There is quite a bit of push back on this data element
Should support testkit and instrument device identifiers, in order to accommodate different patterns
Linking instance data to LIDR entries
Identifying test kit issues for EUAs to better understand these new tests or in post market surveillance of 510k
Allowing to decide if results can be combined (harmonized methods)
manufacturer / model
device identifier of UDI
production identifier of UDI (serial number or lot number)
full UDI
Lab developed tests (some of them may be coverable)
manual assessment of specimen (urin color / clarity, specimen characteristics (gradeing hemolysis, lipemia), grossing)
calculations (if it is not performed by the instrument)
not EVERY result needs a Unique identifier
https://loinc.org/65634-8/ or https://loinc.org/34535-5/
in both of these the map to LOINCs would not neccessarily end up with a testkit/instrument device identifier, since it is the calculation …
Hematology example:
using several reagents, but not all are used for all of these - these would have to be identifed by the vendor which goes with what element
how would the MCV, MCH calculated by the instrument be identified