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首页> 外文期刊>Journal of oncology pharmacy practice: official publication of the International Society of Oncology Pharmacy Practitioners >Preliminary hazard analysis applied to outsourcing sterile chemotherapy preparations
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Preliminary hazard analysis applied to outsourcing sterile chemotherapy preparations

机译：初步危害分析适用于外包无菌化疗制剂

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Background Our hospital organization raised the possibilities of outsourcing their sterile pediatric chemotherapy preparations to another hospital conditional on analyzing the potential hazardous events that need to be anticipated. Methods The study was conducted by a multidisciplinary working group from September 2015 to January 2016 with the support of a risk manager. A list of hazardous situations that could occur during outsourcing process was assessed. First, a map of hazardous situations was developed by crossing outsourcing processes divided into phases classified as critical or not. Second, a map of risk was established by crossing potential consequences of these hazardous situations and elaborating corrective actions to reduce the initial risks. Results The map of hazardous situations identified 183 relevant hazardous situations, 78 of which were considered high priority and 154 scenarios were developed. Slightly more than half of these hazardous situations concerned information system (30%), human resources (14%), and management (11%). The generic hazards of information system and human generated 37 (24%) and 41 (27%) scenarios, respectively. To reduce critical risks, 33 corrective actions were proposed. Working time required was estimated at 35 days. The subcontractor personnel for this new organization included an estimated extra time of 0.7-pharmacist working day and 1.4-pharmacy dispenser working day. Conclusions The preliminary hazard analysis method appeared to apply to our system of outsourcing sterile cytotoxic preparations in another hospital. Regardless, this analysis is complex and requires time and expertise.
机译：背景技术我们医院组织提出了将其无菌儿科化疗准备外包给另一种医院条件的可能性，分析需要预期的潜在危险事件。方法采用2015年9月至2016年1月的多学科工作组进行了一项风险经理。评估外包过程中可能发生的危险情况清单。首先，通过划分为关键或不分为关键的阶段的外包过程开发了危险情况的地图。其次，通过穿越这些危险情况的潜在后果并阐述纠正措施来减少初始风险的潜在后果来建立风险地图。结果危险情况地图确定了183个相关的危险情况，其中78个被认为是高优先级，开发了154个情景。略高于这些危险情况的一半以上信息系统（30％），人力资源（14％）和管理（11％）。信息系统的通用危害和人类生成的37（24％）和41（27％）情景。为减少危急风险，提出了33项纠正措施。所需的工作时间估计在35天。该新组织的分包商人员包括估计的0.7药剂师工作日和1.4药物分配器工作日的额外时间。结论初步危害分析方法似乎适用于我们在另一家医院的外包无菌细胞毒性制剂系统。无论如何，这种分析很复杂，需要时间和专业知识。

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