基于PDCA循环模式进行生物样本全过程质量控制应用探讨  

Application of PDCA cycle model in quality control of the entire process of biological sample management

作　　者：苏慧[1] 张宁梅[2] 陈晓芳 常晓宇 孙强[1] 袁明强 伍霞[1] 裴培 孙点剑一 陈小芳[1] 吴先萍 SU Hui;ZHANG Ningmei;CHEN Xiaofang;CHANG Xiaoyu;SUN Qiang;YUAN Mingqiang;WU Xia;PEI Pei;SUN Dianjianyi;CHEN Xiaofang;WU Xianping(Pengzhou Center for Disease Control and Prevention,Pengzhou,Sichuan Province,611930,PRC)

机构地区：[1]四川省彭州市疾病预防控制中心,四川省彭州市611930 [2]四川省疾病预防控制中心,四川省成都市610041 [3]成都医学院公共卫生学院,四川省成都市610500 [4]北京大学公众健康与重大疫情防控战略研究中心,北京市100191 [5]北京大学公共卫生学院/重大疾病流行病学教育部重点实验室(北京大学),北京市100191 [6]四川省卫生健康委员会,四川省成都市610031

出　　处：《中国医院》2024年第10期65-68,共4页Chinese Hospitals

基　　金：国家自然科学基金(82192900,82192901,82192904,81390540,91846303);国家重点研发计划精准医学研究重点专项(2016YFC0900500);香港Kadoorie Charitable基金;英国Wellcome Trust(202922/Z/16/Z,088158/Z/09/Z,104085/Z/14/Z)。

摘　　要：彭州市项目点在中国慢性病前瞻性研究项目调查中,基于PDCA循环模式构建了由国家项目办、省级指导办公室、地区项目办、实验室及现场调查队组成的四级质量控制体体系。该体系构建了以项目实施方案为纲领性文件,地区项目办公室操作手册为管理制度文件,现场调查手册及实验室标准操作手册为作业指导书,原始记录及流转表格为记录文件的四级文件体系,对生物样本采集、登记、分装、储存、运输实施了全过程质量控制。本文所探讨的质量控制方法,最大程度地避免了人员变动、设备设施、环境条件等对生物样本采集、登记、分装、储存、运输的影响,确保在时间跨度长达17年的4次调查中,每次调查收集到的生物样本均能达到质量要求,为类似的调查项目提供一定的科学依据。In the survey of the China Kadoorie Biobank(CKB)project at the Pengzhou project site,a four-level quality control system was established based on the PDCA(Plan-Do-Check-Act)cycle model.This system was composed of the national project office,provincial guidance offices,regional project offices,laboratories,and field investigation teams.The four-level document system consisted of the project implementation plan as the guiding document,the regional project office operations manual as the management system document,the field investigation manual and laboratory standard operating procedures as the work instructions,and original records and transfer forms as record documents.The system implemented comprehensive quality control over the collection,registration,aliquoting,storage,and transportation of biological samples.The quality control methods discussed in this paper effectively minimized the impact of personnel changes,equipment and facilities,and environmental conditions on the collection,registration,aliquoting,storage,and transportation of biological samples.This ensured that the biological samples collected in four surveys spanning 17 years met quality requirements,providing a scientific basis for similar survey projects.

关 键 词：PDCA 生物样本 质量控制 

分 类 号：R197.3[医药卫生—卫生事业管理]