FRACAS在临床检验中的应用

Application of Failure Report Analysis and Corrective Action System in Laboratory Medicine

故障报告、分析和纠正措施系统（FRACAS）是一种质量管理工具，通过系统地对产品或过程的故障进行报告和踪、分析和采取有效纠正措施，对产品或过程的故障进行控制，其原理是信息反馈，闭环控制。临床检验出现故障可对患造成严重的影响，利用FRACAS可识别故障，并对每个出现的故障进行分析，明确其根本原因，以评价故障的影响，并对个故障采取有效的纠正措施。一旦纠正措施实施后．应测量纠正措施前后的故障率，评价纠正措施的有效性。因此，临实验室可纠正检测过程中出现的故障，同时预防类似故障的再次发生，从而提高检测结果的可靠性和准确性，切实保障者的安全。

Failure report analysis and corrective action system （FRACS）, a tool lor quality control, is a systematic and corn-prehensive approach to report,track and analyze the failure occurred in process,and take corrective actions to improve the quality and reliability of the test results. The principle of FRACAS is information feedback and closed-loop control. Failure in laboratory medicine can lead to serious effect on patients. FRACAS are used to identify the failure, recognize its root cause, evaluate the effects and take actions, which includes prevention, detection and recovery of the failure. Once implemented, a monitoring system should be developed to assess the effectiveness through measuring the failure rate before and after imple- menting corrective actions. While implemented correctly,Laboratory can correct the occurred failure and prevent it from re- occurring with FRACAS to improve the quality and reliability of the results and ensure the safety of patient.