Implementation of a Risk Management Model to Identify and Prevent Preanalytical Errors in Medical Laboratories

Objective: The aim of the study is to apply a risk management model for the examination and prevention of errors occurring in the preanalytical laboratory phase.Method: The data used in this study were obtained from the Error Reporting Sheet of Dokuz Eylul University Hospital Central Laboratory for 2013–2015. The Failure Mode and Effects Analysis FMEA method was used in the study. The pre-analytical laboratory process was defined and FMEA team was formed. By determining the potential effects of failure modes detected in the pre-analytical process, the severity, probability and detectability of them were calculated and potential causes were identified. An action plan was prepared to eliminate or reduce the highrisk failure modes.Results: In the pre-analytical laboratory phase, processes are defined as test request, sampling, identification, barcoding and transfer. The errors that occurred in the pre-analytical phase were classified under 9 types of errors. The highest number of errors was observed in the patient identification process and the number and the ratio of total errors in 2013 are 71 29.58% , in 2014 it is 81 29.89% and in 2015 it is 102 53.97% . It was observed that the failure mode with the highest risk priority number value with 576 points in the pre-analytical phase occurred in the identification process.Conclusion: With the FMEA procedure that can be included in the laboratory’s quality system, it is expected to minimize the possibility of errors in the pre-analytical phase and improve the quality of laboratory tests

Keywords:

Medical laboratory, pre-analytical phase risk management, failure mode and effects analysis,

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