Genomics Reporting Implementation Guide
3.0.0 - release International flag

Genomics Reporting Implementation Guide, published by HL7 International / Clinical Genomics. This guide is not an authorized publication; it is the continuous build for version 3.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/genomics-reporting/ and changes regularly. See the Directory of published versions

Resource Profile: GenomicReport - Detailed Descriptions

Active as of 2024-11-24

Definitions for the genomic-report resource profile.

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

0. DiagnosticReport
2. DiagnosticReport.extension
SlicingThis element introduces a set of slices on DiagnosticReport.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 4. DiagnosticReport.extension:recommended-action
    Slice Namerecommended-action
    Control0..*
    TypeExtension(Recommended Action) (Extension Type: Reference(Medication Recommendation, Followup Recommendation))
    6. DiagnosticReport.extension:genomic-risk-assessment
    Slice Namegenomic-risk-assessment
    Control0..*
    TypeExtension(Genomic Risk Assessment) (Extension Type: Reference(RiskAssessment))
    8. DiagnosticReport.extension:coded-note
    Slice Namecoded-note
    ShortComments about the report that also contain a coded type
    Comments

    May include general statements about the report, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation. The CodedAnnotation data type, while not allowing for or intending to make the content computable, does allow the author to indicate the type of note. This does not replace the use of results or conclusion or conclusionCode. One important note is that Annotation is a FHIR data type, this is NOT about annotations in the genomic context.

    Control0..*
    TypeExtension(Genomic Report Note) (Extension Type: Annotation(Coded Annotation))
    Requirements

    Need to be able to provide free text additional information. Notes SHALL NOT contain information which can be captured in a structured way.

    10. DiagnosticReport.extension:supporting-info
    Slice Namesupporting-info
    Control0..*
    TypeExtension(Supporting info) (Extension Type: Reference(Resource))
    12. DiagnosticReport.extension:genomic-study
    Slice Namegenomic-study
    ShortReference to full details of an genomic study associated with the diagnostic report
    Control0..*
    TypeExtension(Genomic Study Reference) (Extension Type: Reference(Genomic Study))
    14. DiagnosticReport.extension:hla-genotyping-results-allele-database
    Slice Namehla-genotyping-results-allele-database
    Control0..1
    TypeExtension(allele-database) (Extension Type: CodeableConcept)
    16. DiagnosticReport.extension:hla-genotyping-results-glstring
    Slice Namehla-genotyping-results-glstring
    Control0..1
    TypeExtension(glstring) (Complex Extension)
    18. DiagnosticReport.extension:workflow-relatedArtifact
    Slice Nameworkflow-relatedArtifact
    Comments

    Note that in contrast this extension, the supportingInfo extension references other resources from the patient record that were used in creating the resource.

    Control0..*
    TypeExtension(Related artifact) (Extension Type: RelatedArtifact)
    20. DiagnosticReport.category
    Control1..?
    SlicingThis element introduces a set of slices on DiagnosticReport.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ coding
    • 22. DiagnosticReport.category:Genetics
      Slice NameGenetics
      Control1..1
      24. DiagnosticReport.category:Genetics.coding
      Control1..1
      Pattern Value{
        "system" : "http://terminology.hl7.org/CodeSystem/v2-0074",
        "code" : "GE"
      }
      26. DiagnosticReport.code
      Pattern Value{
        "coding" : [{
          "system" : "http://loinc.org",
          "code" : "51969-4"
        }]
      }
      28. DiagnosticReport.effective[x]
      TypedateTime, Period
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      30. DiagnosticReport.result
      SlicingThis element introduces a set of slices on DiagnosticReport.result. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • profile @ resolve()
      • 32. DiagnosticReport.result:diagnostic-implication
        Slice Namediagnostic-implication
        ShortDiagnostic Implication
        Control0..*
        TypeReference(Diagnostic Implication)
        34. DiagnosticReport.result:therapeutic-implication
        Slice Nametherapeutic-implication
        ShortTherapeutic Implication
        Control0..*
        TypeReference(Therapeutic Implication)
        36. DiagnosticReport.result:molecular-consequence
        Slice Namemolecular-consequence
        ShortMolecular Consequence
        Control0..*
        TypeReference(Molecular Consequence)
        38. DiagnosticReport.result:variant
        Slice Namevariant
        ShortVariant
        Control0..*
        TypeReference(Variant)
        40. DiagnosticReport.result:sequence-phase-relation
        Slice Namesequence-phase-relation
        ShortSequence Phase Relationship
        Control0..*
        TypeReference(Sequence Phase Relationship)
        42. DiagnosticReport.result:genotype
        Slice Namegenotype
        ShortGenotype
        Control0..*
        TypeReference(Genotype)
        44. DiagnosticReport.result:haplotype
        Slice Namehaplotype
        ShortHaplotype
        Control0..*
        TypeReference(Haplotype)
        46. DiagnosticReport.result:biomarker
        Slice Namebiomarker
        ShortMolecularBiomarker
        Control0..*
        TypeReference(Molecular Biomarker)
        48. DiagnosticReport.conclusion
        ShortAssessment of overall results
        50. DiagnosticReport.conclusionCode
        ShortCoarse overall interpretation of the genomic results

