minimal Common Oncology Data Elements (mCODE) Implementation Guide
4.0.0-ballot - STU4 Ballot United States of America flag

minimal Common Oncology Data Elements (mCODE) Implementation Guide, published by HL7 International / Clinical Interoperability Council. This guide is not an authorized publication; it is the continuous build for version 4.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-mCODE-ig/ and changes regularly. See the Directory of published versions

Resource Profile: TumorMorphology - Detailed Descriptions

Active as of 2024-04-09 Maturity Level: 4

Definitions for the mcode-tumor-morphology 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 are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 4. DiagnosticReport.extension:relatedCondition
    Slice NamerelatedCondition
    Definition

    Associates the tumor marker test with a condition, if one exists. Condition can be given by a reference or a code. In the case of a screening test such as prostate-specific antigen (PSA), there may be no existing condition to reference.

    ShortCondition associated with this test.
    Control0..*
    TypeExtension(Related Condition Extension) (Extension Type: Choice of: CodeableConcept, Reference(Condition))
    Must Supporttrue
    6. DiagnosticReport.code
    Pattern Value{
      "coding" : [{
        "system" : "http://loinc.org",
        "code" : "77753-2"
      }]
    }
    8. DiagnosticReport.subject
    Definition

    Patient whose test result is recorded.

    TypeReference(Cancer Patient Profile)
    10. DiagnosticReport.specimen
    Control0..1
    TypeReference(Human Specimen Profile)
    Must Supporttrue
    12. DiagnosticReport.result
    SlicingThis element introduces a set of slices on DiagnosticReport.result. The slices are unordered and Open, and can be differentiated using the following discriminators:
    • profile @ $this.resolve()
    • 14. DiagnosticReport.result:histologyBehaviorAndType
      Slice NamehistologyBehaviorAndType
      Definition

      The ICD-O-3 4-digit histology code for the tumor, with the 5th digit behavior code for the tumor

      ShortHistology Behavior Type being reported using ICD-O-3
      Control0..1
      TypeReference(Histologic Behavior and Type)
      16. DiagnosticReport.result:grade
      Slice Namegrade
      Definition

      The histologic grade of the tumor

      ShortTumor grade code being reported using SNOMED
      Control0..1
      TypeReference(Histologic Grade)

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

      0. DiagnosticReport
      Definition

      -


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

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

      -


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

      Control0..*
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Alternate NamesReport, Test, Result, Results, Labs, Laboratory, Lab Result, Lab Report
      Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
      dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
      dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
      dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
      dom-6: A resource should have narrative for robust management (text.`div`.exists())
      us-core-8: effective[x] SHALL be present if the status is 'partial', 'preliminary', 'final', 'amended', 'corrected' or 'appended' ((status='partial' or status='preliminary' or status='final' or status='amended' or status='corrected' or status='appended' ) implies effective.exists())
      us-core-9: issued SHALL be present if the status is 'partial', 'preliminary', 'final', 'amended', 'corrected' or 'appended' ((status='partial' or status='preliminary' or status='final' or status='amended' or status='corrected' or status='appended' ) implies issued.exists())
      2. DiagnosticReport.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 are unordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 6. DiagnosticReport.extension:relatedCondition
        Slice NamerelatedCondition
        Definition

        Associates the tumor marker test with a condition, if one exists. Condition can be given by a reference or a code. In the case of a screening test such as prostate-specific antigen (PSA), there may be no existing condition to reference.

        ShortCondition associated with this test.
        Control0..*
        This element is affected by the following invariants: ele-1
        TypeExtension(Related Condition Extension) (Extension Type: Choice of: CodeableConcept, Reference(Condition))
        Is Modifierfalse
        Must Supporttrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        8. DiagnosticReport.modifierExtension
        Definition

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

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

        ShortExtensions that cannot be ignored
        Comments

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

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

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

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

        The status of the diagnostic report.

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

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

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        12. 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
        Must Supporttrue
        Summarytrue
        Alternate NamesDepartment, Sub-department, Service, Discipline
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        SlicingThis element introduces a set of slices on DiagnosticReport.category. The slices are unordered and Open, and can be differentiated using the following discriminators:
        • pattern @ $this
        • 14. DiagnosticReport.category:LaboratorySlice
          Slice NameLaboratorySlice
          Definition

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

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

          The test, panel or battery that was ordered.


