Encoding laboratory testing data: case studies of the national implementation of HHS requirements and related standards in five laboratories.
Assess the effectiveness of providing Logical Observation Identifiers Names and Codes (LOINC®)-to-In Vitro Diagnostic (LIVD) coding specification, required by the United States Department of Health and Human Services for SARS-CoV-2 reporting, in medical center laboratories and utilize findings to inform future United States Food and Drug Administration policy on the use of real-world evidence in regulatory decisions.
Author(s): Cholan, Raja A, Pappas, Gregory, Rehwoldt, Greg, Sills, Andrew K, Korte, Elizabeth D, Appleton, I Khalil, Scott, Natalie M, Rubinstein, Wendy S, Brenner, Sara A, Merrick, Riki, Hadden, Wilbur C, Campbell, Keith E, Waters, Michael S
DOI: 10.1093/jamia/ocac072