2026-03-10 LIDR Meeting Notes

Date

Mar 10, 2026

Attendees

Bolded names indicates attendance

Name	Organization
Hung Luu - regrets	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
Manjula Dharmawardhana	CDC

Follow up on UDI representation	Adding Conclusion here: Will keep filling this page out to collect all solutions there. Note that we will have a special call to work out where to send the UDI for the test kit on the LIDR WG call on Tuesday, March 24, 2026 9:00-10:00 AM ET – from discussion these are the choices to discuss: OBX-17, OBX-18, INV-1, SID-1, PRT segment.
Vison 2030 work considerations	Answers to the questions around UDI: How many 510k tests have UDI? You would have to query the database using FDA product code and hopefully trap the entire list of IVD tests - i.e., there are many product codes and I am sure an office level search will result in too many non-test products (i.e., instruments, etc).I think that is a requirement for getting the 510k - Yes, most 510K submissions fall under the UDI Rule. We need to better understand the actual number - who at the FDA would know? How can we find that out? what is the request process for UDIs? FDA does not issue UDI-DIs. They are created by the Labeler (US) based on the requirements of the Issuing Agency (e.g., GS1, HIBCC, ICCBBA). what the best way is to find them in the FDA GUDID? Same response as finding 510Ks - you will need to either search by FDA product code or GMDN code to see if you could locate all of the products you are looking for -- I do not think this is an easy process to ensure you have 100% of the tests. As you may remember -- even finding the test kit and analyzer was difficult. I am not sure even AI could make sense of this one yet....but it is worth a try if someone has time to create some prompts. We would have to know how things are named to find them, so that is an issue.
USCDI V7 Draft review	CDC requested elements = 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: Review Mar 3, 2027 notes about email on Adverse Events - list of data elements under Adverse events we don’t need to add anything to the comment we have - Lab Test Date/Timestamps this seems to cover several of the ones we were discussing on the specimen call: results from instrument results verified (could be auto verified or by a person) results released (which often could be combined with verified, but may depends if verified by algorithm or human) Result Interpretation (already in UCSDI) has issue: listing both HL7 ObservationInterpretation code system (which is harmonized across all HL7 products) and SNOMED CT, which most LIS cannot support for that field (assuming EHR-s also don’t) this is OBX-8 in V2 messages this is issue, because of sensitivity reporting, which must be done in either OBX-5 (Result Value) or OBX-8 (Result Interpretation) based on CLSI requirements was discussed in vocab WG during review of LRI Should create a crossmap between SNOMED CT and ObservationInterpretation and then could move HL7 to adopt SCT instead ot allow for merging of these from both OBX-5 and OBX-8 Looking at other levels in USCDI: Accession number? bad definition for Lab Test Performed Date Should review CPOE elements for those data elements that are required for the lab, for example: specimen collection and source sites for the prostate biopsies to calculate the Gleason Score LMP for Pap smears - is actually written into CLIA How are AOEs covers in USCDI? Follow up from the SHIELD Topic #2 call: Sara stated that re-submitting comments does make a difference, especially if focused around these 4 questions: Provide comments on the name and definition of data elements Identify other widely exchanged data elements that could be added - from other USCDI levels or USCDI+ Identify if the proposed data elements are being exchanged today between health IT systems Show that these data elements are broadly usable across healthcare use cases and specialties
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 10, 2026 9 - 10 AM ET

Chat

Andrea Pitkus 9:23 AM
from a google search, "Lab test adverse event reporting requires prompt, detailed documentation of any unexpected or serious adverse events (SAEs) linked to testing, including patient/product details and corrective actions. Serious, unexpected reactions must be reported to the FDA within 15 calendar days (7 days for fatal/life-threatening), while IRB reports for research require immediate or specific, expedited timelines"

https://www.nia.nih.gov/sites/default/files/2018-09/nia-ae-and-sae-guidelines-2018.pdf

Andrea Pitkus 9:31 AM
Per your hemolysis question, here is a FDA recall with customer reported unexpected hemolysis:

Andrea Pitkus 9:32 AM
" alleged hemolysis was observed in the plasma post-centrifugation"

Andrea Pitkus 9:33 AM
For this item they also indicate, "Hemolysis is commonly caused by the following factors: characteristics of blood.Bacterial contamination.Excessively cooling.Filter clogging."

Andrea Pitkus 9:34 AM
CLIA also has adverse event reporting requirements: "CLIA-certified laboratories must report adverse events related to laboratory-developed tests (LDTs) to the FDA within 30 calendar days if they suggest the test caused or contributed to death/serious injury, or malfunctioned. Events posing a serious public health risk require reporting within 5 working days. Laboratories must also report, investigate, and implement corrective actions for nonconforming events to comply with quality regulations."

Andrea Pitkus 9:35 AM
Key Aspects of CLIA/FDA Adverse Event Reporting:

Reporting Requirements: Laboratories are treated as manufacturers for their LDTs and must report events (death, serious injury, or malfunction) to the FDA via their website within 30 days of becoming aware of the event.
Urgent Reports: Events requiring immediate remedial action to prevent, serious public health risks must be reported within 5 working days.
What to Report: Events include, but are not limited to, test kit/reagent failures, instrument malfunctions, and issues with specimen collection or results that affect patient safety.
Report Contents: Reports should include a detailed description of the incident, patient details, product information (if applicable), and the investigation/corrective action taken.

CMS Compliance: While the FDA handles device-related adverse events, CMS oversight involves reporting "Rapid Response" issues, such as those that could affect a wide range of patient results, directly to CMS Regional Offices.

Given it's part of CLIA, but reporting is via FDA pathways per CDC website, we may wish to ask ASTP ONC if they intend USCDI element to include or exclude this reporting and to communicate that to all.

Action items

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