          A code or name that describes this diagnostic report.

          ShortUS Core Laboratory Report Order CodeName/Code for this diagnostic report
          Comments

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

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

          LOINC codes


          Codes that describe Diagnostic Reports.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Alternate NamesType
          Pattern Value{
            "coding" : [{
              "system" : "http://loinc.org",
              "code" : "77753-2"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          18. DiagnosticReport.subject
          Definition

          Patient whose test result is recorded.


          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
          Control10..1
          TypeReference(Cancer Patient Profile, Patient, Group, Device, Location)
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Requirements

          SHALL know the subject context.

          Alternate NamesPatient
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          20. 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.

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

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

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

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

          Alternate NamesObservation time, Effective Time, Occurrence
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          22. 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.

          ShortWhen the report was releasedDateTime this version was made
          Comments

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

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

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

          Alternate NamesDate published, Date Issued, Date Verified
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          24. 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(US Core Practitioner Profile, US Core Organization Profile, US Core CareTeam Profile, US Core PractitionerRole Profile, Practitioner, PractitionerRole, Organization, CareTeam)
          Is Modifierfalse
          Must Supporttrue
          Must Support TypesReference(US Core Practitioner Profile)
          Summarytrue
          Requirements

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

          Alternate NamesLaboratory, Service, Practitioner, Department, Company, Authorized by, Director
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          26. 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..1*
          TypeReference(Human Specimen Profile, Specimen)
          Is Modifierfalse
          Must Supporttrue
          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()))
          28. DiagnosticReport.result
          Definition

          Observations that are part of this diagnostic report.

          ShortObservations
          Comments

          Observations can contain observations.

          Control0..*
          TypeReference(US Core Laboratory Result Observation Profile, Observation)
          Is Modifierfalse
          Must Supporttrue
          Summaryfalse
          Requirements

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

          Alternate NamesData, Atomic Value, Result, Atomic result, Data, Test, Analyte, Battery, Organizer
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          SlicingThis element introduces a set of slices on DiagnosticReport.result. The slices are unordered and Open, and can be differentiated using the following discriminators:
          • profile @ $this.resolve()
          • 30. DiagnosticReport.result:histologyBehaviorAndType
            Slice NamehistologyBehaviorAndType
            Definition

            The ICD-O-3 4-digit histology code for the tumor, with the 5th digit behavior code for the tumor


            Observations that are part of this diagnostic report.

            ShortHistology Behavior Type being reported using ICD-O-3Observations
            Comments

            Observations can contain observations.

            Control0..1*
            TypeReference(Histologic Behavior and Type, Observation)
            Is Modifierfalse
            Must Supporttrue
            Summaryfalse
            Requirements

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

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

            The histologic grade of the tumor


            Observations that are part of this diagnostic report.

            ShortTumor grade code being reported using SNOMEDObservations
            Comments

            Observations can contain observations.

            Control0..1*
            TypeReference(Histologic Grade, Observation)
            Is Modifierfalse
            Must Supporttrue
            Summaryfalse
            Requirements

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

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

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

            0. DiagnosticReport
            Definition

            -

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

            -

            Control0..*
            Is Modifierfalse
            Must Supportfalse
            Summaryfalse
            Alternate NamesReport, Test, Result, Results, Labs, Laboratory, Lab Result, Lab Report
            Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
            dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
            dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
            dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
            dom-6: A resource should have narrative for robust management (text.`div`.exists())
            us-core-8: effective[x] SHALL be present if the status is 'partial', 'preliminary', 'final', 'amended', 'corrected' or 'appended' ((status='partial' or status='preliminary' or status='final' or status='amended' or status='corrected' or status='appended' ) implies effective.exists())
            us-core-9: issued SHALL be present if the status is 'partial', 'preliminary', 'final', 'amended', 'corrected' or 'appended' ((status='partial' or status='preliminary' or status='final' or status='amended' or status='corrected' or status='appended' ) implies issued.exists())
            2. DiagnosticReport.id
            Definition

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

            ShortLogical id of this artifact
            Comments

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

            Control0..1
            Typeid
            Is Modifierfalse
            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 are unordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 16. DiagnosticReport.extension:relatedCondition
              Slice NamerelatedCondition
              Definition

              Associates the tumor marker test with a condition, if one exists. Condition can be given by a reference or a code. In the case of a screening test such as prostate-specific antigen (PSA), there may be no existing condition to reference.

