原卫生部连续数年组织专家对血站执行“一法两规”及相关技术标准开展技术核查,各省级卫生行政部门亦以此为依据对采供血进行了评审和执业验收,标志着我国的血站质量管理进入了法制化、规范化、体系化的轨道。本文对我国17家血液中心和11家中心血站开展专题调研,就其质量管理工作方面承担的职能、质量管理人员结构比例、体系建立和运行构架、体系监控方法与审核方式、分析效果和持续改进方面开展调研,结合专题调研、部分血站采供血发展报告、知网检索相关文献,针对汇总问题提出相关建议。
<<The ministry of health has organized experts to carry out technical verification to blood stations for performing“One Regulation & Two Requirements”and relevant technical standards for several years.Based on above laws and regulations the health administrative department at the provincial level also reviewed and accepted practice to the blood stations,which marked the quality management of blood stations has moved to the phase of legalization,standardization and systematization.In this paper,the authors carry out special investigation to a part of the blood centers and blood stations in our country,and carry out the investigation on following aspects:the responsibility of quality management it undertakes,the proportion of the quality management personnel structure,the establishment of system and running architecture,system monitoring methods and ways of audit,analysis results and continuous improvement.Combined with project survey,some development report of blood stations and relevant literatures searched on HowNet,the authors put forward related suggestions aiming at summarizing problems.
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