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
Chat:
Action items
Quick decisions not requiring context or tracking
For quick, smaller decisions that do not require extra context or formal tracking, use the “Add a decision…” function here.
Decisions requiring context or tracking
For decisions that require more context (e.g., documentation of discussion, options considered) and/or tracking, use the decision template to capture more information.
0 Comments