US Core Implementation Guide
8.0.0 - STU 8 United States of America flag

US Core Implementation Guide, published by HL7 International / Cross-Group Projects. This guide is not an authorized publication; it is the continuous build for version 8.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/US-Core/ and changes regularly. See the Directory of published versions

Resource Profile: USCoreDiagnosticReportProfileLaboratoryReporting - Detailed Descriptions

Page standards status: Trial-use

Definitions for the us-core-diagnosticreport-lab resource profile.

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.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
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. DiagnosticReport.meta.lastUpdated
Definition

When the resource last changed - e.g. when the version changed.

ShortWhen the resource last changedWhen the resource version last changed
Comments

This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

Control0..1
Typeinstant
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
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.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 areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ $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 Laboratory Test Codeshttp://hl7.org/fhir/ValueSet/report-codes
    (extensible to http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes)

    LOINC codes


    Codes that describe Diagnostic Reports.

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

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

    ShortThe subject of the report - usually, but not always, the patient
    Control10..1
    TypeReference(US Core Patient Profile, Group, Device, US Core Location Profile, Patient, Location)
    Is Modifierfalse
    Must Supporttrue
    Must Support TypesReference(US Core Patient Profile)
    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.encounter
    Definition

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

    ShortEncounter associated with DiagnosticReportHealth 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(US Core Encounter Profile, Encounter)
    Is Modifierfalse
    Must Supporttrue
    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()))
    22. DiagnosticReport.effective[x]
    Definition

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

    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] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Must Support TypesdateTime
    Summarytrue
    Requirements

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

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

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

    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()))
    26. 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()))
    28. 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(US Core Practitioner Profile, US Core Organization Profile, PractitionerRole, US Core CareTeam Profile, Practitioner, Organization, CareTeam)
    Is Modifierfalse
    Must Supporticon Added:true
    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 NamesAnalyzed by, Reported by
    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.

    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()))