我国医学独立实验室的调查分析

A nationwide investigation and analysis of present status of independent clinical laboratories in China and suggestions

目的全面了解我国医学独立实验室发展历程和目前存在的问题，进一步探讨对此类新型医疗机构临床实验室的监督管理模式。方法通过全国临检中心网络，采用书面调查与现场查看相结合的方式对国内医学独立实验室进行调查分析。结果医学独立实验室随着中国的经济和检验技术的发展，在国内已初具规模并呈多元化发展的趋势，但在人员结构、全程质量保证、市场竞争、信息对称、生物安全防护等多方面问题仍然存在问题。结论应探索并制定出严格的行业准入要求和合适的监督管理模式，医学独立实验室自身应处理好发展中的“4大关系”，卫生监管部门紧抓“4大监督”环节，以期更好地实现医疗资源共享，营造出人民群众、医院和医学独立实验室多方受益的良好局面。

Objective To have a general picture the history and existing problems of independent clinical labs in China, for the purpose of building a supervision mechanism for such novel clinical institutions--clinical labs. Methods By way of the nationwide network of clinical labs, ICLs in China were surveyed with written questionnaires and field check. Results ICLs have grown into a greater and diversified scale thanks to the development of China＇s economy and laboratory technology. However, such vulnerabilities as unbalanced staff ratio, full-range quality control bugs, cutthroat competition, asymmetrical information disclosure, and bio safety have loomed large in the meantime. Conclusion It is time to formulate a stricter industry access system and appropriate regulatory modes; ICLs should take a good care of the ＂Four relations＂ in their development, and health regulators should play a tighter role in the ＂Four supervisions＂. All these aim at better sharing medical resources, and building a win-win environment for the people, hospitals and ICLs.