MII IG Laborbefund
2027.0.0-ballot - Germany

MII IG Laborbefund - Local Development build (v2027.0.0-ballot) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Changelog

Version: 2027.0.0-ballot

Ballot version for 2027.0.0. It contains the following changes compared to the previous version 2026.0.3.

FHIR / Content Changes:

General:

  • All profiles, ValueSets, the CapabilityStatement and the ImplementationGuide resource carry CRMI metadata (shareable, publishable, ValueSets additionally computable), including approval and review date, effective period, version policy, package provenance and contributors. See Metadata Overview.
  • The package id is now de.medizininformatikinitiative.kerndatensatz.laborbefund, which is the id the module is distributed under. The repository previously declared …kerndatensatz.labor, so a consumer following the packageId stated in the guide could not resolve the package. The canonical is unaffected.
  • Pattern and fixed-value codings use unversioned system URLs; a versioned system URL would not match in a pattern. The ValueSet compositions remain version-bound.
  • Extension references in type.profile carry no version either. An extension slice matches on Extension.url, a uri without a version in the instance, so a version there fixes something that plays no part in matching. Which package version applies is stated in the dependencies; pin-canonicals fixes versions in the published output.
  • Coding.version is flagged Must Support on Observation.code, Observation.valueCodeableConcept and ServiceRequest.code.
  • The Meta module dependency is raised from 2026.0.0 to 2027.0.0-ballot, the version this module is balloted alongside. The CapabilityStatement references that module's Observation interpretation search parameter.

MII_PR_Labor_Laborbefund and MII_PR_Labor_Laboruntersuchung

  • category: category is sliced, open, with one mandatory slice carrying the mandatory HL7 coding — $v2-0074#LAB on the laboratory report, $observation-category#laboratory on the laboratory test. LOINC 26436-6 stays permitted as a further coding but is no longer required. The slicing deliberately sits on category, not on category.coding: category is 1..*, and constraints below a repeating element apply to every repetition, so on category.coding every further category would have to repeat the mandatory codes. A laboratory area belongs beside the mandatory slice as its own category entry. The slice names changed — v2-lab and observation-category; in 2026.0.3 they were lab-category. Names appear in validator messages and in profile diffs. Measured against the category shapes of every release since 2025.0.2, including the microbiology module's: all validate.

MII_PR_Labor_Laboruntersuchung

  • basedOn: NEW on the laboratory test — reference to the laboratory order it is based on. 0..*, constrained to Reference(ServiceRequest) and flagged Must Support (issue #82). The cardinality stays that of the base profile; basedOn is mandatory only on the laboratory report, and has been so unchanged since 2025.0.2.
  • code: The binding moves from code onto the new open slice code.coding[loinc], is tightened from preferred to extensible, and points at a different IPS ValueSet — results-laboratory-pathology-observations-uv-ips instead of results-laboratory-observations-uv-ips. Observation.code itself no longer carries a binding.
  • valueCodeableConcept: Extensible binding to the new ValueSet Coded laboratory result, which combines the qualitative and semiquantitative result ValueSets. The slices qualitativ and semiquantitativ originally foreseen have been dropped, because the two ValueSets overlap and can therefore not be discriminated.
  • interpretation: Extensible binding to the new ValueSet Interpretation, a restricted selection from HL7 v3 ObservationInterpretation (L, LU, N, H, HU). Locally common scales such as --, -, N, +, ++ or L N H map onto these; beyond the "alarm" limits the abnormal codes A, HH, LL and AA may additionally be used.
  • category: Definition made precise ("classification of the laboratory test within the diagnostic discipline and the laboratory group").
  • fix: Invariant mii-lab-2: the expression hasMember.exists() xor value.exists().not() implies dataAbsentReason.exists() did not evaluate as described and now reads hasMember.exists() or value.exists() or dataAbsentReason.exists() — at least one of the three elements has to be present.

MII_CPS_Labor_CapabilityStatement

  • Observation: search parameter based-on is now mandatory (SHALL); it had been commented out.
  • Observation: search parameter interpretation NEW and mandatory (SHALL). R4 defines no such search parameter; the definition in the Meta module is referenced instead, with identical code and type.
  • ServiceRequest: search parameter requester removed (issue #82).

ValueSets

  • NEW: MII_VS_Labor_Interpretation — a restricted selection from HL7 v3 ObservationInterpretation for assessing a laboratory result.
  • NEW: MII_VS_Labor_Laborergebnis_Codiert — the qualitative and semiquantitative result ValueSets combined.
  • MII_VS_Labor_Laborbereich: displays switched to the LOINC preferred terms (for example "Blood bank studies (set)" instead of "BLOOD BANK STUDIES"). The list of concepts itself is unchanged.
  • The CodeSystem references from hl7.terminology.r4 are version-bound (v2-0074 3.0.0, v2-0203 5.0.0, v3-ObservationInterpretation 4.0.0), because the package arrives in two states and resolution would otherwise be ambiguous.

Examples

  • mii-exa-labor-laborwert-ratio states its result as valueQuantity with the composed UCUM unit mg/(24.h) instead of as a valueRatio. A ratio cannot be reached through value-quantity — the R4 expression is (Observation.value as Quantity) | (Observation.value as SampledData) — while the CapabilityStatement requires that parameter as SHALL. The instance id keeps its -ratio suffix, because the URL has been published before.
  • The examples are named after what they contain rather than after their resource type: laboratory report and result creatinine, order full blood count, albumin in 24-hour urine, epithelial cells in urine sediment.

Logical Model

  • MII_LM_Labor: experimental set to false. status was already active.