              ShortCondition associated with this test.
              Control0..*
              This element is affected by the following invariants: ele-1
              TypeExtension(Related Condition Extension) (Extension Type: Choice of: CodeableConcept, Reference(Condition))
              Is Modifierfalse
              Must Supporttrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              18. 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())
              20. 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()))
              22. 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()))
              24. DiagnosticReport.status
              Definition

              The status of the diagnostic report.

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

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

              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.

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

              Codes for diagnostic service sections.

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

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

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

                The test, panel or battery that was ordered.

                ShortUS Core Laboratory Report Order Code
                Comments

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

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

                LOINC codes

                TypeCodeableConcept
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Alternate NamesType
                Pattern Value{
                  "coding" : [{
                    "system" : "http://loinc.org",
                    "code" : "77753-2"
                  }]
                }
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                32. DiagnosticReport.subject
                Definition

                Patient whose test result is recorded.

                ShortThe subject of the report - usually, but not always, the patient
                Control1..1
                TypeReference(Cancer Patient Profile)
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Requirements

                SHALL know the subject context.

                Alternate NamesPatient
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                34. 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()))
                36. 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.

                ShortDiagnostically relevant time (typically the time of specimen collection)
                Comments

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

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

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

                Alternate NamesObservation time, Effective Time, Occurrence
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                38. 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.

                ShortWhen the report was released
                Comments

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

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

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

                Alternate NamesDate published, Date Issued, Date Verified
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                40. 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(US Core Practitioner Profile, US Core Organization Profile, US Core CareTeam Profile, US Core PractitionerRole Profile)
                Is Modifierfalse
                Must Supporttrue
                Must Support TypesReference(US Core Practitioner Profile)
                Summarytrue
                Requirements

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

                Alternate NamesLaboratory, Service, Practitioner, Department, Company, Authorized by, Director
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                42. 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()))
                44. 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..1
                TypeReference(Human Specimen Profile)
                Is Modifierfalse
                Must Supporttrue
                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()))
                46. DiagnosticReport.result
                Definition

                Observations that are part of this diagnostic report.

                ShortObservations
                Comments

                Observations can contain observations.

                Control0..*
                TypeReference(US Core Laboratory Result Observation Profile)
                Is Modifierfalse
                Must Supporttrue
                Summaryfalse
                Requirements

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

                Alternate NamesData, Atomic Value, Result, Atomic result, Data, Test, Analyte, Battery, Organizer
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                SlicingThis element introduces a set of slices on DiagnosticReport.result. The slices are unordered and Open, and can be differentiated using the following discriminators:
                • profile @ $this.resolve()
                • 48. DiagnosticReport.result:histologyBehaviorAndType
                  Slice NamehistologyBehaviorAndType
                  Definition

                  The ICD-O-3 4-digit histology code for the tumor, with the 5th digit behavior code for the tumor

                  ShortHistology Behavior Type being reported using ICD-O-3
                  Comments

                  Observations can contain observations.

                  Control0..1
                  TypeReference(Histologic Behavior and Type)
                  Is Modifierfalse
                  Must Supporttrue
                  Summaryfalse
                  Requirements

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

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

                  The histologic grade of the tumor

                  ShortTumor grade code being reported using SNOMED
                  Comments

                  Observations can contain observations.

                  Control0..1
                  TypeReference(Histologic Grade)
                  Is Modifierfalse
                  Must Supporttrue
                  Summaryfalse
                  Requirements

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

                  Alternate NamesData, Atomic Value, Result, Atomic result, Data, Test, Analyte, Battery, Organizer
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  52. 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()))
                  54. 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()))
                  56. 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
                  58. 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())
                  60. 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())
                  62. 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()))
                  64. 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()))
                  66. DiagnosticReport.conclusion
                  Definition

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

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

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

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

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

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

                  Diagnosis codes provided as adjuncts to the report.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  70. 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()))