| 临床输血质量管理体系的建立 |
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| 引用本文： | 朱培元,栾建凤,叶东,严京梅,周同彬,雷千红,姚根宏.临床输血质量管理体系的建立[J].医学研究生学报,2008,21(7). |
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| 作者姓名： | 朱培元 栾建凤 叶东 严京梅 周同彬 雷千红 姚根宏 |
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| 作者单位： | 南京军区南京总医院输血科,江苏南京,210002 |
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| 基金项目： | 南京军区医学科技创新重点资助项目
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南京军区"十一五"计划课题资助项目 |
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| 摘 要： | 为确保血液和血液成分的安全和合理使用,必须加强临床输血的质量管理。根据ISO9001:2000标准,文中建立了有效的临床输血质量管理体系,其关键控制点涵盖了人员、设备、试剂、环境、血液储存、运输与发放、输血不良反应和计算机管理系统等。编写的质量管理体系文件包括质量手册、程序文件、标准操作规程和质量记录,所有有效文件必须经授权和受控。
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| 关 键 词： | 质量管理体系 临床输血 |
Establishment of quality management system in clinical blood transfusion |
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| ZHU Pei-yuan,LUAN Jian-feng,YE Dong,YAN Jing-mei,ZHOU Tong-bin,LEI Qian-hong,YAO Gen-hong.Establishment of quality management system in clinical blood transfusion[J].Bulletin of Medical Postgraduate,2008,21(7). |
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| Authors: | ZHU Pei-yuan LUAN Jian-feng YE Dong YAN Jing-mei ZHOU Tong-bin LEI Qian-hong YAO Gen-hong |
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| Abstract: | In order to ensure the safe and appropriate use of blood and its components,the quality management in clinical blood transfusion should be strengthened.An effective quality management system(QMS) in clinical blood transfusion was established according to ISO 9001:2000 standards in our department.The key control points of the system included personnel,equipment,reagent,environment,storage,transport and blood distribution,adverse reactions and computer management.QMS documentations on quality manual,documented procedures,standard operating procedures(SOP) and quality records were individually developed.All effective documentations were authorized and monitored. |
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| Keywords: | Quality management system Clinical blood transfusion |
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