XpanDH Laboratory Report
0.1.0 - ci-build 150

XpanDH Laboratory Report, published by XpanDH Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/xpandh-lab/ and changes regularly. See the Directory of published versions

Resource Profile: DiagnosticReportLabXpandh - Detailed Descriptions

Draft as of 2024-09-02

Definitions for the DiagnosticReport-lab-xpandh resource profile.

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

0. DiagnosticReport
2. DiagnosticReport.basedOn
TypeReference(ServiceRequest: Laboratory Order)
4. DiagnosticReport.code
BindingThe codes SHALL be taken from Laboratory Report Types
(required to http://hl7.eu/fhir/laboratory/ValueSet/lab-reportType-eu-lab)
6. DiagnosticReport.subject
TypeReference(Patient)
8. DiagnosticReport.result
TypeReference(Observation Results: laboratory)

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

0. DiagnosticReport
Definition

Laboratory Report DiagnosticReport


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.

ShortLaboratory Report DiagnosticReportA 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.

Control10..*
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:DiagnosticReportCompositionR5
    Slice NameDiagnosticReportCompositionR5
    Definition

    This extension implements the R5 composition element. It allow to link this DiagnosticReport with the Composition documenting this Laboratory Report.

    ShortAssociated Lab Report Composition
    Control1..1
    This element is affected by the following invariants: ele-1
    TypeExtension(Extension Definition for DiagnosticReport.composition for Version 5.0) (Extension Type: Reference(Composition))
    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:DiagnosticReportCompositionR5.extension
    Definition

    An Extension


    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.

    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..0*
    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.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 10. DiagnosticReport.extension:DiagnosticReportCompositionR5.url
      Definition

      Source of the definition for the extension code - a logical name or a URL.

      Shortidentifies the meaning of the extension
      Comments

      The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

      Control1..1
      Typeuri
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-DiagnosticReport.composition
      12. DiagnosticReport.extension:DiagnosticReportCompositionR5.value[x]
      Definition

      Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

      ShortValue of extension
      Control10..1
      TypeReference(Composition: Laboratory Report), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      14. 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())
      16. 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(ServiceRequest: Laboratory Order, 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()))
      18. DiagnosticReport.status
      Definition

      The status of the diagnostic report.

      ShortStatus of the Reportregistered | partial | preliminary | final +
      Comments

      DiagnosticReport.status and Composition.status shall be aligned, based on the http://hl7.eu/fhir/laboratory/ConceptMap/ConceptMap-eu-diagRptStatus2CompStatus mapping

      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()))
      20. DiagnosticReport.category
      Definition

      A code that classifies this laboratory report. Two basic categories has been selected in this guide: laboratory specialty and Study type. Laboratory specialty is characteristic of the laboratory that produced the test result while Study type is an arbitrary classificion of the test type.


      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.

      ShortReport CategoryService category
      Comments

      DiagnosticReport.category and Composition.category shall be aligned


      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.

      Control0..*
      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(Codeable Concept (IPS))
      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:
      • pattern @ $this
      • 22. DiagnosticReport.category:studyType
        Slice NamestudyType
        Definition

        Laboratory services, i.e., results of tests performed, could be characterized using typology of services, commonly called study types. Study type could be seen as an attribute or grouping mechanism that assigns a common clinical sense to certain types of laboratory test results., e.g., Hemoglobin, Platelet count, etc. belongs to 'Hematology study'.


        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.

        ShortThe way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.)Service category
        Comments

        In comparison to the laboratory specialty which is an attribute of laboratory, study type is a categorization of laboratory service. It needs to be mentioned that classification of test to study types in not standardized.


        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.

        Control0..*
        BindingThe codes SHALL be taken from For example codes, see Laboratory Study Typeshttp://hl7.org/fhir/ValueSet/diagnostic-service-sections
        (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab)
        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()))
        24. DiagnosticReport.category:specialty
        Slice Namespecialty
        Definition

        Laboratory specialty is an attribute of any laboratory setting representing professional qualification of the laboratory to execute certain kind of laboratory tests.


