Abstract:

Objective Through analyzing the nonconformities of on-site assessment in 31 clinical laboratories,to find the distribution and common problems of nonconformities,the causes of nonconformities and their control measures. Methods According to the sequence of the Basic Contents and Requirements for Quality Management of Clinical Laboratories in Shanghai Medical Institutions revised in 2014,the nonconformities of on-site assessment from 2006 to 2015 were classified and summarized. Results A total of 1 841 nonconformities were classified and analyzed. The top 5 items were establishing quality control procedures,making and operating standard operating procedure（SOP） of examination project,the management of equipment and material,the laboratory biosafety management and the document and record management. According to characteristics,nonconformities were classified into operation（47.1%）,effectiveness（34.3%） and systematicness（18.6%）. The number of nonconformities over the past 10 years and the main content of the top 10 entries were evaluated. The nonconformities were decreasing yearly. After the items were classified,there was no significant change in the 3 items,including routine quality management,equipment and material management and the confirmation and verification of examination methods. Conclusions Through the sorted analysis of nonconformities,the items which are most likely to be nonconformities are found,and their contents are summarized. By observing the nonconformity changes in the past 10 years,the unsatisfactory correcting effect of nonconformity items is analyzed. There is a certain reference effect in the improvement of examination quality of the similar class units after the analysis of these results .

Key words: Clinical laboratory, Quality management, On-site assessment, Nonconformity