强化实验室认证管理项目对结核病实验室质量管理的效果评价  

An operational research of enhancing tuberculosis laboratory quality management by implement the Strengthening Laboratory Management Toward Accreditation(SLMTA)project

作　　者：郑扬[1] 夏辉[1] 欧喜超[1] 宋媛媛[1] 赵雁林[1] Zheng Yang;Xia Hui;Ou Xichao;Song Yuanyuan;Zhao Yanlin(National Center for Tuberculosis Prevention and Control,Chinese Center for Disease Control and Prevention,Beijing 102206,China)

机构地区：[1]中国疾病预防控制中心结核病预防控制中心,北京102206

出　　处：《中国防痨杂志》2023年第10期967-973,共7页Chinese Journal of Antituberculosis

基　　金：中美新发与再发传染病合作项目(SLMTA/TB SLIPTA)子项目。

摘　　要：目的:评价强化实验室认证管理(strengthening laboratory management toward accreditation,SLMTA)项目干预措施对结核病实验室质量管理的效果。方法:根据选点要求和自愿申报原则选择保山市、南京市和成都市3家医疗机构的结核病实验室为项目实施单位(随机编号为1、2、3号),对项目实验室实施了包括培训、定期沟通、改进措施有效性验证等干预措施,然后在不同阶段(基线、中期和终末期)使用标准化清单对项目实验室进行实验室质量管理的12个质量体系要素的现场评估,并对评价结果进行差异性分析。结果:基线评估时,实验室1、2、3的平均得分率为(43.17±2.48)%,评级均为0星。中期评估时,3家项目实验室的平均得分率为(70.19±4.16)%,实验室1和3达到2星,实验室2达到3星。终末期评估时,3家项目实验室的平均得分率为(87.88±1.37)%,均达到4星级别,3家项目实验室在3个不同时间段的平均得分率差异有统计学意义(F=165.700,P<0.001)。比较12个质量体系要素在基线评估和终末评估时的得分率,发现文件和记录、组织机构和人员、设备、过程控制和内部/外部质量评估、信息管理、内部评审、问题/事件处理和流程改进、纠正措施等8项质量体系要素的平均得分率分别由基线的(46.43±0.00)%、(42.42±5.67)%、(43.31±8.07)%、(52.09±3.90)%、(71.35±5.42)%、(2.22±3.14)%、(25.00±13.61)%和(21.05±15.49)%升高至终末期评估的(83.33±1.68)%、(87.88±11.34)%、(93.66±0.40)%、(88.55±2.95)%、(89.81±0.48)%、(91.11±12.57)%、(88.89±10.39)%和(78.95±0.00)%,差异均有统计学意义(t=31.010,P=0.001;t=10.010,P=0.010;t=9.108,P=0.012;t=9.709,P=0.010;t=4.559,P=0.045;t=11.090,P=0.008;t=4.600,P=0.044;t=5.284,P=0.034)。结论:SLMTA项目的实施有助于提高结核病实验室质量管理,提示可以在全国更广泛地实施项目中的各项干预措施。Objective:To assess the impact of the Strengthening Laboratory Accreditation Administration(SLMTA)program interventions on strengthening quality management in tuberculosis laboratories.Methods:Three laboratories(randomly numbered 1,2,and 3)in Baoshan,Nanjing,and Chengdu were selected as pilot laboratories according to the selection criteria and voluntary declaration principle.Intervention measures,including training,communication,improvement actions,etc.,were implemented in three pilot laboratories(baseline,intermediate,and terminal phases),followed by field assessment using standardized checklists at different phases.The differences in assessment results were analyzed by 12 quality system element.Results:At baseline assessment,the average score rate of three laboratories was(43.17±2.48)%,with 0 star for each laboratory.In the mid-term assessment,the average score rate of the three laboratories was(70.19±4.16)%,with laboratories 1 and 3 achieving 2 stars and laboratory 2 achieving 3 stars.At the final assessment,the average score rate of the three laboratories was(87.88±1.37)%,and all achieved 4 stars.The average scoring rate of the three project laboratories showed significant differences between different project phases(F=165.700,P<0.001).Among the 12 quality system elements,the average score rates of“Documentation and Records”“Organization and Personnel”“Equipment”“Process Control and Internal/External Quality Assessment”“Information Management”“Internal Review”“Management Review”“Internal Review”“Occurrence/Incident Management&Process Improvement”and“Corrective Actions”showed significant difference between baseline and final assessment,increasing from(46.43±0.00)%,(42.42±5.67)%,(43.31±8.07)%,(52.09±3.90)%,(71.35±5.42)%,(2.22±3.14)%,(25.00±13.61)%and(21.05±15.49)%at base line assessment to(83.33±1.68)%,(87.88±11.34)%,(93.66±0.40)%,(88.55±2.95)%,(89.81±0.48)%,(91.11±12.57)%,(88.89±10.39)%and(78.95±0.00)%at final assessment,respecively(t=31.010,P=0.001;t

关 键 词：结核 实验室 医院 管理质量小组 质量控制 评价研究 

分 类 号：R52[医药卫生—内科学] Q-338[医药卫生—临床医学]