        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
        Summaryfalse
        Alternate NamesReport, Test, Result, Results, Labs, Laboratory
        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())
        2. 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()))
        4. DiagnosticReport.extension
        Definition

        An Extension


        May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        ShortExtensionAdditional 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())
        SlicingThis element introduces a set of slices on DiagnosticReport.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 6. DiagnosticReport.extension:recommended-action
          Slice Namerecommended-action
          Definition

          References a proposed action that is recommended based on the results of the diagnostic report.

          ShortRecommended Action
          Control0..*
          This element is affected by the following invariants: ele-1
          TypeExtension(Recommended Action) (Extension Type: Reference(Medication Recommendation, Followup Recommendation))
          Is Modifierfalse
          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())
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          8. DiagnosticReport.extension:genomic-risk-assessment
          Slice Namegenomic-risk-assessment
          Definition

          RiskAssessment delivered as part of a genomics report or observation

          ShortGenomic Risk Assessment
          Control0..*
          This element is affected by the following invariants: ele-1
          TypeExtension(Genomic Risk Assessment) (Extension Type: Reference(RiskAssessment))
          Is Modifierfalse
          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())
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          10. DiagnosticReport.extension:coded-note
          Slice Namecoded-note
          Definition

          Adds codified notes to a report to capture additional content

          ShortComments about the report that also contain a coded type
          Comments

          May include general statements about the report, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation. The CodedAnnotation data type, while not allowing for or intending to make the content computable, does allow the author to indicate the type of note. This does not replace the use of results or conclusion or conclusionCode. One important note is that Annotation is a FHIR data type, this is NOT about annotations in the genomic context.

          Control0..*
          This element is affected by the following invariants: ele-1
          TypeExtension(Genomic Report Note) (Extension Type: Annotation(Coded Annotation))
          Is Modifierfalse
          Requirements

          Need to be able to provide free text additional information. Notes SHALL NOT contain information which can be captured in a structured way.

          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())
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          12. DiagnosticReport.extension:supporting-info
          Slice Namesupporting-info
          Definition

          Other resources from the patient record that may be relevant to the event. The information from these resources was either used to create the instance or is provided to help with its interpretation. This extension should not be used if more specific inline elements or extensions are available. For example, use Observation.hasMember instead of supportingInformation for representing the members of an Observation panel.

          ShortOther information that may be relevant to this event.
          Control0..*
          TypeExtension(Supporting info) (Extension Type: Reference(Resource))
          Is Modifierfalse
          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())
          ele-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())
          14. DiagnosticReport.extension:genomic-study
          Slice Namegenomic-study
          Definition

          Used to reference a GenomicStudy profile

          ShortReference to full details of an genomic study associated with the diagnostic report
          Control0..*
          This element is affected by the following invariants: ele-1
          TypeExtension(Genomic Study Reference) (Extension Type: Reference(Genomic Study))
          Is Modifierfalse
          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())
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          16. DiagnosticReport.extension:hla-genotyping-results-allele-database
          Slice Namehla-genotyping-results-allele-database
          Definition

          Allele Database.

