MII Implementation Guide Microbiology
2027.0.0-ballot2 - Germany

MII Implementation Guide Microbiology - Local Development build (v2027.0.0-ballot2) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Changelog

This document describes the significant changes per release of the IG.

Version Date Type Content
2027.0.0-ballot2 2026-09-14 Re-release, no content change The artefacts are identical to 2027.0.0-ballot; only the version they carry differs. The published package of that version was baked from a project state that still held 31 artefacts retired during this cycle, and it lacked the snapshot of mii-pr-mikrobio-probe.
2027.0.0-ballot 2026-09-14 Content update The information model was improved and uses FHIR data types instead of references to profile canonicals. It is split across three logical models: report, abstract investigation and investigation types. Targeted detection stays in one profile whatever the technique, culture included; general culture answers growth or no growth, and an indeterminate result goes to dataAbsentReason. Microscopy was split into an open and a targeted half, the staining technique moved into an extension of its own, and the MRE class reference was replaced by a category-based resistance category status (MRSA/VRE/LRE/LVRE, Positive/Negative); MRGN remains a standalone classification.
2027.0.0-alpha.5 2026-06-18 Content/technical update (preview) CapabilityStatement extended: DiagnosticReport added with the microbiology profile, supported search parameters for Observation and DiagnosticReport completed and aligned with the SearchParameters of the Laboratory module, and local SearchParameters for Observation.interpretation and triggeredBy added.
2027.0.0-alpha.4 2026-06-11 Technical correction (preview) Technical corrections without content changes to the IG; in particular, unification of the version labelling in the packages.
2027.0.0-alpha.3 2026-05-13 Technical correction (preview) Re-release of packages with technical corrections; no content changes to the IG.
2027.0.0-alpha.2 2026-04-16 Content update (preview) Bindings in several profiles relaxed from required to extensible, method binding for resistance mechanisms moved to a new ValueSet, DiagnosticReport category aligned to MB including a coding slice and an optional LOINC report type (mibi-sub-category), and terminology content for avidity/morphology extended.
2027.0.0-alpha.1 2026-04-14 Breaking (preview) Nationally and European-agreed realignment of the microbiology modelling with new/replaced profile URLs (canonicals), an Observation-oriented structure without Observation.component, updated terminology bindings and a reworked IG navigation.

2027.0.0-ballot2

Date: 2026-09-14

No content change. Every artefact is identical to 2027.0.0-ballot apart from the version it carries. Use this version; the packaging of the previous one was faulty in two ways.

  • The published package contained 31 artefacts that this release cycle had retired — five profiles, five examples and twenty value sets, all still at version 2025.0.2 — because the publication path baked a project state rather than this repository. One of them collided with a current artefact: a second CapabilityStatement on the canonical …/CapabilityStatement/metadata, at 2025.0.2, beside the current one. Which of the two a tool uses would have been decided by its load order.
  • mii-pr-mikrobio-probe shipped without a snapshot, because the biobank package its parent lives in was not resolvable during that build.

Both causes sat in the publication path, not in the module. The artefacts of 2027.0.0-ballot were correct; what was published under that name was not.

2027.0.0-ballot

Date: 2026-09-14

High level (what changed in domain terms?)

  • The logical model used to be a directory of the FHIR profiles: its leaf elements were typed with the canonical URLs of the profiles and contained no domain data elements. The information model now describes the data elements with FHIR data types (CodeableConcept, Quantity, Ratio, dateTime, Coding, Reference).
  • The model is split across three logical models. This allows relations between the classes to be expressed as Reference, and the statements that apply to every investigation are defined once on an abstract base class and inherited, instead of being repeated for every investigation type.
  • Purely FHIR-technical statements without domain content are not part of the information model; this includes the category slices and the extensions for alternative unit representation and numeric precision.
  • Targeted detection stays in one profile whatever the technique - culture, molecular, immunological or biochemical. The question and the type of its answer are the same: is the named target there, Detected or Not detected. The culture is stated by the test code, whose method axis carries Organism specific culture, so it is not repeated in the result. The HL7 EU Lab Semantic Workgroup keeps targeted culture separate and binds growth codes there; this guide deviates and asks about it as ballot question 6.
  • General culture and general determination stay cleanly separated: culture answers whether something grows, determination which pathogen it is. Growth codes are therefore bound on general culture only.
  • An indeterminate result is no longer coded via value[x] but via Observation.dataAbsentReason.
  • The MRE modelling was changed from an organism classification to a category-based status. Previously valueCodeableConcept carried the concrete resistant organism (e.g. MRSA, VRE) and thereby duplicated information from identification, susceptibility and resistance mechanisms. In addition, the underlying SNOMED subtree was broader than "MRE": single-substance resistances such as 838510005 Linezolid resistant Enterococcus are not automatically multi-resistance.
  • Every Observation now expresses the status of one named resistance category: MRSA status = Positive, VRE status = Negative and so on.
  • Negative means that a pathogen present was assessed on the basis of the relevant investigations and does not meet the criteria of the category. It is not to be equated with a negative pathogen detection; where no sufficient assessment is possible, dataAbsentReason is used.
  • The derivation is expressed via Observation.derivedFrom and not via the triggeredBy extension. The underlying investigations should be given, but may be omitted where the status is taken directly from an already categorised laboratory report.

  • MRGN remains a standalone classification and is not rebuilt into single-status statements. For the case that an assessed isolate cannot be assigned to any MRGN class, a negative value was added that the LOINC answer list does not contain.

  • Specimens now have a profile. The module required Observation.specimen for every investigation but gave the reference no target profile, so any Specimen satisfied it. mii-pr-mikrobio-probe derives from the biobank base profile that exists for exactly this purpose, and every investigation profile now points at it.
  • Microscopy was split into an open and a targeted half, as culture and determination already were. The distinction is the question: general microscopy answers with the morphological group seen, targeted microscopy with the detection of an object its test code names. How much was seen is a component in both, never the value - the targeted codes are PrThr terms and ask whether the object is there.
  • Microscopy can now carry a morphology together with its amount. "Few Gram-positive cocci" needs two statements and value[x] carries one, so the amount is a component. Its code is 103392008 |Semi-quantitative value|, the concept the HL7 EU Lab Semantic Workgroup proposes for it.
  • The staining technique left Observation.method for an extension of its own, extension[faerbung]. The element is 0..1 and SNOMED CT holds staining and microscopy in separate hierarchies, so only one of the two could be stated; now both can. The extension binds the hierarchy the HL7 EU Lab Semantic Workgroup uses for the stain, 37926009 |Microbial stain method (procedure)|, and is given whenever a stain was used, including where the test code names it. The Workgroup places the stain on Specimen.processing.procedure; this guide deviates and asks about it as ballot question 2.
  • Parasitology became expressible on the result side. Three organism roots were missing — helminths, arachnids and insects — so a worm egg, a scabies mite or a fly larva had no result code. The test code side still depends on a LOINC code that does not yet exist.
  • Serology is exempt from post-coordinating the specimen. The HL7 EU Lab Semantic Workgroup allows the specimen to stay pre-coordinated there, because few materials are involved and most are serum. The exemption covers the test code only; a Specimen resource is still expected.
  • Susceptibility results may now be given as a category where no measurement exists, which the European model settles explicitly. One invariant remains, asking as a warning that a measured value carry an interpretation.
  • Points that the sources leave open, or where this guide deviates from them, are now stated as ballot questions rather than resolved silently. Seven are open, each on the page it belongs to and collected on the index page. Their answers depend on what sites can deliver, which is why they are put to the ballot rather than decided here.
  • The Bartlett score was spelled "Barlett" throughout, in the canonical URLs as well. The score is named after John G. Bartlett; "Barlett" is not a name. Since the misspelling had reached three published canonicals, correcting only the visible text would have left the URLs permanently wrong, so the identifiers were corrected too. This is a breaking change for a typing error, taken deliberately in a major version with a ballot rather than carried forward indefinitely.
  • The diagnostic chain is now documented where it is used: every profile that takes part in one states its own position in it, rather than the relations being described only on the profile-selection page.

