Abstract
The aim of this study is to analyse the potential risks of medical laboratory activities in all processes: Strategic, operational (pre-preanalytical, preanalytical, analytical, postanalytical and post-postanalytical) and support. Also, we value the impact of these risks in the patient safety. The methodology used in this study to identify and estimate the possible failure modes was the Failure Model and Effects Analysis (FMEA). The real failures then were registered in the same processes according to the methodology Failure Reporting Analysis and Corrective Action System (FRACAS). Moreover, it used the basis of available information of the laboratory quality system. The Risk Priority Number (RPN) with FMEA and FRACAS was calculated for every laboratory processes and it was made a comparative of the results obtained with both methodologies. Based on these results, we made the risk map in medical laboratory. These results allowed us identifying critical points in all laboratory processes and prioritize the control of these points. Furthermore, it helped to select preventive or corrective action that should be incorporated in the laboratory improvement planning and risk management.
Highlights
The Risk Priority Number (RPN) with Failure Model and Effects Analysis (FMEA) and Failure Reporting Analysis and Corrective Action System (FRACAS) was calculated for every laboratory processes and it was made a comparative of the results obtained with both methodologies
Our study aims calculate the impact of the failure modes in a medical laboratory and compare the risk with two risk management tools: Failure Mode and Effects Analysis (FMEA) versus the Failure Reporting Analysis and Corrective Action System (FRACAS)
The results show the priority risks identified by FMEA
Summary
Patient safety is defined as the absence of avoidable patient harm during the process of medical attention. All medical attention brings inherent risk of adverse events (AE) that could cause injury, disabilities and even death of the patient. This paper told that at least 1,000,000 of AE happen in the United States yearly, and carry on the death of 44,000 to 98,000 people. This studies a real important revolution in health world, being aware of the error rate attributable to health system that has great impact on patients. At the beginning of the 2000s some initiatives appeared and some strategies were proposed to analyze and to see how you can reduce the rate of preventable errors
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