          ShortAllele Database
          Control0..1
          This element is affected by the following invariants: ele-1
          TypeExtension(allele-database) (Extension Type: CodeableConcept)
          Is Modifierfalse
          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())
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          18. DiagnosticReport.extension:hla-genotyping-results-glstring
          Slice Namehla-genotyping-results-glstring
          Definition

          glstring.

          Shortglstring
          Control0..1
          This element is affected by the following invariants: ele-1
          TypeExtension(glstring) (Complex Extension)
          Is Modifierfalse
          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())
          20. DiagnosticReport.extension:workflow-relatedArtifact
          Slice Nameworkflow-relatedArtifact
          Definition

          Documents the 'knowledge artifacts' relevant to the base resource such as citations, supporting evidence, documentation of processes, caveats around testing methodology.

          ShortDocumentation relevant to the 'parent' resource
          Comments

          Note that in contrast this extension, the supportingInfo extension references other resources from the patient record that were used in creating the resource.

          Control0..*
          TypeExtension(Related artifact) (Extension Type: RelatedArtifact)
          Is Modifierfalse
          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())
          ele-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())
          22. 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())
          24. DiagnosticReport.status
          Definition

          The status of the diagnostic report.

          Shortregistered | partial | preliminary | final +
          Control1..1
          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|4.0.1)

          The status of the diagnostic report.

          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
          Summarytrue
          Requirements

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

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          26. 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.

          ShortService 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
          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:
          • value @ coding
          • 28. DiagnosticReport.category:Genetics
            Slice NameGenetics
            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.

            ShortService 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
            Summarytrue
            Alternate NamesDepartment, Sub-department, Service, Discipline
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            30. DiagnosticReport.category:Genetics.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control10..1*
            TypeCoding
            Is Modifierfalse
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Pattern Value{
              "system" : "http://terminology.hl7.org/CodeSystem/v2-0074",
              "code" : "GE"
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            32. DiagnosticReport.code
            Definition

            A code or name that describes this diagnostic report.

            ShortName/Code for this diagnostic report
            Control1..1
            BindingThe codes SHOULD be taken from LOINCDiagnosticReportCodeshttp://hl7.org/fhir/ValueSet/report-codes
            (preferred to http://hl7.org/fhir/ValueSet/report-codes)

            Codes that describe Diagnostic Reports.

            TypeCodeableConcept
            Is Modifierfalse
            Summarytrue
            Alternate NamesType
            Pattern Value{
              "coding" : [{
                "system" : "http://loinc.org",
                "code" : "51969-4"
              }]
            }
            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.

            ShortClinically 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
            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
            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.result
            Definition

            Observations that are part of this diagnostic report.

            ShortObservations
            Comments

            Observations can contain observations.

            Control0..*
            TypeReference(Observation)
            Is Modifierfalse
            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()))
            SlicingThis element introduces a set of slices on DiagnosticReport.result. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • profile @ resolve()
            • 38. DiagnosticReport.result:diagnostic-implication
              Slice Namediagnostic-implication
              Definition

              Observations that are part of this diagnostic report.

              ShortDiagnostic ImplicationObservations
              Comments

              Observations can contain observations.

              Control0..*
              TypeReference(Diagnostic Implication, Observation)
              Is Modifierfalse
              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()))
              40. DiagnosticReport.result:therapeutic-implication
              Slice Nametherapeutic-implication
              Definition

              Observations that are part of this diagnostic report.

              ShortTherapeutic ImplicationObservations
              Comments

              Observations can contain observations.

              Control0..*
              TypeReference(Therapeutic Implication, Observation)
              Is Modifierfalse
              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()))
              42. DiagnosticReport.result:molecular-consequence
              Slice Namemolecular-consequence
              Definition

              Observations that are part of this diagnostic report.

              ShortMolecular ConsequenceObservations
              Comments

              Observations can contain observations.

              Control0..*
              TypeReference(Molecular Consequence, Observation)
              Is Modifierfalse
              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()))
              44. DiagnosticReport.result:variant
              Slice Namevariant
              Definition

              Observations that are part of this diagnostic report.

