Comparison of Transfusion-Related Adverse Event Patterns Using National Health Insurance Claims and Hemovigilance System Data, 2015∼2024

Background: Hemovigilance ensures transfusion safety by monitoring adverse reactions related to the use of blood and blood components.The Korean Hemovigilance System (KOHEVIS) is a passive surveillance system based on voluntary reports from clinicians, whereas the National Health Insurance (NHI) claims database serves as an active surveillance source at a national level.This study compared the characteristics of transfusion-related adverse events (TRAEs) reported in these two national data sources.Methods: TRAEs reported to the KOHEVIS, and the NHI claims database between 2015 and 2024 were analyzed.TRAEs in the claims database were identified using the Korean Standard Classification of Diseases (KCD) codes T803T806, which were then mapped to the corresponding categories in KOHEVIS.Annual trends and reporting patterns were compared by type of reaction.Results: In the claims database, the annual number of cases was 2444 for ABO incompatibility (T803), 1633 for Rh incompatibility (T804), and 80170 for allergic reactions (T805T806).In the KOHEVIS, the annual number of acute hemolytic reactions was 48, and that of delayed hemolytic reactions was 13.The total number of reports in the KOHEVIS increased from 3,387 in 2015 to 7,818 in 2024, mainly due to an increase in febrile non-hemolytic transfusion reactions (from 1,604 to 3,852) and allergic reactions (from 773 to 2,801). Conclusion:The NHI claims database is suitable for nationwide trend analysis and early detection of severe TRAEs, whereas the KOHEVIS provides higher sensitivity for mild reactions.Combining the two data sources through cross-validation and phased integration could improve the accuracy and completeness of transfusion safety surveillance in Korea.(