2023-12-04 LIDR WG Meeting Notes

Hung Luu

Children’s

Riki Merrick

Vernetzt, APHL

Andrea Pitkus

UW

Pam Banning

3M

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

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

• UDI presentation - link to recording: Watch the Recording - passcode = %jP0B?^^

• 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 Analyzers

• 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

Google Sheet review and discussion

• Continued discussion from last week - adding rows for plasma / serum and the units of measure

• Question: Do we want to be descriptive = list all allowable combinations, or do we want to be prescriptive = list the best combination(s)?

  • Content needs to reflect the package insert; described units must match / be equivalent

  • LOINC strategy: same LOINC for all mass concentrations, regardless of scaling, so differnt units, but conversion is by factor 10

  • We should add the operational definition of “equivalence” to the the glossary (done, but needs review!)

  • Labs have to follwo the package insert, but they also have to work with limitations in their LIS

    • if LIS has limit on digits, might have to use scientific notation and update the units

      • absolute neutrophil count can be reported in cells/uL or 1000 cells/uL - but these should be different LOINCs (analyte is different, not scale)

      • Issue with absolute neutrophil count is that it is a calculation (WBC numeric concentrate*Differential value of neutrophils though since calculation, units should remain the same as for WBC), so not explictily provided for in the package insert - LIDR SHOULD include these to drive standardization

      • Related issue are timing of samples (6 hour urine vs 12 hour vs 24 hour vs XXX hour) - these should also be specified in LIDR, but would not necessarily be specified by the vendor in their LIVD file, becasue the instruments won't have the clinical context

    • If insert is mmol/L, can lab report in nmol/dL?

    • changes from package insert require separate validation by the lab, so essentially creating a lab developed test (LDT)

  • If package insert allows for 2 approaches, i.e. resulting in 2 LOINCs, then both need to be there - the lab decides which one to use

  • GOAL: achieve as much standardization as we can achieve; include ALL LOINCs that are needed to report, including calculations with applicable units of measure

    • current: limit interpretation of package insert content by labs

    • over time: harmonize package inserts across manufacturers (method appropriate value sets for qualitative result values for example; there are medicolegal reasons certain concepts apply to some, but not other tests: repeatedly reactive for example depends on the testing protocol) - this is what the Standards and Vocabulary WG is creating - so that we can have consistent guidance regardless of what HL7 product is being used for exchange (V2, CDA, FHIR) - so keep best practice for vendors out of LIDR

POLICY: LIDR represents what labs SHOULD use, provide coding for ALL aspects of what needs to be reported, including units of measure, which MUST match what is in the package insert and provide consistent units of measure for calculations (if not part of the package insert)

Next Steps

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

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

Next call

Monday 12/11/2023 9 - 10 AM ET

NO CALLS: Dec 25 and Jan 1

Adjourned

10:06 AM ET