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
This page summarizes the main changes applied to this version of the guide.
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.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.lowComparator and highComparator modifier extensions on Observation.referenceRange, pre-adopting the R6 solution for exclusive or explicitly inclusive bounds.Substance and BiologicallyDerivedProduct to the reference targets of Observation.focus, now that the EU core profile allows them.Patient and BiologicallyDerivedProduct to the reference targets of the SpecimenFocus extension. The Specimen profile no longer narrows those targets a second time.alternate-reference extension on Specimen.collection.collector.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.1.. constraint on Specimen.type.http://hl7.eu/fhir/StructureDefinition/laboratory-accredited. The profiles keep referencing it, so nothing changes for implementers.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.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.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.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.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.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.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.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.LabStudyTypesEuVs. Markdown collapses single line breaks, so the notes were rendered as a single paragraph, and their labels had no space after the colon.ServiceRequest.supportingInfo, while keeping its target types open.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.Specimen-container-device-example, a blood specimen collected into an evacuated tube whose container is described by a contained Device referenced through the extension.hl7.fhir.eu.extensions.r4 (FHIR-53210).bodyStructure references (FHIR-44969).DIagRptStatus-to-CompStatus-map.fsh (FHIR-53126).sct-expansion-params.fsh, index updates).Updated lab-related profiles:
bundle.fshbundle-lab.fshcomposition-lab.fshdiagnosticReport-lab.fshobservation-lab.fsh
(FHIR-44969, FHIR-53224, FHIR-53529, FHIR-53584, FHIR-55624, FHIR-56181)DiagnosticReport.media.link mapping.RelatedPerson-based representation (FHIR-56314, FHIR-55624).Updated bundle definitions:
Bundle-MicroCultureSuscLabResultDetailed.fshBundle-IT-CDA2FHIR.fshBundle-HepatitisPanel.fsh
(FHIR-53224, FHIR-55624, FHIR-56181)NPU-microbiology-example.fsh (maintainance update, no dedicated FHIR tracker).Examples.fsh) (FHIR-55624, FHIR-56314).alias-systems.fsh, alias-lab.fsh) (FHIR-46043, FHIR-53210, FHIR-53224, FHIR-53529).sushi-config.yaml and aliases (FHIR-53210, FHIR-53224).README.md, index.md) (FHIR-53126).pat-cnt-2or3-char error fixed.ConceptMap.sourceUri and ConceptMap.targetUri errors...* (fix).Patient.animal.