• 中国科学论文统计源期刊
  • 中国科技核心期刊
  • 美国化学文摘(CA)来源期刊
  • 日本科学技术振兴机构数据库(JST)

临床输血与检验 ›› 2026, Vol. 28 ›› Issue (2): 231-237.DOI: 10.3969/j.issn.1671-2587.2026.02.013

• 调查研究 • 上一篇    下一篇

联合内审推进长三角血站同质化发展实践

张兰珺, 章怿, 朱红芹, 丁威, 吴君胜, 邱颖婕   

  1. 上海市血液中心,上海 200051
  • 收稿日期:2025-07-23 接受日期:2025-09-01 出版日期:2026-04-20 发布日期:2026-04-22
  • 通讯作者: 邱颖婕,主要从事质量管理和控制工作,(E-mail)qiuyingjie@sbc.org.cn。
  • 作者简介:张兰珺,主要从事质量管理工作,(E-mail)zhanglanjun@sbc.org.cn。

Development of Quality Homogenization of Blood Banks in Yangtze River Delta Region

ZHANG Lanjun, ZHANG Yi, ZHU Hongqin, DING Wei, WU Junsheng, QIU Yingjie   

  1. Shanghai Blood Center, Shanghai 200051
  • Received:2025-07-23 Accepted:2025-09-01 Online:2026-04-20 Published:2026-04-22

摘要: 目的 缩小血站质量管理的差异化,通过管理机制创新实现长三角血站质量体系的同质化、高质量协同发展,为行业发展提供借鉴。方法 自2021年起,通过“统一培训、统一评审标准、统一评审方法、统一结果判定”的“四统一”模式,对长三角血站进行联合内部审核,并对发现的不合格项进行分类、对比、分析。目前该模式已覆盖4家血液中心和21家中心血站。结果 2021年、2023年和2024年共发现不合格项188项,其中血液中心69项,中心血站119项。根据《血站质量管理规范》等法律法规,这些不合格项主要涉及“安全与卫生”(29项,占15.43%)、“设备”(23项,占12.23%)、“记录”(22项,占11.70%)和“血液检测”(22项,占11.70%)。对不合格原因分类与分析,系统性不合格项23项(占12.23%),执行不合格项48项(占25.53%),有效性不合格项117项(占62.23%)。结论 通过“四统一”模式对长三角血站进行联合内部审核在血站质量同质化中的实施,为完善跨区域血液质量管理模式,探索跨区域公共卫生管理协同路径提供实践范例和参考模式。

关键词: 血站, 联合内审, 同质化, 长三角区域

Abstract: Objective Improving the disparities in quality management of blood banks, achieving homogeneous and high-quality collaborative development of the Yangtze River Delta blood station quality system through management mechanism innovation, and providing references for industry advancement. Methods Since 2021, the "Four Unities" joint internal audit model, which includes "Unified training", "Unified review standards", "Unified audit methods" and "Unified result judgment", has been implemented. This model now covers 4 blood centers and 21 central blood banks, and continuous improvement is achieved by categorizing, comparing, and analyzing terms of nonconformity. Results In 2021, 2023 and 2024, 188 terms of nonconformity were identified: 69 at blood centers and 119 at central blood banks. According to "Quality Management Standards for Blood Banks", these non-conformities mainly involve "Safety and Hygiene" (29 items, 15.43%), "Equipment"(23 items, 12.23%), "Records" (22 items, 11.70%) and "Blood Testing" (22 items, 11.70%). According to the classification and analysis of unqualified reasons, there were 23 items of systematic nonconformity (12.23%), 48 items of implementation nonconformity (25.53%) and 117 items of effectiveness nonconformity (62.23%), which caused by the non-conformity between the operating procedures and the quality manual, the failure to implement the requirements and the existence of differences or incorrect records in the operation. Conclusion The implementation of joint internal audits for blood banks in the Yangtze River Delta region through the "Four Unifications" model in quality homogenization provides practical examples and reference models for improving cross-regional blood quality management systems and exploring collaborative approaches for public health management across regions.

Key words: Blood banks, Joint internal audit, Homogenization, The Yangtze River Delta region

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