Global Diagnostics of Hemophilia and Bleeding Disorders: Insights From World Federation of Hemophilia International External Quality Assessment Scheme Program 2016-2023.

INTRODUCTION: Accurate laboratory diagnosis is essential for the effective management of bleeding disorders. The World Federation of Hemophilia (WFH) International External Quality Assessment Scheme (IEQAS) provides an international platform for comparative evaluation of laboratory performance. AIM: To evaluate global laboratory performance in the diagnosis and monitoring of bleeding disorders, and to assess the impact of training and capacity-building initiatives on laboratory quality. METHODS: We conducted an analysis of data from 268 laboratories in 114 countries participating in the WFH IEQAS program between 2016 and 2023. RESULTS: The proportion of countries with at least one participating laboratory was 71% in the Americas, 65% in Africa, 54% in Asia, 50% in Europe, 28% in the Middle East, and 7% in Oceania. Most laboratories were in upper-middle-income countries. Across all surveys, only 50% of factor VIII activity assay results fell within the expected target range. Oceania demonstrated the highest rate of consensus (78%, based on two laboratories), followed by Asia (58%), the Americas (53%), and Europe (53%). Longitudinal analysis revealed progress in Africa and the Middle East. Two hemophilia center laboratories monitored over seven years following training showed divergent outcomes: one sustained improvement, while the other achieved only transient gains. CONCLUSIONS: Substantial variability persists in global laboratory performance for bleeding disorder diagnostics, with marked regional disparities. Improvements in Africa and the Middle East demonstrate the positive impact of targeted training and capacity-building. The WFH IEQAS program provides a robust framework for comparative evaluation laboratory performance and guiding interventions to strengthen diagnostic capacity worldwide.