Callery M F, Nevalainen D E, Kirst T M
Blood Center Training Systems, St. Paul, Minnesota.
Transfusion. 1994 Oct;34(10):899-906. doi: 10.1046/j.1537-2995.1994.341095026978.x.
Blood banking has dramatically changed in the past few years. Is the old business hierarchy and medical model for management still workable? How do we want to organize our work today for success in the future? Implementation of quality systems may seem overwhelmingly complex at this time to many blood banking establishments. However, by methodically adhering to the requirements of organization development described in this review, blood centers can achieve goals of quality improvement and TPC. The FDA and the pharmaceuticals and medical device industries have set the direction and provided guidance to blood establishments. The AABB, American Society for Quality Control, the American Society for Training and Development, and numerous other professional organizations can contribute information and materials. The FDA's document on quality assurance and the CFR are the basic texts guiding the approach presented in this paper. The organization's structure and processes may need to be reengineered to meet the requirements of a culture based on quality and process control.
在过去几年中，血液库发生了巨大变化。旧有的业务层级和管理医疗模式是否仍然可行？我们如今应如何组织工作以在未来取得成功？此时，对许多血液库机构而言，实施质量体系似乎极其复杂。然而，通过有条不紊地遵循本综述中所述的组织发展要求，血液中心能够实现质量改进和全面质量管理的目标。美国食品药品监督管理局（FDA）以及制药和医疗设备行业已指明方向并为血液机构提供了指导。美国血库协会（AABB）、美国质量控制协会、美国培训与发展协会以及众多其他专业组织能够提供信息和资料。FDA关于质量保证的文件和《联邦法规汇编》（CFR）是指导本文所阐述方法的基础文本。可能需要对组织的结构和流程进行重新设计，以满足基于质量和过程控制的文化要求。
