医学实验室风险管理

Risk management in clinical laboratory

风险是影响检验结果的潜在危害，风险管理是在风险方面指导和控制组织的协调活动。如何做好检验过程实验活动中潜在风险的识别与管理，并在管理中集成检验风险管理、质量管理与生物安全管理的共性？如何在保障检验方针、目标与指标实现的同时，将影响检验结果的风险降至最少？本文针对医学实验室检验过程多要素的风险管理，举例介绍了风险管理过程中的策划、风险管理流程、风险评估、风险监督、风险审核以及风险管理如何文件化，目的是推进我国医学实验室风险管理的开展并走向科学与规范，更加有效的发挥医学实验室的服务功能及其在临床疾病诊疗中的作用。（中华检验医学杂志，2015，38：589－591）

Risk is potential hazards to the accuracy of laboratory tests.Risk management is the coordination of a series activities to control risks. This article addresses the following issues： how to efficiently identify and manage the potential risks that exist in examination activities throughout the whole process, and summarize the general characteristics from lab risk management, quality management and biosafety management？How to minimize risks that may affect examination results, as well as to ensure the achievements of examination policy, quality objectives and indicators at the same time？ Focusing on risk management for multi-factors throughout the whole examination process in clinical lab, this article lists a series of activities adopted in risk management, including plan, process management, risk assessment, risk supervision, risk management audit and documentation for risk management as well.This article will push on improvement of risk management in Chinese clinical lab in a scientific and standard way, so as to perform lab service more efficiently and play an even better role in clinical diagnosis.