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
Chat:
Recording:
Action items
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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)
Decisions requiring context or tracking
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