2024-07-29 LIDR Meeting notes

Hung Luu - regrets

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

• Review LIDR White Paper | Functional requirements Stan

  • Discussing the 5 use cases

    • between order from clin system to LIS and order from LIS to instrument may change LOINC (and back for the result), because the system detail isn’t tracked in the instrument

      • 24 hr urine - urine - 24 hr urine

      • also may need to add interpretations on the result side

        • some flags come off instrument - OOO / below detection limit

        • others are assigned in LIS - taking patient specific reference range and comparing to result to assign the HH flag

      • specimen condition (for example hemolyzed)

        • traditionally this is a chartable footnote (comment)

          • if result is sent depends on the severity (grossly hemolyzed may have no result (often using a *) and the footnote, while mildly hemolyzed may stil report a numeric result with the footnote)

          • also depends if part of a panel or if single test (if the latter may just be rejected and not even performed)

        • some IVD can detect specimen condition and report as additional “result” where the condition is in the question and the answer is presence/absence or grading (ord)

      • if no result could that be sent as data absent reason?

        • yes, but was only recently added (in v2.9, after we added it in FHIR) and pre-adopted into LRI, but not many support yet

        • this can also be used when patient refused specimen collection

  • Middleware use

    • often used when LIS not capable of interfacing with instrument

    • for automation (use of tracks, decision about which analyzer, including pre-analytical processing like centrifuging etc

    • may not be used for low volumne test, when IVD not capable of interfacing

    • mapping to/from the IVD specific codes happens here (they are included in LIVD and would have the appropriate LOINC mapping in LIVD)

    • via email from Xavier:

      • about what a middleware may do in term of sending LOINC codes & connectivity to the LIS - example of the bioMérieux microbio middleware (MAESTRIA™ (biomerieux.com)

  • there are these kind of tests on the order side:

    • single test

    • simple panel

    • panel of panels (of panel + single tests / potentially with multiple different specimen)

      • explosion of this depends on where mapping needs to occur

        • could be in EHR-s CPOE before going out to LIS or within the LIS module of the EHR-s before going out to labs LIS or in the Lab’s LIS

    • not every panel will have a specific LOINC - though that may change; when Regenstief changes its policy, may have to notify prior submitters that they can re-submit

• Accession number - what is that?

  • it depends on the organization

  • it is usually what is considered the primary key to finding “the record”, which could be

    • the order

    • the original specimen (or its container ID)

    • all orders on all samples for this patient at this point in time (requisition)

  • format is not uniform

    • can include the lab section

    • in anatomic pathology often follows specific schema to include the case/cassette/block/slide/silde image etc

    • most of the time alphanumeric

    • is patient instance data and NOT part of LIVD / LIDR

• Do we need to include Reference lab testing?

  • is special case of #1, where instead of the clinical system sending to lab system, it would be a lab system - has some sub-cases

    • hospital → internal lab → reference lab, where internal lab may do some processing of the sample, or even just aliquoting), so may have some additional data requiremetns for the exchange

ACTION ITEMS

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

Next call

Monday 8/5/2024 9:05 - 9:55 AM ET

Adjourned

9: 50 AM ET