2026-02-24 LIDR Meeting Notes

Date

Feb 24, 2026

Attendees

Bolded names indicates attendance

Name	Organization
Hung Luu	Children’s
Riki Merrick	Vernetzt, APHL
Andrea Pitkus	University of Wisconsin
Pam Banning	3M - Solventum
Xavier Gansel	Biomerieux
Amy McCormick	Epic
Dan Rutz	Epic
Rob Rae	CAP
Rob Hausam	Hausam Consulting
Stan Huff	University of Utah
Ed Heierman	Abbott / IICC
Carmen Pugh	long term lab professional
Laurent Lardin	Biomerieux
Ralf Herzog	Roche
Christina Gallegos	APHL

Follow up on UDI representation	Adding Conclusion here: Will keep filling this page out to collect all solutions there.
Vison 2030 work considerations	How many 510k tests have UDI? think that is a requirement for getting the 510k what is the request process for UDIs? what the best way is to find them in the FDA GUUID Waiting for answer
USCDI V7 Draft review	Dates that are important for CLIA: Specimen collection date/time = observation effective date/time = clinically relevant time Specimen received date/time Lab analysis date (from instrument) lab result verified and released date/time See publications that support collection / use of some of these: We should update the mapping here to include the new elements: https://confluence.hl7.org/spaces/OO/pages/256515226/US+-+CLIA+Elements+mapping+to+HL7+data+elements Discussed: Device Type, Diagnostic Report Date, Medical Device class and UDI - made changes directly on the feedback page Really need a data model to get to interoperability for each use case Having the current classes potentially creates a confusion across different domains, about which are appropriate to use (if the classes themselves are not use cases, they should not be used for grouping) Different domains have different needs, including different data elements, so focusing on each domain / use case and identifying all elements needed - for example using the procedure class for orders, which has different vocabulary bindings than the laboratory orders element in the Orders Class (which didn't exist in older versions of USCDI). Do we need to mention that any newer versions of the report need to be made available to other downstream users (like copy-to-providers)? - not sure we can attach that requirement to a single data element
LIDR Patterns	Biomerieux culture plates Toxicology screening vs confirmatory challenge tests urine dipstick variations required specimen pre-processing before running on instrument?
Action Item Follow up	Pull out the definitions from LIVD for test kit and equipment and put here: SHIELD Glossary Review operational definition of “equivalence” Will look for a CLSI defintion also check IFCC definition Outreach to Dr. DeBaca Hung will check for more info and maybe see, if she could participate in SHIELD Keep updating the googlesheet: Potassium LIVD data Shared Reportable Conditions LIVD google sheet for crowdsourcing with CSTE - added sign up sheet for PHAs to specific conditions and see how that develops Have LIVD File Repository Requirements Have draft budget (for setting up a web-based database and yearly maintenance): https://aphlinformatics.atlassian.net/wiki/download/attachments/915407143/LIDR - Budget.xlsx?api=v2 Define next steps to migrate existing LIVD files into FHIR LIVD catalog format and find a FHIR server to host
Next call	Tuesday Mar 3, 2026 9 - 10 AM ET

Chat

Andrea Pitkus 9:32 AM
CLIA language, "(k) When errors in the reported patient test results are detected, the laboratory must do the following:
(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors.
(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results.
(3) Maintain duplicates of the original report, as well as the corrected report."

Action items

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