上海市临床实验室自建检测方法的市场需求和政府监管政策建议

Suggestions on market demand for laboratory developed testing methods in Shanghai clinical laboratories and government regulatory policy recommendations

对上海市临床实验室自建检测方法开展情况进行现场调查和问卷调查,了解医疗机构对实验室自建检测方法的需求,在讨论政策环境和可行性的基础上,提出开展临床实验室自建检测方法的政策建议,建议通过试点先行、评估备案、强化监管、联合管理的模式推进临床实验室自建检测项目落地。

In order to understand the needs of medical institutions for laboratory developed testing methods,the on-site investigation and questionnaire survey among clinical laboratories in Shanghai was done.On the basis of discussion of policy environment and feasibility,policy recommendations on laboratory developed testing methods were put forward.It is suggested that the implementation of laboratory developed testing projects be advanced through pilot experiment,evaluation,filing,strengthened supervision and joint management.