[Microbiological testing of flexible endoscopes: contribution of the approach of accreditation in the implementation of regulation]. / Analyse microbiologique des solutions de contrôle d'endoscope : apport de la démarche d'accréditation dans la mise en application de la réglementation.

The microbiological surveillance of flexible endoscopes reprocessing involves counts of the mesophilic total aerobic revivable flora and the detection of indicator microorganisms of dysfunction. We presented the assay at the COFRAC certification, to ensure a maximal level of confidence in the quality of our results. The existing quality system management was used by the type B widened flexible scope for data from previous accreditations for the identification of Staphylococcus aureus, Enterococci and Enterobacteriaceae. The quality insurance of the results and the technical authorization were guaranteed by the participation at a program of interlaboratory comparisons and the elaboration of internal quality controls. Risks analyses and conventions were wrote with endoscopy sectors. The visit led the opening of a single and not critical deviation sheet on the control of consumables and the accreditation for the analysis was pronounced.

[Accreditation of the screening for the rectal carriage of vanA and/or vanB Vancomycin-resistant enterococci by an accredited laboratory under the standard NF EN ISO/IEC 17025:2005]. / Accréditation du dépistage du portage rectal des entérocoques résistants aux glycopeptides vanA et/ou vanB par un laboratoire déjà accrédité en portée B selon la norme NF EN ISO/CEI 17025:2005.

The quality of the screening of vanA and/or vanB Vancomycin-resistant enterococcal (VRE) carriage by patients transferred from foreign countries plays a role in the management of risks linked to extensively drug resistant organisms (XDRO). Accreditation of the screening according to the NF EN ISO 15189 and NF EN ISO/IEC 17025 standards contributes to satisfy the level of quality. Our laboratory was already accredited according to the NF EN ISO/IEC 17025 standard. We used its quality management system and the type B widened flexible scope to identify the required criteria based on microbiology and infection control standards and those of Afnor and Cofrac, and to validate the screening procedure. Accreditation was obtained for use of the Type B scope, for culture-based detection and identification (codes BA1 and BA5), for determination of the minimal inhibitory concentrations of glycopeptides (code BA6), and for the detection of resistance genes to glycopeptides by polymerase chain reaction (code BA8). The maturity of our quality management system contributed to validate the screening procedures following the required criteria of the NF EN ISO/IEC 17025 standard.

Problems associated with the microbiological control of the breast milk from hospital milk bank units.

The microbiological tests on breast milk performed when samples of pasteurized breast milk are added to hospital milk banks are covered by French regulations dating from December 3rd 2007. They involve counts of the aerobic total flora and of Staphylococcus aureus in a sample of milk before pasteurization, and culture after pasteurization to check that the treated milk is sterile. The regulations specify the nature of the agar plates to be used, together with the conditions for plating and incubation, but they lack detail in other areas. We developed a quality assurance system, modified our process to meet the statutory requirements, prepared for COFRAC certification of the laboratory for this parameter, and proposed solutions to overcome the inadequacies of the regulations. The modifications of the process associated with the quality approach led to a successful initial certification visit. However, the preparation for this certification highlighted other inadequacies of the regulations that might affect the final results obtained for total flora and S. aureus counts. We think that the text should be modified to overcome these problems and to ensure high-quality counting such that those running hospital milk banks can have confidence in the laboratory results they receive.

[Accreditation of a hygiene hospital laboratory for sampling and analysis activities for the detection and counting of Legionella in water]. / Accréditation d'un laboratoire d'hygiène hospitalière pour le prélèvement et l'analyse de recherche et dénombrement des légionelles dans l'eau.

Since January 1(st) 2012, detection and counting of Legionella bacteria have been obligatory in France and must be carried out by COFRAC-accredited laboratories. In our establishment, sampling and analysis were outsourced and our hospital was scheduled to move to a new site. We aimed to develop both these activities in-house and to obtain COFRAC accreditation, whilst organizing the move to the new site. We set up a quality assurance system bringing together staff from the hygiene laboratory and institutional resource managers. We set up sampling and analysis activities in-house 13 months before requesting accreditation. The initial evaluation took place before we moved and identified 17 areas of deficiency, six of which were considered critical. After we had moved, a subsequent evaluation considered 14 of these deficiencies to have been corrected, included the six initially identified as critical. We were therefore awarded accreditation. The quality assurance system established during the year before our request was submitted led to accreditation two and a half years after the transfer in-house of sampling and analysis activities, despite our hospital moving during this period.