Abstract:Abstract:?Objective?To study the quality level of the clinical laboratory accredited by ISO 15189 in China by analyzing the data of pre-analytical quality indicators.?Methods?The National Center for Clinical Laboratories organized 31 provincial centers to launch a synchronous quality indicators (QIs)-External Quality Assessment (EQA) program. The data were reported via online Clinet-EQA system. The essential information of the clinical laboratories accredited by ISO 15189 and the data of pre-analytical quality indicators during the period from 2016 to 2019 were collected. The statistical analysis was conducted according to professional categories or the levels of informatization.?Results?All the pre-analytical quality indicators achieved the minimum acceptable 3σ metric in the clinical laboratories accredited by ISO 15189 except for contamination rates of blood culture and hemolysis rate of specimens. The ratios of laboratories over 4σ metric were 99.67%, 99.51%, 100%, 97.11%, 96.75% and 38.74% for the rates of incorrect sample type, incorrect fill level, incorrect sample container, sample hemolysis, clotting of anticoagulant samples and blood culture contamination, respectively. The distributions of median pre-examination turnaround time of the specimens from the emergency and inpatients were 50 minutes and 10-100 minutes respectively.?Conclusion?The quality levels of pre-analytical quality indicators of the clinical laboratories accredited by ISO 15189 in China have presented better performance to some extent, but the contamination rate of blood culture, clotted rate of anticoagulant samples and the hemolysing rate of specimen should be paid considerable attention in the future.