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: US Core DiagnosticReport Profile for Laboratory Results Reporting

Official URL: http://hl7.org/fhir/us/core/StructureDefinition/us-core-diagnosticreport-lab Version: 8.0.0
Standards status: Trial-use Computable Name: USCoreDiagnosticReportProfileLaboratoryReporting
Other Identifiers: OID:2.16.840.1.113883.4.642.40.2.42.20

Copyright/Legal: Used by permission of HL7 International, all rights reserved Creative Commons License

The US Core DiagnosticReport Profile for Laboratory Results Reporting inherits from the FHIR DiagnosticReport resource; refer to it for scope and usage definitions. Laboratory results are grouped and summarized using the DiagnosticReport resource, which typically references Observation resource(s). Each Observation resource represents an individual laboratory test and result value or component result values or a nested panel (such as a microbial susceptibility panel) that references other observations. Laboratory results can also be presented in report form or as free text. This profile sets minimum expectations for the DiagnosticReport resource to record, search, and fetch laboratory results associated with a patient. It specifies which core elements, extensions, vocabularies, and value sets SHALL be present and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption.

Example Usage Scenarios:

The following are example usage scenarios for the US Core DiagnosticReport Profile for Laboratory Results Reporting:

  • Query for lab reports belonging to a Patient
  • Record or update a lab report for a specific Patient

Mandatory and Must Support Data Elements

The following data elements must always be present (Mandatory definition) or must be supported if the data is present in the sending system (Must Support definition). They are presented below in a simple human-readable explanation. Profile specific guidance and examples are provided as well. The Formal Views below provides the formal summary, definitions, and terminology requirements.

Each DiagnosticReport Must Have:

  1. a status
  2. a category code of 'LAB'
  3. a code (preferably a LOINC code) which tells you what is being measured
  4. a patient
  5. the diagnostically relevant time (known as the "effective time" and typically the time of specimen collection)*
  6. when the report was released*

*These elements have the following constraints: SHALL be present if status is 'partial', 'preliminary', 'final', 'amended', 'corrected', or 'appended'.

Each DiagnosticReport Must Support:

  1. a timestamp when the resource last changed*
  2. encounter associated with DiagnosticReport
  3. who issues the report*
  4. a results interpreter*
  5. a result

* see guidance below

Profile Specific Implementation Guidance:

  • Additional codes that translate or map to the DiagnosticReport codes or category codes are allowed. For example:
    • providing both a local system code and a LOINC code that it maps to
    • providing a more specific category code to the "LAB" category code, such as "CH" (chemistry), in an additional coding element.

  • *The profile elements DiagnosticReport.performer and DiagnosticReport.resultsInterpreter communicate the individual level provenance author data corresponding to the U.S. Core Data for Interoperability (USCDI) Provenance Author Data Elements.

  • Results that are free text or report form are represented using the 'presentedForm' element in DiagnosticReport.
  • * See the US Core General Guidance page for Searching Using lastUpdated. Updates to Meta.lastUpdated SHOULD reflect:
    • New laboratory reports
    • Changes in the status of laboratory reports, including events that trigger the same status (e.g., amended → amended).

Usage:

Changes since version 7.0.0:

  • The data elements list has changed

    • Formal Views of Profile Content

    Description of Profiles, Differentials, Snapshots and how the different presentations work.

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. DiagnosticReport C 0..* DiagnosticReport A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
    dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
    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
    dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
    dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
    dom-6: A resource should have narrative for robust management
    us-core-8: effective[x] SHALL be present if the status is 'partial', 'preliminary', 'final', 'amended', 'corrected' or 'appended'
    us-core-9: issued SHALL be present if the status is 'partial', 'preliminary', 'final', 'amended', 'corrected' or 'appended'
    ... meta SΣ 0..1 Meta Metadata about the resource
    ele-1: All FHIR elements must have a @value or children
    .... lastUpdated SΣ 0..1 instant When the resource last changed
    ele-1: All FHIR elements must have a @value or children
    ... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
    ele-1: All FHIR elements must have a @value or children
    ... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
    ele-1: All FHIR elements must have a @value or children
    ext-1: Must have either extensions or value[x], not both
    ... status ?!SΣC 1..1 code registered | partial | preliminary | final +
    Binding: DiagnosticReportStatus (required)
    ele-1: All FHIR elements must have a @value or children
    ... Slices for category SΣ 1..* CodeableConcept Service category
    Slice: Unordered, Open by value:$this
    Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections.


