Analysis of error sources for routine chemistry external quality assessment program in China / 中华检验医学杂志

ABSTRACT

Objective To investigate and analyze the reasons of fa0ilure in external quality assessment(EQA) for routine chemistry and provide the basis for the corrective and preventive actions.Methods Based on the network system of NCCL EQA the reasons of failure in 2013 national routine chemistry external quality assessment program were investigated,among which the reasons were classified and analyzed with seven sources of problems which were clerical errors,methodological problems,equipment problems,technical problems,EQA materials problems,EQA Evaluation problems and unable to explain after investigation.Results The return rate of this root cause investigation for each analyte ranged from 33.3％ to 80.0％.The major reason for unacceptable analyte included clerical errors (6.5％) (decimal point position error70.1％;unit error20.8％;instrument or method coding error8.1％),methodological problems (45.1％)(calibration54.2％;reagent38.0％;EQA material:7.8％),equipment problems (28.5％) (no regular maintenance98.0％;pipeline error2.0％),technical problems (8.2％) (do not follow SOP80.4％;EQA material redissolve error10.6％;placing order error9.0％) and unable to explain (11.7％) (system error68.2％;random error31.8％).There were no EQA materials problems or EQA Evaluation problems in this survey.Analysis systems' grouping statistics were implemented for seven analytes including sodium,chlorine,phosphorus,direct bilirubin,total iron binding capacity,copper,and zinc.Unsatisfied EQA proportions of mating system were lower than nonmatching ones for the majority of analytes.Conclutions Further work on EQA should be undertaken by clinical laboratories.Laboratories should use reagents with high quality as well as improve the operation technology and sense of responsibility.Only in this way,can the accuracy and reliability of testing results be guaranteed.