2023-09-25 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

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

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

• UDI presentation:

  • Planned for Oct 2

• 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

Review the use case page

Please add any content for the different use cases

Reviewing the in-scope / out-of-scope elements

• Standards WG was also talking about reagents - how to we keep in sync between WG?

  • have a liasion / do that at the Steering Committee

• UDI is in-scope - at the device level, not instance level

  • we need to define the process of how to add/update existing elements, then nothing is out of scope

  • identify the high volume, least complex tests

• Lot numbers being withdrawn by manufacturers - this is important at the result level, because those are no longer valid to be used for diagnostics

• Standards WG can looks at the information modeling issue - what has to be send along with the results

• What is stored in the data repository vs what is needed for result data exchange

• initial scope on result values - why do we need orders?

  • orders provide some clinical context around the results

  • part of the medical record may also be important, but if we model this content consistently we could make those elements accessible via APIs when needed

Adjourned

9:31 AM ET