上海地区社会办医疗机构临床检验质量问题分析

Analysis of clinical test quality in non-government medical institutions in Shanghai

目的了解上海地区社会办医疗机构临床检验质量现状,分析存在的问题。方法对2019年上海地区40所医学检验实验室和36家核定床位100张及以上民办医院检验科现场质量督查不符合项进行统计分析。结果共发现654个不符合项,主要涉及实验室设备、试剂和耗材(16.21%),检验结果质量保证(14.98%),评估与审核(7.49%),质量管理体系(7.03%),人员(6.57%),受委托实验室的检验(6.57%),管理评审(5.50%),组织和管理责任(5.20%)等主条款。对应的比较集中或严重的次条款分别涉及设备校准(54.72%)、实验室间比对(43.88%)、室内质量控制(40.82%)、内部审核(42.86%)、程序和文件(82.61%)、人员资质(37.21%)、培训(34.88%)与能力评估(18.60%)、受委托实验室的选择与评估(72.09%)、管理评审报告(58.33%)与程序(38.89%)、实验室主任(47.06%)、组织总则(14.71%)。结论上海地区社会办医疗机构临床检验质量仍存在许多缺陷和不足,亟待加强培训和综合监管,以促进社会办医疗机构医学实验室持续、健康、规范发展。

Objective To investigate the status and analyze the problems of clinical test quality in non-government medical institutions in Shanghai.Methods Statistical analysis was performed on the non-conformities of on-site clinical test quality inspection of 40 medical laboratories and 36 socially run hospitals with 100 or more approved beds in Shanghai in 2019.Results A total of 654 non-conformities were found,which mainly focused on equipments,reagents and consumables(16.21%),ensuring quality of examination results(14.98%),evaluation and audits(7.49%),quality management system(7.03%),personnel(6.57%),examination by referral laboratories(6.57%),management review(5.50%)and organization and management responsibility(5.20%).The corresponding sub-clauses more prevalent or severe were equipment calibration(54.72%),inter-laboratory comparison(43.88%),internal quality control(40.82%),internal auditing(42.86%),procedures and documents(82.61%),personnel qualifications(37.21%),training(34.88%),capability assessment(18.60%),selection and assessment on referral laboratories(72.09%),management review report(58.33%),management review procedures(38.89%),laboratory director(47.06%)and organization(14.71%).Conclusions There are many deficiencies and weaknesses that could affect the clinical test quality in non-government medical institutions in Shanghai,so it is imperative to strengthen the training and comprehensive supervision to promote the continued healthy and standardized development of non-government medical institutions'medical laboratories.