ABSTRACT
The performance of clinical laboratories plays a fundamental role in the quality and effectiveness of healthcare. To evaluate the laboratory performance in Alexandria University Hospital Clinical Laboratories using key quality indicators and to compare the performance before and after an improvement plan based on ISO 15189 standards. The study was carried out on inpatient samples for a period of 7 months that was divided into three phases: phase I included data collection for evaluation of the existing process before improvement [March-May 2012]; an intermediate phase, which included corrective, preventive action, quality initiative and steps for improvement [June 2012]; and phase II, which included data collection for evaluation of the process after improvement [July 2012-September 2012]. In terms of the preanalytical indicators, incomplete request forms in phase I showed that the total number of received requests were 31 944, with a percentage of defected request of 33.66%; whereas in phase II, there was a significant reduction in all defected request items [P< 0.001] with a percentage of defected requests of 9.64%. As for the analytical indicators, the proficiency testing accuracy score in phase I showed poor performance of 10 analytes in which total error [TE] exceeded total error allowable [Tea], with a corresponding sigma value of less than 3, which indicates test problems and an unreliable method. The remaining analytes showed an acceptable performance in which TE did not exceed the TEa, with a sigma value of more than 6. Following an intervention of 3 months, the performance showed marked improvement. Error tracking in phase I showed a TE of [5.11%], whereas in phase II it was reduced to 2.48% [P<0.001]. For the postanalytical indicators, our results in phase I showed that the percentage of nonreported critical results was 26.07%. In phase II, there was a significant improvement [P< 0,001]. The percentage of nonreported results was 11.37%, the reasons were either inability to contact the authorized doctor [8.24%], wrong patient identification [1.0%], lack of reporting by lab doctor [1.11%], and finally, lack of reporting by the lab technician [1.03%]. Standardization and monitoring of each step in the total testing process is very important and is associated with the most efficient and well-organized laboratories