        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.

        ShortThe clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry)Service category
        Comments

        Specialty could be used as parameter for searching/querying of laboratory test results.


        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.

        Control0..*
        BindingThe codes SHALL be taken from For example codes, see Laboratory Specialtyhttp://hl7.org/fhir/ValueSet/diagnostic-service-sections
        (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab)
        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()))
        26. DiagnosticReport.code
        Definition

        Specifies that it refers to a Laboratory Report


        A code or name that describes this diagnostic report.

        ShortType of (Laboratory) ReportName/Code for this diagnostic report
        Comments

        At least one DiagnosticReport.code.coding and Composition.type.coding SHALL be equal

        Control1..1
        This element is affected by the following invariants: ele-1
        BindingThe codes SHALL be taken from The codes SHOULD be taken from Laboratory Report Typeshttp://hl7.org/fhir/ValueSet/report-codes
        (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-reportType-eu-lab)
        TypeCodeableConcept(Codeable Concept (IPS))
        Is Modifierfalse
        Alternate NamesType
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        28. DiagnosticReport.subject
        Definition

        Who or what this report is about. The report can be about a human patient, a living subject, a device (e.g. a machine), a location or even a group of subjects (such as a document about a herd of livestock, or a set of patients that share a common exposure).


        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.

        ShortWho and/or what this report is aboutThe subject of the report - usually, but not always, the patient
        Comments

        DiagnosticReport and Composition SHALL have the same subject

        Control10..1
        TypeReference(Patient, 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()))
        30. DiagnosticReport.result
        Definition

        Observations that are part of this diagnostic report.

        ShortresultsObservations
        Comments

        Observations can contain observations.

        Control0..*
        TypeReference(Observation Results: laboratory, 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()))
        32. 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..0*
        TypeReference(ImagingStudy)
        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

        Laboratory Report DiagnosticReport

        ShortLaboratory Report DiagnosticReport
        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
        Control1..*
        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:DiagnosticReportCompositionR5
          Slice NameDiagnosticReportCompositionR5
          Definition

          This extension implements the R5 composition element. It allow to link this DiagnosticReport with the Composition documenting this Laboratory Report.

          ShortAssociated Lab Report Composition
          Control1..1
          This element is affected by the following invariants: ele-1
          TypeExtension(Extension Definition for DiagnosticReport.composition for Version 5.0) (Extension Type: Reference(Composition))
          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:DiagnosticReportCompositionR5.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
          20. DiagnosticReport.extension:DiagnosticReportCompositionR5.extension
          Definition

          An Extension

          ShortExtension
          Control0..0
          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.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 22. DiagnosticReport.extension:DiagnosticReportCompositionR5.url
            Definition

            Source of the definition for the extension code - a logical name or a URL.

            Shortidentifies the meaning of the extension
            Comments

            The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

            Control1..1
            Typeuri
            Is Modifierfalse
            XML FormatIn the XML format, this property is represented as an attribute.
            Summaryfalse
            Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-DiagnosticReport.composition
            24. DiagnosticReport.extension:DiagnosticReportCompositionR5.value[x]
            Definition

            Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

            ShortValue of extension
            Control1..1
            TypeReference(Composition: Laboratory Report)
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            26. 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())
            28. DiagnosticReport.identifier
            Definition

            Identifiers assigned to this Laboratory Report by the performer or other systems. It shall be common to several report versions

            ShortReport identifier
            Comments

            Composition.identifier SHALL be equal to one of the DiagnosticReport.identifier, if at least one exists

            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()))
            30. 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(ServiceRequest: Laboratory Order)
            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()))
            32. DiagnosticReport.status
            Definition

            The status of the diagnostic report.

            ShortStatus of the Report
            Comments

            DiagnosticReport.status and Composition.status shall be aligned, based on the http://hl7.eu/fhir/laboratory/ConceptMap/ConceptMap-eu-diagRptStatus2CompStatus mapping

            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()))
            34. DiagnosticReport.category
            Definition

            A code that classifies this laboratory report. Two basic categories has been selected in this guide: laboratory specialty and Study type. Laboratory specialty is characteristic of the laboratory that produced the test result while Study type is an arbitrary classificion of the test type.

