Wyniki badań medycznych w FHIR

Wyniki badań medycznych to priorytetowa kategoria Europejskiej Przestrzeni Danych dotyczących Zdrowia (art. 14 ust. 1 lit. (e) rozporządzenia (UE) 2025/327). Stosuje się ją od 26 marca 2031. HL7 Europe obejmuje ją przewodnikami: laboratory 2.1.0.

Rozporządzenie: Regulation (EU) 2025/327, Article 14(1)(e), Annex I
Stosuje się od: 26 marca 2031
Przewodniki HL7 Europe: hl7.fhir.eu.laboratory 2.1.0, opublikowany
Modele logiczne Xt-EHR: EHDSLaboratoryReport
Typ dokumentu: LOINC 11502-2 Laboratory report
Walidator: Otwórz walidator profili EHDS

Co mówi rozporządzenie

Załącznik I do rozporządzenia opisuje główne cechy tej kategorii. Tekst jest angielskim oryginałem.

Medical test results, including laboratory and other diagnostic results and related reports
Electronic health data representing results of studies performed in particular through in vitro diagnostics such as clinical biochemistry, haematology, transfusion medicine, microbiology, immunology and others, and including, where relevant, reports supporting the interpretation of the results.

Profile FHIR 11

Profile zdefiniowane przez powyższe przewodniki. Kolumna reguł liczy elementy, w których profil wykracza poza bazowy FHIR (wymagane, zakazane lub ograniczone) i które sprawdza walidator; spośród slice’ów sprawdzane są tylko wymagane, które odróżnia stała wartość lub typ zasobu.

Profil	Zasób	Przewodnik HL7 Europe	Sprawdzane reguły	Slice’y sprawdzane / zdefiniowane
Bundle: Laboratory Report`http://hl7.eu/fhir/laboratory/StructureDefinition/Bundle-eu-lab`	`Bundle`	laboratory	11	2 / 20
Composition: Laboratory Report`http://hl7.eu/fhir/laboratory/StructureDefinition/Composition-eu-lab`	`Composition`	laboratory	6	0 / 10
Device: Measuring`http://hl7.eu/fhir/laboratory/StructureDefinition/Device-measuring-eu-lab`	`Device`	laboratory	0	0 / 2
Device: Specimen`http://hl7.eu/fhir/laboratory/StructureDefinition/Device-specimen-eu-lab`	`Device`	laboratory	0	0 / 0
DiagnosticReport: Laboratory Report`http://hl7.eu/fhir/laboratory/StructureDefinition/DiagnosticReport-eu-lab`	`DiagnosticReport`	laboratory	8	2 / 10
Observation Results: laboratory`http://hl7.eu/fhir/laboratory/StructureDefinition/Observation-resultslab-eu-lab`	`Observation`	laboratory	4	1 / 43
Patient: Animal`http://hl7.eu/fhir/laboratory/StructureDefinition/Patient-animal-eu-lab`	`Patient`	laboratory	3	1 / 5
RelatedPerson: AnimalSpecimen`http://hl7.eu/fhir/laboratory/StructureDefinition/animal-specimen-eu-lab`	`RelatedPerson`	laboratory	8	1 / 2
ServiceRequest: Laboratory Order`http://hl7.eu/fhir/laboratory/StructureDefinition/ServiceRequest-eu-lab`	`ServiceRequest`	laboratory	1	0 / 1
Specimen: Laboratory`http://hl7.eu/fhir/laboratory/StructureDefinition/Specimen-eu-lab`	`Specimen`	laboratory	2	1 / 4
Substance: Specimen Additive Substance`http://hl7.eu/fhir/laboratory/StructureDefinition/Substance-additive-eu-lab`	`Substance`	laboratory	0	0 / 0

Struktura dokumentu

Profile dokumentów tej kategorii: sekcje, które może zawierać Composition, i wpisy, które może zawierać Bundle, tak jak określają je profile. Nazwy to nazwy slice’ów; kod sekcji to kod LOINC ustalony przez profil.

