Data from: Encoding laboratory testing data: case studies of the national implementation of HHS requirements and related standards in five laboratories

Objective: 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. Materials and Methods: We compared gaps and similarities
between diagnostic test manufacturers’ recommended LOINC® codes and the
LOINC® codes used in medical center laboratories for the same tests.
Results: Five medical centers and three test manufacturers extracted data
from laboratory information systems (LIS) for prioritized tests of
interest. The data submission ranged from 74 to 532 LOINC® codes per site.
Three test manufacturers submitted 15 LIVD catalogs representing 26
distinct devices, 6956 tests, and 686 LOINC® codes. We identified
mismatches in how medical centers use LOINC® to encode laboratory tests
compared to how test manufacturers encode the same laboratory tests. Of
331 tests available in the LIVD files, 136 (41%) were represented by a
mismatched LOINC® code by the medical centers (chi-square 45.0, 4 df, P
< .0001). Discussion: The five medical centers and three test
manufacturers vary in how they organize, categorize, and store LIS catalog
information. This variation impacts data quality and
interoperability.  Conclusion: The results of the study indicate
that providing the LIVD mappings was not sufficient to support laboratory
data interoperability. National implementation of LIVD and further efforts
to promote laboratory interoperability will require a more comprehensive
effort and continuing evaluation and quality control.