Variation in LOINC Code Adoption Impedes Lab Data Interoperability

Variation in the adoption of Logical Observation Identifiers Names and Codes (LOINC) codes has hampered laboratory data interoperability, according to a study published in JAMIA.

The objective of the (LOINC)-to-In Vitro Diagnostic (LIVD) specification, required by HHS for COVID-19 reporting, is to define an industry format to facilitate the publication of LOINC codes for vendor IVD tests and results.

Researchers compared gaps and similarities between diagnostic test manufacturers’ recommended LOINC codes for 331 tests and the LOINC codes used in five medical center laboratories for the same tests.

The medical centers varied in organizing, categorizing, and storing LIS catalog information, impacting data quality and interoperability.

The study authors noted six key findings:

1. Medical center LIS test catalogs included data quality inaccuracies with LOINC, such as using codes that were not proper LOINC codes, trial LOINC codes, deprecated LOINC codes, and discouraged LOINC codes.
2. Medical center laboratory information system (LIS) catalogs contained duplicative information or tests that changed meaning over time.
3. Medical centers noted that the LIVD catalog is helpful as a centralized platform, taking away LOINC guesswork.
4. Medical Centers also said the LIVD catalog is helpful in the selection of LOINC codes associated with specific COVID-19 testing platforms.
5. There were minor inconsistencies in how manufacturers organized and stored IVD test information within LIVD catalogs, likely due to not using the same version of the LIVD standard.
6. There is potential for the LIVD catalogs to help improve semantic interoperability and LIS data quality. There is also room for improvement of the LIVD catalog data elements and accessibility of LIVD files by labs.

Additional efforts for standardization are needed to promote interoperability of laboratory data, the study authors said.

“Even within institutions with sophisticated IT and LIS environments, there may be an incomplete understanding of LOINC,” the researchers noted. “Communication of the availability, centralized distribution, and support for LIVD files and harmonized standards is needed to support laboratory informatics infrastructure and capacity to respond to analyze data.”

Additionally, the researchers suggested that there is a need to update the format of LIVD to make it more accessible by including proper value sets for specimen type, results when qualitative, coded units of measures for quantitative results, and additional metadata.

Collaboration among key players in the laboratory ecosystem, including standards development organizations, device manufacturers, and medical centers, could help support these developments.  

The authors pointed out that their research has several limitations.

“This study only includes LIVD catalogs from three IVD manufacturers,” they wrote. “Three of the pilot sites had a low number of tests (< 30) performed on instruments from the three participant manufacturers in the study. Furthermore, we did not require the use of LIVD prior to assignment of LOINC codes to their tests.”