临床样本库质量建设机制分析

Analysis on clinical Bio-Bank quality construction mechanism

目的借助全面质量管理理论，分析临床样本库的全面质量管理含义、基本特征、基本原则和管理机制，为临床样本库的质量建设提供理论依据。方法采用理论研究和文献研究方法，对临床样本库的全面质量管理内容进行定性分析，提出临床样本库的全面质量管理理论框架。结果从理论层面对生物样本全面质量管理的内涵、概念及基本特征等进行了探究和界定；在应用层面提出了应用原则与基本操作方法。结论把全面质量管理应用到临床样本库建设管理中，其科学独特的管理内涵能够有效优化样本库管理制度和样本标准化操作流程的PDCA循环，对提高临床生物样本的质量至关重要。

Objective Based on Total Quality Management （TQM） theory, our study aims to analyze the clinical Bio-Bank overall quality management implications, basic characteristics, principles, and management mechanisms, and provide theoretical basis for the clinical Bio-Bank quality construction. Methods Using theoretical and literature research methods, Bio-Bank overall quality management qualitative analysis was conducted, putting forward a framework of Bio-Bank comprehensive quality management. Results Biological sample overall quality management was defined theoretically including its connotation, concepts and basic characteristics. We also put forward an application principle and basic operation method at the application level. Conclusions Total Quality Management （TQM） is applied to the clinical Bio-Bank construction, from where, the scientific and unique management content can effectively optimize the Bio-Bank management regulation and standardization of the sample operation procesical Bio Bank; Qualitys in the PDCA cycle, which is critical to improve the quality of clinical Bio-Bank.