              ShortVariantObservations
              Comments

              Observations can contain observations.

              Control0..*
              TypeReference(Variant, Observation)
              Is Modifierfalse
              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.result:sequence-phase-relation
              Slice Namesequence-phase-relation
              Definition

              Observations that are part of this diagnostic report.

              ShortSequence Phase RelationshipObservations
              Comments

              Observations can contain observations.

              Control0..*
              TypeReference(Sequence Phase Relationship, Observation)
              Is Modifierfalse
              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()))
              48. DiagnosticReport.result:genotype
              Slice Namegenotype
              Definition

              Observations that are part of this diagnostic report.

              ShortGenotypeObservations
              Comments

              Observations can contain observations.

              Control0..*
              TypeReference(Genotype, Observation)
              Is Modifierfalse
              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()))
              50. DiagnosticReport.result:haplotype
              Slice Namehaplotype
              Definition

              Observations that are part of this diagnostic report.

              ShortHaplotypeObservations
              Comments

              Observations can contain observations.

              Control0..*
              TypeReference(Haplotype, Observation)
              Is Modifierfalse
              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()))
              52. DiagnosticReport.result:biomarker
              Slice Namebiomarker
              Definition

              Observations that are part of this diagnostic report.

              ShortMolecularBiomarkerObservations
              Comments

              Observations can contain observations.

              Control0..*
              TypeReference(Molecular Biomarker, Observation)
              Is Modifierfalse
              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()))
              54. DiagnosticReport.conclusion
              Definition

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

              ShortAssessment of overall resultsClinical 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()))
              56. DiagnosticReport.conclusionCode
              Definition

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

              ShortCoarse overall interpretation of the genomic resultsCodes for the clinical conclusion of test results
              Control0..*
              BindingFor example codes, see SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/clinical-findings
              (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()))

              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
              Summaryfalse
              Alternate NamesReport, Test, Result, Results, Labs, Laboratory
              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())
              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
              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

              An Extension

              ShortExtension
              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              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())
              SlicingThis element introduces a set of slices on DiagnosticReport.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 16. DiagnosticReport.extension:recommended-action
                Slice Namerecommended-action
                Definition

                References a proposed action that is recommended based on the results of the diagnostic report.

                ShortRecommended Action
                Control0..*
                This element is affected by the following invariants: ele-1
                TypeExtension(Recommended Action) (Extension Type: Reference(Medication Recommendation, Followup Recommendation))
                Is Modifierfalse
                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.extension:genomic-risk-assessment
                Slice Namegenomic-risk-assessment
                Definition

                RiskAssessment delivered as part of a genomics report or observation

                ShortGenomic Risk Assessment
                Control0..*
                This element is affected by the following invariants: ele-1
                TypeExtension(Genomic Risk Assessment) (Extension Type: Reference(RiskAssessment))
                Is Modifierfalse
                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())
                20. DiagnosticReport.extension:coded-note
                Slice Namecoded-note
                Definition

                Adds codified notes to a report to capture additional content

                ShortComments about the report that also contain a coded type
                Comments

                May include general statements about the report, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation. The CodedAnnotation data type, while not allowing for or intending to make the content computable, does allow the author to indicate the type of note. This does not replace the use of results or conclusion or conclusionCode. One important note is that Annotation is a FHIR data type, this is NOT about annotations in the genomic context.

                Control0..*
                This element is affected by the following invariants: ele-1
                TypeExtension(Genomic Report Note) (Extension Type: Annotation(Coded Annotation))
                Is Modifierfalse
                Requirements

                Need to be able to provide free text additional information. Notes SHALL NOT contain information which can be captured in a structured way.

                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())
                22. DiagnosticReport.extension:supporting-info
                Slice Namesupporting-info
                Definition

                Other resources from the patient record that may be relevant to the event. The information from these resources was either used to create the instance or is provided to help with its interpretation. This extension should not be used if more specific inline elements or extensions are available. For example, use Observation.hasMember instead of supportingInformation for representing the members of an Observation panel.

