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

Carmen Pugh

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 - DATE?

Call Schedule

send OOO via chat or email

 LIDR White Paper Review

Reviewing the comments on the LIDR White Paper = LIDR White Paper

• Need to check reference style and pick one

• Reviewed comments on introduction - Still need to check for best place to talk about CLSI AUTO-16/IHE LAW (question: has anyone implemented in the US in production?)

• Review updated LIDR content creation diagram:

  • What kind f content would come from FDA?

    • CLIA setting, at home use etc

    • maybe additional elements from the package insert once test is approved and that information is public

    • Need to make sure the linkage for any feedback / additionally submitted content is properly linked to the correct LIDR entry

      • Hung found some LIVD entries has split rows - Russ is checking for the exact examples

  • Does distribution include naming convention?

    • different labs may create different names for the same test

    • would the unqiue LIDR row ID help with that?

    • don't want to get hung up on single id again - labs need to report based on the LIDR fingerprint (all the correctly coded data like LOINC, SCT, proper specimen infomration, unit sof measure, UDI

  • Note that this diagram does not include the details of distribution - we left this here to make clear that content doesn’t just go into LIDR, but also comes back out - but there is feedback ability - hence the double-arrows

  • What if a lab decides to report slightly different from how the maunufacturer prefers - example Flu A/B test or HIV 1/2 test - manufacturer has single nominal results vs lab sets these up as 2 individual tests with ordinal test - both are valid and the latter is often used to ensure that display for provider is not changed in a way that information could get lost

    • LIDR administrator can make those updates

    • Who is the LIDR administrator - needs to be impartial

    • Ideally SHIELD community administers LIDR

    • In Figure 7 there is “Labs' conformance to LIDR' - what happens if the update is not in LIDR?

      • no reason for not including, unless mapping is incorrect

  • How does feedback from the labs to vendor work?

    • Via LIDR and or direct

  • Diagram ready to beautify - Russ will ask Peyton and team to do

• Roadmap for LIDR - how do we make LIDR a reality?

  • Riki just drafted - ideally should become an actual tool, but that will need funding and assurance of impartial administation

  • may not move forward on just goodwill

  • Xavier might be able to help with the FHIR pilot of LIVD

• Other notes:

  • Hung was approached by Siemens after his article https://doi.org/10.3343/alm.2024.0323 which mentioned SHIELD LIDR - fingers crossed we can get them to join/support

    • Pam has worked with Siemens in the past on LOINC mapping and teaching about LIVD format in US

    • This is from Norway

ACTION ITEMS

All read the roadmap and the how to get invovled

Review on 11/04 then send to Steering Committee for review and vote 11/05 or the next

Next call

Monday 11/04/2024 9:05 - 9:55 AM ET

Adjourned

9:55 AM ET