Quality Control In Laboratories of Medical Biology (LBM): the Statistical Process Control (SPC)

Abstract

The quality has become more important in our society and in the health field as well. It is more deployed specifically in medical laboratories (LAMB). Since September 2010, the medical biology in Morocco is governed by the Guide of Good Execution of Analyzes (GGEA) * [1, 2]. However, in the third chapter, Quality Assurance, the GGEA recommends internal quality control. This control is a fundamental issue in the implementation of the quality assurance approach in LMBs [3]. Beyond its enforceable character, it remains an important condition for the success and for the effectiveness of external quality control [4]. 13% of NC * [4] are detected in the analytical phase in despite of the automation of its analysis process and the permanent acquisition of the last generation of the automats. LMBs work practically with Shewhart standards which is fixing a specific level and area of trust for statistical process control [5]. Each sector has its realities and its statistical standards and they must be, the both, fixed and adapted to each sector, activity or parameter. They must be studied again in despite of all the random and assignable causes of process variability. In this context that we perform this study on statistical process control in LMBs to show the temporal evolution of a process and to detect the possible changes to modify its performance. This study shows the interest of the application of these methods coming from the industrial environment for monitoring and improving the quality of a process in the field of transfusion. It also highlights the difficulties caused by the retrospective search for the sources of uncontrolled variations of a process. To do this, we carry out a statistical study with the standards, to re-fixit and make a comparative study of the two to appreciate the effectiveness of each control and the performance of the biochemical analyzer Konelab 20i at the laboratory of medical biology analysis CASABARATA.