Department of Pharmacy, Michigan Medicine, Ann Arbor, MI.
College of Pharmacy, University of Michigan, Ann Arbor, MI.
Am J Health Syst Pharm. 2020 Dec 4;77(24):2089-2100. doi: 10.1093/ajhp/zxaa326.
This article is one of the 5 articles describing steps taken to enhance sterile compounding compliance at a large, multisite academic medical center. This article focuses on the development of a comprehensive personnel training and assessment program for sterile compounding.
Increased regulatory oversight and the release of new United States Pharmacopeia chapters motivated the reenvisioning of the medical center's sterile compounding personnel training and assessment program. The main challenges facing any entity undertaking sterile compounding include identification of compounding staff, development of policies and procedures, and baseline and ongoing training including observational competency assessments and record keeping. These challenges are exacerbated by high work volumes and variation in compounding practices encountered within a large multisite institution. Our organization developed a team of specialized pharmacists and pharmacy technicians to implement and enforce changes promoting the safe production and use of compounded sterile products and meet rising regulatory requirements. This team worked within various operational areas to customize purchased policies and procedures and group compounding staff based on training needs. The team performs ongoing personnel monitoring and training of new compounders in a shared training space. Challenges encountered and future considerations for program enhancement are described.
Implementation of standards and enforcement of staff behaviors in a large academic medical center is perhaps best completed by a team of highly trained experts working in collaboration with supervisors and using a dedicated training and testing space, as evidenced by the success of the described program in overecoming past challenges.
本文是描述在大型多站点学术医疗中心提高无菌调配合规性所采取措施的 5 篇文章之一。本文重点介绍了全面人员培训和评估计划的制定,以促进无菌调配。
监管力度的增加和新的美国药典章节的发布,促使医疗中心重新构想无菌调配人员的培训和评估计划。任何从事无菌调配的实体都面临着主要挑战,包括确定调配人员、制定政策和程序,以及进行基线和持续培训,包括观察能力评估和记录保存。这些挑战因高工作量和大型多站点机构中遇到的调配实践差异而加剧。我们的组织组建了一个由专业药剂师和药剂技术员组成的团队,以实施和执行促进安全生产和使用无菌调配产品并满足不断提高的监管要求的变革。该团队在各个运营领域内合作,定制购买的政策和程序,并根据培训需求对调配人员进行分组。该团队在共享的培训空间中对人员进行持续监测和对新调配人员进行培训。描述了遇到的挑战和未来计划增强的考虑因素。
在大型学术医疗中心实施标准并执行员工行为规范,最好由一支训练有素的专家团队与主管合作完成,并使用专用的培训和测试空间,正如所描述的计划在克服过去的挑战方面取得的成功所证明的那样。