Bundle: Laboratory Report: wpisy Bundle 20

Wpis	Licz.	Zasób FHIR	Profil
`composition`	`1..1`	`Composition`	`CompositionLabReportEu`
`diagnosticReport`	`1..1`	`DiagnosticReport`	`DiagnosticReportLabEu`
`patient`	`0..*`	`Patient`
`observation`	`0..*`	`Observation`
`specimen`	`0..*`	`Specimen`	`SpecimenEu`
`serviceRequest`	`0..*`	`ServiceRequest`	`ServiceRequestLabEu`
`organization`	`0..*`	`Organization`
`practitioner`	`0..*`	`Practitioner`	`PractitionerEuCore`
`practitionerRole`	`0..*`	`PractitionerRole`	`PractitionerRoleEuCore`
`bodyStructure`	`0..*`	`BodyStructure`	`BodyStructureEuCore`
`encounter`	`0..*`	`Encounter`
`location`	`0..*`	`Location`	`LocationEuCore`
`provenance`	`0..*`	`Provenance`
`coverage`	`0..*`	`Coverage`
`device`	`0..*`	`Device`
`condition`	`0..*`	`Condition`	`ConditionEuCore`
`procedure`	`0..*`	`Procedure`	`ProcedureEuCore`
`medication`	`0..*`	`Medication`	`MedicationEuCore`
`medicationStatement`	`0..*`	`MedicationStatement`	`MedicationStatementEuCore`
`medicationAdministration`	`0..*`	`MedicationAdministration`

Composition: Laboratory Report: sekcje 1

Sekcja	Licz.	Kod sekcji	Opis
`annotations`	`0..*`	`LOINC 48767-8`	Annotation comment

Powiązania terminologiczne 2

Value sets, z którymi profile tej kategorii wiążą elementy powiązaniem required lub extensible. Powiązanie required dopuszcza tylko kody z value set; extensible oczekuje ich, chyba że żaden nie pasuje. Value sets definiowane w pakietach HL7 Europe są wypisane z kodami w wykazie value sets.

Profile określają też powiązania: preferred – 13, example – 2.

Value set	Powiązanie	Używany przez	Kody
Laboratory Specialty`http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab`	`required`	CompositionLabReportEu `category:specialty`DiagnosticReportLabEu `category:specialty`ObservationResultsLaboratoryEu `category:specialty`	kody: 8
Laboratory Study Types`http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab`	`required`	CompositionLabReportEu `category:studyType`DiagnosticReportLabEu `category:studyType`ObservationResultsLaboratoryEu `category:studyType`	kody: 7

Rozszerzenia 7

Rozszerzenia HL7 Europe, które zawierają profile tej kategorii, z elementem, który je przechowuje.

Rozszerzenie	Kontekst	Wartość	Użyte w
Device Laboratory Test Kit`http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit`	`Observation`	`Reference`	ObservationResultsLaboratoryEu `extension:labTestKit` 0..*
Document DiagnosticReport Reference`http://hl7.eu/fhir/extensions/StructureDefinition/composition-diagnosticReportReference`	`Composition`	`Reference`	CompositionLabReportEu `extension:diagnosticReport` 0..1
Composition: Information recipient`http://hl7.eu/fhir/StructureDefinition/information-recipient`	`Composition`	`Reference`	CompositionLabReportEu `extension:informationRecipient` 0..*
Many: Laboratory Accredited`http://hl7.eu/fhir/StructureDefinition/laboratory-accredited`	`ObservationServiceRequest`	`boolean`	ObservationResultsLaboratoryEu `extension:accredited` 0..1ServiceRequestLabEu `extension:accreditedLab` 0..1
Certified Reference Material: CodeableConcept`http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable`	`Observation`	`CodeableConcept`	ObservationResultsLaboratoryEu `extension:certifiedRefMaterialCodeable` 0..*
Certified Reference Material: Identifier`http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer`	`Observation`	`Identifier`	ObservationResultsLaboratoryEu `extension:certifiedRefMaterialIdentifer` 0..*
Specimen Focus`http://hl7.eu/fhir/laboratory/StructureDefinition/specimen-focus`	`Specimen`	`Reference`	SpecimenEu `extension:focus` 0..1

Model logiczny EHDSLaboratoryReport 43

Elementy modelu logicznego Xt-EHR z licznością i obowiązkami. Obowiązki mówią producentom i odbiorcom danych, co system MUSI lub POWINIEN robić z każdym elementem.

Obowiązki według uczestnika

Ile elementów EHDSLaboratoryReport niesie dany obowiązek dla danego uczestnika.