                ShortOther information that may be relevant to this event.
                Control0..*
                TypeExtension(Supporting info) (Extension Type: Reference(Resource))
                Is Modifierfalse
                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())
                24. DiagnosticReport.extension:genomic-study
                Slice Namegenomic-study
                Definition

                Used to reference a GenomicStudy profile

                ShortReference to full details of an genomic study associated with the diagnostic report
                Control0..*
                This element is affected by the following invariants: ele-1
                TypeExtension(Genomic Study Reference) (Extension Type: Reference(Genomic Study))
                Is Modifierfalse
                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())
                26. DiagnosticReport.extension:hla-genotyping-results-allele-database
                Slice Namehla-genotyping-results-allele-database
                Definition

                Allele Database.

                ShortAllele Database
                Control0..1
                This element is affected by the following invariants: ele-1
                TypeExtension(allele-database) (Extension Type: CodeableConcept)
                Is Modifierfalse
                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())
                28. DiagnosticReport.extension:hla-genotyping-results-glstring
                Slice Namehla-genotyping-results-glstring
                Definition

                glstring.

                Shortglstring
                Control0..1
                This element is affected by the following invariants: ele-1
                TypeExtension(glstring) (Complex Extension)
                Is Modifierfalse
                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())
                30. DiagnosticReport.extension:workflow-relatedArtifact
                Slice Nameworkflow-relatedArtifact
                Definition

                Documents the 'knowledge artifacts' relevant to the base resource such as citations, supporting evidence, documentation of processes, caveats around testing methodology.

                ShortDocumentation relevant to the 'parent' resource
                Comments

                Note that in contrast this extension, the supportingInfo extension references other resources from the patient record that were used in creating the resource.

                Control0..*
                TypeExtension(Related artifact) (Extension Type: RelatedArtifact)
                Is Modifierfalse
                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())
                32. 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())
                34. 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
                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()))
                36. 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()))
                38. DiagnosticReport.status
                Definition

                The status of the diagnostic report.

                Shortregistered | partial | preliminary | final +
                Control1..1
                BindingThe codes SHALL be taken from DiagnosticReportStatus
                (required to http://hl7.org/fhir/ValueSet/diagnostic-report-status|4.0.1)

                The status of the diagnostic report.

                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
                Summarytrue
                Requirements

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

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                40. 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.

                ShortService 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
                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:
                • value @ coding
                • 42. DiagnosticReport.category:Genetics
                  Slice NameGenetics
                  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.

                  ShortService 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
                  Summarytrue
                  Alternate NamesDepartment, Sub-department, Service, Discipline
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  44. DiagnosticReport.category:Genetics.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
                  46. DiagnosticReport.category:Genetics.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())
                  SlicingThis element introduces a set of slices on DiagnosticReport.category.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 48. DiagnosticReport.category:Genetics.coding
                    Definition

                    A reference to a code defined by a terminology system.

                    ShortCode defined by a terminology system
                    Comments

                    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                    Control1..1
                    TypeCoding
                    Is Modifierfalse
                    Summarytrue
                    Requirements

                    Allows for alternative encodings within a code system, and translations to other code systems.

                    Pattern Value{
                      "system" : "http://terminology.hl7.org/CodeSystem/v2-0074",
                      "code" : "GE"
                    }
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    50. DiagnosticReport.category:Genetics.text
                    Definition

                    A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                    ShortPlain text representation of the concept
                    Comments

                    Very often the text is the same as a displayName of one of the codings.

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

                    The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

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

                    A code or name that describes this diagnostic report.

                    ShortName/Code for this diagnostic report
                    Control1..1
                    BindingThe codes SHOULD be taken from LOINCDiagnosticReportCodes
                    (preferred to http://hl7.org/fhir/ValueSet/report-codes)

                    Codes that describe Diagnostic Reports.

                    TypeCodeableConcept
                    Is Modifierfalse
                    Summarytrue
                    Alternate NamesType
                    Pattern Value{
                      "coding" : [{
                        "system" : "http://loinc.org",
                        "code" : "51969-4"
                      }]
                    }
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    54. 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.

