2023-09-18 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

Sandy Jones

CDC

Stan Huff

Graphite

Ed Heierman

Abbott / IICC

Andrew Quinn

Laurent Lardin

Biomerieux

Anthony Killeen

UMN

Craig Collom

Marti Velezis

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

• UDI presentation:

  • What UDI is and what it isn’t, what we can expect and what we can’t, when is a device subject to the UDI rule in the US

  • What is being represented by the UDI in test data

  • What is GUUID

  • How will the UDI be used in the patient data / what other data might be needed to get what we are expecting = specificity of implementation of UDI

  • Planned for Oct 2

• Outreach to Dr. DeBaca – provided LOINCs for some situations

  • Calculated items – how to deal with UDIs for that

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

• Hung is still working on the examples

• Riki to still reach out to Ed

Review the use case page

Please add any content for the different use cases

Any deadlines we need to have the requirements done by

only internally - but the white paper shoudl be fairly short term

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

• Do we track reagents?

  • If instrument can produce result in 2 different ways – colorimetric vs chemical

  • Need to have the nomenclature correct:

  • Reagent kit used on an instrument vs test kits without instruments

  • Testkit when they can be used on multiple instruments (e.g. PCR)

• Next step: Pull out the definitions from LIVD for test kit and equipment and put here: SHIELD Glossary