医疗失效模式与效应分析在I期临床试验血液样本管理中的应用

目的：探讨应用医疗失效模式与效应分析在I期临床试验血液样本管理中的应用效果，为提升血液样本管理质量提供依据。方法：采用方便抽样法抽取I期临床试验健康受试者的血液样本作为研究对象，根据是否实施医疗失效模式与效应分析方法分为对照组3 080个，观察组3 064个。比较两组血液样本不合格率、不合格项目的数量、受试者满意度及研究者考试合格率情况。结果：对照组血液样本不合格率1.95%，观察组血液样本不合格率0.59%，两组差异有统计学意义（P<0.05）。观察组血液样本不合格项目的数量低于对照组，两组差异有统计学意义（P<0.05）。观察组受试者满意度、研究者考试合格率高于对照组，两组差异有统计学意义（P<0.05）。结论：实施医疗失效模式与效应分析不仅为临床试验药物浓度检测分析提供合格的生物样本，还增强研究者规范化专业化水平，有助于临床试验整体质量的进步。

Application of medical failure mode and effect analysis in blood sample management in phase I clinical trials#br#

AIM: To explore the application effect of medical failure mode and effect analysis in the blood sample management of phase I clinical trials, and to provide a basis for improving the quality of blood sample management. METHODS: Convenient sampling was used to draw blood samples from healthy subjects in phase I clinical trials as the research objects. According to whether the medical failure mode and effect analysis method was implemented, they were divided into 3 080 control groups and 3 064 observation groups. The unqualified rate of blood samples, the number of unqualified items, the satisfaction of subjects and the passing rate of the researcher's examination between the two groups were compared. RESULTS: The unqualified rate of blood samples in the control group was 1.95%, and the unqualified rate of blood samples in the observation group was 0.59%. The difference between the two groups was statistically significant (P<0.05). The number of unqualified items in the blood samples of the observation group was lower than that of the control group, and the difference between the two groups was statistically significant (P<0.05). The satisfaction of subjects in the observation group and the passing rate of the investigator were higher than those in the control group, and the difference between the two groups was statistically significant (P<0.05). CONCLUSION: The implementation of medical failure mode and effect analysis not only provides qualified biological samples for the detection and analysis of drug concentration in clinical trials, but also enhances the standardization and specialization of researchers, and contributes to the improvement of the overall quality of clinical trials.