L'accréditation en bactériologie

Because of its specificity, accreditation in bacteriology of medical biology laboratories is more difficult to implement compared to others specialities because of its partial automation and a large part of manual techniques. Concrete examples will be given on the basis of the experience in our laboratory. Key issues in accreditation will be discussed, including management, documentary system, continual improvement, pre examination procedures, evaluation/validation of methods, quality controls, post examination procedures. An analysis of the main factors must be implemented at each evaluation step of the performances of the automated and manual techniques. A particular attention must be paid to ongoing continual improvement (resolution of nonconformities and complaints, customer satisfaction survey, enquiries, corrective and preventive actions, quality indicators, internal audits, management reviews, action plans). Furthermore the operational implementation of human resources management must be formalized by the laboratory management: personal report, training plan, authorization, and technical skills assessment. For the analytical process, the on-site check-up focused on the manual and automated techniques and on the microbial security. A methodical reflexion has been performed in order to choose certified reference materials (quality control strain American Type Culture Collection) for internal quality controls. The technical and organisational mesures taken have enabled us to be in compliance with the SH REF 02 system of reference based on the NF ISO 15189 standard.