Laboratory Results defects and Its Relations with Patient Safety

Abstract

The purpose of this study is to analyse potential threats of medical laboratory activities at Strategic, operational (pre-preanalytical, preanalytical, analytical, postanalytical and post-postanalytical), and support process. Moreover, we appreciate the risk with these in patient safety. In this study, the Failure Model and Effects Analysis (FMEA) method was presented to identify and estimate the possible failure modes. The real failures were not registered in the same processes then in according to Failure Reporting Analysis and Corrective Action System (FRACAS) methodology [1, 2]. In addition, it was based on the quality system of the available information of the laboratory. The RPN was calculated with each one of the methodologies for each laboratory process, and a comparative of the results obtained with both methodologies was carried out. From these results we prepare the risk map in medical laboratory. These results permitted us to identify the critical points existent in all laboratory processes and thus above all to prioritize the control of which points. Additionally, it assisted in choosing preventive or corrective action that should be included in the laboratory quality improvement and risk management plans.