上海市静安区31个临床实验室现场评审不符合项分析

Analysis on the nonconformities of on-site assessment in 31 clinical laboratories at Jing’an District of Shanghai

目的通过对上海市静安区检验质量控制管理网络单位(以下简称为网络单位)31个临床实验室10年现场评审不符合项的分析,发现不符合项的分布规律及共性问题,探讨不符合项产生的原因以及控制措施。方法按照2014年修订的《上海市医疗机构临床实验室质量管理基本内容和要求》的条目顺序,归类汇总分析2006—2015年现场检查不符合项。结果将1 841项不符合项按条目归类,数量较多的前5个条目依次为:建立质量控制程序,制定和执行检验项目标准操作规程(SOP),设备、材料管理,实验室生物安全管理,文件和记录管理。按性质分类:实施性占47.1%,效果性占34.3%,体系性占18.6%。汇总10年间不符合项分布数量以及排前10位条目的主要内容,发现每年不符合项呈逐年减少的趋势,按条目归类后发现日常质量管理,设备、材料管理,检验方法的确认与验证3个条目减少趋势不明显。结论通过不符合项的归类分析,发现了最容易发生不符合项的条目,并汇总了常见不符合项的内容。通过观察不符合项的10年变化,分析其整改效果不满意的项目。分析结果对同类同级单位实验室检验质量的改进起到了一定的借鉴作用。

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.