Improving safety of preparation and administration of medicines and enteral nutrition in a neonatal care unit: Global risk analysis.

OBJECTIVE: To date, few adapted pharmaceutical forms are available for infants leading to multiple steps of preparation and medicines dilution before administration. The main purpose of this study was to assess the risks on the steps of preparation and administration of medicines in a neonatal care unit and to propose corrective actions to ensure the medicines safety. METHODS: A global risk analysis was performed, conducted by a multidisciplinary working group of 9 experts, that is 9 meetings. RESULTS: We identified 57 scenarios: 59,6% of scenarios had an initial criticality C1, 31,6% C2 and 8,8% C3. The most risky phases were phases of needs identification including the step of doses calculation and phases of preparation. The strategic management together with the human factor were the most risky dangers. Nineteen corrective actions were proposed. After implementing those actions, 82,5% of scenarios had residual criticality C1, 17,5% C2 and no scenario had residual criticality C3. Follow-up actions have been implemented to control the residual risk as in service training. CONCLUSION: Neonatal unit care is a risky service and should be a priority in the risk management policy. This analysis joins the quality policy implemented in the hospital and similar risk analysis is on process.

[Experiment of an anesthetic adverse events reporting]. / Expérience d'un système de recueil d'évènements indésirables en anesthésie.

OBJECTIVES: This article summarizes functioning and results of anaesthesia adverse effects reporting system over its first 18 months, from August 2006 to February 2008. STUDY DESIGN: Monocentric retrospective study. METHODS: Reporting system is available 24/24h, 7/7 to every employee with an individual password. A committee with anaesthesiologists, nurses and risk management engineer examines every notification by two months. We evaluated number of reports, type of reporter, type of dysfunction reported and solutions. Numerical data are compared with a Student t test or X(2) test. A p-value of less than 0.05g being considered as statistically significant. RESULTS: One hundred and eighty-five reports were registered for the first 18 months (1% of anesthesia activity) with a slowdown with time (p=0.02). Eighty-six percent of the statements were made by anesthesiologists, but some physicians had never reported. Malfunctions shared between different services (identity, operating room organisation) are rarely solved (67%) compared to specific anesthesia problems (93%) (p<0.001). CONCLUSION: The reporting system is simple and available but some professionals don't declare, generating reporting bias. This network underlines major general dysfunctions (identity) but ways to solve are limited to date.