我国医学独立实验室现存问题与监管模式的探讨

摘要

Zhejiang Center for Clinical Laboratory has concerned the development of independent clinical laboratory for five years.Through combining with questionaire and field survey for three years, and with the related contents in Medical Institutions Clinical Trial Management Methods, research is done on medical independerd clinical laboratory to know its developmental status quo, to find the vulnerability of management and defects of quality, and to explore supervision and management mode for independent clinical laboratories.It is proposed that four aspects, which are management, quality, benefit and safety, should be supervized and managed more to promote the development of independent clinical laboratories.%浙江省临床检验中心5年来关注国内医学独立实验室的发展,连续3年以书面问卷和现场调查相结合的方式,结合<医疗机构临床实验室管理办法>的相关内容,对医学独立实验室进行调查研究,了解其发展的现状,发现当前存在的管理漏洞和质量缺陷,探讨对我国医学独立实验室监督管理的模式,并提出应重点对"管理、质量、效益、安全"4个方面进行有效监管,促使其健康发展.