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

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 - wil assign PHAs to sepcific 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

Call Schedule

send OOO via chat or email

Review LIDR White Paper

LIDR Elements Discussion

• What is the use case for the Potassium file example?

  • for inclusion in patient result or in lab communication?

  • LIVD is for communication between LIS and instrument, LIDR is the bigger representation of data for EHR-s to LIS?

  • Riki’s thoughts: for setting up the test in the lab (and for IVD-to LIS communications, for clinican to undersant the result, for researchers what might be going on for this group of IVD instruments, maybe even for patients to better understand their results

• For clinicians there are elements that do not come off the instruments.

  • we may want to indicate in LIDR which columns would be important for which use case - may be on a test by test basis.

  • Some elements are static - always true, while others might be dymanic

  • Indicate in the table when an element is not applicable (as important / optional - example source site for venupuncture)

  • may need to have elements that explain which elements are dynamic for this particular test for a patient result- and maybe what they are

    • AOEs for 24 hour urine collection for example

    • Some panels report all elements, while others just report the sumary calculation

• For UDI there are patterns - heamtology uses different reagents for many cell types, stains have different reagents

  • Device Identifier of the UDI is what we are talking about in LIDR - in the patient examples we may have production identifiers (instance level) - or a full UDI string

• What UDI would be applicable to a calculation?

  • UDI applies to a device - UDI does not apply to a result, it is describing the system that was used

• Operational definition for test will be important so we are not talking past each other

• Package insert items - are those are discretely captured by FDA?

  • If not, how could we move towards that?

• Relationship between LIDR and IHE LAW? We would expect to develop elements needed in IHE LAW = CLSI AUTO-16 in LIDR and vice versa

  • LAW: Analyzer workflow (order query or direct sending orders and reporting results back to the LIS)

    • data that moves from IVD to LIS (analyzer manager)

• Need to define the different testing patterns and what elements we might need for them

• Start with quantitative tests first and include the process of how to expand on LIDR elements for additonal testing patterns

  • Start with LIVD on FHIR - that can then build the first LIDR out of the collections of these files provided by IVD vendors

  • and then build in additional elements particularly elements that are transactional in LAW and

    • Some other elements desired by CDC - like CLIA complexity

    • consider not including the panel order codes (they were included in LIVD for COVID) - for some of the multi-plex products this may be helpful, but hard to deal with for any panel

      • Even for some of the more variable panels, there often is information in the order that is helpful to understanding the results - or even affect the LOINC of the resulted test

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 2/12/2024 9 - 10 AM ET

Adjourned

 9:52 AM ET