Abstract:

Objective To evaluate the risk of urine routine tests in clinical application. Methods The risk levels of urine dry chemical analysis and urine sediment analysis were evaluated by failure mode and effect analysis（FMEA）. Fishbone diagram was used to analyze probable factors and identify causes that may affect the accuracy of protein and cast determinations. The effect was confirmed by brainstorming and experience sharing. Results There was no unacceptable risk in all urine routine tests,and 11 tests were acceptable. The risk of remaining tests was negligible. According to Pareto rule,the determinations of protein and cast were needed to be improved in risk management. The causes obtained from fishbone diagram analysis were as follows：examiners did not follow the re-test rules when they did urinalysis;the microscope lens was unclear;the time of urine specimens placed was too long. The determination rate of cast in protein-positive urine specimens increased from 1.55% to 6.83% （P<0.01）. Conclusions The risks of protein and cast determinations in urine routine tests are undercontrol through this risk management.

Key words: Urinalysis, Risk management, Failure mode and effect analysis, Fishbone diagram