2023-12-18 LIDR WG Meeting Notes

Hung Luu

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”

• 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:

• 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?

  • every test has a specimen source site, but it is not as important to be communicated for some tests - adding in N/A that will create confusion, because it exists

  • for Potassium it is not needed to determine the LOINC

  • but we want to also suggest to the lab when to report - is that in our authority?

  • We want the table to be consistent so that any user of data understands what defines the test

  • for systems each of the elements need to be available

  • you can automate for specific tests if there is only one collection method

• We seem to have different definitions for specimen source

  • we MUST create operational definitions for the individual attributes of a specimen

    • type - what is collected in the container and sent to the lab

      • cannot collect serum/plasma (only blood with specific additives)

    • there are also derived specimen like isolates, that are cultured

  • We are working on the specimen cross-mapping table to help sort this out

  • source / source site needs to be sorted out more

    • CLIA calls it source

    • location on the body is important for many tests

    • source is organ system - for ser/plas it is blood; peripheral blood can be venous, artrial, capillary, line - body location matters for blood cultures

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

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 1/8/2024 9 - 10 AM ET

NO CALLS: Dec 25 and Jan 1

HAPPY NEW YEAR!!!

Adjourned