Article(id=1241676523216884537, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241676522256388920, articleNumber=null, orderNo=null, doi=10.20043/j.cnki.MPM.202408028, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1722528000000, receivedDateStr=2024-08-02, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1773968352369, onlineDateStr=2026-03-20, pubDate=1731168000000, pubDateStr=2024-11-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773968352369, onlineIssueDateStr=2026-03-20, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773968352369, creator=13701087609, updateTime=1773968352369, updator=13701087609, issue=Issue{id=1241676522256388920, tenantId=1146029695717560320, journalId=1227665162245664772, year='2024', volume='51', issue='21', pageStart='3841', pageEnd='4032', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773968352140, creator=13701087609, updateTime=1773968629818, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1241677686985249701, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241676522256388920, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1241677686985249702, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241676522256388920, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=4027, endPage=4032, ext={EN=ArticleExt(id=1241676523619537723, articleId=1241676523216884537, tenantId=1146029695717560320, journalId=1227665162245664772, language=EN, title=Construction of a training system for laboratory operators in biosafety level 2 laboratories, columnId=1240375111455404044, journalTitle=Modern Preventive Medicine, columnName=Talent Development, runingTitle=null, highlight=null, articleAbstract=
Objective

To establish a training system for laboratory operators in Biosafety Level 2 laboratories, aimed at enhancing the knowledge level of personnel, standardizing operational skills, and reducing laboratory accidents.

Methods

The Delphi method was employed to conduct two rounds of consultations with 17 experts in the field of biosafety from Beijing, Shanghai,Xinjiang, Fujian, Anhui, Chongqing, Guangzhou, and Shenzhen to determine the indicator system, while the Analytic Hierarchy Process (AHP) was used to establish the weights of the indicators.

Results

The response rates for the two rounds of questionnaires were 94.44% and 100.00%, respectively, with expert authority coefficients of 0.962 and 0.944. The Kendall's coefficient of concordance (W) was high (all P < 0.01). Ultimately, the training system was defined to include 5 primary indicators, 21 secondary indicators, and 83 tertiary indicators.

Conclusion

This training system is structurally complete and content-rich, demonstrating strong scientific validity and reliability, and can serve as a reference for the training and assessment of laboratory operators in Biosafety Level 2 laboratories.

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目的

构建二级生物安全实验室实验操作人员培训体系,为提升人员知识水平,规范操作技能,降低实验室意外事件提供保障。

方法

采用德尔菲法对分别来自北京、上海、新疆、福建、安徽、重庆、广州、深圳地区的17名生物安全领域专家进行两轮函询,确定指标体系,应用层次分析法确定指标权重。

结果

两轮问卷回收率为94.44%、100.00%,专家权威系数为0.962、0.944,肯德尔协调系数(W)的值较高(均P<0.01),最终确定培训体系包括5个一级指标、21个二级指标、83个三级指标。

结论

该培训体系结构完整、内容全面,有较强的科学性及可靠性,能为二级生物安全实验室实验操作人员培训及考核提供参考依据。

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刘万里,E-mail:
, copyrightStatement=本刊刊出的所有文章不代表中华预防医学会和本刊编委会的观点,除非特别声明。, copyrightOwner=中华预防医学会和四川大学华西公共卫生学院, extLink=null, articleAbsUrl=null, sourceXml=vnbch40p2z487NUUgFX6Dg==, magXml=e+LMhak3ndC2DqsM0trCOA==, pdfUrl=null, pdf=7OdLBsZLrC42Y4oOpUlH8g==, pdfFileSize=580928, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=4PDY0PmjOgeHKRo+5uLfxw==, mapNumber=null, authorCompany=null, fund=null, authors=

张倩倩(1997—),女,硕士在读,研究方向:实验室生物安全

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China Medicine and Pharmacy, 2024, 14(4): 174-178.(In Chinese), articleTitle=Exploration of the management system of low-level biosafety laboratories in China, refAbstract=null)], funds=[Fund(id=1241821867728765743, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241676523216884537, awardId=WJWY-202348, language=CN, fundingSource=新疆维吾尔自治区卫生健康青年医学科技人才专项科研项目(WJWY-202348), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1241821857700184492, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241676523216884537, xref=1., ext=[AuthorCompanyExt(id=1241821857708573100, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241676523216884537, companyId=1241821857700184492, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=School of Public Health, Xinjiang Medical University, Urumqi, Xinjiang 830054, China), AuthorCompanyExt(id=1241821857721156013, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241676523216884537, companyId=1241821857700184492, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.新疆医科大学公共卫生学院,新疆 乌鲁木齐 830054)]), AuthorCompany(id=1241821857851179449, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241676523216884537, xref=2., ext=[AuthorCompanyExt(id=1241821857867956668, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241676523216884537, companyId=1241821857851179449, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.新疆维吾尔自治区疾病预防控制中心实验室管理办公室,新疆 乌鲁木齐 830002)])], figs=[ArticleFig(id=1241821866499834601, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241676523216884537, language=EN, label=Table 1, caption=

Basic information of experts [n=17,n(%)]

