L'accréditation en bactériologie : enjeux, difficultés et particularités

Due to its specificity, the accreditation of bacteriology is more difficult to implement than other biological disciplines. Recognizing these challenges, the French Society for Microbiology (SFM) established a working group, the QUAMIC group, to support laboratories in their approach and to facilitate the setting of the process. A methodological approach has been developed and it was decided to provide documents with examples to facilitate the implementation of accreditation. The medical microbiology is fundamentally different from other biological specialties because it focuses on the living world. Therefore, microbiology cannot be understood, in terms of accreditation, in the same manner that other disciplines, such as biochemistry for which the analysis determines a substrate or a constituent in a biological fluid. Microbiological analysis is usually intended, first, to highlight one or several microorganisms responsible for an infectious syndrome in miscellaneous specimens and sometimes among a complex commensal flora and, secondly, to study their susceptibility to antimicrobial agents. All these features have been included into the QUAMIC document with chapters and files relating to the pre-analytical, the analytical and post-analytical parts. This document cannot be exhaustive and the aim is rather to provide to microbiologists some reference materials and examples on how to manage quality control and to prepare a validation document, or to describe the involvement in the provision of advice, so everyone can develop an efficient quality management, sustainable, appropriate, without entering into the trap of excess and over-quality. This document is being called to live and evolve over time, it will be updated steadily according to both the developments of requirements, technical developments and needs. It will also be enriched with chapters specific to virology and mycology. The authors hope to contribute to meet the needs of microbiologists but also to those COFRAC evaluators.