Status analysis of 15 quality indicators at clinical laboratories of 8 029 medical institutions in China.

Abstract

Objective To investigate the 15 quality indicators of clinical laboratories at medical institutions in China, and to explore the model of quality specifications. Methods Online questionnaires were sent to 8 029 clinical laboratories, with the results analyzed by SPSS 20.The 25th percentile, 50th percentile, and 75th percentile of the distribution, according to the level of the hospital, were regarded as the optimum, appropriate and minimum quality specifications for each quality indicator, respectively. Results As shown in the median, sigma values of most indicators were greater than 3.The defect percentages of test uncovered by internal quality control(IQC) and test covered by inter-laboratory comparison were 52.56% and 14.27%, respectively, both too poor to calculate the sigma values.The turnaround time(TAT) differed greatly among the subjects.The longest time of pre-examination TAT and intra-laboratory TAT were clinical immunity.The minimum quality specifications for the quality indicators were from 3σto 6σ. Conclusions Laboratories should strengthen their IQC and inter-laboratory comparison, and their continuing education training to realize the continuous quality improvement. Key words: Hospital departments; Clinical laboratory; Quality indicator; External quality assessment; Continuous improvement