Application of the FMEA Method in Improving the Quality Management of Emergency Complete Blood Count Testing.

Objective: Failure mode and effects analysis (FMEA) was used to identify factors that contribute to quality management deficiencies in laboratory testing of emergency complete blood count (CBC).

Methods: Improvements included instrument updates, personnel training, and laboratory information system optimization. We used operational data from January 2021 (control group) and January 2022 (FMEA group) to compare the risk priority number (RPN) of FMEA, emergency CBC laboratory turnaround time (TAT), error report rate, and specimen failure rate.

Results: After the implementation of FMEA, the average RPN dropped from 36.24 ± 9.68 to 9.45 ± 2.25, (t = 20.89, P < .05). Additionally, the median TAT for emergency CBCs decreased from 23 min to 11 min as did the interquartile distance (17-34 min to 8-16 min) (P < .05). The rate of emergency CBC error reports decreased from 1.39% to 0.71% (P < .05), and the specimen failure rate decreased from 0.95% to 0.32% (P < .05). Patient satisfaction also increased from 43% to 74% (P < .05), and the technician-performed morphology assessment pass rate increased from 16.7% to 100% (P < .05).

Conclusion: Improving the emergency CBC testing process with FMEA can shorten emergency CBC laboratory TAT and reduce specimen failure rates and reporting error rates. The FMEA can be used to improve quality management in emergency CBC laboratories.