摘要
目的:根据医学检验所实际运行状况,评价原卫生部2009年印发的《医学检验所基本标准(试行)》符合性,完善医学检验所的资质管理。方法:通过访谈、问卷调研等方式抽样调查北京市10家第三方医学检验所资质和运行状况。通过差异分析法比较医学检验所实际运行与基本标准所存在的差距。结果:①试行标准设计合理,综合符合率>80%。在17项核心条款中符合性好的12条,符合性中等的4条,符合性差的1条,不符合条款的主要内容为人员配置和质量控制;②第三方医学检验所具有高级技术人员匮乏、培训体系薄弱、中转检验业务常态化、以及管理营销团队壮大等特点。结论:医学检验所的资质条款应适当修改,其内容为:①适当缩小必须的房屋面积,缩小各临床检验专业需要的检验专业卫生技术人员最低数量;②将第三方医学检验所纳入公立医院的培训体系;③明确惩罚性措施,尤其是针对质量控制方面的惩罚性措施。
Objective： To do the assessment on the adaptability on ＂Tentative Qualifications for Independent Laboratories＂ released in 2009 and provide amendment suggestions for the ＂Tentative Qualification＂. Thrive to build an applicable norm for independent laboratories. Methods： Combined methods including sampling survey, interviewing, and questionnaire and discriminate analysis were performed. Results： ＂Tentative Qualifications＂ is proved to be reasonable, with a combinedcoincidence rate of over 80%. Amongst the 17 core terms, 12 terms are highly coincidental, 4 terms show intermediate coincidence, while 1 term reveals least coincidence. Furthermore, independent laboratories generally suffer from a lack of senior technical staff and deficient training program. There is a trend in third party testing and booming marketing and management team. Conclusion： Firstly, amending terms relating downsizing of essential floor space and minimum number of professional medical technicians. Secondly, adding new terms as such favoring independent laboratories included in the training system of public hospitals. Finally, punitive measures, especially those against quality control, should be advanced.
出处
《中国医学装备》
2014年第5期7-10,共4页
China Medical Equipment
基金
国家科技支撑计划(2012BAH24F01)"第三方医学检验服务模式
总体方案及监管技术研究"
关键词
医学检验所
资质
符合性
完善
Independent laboratories
Qualifications
Adaptability
Improvement suggestions
