Berte L M
Quality Systems Consultant, Elmhurst, IL, USA.
Am J Clin Pathol. 1997 Apr;107(4 Suppl 1):S36-42.
The initiation of testing for antibody to HIV in the donor blood supply opened a new era of operational, safety, and legal complications for facilities in which transfusion medicine is practiced. Mounting dissatisfaction with increasing incidents of questionable release of blood forced regulators to take tougher actions. Blood banks were surprised and concerned that their practices could no longer effectively ensure blood safety. Concurrently, US businesses and manufacturers were looking for new answers regarding the question of improved quality in goods and services. The progression from quality control to quality systems is reviewed. In addition, where transfusion medicine is today, and where it has yet to go, as well as the tools available to make the transition, are discussed.
在供血中开展HIV抗体检测，为从事输血医学的机构开启了一个在操作、安全和法律方面出现并发症的新时代。对血液放行问题频发的不满情绪与日俱增，迫使监管机构采取更严厉的行动。血库惊讶并担心其做法已无法有效确保血液安全。与此同时，美国企业和制造商正在寻找有关提高商品和服务质量问题的新答案。本文回顾了从质量控制到质量体系的发展历程。此外，还讨论了输血医学的现状、未来发展方向以及实现转型所需的工具。
