ABSTRACT
GLP test facility management refers to the proper management and organization of a facility that conducts studies according to GLP regulations. Compliance with GLP regulations is necessary for data generated in such facilities to be accepted by regulatory authorities. According to GLP Principles, Test facility management (TFM) is responsible for a wide range of tasks and responsibilities to ensure the smooth and efficient operation of the facility. The framework in which the TFM operates within the Test Facility is certainly much more complex than in the early days of the GLP, and moreover it is unlikely that anything will change from a scientific and technological point of view in the years to come. Several aspects have changed from a scientific and technological point of view, and we know that innovation is very rapid. From the above considerations emerges the need for a major change in the performance of the TFM's role.
ABSTRACT
BACKGROUND: The objective of this study was to validate the Simplified Acute Physiology Score SAPS 3 Admission Score (SAPS 3) and to compare its fit with that of SAPS II in an independent sample of patients admitted to a single-centre intensive care unit (ICU). METHODS: The data for all adult patients consecutively admitted to an eight-bed ICU of a 700-bed university hospital between 1 January 2006 and 2 September 2007 were collected. SAPS II and SAPS 3 were computed, as well as the predicted hospital mortality. The calibration of SAPS II and SAPS 3, according to the general equation (GE), and equations for Southern Europe and Mediterranean countries (SE&MC), and Central and Western Europe (C&WE), were assessed by the goodness-of-fit Hosmer-Lemeshow H and C statistics. Standardized mortality ratios (SMR) with 95% confidence interval (95% CI) were computed for SAPS II and SAPS 3 equations. RESULTS: Six hundred and eighty-four patients were studied (males 63%). The median age was 73 (quartiles 65-80) years. The fit of SAPS 3 using the C&WE equation (H 13.49, P=0.095; C 12.73, P=0.121) as well as that of SAPS II was acceptable (H 6.02, P=0.644; C12.08, P=0.147), while SAPS 3 GE (H 23.36, P=0.002; C 22.37, P=0.004) and S&MC (H 25.73, P=0.001; C 26.19, P=0.001) did not fit well. SAPS 3 GE, SAPS 3 SE&M Countries and the SAPS II significantly over estimated the mortality. Only 95% CI of SMR for SAPS 3 C&WE included 1 (SMR 0.97; 95% CI 0.89-1.05). CONCLUSION: Each ICU should identify the SAPS 3 equation most suitable for its case mix. The SAPS II model tended to overestimate the mortality.
