前瞻性风险分析在临床检验中的应用

摘要

前瞻性风险分析(PRA)可保证临床实验室检测质量,但目前实验室缺乏执行PRA的实用方法.可采用经典的故障模式和效应分析(FMEA)方法为实验室的关键过程制定PRA.首先根据调查确定过程的主要步骤,为预先定义的差错类型的概率(P)、结果(C)和检测度(D)打分,再用P和C的分数计算整体风险分数(R).根据事先规定的R和D的标准确定潜在差错是否需要更详细的分析,并确定是否需要采取降低风险的措施.文章介绍了在检验前和检验中应用PRA的结果.%Prospective risk analysis (PRA) is an element in quality assurance for clinical laboratories.However,practical approaches to conducting PRA are scarce.On the basis of classical failure mode and effect analysis (FMEA) method,an approach to PRA is developed for key laboratory processes.Firstly,major steps of the process under investigation are identified.Scores are then given for the probability (P) and consequence (C) of predefined types of failures and the chances of detecting (D) these failures.Based on the P and C scores,an overall risk score (R) is calculated.Based on predetermined criteria for R and D,it is determined whether a more detailed analysis is required for potential failures and where risk-reducing measures are necessary.As an illustration,this review presents the results of the application of PRA to pre-analytical and analytical activities.