Lab Domain (IVD)

Special Issue

LIDR elements

Use case

Micro

AST testing with cards - UDI for cards may be in LIDR, but not on the analyzer - may need cross-walk between card type and UDIAccessGUDID - DEVICE: VITEK® 2 AST-GN80 (03573026531034) (nih.gov)



Micro

organism specific reference range for AST



Micro

specimen type specific reference ranges / break points



Chemistry

different reagents on the same instrument



Hematology




Genomics




All areas

1 UDI : multiple lab results



All areas

multiple UDIs (max #?): single lab result



All areas

Multiple results and values used for the meaning/value of a single result (i.e. calculations.) Timed urines, challenge testing, any calculations with individual results.



How would eGFR results be represented in LIDR including those by different formulas?

CKD/Epi vs 2021 CKD-Epi, etc.) Each has different result values.

All Areas




All Areas

Instrument calculated results with one or more instrument result values.

e.g. CBC results: MCH, MCHC, MCV, etc.

Chem: ROMA



All Areas

Manual assessments/ lab results reported from analyzers or manually.

Urine Color

Urine Clarity





All areas

Corrected results and values dependent on other data elements/result values

e.g. WBC corrected due to NRBCs

Temperature corrected Blood Gases results

Calcium corrected for albumin or total protein