            ShortReport Category
            Comments

            DiagnosticReport.category and Composition.category shall be aligned

            Control0..*
            BindingFor example codes, see DiagnosticServiceSectionCodes
            (example to http://hl7.org/fhir/ValueSet/diagnostic-service-sections)

            Codes for diagnostic service sections.

            TypeCodeableConcept(Codeable Concept (IPS))
            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:
            • pattern @ $this
            • 36. DiagnosticReport.category:studyType
              Slice NamestudyType
              Definition

              Laboratory services, i.e., results of tests performed, could be characterized using typology of services, commonly called study types. Study type could be seen as an attribute or grouping mechanism that assigns a common clinical sense to certain types of laboratory test results., e.g., Hemoglobin, Platelet count, etc. belongs to 'Hematology study'.

              ShortThe way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.)
              Comments

              In comparison to the laboratory specialty which is an attribute of laboratory, study type is a categorization of laboratory service. It needs to be mentioned that classification of test to study types in not standardized.

              Control0..*
              BindingThe codes SHALL be taken from Laboratory Study Types
              (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab)
              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()))
              38. DiagnosticReport.category:specialty
              Slice Namespecialty
              Definition

              Laboratory specialty is an attribute of any laboratory setting representing professional qualification of the laboratory to execute certain kind of laboratory tests.

              ShortThe clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry)
              Comments

              Specialty could be used as parameter for searching/querying of laboratory test results.

              Control0..*
              BindingThe codes SHALL be taken from Laboratory Specialty
              (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab)
              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()))
              40. DiagnosticReport.code
              Definition

              Specifies that it refers to a Laboratory Report

              ShortType of (Laboratory) Report
              Comments

              At least one DiagnosticReport.code.coding and Composition.type.coding SHALL be equal

              Control1..1
              This element is affected by the following invariants: ele-1
              BindingThe codes SHALL be taken from Laboratory Report Types
              (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-reportType-eu-lab)
              TypeCodeableConcept(Codeable Concept (IPS))
              Is Modifierfalse
              Alternate NamesType
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              42. DiagnosticReport.subject
              Definition

              Who or what this report is about. The report can be about a human patient, a living subject, a device (e.g. a machine), a location or even a group of subjects (such as a document about a herd of livestock, or a set of patients that share a common exposure).

              ShortWho and/or what this report is about
              Comments

              DiagnosticReport and Composition SHALL have the same subject

              Control1..1
              TypeReference(Patient)
              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()))
              44. DiagnosticReport.encounter
              Definition

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

              ShortThe healthcare event which this Laboratory Report is about (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).

              DiagnosticReport and Composition SHALL have the same encounter.

              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()))
              46. 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
              TypeChoice of: dateTime, 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()))
              48. 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()))
              50. DiagnosticReport.performer
              Definition

              The diagnostic service that is responsible for issuing the report.

              ShortResponsible Diagnostic Service.
              Comments

              If a DiagnosticReport.resultsInterpreter exists this is expected to be a Composition.author; otherwise a DiagnosticReport.performer should be an author.

              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()))
              52. DiagnosticReport.resultsInterpreter
              Definition

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

              ShortPrimary result interpreter
              Comments

              If a DiagnosticReport.resultsInterpreter exists this is expected to be a Composition.author; otherwise a DiagnosticReport.performer should be an author.

              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()))
              54. 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: Laboratory)
              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()))
              56. DiagnosticReport.result
              Definition

              Observations that are part of this diagnostic report.

              Shortresults
              Comments

              Observations can contain observations.

              Control0..*
              TypeReference(Observation Results: laboratory)
              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()))
              58. 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..0
              TypeReference(ImagingStudy)
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              60. 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()))
              62. 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
              64. 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())
              66. 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())
              68. 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()))
              70. 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()))
              72. 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()))
              74. 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()))
              76. 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 (pdf recommended)
              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()))