Leuven University Fertility Center, Leuven, Belgium.
Semin Reprod Med. 2012 Jun;30(3):191-8. doi: 10.1055/s-0032-1311521. Epub 2012 May 14.
Since 2004, assisted conception is encompassed by the European Directive on the Quality and Safety of Tissues and Cells (2004/23/EC). The aim of a standard for quality and safety is to minimize risks of errors, contamination, and accidents and to maximize efficiency of use. This article presents a case study of the implementation of the Tissues and Cells Directive in the Leuven University Fertility Center (LUFC) with a focus on the assisted reproductive technologies laboratory with respect to laboratory facilities, quality management system, traceability, storage conditions as well as serological screening. Although the current European Union (EU) Directive can be considered a step in the right direction to improve patient safety, questions remain as to whether the implementation of this EU Directive, requiring extra time and money, has resulted in higher quality with respect to the quality dimensions of effectiveness, efficiency, timeliness, equity, and patient centeredness.
自 2004 年以来，辅助受孕被纳入了欧洲关于组织和细胞质量与安全的指令（2004/23/EC）。质量与安全标准的目的是将错误、污染和事故的风险降到最低，并将使用效率最大化。本文通过列日大学生育中心（LUFC）实施组织和细胞指令的案例研究，重点介绍了辅助生殖技术实验室的实验室设施、质量管理体系、可追溯性、储存条件以及血清筛查情况。尽管当前的欧盟指令可以被视为提高患者安全的正确方向的一步，但仍存在一些问题，即实施该欧盟指令是否需要额外的时间和金钱，是否会提高质量，体现在有效性、效率、及时性、公平性和以患者为中心等质量维度上。