    ele-1: All FHIR elements must have a @value or children
    .... category:LaboratorySlice SΣ 1..1 CodeableConcept Service category
    Binding: DiagnosticServiceSectionCodes (example): Codes for diagnostic service sections.


    ele-1: All FHIR elements must have a @value or children

    Required Pattern: At least the following
    ..... coding 1..* Coding Code defined by a terminology system
    Fixed Value: (complex)
    ...... system 1..1 uri Identity of the terminology system
    Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0074
    ...... code 1..1 code Symbol in syntax defined by the system
    Fixed Value: LAB
    ... code SΣ 1..1 CodeableConcept US Core Laboratory Report Order Code
    Binding: US Core Laboratory Test Codes (extensible): LOINC codes


    ele-1: All FHIR elements must have a @value or children
    ... subject SΣ 1..1 Reference(US Core Patient Profile) The subject of the report - usually, but not always, the patient
    ele-1: All FHIR elements must have a @value or children
    ... encounter SΣ 0..1 Reference(US Core Encounter Profile) Encounter associated with DiagnosticReport
    ele-1: All FHIR elements must have a @value or children
    ... effective[x] SΣC 0..1 Diagnostically relevant time (typically the time of specimen collection)
    ele-1: All FHIR elements must have a @value or children
    .... effectiveDateTime dateTime
    ... issued SΣC 0..1 instant When the report was released
    ele-1: All FHIR elements must have a @value or children
    ... performer SΣ 0..* Reference(US Core Practitioner Profile) Responsible Diagnostic Service
    ele-1: All FHIR elements must have a @value or children
    ... resultsInterpreter SΣ 0..* Reference(US Core Practitioner Profile) Primary result interpreter
    ele-1: All FHIR elements must have a @value or children
    ... result S 0..* Reference(US Core Laboratory Result Observation Profile) Observations
    ele-1: All FHIR elements must have a @value or children

    doco Documentation for this format

    Terminology Bindings

    PathConformanceValueSet / CodeURI
    DiagnosticReport.statusrequiredDiagnosticReportStatus
    http://hl7.org/fhir/ValueSet/diagnostic-report-status
    from the FHIR Standard
    DiagnosticReport.categoryexampleDiagnosticServiceSectionCodes
    http://hl7.org/fhir/ValueSet/diagnostic-service-sections
    from the FHIR Standard
    DiagnosticReport.category:LaboratorySliceexamplePattern: LAB
    http://hl7.org/fhir/ValueSet/diagnostic-service-sections
    from the FHIR Standard
    DiagnosticReport.codeextensibleUSCoreLaboratoryTestCodes
    http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
    from this IG

    Constraints

    IdGradePath(s)DetailsRequirements
    us-core-8errorDiagnosticReporteffective[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-9errorDiagnosticReportissued 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()

     

    Other representations of profile: CSV, Excel, Schematron

    Notes:

    Quick Start

    Below is an overview of the required Server RESTful FHIR interactions for this profile - for example, search and read operations - when supporting the US Core interactions to access this profile's information (Profile Support + Interaction Support). Note that systems that support only US Core Profiles (Profile Only Support) are not required to support these interactions. See the US Core Server CapabilityStatement for a complete list of supported RESTful interactions for this IG.

    • See the Scopes Format section for a description of the SMART scopes syntax.
    • See the Search Syntax section for a description of the US Core search syntax.
    • See the General Requirements section for additional rules and expectations when a Server requires status parameters.
    • See the General Guidance section for additional guidance on searching for multiple patients.

