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卫计委:严禁采集未成年人、孕产妇等特殊人群血浆

2016-12-17 04:16:47   

京华时报讯(记者马金凤)为保障用血安全,国家卫生计生委发布《关于促进单采血浆站健康发展的意见》(以下简称《意见》),提出严禁采集未成年人等特殊人群血浆。此外,2019年底实现单采血浆站核酸检测全覆盖。

《意见》要求,维护供血浆者健康权益,依法依规做好供血浆者健康征询、体格检查和健康保障等工作。各单采血浆站要按照《单采血浆站管理办法》《单采血浆站技术操作规程》等规章规程提出,严禁采集未成年人、孕产妇、月经期妇女以及体弱多病等特殊人群血浆。

此外,《意见》还要求,保障原料血浆质量安全,加强实验室建设和管理,保障原料血浆质量安全。血液制品生产企业依法开展核酸检测试点工作,到2019年实现核酸检测全覆盖。

据了解,之所以要求核酸检测全覆盖是因为,核酸是最基本的遗传物质,广泛存在于所有动物、植物细胞、微生物内,决定着生物的类型和遗传信息。血液核酸检测能检测出血液中特定的病毒核酸,从而确定血液中是否含有病毒。同时,核酸检测可缩短病毒检测“窗口期”,是进一步提高我国临床用血安全水平、降低经输血传播疾病风险的重要举措。

>>释疑

原料血浆是单采血浆站采集的专用于血液制品生产原料的血浆,直接关系血液制品质量安全和人民群众健康权益。2015年底全国共有201家单采血浆站,分别为28家血液制品生产企业提供原料血浆。“十二五”期间,全国采集原料血浆由2011年的3800余吨增长到2015年的近6000吨,生产人血白蛋白、静注人免疫球蛋白、人凝血因子Ⅷ、人凝血酶原复合物均有较大幅度增长,血液制品临床供需矛盾逐步得到缓解。

单采血浆站是采集并向血液制品生产企业提供原料血浆的单位,由血液制品生产企业设置。目前,我国血液制品行业存在产业集中化程度低、生产规模小、技术研发能力弱、生产效率低,部分血液制品生产企业对单采血浆站投入不足和管理不到位,单采血浆站采供浆能力有待进一步提升。

责任编辑:高宗影 CN060
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