2023-12-11 LIDR WG Meeting Notes

Hung Luu (regrets)

Children’s

Riki Merrick

Vernetzt, APHL

Andrea Pitkus

UW

Pam Banning

3M

Xavier Gansel

Biomerieux

Amy McCormick

Epic

Dan Rutz

Epic

Rob Rae

CAP

Rob Hausam

Hausam Consulting

Sandy Jones

CDC

Stan Huff

Graphite

Ed Heierman

Abbott / IICC

Andrew Quinn

Laurent Lardin

Biomerieux

Anthony Killeen

UMN

Craig Collom

Marti Velezis

 Sonrisa / FDA

Walter Sujansky

FDA

Susan Downer

JMC

Ralf Herzog

Roche

Cornelia Felder

Roche

Daniel Golson

JMC

Andrea Prada

JMC

Maria Sagat

 CAP

Raja Cholan

FDA

Russ Ott

FDA

Akila Namasivayam

FDA

Reviewing minutes from the last call - 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”

• UDI presentation - link to recording: Watch the Recording - passcode = %jP0B?^^

• Outreach to Dr. DeBaca

  • Hung will check for more info and maybe see, if she could participate in SHIELD

• Hung is still working on the examples

• Waiting for response from Ed

• Keep updating the googlesheet: https://docs.google.com/spreadsheets/d/1LJ93VdGBVDEJ49kqUV-Yro0O3qZAs-1PB-hE8KI0vPQ/edit?usp=sharing

• 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

• Sign up for sections to provide draft content on the LIDR White Paper

• Review LIDR Use Cases and sign up to lead one of these

Google Sheet review and discussion

• Continued discussion from last week:

• Specimen specific rows - do we keep those?

  • LOINC created Ser/Pl terms when those are considered equivalent for the analyte, else they have separate LOINC terms

  • CLIA reporting requriements = https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-K/subject-group-ECFR9482366886d579f/section-493.1291, but does not describe how these have to be met for electronic reporting - would be good to get input from CLIA / CMS for these details

    • Specimen are declared in the catalog for each lab, after the lab validates the test and sets up the reference ranges

    • specimen is declared by the labs - in test name, other field sometimes

      • specifically when there can be many sources for the same specimen type - example wound swab - important to capture the location of the wound

    • we need to clarify what some of the terms used in CLIA mean and how they translate to the terms used in electronic data

  • Lab is sending it to the first downstream entity, but data might be changed when it gets incorporated into the physician view

  • LOINC created Ser/Pl for these reasons:

    • in labs some set this up as Ser/Pl from the test level

    • found it is equivalent for the analyte where available

  • when instrument is set up, the specimen is chosen (that also applies to the units of measure) as part of the validation process

  • Is there a clinically relevant difference?

    • not for this analyte

  • Notes after Riki left:

    • Agreement that fields needed for Specimen Type, Specimen Source Site, Method, Time Aspects of testing

    • Questions/discussion about purpose of LIDR. What is is supposed to contain and what is it’s intended use. Ensuring content meets both needs

    • Discussion on precoordinated versus post coordinated codes/info/rows in LIDR from a structuring perspective/

      • Represent both as labs may implement both

      • Indicate which are “equivalent”

    • Discussion on use of LOINCs (mapping) with IVD test information (and where). Need to continue discussion.

  • For next time

    • For the Potassium fields, how do we want to indicate a field is not applicable (i.e. specimen source)? Use N/A, leave it blank, etc. Do we need a response that is human and computer processable?

    • Can we get UDIs for the Potassium, other info to fill out for all applicable fields for serum and plasma examples?

    • Can

Next Steps

Please see the action items at top of this page - Next deliverable is White paper outline by end of this year

And we need to prioritize the use cases, so that we can finalize the requiements for the first phase of LIDR, which need to be included in the White paper

Next call

Monday 12/18/2023 9 - 10 AM ET

NO CALLS: Dec 25 and Jan 1

Adjourned