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.