Background: Timely delivery of correct results has long been considered as the goal of quality management in
clinical laboratory. With increasing workload as well as complexities of laboratory testing and patient care, the
traditional technical adopted like internal quality control (IQC) and external quality assessment (EQA) may
not enough to cope with quality management problems for clinical laboratories. We applied failure mode and effects
analysis (FMEA), a proactive tool, to reduce errors associated with the process beginning with sample collection
and ending with a test report in a clinical chemistry laboratory. Our main objection was to investigate the
feasibility of FMEA in a real-world situation, namely the working environment of hospital.