Commercy, France
Commercy, France

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Antimicrobial susceptibility testing by E-test® is based on strips coated with an exponential gradient of antibiotic. The E-test® method is a qualitative test method with an interpretation in therapeutic categories (sensitive, intermediate, resistant). The E-test® susceptibility testing method is based on the diffusion of the antibiotic from a preformed antibiotic gradient from a strip. The aim of this work is to contribute to meet the requirements of the standard ISO 15189 in terms of performances' check, harmonization of the professional practises and evaluation of the skills/know-how. The study was realized by measuring 90 minimal inhibitory concentrations with 17 types of different E-test® strips (15 bactericidal and 2 bacteriostatic antibiotics), 7 ATCC' strains, 5 samples of external quality controls and 25 clinical isolates. The implementation of the tests is delicate on the one hand because of the supplier's recommandations which must be necessarily respected and on the other hand the difficulties of reading and interpretation of the tests. © 2014 - Elsevier Masson SAS - Tous droits réservés.

The audit is a tool for progress and a decision-making support benefiting the company and the management team. Auditing clinical bacteriology is a challenge because it requires a good knowledge of the critical points of the various processes in order to optimize the efficiency of an audit engagement. The analysis and the risk discernment is an essential stage of the on-site evaluation. The aim of an audit is to make an assessment of strong points and weaknesses of the audited area. The objective of this article is to provide a methodological approach to be audited or to run an evaluation in bacteriology. We offer here a review of the various stages of the audit in line with the accreditation according to the standard ISO 15189. Assessment examples of the efficiency of enforcement (pre-analytic, analytic and post-analytic), management and support processes will be presented and discussed. © 2014 - Elsevier Masson SAS - Tous droits réservés.

Carod J.-F.,Center Hospitalier Louis Jaillon Gcs Of Larc Jurassien | Klein J.-P.,Laboratoire Syndibio
Revue Francophone des Laboratoires | Year: 2014

NF EN ISO1589 and ISO 22870 include Competency assessment expectations. Risk analysis should be applied to both training and experience. Citations are often reported in this process which is the biggest challenge of the Human Resources chapter. But assessing competency is compulsory for laboratory directors since it enables agents to perform their tasks. When we address competency assessment in our laboratories, we must understand that when done properly, competency assessment will reward our organizations and assist us in providing the best possible care to our patients. The goal of this paper is to help laboratory directors and supervisors to implement competency assessment in the bacteriology laboratory taking into account the agent's experience and up-do-date'state of the art. © 2014 - Elsevier Masson SAS - Tous droits réservés.

Klein J.-P.,Laboratoire Syndibio
Annales de Biologie Clinique | Year: 2014

On the way for the accreditation which should lead us until 2020, we wish to share some reflections stemming from the daily practice concerning the compulsory quality approach for everyone. Several themes as training and skills evaluation, external quality controls, risk management and action plans have a great relevance and are a matter of public concern. Their consideration contributes not only to the reassurance of processes but also to knowledge improvement. In the following paragraphs we will present an overview of these themes which are all key elements for project management.

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