Modern medical laboratory techniques aid clinicians in diagnosing, preventing, and treating diseases by analyzing blood, urine, tissue samples, cerebrospinal fluid, exhaled air, and wound secretions utilizing contemporary medical laboratory techniques. In order for the results to be evaluated correctly, a number of requirements must be met, including the correct reproduction of the results of clinical laboratory tests.
This implementation guide is based on the HL7 Europe Laboratory Report and the European eHealth Network. It enables the cross-border exchange of laboratory results in Europe. The aim of the interoperability of electronic laboratory records is to ensure the uniform processing of information between health information systems, regardless of their technology, application or platform, so that it can be meaningfully interpreted by the recipient. Citizens should have better control over their health data, especially their laboratory data, just as healthcare professionals should have easy and secure access to their patients' laboratory data.
The implementation guide uses the Swiss Core profiles from CH Core and the terminology from CH Term.
Management Summary
This implementation guide specifies the exchange format for the comprehensive and correct reproduction of clinical laboratory results. These consist of the following data in detail:
Administrative Data
Patient Information: Include the patient's name, age, gender, date of birth, and any other relevant identification details.
Order Data: Ordering practitioner, organization, ordering date, recipients.
Laboratory Information: Include details about the laboratory that performed the analysis, such as the name, address, and contact information.
Authorized Signatures: Include the signatures or electronic authentication of the laboratory personnel responsible for conducting and validating the tests.
Laboratory Analytic-Test Data
Specimen Information: Specification of the preanalytic conditions, the type of specimen collected for analysis. This could include details like the date and time of collection.
Test Request Details: Information about the tests requested are provided by the requester. It includes the name of the test, mostly in form of a code, the reason for the test, and any specific instructions given.
Test Results: The results of each test performed must be presented. Appropriate units of measurement and reference ranges for comparison must be presented. Any values that fall outside the normal range are highlighted.
Reference Ranges: Normal or expected range of values for each test are included. This helps healthcare providers interpret the results in the context of the patient's health. Since these data may be dependent from the used test-kits, the identification of the test-kits (UDI) might be useful. Alternatively, the likelihood ratio of the test, if available, can be used for the interpretation of the results. The likelihood ratio is not dependent on the kind of used test-kit.
Certain results are shown in the form of images, e.g. electrophoresis of haemoglobin, haematology scatter-plots, microbiological cultures, or MALDI-TOF mass spectrometry.
Interpretation or Comments: Include any additional comments or interpretations provided by the laboratory. This can help healthcare providers understand the clinical significance of the results.
Date and Time of Analysis: Provide the date and time when the laboratory tests were conducted.
Observation Profiles: We have proposed some profiles hoping they are useful for the laboratories. These profiles represent laboratory result panels, like CBC panel for automated blood cell count, which corresponds to haematogram II of the 'Analysenliste (AL)'. The use of these panels is not mandatory, they are intended as an aid and template and should be adapted to your own requirements.
Download: You can download this implementation guide in NPM format from here.
Must Support
To fulfill the requirements of the estimated glomerular filtration rate (eGFR) formulas and the requirements of the L4CHLAB Dataset the corresponding FHIR elements 'mustSupport' flag have been set to true: Required if known. If the sending application has data for the element, it is required to populate the element with a non-empty value. If the value is not known, the element may be omitted. A receiving application may ignore the information conveyed by the element. A receiving application shall not raise an error solely due to the presence or absence of the element.
IP Statements
This document is licensed under Creative Commons "No Rights Reserved" (CC0).
HL7®, HEALTH LEVEL SEVEN®, FHIR® and the FHIR ® are trademarks owned by Health Level Seven International, registered with the United States Patent and Trademark Office.
This implementation guide contains and references intellectual property owned by third parties ("Third Party IP"). Acceptance of these License Terms does not grant any rights with respect to Third Party IP. The licensee alone is responsible for identifying and obtaining any necessary licenses or authorizations to utilize Third Party IP in connection with the specification or otherwise.
This publication includes IP covered under the following statements.
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
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.
A graphic overview of the dependencies, in particular with regard to the exchange format of reportable laboratory results in Switzerland, can be found here. It also shows the dependency on the European laboratory project.
This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Sat, Apr 27, 2024 18:39+1000+10:00)
International Patient Summary (IPS) FHIR Implementation Guide (built Tue, Nov 22, 2022 03:24+0000+00:00)
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.eu.extensions#0.1.0
This guide lists the extensions speciifed for the European REALM. (built Tue, Feb 20, 2024 08:56+0100+01:00)
Package hl7.fhir.eu.laboratory#0.1.0
This guide describes how the Laboratory Report can be represented in the European REALM. (built Mon, Feb 26, 2024 08:09+0100+01:00)
® are trademarks owned by Health Level Seven International, registered with the United States Patent and Trademark Office.