Obowiązek	Uczestnik	Elementy
`SHALL:able-to-populate`	producent	34
`SHALL:display`	odbiorca	20
`SHALL:process`	odbiorca	5
`SHOULD:able-to-populate`	producent	5
`SHOULD:display`	odbiorca	6
`SHOULD:process`	odbiorca	2

Elementy 43

Element	Licz.	Obowiązki	Opis
`header`	`1..1`	`SHALL:able-to-populate` producent Each producer of a laboratory report SHALL be able to provide basic information, such as type of the report, authorship, status of the report, title, etc. This information is crucial for safe identification of the report and for searchability of the report using standardized searching parameters.`SHALL:process` odbiorca EHR systems that consume laboratory report SHALL process document header information.	Laboratory Report header
`subject`	`1..1`	`SHALL:able-to-populate` producent EHR systems SHALL provide information about the subject of care.`SHALL:display` odbiorca EHR system SHALL render information about the subject of care in such a way that unambiguous assignment to the care subject is preserved.`SHALL:process` odbiorca Information about the subject of care SHALL be processed by the EHR system in such a way that the identity of the subject of care cannot be confused.	Patient/subject information
`identifier`	`1..*`	`SHALL:able-to-populate` producent`SHOULD:display` odbiorca`SHALL:process` odbiorca	Unique identifier of the document
`author[x]`	`1..*`	`SHALL:able-to-populate` producent`SHALL:display` odbiorca	Author(s) by whom the laboratory result report was authored.
`date`	`1..1`	`SHALL:able-to-populate` producent`SHALL:display` odbiorca	Date of finalising/issuing the document
`status`	`1..1`	`SHALL:able-to-populate` producent`SHALL:display` odbiorca	Status of the document
`source`	`0..0`		Source of information (e.g. patient, patient's proxy). Used in case the patient has authored the information or the author has submitted patient-stated information.
`language`	`0..1`	`SHALL:able-to-populate` producent	Language in which the resource is written. Language is expressed by the IETF language tag.
`documentType`	`1..1`	`SHALL:able-to-populate` producent	Type of document at hand, e.g. 60591-5 Patient summary document.
`documentTitle`	`1..1`	`SHALL:able-to-populate` producent	Human readable document title that can be displayed in search results, etc. This can be documentType's display name, or it can be assembled from multiple elements. Examples: 'Laboratory Result Report', 'Patient Summary of Jane Green 10.12.2024'
`period`	`0..1`	`SHALL:able-to-populate` producent	Time of service that is being documented
`version`	`0..1`		Business version of the document. The exact algorithm for versioning is decided by the producer/custodian
`attestation`	`0..*`	`SHALL:able-to-populate` producent`SHALL:display` odbiorca	Document attestation details
`attester[x]`	`1..1`	`SHALL:able-to-populate` producent`SHALL:display` odbiorca	Attester who validated the document
`datetime`	`1..1`	`SHALL:able-to-populate` producent	Date and time of the approval of the document by Attester
`legalAuthentication`	`0..*`	`SHALL:able-to-populate` producent	Document legal authentication details
`legalAuthenticator[x]`	`1..1`	`SHALL:able-to-populate` producent	The person or organisation taking responsibility for the content of the document.
`datetime`	`1..1`	`SHALL:able-to-populate` producent	Date and time when the document was authorised
`eventType`	`0..*`	`SHALL:able-to-populate` producent	Categorisation of the event covered by the document (e.g. laboratory study types, imaging study types including modality, etc.). Selection of such tags or labels depends on the use case and agreement between data sharing parties. This meta-data element serves primarily for searching and filtering purposes.
`serviceSpecialty`	`0..*`	`SHALL:able-to-populate` producent`SHOULD:display` odbiorca	Additional details about where the content was created (e.g. clinical specialty)
`custodian`	`0..1`	`SHALL:able-to-populate` producent	Organisation that is in charge of maintaining the document/report.
`intendedRecipient[x]`	`0..*`		Intended recipient
`presentedForm`	`0..*`	`SHALL:able-to-populate` producent Each EHR system that is a producer of a laboratory report SHALL be able to provide the entire report as issued by the laboratory in a human readable format, e.g. PDF.`SHALL:process` odbiorca EHR systems that consume laboratory report SHALL process the human readable version of the report.`SHALL:display` odbiorca EHR systems that consume laboratory report SHALL render human readable version of the report to the endusers.	A narrative easy-to-read representation of the full data set, e.g. PDF-version of a document
