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

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. Conclsion 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. Key words: Independent clinical laboratory;  Quality management;  Supervision pattern