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The medical biology laboratory accreditation according to the Iso 15189 standard, which main lines are mentioned in the article, is henceforth becoming a statutory obligation in France. All laboratories must apply, at least partly, to the COFRAC, by 31(st) October 2012. The EFS has largely anticipated the necessary steps to reach this objective and has developed an approach based on six basic processes. To date, 24 laboratories of various technical fields are accredited and several other submissions are pending. The Iso 15189 standard requirements match those already implemented at the EFS with the Certification. The trade standard operating procedures are almost included in the risk control management. Through the involvement of all the EFS members following precision action plans based on the sharing of successful experiences and the harmonization of trade practices, this compulsory objective will be reached and the deadline respected., (Copyright © 2011 Elsevier Masson SAS. All rights reserved.)

Objective: Record keeping contributes to the quality of health care in addition to fulfilling medicolegal and accreditation regulations. We conducted an audit of patient files in 15 public hospitals in Aquitaine to determine their compliance with national laws., Methods: One hundred patient files were randomly selected in each hospital. Their compliance with 18 criteria established in 1992 by the ANDEM was studied. These 18 criteria were updated in accordance with the latest decrees from the health ministry and precisely defined in order to achieve good reproducibility of the measurements., Results: Ten percent of the files fulfilled all 18 criteria. Each component of the record was correctly identified and the name of the general practitioner, admission documents, and delivery, anesthesia and transfusion records were almost always present. Surgery reports were found in 65 to 89% of the files. Low compliance with three criteria was observed: authorization to give health care to a minor (39 to 80% of the files), identification of the physician who prescribed the drugs during hospitalization (6 to 32%) and discharge prescription (42 to 95%). We also pinpointed problems concerning archiving and retrieval, especially concerning the results of complementary exams which were not necessarily stored with the patient files., Conclusion: This audit allowed us to define the first steps of a quality improvement project for patient records. We were able to deduct recommendations for analyzing compliance with legal requirements and suggest that the 1992 ANDEM criteria be updated to allow for valid comparisons between health care establishment.