Reported Transfusion-related Patient Safety Incidents in South Korea: A Nationwide Analysis of a Voluntary Reporting System, 2016 to 2024

Objective: This study analyzed transfusion-related patient safety incidents reported to the Korea Patient Safety Reporting and Learning System by tertiary and general hospitals between 2016 and 2024 to characterize national reporting trends, describe nurse involvement characteristics, and identify factors associated with harm among reported incidents. Methods: The 285 reported incidents were analyzed using statistical process control, Poisson and Joinpoint regression, and Firth penalized logistic regression. As no transfusion episode denominator exists, measures are proportions of reported incidents, not incidence rates. Results: The number of reported incidents increased from 2 in 2016 to 47 in 2023, although their proportion among all reported patient safety incidents declined; the crude reporting rate for 2017 to 2024 was 0.84 per 100,000 blood components supplied. Outcomes encompassed near miss (15.4%), no harm (48.8%), mild harm (26.3%), and moderate harm or worse (9.5%), with special-cause variation observed only in 2017. Following the 2021 amendment, harm reports decreased from 41.9% to 30.7% but were unchanged excluding near misses (41.9% vs. 41.8%), whereas moderate harm or worse increased from 5.1% to 16.4% ( P =0.009). Nurses accounted for 59.8% of 425 involvements; high-risk locations independently predicted harm (adjusted odds ratio=2.49, 95% CI: 1.29-4.86). Conclusions: Transfusion-related patient safety incidents in Korea are concentrated in high-acuity settings, comprising a significant proportion of nursing personnel. Translating these results into safer transfusion practices will necessitate shifting from individual vigilance to structural resilience through setting-specific safety protocols in high-risk locations, enhanced nursing support and competency building, and improved national hemovigilance infrastructure.