`body`	`0..1`	`SHALL:able-to-populate` producent Each EHR system that is a producer of a laboratory report SHALL be able to provide structured information about the laboratory investigation, such as order information, supporting information, specimen details and result data.`SHALL:process` odbiorca EHR systems that consume laboratory report SHALL process structured body information.	Laboratory Report structured body
`orderInformation`	`0..*`	`SHALL:able-to-populate` producent EHR systems SHALL be able to populate information about one or more order which this report is based on.`SHALL:display` odbiorca Consumer EHR systems SHALL display key order information to ensure traceability between order and report.	Order Information (Laboratory Result Report could respond to multiple test orders)
`orderId`	`1..*`	`SHALL:able-to-populate` producent`SHOULD:process` odbiorca Consumer systems SHOULD use this element to pair result report with laboratory order.	An identifier of the laboratory test order. Laboratory Result Report may respond to multiple orders.
`orderDateAndTime`	`0..1`		Date and time of the order placement.
`orderPlacer[x]`	`0..1`	`SHALL:able-to-populate` producent`SHOULD:display` odbiorca	The person/organisation "authorised" to place the order. Order placer could be either a health professional, health professional organisation or the patient himself.
`orderReason[x]`	`0..*`	`SHALL:able-to-populate` producent`SHALL:display` odbiorca	An explanation or justification for why this service is being requested in coded form.
`clinicalQuestion`	`0..1`	`SHALL:able-to-populate` producent`SHALL:display` odbiorca	Specification of clinical question (goal of the investigation) to be answered by the laboratory investigation.
`supportingInformation`	`0..1`	`SHOULD:able-to-populate` producent`SHALL:display` odbiorca	Additional clinical information about the patient or specimen that may influence the services or their interpretations. This information includes diagnosis, clinical findings and other observations. In laboratory ordering these are typically referred to as 'ask at order entry questions (AOEs).' This includes observations explicitly requested by the producer (filler) to provide context or supporting information needed to complete the order. For example, reporting the amount of inspired oxygen for blood gas measurements.
`observation`	`0..*`	`SHOULD:able-to-populate` producent`SHALL:display` odbiorca	Clinical findings and other observations.
`condition`	`0..*`	`SHALL:able-to-populate` producent`SHALL:display` odbiorca	Condition that may influence the service or result interpretation.
`medicationAdministration`	`0..*`	`SHALL:able-to-populate` producent`SHALL:display` odbiorca	Medication administered before ordering the service.
`sexForClinicalUse`	`0..1`	`SHALL:able-to-populate` producent`SHALL:display` odbiorca	A Sex Parameter for Clinical Use is a parameter that provides guidance on how a recipient should apply settings or reference ranges that are derived from observable information such as an organ inventory, recent hormone lab tests, genetic testing, menstrual status, obstetric history, etc.. This property is intended for use in clinical decision making, and indicates that treatment or diagnostic tests should consider best practices associated with the relevant reference population
`vaccination`	`0..*`	`SHOULD:able-to-populate` producent`SHALL:display` odbiorca	Vaccination history of the patient.
`otherSupportingInformation`	`0..*`	`SHOULD:able-to-populate` producent`SHOULD:display` odbiorca	Any other type of relevant supporting information
`specimen`	`0..*`	`SHALL:able-to-populate` producent`SHALL:display` odbiorca	Specimen information
`serviceRequest`	`0..*`	`SHALL:able-to-populate` producent`SHOULD:display` odbiorca	Specification of requested service or services
`resultData`	`1..1`	`SHALL:able-to-populate` producent`SHALL:display` odbiorca	Laboratory report result data
`commentsInterpretationAndRecommendations`	`0..*`	`SHALL:able-to-populate` producent`SHALL:display` odbiorca	Narrative Comments, such as a textual interpretation or advice accompanying the result report, for example.
`laboratoryTestResults`	`0..*`	`SHALL:able-to-populate` producent`SHALL:display` odbiorca	Observation details (report could consist of multiple observations)
`attachments`	`0..*`	`SHOULD:able-to-populate` producent Each EHR system that is a producer of a laboratory report SHOULD be able to provide attachments related to the report, such as documents, diagrams, images of the results, etc.`SHOULD:process` odbiorca EHR systems that consume laboratory report SHOULD process attachments related to the report.`SHOULD:display` odbiorca EHR systems that consume laboratory report SHOULD render attachments related to the report to the endusers.	Report attachments