Detailed changes for implementers (per artefact URL / canonical)

Profiles (StructureDefinitions)
Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
mii-pr-mikrobio-spezifische-bestimmung content updated the result ValueSet additionally contained Positive, No growth and the full organism ValueSet still covers targeted detection by any technique, culture included; the result is now only detection or exclusion, and the test and method ValueSets name the culture codes explicitly Results carrying organism or growth codes are no longer conformant Change a targeted culture result from Organism growth / No growth to Detected / Not detected; represent organism statements via mii-pr-mikrobio-allgemeine-bestimmung
mii-pr-mikrobio-allgemeine-kultur content updated code fixed to 11475-1; value[x] bound to mii-vs-mikrobio-allgemeine-kultur-ergebnis-snomed code from mii-vs-mikrobio-allgemeine-kultur-tests-loinc (extensible), which also admits the method-neutral 41852-5, with the new invariant allgemeine-kultur-method-with-neutral-code requiring Observation.method for that code; value[x] bound to mii-vs-mikrobio-kultur-ergebnis-snomed, shared by both cultures (required); the detected organism is no longer represented here but via determination The code binding is a relaxation, every previously valid instance stays valid - but with 41852-5 the method becomes mandatory, because only it identifies the investigation as a culture. The result codes Positive and Indeterminate are no longer valid Change results to 365698005 or 264868006, indeterminacy via dataAbsentReason. 11475-1 remains recommended: it names the technique itself and so distinguishes the culture from general identification, which the European sources leave unaddressed
mii-pr-mikrobio-probe new - Specimen profile derived from MII_PR_Biobank_Specimen_Bioprobe_Core; keeps the inherited specimen type binding and documents the microbiological expectations on type, collection.collected[x] and parent Observation.specimen now has a target profile; a Specimen must satisfy the biobank base profile, which makes status, type, subject, collection and collection.collected[x] mandatory Add collection.collected[x] to existing Specimen resources. The storage temperature extension below Specimen.processing is no longer required: the base profile relaxed it to 0..1 in 2027.0.0-ballot
mii-pr-mikrobio-spezifische-mikroskopie new previously not representable Targeted microscopy: an ordinal LOINC code names the object and the stain, value[x] is Detected / Not detected, component[menge] carries the amount as a grade, a count per high power field or a range of such a count, and extension[faerbung] states the stain Acid-fast stains, host cell counts and clue cells become codeable; they had no profile before Move such findings here from general microscopy, where the amount had to be forced into interpretation. The value answers the detection question the code asks; put the grade in the component
mii-pr-mikrobio-mikroskopie content updated code fixed to 105059-0; no component; title "Mikroskopie" code from mii-vs-mikrobio-allgemeine-mikroskopie-tests-loinc (extensible), which also admits 664-3; new component[menge] for the amount, as a grade or as a count per high power field, its code a pattern of system and code alone and its units bound; the stain moves into extension[faerbung] and method keeps the microscopy technique; title "Allgemeine Mikroskopie" The fixed code is no longer enforced; a morphology and its amount can be sent together 105059-0 remains preferred. Move stain codes out of Observation.method into extension[faerbung], taking the procedure code instead of the qualifier value - 62777006 for 708061008
mii-pr-mikrobio-empfindlichkeit content updated value[x] only Quantity; method unbound; ^purpose without a delimitation note value[x] takes Quantity or CodeableConcept; method bound to mii-vs-mikrobio-empfindlichkeit-methode-snomed (extensible); the norm is required wherever the category stands - valueCodeableConcept.extension[Norm] and interpretation.extension[Norm] are both 1..1; one invariant left, asking as a warning that a measured value carry an interpretation; ^purpose now states that single-substance resistances of an identified pathogen are represented here (e.g. 29258-1 with interpretation R or S) and that targeted detection of a resistant pathogen belongs to specific determination A laboratory that reports only SIR no longer has to leave value[x] empty, and no longer has to repeat the category in interpretation to give the norm a place. Method codes are now constrained where they were free State the norm beside the category, wherever you put the category
mii-pr-mikrobio-voraussichtliche-empfindlichkeit content updated description: expected susceptibility derived from genotypic findings description: derived from genotypic resistance detections; code documents the boundary against measured susceptibility Documentation only, no constraint change The scope stays genotypic on purpose: measured on 2026-09-10 LOINC has 99 [Susceptibility] codes with method Genotyping and none with an immunoassay method, so a protein-based prediction is not codeable
mii-pr-mikrobio-diagnostic-report content updated result referenced 18 investigation profiles; category[mibi-sub-category] was 0..1; conclusion unmentioned result now names the 2027 profile set including targeted microscopy; category[mibi-sub-category] widened to 0..*; conclusion documented as the load-bearing element for serological reports Reports covering several study types - e.g. bacteriological and mycological - can give all applicable report types, and may reference targeted microscopy no migration needed; single values transmitted so far remain valid
mii-pr-mikrobio-titer, -aviditaet, -antigen-antikoerper-quantitativ, -spezifische-bestimmung content updated the specimen post-coordination convention applied without exception code states that serology is exempt: a pre-coordinated specimen is permitted there. On specific determination the exemption attaches to the serological use, since the profile also serves the molecular bench Documentation only. The exemption covers the test code, not Observation.specimen, which is still required -
mii-pr-mikrobio-keimzahl content updated valueQuantity.code documented only the denominator-free case valueQuantity.code states the preference for the CFU-annotated units over /mL, /g and 1 Documentation only; all units remain valid Prefer [CFU]/mL, [CFU]/g, [CFU]. /mL is a bare reciprocal in UCUM and 1 the dimensionless one; the migration is mechanical
mii-pr-mikrobio-allgemeine-bestimmung content updated code fixed to 41852-5; title "MII PR Mikrobio Allgemeine Bestimmung" code from mii-vs-mikrobio-allgemeine-bestimmung-tests-loinc (extensible); title "MII PR Mikrobio Allgemeine Bestimmung (Identifizierung)" The fixed code is no longer enforced; id and canonical unchanged 41852-5 stays valid and is part of the new value set. "Bestimmung" is ambiguous in a culture context, where the profile in fact carries the MALDI-TOF species identification
all Observation profiles of the module content updated Observation.specimen 1.. without a target profile specimen only Reference(mii-pr-mikrobio-probe) A referenced Specimen must now satisfy the new profile Check existing Specimen resources against mii-pr-mikrobio-probe, in particular for collection.collected[x]
mii-pr-mikrobio-bartlett-score replaced mii-pr-mikrobio-barlett-score same profile under the corrected identifier; name, title and description now read "Bartlett", as LOINC 75371-5 does The old canonical no longer resolves; references and meta.profile must be re-pointed Replace barlett with bartlett in the canonical. No content change beyond the spelling, so no data migration is needed
mii-pr-mikrobio-nugent-score content updated valueQuantity.unit was fixed to 1; no value-range check the fixed unit is dropped in favour of a ^comment; new invariant nugent-score-0-to-10 (value >= 0 and value <= 10, severity error) Instances with a score outside 0-10 are rejected; Quantity.unit is freely choosable, e.g. Nugent score, with the UCUM code 1 unchanged Check existing instances against the value range; populate unit meaningfully where useful
mii-pr-mikrobio-resistenzmechanismen-determinanten content updated description: detection of resistance genes or resistance mutations in a specimen description additionally covers proteins and functional tests (e.g. CIM test) as well as isolates as investigation material The domain scope is broader than previously documented Check functional resistance tests previously represented elsewhere against this profile
mii-pr-mikrobio-virulenzfaktor content updated description: detection in a specimen description: detection in a specimen or an isolate Clarification of the investigation material -
