HL7 Europe Laboratory Report
0.1.1 - trial-use 150

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Official URL: http://hl7.eu/fhir/laboratory/ImplementationGuide/hl7.fhir.eu.laboratory | Version: 0.1.1
Active as of 2025-03-25 | Computable Name: Hl7EuLaboratoryIg
Other Identifiers: OID:2.16.840.1.113883.2.51.22.1
Copyright/Legal: Used by permission of HL7 Europe, all rights reserved Creative Commons License

> Obligations have been added to this version of the guide only as Informative material to collect feedback about their usage.

> For more details about obligations please refer to the Obligations page

### The Laboratory Domain

Clinical laboratory results play an important role in diagnosis, treatment, and follow-up of patients. The availability of high quality test results, and the capacity of sharing them, is therefore essential being often the basis for clinical decision making. For this reason the Laboratory has been selected as one of the priority domains for the European EHR eXchange Format (E-EHRxF).

### Scope

Specify a set of rules to be applied to HL7 FHIR to define how to represent a Laboratory Report in the European Context, coherently with the European eHN Guidelines (see the European eHealth - Key documents ).

This Implementation Guide applies to laboratory reports within the core fields of in-vitro diagnostics, for example clinical biochemistry, haematology, immunohematology, microbiology, immunology, while leaving out some specialised laboratory domains like histopathology or medical genetics. This version focuses only on common rules that apply to all the in-scope situations, without specifying specialized domain-specific profiles, as for example microbiology profiles.

This guide is not limited to test results performed by clinical laboratories on Human specimens (from human subject), but it considers also results on non-human materials or living subjects; or non-human specimens paired with a human subject. Derived guides may restrict the scope as needed (e.g. limiting the scope to well-identified human beings)

### Purpose

The goal of this Implementation Guide is to define an European standard for the Laboratory Report to facilitate the harmonization among the national initiatives and prepare the ground for the European EHR eXchange Format (E-EHRxF).

This project is promoted by HL7 Europe, but realized in collaboration with several other European and national organizations and projects.

The aspiration of this guide is that of being used as basis for European National Guides, the European EHRxF and - consequently - by MyHealth@EU for the EU cross-border services.

### Background

The project background is described in the background page.

### Design choices

The solution adopted by this guide - and detailed in the Design choices page - balances the business requirement of Laboratory Report as legally signable document (i.e. as a FHIR document), with the expectation to get Lab Report by searching per DiagnosticReport. All this, taking into account the R5 DiagnosticReport design pattern where the DiagnosticReport <-> Composition relationship is directed from the DiagnosticReport to the Composition resource. This is done by supporting both perspectives (see figure below) requiring the document bundle ( BundleLabReportEu ) to always include a DiagnosticReport ( DiagnosticReportLabEu ) and enabling the pre-adoption of the R5 rules for the inclusion of entries in the Document Bundle.

Figure 1 - Overview of the report design approach

### Navigating the profiles

The following diagrams provide a browseable overview of the profiles specified by this guide (not all the relationships have been reported).

The first highlights the most relevant relationships starting from the DiagnosticReport ( DiagnosticReportLabEu ) resource (REST Perspective).

Figure 2 - Overview of the profiles relationships

The second the profiles included in the document bundle ( BundleLabReportEu ) (Document Perspective).

Figure 3 - Overview of the document structure

### Dependencies

IG | Package | FHIR | Comment
--- | --- | --- | ---
HL7 Europe Laboratory Report | hl7.fhir.eu.laboratory#0.1.1 | R4 |
HL7 Terminology (THO) | hl7.terminology.r4#6.2.0 | R4 | Automatically added as a dependency - all IGs depend on HL7 Terminology
FHIR Extensions Pack | hl7.fhir.uv.extensions.r4#5.2.0 | R4 | Automatically added as a dependency - all IGs depend on the HL7 Extension Pack
International Patient Summary Implementation Guide | hl7.fhir.uv.ips#1.1.0 | R4 |
HL7 Terminology (THO) | hl7.terminology.r4#5.3.0 | R4 |
FHIR Extensions Pack | hl7.fhir.uv.extensions.r4#1.0.0 | R4 |
fhir.dicom | fhir.dicom#2022.4.20221006 | R4 |
HL7 Europe Extensions | hl7.fhir.eu.extensions#0.1.0 | R4 |

