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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 :

  Planned for Oct 9

  - link to recording:

• 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

• 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