mii-pr-mikrobio-resistenzkategorie-status new mii-pr-mikrobio-mre-klasse carried the concrete resistant organism (MRSA, VRE) in valueCodeableConcept one Observation per named resistance category, Positive / Negative as the value, the category in Observation.code, and derivedFrom 0..* Must Support for the investigations it rests on The MRE statement is no longer an organism classification. Negative means the pathogen was assessed against the category's criteria and does not meet them - it is not a negative pathogen detection Split organism-valued MRE instances: the category status goes here, the organism into mii-pr-mikrobio-allgemeine-bestimmung, the underlying susceptibility findings into derivedFrom
mii-pr-mikrobio-mre-klasse removed/deprecated the MRE class as an organism classification replaced by mii-pr-mikrobio-resistenzkategorie-status The canonical no longer resolves; meta.profile and references must be re-pointed See the row above. The underlying SNOMED subtree was also broader than "MRE": single-substance resistances such as 838510005 Linezolid resistant Enterococcus are not automatically multi-resistance
mii-pr-mikrobio-mrgn-klasse content updated valueCodeableConcept only with the LOINC classes; no statement on the delimitation against pathogen detection valueCodeableConcept additionally with keine-mrgn-klasse; ^purpose and valueCodeableConcept ^short make clear that the profile classifies an already identified isolate and does not replace a detection test, and derivedFrom is now 0..* Must Support with the same rationale as at the resistance category status Assessed isolates without an MRGN assignment can be represented; the required binding remains; the susceptibility findings the classification rests on should be referenced Move negative cases previously transmitted as a missing Observation or via dataAbsentReason to keine-mrgn-klasse
all Observation profiles of the module content updated dataAbsentReason inherited unbound from the laboratory base bound via the shared RuleSet to mii-vs-mikrobio-data-absent-reason (extensible) Indeterminate results are represented here instead of via value[x] Move occurrences of 82334004 from value[x] to dataAbsentReason
all Observation profiles of the module content updated each profile sliced Observation.category itself, and the microbiology category was one CodeableConcept carrying MB, 26436-6, laboratory and 18725-2 together the slicing comes from the laboratory base profile; the module adds only category[mibi-category] = MB, while laboratory and 26436-6 sit in the base profile's own observation-category slice and 18725-2 is dropped An instance now carries TWO category entries instead of one with four codings Split the category: observation-category with laboratory and 26436-6, plus a separate entry with MB. See any example
mii-ex-mikrobio-faerbung new the stain was carried in Observation.method Extension on Observation with a CodeableConcept bound to mii-vs-mikrobio-faerbung-snomed (extensible) Stain and microscopy technique can now be stated together, which Observation.method could not at 0..1; the stain is readable in one place whichever test code a laboratory picks Move stain codes from method to the extension and take the procedure code instead of the qualifier value, e.g. 62777006 for 708061008. Give the extension also where the test code names the stain
mii-ex-mikrobio-empfindlichkeit-norm content updated context Observation.interpretation only context additionally Observation.value[x] The norm can now be stated where the category stands, so a categorical result no longer has to be repeated in interpretation just to give the norm a place No migration: widening the context is additive, and instances carrying the norm on interpretation stay valid
Terminologies (ValueSets)
Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
mii-vs-mikrobio-allgemeine-bestimmung-tests-loinc new the code was fixed in the profile six codes: 41852-5, 23667-9, 42805-2, 41461-5, 66885-5, 101534-6, extensible General determination accepts the identification codes a laboratory actually sends, not one fixed code 41852-5 stays valid
mii-vs-mikrobio-allgemeine-kultur-tests-loinc new the code was fixed in the profile 11475-1 and 41852-5, extensible The general culture accepts the method-neutral code 11475-1 stays recommended
mii-vs-mikrobio-allgemeine-mikroskopie-tests-loinc new the code was fixed in the profile 105059-0 plus the nominal codes that carry a stain: 664-3 Gram, 11545-1 acid fast, 676-7 rhodamine-auramine General microscopy accepts a code that carries the stain 105059-0 stays recommended
mii-vs-mikrobio-spezifische-mikroskopie-tests-loinc new - Ordinal [Presence] codes filtered per stain: Gram, acid fast, auramine, with SCALE_TYP Ord Test codes for targeted microscopy The stain list is deliberately incomplete: it covers the stains a laboratory has evidenced
mii-vs-mikrobio-mikroskopie-semiquantitativ-snomed new - Seven grades on two SNOMED axes: presence findings 441614007, 441517005, 441521003 and the degree descriptors Few, Moderate number, Numerous, Scanty Amount value set of the component in both microscopy profiles The two axes are not interchangeable; which family the European model prefers is still open. Presence codes are not in it: Present, Absent, None and No organisms seen answer the detection question and belong in value[x]
mii-vs-mikrobio-mikroskopie-gesichtsfeld-einheiten-ucum new the counted form of the amount had no unit constraint at all /[HPF] and /[LPF], extensible, bound on the amount component's valueQuantity.code and on both valueRange bounds A count per field is constrained to the field-of-view units, as every other quantitative statement of this module is Both codes validate against UCUM; the binding is extensible, so a further unit stays possible
mii-vs-mikrobio-aviditaet-ergebnis content updated L, I, H from v3-ObservationInterpretation L and H unchanged, I replaced by 280414007 Equivocal result, the code this guide already uses for a borderline finding in culture and targeted determination I was not merely imprecise but wrong: THO subsumes it under the susceptibility branch and defines it as a bacterial strain inhibited by an antimicrobial agent with uncertain therapeutic effect, citing CLSI. L and H stay because the parent binds interpretation extensibly to a list that holds them, and an extensible binding demands the code from the list wherever one applies; for the middle the list offers none, which is what admits an outside code Map I to 280414007. Laboratories report all three categories, so the middle one stays
mii-vs-mikrobio-empfindlichkeit-methode-snomed new Observation.method was unbound on the susceptibility profile The five techniques the HL7 EU Lab Semantic Workgroup names: broth dilution, disk diffusion, gradient strip, manual and automated MIC microdilution Method codes are constrained where they were free The HL7 EU Lab Semantic Workgroup names procedure concepts for the same five techniques; this module keeps qualifier values, as its other nine method lists do. Reported back
mii-vs-mikrobio-faerbung-snomed new - The descendants of 37926009 Microbial stain method (procedure) Stains are coded with the same hierarchy the HL7 EU Lab Semantic Workgroup uses, so the value can move to the Specimen later without being recoded The procedure axis, not the qualifier axis used before: 62777006 instead of 708061008
mii-vs-mikrobio-morphologie-methode-snomed content updated microscopy techniques below 278289002 and staining techniques below 703857004 278289002 alone Stain codes are no longer valid in Observation.method Move them to extension[faerbung], see the extension row above
mii-vs-mikrobio-organismen-snomedct content updated six roots nine roots; added 441649000 Cestoda/Trematoda/Nemata, 76222001 Arachnid, 106763003 Class insecta Multicellular parasites become expressible as an identification result Purely additive. The fourth root, slime mould, is annotated "to be confirmed" in the source itself
mii-vs-mikrobio-morphologie-ergebnis-snomed content updated 15 codes, all (finding), all arranged forms 29 codes grouped by axis: arranged forms as (finding), bare morphologies as (organism) because SNOMED carries them only there, fungal morphology, and No organisms seen / No cells seen / Clue cells present The commonest Gram findings become expressible; of the previous 15 codes a real laboratory catalogue used three The four bare bacterial morphologies are descendants of the bacteria domain and therefore also valid values of general determination. Read the granularity from the profile or the test code, never from value[x] alone
mii-vs-mikrobio-antigen-antikoerper-quantitativ-einheiten-ucum content updated eight units, mL and L mixed without preference ten units in three groups; ng/L and pg/L added, litre marked as preferred All previous units stay valid The HL7 EU Lab Semantic Workgroup recommends litre for serology; [IU]/mL remains permitted as the internationally common notation
