HL7 Europe Laboratory Report
2.0.1-ci - ci-build 150

HL7 Europe Laboratory Report, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 2.0.1-ci built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/laboratory/ and changes regularly. See the Directory of published versions

Change Log

This page summarizes the main changes applied to this version of the guide.

From 2.0.0 to 2.0.1

  • Profiles and constraints
    • FHIR-57444: Removed the Composition.section:attachment slice, following the resolution of FHIR-53138. Additional data such as images or diagrams is conveyed through DiagnosticReport.media, whose definition and short description were clarified.
    • FHIR-57208: Added an optional statusReason extension to ObservationResultsLaboratoryEu and DiagnosticReportLabEu, together with a note on status that the statuses amended, corrected, cancelled and entered-in-error should be accompanied by the reason for that status.
    • FHIR-55966: Added the optional lowComparator and highComparator modifier extensions on Observation.referenceRange, pre-adopting the R6 solution for exclusive or explicitly inclusive bounds.
    • FHIR-57055: Added Substance and BiologicallyDerivedProduct to the reference targets of Observation.focus, now that the EU core profile allows them.
    • FHIR-57050: Added Patient and BiologicallyDerivedProduct to the reference targets of the SpecimenFocus extension. The Specimen profile no longer narrows those targets a second time.
    • FHIR-57901: Allowed a patient or a related person as the specimen collector, through the alternate-reference extension on Specimen.collection.collector.
    • FHIR-57547: Removed the enumerated subject target types. DiagnosticReportLabEu and ServiceRequestLabEu now name exactly what the base resource allows, with the patient pinned to patient-eu-core. The animal patient profile is no longer named as a possible subject; the profile itself stays.
    • FHIR-57895: Removed the 1.. constraint on Specimen.type.
    • FHIR-57043: Removed the definition of the Laboratory Accredited extension. It is defined in the HL7 Europe Extensions IG from now on, under the unchanged canonical http://hl7.eu/fhir/StructureDefinition/laboratory-accredited. The profiles keep referencing it, so nothing changes for implementers.
  • Technical corrections
    • FHIR-57051: Replaced the extension used on Specimen.collection.bodySite. The profile used http://hl7.org/fhir/StructureDefinition/bodySite, whose context is Procedure.bodySite and which was therefore never allowed here. It is replaced by the cross-version extension extension-Specimen.collection.bodySite, which declares the matching context and, carrying the reference half of what became a CodeableReference in R5, is nested under the bodySite element rather than under collection. Instances that use the old extension have to be migrated.
    • FHIR-58773: Set Specimen.container.extension:device to 1..1. The R5 cross-version extension defines its own root as 1..1 while the profile constrained the slice to 0..1 โ€” a mismatch no tooling reports, because the cardinality of a contains rule is only checked against the base element. Specimen.container itself stays 0..*, so the constraint applies only where a container is present.
    • FHIR-57047: Removed the closed slicing on Observation.value[x] and Observation.component.value[x]. The parent profile medicalTestResult-eu-core already defines the same discriminator with an open slicing, so data types beyond the listed slices are no longer prohibited. The listed slices and their constraints are unchanged.
    • FHIR-57048: Removed the additional bindings on Observation.value[x]:valueCodeableConcept and Observation.component.value[x]:valueCodeableConcept. The value set bound to the element already composes the IPS blood group, presence/absence, microorganism and pathology value sets, so the additional bindings covered ground the basic binding covers.
    • FHIR-56821: Updated the eu-lab-1 and eu-lab-2 invariants to recognise the R5 value[x] and component.value[x] cross-version extensions, which they rejected before, and added examples covering every valid way a laboratory result value may be expressed. Removed the pinned version from the extension canonicals in the aliases.
    • FHIR-57057: Changed eu-lab-1 and eu-lab-2 to test hasValue() instead of exists(), so that an element carrying an extension but no value no longer satisfies the invariant.
    • FHIR-57052: Restricted dr-comp-enc and dr-comp-subj to comparing Reference.reference, and only where both references are present. Comparing the whole Reference reported a difference in display text or identifier as an error.
    • FHIR-57053: Changed dr-comp-type to compare system, version and code rather than the whole coding, and removed dr-comp-category together with its obeys rule: the two categories need not be the same, one classifies the document and the other the medical discipline of the report.
  • Terminology
    • FHIR-57058: Reworked the description of LabStudyTypesEuVs. Markdown collapses single line breaks, so the notes were rendered as a single paragraph, and their labels had no space after the colon.
  • Guidance
    • FHIR-56397: Added guidance on the resource types most commonly expected in ServiceRequest.supportingInfo, while keeping its target types open.
    • FHIR-57046: Kept the guidance that Composition.identifier has to equal one of the DiagnosticReport.identifier and pointed it at the invariant that enforces it, dr-comp-identifier in the constraints section of the Bundle profile.
  • Examples
    • FHIR-58773: Added Specimen-container-device-example, a blood specimen collected into an evacuated tube whose container is described by a contained Device referenced through the extension.

