Implantation de la règle six sigma et évaluation de la phase analytique au sein du service de biochimie du chu de Sétif

Abstract

Context: The establishment of a quality control system in the laboratory is essential in order to ensure good quality of the results, The six sigma methodology is an approach increasingly used in quality management in order to evaluate the performance of methods and to optimize internal quality control management. The objectives: to apply an internal quality control system (IQC) in the biochemistry laboratory CHU Sétif, and to evaluate the analytical quality of some biochemical parameters on three COBAS 6000 and Siemens automatons (ADVIA1800, Dimension Exl) from six sigma approach, and to discuss the main factors influencing the sigma index. Materials and methods: two levels of control serum marketed Bio-rad were analyzed for the ADVIA1800 automaton and dimension Exl. and two precicontrol levels adapted to the COBAS 6000 rock automaton; the statistical parameters were calculated by EXCEL the calculator of the smart labtools website, Six sigma was calculated using two reference systems ( CLIA , Ricos and Al). Results: The comparative study of the sigmas demonstrated a difference in analytical performance between the 3 automatons: COBAS 6000 more efficient than ADVIA1800 and Dimension Exl for most parameters; but this necessitates a re-evaluation of cobas 6000 using outsourced bio rad internal controls, and there is a significant difference between the calculated sigma values according to the chosen benchmark of total error. Conclusion: It is necessary to continue this work and reveal the different problems in all the analytical phase in order to correct them, and achieve effective levels of six sigma for the medical analysis laboratory for the different biochemical parameters.