all ValueSets and examples of the module content updated LOINC and SNOMED CT were referenced without a version LOINC pinned to 2.82, SNOMED CT to the 2026-07-01 international release, in every ValueSet composition and in Coding.version of the examples Expansions become reproducible for this release line; consumers validating Coding.version see a value where there was none No migration: the version is additive. A server expanding against another release may return a different expansion
dependencies content updated …kerndatensatz.laborbefund 2027.0.0-ballot.rc4, …kerndatensatz.biobank 2027.0.0-ballot.rc2 both at the final 2027.0.0-ballot The laboratory parent is differential-identical to rc4, measured on the registry tarballs. The biobank release relaxes Specimen.processing.extension:temperaturbedingungen from 1..1 to 0..1 and moves the requirement to the storage slice Nothing to migrate. A Specimen that carried a storage temperature under a processing step only to satisfy the old requirement can drop it
mii-vs-mikrobio-spezifische-bestimmung-methode-snomed content updated nine techniques twelve; added 702675006 probe with target amplification, 1259932009 loop-mediated isothermal amplification and 1304162005 nucleic acid sequencing The commonest modern targeted PCR, isothermal amplification and sequencing become codeable Beside 258066000, not instead of it: not every amplification is probe-based
mii-vs-mikrobio-allgemeine-kultur-methode-snomed content updated aerobic and anaerobic culture additionally 702658000 microbial culture technique A laboratory that does not distinguish aerobic from anaerobic has a method code Needed because the method-neutral test code now requires a method
mii-vs-mikrobio-empfindlichkeit-phenotyp-loinc content updated filter only additionally 106843-6 and 103673-0, enumerated Two genuine susceptibility tests enter the set Both carry PROPERTY Susc but sit in CLASS MICRO and DRUG/TOX; the HL7 EU Lab Semantic Workgroup itself asks Regenstrief to correct them
mii-vs-mikrobio-bartlett-score-loinc replaced mii-vs-mikrobio-barlett-score-loinc same value set under the corrected identifier The old canonical no longer resolves Replace barlett with bartlett in the canonical
mii-vs-mikrobio-kultur-ergebnis-snomed new - Shared result ValueSet for general and specific culture with 365698005 Organism growth and 264868006 No growth Uniform result coding for both culture profiles see mii-vs-mikrobio-allgemeine-kultur-ergebnis-snomed
mii-vs-mikrobio-allgemeine-kultur-ergebnis-snomed removed/deprecated Positive, No growth, Indeterminate; general culture only replaced by mii-vs-mikrobio-kultur-ergebnis-snomed Old reference invalid Move to the new canonical; Positive to 365698005, Indeterminate to dataAbsentReason
mii-vs-mikrobio-data-absent-reason new - FHIR base codes for missing data, extended by 82334004 Indeterminate Target terminology for indeterminate results Move indeterminate results from value[x] here
mii-vs-mikrobio-allgemeine-bestimmung-ergebnis-snomed new mii-pr-mikrobio-allgemeine-bestimmung bound value directly to mii-vs-mikrobio-organismen-snomedct; a negative result could not be represented organism ValueSet plus 260415000 Not detected Where the specimen was examined but no pathogen identified, that is now representable as a result instead of as a missing value Move negative cases previously omitted or transmitted via dataAbsentReason to 260415000; dataAbsentReason remains reserved for the indeterminate result
mii-vs-mikrobio-spezifische-bestimmung-tests-loinc content updated ten LOINC method types including LP6429-7, each only with PROPERTY LP6850-4 (Prid) nine method types without LP6429-7, each additionally with PROPERTY LP217195-9 (PrThr); extended by the individual codes 105904-7 (method-neutral VRE detection, METHOD_TYP empty) and 35492-8 (MRSA PCR, listed by LOINC under CLASS LP7755-4) Culture codes are no longer contained here. The PrThr terms are a prerequisite for negative detection results; the individual codes are not caught by the filters and are therefore included explicitly Move culture cases to the new profile and test ValueSet
mii-vs-mikrobio-spezifische-bestimmung-ergebnis-snomed content updated Detected/Not detected plus Positive, No growth, Indeterminate and the full organism ValueSet only Detected / Not detected Organism and growth codes as well as Indeterminate are no longer valid Organism statements via general determination, growth via culture, indeterminacy via dataAbsentReason
mii-cs-mikrobio-resistenzkategorie new - MII CodeSystem with the investigation codes mrsa-status, vre-status, lre-status, lvre-status Necessary because neither SNOMED CT (hierarchy Observable entity) nor LOINC contains suitable concepts The state of research and the rejected candidates are documented in the CodeSystem; if a standard code becomes available it is to be adopted with priority
mii-vs-mikrobio-resistenzkategorie-status new - Investigation codes for the resistance category status, bound required Binds Observation.code of the new profile -
mii-vs-mikrobio-resistenzkategorie-status-ergebnis new - 10828004 Positive / 260385009 Negative, bound required Binds Observation.value of the new profile -
mii-vs-mikrobio-mre-klasse-snomedct removed/deprecated SNOMED subtree Resistant bacteria / fungi / virus as the value of the MRE class dropped without replacement Old reference invalid; the value is no longer an organism species Move to mii-vs-mikrobio-resistenzkategorie-status-ergebnis, move the organism statement into pathogen identification
mii-cs-mikrobio-mrgn-ergebnis new - MII CodeSystem with keine-mrgn-klasse The LOINC answer list LL6195-3 for 99780-9 contains only 2MRGN/3MRGN/4MRGN and therefore no negative value -
mii-vs-mikrobio-mrgn-klasse-loinc content updated only LA33214-0, LA33215-7, LA33216-5 additionally keine-mrgn-klasse Assessed isolates without an MRGN assignment can be represented; the required binding remains -
mii-vs-mikrobio-resistenzmechanismen-determinanten-loinc content updated all LOINC codes with CLASS LP7755-4 and PROPERTY LP217195-9 additionally an exclude of 35492-8 Besides resistance determinants, the CLASS filter also caught the pathogen detection 35492-8. The profile assignment follows the semantics: the code detects a pathogen, not a determinant, and is therefore included in mii-vs-mikrobio-spezifische-bestimmung-tests-loinc Move instances with 35492-8 from mii-pr-mikrobio-resistenzmechanismen-determinanten to mii-pr-mikrobio-spezifische-bestimmung
mii-vs-mikrobio-detected-not-detected-snomed content updated Detected, Not detected, Indeterminate without Indeterminate Affects virulence factor and resistance mechanisms Move 82334004 to dataAbsentReason
Logical model
Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
mii-lm-mikrobio-logical-model content updated collective model whose leaf elements were typed with the profile canonicals; Befundtyp was 0..1 Now describes only the microbiological report and references mii-lm-mikrobio-untersuchung via Untersuchung; canonical and id remain unchanged, type now corresponds to the canonical URL; Befundtyp is 0..* Mappings onto the former collective model no longer apply; tools that check type against the canonical now find matching values Split mappings across the three node structures
mii-lm-mikrobio-untersuchung new - Abstract base class of all microbiological investigations; target of the model-internal references New artefact in the information model Map the statements applying to every investigation against this
mii-lm-mikrobio-untersuchungsarten new - The domain variants, derived from mii-lm-mikrobio-untersuchung, with AllgemeineMikroskopie and SpezifischeMikroskopie as separate variants, both carrying a Menge[x] element beside the result, Empfindlichkeit.Ergebnis[x] as Quantity or CodeableConcept and BartlettScore in the corrected spelling New artefact in the information model Map variant-specific elements against this
CapabilityStatement
Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
mii-cps-mikrobio-metadata content updated 18 supported Observation profiles; search parameters without titer 19 profiles: mii-pr-mikrobio-mre-klasse replaced by mii-pr-mikrobio-resistenzkategorie-status, mii-pr-mikrobio-spezifische-mikroskopie added and mii-pr-mikrobio-barlett-score corrected to -bartlett-score; search parameter titer declared for Observation Servers declaring conformance list a changed profile set, and the canonical of the MRE class is no longer among them Check the /metadata output and conformance tests against the changed profile set
SearchParameter
Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
mii-sp-mikrobio-observation-titer new Titres were not searchable: mii-pr-mikrobio-titer represents the value as a Ratio, but the base parameter Observation-value-quantity covers only Quantity and SampledData local SearchParameter titer (quantity) on Observation.value.ofType(Ratio).denominator, included in the CapabilityStatement Searching by dilution level becomes possible; since the numerator is fixed at 1, a larger denominator corresponds to a higher titre, e.g. ?titer=gt160 no migration needed; existing titre instances remain unchanged
Examples and IG page structure

