories are allowed using various categorization schemes. The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in DiagnosticReport.code.

      Control1..1
      BindingFor example codes, see DiagnosticServiceSectionCodes
      (example to http://hl7.org/fhir/ValueSet/diagnostic-service-sections)

      Codes for diagnostic service sections.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Alternate NamesDepartment, Sub-department, Service, Discipline
      Pattern Value{
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/v2-0074",
          "code" : "LAB"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      28. DiagnosticReport.code
      Definition

      The test, panel or battery that was ordered.

      ShortConsult LIVD: https://www.cdc.gov/csels/dls/livd-codes.html to obtain the values to be used for each particular use case.
      Comments

      UsageNote= The typical patterns for codes are: 1) a LOINC code either as a translation from a "local" code or as a primary code, or 2) a local code only if no suitable LOINC exists, or 3) both the local and the LOINC translation. Systems SHALL be capable of sending the local code if one exists.

      Control1..1
      BindingUnless not suitable, these codes SHALL be taken from US Core Laboratory Test Codes
      (extensible to http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes)

      LOINC codes

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Alternate NamesType
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      30. DiagnosticReport.subject
      Definition

      The subject of the report. Usually, but not always, this is a patient. However, diagnostic services also perform analyses on specimens collected from a variety of other sources.

      Short(USCDI) The subject of the report - usually, but not always, the patient
      Control1..1
      TypeReference(Patient - At Home In Vitro Test)
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

      SHALL know the subject context.

      Alternate NamesPatient
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      32. DiagnosticReport.encounter
      Definition

      The healthcare event (e.g. a patient and healthcare provider interaction) which this DiagnosticReport is about.

      ShortHealth care event when test ordered
      Comments

      This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

      Control0..1
      TypeReference(Encounter)
      Is Modifierfalse
      Summarytrue
      Requirements

      Links the request to the Encounter context.

      Alternate NamesContext
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      34. DiagnosticReport.effective[x]
      Definition

      The time or time-period the observed values are related to. When the subject of the report is a patient, this is usually either the time of the procedure or of specimen collection(s), but very often the source of the date/time is not known, only the date/time itself.

      Short(USCDI) Diagnostically relevant time (typically the time of specimen collection)
      Comments

      If the diagnostic procedure was performed on the patient, this is the time it was performed. If there are specimens, the diagnostically relevant time can be derived from the specimen collection times, but the specimen information is not always available, and the exact relationship between the specimens and the diagnostically relevant time is not always automatic.

      Control0..1
      This element is affected by the following invariants: us-core-8
      TypedateTime
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Must Support TypesdateTime
      Summarytrue
      Requirements

      Need to know where in the patient history to file/present this report.

      Alternate NamesObservation time, Effective Time, Occurrence
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      36. DiagnosticReport.issued
      Definition

      The date and time that this version of the report was made available to providers, typically after the report was reviewed and verified.

      Short(USCDI) When the report was released
      Comments

      May be different from the update time of the resource itself, because that is the status of the record (potentially a secondary copy), not the actual release time of the report.

      Control0..1
      This element is affected by the following invariants: us-core-9
      Typeinstant
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Requirements

      Clinicians need to be able to check the date that the report was released.

      Alternate NamesDate published, Date Issued, Date Verified
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      38. DiagnosticReport.performer
      Definition

      The diagnostic service that is responsible for issuing the report.

      Short(USCDI) Responsible Diagnostic Service
      Comments

      This is not necessarily the source of the atomic data items or the entity that interpreted the results. It is the entity that takes responsibility for the clinical report.

      Control0..*
      TypeReference(US Core Practitioner Profile, US Core Organization Profile, US Core CareTeam Profile, US Core PractitionerRole Profile)
      Is Modifierfalse
      Must Supporttrue
      Must Support TypesReference(US Core Practitioner Profile)
      Summarytrue
      Requirements

      Need to know whom to contact if there are queries about the results. Also may need to track the source of reports for secondary data analysis.

      Alternate NamesLaboratory, Service, Practitioner, Department, Company, Authorized by, Director
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      40. DiagnosticReport.resultsInterpreter
      Definition

      The practitioner or organization that is responsible for the report's conclusions and interpretations.

      ShortPrimary result interpreter
      Comments

      Might not be the same entity that takes responsibility for the clinical report.

      Control0..*
      TypeReference(Practitioner, PractitionerRole, Organization, CareTeam)
      Is Modifierfalse
      Summarytrue
      Requirements

      Need to know whom to contact if there are queries about the results. Also may need to track the source of reports for secondary data analysis.