Package hl7.fhir.uv.extensions.r4#5.2.0 This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Mon, Feb 10, 2025 21:45+1100+11:00)

Package hl7.fhir.uv.extensions.r4#1.0.0 This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Sun, Mar 26, 2023 08:46+1100+11:00)

Package hl7.fhir.uv.ips#1.1.0 International Patient Summary (IPS) FHIR Implementation Guide (built Tue, Oct 24, 2023 13:36+0000+00:00)

Package hl7.fhir.eu.extensions#0.1.0 This guide lists the extensions speciifed for the European REALM. (built Mon, Feb 19, 2024 08:53+0100+01:00)

### Cross Version Analysis

This is an R4 IG. None of the features it uses are changed in R4B, so it can be used as is with R4B systems. Packages for both R4 (hl7.fhir.eu.laboratory.r4) and R4B (hl7.fhir.eu.laboratory.r4b) are available.

### Global Profiles

There are no Global profiles defined

### IP statements

This publication includes IP covered under the following statements.

- https://cms.npu-terminology.org/wp-content/uploads/2024/06/NPU-License-Terms-of-Use.pdf
  Show Usage
  - Nomenclature for Properties and Units (NPU): NpuVs and Observation/4335db48-7090-45b3-a2c2-45b45f94a67c
- Copyright HL7. Licensed under creative commons public domain
  Show Usage
  - contactRole2: Bundle/SimpleChemistryResultReport
- ISO Maintains the copyright on the country codes, and controls it's use carefully. For futher details see the ISO 3166 web page: https://www.iso.org/iso-3166-country-codes.html
  Show Usage
  - ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code: AddressEu
- The UCUM codes, UCUM table (regardless of format), and UCUM Specification are copyright 1999-2009, Regenstrief Institute, Inc. and the Unified Codes for Units of Measures (UCUM) Organization. All rights reserved. https://ucum.org/trac/wiki/TermsOfUse
  Show Usage
  - Unified Code for Units of Measure (UCUM): Bundle/BundleHepatitisPanel, Bundle/BundleLabResultMicroCultureSusc... Show 8 more, Bundle/IT-CDA2FHIR-17e2cad1-c3e3-4901-adb1-c35a0b82b883, Bundle/SimpleChemistryResultReport, Observation/4335db48-7090-45b3-a2c2-45b45f94a67c, Observation/d29b286d-b99c-410f-af4e-9455ea49d0af, Observation/obs-org-id1-susc-1, Observation/obs-org-id1-susc-2, Observation/obs-org-id1-susc-3 and Observation/obs-org-id1-susc-4
- This material contains content from LOINC. LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc.
  Show Usage
  - LOINC: Bundle/BundleHepatitisPanel, Bundle/BundleLabResultMicroCultureSusc... Show 25 more, Bundle/BundleLabResultReportPOC, Bundle/IT-CDA2FHIR-17e2cad1-c3e3-4901-adb1-c35a0b82b883, Bundle/SimpleChemistryResultReport, Composition/comp-lab-example, CompositionLabReportEu, DiagnosticReport/dr-lab-example, DiagnosticReportLabEu, LabOrderCodesEuVs, LabReportTypesEuVs, LabStudyTypesEuVs, LoincVs, Observation/4335db48-7090-45b3-a2c2-45b45f94a67c, Observation/d29b286d-b99c-410f-af4e-9455ea49d0af, Observation/obs-anaerobic-culture, Observation/obs-gs-org1, Observation/obs-org-id1, Observation/obs-org-id1-susc-1, Observation/obs-org-id1-susc-2, Observation/obs-org-id1-susc-3, Observation/obs-org-id1-susc-4, Observation/obs-org-id1-susc-panel, Observation/obs-wbc, ObservationResultsLaboratoryEu, ServiceRequest/srv-request-example and ServiceRequestLabEu
