DOI: 10.5061/dryad.0cfxpnw55
title: Data from: Encoding laboratory testing data: case studies of the national implementation of HHS requirements and related standards in five laboratories

description: 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
 &lt; .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.
description: 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, 6,956 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
 &lt; .0001). Data Collection from Medical Center
 Laboratory Pilot Sites: Each medical center was asked to extract about 100
 LOINC® Codes from their LIS for prioritized tests of interest focused on
 high-risk conditions and SARS-CoV-2. For each selected test (e.g.,
 SARS-CoV-2 RNA COVID-19), we collected the following data elements: test
 names/descriptions (e.g., SARS coronavirus 2 RNA [Presence] in Respiratory
 specimen by NAA with probe detection), associated instruments (e.g., IVD
 Vendor Model), and LOINC® codes (e.g., 94500-6). High risk conditions were
 defined by referencing the CDC’s published list of Underlying Medical
 Conditions Associated with High Risk for Severe COVID-19.[29] A data
 collection template spreadsheet was created and disseminated to the
 medical centers to help provide consistency and reporting clarity for data
 elements from sites. Data Collection from IVD
 Manufacturers: We coordinated with SHIELD stakeholders and the IICC to
 request manufacturer LIVD catalogs containing the LOINC® codes per IVD
 instrument per test from manufacturers.