Odwzorowanie EHDSLaboratoryReport na FHIR 47

Jak każdy element logiczny trafia do FHIR, według przewodnika HL7 Europe. Odwzorowane na: BundleLabReportEu, CompositionLabReportEu, DiagnosticReportLabEu, ServiceRequestLabEu.

Element	Relacja	Zasób FHIR	Element FHIR	Uwagi
`header`	powiązany z	`Composition`	`.`
`subject`	równoważny	`Composition`	`subject`	Also aligned with DiagnosticReport.subject.
`identifier`	równoważny	`Composition`	`identifier`
`identifier`	równoważny	`DiagnosticReport`	`identifier`
`identifier`	równoważny	`Bundle`	`identifier`
`author[x]`	równoważny	`Composition`	`author`
`date`	równoważny	`Composition`	`date`
`status`	równoważny	`DiagnosticReport`	`status`	Composition and DiagnosticReport status are expected to be aligned.
`language`	równoważny	`Composition`	`language`
`documentType`	równoważny	`Composition`	`type`
`documentType`	równoważny	`DiagnosticReport`	`code`
`documentTitle`	równoważny	`Composition`	`title`
`period`	powiązany z	`Composition`	`event.period`
`version`	powiązany z	`Composition`	`extension:version`
`attestation`	powiązany z	`Composition`	`attester`
`attester[x]`	równoważny	`Composition`	`attester.party`
`datetime`	równoważny	`Composition`	`attester.time`
`legalAuthentication`	powiązany z	`Composition`	`attester`
`legalAuthenticator[x]`	powiązany z	`Composition`	`attester.party`	May require attester mode constraints by implementation rules.
`datetime`	równoważny	`Composition`	`attester.time`
`eventType`	powiązany z	`Composition`	`category:studyType`	The model gives laboratory study types as an example. This guide carries them in the studyType slice, which DiagnosticReport.category has as well.
`serviceSpecialty`	powiązany z	`Composition`	`category:specialty`	The slice is bound to LabSpecialtyEuVs. DiagnosticReport.category has the same slice.
`custodian`	równoważny	`Composition`	`custodian`
`presentedForm`	równoważny	`DiagnosticReport`	`presentedForm`
`intendedRecipient[x]`	równoważny	`Composition`	`extension:informationRecipient`	Uses EU extension on Composition.
`body`	powiązany z	`Composition`	`section`
`orderInformation`	powiązany z	`ServiceRequest`	`.`	Each order is a ServiceRequestLabEu, which DiagnosticReport.basedOn references. The child elements map to elements of that ServiceRequest.
`orderId`	równoważny	`ServiceRequest`	`identifier`
`orderDateAndTime`	równoważny	`ServiceRequest`	`authoredOn`
`orderPlacer[x]`	równoważny	`ServiceRequest`	`requester`
`orderReason[x]`	równoważny	`ServiceRequest`	`reasonCode / reasonReference`	Mapping depends on coded, textual, or referenced reason source.
`clinicalQuestion`	powiązany z	`ServiceRequest`	`note`
`supportingInformation`	powiązany z	`ServiceRequest`	`supportingInfo`
`observation`	równoważny	`ServiceRequest`	`supportingInfo`
`condition`	równoważny	`ServiceRequest`	`supportingInfo`
`medicationAdministration`	równoważny	`ServiceRequest`	`supportingInfo`
`sexForClinicalUse`	powiązany z	`Patient`	`extension:sex-for-clinical-use`	PatientEuCore of HL7 Europe Base profiles this extension.
`vaccination`	równoważny	`ServiceRequest`	`supportingInfo`
`otherSupportingInformation`	równoważny	`ServiceRequest`	`supportingInfo`
`specimen`	równoważny	`DiagnosticReport`	`specimen`	Also represented as Bundle entries of type SpecimenEu.
`serviceRequest`	równoważny	`DiagnosticReport`	`basedOn`
`resultData`	powiązany z	`DiagnosticReport`	`result / conclusion / presentedForm`
`laboratoryTestResults`	równoważny	`DiagnosticReport`	`result`	Observation resources are included as Bundle entries.
`laboratoryTestResults`	równoważny	`Composition`	`section.entry`
`commentsInterpretationAndRecommendations`	powiązany z	`Composition`	`section:text`	Often represented in annotation/comment section.
`commentsInterpretationAndRecommendations`	powiązany z	`DiagnosticReport`	`conclusion / conclusionCode`	When implemented in the DiagnosticReport profile instance.
`attachments`	powiązany z	`DiagnosticReport`	`media.link.extension:link`	Each attachment is a DocumentReference, referenced through the alternate-reference extension on media.link. The rendered report itself maps from presentedForm.

Dokumenty CDA (eHDSI)

Tę samą kategorię niosą w CDA te szablony dokumentów eHDSI. Ich struktura, zbiory wartości i walidator dokumentów CDA są w przewodniku CDA.

eHDSI OrCD Laboratory Result

Źródła

Rozporządzenie (UE) 2025/327, Dziennik Urzędowy Unii Europejskiej; przewodniki wdrożeniowe FHIR HL7 Europe; modele logiczne Xt-EHR (xtehr.eu.ehds.models). Przewodniki w ballocie mogą się jeszcze zmienić. Ten przewodnik ma charakter informacyjny: nie jest poradą prawną ani certyfikacją zgodności.