2027.0.0-alpha.5

High level (what changed in domain terms?)

  • The CapabilityStatement of the metadata interface was completed so that servers can declare their support for microbiological Observation and DiagnosticReport resources more precisely.
  • DiagnosticReport is now shown in the CapabilityStatement as its own resource block with the profile mii-pr-mikrobio-diagnostic-report.
  • The search parameters that must be supported were extended for Observation and DiagnosticReport, adapted to the profile content used, and reconciled with the SearchParameters of the Laboratory module.
  • Local SearchParameters were added for the microbiology-specific search on Observation.interpretation and on the R5 extension Observation.triggeredBy.

Detailed changes for implementers (per artefact URL / canonical)

CapabilityStatement
Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
mii-cps-mikrobio-metadata content updated the CapabilityStatement declared only Observation; the search parameter list was incomplete additional resource block for DiagnosticReport with mii-pr-mikrobio-diagnostic-report; extended search parameters for Observation and DiagnosticReport, aligned with the Laboratory module Servers must support the declared search for both resource types accordingly Check the /metadata output and conformance tests against the updated SearchParam list
SearchParameter
Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
Observation-interpretation new no local declaration in the CPS local SearchParameter for Observation.interpretation (token) and inclusion in the CapabilityStatement Searching by interpretation, e.g. susceptibility or avidity interpretations, can be declared capability-based no migration needed; existing instances remain unchanged
Observation-triggered-by new triggeredBy was profiled but not declared as a search parameter local SearchParameter for the triggering Observation inside the R5 cross-version extension Observation.triggeredBy (reference) and inclusion in the CapabilityStatement Trigger relationships between microbiological Observations can be searched for specifically no migration needed; existing instances remain unchanged
Supported search parameters
  • Observation: newly added are _lastUpdated, based-on, data-absent-reason, device, derived-from, encounter, identifier, interpretation, method, specimen, status, triggered-by, value-concept and value-quantity.
  • DiagnosticReport: the resource block is new and declares the search parameters _id, _profile, _lastUpdated, status, based-on, category, code, subject, encounter, date, issued, performer, specimen, result and conclusion.
  • The selection of standard SearchParameters was deliberately aligned with the CapabilityStatement of the Laboratory module; the microbiology-specific additions are the local SearchParameters interpretation and triggered-by.

2027.0.0-alpha.4

High level (what changed in domain terms?)

  • No domain changes. For this release, only packages with technical corrections were republished.

Detailed changes for implementers (per artefact URL / canonical)

General
  • fix: unification of the version labelling of the 2027 artefacts to 2027.0.0-alpha.4; version statements in the packages had previously not been consistent throughout.
  • Technical corrections in the package release without content changes to profiles, ValueSets, extensions, CapabilityStatement or examples.

2027.0.0-alpha.3

High level (what changed in domain terms?)

  • No domain changes. For this release, only packages with technical corrections were republished.

Detailed changes for implementers (per artefact URL / canonical)

General
  • No content changes to profiles, ValueSets or examples.
  • The release serves solely to provide technically corrected packages.

2027.0.0-alpha.2

High level (what changed in domain terms?)

  • Several terminology bindings previously defined as required were changed to extensible, so that domain-valid local codings remain permissible within the rules.
  • For mii-pr-mikrobio-resistenzmechanismen-determinanten, the method binding was moved to a dedicated method ValueSet for resistance mechanisms.
  • For mii-pr-mikrobio-diagnostic-report, the category assignment was changed to v2-0074#MB (Microbiology) plus an optional LOINC report type; MB is additionally carried as a coding slice (v2-microbiology) and the report type is represented via mibi-sub-category. A SNOMED category code is no longer required for this.
  • The shared category rules of the microbiological Observation profiles were adapted so that microbiology is modelled explicitly via its own mibi-category slice; because of the current inheritance from the laboratory parent, the laboratory codes remain in the same slice for now.
  • The result ValueSet for avidity was extended by Intermediate.
  • The morphology result ValueSet was extended by additional fungal hypha findings.

Detailed changes for implementers (per artefact URL / canonical)

Profiles (StructureDefinitions)

Shared adaptation for the microbiological Observation profiles: The category representation was unified. Microbiology is now modelled via its own mibi-category slice, including the coding slice v2-microbiology (v2-0074#MB, 1..1) and optionally loinc-microbiology-studies (loinc#18725-2, 0..1). Because of the current constraints from ObservationLab, the inherited laboratory codes (loinc-observation, observation-category) remain in the same slice for now; a further separation is planned for a follow-up release once the laboratory parent has been adapted accordingly. That future adaptation will be fully compatible; it only improves the presentation of the profile.

Also applying to all microbiological Observation profiles: dataAbsentReason is newly bound to mii-vs-mikrobio-data-absent-reason (extensible). Indeterminate results are moved there and no longer coded via value[x].

Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
mii-pr-mikrobio-empfindlichkeit content updated code and valueQuantity.code were bound required both bindings are extensible Greater flexibility in test code and unit coding Use ValueSet codes primarily; local codes only where domain-necessary
mii-pr-mikrobio-keimzahl content updated code, valueQuantity.code, interpretation were bound required these bindings are extensible Reduced rejection rate for terminological edge cases Keep existing mappings, check deviations for conformance
mii-pr-mikrobio-resistenzkategorie-status replaced mii-pr-mikrobio-mre-klasse Category-based status: code names the assessed resistance category (MII CodeSystem mii-cs-mikrobio-resistenzkategorie), valueCodeableConcept is 10828004 Positive / 260385009 Negative (required), derivedFrom is 0..* MS (SHOULD) Profile URL change (canonical); the former organism statement in the value is dropped without replacement; one Observation must be created per assessed category Resolve old instances: the previous value (e.g. 115329001 MRSA) becomes the category in code (mrsa-status) with value = Positive; the pathogen itself remains in the pathogen identification. Add the underlying investigations in derivedFrom
mii-pr-mikrobio-mikroskopie content updated result and method binding were required result and method binding are extensible Higher interoperability with heterogeneous method catalogues Deliver ValueSet codes with priority; mark local additions clearly
mii-pr-mikrobio-molekulare-pathogenlast content updated unit binding (valueQuantity.code) was required unit binding is extensible More room for specialised unit codes Continue to prefer UCUM standard codes
mii-pr-mikrobio-spezifische-bestimmung content updated result binding was required result binding is extensible Qualitative result coding is validated less restrictively Continue to use the mapping to the target ValueSet as the primary path
mii-pr-mikrobio-voraussichtliche-empfindlichkeit content updated test code binding was required test code binding is extensible Better coverage of local genotypic test codings Check and document local test codes against the target ValueSet
mii-pr-mikrobio-resistenzmechanismen-determinanten content updated method binding to MII_VS_Mikrobio_Spezifische_Bestimmung_Methode_SNOMED method binding to MII_VS_Mikrobio_Resistenzmechanismen_Methode_SNOMED More precise method validation for resistance mechanisms Move method codes to the new ValueSet
mii-pr-mikrobio-diagnostic-report content updated microbiological category secured via an SCT code in the category coding plus an additional invariant microbiological category modelled via mibi-category (v2-0074#MB) with the coding slice v2-microbiology (1..1) and the optional coding slice loinc-microbiology-studies (loinc#18725-2, 0..1); additional optional category slice mibi-sub-category (mii-vs-mikrobio-befundtyp-loinc) Category population is more consistent with the parent profile; no additional SCT category coding required; the optional LOINC representation is possible both at coding level and via sub-category Move producers/mappers to the mandatory mibi-category including v2-microbiology; populate loinc-microbiology-studies and mibi-sub-category only where needed
Terminologies (ValueSets)
Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
mii-vs-mikrobio-resistenzmechanismen-methode-snomed new - Dedicated method ValueSet for the detection of resistance genes/mutations (molecular procedures) New terminology reference in the profile mii-pr-mikrobio-resistenzmechanismen-determinanten Map method codes onto this ValueSet
mii-vs-mikrobio-aviditaet-ergebnis content updated only Low/High Intermediate added Result validation now allows a three-level interpretation Where present, map Intermediate findings onto the ValueSet
mii-vs-mikrobio-morphologie-ergebnis-snomed content updated no explicit fungal hypha subtypes additional SNOMED codes for hypha morphologies added (among others septate/non-septate, branching/non-branching) Finer morphological result coding possible Check local mycology codings against the new concepts

2027.0.0-alpha.1

Origin and agreement

The changes in this release are based on:

  • national agreement between the MII, MIO42/KBV, the RKI and further laboratory stakeholders
  • agreement in HL7 Europe on a uniform microbiology representation in the EHDS context

High level (what changed in domain terms?)

  • Several earlier profiles were replaced by new 2027 profiles (breaking change).
  • The microbiology modelling is Observation-oriented throughout; the former Observation.component semantics were moved into standalone Observation profiles. This enables full compatibility with the Laboratory module.
  • Culture and determination logic was split into general and specific paths.
  • Quantitative partial findings (e.g. Ct value, Nugent score, Barlett score, titre, avidity, pathogen load) are modelled as separate profiles.
  • Susceptibility is now represented via a combined model of interpretation (with a susceptibility binding) and a norm extension stating the interpretation standard used.
  • Observation profiles derive from ObservationLab (Laboratory module 2026.0.0), the DiagnosticReport from DiagnosticReportLab.
  • For Observations, the triggeredBy semantics are now supported via the R5 extension extension-Observation.triggeredBy, in order to represent diagnostic chains between investigations that build on one another; the kind of triggering is modelled via triggeredBy.type (in particular reflex for follow-up diagnostics triggered by previous results).
  • Terminology bindings were consolidated (LOINC/SNOMED/UCUM), including filter and naming clean-up.
  • The IG navigation under FHIR profiles reflects the new domain structure: culture, determination, quantitative tests, further properties, diagnostic report.

Detailed changes for implementers (per artefact URL / canonical)

