[Statistical Process Control applied to viral genome screening: experimental approach].

Abstract

During the National Multicentric Study concerning the introduction of NAT for HCV and HIV-1 viruses in blood donation screening which was supervised by the Medical and Scientific departments of the French Blood Establishment (Etablissement français du sang--EFS), Transcription-Mediated transcription Amplification (TMA) technology (Chiron/Gen Probe) was experimented in the Molecular Biology Laboratory of Montpellier, EFS Pyrénées-Méditerranée. After a preliminary phase of qualification of the material and training of the technicians, routine screening of homologous blood and apheresis donations using this technology was applied for two months. In order to evaluate the different NAT systems, exhaustive daily operations and data were registered. Among these, the luminescence results expressed as RLU of the positive and negative calibrators and the associated internal controls were analysed using Control Charts, Statistical Process Control methods, which allow us to display rapidly process drift and to anticipate the appearance of incidents. This study demonstrated the interest of these quality control methods, mainly used for industrial purposes, to follow and to increase the quality of any transfusion process. it also showed the difficulties of the post-investigations of uncontrolled sources of variations of a process which was experimental. Such tools are in total accordance with the new version of the ISO 9000 norms which are particularly focused on the use of adapted indicators for processes control, and could be extended to other transfusion activities, such as blood collection and component preparation.