HL7 Europe Laboratory Report
2.2.0-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 2.2.0-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 2.1.0

Version 2.1.0 is an STU update of the 2.0.0 release. Alongside the corrections listed below it adds capability the published version does not offer, which is why it is an update rather than a technical correction.

  • 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.
    • FHIR-57051 / FHIR-57901: Added Specimen-collection-example, a capillary blood specimen the patient collected themselves, with the collection body site conveyed through the R5 cross-version extension and the collector through the alternate-reference extension.
    • FHIR-57050: Added Specimen-focus-bdp-example, a sample drawn from a red blood cell unit, where the entity the specimen was collected from is a BiologicallyDerivedProduct and the subject of record is the patient.
    • FHIR-57055: Added obs-focus-substance-example and obs-focus-bdp-example, results about a substance and about a blood unit rather than about the patient directly.
    • FHIR-57208: Added obs-status-reason-example, a cancelled result carrying the reason for that status.
    • FHIR-57208 / FHIR-57444: Added dr-status-reason-media-example, a corrected report carrying the reason for that status and the additional data in DiagnosticReport.media, together with the result it is issued for.

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).