Profiles (StructureDefinitions)
Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
mii-pr-mikrobio-allgemeine-kultur replaced mii-pr-mikrobio-kultur-nachweis General culture as its own profile with explicit bindings for test/result/method References and profile mappings must be moved to the new profile URL (canonical) Migrate instances from the old profile to the new profile URL; check the result coding
mii-pr-mikrobio-keimzahl content updated unchanged value[x] was restricted to Quantity, the ValueSet for semi-quantitative results was bound to .interpretation, UCUM bindings were made more precise Validation may apply more strictly to units and value type Check examples and interfaces against the updated value constraints
mii-pr-mikrobio-mikroskopie content updated unchanged components were removed and moved into standalone Observation profiles; value[x] and the method binding were moved to morphology-specific ValueSets The structure of the resources and the terminology check change; content previously carried in components must now be transmitted as separate referenceable Observations Move existing Observation.component representations into standalone Observation resources and check the codings against the new result/method ValueSets
mii-pr-mikrobio-empfindlichkeit content updated unchanged susceptibility model with susceptibility interpretation + norm extension Semantic change in interpretation/norm representation Transport norm information via the extension; observe the interpretation binding
mii-pr-mikrobio-nugent-score new - Former component information as a standalone Observation Take the new profile into account in result transmission and references Where previously represented as a component, move to its own Observation resource
mii-pr-mikrobio-barlett-score new - Former component information as a standalone Observation Take the new profile into account in result transmission and references Where previously represented as a component, move to its own Observation resource
mii-pr-mikrobio-allgemeine-bestimmung new - Former component information on pathogen identification (e.g. NameMikroorganismus) from previously combined report profiles, as a standalone Observation Add the new profile to profile routing and mapping For general determination there is no 1:1 predecessor profile; move component-based identification statements onto this profile
mii-pr-mikrobio-spezifische-bestimmung replaced/extended mii-pr-mikrobio-molekulare-diagnostik Specific determination as a broader profile with dedicated test/method/result bindings for targeted detections, including the migration of former component-based detection parts Profile URL change (canonical) and terminology adaptation needed; existing assumptions that only molecular-diagnostic findings are represented are no longer valid Migrate old instances and previous component-based targeted-detection mappings onto this profile URL and the current ValueSets
mii-pr-mikrobio-ct-wert new - Former component information (Ct value) as a standalone quantitative Observation Add the new profile and new tests/examples to the pipelines Where previously represented as a component, move to its own Observation resource
mii-pr-mikrobio-virulenzfaktor content updated unchanged Harmonisation onto consistent detected/not-detected semantics Result codes must match the updated bindings Check the SNOMED coding including display/code against the ValueSet
mii-pr-mikrobio-resistenzmechanismen-determinanten replaced mii-pr-mikrobio-resistenzgene + mii-pr-mikrobio-resistenzmutation Merged profile for determinants/mechanisms; former component content on gene/mutation statements is now represented via Observation.code (pre-coordinated LOINC determinants where available) and valueCodeableConcept (detected/not detected) Two old profiles are functionally consolidated into one new profile; component-based data models must be moved to code/value semantics Merge the old paths; consolidate references and mapping tables
mii-pr-mikrobio-antigen-antikoerper-quantitativ new - Former component information (quantitative antigen/antibody result) as a standalone profile Integrate the new profile into routing, ETL and validation Where previously represented as a component, move to its own Observation resource; deliver the unit system and method binding explicitly
mii-pr-mikrobio-aviditaet new - Former component information (avidity) as a standalone profile including result semantics Integrate the new profile into routing, ETL and validation Where previously represented as a component, move to its own Observation resource; map avidity values/interpretation onto the new bindings
mii-pr-mikrobio-titer new - Former component information (quantitative serological result / titre) as a standalone profile (ratio-oriented) Integrate the new profile into routing, ETL and validation Where previously represented as a component, move to its own Observation resource
mii-pr-mikrobio-molekulare-pathogenlast new - Former component information (quantitative molecular load / viral load result) as a standalone profile Integrate the new profile into routing, ETL and validation Where previously represented as a component, move to its own Observation resource; adopt the unit/method binding per the new profile
mii-pr-mikrobio-diagnostic-report content updated unchanged Parent moved to the Laboratory module 2026 DiagnosticReport, with updated result references Aggregation and result references must cover the complete 2026 profile set Check DiagnosticReport creation and reference resolution against the new profile set
Discontinued legacy profiles (canonical URLs)
Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
mii-pr-mikrobio-kultur-nachweis removed/replaced active up to the previous version replaced by the new 2027 profile for general culture The profile is no longer published in the 2027 model Move to the new 2027 culture structure
mii-pr-mikrobio-molekulare-diagnostik removed/replaced active up to the previous version replaced by the new 2027 profile for specific determination The profile is no longer published in the 2027 model Move to the new 2027 determination structure
mii-pr-mikrobio-resistenzgene removed/replaced active up to the previous version merged into the 2027 profile for resistance mechanisms/determinants The profile is no longer published in the 2027 model Map former component statements on the gene name (component[NamedesGens*]) onto the pre-coordinated Observation.code coding in the target profile; detection continues via valueCodeableConcept
mii-pr-mikrobio-resistenzmutation removed/replaced active up to the previous version merged into the 2027 profile for resistance mechanisms/determinants The profile is no longer published in the 2027 model Map former component statements on the resistance mutation (component[MicroorganismResistanceMutation]) onto the pre-coordinated Observation.code coding in the target profile; detection continues via valueCodeableConcept
mii-pr-mikrobio-serologie-immunologie removed/replaced active up to the previous version moved into the 2027 profile Specific determination; the components were moved into their own profiles The profile is no longer published in the 2027 model Move the mapping into the 2027 profiles
Terminologies (ValueSets)
New/renamed ValueSet URLs (canonicals)
Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
mii-vs-mikrobio-allgemeine-bestimmung-methode-snomed new - New method ValueSet for general determination New terminology reference in the profile bindings Check source-system codes against the new ValueSet
mii-vs-mikrobio-allgemeine-kultur-ergebnis-snomed new - New result ValueSet for general culture Result validation in the culture profiles changes Map culture result codes onto the new ValueSet
mii-vs-mikrobio-allgemeine-kultur-methode-snomed new - New method ValueSet for general culture Method validation in the culture profiles changes Map method codes onto the new ValueSet
mii-vs-mikrobio-antigen-antikoerper-methode-snomed new - Method ValueSet for quantitative antigen/antibody findings New binding in the corresponding profile Check method codes against the new ValueSet
mii-vs-mikrobio-antigen-antikoerper-quantitativ-einheiten-ucum new - UCUM units for quantitative antigen/antibody findings Unit codes are validated explicitly Deliver unit codes and the UCUM system consistently
mii-vs-mikrobio-antigen-antikoerper-quantitative-tests-loinc new - Test ValueSet for quantitative antigen/antibody findings Test code binding in the profiles Map test codes onto the new ValueSet
mii-vs-mikrobio-aviditaet-ergebnis-snomed new - Result ValueSet for avidity Result validation changed Map the avidity interpretation onto the new ValueSet
mii-vs-mikrobio-aviditaet-tests-loinc new - Test ValueSet for avidity Test code binding changed Map test codes onto the new ValueSet
mii-vs-mikrobio-ct-wert-loinc new - Meaningful canonical name for the Ct test ValueSet New reference in the Ct profile Do not use the old technical name any more
mii-vs-mikrobio-detected-not-detected-snomed new - Uniform detected/not-detected semantics Several profiles use a uniform result ValueSet Harmonise positive/negative detections onto this ValueSet
mii-vs-mikrobio-molekulare-pathogenlast-methode-snomed new - Method ValueSet for pathogen load New method binding Deliver method codes per the new ValueSet
mii-vs-mikrobio-molekulare-pathogenlast-tests-loinc new - Test ValueSet for pathogen load New test binding Deliver test codes per the new ValueSet
mii-vs-mikrobio-morphologie-ergebnis-snomed new - Result ValueSet for microscopy/morphology Result validation changed Map morphology result codes onto the new ValueSet
mii-vs-mikrobio-morphologie-methode-snomed new - Method ValueSet for microscopy/morphology Method validation changed Map method codes onto the new ValueSet
mii-vs-mikrobio-positiv-negativ-snomed new - Harmonised positive/negative ValueSet Qualitative profiles use the new binding Replace old ValueSet references
mii-vs-mikrobio-resistenzmechanismen-determinanten-loinc new mii-vs-mikrobio-resistenzgene-loinc, mii-vs-mikrobio-resistenzmutation-loinc Merged test ValueSet for determinants Two former terminology strands are consolidated Merge the mapping tables
mii-vs-mikrobio-spezifische-bestimmung-methode-snomed new - Method ValueSet for specific determination New method binding Check method codes against the new ValueSet