                    ShortThe subject of the report - usually, but not always, the patient
                    Control0..1
                    TypeReference(Patient, Group, Device, Location)
                    Is Modifierfalse
                    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()))
                    56. 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()))
                    58. 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.

                    ShortClinically 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
                    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
                    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()))
                    60. 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.

                    ShortDateTime 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
                    Typeinstant
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    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()))
                    62. DiagnosticReport.performer
                    Definition

                    The diagnostic service that is responsible for issuing the report.

                    ShortResponsible 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(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 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()))
                    64. 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()))
                    66. 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()))
                    68. DiagnosticReport.result
                    Definition

                    Observations that are part of this diagnostic report.

                    ShortObservations
                    Comments

                    Observations can contain observations.

                    Control0..*
                    TypeReference(Observation)
                    Is Modifierfalse
                    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()))
                    SlicingThis element introduces a set of slices on DiagnosticReport.result. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • profile @ resolve()
                    • 70. DiagnosticReport.result:diagnostic-implication
                      Slice Namediagnostic-implication
                      Definition

                      Observations that are part of this diagnostic report.

                      ShortDiagnostic Implication
                      Comments

                      Observations can contain observations.

                      Control0..*
                      TypeReference(Diagnostic Implication)
                      Is Modifierfalse
                      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()))
                      72. DiagnosticReport.result:therapeutic-implication
                      Slice Nametherapeutic-implication
                      Definition

                      Observations that are part of this diagnostic report.

                      ShortTherapeutic Implication
                      Comments

                      Observations can contain observations.

                      Control0..*
                      TypeReference(Therapeutic Implication)
                      Is Modifierfalse
                      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()))
                      74. DiagnosticReport.result:molecular-consequence
                      Slice Namemolecular-consequence
                      Definition

                      Observations that are part of this diagnostic report.

                      ShortMolecular Consequence
                      Comments

                      Observations can contain observations.

                      Control0..*
                      TypeReference(Molecular Consequence)
                      Is Modifierfalse
                      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()))
                      76. DiagnosticReport.result:variant
                      Slice Namevariant
                      Definition

                      Observations that are part of this diagnostic report.

                      ShortVariant
                      Comments

                      Observations can contain observations.

                      Control0..*
                      TypeReference(Variant)
                      Is Modifierfalse
                      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()))
                      78. DiagnosticReport.result:sequence-phase-relation
                      Slice Namesequence-phase-relation
                      Definition

                      Observations that are part of this diagnostic report.

                      ShortSequence Phase Relationship
                      Comments

                      Observations can contain observations.

                      Control0..*
                      TypeReference(Sequence Phase Relationship)
                      Is Modifierfalse
                      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()))
                      80. DiagnosticReport.result:genotype
                      Slice Namegenotype
                      Definition

                      Observations that are part of this diagnostic report.

                      ShortGenotype
                      Comments

                      Observations can contain observations.

                      Control0..*
                      TypeReference(Genotype)
                      Is Modifierfalse
                      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()))
                      82. DiagnosticReport.result:haplotype
                      Slice Namehaplotype
                      Definition

                      Observations that are part of this diagnostic report.

                      ShortHaplotype
                      Comments

                      Observations can contain observations.

                      Control0..*
                      TypeReference(Haplotype)
                      Is Modifierfalse
                      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()))
                      84. DiagnosticReport.result:biomarker
                      Slice Namebiomarker
                      Definition

                      Observations that are part of this diagnostic report.

                      ShortMolecularBiomarker
                      Comments

                      Observations can contain observations.

                      Control0..*
                      TypeReference(Molecular Biomarker)
                      Is Modifierfalse
                      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()))
                      86. 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()))
                      88. 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).

                      ShortKey images associated with this report
                      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()))
                      90. 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
                      92. 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())
                      94. 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())
                      96. 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()))
                      98. 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()))
                      100. DiagnosticReport.conclusion
                      Definition

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

                      ShortAssessment of overall 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()))
                      102. DiagnosticReport.conclusionCode
                      Definition

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

                      ShortCoarse overall interpretation of the genomic 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()))
                      104. 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()))