上海市第三方医学检验机构联合监管结果分析

Analysis of Joint Supervision Results of the Independent Clinical Laboratory in Shanghai

目的为掌握上海市第三方医学检验机构依法执业和质量管理情况,分析发现的问题并提出监管对策。方法采用卫生计生监督机构和临床检验质控联合检查的方式,依据第三方医学检验机构综合评价指标,对联合监管结果进行分析。结果上海市第三方医学检验机构总体情况良好,但仍存在机构和人员资质、检验报告书写和实验室检验质量控制等方面的问题。结论应进一步完善相关行业标准,明确管理要求;加强事中事后监管,建立退出机制;引导市场理性投资,做好社会服务。

Objective To grasp the legal practice and quality management of the independent clinical laboratory in Shanghai,to analyze the problems found and propose regulatory countermeasures.Methods The joint supervision results were analyzed according to the comprehensive evaluation index of the independent clinical laboratory by means of joint supervision of health and family planning supervision and clinical inspection quality control institutions.Results The overall situation of the independent clinical laboratory in Shanghai was good,but there were still problems in the qualifications of institutions and personnel,the writing of inspection reports and the quality control of laboratory inspections.Conclusion It is necessary to further improve relevant industry standards,clarify management requirements,strengthen post-event supervision,establish an exit mechanism,guide market rational investment,and do a good job in social services.