2024-06-10 LIDR Meeting Notes

Hung Luu

Children’s

Riki Merrick

Vernetzt, APHL

Andrea Pitkus

UW

Pam Banning

3M - Solventum

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

Desiree Mustaquim

CDC

Christina Gallegos

APHL

John Spinosa

Lantana

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

• 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

• Review LIDR Use Cases and sign up to lead one of these - prioritize these use cases, so that we can finalize the requirements for the first phase of LIDR

• Define next steps to migrate existing LIVD files into FHIR LIVD catalog format and find a FHIR server to host

• Marti can share the LIDR categorical data to instance data mapping for each element for June 3, 2024

Call Schedule

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LIDR Elements Discussion

 Specimen Information should include 3 elements to be completely defined

• Specimen Type - Specimen SNOMED Hierarchy

• Collection Method - SNOMED Procedure Hierarchy

• Specimen Source

Discussion around Specimen Source

• Only include Anatomic Site

• Allow use of SSNOMED Substance Hierarchy

• Should be a required element when appropriate

• May be out of scope for inclusion in LIDR as it would be difficult to anticipate all the possible anatomic sites a specimen may be collected from (e.g., mpox with multiple possible lesion sites or wound culture)

Where Specimen Source site is essential such as included in 510(k) approval the information could be incorporated into the Specimen Type (e.g., nasopharyngeal swab, vaginal swab)

Should the white paper address Specimen Source if it is a recommended data element but is not included in LIDR

Discussion about inclusion of reference range:

• vendor provided reference range is the only thing that could be in LIDR - supports labs setting up the test - for instance data, will have to use the refernece range provided with the result

Sidebar: Sequoia Lab Tiger team (TEFCA members recommendation around lab use cases) - we want to make sure their IGs supports real world evidence and provide them with the solutions SHIELD has already come up

ACTION ITEMS

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

Next call

Monday 6/17/2024 9 - 10 AM ET

Adjourned