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[监管框架与认证流程的更新]

[Update on regulatory framework and certification process].

作者信息

Legrand D

机构信息

EFS Alpes-Méditerranée, Marseille, France.

出版信息

Transfus Clin Biol. 2008 Nov;15(5):193-6. doi: 10.1016/j.tracli.2008.09.017. Epub 2008 Oct 18.

DOI:10.1016/j.tracli.2008.09.017
PMID:18930686
Abstract

Patients receiving blood transfusion must benefit from the same quality of care, no matter where they are treated. In an effort to enhance transfusion safety, regulations applicable to blood depot facilities have been considerably reinforced over the last few years. At the present time, facilities authorized to store and distribute labile blood products are subject to the same principles of good practice as transfusion centers. A series of regulations published in 2007 established the duties and responsibilities of depot facilities according to category (emergency, intermediary or distribution) and set out the conditions for certification.

摘要

接受输血的患者无论在何处接受治疗,都必须受益于同等质量的护理。为提高输血安全性,过去几年里,适用于血库设施的相关规定得到了大幅加强。目前,获准储存和分发易变血液制品的设施须遵循与输血中心相同的良好操作原则。2007年发布的一系列规定明确了不同类别(应急、中转或配送)血库设施的职责,并规定了认证条件。

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