医院冷链药品管理中的HFMEA和RCA联合应用价值探讨

Discussion of the Combined Application Value of HFMEA and RCA in the Hospital Drug Cold Chain Management

关键词:  冷链药品  失效模式与效应分析  根本原因分析  风险管理

Key words:  cold chain drugs  failure mode and effect analysis  root-cause analysis  safety management

摘要:

目的 探讨医疗失效模式与效应分析（health care failure mode and effect analysis，HFMEA）和根本原因分析（root cause analysis，RCA）法在医院冷链药品管理中的联合应用效果。方法 根据追踪方法学原理，运用HFMEA方法评估医院冷链药品日常管理，列出医院冷链管理过程中可能出现的失效模式，并对其中的关键失效模式利用RCA法进行分析和评估，找出影响冷链药品安全的根本原因，实施改进措施并评估实施后的效果。结果 联合应用HFMEA和RCA后，医院冷链药品管理不良事件发生率均明显下降；影响冷链药品安全管理的风险优先数（risk priority number，RPN）值由369分下降到45分，冷链药品断链风险点由29处下降至4处，冷链闭环管理中存在的断链时间由190 min下降至12.5 min，改进前后比较差异具有统计学意义（P<0.05）。结论 将HFMEA和RCA联合应用于医院冷链药品的风险管理，可以提高医院冷链药品管理风险意识，降低药物不良事件发生率。

Abstract:

OBJECTIVE To explore the combined application effect of Healthcare Failure Mode and Effect Analysis (HFMEA) and root cause analysis (RCA) in safety management of the hospital drug cold chain management. METHODS According to the principle of tracing method, HFMEA method was used to evaluate hospital cold chain drugs daily management, and RCA was used to analyze and evaluate the key mode in these potential failure modes so as to find the root cause which might affect the safety of the hospital drug cold chain management, then the improved measures were implemented and the effects of new measurement were evaluated. RESULTS After combined application of HFMEA model and RCA, drug adverse events occurred in the hospital cold chain management were significantly decreased; the risk priority number (RPN) reflecting drug safety management of cold chain decreased from 369 points to 45 points, and the cold chain scission point in each department deceased from 29 to 4, and the cold chain broken time down from 190 min to 12.5 min, with statistically significant difference (P<0.05) before and after the implementation. CONCLUSION The combined application of HFMEA and RCA in the hospital drug cold chain management can improve the risk awareness of hospital cold chain drug management, reduce the incidence of adverse drug events.