Project Summary for LOINC - IVD Test Code (LIVD) Mapping
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Project Details
Number | 1335 View Ballot Items List (with NIBs) |
---|---|
Name | LOINC - IVD Test Code (LIVD) Mapping |
Sponsor(s) | Orders and Observations Work Group |
Co-Sponsor(s) | Devices Work Group, Terminology Infrastructure Work Group |
Steering Division | Administrative |
Description | The objective of the project is to define an implementation guide on how to convey existing and future LOINC to IVD Test Code mappings using FHIR resources that enable laboratories to more efficiently and effectively map lab test/analyte codes between the two code systems.
The requirements will be provided through the 'Digital Format for Publication of LOINC for Vendor IVD Test Results' whitepaper published by IICC in cooperation with the NLM and CDC. As needed, propose updates and/or extensions to core resources and define necessary profiles. |
Project Facilitator | Ed Heierman / Rob Hausam / Hans Buitendijk |
Status | STU - Balloting |
SD Approval Date | May 8, 2017 |
TSC Approval Date | Jun 15, 2017 |
Type | Ballot - STU to Normative |
Objectives / Deliverables | DAM addressing Whitepaper Requirements to FHIR Mapping - Target: May 2017 Implementation Guide Development - Target: June 2017 STU R1 Ballot - Target: September 2017 Ballot Reconciliation - Target: October 2017 Publication and STU Period starts - Target: December 2017 Connectathon at IHE/HIMSS (can we do non-IHE profiles?) - Target: January/February 2018 STU R2 Ballot - Target: September 2018 Publication and STU Period starts - Target: December 2018 Connectathon at IHE/HIMSS - Target: January/February 2019 Normative R1 Ballot - Target: September 2019 Publication - Target: December 2019 Targeted new publication before May 2021 |
Next Milestone Date | 2024 May WGM |
Project End Date | 2025 May WGM |
Project Intent | Revise Current Standard, Implementation Guide |
Project Need | Laboratories are challenged to accurately and consistently map local and LOINC testing codes to the corresponding IVD test/analyte codes used in the various IVD devices. Due to widely varying requirements and capabilities, IVD devices can be configured in many different ways and use code systems unique to their capabilities. However, upon transmitting the results from the device to the LIS and onwards, these IVD test/analyte codes need to be translated to the appropriate LOINC codes. Ultimately that is the laboratory’s responsibility. Establishing accurate mappings requires skill and experience to understand when to use a particular LOINC code. To date, laboratories have no specific guidance and need to rely mostly on institutional expertise. The industry is interested in having device manufacturers provide suggested/recommended mappings that laboratories can use as a starting point, thereby substantially reducing effort and increasing consistency across the industry where those devices are used. Ultimately, final mappings remain the responsibility of the laboratories to accommodate local variations. To communicate these mappings, IICC has endeavored to define a minimum data set and parameters that need to be provided and has agreed to an initial format using JSON. While that provides a machine-readable format that enables parties to consistently exchange and interpret, this format is not using the FHIR resources to define that format. The introduction of FHIR would maintain the consistency as desired of the mapping definitions itself. Also, it would provide an initial stepping stone to introduce FHIR into the full loop of laboratory test ordering and result reporting where next steps can be built on common definitions, as well as deploy a format that is starting to be widely adopted in the industry. |
Implementers | 1) IICC (IVD Industry Connectivity Consortium) – this includes multiple vendors of both diagnostic instrument and laboratory information systems 2) Abbott Laboratories (Ed Heierman) |
Security Risks | No |
External Drivers | IICC is driving initial piloting using the JSON format and before wider deployment we would want to have the FHIR based format ready. |
Common Names / Keywords/ Aliases | LIVD |
Lineage | |
Dependancies | Availability of core resources. |
Project Document Repository | FHIR Implementation Guide space |
Backwards Compatibility | N/A |
External Vocabularies | Yes |
Products | FHIR Profile |
Joint Copyright? | No |
External Pjt Collaborators | IICC |
Realm | Universal |
HL7 Affiliate | |
Stakeholders | Clinical and Public Health Laboratories, Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs) |
Vendors | Equipment; Health Care IT; Lab |
Providers | Clinical and Public Health Laboratories |
Ballot Cycle Info | 2023 Jan Ballot Cycle Info: STU Ballot Results: Postponed Document Name: HL7 FHIR Implementation Guide: LOINC – IVD Test Code (LIVD) Mapping, Release 1 2021 Jan Ballot Cycle Info: STU Ballot Results: Did not meet basic vote requirements. 18 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: LOINC - IVD Test Code (LIVD) Mapping, Release 1 2019 Sept Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 2 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: LOINC - IVD Test Code (LIVD) Mapping, Release 1 2018 Oct Ballot Cycle Info: COMMENT ONLY Ballot results: Met basic vote requirements. 9 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: LOINC - IVD Test Code (LIVD) Mapping, Release 1 2018 May Ballot Cycle Info: COMMENT ONLY Ballot results: Postponed Document Name: HL7 FHIR® Implementation Guide: LOINC - IVD Test Code (LIVD) Mapping, Release 1 |
Misc Notes | 2023 December: TSC approved Out of Cycle Ballot Request for HL7 FHIR Implementation Guide: LOINC – IVD Test Code (LIVD) Mapping, Release 1 Goal to reballot new document after publication May 2021 |
U.S. Govt Interest? | Yes |
USRSC Approval | Not Needed |
FMG Approval | All Received |
ARB Approval | Received |
Start Date | Dec 22, 2023 |
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