      Alternate NamesAnalyzed by, Reported by
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      42. DiagnosticReport.specimen
      Definition

      Details about the specimens on which this diagnostic report is based.

      ShortSpecimens this report is based on
      Comments

      If the specimen is sufficiently specified with a code in the test result name, then this additional data may be redundant. If there are multiple specimens, these may be represented per observation or group.

      Control0..*
      TypeReference(Specimen)
      Is Modifierfalse
      Summaryfalse
      Requirements

      Need to be able to report information about the collected specimens on which the report is based.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      44. DiagnosticReport.result
      Definition

      Observations that are part of this diagnostic report.

      ShortObservation representing the result of the at-home in-vitro test.
      Comments

      Observations can contain observations.

      Control1..1
      TypeReference(Observation - At-Home In-Vitro Test Result - COVID-19)
      Is Modifierfalse
      Must Supporttrue
      Summaryfalse
      Requirements

      Need to support individual results, or groups of results, where the result grouping is arbitrary, but meaningful.

      Alternate NamesData, Atomic Value, Result, Atomic result, Data, Test, Analyte, Battery, Organizer
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      46. DiagnosticReport.imagingStudy
      Definition

      One or more links to full details of any imaging performed during the diagnostic investigation. Typically, this is imaging performed by DICOM enabled modalities, but this is not required. A fully enabled PACS viewer can use this information to provide views of the source images.

      ShortReference to full details of imaging associated with the diagnostic report
      Comments

      ImagingStudy and the image element are somewhat overlapping - typically, the list of image references in the image element will also be found in one of the imaging study resources. However, each caters to different types of displays for different types of purposes. Neither, either, or both may be provided.

      Control0..*
      TypeReference(ImagingStudy)
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      48. DiagnosticReport.media
      Definition

      A list of key images associated with this report. The images are generally created during the diagnostic process, and may be directly of the patient, or of treated specimens (i.e. slides of interest).

      ShortImages related to the test, such as a photo of the test result, images to support proctor interpretation of test results, etc. Not included in V2 IG.
      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Summarytrue
      Requirements

      Many diagnostic services include images in the report as part of their service.

      Alternate NamesDICOM, Slides, Scans
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      50. DiagnosticReport.media.id
      Definition

      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

      ShortUnique id for inter-element referencing
      Control0..1
      Typestring
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      52. DiagnosticReport.media.extension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element. 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.

      ShortAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      54. DiagnosticReport.media.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
      Summarytrue
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content, modifiers
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      56. DiagnosticReport.media.comment
      Definition

      A comment about the image. Typically, this is used to provide an explanation for why the image is included, or to draw the viewer's attention to important features.

      ShortComment about the image (e.g. explanation)
      Comments

      The comment should be displayed with the image. It would be common for the report to include additional discussion of the image contents in other sections such as the conclusion.

      Control0..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summaryfalse
      Requirements

      The provider of the report should make a comment about each image included in the report.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      58. DiagnosticReport.media.link
      Definition

      Reference to the image source.

      ShortReference to the image source
      Control1..1
      TypeReference(Media)
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      60. DiagnosticReport.conclusion
      Definition

      Concise and clinically contextualized summary conclusion (interpretation/impression) of the diagnostic report.

      ShortClinical conclusion (interpretation) of test results
      Control0..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summaryfalse
      Requirements

      Need to be able to provide a conclusion that is not lost among the basic result data.

      Alternate NamesReport
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      62. DiagnosticReport.conclusionCode
      Definition

      One or more codes that represent the summary conclusion (interpretation/impression) of the diagnostic report.

      ShortCodes for the clinical conclusion of test results
      Control0..*
      BindingFor example codes, see SNOMEDCTClinicalFindings
      (example to http://hl7.org/fhir/ValueSet/clinical-findings)

      Diagnosis codes provided as adjuncts to the report.

      TypeCodeableConcept
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      64. DiagnosticReport.presentedForm
      Definition

      Rich text representation of the entire result as issued by the diagnostic service. Multiple formats are allowed but they SHALL be semantically equivalent.

      ShortEntire report as issued
      Comments

      "application/pdf" is recommended as the most reliable and interoperable in this context.

      Control0..*
      TypeAttachment
      Is Modifierfalse
      Summaryfalse
      Requirements

      Gives laboratory the ability to provide its own fully formatted report for clinical fidelity.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))