Effectiveness of FMEA in Preanalytical phase in minimizing laboratory errors

Abstract

Background: The laboratory ‘errors’ effects quality of health care . The errors in preanalytical phase account for over 60 percent of laboratory errors. Application of the Failure mode and effects analysis (FMEA) in pre analytical phase of total laboratory testing process, in reducing and eliminating laboratory errors. Objective: Effectiveness of FMEA in preanalytical phase .The risks are identified and effectiveness of the mitigation process will be evaluated and monitored. Thereby develop quality services to the patient. Methods: In identifying the risk, the risk score is calculated in FMEA method by the multiplication of three risk parameters; the probability (P), the severity. (S) and the detection (D), in order to produce a risk priority number (RPN = P × S × D). Allowing risk investigation and risk minimization. Results: Before Failure Mode Effective Analysis (FMEA) Results in the 2023 : Total Number sample rejections: 174 Samples. Total Number of Sample rejections due to LIS Problem: 35 Samples. Total Number of Sample rejections due to Other Causes (Ex: Sample Lyse, Sample Clot, Low Volume, etc): 89 Samples. After Failure Mode Effective Analysis (FMEA) Results in 2023: Total Number of Sample rejections due to LIS Problem: Nil. Total Number of Sample rejections due to Other Causes (Ex: Sample Lyse, Sample Clot, Low Volume, etc): 50 Samples.  Conclusions: FMEA identifies and rectifies the failure modes of the testing process in the laboratory, which can reduce and eliminate laboratory risks and errors .This provides accurate and reliable results to the patient and assist in maintaining the continuous delivery of quality patient care in most effective processes. In estimates of risk, along with the ‘probability’and ’ severity’, detectability has significance role. If detectability score is very high we can eliminate and can minimize the lab errors.

Keywords: Risk management, FMEA, Laboratory errors