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Standard Development Organizations
Regenstrief
SNOMED International
HL7
Federal agencies
FDA
CDC
NLM
NIH
CMS
Implementers (Labs, also cross-pollinate with implementation subcommittee)
Health Partners
University of Nebraska
Intermountain Healthcare
Memorial Sloan Kettering Cancer Center
IVD Industry (also cross-pollinate with industry subcommittee)
IICC representatives
Abbott
Biomerieux
Roche
LIS/LIMS vendors
Epic
Cerner (reached out)
Terminology Services (also cross-pollinate with tooling subcommittee)
3M
IMO
Clinical Architecture
Professional associations
Association of Public Health Laboratories (currently maintains the COVID-19 LIVD file)
College of Anatomic Pathology American Pathologists (CAP)
ASCP
ASCLS
Others?
Industry Impact
Incentives
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Vendors thought that the FDA would hold them accountable for encouraging “off-label use” based on the interpretation of the LOINC code(s) published
Vendors may want to limit access to their mappings to paying customers only (or at least know who is downloading LIVD files)
Vendors operate internationally, so need to ensure mappings are not just US regulation focused
Will IVD vendors provide all LOINCs for an analyte/assay, including all timed, challenge, stimulation/suppression, calculated, ratios, etc.?
300+ glucose tolerance tests. 75 g bolus 1 hour post glucola challenge
2 hr timed urine calcium
Serum Calcium/Creatinine ratio; Spot Urine Calcium/Creatinine Ratio
Total Volume, specimen source and Ask at Order Entry (AOE) LOINCs
“generic interpretations” (not specific for any test result) Immunologist review of results; Coagulation panel interpretation, Service Comment, etc.
Calculated tests: eGFR (each formula such as male/female), 24 hr urine calcium rate (utilizing hours of collection and total volume in the calculation),
Standards Development Issues
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