    US Core Scopes

    Servers providing access to laboratory data SHALL support these US Core SMART Scopes:

    Mandatory Search Parameters:

    The following search parameters and search parameter combinations SHALL be supported:

    1. SHALL support searching for all diagnosticreports for a patient using the patient search parameter:

      GET [base]/DiagnosticReport?patient={Type/}[id]

      Example:

      1. GET [base]/DiagnosticReport?patient=1137192

      Implementation Notes: Fetches a bundle of all DiagnosticReport resources for the specified patient (how to search by reference)

    2. SHALL support searching using the combination of the patient and category search parameters:

      GET [base]/DiagnosticReport?patient={Type/}[id]&category=http://terminology.hl7.org/CodeSystem/v2-0074|LAB

      Example:

      1. GET [base]/DiagnosticReport?patient=f201&category=http://terminology.hl7.org/CodeSystem/v2-0074|LAB

      Implementation Notes: Fetches a bundle of all DiagnosticReport resources for the specified patient and a category code = LAB (how to search by reference and how to search by token)

    3. SHALL support searching using the combination of the patient and code search parameters:
      • including optional support for OR search on code (e.g.code={system|}[code],{system|}[code],...)

      GET [base]/DiagnosticReport?patient={Type/}[id]&code={system|}[code]{,{system|}[code],...}

      Example:

      1. GET [base]/DiagnosticReport?patient=1032702&code=http://loinc.org|24323-8

      Implementation Notes: Fetches a bundle of all DiagnosticReport resources for the specified patient and report code(s). SHOULD support search by multiple report codes. (how to search by reference and how to search by token)

    4. SHALL support searching using the combination of the patient and category and date search parameters:
      • including support for these date comparators: gt,lt,ge,le
      • including optional support for AND search on date (e.g.date=[date]&date=[date]]&...)

      GET [base]/DiagnosticReport?patient={Type/}[id]&category=http://terminology.hl7.org/CodeSystem/v2-0074|LAB&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}

      Example:

      1. GET [base]/DiagnosticReport?patient=f201&category=http://terminology.hl7.org/CodeSystem/v2-0074|LAB&date=ge2010-01-14T00:00:00Z

      Implementation Notes: Fetches a bundle of all DiagnosticReport resources for the specified patient and date and a category code = LAB (how to search by reference and how to search by token and how to search by date)

    Optional Search Parameters:

    The following search parameter combinations SHOULD be supported:

    1. SHOULD support searching using the combination of the patient and status search parameters:
      • including support for OR search on status (e.g.status={system|}[code],{system|}[code],...)

      GET [base]/DiagnosticReport?patient={Type/}[id]&status={system|}[code]{,{system|}[code],...}

      Example:

      1. GET [base]/DiagnosticReport?patient=1137192&status=completed

      Implementation Notes: Fetches a bundle of all DiagnosticReport resources for the specified patient and status (how to search by reference and how to search by token)

    2. SHOULD support searching using the combination of the patient and code and date search parameters:
      • including optional support for OR search on code (e.g.code={system|}[code],{system|}[code],...)
      • including support for these date comparators: gt,lt,ge,le
      • including optional support for AND search on date (e.g.date=[date]&date=[date]]&...)

      GET [base]/DiagnosticReport?patient={Type/}[id]&code={system|}[code]{,{system|}[code],...}&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}

      Example:

      1. GET [base]/DiagnosticReport?patient=f201&code=http://loinc.org|24323-8&date=ge2019-01-14T00:00:00Z

      Implementation Notes: Fetches a bundle of all DiagnosticReport resources for the specified patient and date and report code(s). SHOULD support search by multiple report codes. (how to search by reference and how to search by token and how to search by date)

    3. SHOULD support searching using the combination of the patient and category and _lastUpdated search parameters:
      • including support for these _lastUpdated comparators: gt,lt,ge,le
      • including optional support for AND search on _lastUpdated (e.g._lastUpdated=[date]&_lastUpdated=[date]]&...)

      GET [base]/DiagnosticReport?patient={Type/}[id]&category={system|}[code]&_lastUpdated={gt|lt|ge|le}[date]{&_lastUpdated={gt|lt|ge|le}[date]&...}

      Example:

      1. GET [base]/DiagnosticReport?patient=f201&category=http://terminology.hl7.org/CodeSystem/v2-0074|LAB&_lastUpdated=ge2010-01-14T00:00:00Z

      Implementation Notes: Fetches a bundle of all DiagnosticReport resources for the specified patient and a category code = LAB and _lastUpdated. See the US Core General Guidance page for Searching Using lastUpdated. (how to search by reference and how to search by token and how to search by date)