结核病临床检验实验室生物安全管理指标体系构建  

Construction of a biosafety management indicator system for tuberculosis clinical testing laboratories

作　　者：柳芳超 张迪[1] 弭凤玲[1] 李自慧[2] 黄海荣 潘丽萍[2] 时广利[4] 姜广路 潘军华 Liu Fangchao;Zhang Di;Mi Fengling;Li Zihui;Huang Hairong;Pan Liping;Shi Guangli;Jiang Guanglu;Pan Junhua(Science and Technology Department,Beijing Chest Hospital,Capital Medical University,Beijing 101149,China;Molecular Biology Laboratory,Beijing Chest Hospital,Capital Medical University,Beijing 101149,China;National Clinical Laboratory of Tuberculosis,Beijing Chest Hospital,Capital Medical University,Beijing 101149,China;Laboratory Department,Beijing Chest Hospital,Capital Medical University,Beijing 101149,China)

机构地区：[1]首都医科大学附属北京胸科医院科技处,北京101149 [2]首都医科大学附属北京胸科医院分子生物学实验室,北京101149 [3]首都医科大学附属北京胸科医院/国家结核病临床实验室,北京101149 [4]首都医科大学附属北京胸科医院检验科,北京101149

出　　处：《中国防痨杂志》2025年第5期569-576,共8页Chinese Journal of Antituberculosis

基　　金：首都卫生发展科研专项(首发2022-1G-2162);北京市卫生健康委员会高层次公共卫生技术人才建设项目(学科带头人-03-16)。

摘　　要：目的:构建结核病临床检验实验室生物安全管理指标体系。方法:在课题组前期实验室生物安全管理与检查督导工作经验基础上,通过文献研究集中收集国内实验室生物安全标准,包括《WS 233—2017病原微生物实验室生物安全通用准则》《CNAS—CL05—2009实验室生物安全认可准则》《GB 19489—2008实验室生物安全通用要求》等,经课题组内部讨论初步筛选结核病临床检验实验室生物安全管理候选指标池并搭建体系框架,据此进行两轮外部专家咨询,根据专家对每一个指标的纳入排除情况以及重要性评分,确定指标体系内容,并运用层次分析法计算各个指标的权重系数,形成结核病临床检验实验室生物安全管理三级评价指标体系。结果:第一轮、第二轮分别收集专家咨询表15份和14份,咨询表回收率分别为100.0%、93.3%,第一轮主要针对指标体系结构进行删改,第二轮则进行指标重要性评分,第二轮咨询专家权威系数为0.76,咨询结果可靠。两轮调查各层级指标的协调系数均>0.1,经Kendall’s W一致性检验,除一级指标外,P值均<0.05,专家意见一致性较好。最终形成一套可操作的结核病临床检验实验室生物安全管理指标体系,包含5个一级指标、13个二级指标和44个三级指标。结论:依据科学理论构建了结核病临床检验实验室生物安全管理指标体系,可用于评价结核病临床检验实验室的生物安全管理水平,也可指导实验室通过定期自查提高管理效率,为医疗机构管理者制定管理制度与政策提供科学依据。Objective:To construct a biosafety management indicator system for clinical testing laboratories dealing with tuberculosis.Methods:Based on the research team’s previous experience in laboratory biosafety management and inspection supervision,a literature review was conducted to collect domestic laboratory biosafety standards,including“WS 233—2017 General Guidelines for Biosafety in Pathogen Microorganism Laboratories”,“CNAS—CL05—2009 Laboratory Biosafety Accreditation Criteria”,and“GB 19489—2008 General Requirements for Laboratory Biosafety”.After internal discussions within the research team,a preliminary pool of candidate biosafety management indicators was developed,and a framework for the system was constructed.Two rounds of external expert consultations were conducted based on this framework,with experts determining inclusion/exclusion of each indicator and evaluating their importance rate.Analytic Hierarchy Process(AHP)was used to calculate weight coefficients of each indicator,ultimately forming a three-level evaluation indicator system for biosafety management in tuberculosis clinical testing laboratories.Results:A total of 15 and 14 expert consultation forms were collected in the first and second round,with response rates of 100.0%and 93.3%,respectively.The first round mainly focused on revising the structure of the indicator system,while the second round involved rating importance of indicators.The authority coefficient of experts in the second round was 0.76,indicating high reliability.The coordination coefficients of indicators at all levels in both rounds were greater than 0.1,and the Kendall’s W consistency test showed that,except for the first-level indicators,all P-values were less than 0.05,indicating good consistency among expert opinions.A practical and operational three-level biosafety management indicator system for tuberculosis clinical testing laboratories was finalized,comprising 5 first-level indicators,13 second-level indicators,and 44 third-level indicators.Concl

关 键 词：结核 实验室感染 安全管理 模型 组织管理 

分 类 号：R52[医药卫生—内科学] R194[医药卫生—临床医学]