Implementation Guide:

  • The guide is published with the IG Publisher instead of Simplifier, bilingual (English default, German translation) and rendered at the module URL.
  • New page Interpretations and Comments, treating the subject in three parts: the coded interpretation and which codes apply, the comments in Observation.note, and the interpretation-affecting properties. It sets out how the narrow FHIR sense of "interpretation" relates to its wider use in the Rili-BÄK and ISO 15189 (both linked), what a coded interpretation is worth for secondary use and where its data quality is limited.
  • The module description is split by subject: Laboratory Timestamps, Interpretations and Comments and Specimen are pages of their own.
  • The guidelines are cited uniformly across the guide as "Rili-BÄK 2023" and "ISO 15189:2024".
  • Project Context no longer describes the Microbiology module as planned — it is published — and now names the findings that belong there rather than in this module, together with how that module binds its examination types to LOINC.

Version: 2026.0.3

Version 2026.0.3 contains the following changes compared to the previous version 2026.0.2 (for a complete overview of the changes, the differential view on GitHub can be used).

Note: Version 2026.0.3 is a package release carrying out technical corrections. The Implementation Guide was not changed in substance.

FHIR / Content Changes:

General:

  • fix: Unification of the version designation of the 2026 artifacts on 2026.0.3; several profiles, extensions, ValueSets and the CapabilityStatement still referenced 2026.0.0.
  • fix: Update of the meta.profile and supportedProfile references from 2026.0.0 to 2026.0.3.

Examples:

  • fix: Update of the example instances to profile version 2026.0.3; some profile references still pointed at 2026.0.0.

Implementation Guide:

  • Update of the IG version from 2026.0.0 to 2026.0.3 in package.json, sushi-config.yaml, qc/custom.rules.yaml and the FSH rule sets.
  • Update of the reference to the current stable version in README.md from 2026.0.0 to 2026.0.3.

Version: 2026.0.2

Version 2026.0.2 contains the following changes compared to the previous version 2026.0.1 (for a complete overview of the changes, the differential view on GitHub can be used).

Note: Version 2026.0.2 is a package release carrying out technical corrections. The Implementation Guide was not changed in substance.

FHIR / Content Changes:

General:

  • fix: Correction of the dependency from hl7.fhir.uv.extensions to hl7.fhir.uv.extensions.r4, so that the R4 extensions in use resolve correctly.
  • fix: Version specification of the referenced FHIR ValueSet identifier-type on 4.0.1.

Examples:

  • fix: Correction of the LOINC display text in the example mii-exa-labor-laborwert ("hohe Vergrößerung").

Version: 2026.0.1

Version 2026.0.1 contains the following changes compared to the previous version 2026.0.0 (for a complete overview of the changes, the differential view on GitHub can be used).

Note: Version 2026.0.1 is a package release carrying out technical corrections. The Implementation Guide was not changed in substance.

FHIR / Content Changes:

General:

  • fix: hl7.fhir.uv.extensions was added as a dependency in order to support snapshot generation by Simplifier. MII_PR_Labor_Laboruntersuchung had no snapshot until then.

Version: 2026.0.0

Version 2026.0.0 contains the following changes compared to the previous version 2025.0.2 (for a complete overview of the changes, the differential view on GitHub can be used).

FHIR / Content Changes:

General:

  • All profiles and ValueSets now carry a CC BY 4.0 licence statement
  • Extended Must Support (MS) flags on the child elements of complex datatypes, for better interoperability
  • Improved multilingual documentation (German/English) with translation inserts for MS elements
  • All profiles: coding elements (system, code, display) are now flagged MS
  • Update of the IPS dependency to 2.0.0

MII_PR_Labor_Laboruntersuchung

  • New modifierExtension for interpretation-affecting properties (0..* MS)
    • Allows laboratory tests to be marked with particular properties that affect the interpretation of the laboratory value (for example haemolysis, lipaemia, icterus)
  • identifier[analyseBefundCode]: Short descriptions and definitions added
  • value[x]: Extended Must Support flags
  • effective[x]: Definition made precise as "clinical reference time"

MII_PR_Labor_Laboranforderung

  • Extended multilingual documentation

MII_PR_Labor_Laborbefund

  • category: Structural change from 1..1 MS to 1.. MS
    • New slice "lab-category" (1..1 MS) with pattern-based constraints
    • Replaces the previous coding slices (loinc-lab, diagnostic-service-sections)
    • category[lab-category] combines $loinc#26436-6 and $v2-0074#LAB as a pattern
    • category[lab-category].coding requires at least 2 codings (system, code, display as MS)

Extension - MII_EX_Labor_Interpretationsbeeinflussende_Probeneigenschaft (NEW)

  • New modifierExtension for marking interpretation-affecting properties
  • Context: Observation
  • value[x]: 1.. MS, only Coding permitted
  • Bound to the new ValueSet MII_VS_Labor_InterpretationsbeeinflussendeProbeneigenschaften_SNOMEDCT
  • Important: Flagged as isModifier, because the interpretation of the measured value is affected

Extension - MII_EX_Labor_Quelle_Klinisches_Bezugsdatum

  • Context extended: DiagnosticReport.effective.ofType(dateTime) added
  • CC BY 4.0 licence added

ValueSets

  • All ValueSets: CC BY 4.0 licence statement added
  • NEW: MII_VS_Labor_InterpretationsbeeinflussendeProbeneigenschaften_SNOMEDCT
    • Codes for haemolysis, lipaemia, icterus (SNOMED CT)

Implementation Guide:

  • Improved documentation of the timestamps in the laboratory
  • Documentation on interpretation-affecting specimen properties added
  • Updated examples for all profiles