RESUMEN
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.
Asunto(s)
Técnicas Microbiológicas , Bancos de Leche Humana/normas , Leche Humana/microbiología , Acreditación , Adulto , Femenino , Unidades Hospitalarias/legislación & jurisprudencia , Unidades Hospitalarias/normas , Humanos , Recién Nacido , Legislación Médica , Técnicas Microbiológicas/métodos , Técnicas Microbiológicas/normas , Bancos de Leche Humana/legislación & jurisprudencia , Pasteurización/legislación & jurisprudencia , Pasteurización/normas , Control de CalidadRESUMEN
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.