Implementation of a risk management model in determination and prevention of error resources in the preanalytical process in medical laboratories

Aims: The aim of the study to implement a risk management model to examine and prevent errors in the pre-analytical phase of a medical laboratory that prevent the achievement of the goals set in accordance with the quality standards. Method: The data used in this study were obtained from the "Error Reporting Forms" of DEU Hospital Central Laboratory between the years of 2013-2015. One of the qualitative risk management techniques, Failure Mode and Effect Analysis (FMEA) was used in the study. First, the pre-analytical laboratory process in which FMEA is applied is defined. In the next stage, the team that will carry out the FMEA study was formed. Then, the flow of the pre-analytical laboratory process was determined. The potential effects of the failure modes identified in this flow were determined, the severity, probability and detectability of the failure modes were calculated and potential reasons were determined. Finally, an action plan has been prepared to eliminate or mitigate the high-risk types of errors. Results: In the pre-analytical laboratory phase, the processes are defined by the FMEA team as "test request", "sampling", "identification", "barcoding" and "sample transfer". The errors occurred in the pre-analytical phase were classified under 9 types of errors. The highest number of errors is in the identification of the patient ID information, the number and the ratio of total errors in 2013 is 71 (29.58%), in 2014 81 (29.89%) and in 2015 102 (53.97%). The potential effects and causes of the identified error types were determined, and the severity, probability and detectability values were scored and RPN values were calculated by calculating the multiplication of these factors. It was observed that the error type with the highest RPM value of 576 points occurred in the identification process of the patients during the pre-analytical phase. Conclusion: FMEA is a reliable tool for performance improvement and a proactive risk management model that identifies, prioritizes and mitigates risks. An FMEA procedure that can be included in a medical laboratory's existing quality management system is expected to minimize the likelihood of errors in the pre-analytical phase and improve the quality of laboratory tests.