From 0.1.1 to 2.0.0

๐Ÿ”ง Model Alignment and Refactoring

  • Aligned model maps with the Xt-EHR model (FHIR-53126).
  • Added attachments section (FHIR-53138).
  • Updated dependencies, including fix to hl7.fhir.eu.extensions.r4 (FHIR-53210).
  • Updated bodyStructure references (FHIR-44969).
  • Updated resource references to align with revised base profile names (FHIR-44969).
  • Updated DIagRptStatus-to-CompStatus-map.fsh (FHIR-53126).
  • Added terminology expansion parameter support and documentation updates (sct-expansion-params.fsh, index updates).

๐Ÿงน Scope Reduction and Cleanup

  • Removed ConceptMaps and associated diagrams (FHIR-53126).
  • Removed logical models based on the eHN guidelines (FHIR-53126).
  • Cleaned up obsolete or unused configuration elements (FHIR-53210, FHIR-53224).

๐Ÿงช Profiles, Bundles, and Examples

  • Updated lab-related profiles:

    • bundle.fsh
    • bundle-lab.fsh
    • composition-lab.fsh
    • diagnosticReport-lab.fsh
    • observation-lab.fsh (FHIR-44969, FHIR-53224, FHIR-53529, FHIR-53584, FHIR-55624, FHIR-56181)
  • Updated animal/device related profile handling (FHIR-50157, FHIR-53530, FHIR-56314).
  • Added dedicated device profiles and related value sets for laboratory reporting (FHIR-53530).
  • Added and aligned laboratory accreditation extension usage across Observation/ServiceRequest and examples (FHIR-53127, FHIR-53224).
  • Added cross-version support for DiagnosticReport.media.link mapping.
  • Added missing-data guidance and alignment of animal examples to RelatedPerson-based representation (FHIR-56314, FHIR-55624).
  • Updated bundle definitions:

    • Bundle-MicroCultureSuscLabResultDetailed.fsh
    • Bundle-IT-CDA2FHIR.fsh
    • Bundle-HepatitisPanel.fsh (FHIR-53224, FHIR-55624, FHIR-56181)
  • Created and refined NPU-microbiology-example.fsh (maintainance update, no dedicated FHIR tracker).
  • Updated example definitions and references (Examples.fsh) (FHIR-55624, FHIR-56314).
  • Updated alias definitions (alias-systems.fsh, alias-lab.fsh) (FHIR-46043, FHIR-53210, FHIR-53224, FHIR-53529).
  • Added guidance on result ordering/grouping and section modeling variants in lab report narrative.
  • Added guidance on MTR/LTR, panels, and reflex tests.

๐Ÿ›  Build and Infrastructure

  • Updated sushi-config.yaml and aliases (FHIR-53210, FHIR-53224).
  • Fixed QA errors (FHIR-53224).
  • Added new supporting scripts
  • Updated documentation (README.md, index.md) (FHIR-53126).

From 0.1.0 to 0.1.1

  • Obligation codes fixed.
  • Obligation URL fixed.
  • Invariant pat-cnt-2or3-char error fixed.
  • Fixed typos.
  • Fixed ConceptMap.sourceUri and ConceptMap.targetUri errors.
  • Changed pattern discriminator to value.
  • Implemented a workaround to fix the issue with polymorphic element for R5 extension.
  • Bundle profile: changed the cardinality of the Patient slice to ..* (fix).
  • Added missing example binding for Patient.animal.
  • Updated some non-required value sets (Body Structure site laterality; site Qualifier; Specimen Types; Lab Technique) (FHIR-46043).