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Date

Attendees

 

Name

Organization

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

 

Agenda and Notes

Topic

Notes

Topic

Notes

Reviewing minutes from the last call - Action Item Follow up

Call Schedule

send OOO via chat or email

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 6/24/2024 9 - 10 AM ET

Adjourned

 

Action items

  •  

Quick decisions not requiring context or tracking

For quick, smaller decisions that do not require extra context or formal tracking, use the “Add a decision…” function here.

    Decisions requiring context or tracking

    For decisions that require more context (e.g., documentation of discussion, options considered) and/or tracking, use the decision template to capture more information.