- This material contains content that is copyright of SNOMED International. Implementers of these specifications must have the appropriate SNOMED CT Affiliate license - for more information contact https://www.snomed.org/get-snomed or info@snomed.org.
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  - SNOMED Clinical Terms&reg; (SNOMED CT&reg;): BodyStructureEuLab, Bundle/BundleHepatitisPanel... Show 27 more, Bundle/BundleLabResultMicroCultureSusc, Bundle/BundleLabResultReportPOC, Bundle/IT-CDA2FHIR-17e2cad1-c3e3-4901-adb1-c35a0b82b883, Bundle/SimpleChemistryResultReport, CompositionLabReportEu, DiagnosticReportLabEu, LabLateralityEuVs, LabSiteQualifierEuVs, LabSpecialtyEuVs, LabSpeciesTypesEuVs, LabSpecimenAdditiveEu, LabSpecimenContainerEu, LabSpecimenTypesEuVs, LabTechniqueEuVs, Observation/obs-anaerobic-culture, Observation/obs-gs-org1, Observation/obs-gs-org1-quant, Observation/obs-org-id1, Observation/obs-org-id1-growth, Observation/obs-wbc, ObservationResultsLaboratoryEu, Patient/Patient-animal-example, PatientAnimalEu, ServiceRequest/srv-request-example, Specimen/Specimen-animal-example, SpecimenAdditiveSubstance and SpecimenEu
- This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html
  Show Usage
  - Observation Category Codes: Bundle/BundleHepatitisPanel, Bundle/BundleLabResultMicroCultureSusc... Show 20 more, Bundle/BundleLabResultReportPOC, Bundle/IT-CDA2FHIR-17e2cad1-c3e3-4901-adb1-c35a0b82b883, Bundle/SimpleChemistryResultReport, Observation/4335db48-7090-45b3-a2c2-45b45f94a67c, Observation/d29b286d-b99c-410f-af4e-9455ea49d0af, Observation/obs-aerobic-culture, Observation/obs-anaerobic-culture, Observation/obs-gram-stain, Observation/obs-gs-org1, Observation/obs-gs-org1-quant, Observation/obs-org-id1, Observation/obs-org-id1-growth, Observation/obs-org-id1-susc-1, Observation/obs-org-id1-susc-2, Observation/obs-org-id1-susc-3, Observation/obs-org-id1-susc-4, Observation/obs-org-id1-susc-panel, Observation/obs-wbc, ObservationEuObligations and ObservationResultsLaboratoryEu
  - Observation Reference Range Meaning Codes: Bundle/BundleHepatitisPanel and Bundle/SimpleChemistryResultReport
  - identifierType: Bundle/BundleHepatitisPanel, Bundle/BundleLabResultMicroCultureSusc, Bundle/BundleLabResultReportPOC, Bundle/SimpleChemistryResultReport and Patient/pat-lab-example
  - ActCode: Bundle/IT-CDA2FHIR-17e2cad1-c3e3-4901-adb1-c35a0b82b883
  - ObservationInterpretation: Bundle/BundleHepatitisPanel, Bundle/BundleLabResultMicroCultureSusc... Show 6 more, Bundle/IT-CDA2FHIR-17e2cad1-c3e3-4901-adb1-c35a0b82b883, Bundle/SimpleChemistryResultReport, Observation/obs-org-id1-susc-1, Observation/obs-org-id1-susc-2, Observation/obs-org-id1-susc-3 and Observation/obs-org-id1-susc-4
  - ParticipationType: Bundle/IT-CDA2FHIR-17e2cad1-c3e3-4901-adb1-c35a0b82b883
  - RoleCode: Bundle/SimpleChemistryResultReport
- Used by permission of HL7 Europe, all rights reserved Creative Commons License
  Show Usage
  - Laboratory Code: example: Bundle/BundleHepatitisPanel

### Authors and Contributors

Please refer to the Authors and Contributors page.