Applications of two analytical specifications in the external quality assessment schemes and the external comparision of internal quality control

Abstract

Objective To study the applicability of a new analytical specification defined in WS/T 403-2012 in the external quality assessment schemes and the external comparision of internal quality control. Methods It was a quality management method study. Total error allowable criterions listed in WS/T 403-2012 and GB/T 20470-2006 were selected to assess the results of 23 analytes in the 1st challenge of 2013 routine chemistry external quality assessment. The acceptable rate of 23 analytes were calculated with the two specifications.Criterions of imprecision derived from the two standards were applied to assess the coefficient of variation with internal quality control data. Results With the specification based on WS/T 403-2012, the ratio of laboratories that all five samples were passed in the 1st challenge for 23 analytes ranged from 55.5% to 94.7%. The ratio of laboratories with 80% or more samples passed in 2013 EQA ranged from 73.9% to 98.5%. While ratios of two kinds described above evaluated based on GB/T 20470-2006 ranged from 63.0% to 99.2%, and from 90.0% to 99.7%, respectively. The acceptable rate of CV according to the two criterions ranged from 55.5% to 94.7% and 63.0% to 99.2%, respectively. Conclusions As evaluation criterions of external quality assessment allowable total error and internal quality control imprecision in routine chemistry, the specification in WS/T 403-2012 can be used to assess the analytical performance of clinical laboratory more objectively and comprehensively. It can help laboratories to identify the latent problems for further quality improvement.（Chin J Lab Med,2014,37:866-869） Key words: Diagnostic tests, routine; Clinical chemistry tests; Laboratories, hospital; Quality contro