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  • Providing review of mappings

  • Requirements in regulations (for example support for keeping mappings updated to the latest version of the mapped to standards)

  • Like to see that data instances of test data is being collected for regulatory use – so FDA would need to share the requirements

  • Industry is being asked by customers to provide LOINC mapping (not so much SNOMED codes yet) because there is a requirement for reporting to PH as well as for MU to have the tests be represented using LOINC

  • ONC should clearly state that LOINC mapping is still required and needs to be maintained (and at what frequency-i.e. per LOINC manual 90 days after release)

Issues

  • 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.? (even those which the IVD vendor may be unaware on instance basis such as which challenge, stimulant, suppression was used for a lab’s protocol for endocrine tests-glucose, insulin, growth hormone, ACTH, cortisol, 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),

    • What level of granularity of LOINC is provided?

      • serum glucose

      • serum glucose post challenge

      • serum glucose 1 hour post challenge

      • serum glucose 1 hr post challenge glucose

      • serum glucose 1 hr post 100g glucose challenge

      • serum glucose 1 hr post 100g glucose oral bolus challenge

  • What about test results where there is no LOINC yet or at the granularity/specificity needed?

  • What about Lab Developed Tests (may be from performing lab-such as reference or public health lab, not vendor)

  • What about patient performed/home tests (home covid, pregnancy test, etc.)

Standards Development Issues

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