Abstract:

Objective To decrease the risks of biochemical determinations [serum creatinine（Cr）,blood urea nitrogen（BUN）,uric acid（UA） and cystatin C（Cys C）] for chronic kidney diseases,in order to maintain the accuracy of determinations. Methods Failure mode and effect analysis（FMEA） was used to identify risk points,and 4 staffs and 4 experienced staffs（above 5-year experience） estimated these identified risk points. Quality control circle was used to analyze the main factors for these risk points and take related measures. Results The main cause for serum Cr,BUN and UA was inappropriate preparation of patients. However,for Cys C,the main cause was determination method. By quality control circle,strengthening communication with patients,selecting Cys C reagents with optimal performance and emphasizing the standard operating procedure of pre-analytical process for staffs were 3 strategies for improvement. The review rate of biochemical determinations for chronic kidney diseases decreased from 0.98% to 0.13%. Conclusions The application of risk assessment could identify the potential risks for determination quality. The relevant strategies could decrease the probability of malpractice. Meanwhile,it could increase the accuracy of determinations.

Key words: Chronic kidney diseases, Failure mode and effect analysis, Quality control circle