This page is part of the CH LAB-Report (R4) (v0.1.1: DSTU 1 Draft) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

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Official URL: http://fhir.ch/ig/ch-lab-report/ImplementationGuide/ch.fhir.ig.ch-lab-report				Version: 0.1.1
Active as of 2023-12-28				Computable Name: CH_LAB_REPORT
Copyright/Legal: CC0-1.0

Introduction

The examination of blood, urine, tissue samples, cerebrospinal fluid, exhaled air and wound secretions using modern medical laboratory methods helps clinicians to diagnose, prevent and treat diseases. 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.

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, sex, 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.
• Authorised Signatures: Include the signatures or electronic authentication of the laboratory personnel responsible for conducting and validating the tests.

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.

Download: You can download this implementation guide in NPM format from here.

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.

• CC0-1.0
  Show Usage
  • eCH-011 Types: ChLabPatient
  • eCH-011 MaritalStatus: Bundle/LabResultReport-1-tvt and Bundle/LabResultReport-4-sepsis
• Copyright HL7. Licensed under creative commons public domain
  Show Usage
  • degreeLicenseCertificate: Bundle/LabResultReport-1-tvt and Bundle/LabResultReport-4-sepsis
  • additivePreservative: Bundle/LabResultReport-1-tvt
  • specimenCollectionMethod: Bundle/LabResultReport-4-sepsis
  • relevantClincialInformation: Bundle/LabResultReport-1-tvt
• 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: CH_LAB_REPORT, ChCorePatientEch11PlaceOfOrigin... Show 30 more, ChLabCBC, ChLabDiagnosticReport, ChLabErythrocyteCount, ChLabErythrocyteDistWidthRatio, ChLabErythrocyteDistributionWidth, ChLabHematocrit, ChLabHemoglobin, ChLabLeucocyteCount, ChLabMeanCorpuscularHemoglobin, ChLabMeanCorpuscularHemoglobinConcentration, ChLabMeanCorpuscularVolume, ChLabObservationDefinition, ChLabObservationResultsLaboratory, ChLabPatient, ChLabPlateletCount, ChLabPlateletDistributionWidth, ChLabPlateletMeanVolume, ChLabPractitioner, ChLabPractitionerRole, ChLabReportComposition, ChLabReportDeviceAnalyzer, ChLabReportDeviceDefinition, ChLabReportDeviceTestKit, ChLabReportDocument, ChLabReportServiceRequest, ChLabReportSpecimen, ChLabReportSpecimenDefinition, CompositionBasedOnOrderOrRequisition, LabStudyTypesEuVs and ObservationInstantiatesR5
• 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/LabResultReport-1-tvt and Bundle/LabResultReport-4-sepsis
• 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/LabResultReport-1-tvt, Bundle/LabResultReport-4-sepsis... Show 17 more, ChLabCBC, ChLabDiagnosticReport, ChLabErythrocyteCount, ChLabErythrocyteDistWidthRatio, ChLabErythrocyteDistributionWidth, ChLabHematocrit, ChLabHemoglobin, ChLabLeucocyteCount, ChLabMeanCorpuscularHemoglobin, ChLabMeanCorpuscularHemoglobinConcentration, ChLabMeanCorpuscularVolume, ChLabObservationResultsLaboratory, ChLabPlateletCount, ChLabPlateletDistributionWidth, ChLabPlateletMeanVolume, ChLabReportComposition and LabStudyTypesEuVs
• 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.
  Show Usage
  • SNOMED Clinical Terms® (SNOMED CT®): Bundle/LabResultReport-1-tvt, Bundle/LabResultReport-4-sepsis... Show 5 more, ChLabDiagnosticReport, ChLabObservationResultsLaboratory, ChLabReportComposition, ChLabReportDeviceAnalyzer and ChLabReportDeviceTestKit
• 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
  Show Usage
  • Observation Category Codes: Bundle/LabResultReport-1-tvt, Bundle/LabResultReport-4-sepsis... Show 13 more, ChLabErythrocyteCount, ChLabErythrocyteDistWidthRatio, ChLabErythrocyteDistributionWidth, ChLabHematocrit, ChLabHemoglobin, ChLabLeucocyteCount, ChLabMeanCorpuscularHemoglobin, ChLabMeanCorpuscularHemoglobinConcentration, ChLabMeanCorpuscularVolume, ChLabObservationResultsLaboratory, ChLabPlateletCount, ChLabPlateletDistributionWidth and ChLabPlateletMeanVolume
  • Observation Reference Range Meaning Codes: Bundle/LabResultReport-1-tvt
  • identifierType: Bundle/LabResultReport-1-tvt, Bundle/LabResultReport-4-sepsis and ChLabPatient
• 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
  Show Usage
  • MaritalStatus: Bundle/LabResultReport-1-tvt and Bundle/LabResultReport-4-sepsis
  • ObservationInterpretation: Bundle/LabResultReport-4-sepsis
  • RoleCode: ChLabPatient

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 (ch.fhir.ig.ch-lab-report.r4) and R4B (ch.fhir.ig.ch-lab-report.r4b) are available.

Dependency Table

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 ihe.formatcode.fhir#1.1.0 Implementation Guide for IHE defined FormatCode vocabulary. (built Thu, Feb 24, 2022 16:55-0600-06:00)

Package ch.fhir.ig.ch-epr-term#2.0.10 Implementation guide for the meta data specified in the framework of Annex 3 and 9 of the FDHA Ordinance on the electronic patient record in Switzerland (built Tue, Dec 19, 2023 12:36+0100+01:00)

Package ch.fhir.ig.ch-core#4.0.1 FHIR implementation guide CH Core (built Thu, Dec 28, 2023 08:42+0100+01:00)

Package hl7.fhir.uv.ips#1.1.0 International Patient Summary (IPS) FHIR Implementation Guide (built Tue, Nov 22, 2022 03:24+0000+00:00)

Package hl7.fhir.eu.laboratory#0.1.0-ballot This guide describes how the Laboratory Report can be represented in the European REALM. (built Wed, Dec 6, 2023 08:25+0000+00:00)

Globals Table

There are no Global profiles defined