Department of Pharmacy, Michigan Medicine, Ann Arbor, MI, and College of Pharmacy, University of Michigan, Ann Arbor, MI.
Am J Health Syst Pharm. 2020 May 19;77(11):882-891. doi: 10.1093/ajhp/zxaa063.
Highly publicized safety issues arising from poor sterile compounding practices in facilities around the United States have garnered substantial attention in recent years. This attention has led to increased scrutiny of health systems by regulatory bodies, new regulatory requirements, and changes to existing regulations or their interpretation. Health systems are often resource constrained, and the added work resulting from this scrutiny challenges pharmacy departments in meeting regulatory requirements and United States Pharmacopeia chapter 797 standards for sterile compounding. This article describes the creation of a dedicated compounding compliance team (CCT) and the team's responsibilities in support of pharmacy operations in achieving compliance with those standards.
Visits to our organization by several regulatory bodies resulted in findings that required substantial work in order to achieve compliance with sterile compounding standards. Given the number and complexity of findings and the need for timely resolution, it was felt that specialized staff were needed to understand, evaluate, and correct identified deficiencies and help the already overburdened staff and leadership comply with existing standards. A CCT was formed, and work was simultaneously initiated on ensuring proper credentialing and training of all compounding staff, development of standard operating procedures, improvements in facilities, environmental monitoring, equipment certifications, practice auditing, and documentation. Key activities of the team included strategic planning, building relationships, communicating with stakeholders, self-education, and record keeping. Key partners included environmental services, facilities, and infection prevention and control personnel and departmental staff and leaders.
The formation and collaborative work of a CCT at an academic medical center was successful in changing the culture of the organization and achieving compliance during visits from several regulatory agencies.
近年来，美国各地医疗机构无菌配制操作不良而引发的备受关注的安全问题，引起了广泛关注。这些关注导致监管机构对医疗系统进行了更严格的审查，出台了新的监管要求，并对现有法规或其解释进行了修改。医疗系统通常资源有限，因此，由于这些审查而增加的工作给药剂部门满足监管要求和美国药典第 797 章无菌配制标准带来了挑战。本文介绍了创建专门的配制合规团队（CCT）及其在支持药剂部门实现合规性方面的职责，以支持药剂部门达到这些标准。
几家监管机构对我们机构的检查发现，需要大量工作才能达到无菌配制标准的要求。鉴于发现的问题数量和复杂性，以及及时解决问题的需要，人们认为需要专门的人员来理解、评估和纠正已确定的缺陷，并帮助已经负担过重的员工和领导层遵守现有标准。成立了一个 CCT，并同时着手确保所有配制人员的适当认证和培训、制定标准操作规程、改进设施、环境监测、设备认证、实践审核和文件记录。团队的主要活动包括战略规划、建立关系、与利益相关者沟通、自我教育和记录保存。关键合作伙伴包括环境服务、设施以及感染预防和控制人员以及部门员工和领导。
在学术医疗中心成立并协作的 CCT 成功改变了组织文化，并在几家监管机构的检查中达到了合规性。