mii-vs-mikrobio-spezifische-bestimmung-tests-loinc new mii-vs-mikrobio-molekulare-diagnostik-loinc, mii-vs-mikrobio-kulturtests-loinc Test ValueSet for specific determination (LOINC filters updated) Test validation and filter logic changed Align local test lists with the new LOINC filters
mii-vs-mikrobio-spezifische-bestimmung-ergebnis-snomed new - Result ValueSet for specific determination New result binding Map result codes onto the new ValueSet
mii-vs-mikrobio-susceptibility renamed mii-vs-mikrobio-clsi-hl7 Vendor/norm-neutrally named susceptibility ValueSet Reference name and canonical URL have changed Move the old ValueSet URL consistently to the new URL
mii-vs-mikrobio-titer-methode-snomed new - Method ValueSet for titre New method binding Check method codes against the new ValueSet
mii-vs-mikrobio-titer-tests-loinc new - Test ValueSet for titre New test binding Check test codes against the new ValueSet
ValueSet URLs updated in content (canonicals)
Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
mii-vs-mikrobio-empfindlichkeit-einheiten-ucum content updated unchanged UCUM definitions cleaned up ({}-free semantics) Unit codes are checked more strictly Deliver UCUM codes per the new ValueSet
mii-vs-mikrobio-keimzahl-einheiten-ucum content updated unchanged UCUM semantics cleaned up (1 instead of {} expressions) Unit codes / parser behaviour may change Check the unit mapping and the example values
mii-vs-mikrobio-keimzahl-loinc content updated unchanged 2027-conformant test selection Test validation may change Check colony-count codes against the updated scope
mii-vs-mikrobio-molekulare-diagnostik-einheiten-ucum content updated unchanged UCUM semantics cleaned up ({}-free modelling) Unit codes are checked more strictly Check the unit mapping in pathogen-load / molecular findings
mii-vs-mikrobio-virulenz-loinc content updated unchanged Virulence test scope updated Test validation may change Check virulence codes against the updated scope
mii-vs-mikrobio-empfindlichkeit-phenotyp-loinc content updated CLASS LP7755-4, PROPERTY LP6870-2, STATUS ACTIVE, additionally ORDER_OBS Observation and an exclude of METHOD_TYP LP28723-2 (genotypic method) the ORDER_OBS restriction and the exclude are dropped; the remaining filters are CLASS, PROPERTY, STATUS The ValueSet is thereby a superset of mii-vs-mikrobio-empfaenglichkeit-genotyp-loinc; mii-pr-mikrobio-empfindlichkeit and mii-pr-mikrobio-voraussichtliche-empfindlichkeit can no longer be distinguished terminologically by the test code. In addition, codes without ORDER_OBS Observation are now included The assignment to the phenotypic or genotypic profile can no longer be derived from the test code and must follow from the profile used
Removed/deprecated ValueSet URLs (canonicals)
Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
mii-vs-mikrobio-antigen-assay-einheiten-ucum removed/deprecated active up to the previous version replaced by profile-specific UCUM ValueSets Old references invalid Move to mii-vs-mikrobio-antigen-antikoerper-quantitativ-einheiten-ucum
mii-vs-mikrobio-aviditaet-snomedct removed/deprecated active up to the previous version replaced by separate test/result sets Old reference invalid Move to ...-aviditaet-tests-loinc and ...-aviditaet-ergebnis-snomed
mii-vs-mikrobio-eucast-snomedct removed/deprecated active up to the previous version replaced by the susceptibility/norm model Old reference invalid Move to mii-vs-mikrobio-susceptibility plus the norm extension
mii-vs-mikrobio-kultur-methode-snomedct removed/deprecated active up to the previous version replaced by the general/specific culture method strands Old reference invalid Move to ...-allgemeine-kultur-methode-snomed or the specific profiles
mii-vs-mikrobio-kulturtests-loinc removed/deprecated active up to the previous version replaced by more specific test ValueSets Old reference invalid Move to mii-vs-mikrobio-spezifische-bestimmung-tests-loinc
mii-vs-mikrobio-mikroskopie-tests-loinc removed/deprecated active up to the previous version microscopy organised via the new morphology logic Old reference invalid Switch to the current microscopy bindings
mii-vs-mikrobio-mikroskopiemethoden-snomedct removed/deprecated active up to the previous version replaced by mii-vs-mikrobio-morphologie-methode-snomed Old reference invalid Move method codes to the new ValueSet
mii-vs-mikrobio-molekulare-diagnostik-loinc removed/deprecated active up to the previous version replaced by the specific determination / pathogen load ValueSets Old reference invalid Move to ...-spezifische-bestimmung-tests-loinc or ...-molekulare-pathogenlast-tests-loinc
mii-vs-mikrobio-morphologie-snomedct removed/deprecated active up to the previous version split into result/method ValueSets Old reference invalid Move to ...-morphologie-ergebnis-snomed and ...-morphologie-methode-snomed
mii-vs-mikrobio-positiv-negativ-snomedct removed/deprecated active up to the previous version replaced by the harmonised canonical name without -ct Old reference invalid Move to mii-vs-mikrobio-positiv-negativ-snomed
mii-vs-mikrobio-qualitative-labor-ergebnisse-snomedct removed/deprecated active up to the previous version replaced by domain-specific result ValueSets Old reference invalid Move to the profile-specific result ValueSets
mii-vs-mikrobio-resistenzgene-loinc removed/deprecated active up to the previous version merged into the determinants ValueSet Old reference invalid Move to mii-vs-mikrobio-resistenzmechanismen-determinanten-loinc
mii-vs-mikrobio-resistenzmutation-loinc removed/deprecated active up to the previous version merged into the determinants ValueSet Old reference invalid Move to mii-vs-mikrobio-resistenzmechanismen-determinanten-loinc
mii-vs-mikrobio-serologie-immunologie-loinc removed/deprecated active up to the previous version replaced by differentiated serology/antigen/titre bindings Old reference invalid Move to the new profile-specific test ValueSets
mii-vs-mikrobio-serologischer-test-einheiten-ucum removed/deprecated active up to the previous version replaced by concrete profile-specific UCUM ValueSets Old reference invalid Re-bind units per target profile
Extension / logical model / CapabilityStatement
Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
mii-ex-mikrobio-empfindlichkeit-norm new - Local extension for representing the norm (e.g. system/version/category) in the susceptibility context The new extension must be supported where a norm is referenced Add extension mapping to the susceptibility pipelines
extension-Observation.triggeredBy newly used not used in the IG so far R5 extension for representing triggering previous investigation results in Observations; the kind of triggering is modelled via triggeredBy.type (among others reflex) Systems must be able to process trigger relationships and the domain kind of triggering (type) Map existing trigger information including the kind of triggering onto triggeredBy/triggeredBy.type
mii-lm-mikrobio-logical-model content updated flatter/older structure Category-oriented restructuring: culture, determination, quantitative tests, further properties, diagnostic report Mapping documents and implementation guides must be reassigned Move logical mappings to the new node structure
mii-cps-mikrobio-metadata content updated older supportedProfile set and IG reference supportedProfile updated to the 2027 profile set and ImplementationGuide|2027.0.0-alpha.1 Capability-based clients may check a different profile set Revalidate profile discovery / conformance tests against the new set
Examples and IG page structure
Artefact (canonical URL) Type of change Before (where relevant) After Implementation impact Migration note
mii-exa-mikrobio-allgemeine-kultur new - Minimal example for the new profile New reference example for implementers Add to the test data catalogue
mii-exa-mikrobio-spezifische-kultur new - Minimal example for culture-based targeted detection in the profile mii-pr-mikrobio-spezifische-bestimmung New reference example for implementers Add to the test data catalogue
mii-exa-mikrobio-allgemeine-bestimmung new - Minimal example for the new profile New reference example for implementers Add to the test data catalogue
mii-exa-mikrobio-spezifische-bestimmung new - Minimal example for the new profile New reference example for implementers Add to the test data catalogue
mii-exa-mikrobio-resistenzmechanismen-determinanten new - Minimal example for the new profile New reference example for implementers Add to the test data catalogue
mii-exa-mikrobio-antigen-antikoerper-quantitativ new - Minimal example for the new profile New reference example for implementers Add to the test data catalogue
mii-exa-mikrobio-aviditaet new - Minimal example for the new profile New reference example for implementers Add to the test data catalogue
mii-exa-mikrobio-ct-wert new - Minimal example for the new profile New reference example for implementers Add to the test data catalogue
mii-exa-mikrobio-titer new - Minimal example for the new profile New reference example for implementers Add to the test data catalogue
mii-exa-mikrobio-nugent-score new - Minimal example for the new profile New reference example for implementers Add to the test data catalogue
mii-exa-mikrobio-barlett-score new - Minimal example for the new profile New reference example for implementers Add to the test data catalogue
mii-exa-mikrobio-molekulare-pathogenlast new - Minimal example for the new profile New reference example for implementers Add to the test data catalogue
mii-exa-mikrobio-kultur-nachweis removed/deprecated legacy example present dropped in favour of the new culture examples Legacy example no longer fits the 2027 model Deprecated; do not use further
mii-exa-mikrobio-molekulare-diagnostik removed/deprecated legacy example present dropped in favour of specific determination Legacy example no longer fits the 2027 model Deprecated; do not use further
mii-exa-mikrobio-resistenzgene removed/deprecated legacy example present dropped in favour of the determinants profile Legacy example no longer fits the 2027 model Deprecated; do not use further
mii-exa-mikrobio-resistenzmutation removed/deprecated legacy example present dropped in favour of the determinants profile Legacy example no longer fits the 2027 model Deprecated; do not use further