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1、基于医疗失效模式与效应分析建立危害药品防护流程 常惠礼 林杰茹 广州医科大学附属第六医院药学部 摘 要： 目的 基于医疗失效模式与效应分析 (HFMEA) 建立危害药品给药过程防护流程, 提升医护人员及相关人员的安全防护水平。方法 参考 HFMEA 方法, 对现有的危害药品给药各环节进行危害程度评估, 分析原因并提出改善方法。项目改善期间为 2016 年 3 月至 7 月, 从危害药品给药各个环节流程中找出 29 项失效模式和 20 项失效原因, 最后拟出 14 项失效模式与合并归纳缺乏危害药品验收入库及贮存防护流程、院内对医嘱开立未有明确分级管理制度以及缺乏该类药物摆药贴签核对管理规定等 9
2、 项失效原因进行改善。通过要求供货商使用专用配送箱单独配送并明确标识, 验收时佩戴双层口罩、手套、设立专柜单独贮存并有警示标志以及汇总数据写报告, 交予药学部, 向医务部提出申请分级管理等改善对策。结果 改善对策实施后 (2016 年 8 月 1 日至 12 月 31 日) , 危害药品 (静脉滴注类) 集中调配率为 100%, 较改善前 (2016 年 3 月至 7 月) 提高 20%;各环节防护流程执行率为 98%, 较改善前 (2016 年 3 月至 7 月) 提高 78%, 未出现危害药品给药过程的职业暴露事件。建立防护流程后, 持续改进小组对失效模式又进行了一次危害程度评估, 结果危
3、害程度平均分由改善前的 14 分降至改善后的 1 分, 效果明显。结论 运用 HFMEA 方法, 采取前瞻性风险评估, 建立危害药品给药过程的防护流程, 有效提高了危害药品的集中调配比例, 医护人员安全防护意识大大提高, 各环节防护流程执行率也随之提升, 医护人员与相关人员的安全防护水平进一步提升。关键词： 医疗失效模式与效应分析; 危害药品; 给药过程防护; 作者简介：常惠礼, 男, 大学本科, 副主任药师, 研究方向为医院药学和临床药学, (电话) 0763-3113793 (电子信箱) 。Establishment of Protection Process of Harmful Dru
4、g Based on Healthcare Failure Mode and Effect AnalysisChang Huili Lin Jieru Department of Pharmacy, The Sixth Affiliated Hospital of Guangzhou Medical University; Abstract： Objective To establish the protection process of harmful drug based on healthcare failure mode and effect analysis (HFMEA) , in
5、 order to improve the safety and protection level of medical staffs and related personnels. M etho ds According to the HFMEA method, the damage degree of the existing drug delivery process was evaluated, the reasons were analyzed and the improvement methods were put forward. The duration of the proj
6、ect was from March to July in 2016, 29 failure modes and 20 failure reasons were found out in the drug delivery process. At last, 14 failure modes and 9 failure reasons ( such as lack of protection process of acceptance and storage of harmful drug, no clear hierarchical management system for medical
7、 orders in the hospital, lack of administrative regula-tions to check the dispensing and labeling of the drugs) were drawn up. The suppliers were required to use special distribution boxes to distribute and identify them separately. At the time of acceptance, we should wear double-layer masks, glove
8、s, set up separate coun-ters with store warning signs and collect data, write reports, submit them to the pharmacy department, and put forward the improvement measures for the medical department to apply for classification management. Results After the implementation of the countermeasures (from Aug
9、ust 1 st to December 31 st in 2016) , the centralized allocation rate of harmful drug (intravenous drip) was 100%, which was increased by 20% compared with before the improvement (from March to July in 2016) . The implementation rate of the protection pro-cess of each link was 98%, which was increas
10、ed by 20% compared with before the improvement (from March to July in 2016) . No occupational exposure events were occurred in the process of using harmful drug. After establishing the protection process, the continuous improvement team carried out an evaluation of the damage degree to the failure m
11、ode, the result showed that the average degree of damage changed from 14 points before improvement to 1 point after improvement. The effect was obvious. C o nclusio n The protective process for harmful drug is established by using the method of HFMEA and the forward-looking risk assessment, it can e
12、ffectively im-prove the proportion of the centralized allocation of harmful drug, the awareness of the safety and protection of the medical and nursing staffs, and the implementation rate of the protection process in each link, in order to further improve the level of safety and protection of medica
13、l staffs and related personnels.Keyword： healthcare failure mode and effect ananlysis; harmful drug; protection of drug delivery process; 失效模式与效应分析 (failure mode and effect analysis, FMEA) 是一种系统性、前瞻性的分析工具, 用以确定潜在风险和安全隐患, 是预防问题发生的风险管理手段1。美国退伍军人事务局 (VA) 改进传统 FMEA 并用于医疗卫生行业2, 转化为医疗行业的风险管理。这种风险管理定义为, 减少
14、医疗差错确保患者安全的各种行动3。本质上, FMEA 针对每一个故障评估其整个系统、设计、过程或服务产生的影响, 使用优先矩阵评价法等方法以确认潜在失效模式及预测其产生的效应, 并评估其发生率和严重度, 从而计算出风险程度, 最后采取改善方法, 避免失效模式与效应发生4。危害药品是指能产生职业暴露危险或者危害的药品, 即具有遗传毒性、致癌性、致畸性, 或对生育有损害作用, 以及在低剂量下可产生严重的器官或其他方面毒性的药品, 包括肿瘤化学治疗药品和细胞毒药品5。曾有研究发现, 肿瘤科护理人员在调配环磷酰胺的 57 d 内, 所采集的 30 个尿液样本中有 7 个检出环磷酰胺。同年, Nikul
15、a 等的研究报告指出, 肿瘤科护理人员体内较高的机会发现染色体结构异常6。我国 2010 年 4 月 20 日发布的静脉用药集中调配质量管理规范中提出, 医疗机构对肠外营养液和危害药品静脉用药实行集中调配与供应, 危害药品调配应当重视操作者的职业防护。我院虽已对危害药品的集中调配进行防护及规范, 但未建立给药过程的全程防护。现借鉴 FMEA 的思路与方法, 建立给药过程全程防护流程, 以预防因危害药品防护不足导致不良事件发生。1 对象与方法1.1 研究对象针对我院现有危害药品给药过程的各环节工作流程, 参考 2002 年 De Rosier 的医疗失效模式与效应分析 (HFMEA) 的改善步骤
16、7, 寻找失效原因并提出改善方案。1.2 方法1.2.1 主题选定根据现有危害药品给药流程及静脉用药集中调配质量管理规范5, 发现我院现有流程不完善, 国家对此方面的规定不详细, 故拟订本次的活动改善主题为:运用 FMEA 方法建立危害药品给药过程防护流程。1.2.2 现状分析综合讨论:邀请医院感染控制管理科、肿瘤内科、药学部、护理部以及后勤保障部共同参与改善方案的讨论。根据现有危害药品给药过程防护流程, 分别从危害药品验收入库及贮存保管、摆药及贴签核对、无菌调配、成品复核、输液输送、护理站交接、患者给药、给药后废弃物处理依照顺序, 根据工作连贯性绘画出改善前的相关流程图。危害程度评估:根据危害药品给药过程失效模式发生率 (经常发生, 记 4 分;偶尔发生, 记 3 分;不常发生, 记 2 分;罕见, 记 1 分) 与严重程度 (严重, 记 4分;重度, 记 3 分;中度, 记 2 分;轻度, 记 1 分) 评分 (分级定义详见表 1) 8,并进行二维计算。表 1 危害程度评估
