Page Comparison

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

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:

  • Planned for Oct 9

  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

Call time

How can we start doing some actual work?

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

Use the LIVD on FHIR as prototype (still need to add in value sets for specimen) - need to also add category for method (should be kept out and reported separately)

Create example LIVD file for these types of tests:

• harmonized (i.e. results are interchangeable between instruments)

  • Electrolytes

    • serum potassium

• not harmonized

  • blood potassium?

Keep out timed tests and calculations for now

Next step review FDA 510k webpage to find all the instruments that can do serum potassium https://loinc.org/2823-3 mili equivalents /mL - can be interchanged with millimoles/mL

Looking at the FDA webpages:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm

https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm - this one seems to get us closest to what we may need - in decision summary for each instrument

Next Steps

• Set up googlesheet to collect the data: Potassium Analyzers

• Riki to reach out to FDA to see, if they can provide the IFU for all approved serum electrolyte instruments - if not provide tutorial on how best to search for them

• Pam to reach out to SHIELD participating vendors to see, if we can get their LIVD files - these were the vendors contacted:

  • Roche

  • Abbott

  • Hologic

  • Siemens

  • BD

  • Thermo Fisher

  • Cepheid

  • BioMerieux stated during the meeting they didn’t provide K analyzers

Next calls

Adjourned

• Set up googlesheet to collect the data: Potassium Analyzers

• Pam collected these:

  • Roche

  • Abbott

  • Siemens

• No K+ Analyzers:

  • BD

  • Hologic

  • Biomerieux

  • Cepheid

  • Thermo Fisher

• During the call we migrated all LIVD content we had into the googlesheet - discussion:

  • Updated LOINC Longname for Roche urine test (green field)

  • added sort column

  • sorted by system

  • added column for Vendor Method, which we hope to be able to use to identify tests that could be harmonized

  • added column for Harmonization indicator

  • What about different clinical context like collection over time or challenge tests?

    • recommendation is for the LIS to add the clinical context - it has it based on the ordered test, IVD will not have that

    • should the IVD sent the LOINC for single point in time / no challenge or NOT send a LOINC?

      • might be easy to say now, IVD send LOINC every time, but there is a risk that LIS does NOT overwrite based on clinical context

      • so better for IVD to not send LOINC, for any test with clinical context

      • add a column to alert LOINC review by LIS needed in LIDR

      • what if over time (IVDs are used for 10+ years) a test that didn’t have clinical context now has it - IVD would have to update LOINC sending behavior; Labs would have to re-review LIVD and update their mapping - not sure that would happen predictably, so might end up with incorrect LOINCs over time

      • IVD can always send analyte code (vendor local code), IVD can send LOINC if all clinical context is known

• Plan is to work on the serum based Potassium tests first, add spot urine and then deal with timed samples after that

• Question: Are IVD vendors expected to provide ALL POSSIBLE LOINCs for their test in the LIVD file?

  • IVD vendors should match what the package insert says, no more, no less

Next Steps

• Find IFUs for all the Potassium related FDA approved tests

• Review and add Vendor Method for all tests in our googlesheet

Next call

Monday 11/13/2023 9 - 10 AM ET

Adjourned

10:02 AM ET