Geraudie Bastien, Kabiche Sofiane, Rigal Marthe, Malki Myriam, Fontan Jean-Eudes, Jacolot Anne, Schlatter Joël
1 Hôpital Avicenne, Hôpitaux Universitaires de Paris-Seine-Saint-Denis (HUPSSD), Bobigny, France.
2 Hôpital Jean Verdier, Hôpitaux Universitaires de Paris-Seine-Saint-Denis (HUPSSD), Bondy, France.
J Oncol Pharm Pract. 2018 Jan 1:1078155218785239. doi: 10.1177/1078155218785239.
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.
背景 我院机构提出了将儿科无菌化疗制剂外包给另一家医院的可能性，前提是要分析需要预见的潜在危险事件。方法 本研究由一个多学科工作小组在一名风险经理的支持下于2015年9月至2016年1月进行。评估了外包过程中可能出现的危险情况清单。首先，通过交叉划分分为关键或非关键阶段的外包流程来绘制危险情况图。其次，通过交叉这些危险情况的潜在后果并制定纠正措施以降低初始风险来建立风险图。结果 危险情况图确定了183个相关危险情况，其中78个被视为高度优先，共制定了154个场景。这些危险情况略多于一半涉及信息系统（30%）、人力资源（14%）和管理（11%）。信息系统和人为因素的一般危险分别产生了37个（24%）和41个（27%）场景。为降低关键风险，提出了33项纠正措施。估计所需工作时间为35天。这个新机构的分包商人员估计额外需要0.7个药剂师工作日和1.4个药房配药员工作日。结论 初步危险分析方法似乎适用于我院将无菌细胞毒性制剂外包给另一家医院的系统。尽管如此，这种分析很复杂，需要时间和专业知识。
