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This work explores the application of a complementary indicator of the analytical process, the average number of patient samples containing unacceptable analytical error due to undetected out-of-control error condition (ANPTE). The implementation of this additional indicator in clinical laboratory daily routine led to the implementation of a stand-alone software application which enables the integration of this indicator on the clinical lab management support system for quality control purposes.
The quality of analytical processes of clinical laboratories is of fundamental importance namely: to perform diagnostics, monitor patient’s clinical evolution and their responsiveness to treatment of several diseases, as well as for screening the presence of diseases in apparently healthy individuals. The quality verification check is done based on control samples that test the operational procedures and the validity of the tests. A correct quality control must be implemented to allow statistical treatment of results of control samples. The main goal is to ensure the quality of laboratory results by monitoring analytical system’s operations for error detection, at the earliest possible stage in the process. That is the earliest possible detection of a flaw which has negative implications in the system’s performance hence decreasing the risks meaningful clinical variation which are known to have a negative impact on medical decisions.
The evolution of clinical laboratories has led to greater automation of processes radically changing the way of implementation of the analysis, impacting on how quality is managed in this sector. A performance measurement focused on patient analysis results and frequency-dependent events of quality control is more suitable for nowadays laboratories which operate in continuous flow mode. The application of this additional indicator of performance evaluation, supported by a software tool integrated in daily routine, will potentially result in value added on quality management of clinical laboratories.
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Quality Indicators Quality Control Analytical Error Preventive Action Quality Management Corrective Action Deming Cycle Control Charts
