Page Comparison

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

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

• Hung is still working on the examples

• Waiting for response from Ed

• 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

• Sign up for sections to provide draft content on the LIDR White Paper

• Review LIDR Use Cases and sign up to lead one of these

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

Call Schedule

send OOO via chat or email

Review LIDR White Paper

LIDR Elements Discussion

• Looking for a FHIR server to try the hosted LIVD format

• Also looking for a tool that converts excel to LIVD format

• How to deal with lab results that are needed, but not yet in LIVD?

  • Should we use excel first to cover the additional cases and to better understand the patterns we will have to cover

  • would be good to have content for a simple culture and represent the patterns

• We need to get vendor participation for this - can we get some hematology examples from Abbott, Sysmex?

• Unique device identifier - for test kit and instrument

  • ideally use FDA device ID of the UDI

  • we have to ensure we can figure out what we need for the different pattern for each test result to help vendors understand how they can implement it when more than one device identifier is needed - so asking to have this in UCSDI or USCDI+ will be important, to put vendors on notice that this is an element to have support for

  • On CDC side they saw this data, but not very good data quality - would need to

  • Inclusion in USDCI does not require actual use, just the HIT system vendors to be able to support the element - this will take a while to be implemented / required (version 3 will be implemented in Jan 2026 - so it is many years down the line before it will be required

  • need to be sure vendors can support all the testkit identifiers

  • equipment identifier is at a lower level than the testkit identifier

  • who is producing the kit and which kit it is

  • for each result we need to identify what is relevant for understanding the result and how comparable it is to others

  • this is affected by more attributes, besides the testkit

  • in PT CAP has been using one identiifer for the method to group results

    • this is a reference to a specific protocol?

    • and can this protocol indicate

  • In LIVD we created an instrument - test kit combination - in PT and in CLIA we have validation of the CLIA test system which combines reagents and instruments

    • per one package insert there can be more than one instrurment

    • OO is going to talk about this on the main call this week

  • there may also be tests where this detail is not needed

  • Hung will use a PT protocol for hematology and mock that up

ACTION ITEMS

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

And we need to prioritize the use cases, so that we can finalize the requirements for the first phase of LIDR, which need to be included in the White paper

Next call

Monday 2/26/2024 9 - 10 AM ET

Adjourned

 10:03 AM ET