, figureFileSmall=null, figureFileBig=null, tableContent=
项目人数
学历
本科1(5.88)
硕士及以上16(94.12)
生物安全领域的工作年限(年)
10~196(35.30)
20~297(41.17)
≥304(23.53)
职称
副高级2(11.76)
高级15(88.24)
是否为研究生导师
6(35.29)
11(64.71)
组织机构
疾控中心5(29.41)
认可中心1(5.88)
实验室1(5.88)
学校2(11.76)
研究所4(23.53)
医院4(23.53)
), ArticleFig(id=1241821866625663728, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241676523216884537, language=CN, label=表1, caption=

专家函询基本情况[n=17,n(%)]

, figureFileSmall=null, figureFileBig=null, tableContent=
项目人数
学历
本科1(5.88)
硕士及以上16(94.12)
生物安全领域的工作年限(年)
10~196(35.30)
20~297(41.17)
≥304(23.53)
职称
副高级2(11.76)
高级15(88.24)
是否为研究生导师
6(35.29)
11(64.71)
组织机构
疾控中心5(29.41)
认可中心1(5.88)
实验室1(5.88)
学校2(11.76)
研究所4(23.53)
医院4(23.53)
), ArticleFig(id=1241821866743104246, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241676523216884537, language=EN, label=Table 2, caption=

Expert authority

, figureFileSmall=null, figureFileBig=null, tableContent=
咨询轮次CaCsCr
第一轮0.9710.9530.962
第二轮0.9290.9590.944
), ArticleFig(id=1241821866852156154, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241676523216884537, language=CN, label=表2, caption=

专家权威程度

, figureFileSmall=null, figureFileBig=null, tableContent=
咨询轮次CaCsCr
第一轮0.9710.9530.962
第二轮0.9290.9590.944
), ArticleFig(id=1241821866982179586, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241676523216884537, language=EN, label=Table 3, caption=

Kendall harmony coefficient of two rounds of expert correspondence (W)

, figureFileSmall=null, figureFileBig=null, tableContent=
咨询轮次指标Wχ2P
第一轮一级指标0.32922.348<0.001
二级指标0.405137.684
三级指标0.383722.784
总体0.382889.750
第二轮一级指标0.32722.264<0.001
二级指标0.499169.583
三级指标0.352490.72
总体0.372683.635
), ArticleFig(id=1241821867137368845, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241676523216884537, language=CN, label=表3, caption=

两轮专家函询的肯德尔和谐系数(W)

, figureFileSmall=null, figureFileBig=null, tableContent=
咨询轮次指标Wχ2P
第一轮一级指标0.32922.348<0.001
二级指标0.405137.684
三级指标0.383722.784
总体0.382889.750
第二轮一级指标0.32722.264<0.001
二级指标0.499169.583
三级指标0.352490.72
总体0.372683.635
), ArticleFig(id=1241821867300946709, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241676523216884537, language=EN, label=Table 4, caption=

Weights of indexes at all levels of the training system for experimental operators in secondary biosafety laboratories

, figureFileSmall=null, figureFileBig=null, tableContent=
指标重要性评分(CV权重组合权重
A1实验室生物安全相关制度体系4.35±0.490.113 30.129 0
B1-1法律法规4.47±0.510.115 00.426 50.055 0
C1-1-1中华人民共和国生物安全法4.82±0.390.081 50.417 00.022 9
C1-1-2中华人民共和国传染病防治法4.35±0.610.139 30.149 80.008 2
C1-1-3病原微生物实验室生物安全管理条例4.65±0.490.106 00.297 90.016 4
C1-1-4医疗废物管理条例4.47±0.510.115 00.135 40.007 4
B1-2部门规章4.41±0.510.115 00.221 60.028 6
C1-2-1人间传染的高致病性病原微生物实验室和实验活动生物安全审批管理办法3.94±0.750.189 80.175 40.005 0
C1-2-2人间传染的病原微生物目录4.82±0.390.081 50.408 20.011 7
C1-2-3可感染人类的高致病性病原微生物菌(毒)种或样本运输管理规定4.35±0.610.139 30.250 40.007 2
C1-2-4医疗卫生机构医疗废物管理办法4.24±0.560.132 50.166 00.004 7
B1-3指南、规范和标准4.76±0.440.091 80.351 80.045 4
C1-3-1 Laboratory Biosafety Manual3.94±0.750.189 80.047 50.002 2
C1-3-2实验室生物安全通用要求4.53±0.620.137 70.243 40.011 1
C1-3-3生物安全实验室建筑技术规范3.88±0.600.154 60.113 90.005 2
C1-3-4病原微生物实验室生物安全通用准则4.47±0.620.139 60.206 90.009 4
C1-3-5生物安全柜4.35±0.700.161 40.094 60.004 3
C1-3-6病原微生物实验室生物安全标识4.29±0.690.159 90.082 90.003 8
C1-3-7医疗废物分类目录4.24±0.660.156 60.077 10.003 5
C1-3-8消毒技术规范4.47±0.510.115 00.133 60.006 1
A2实验室风险管理4.76±0.440.091 80.197 8
B2-1实验室生物安全风险识别4.94±0.240.049 20.333 30.065 9
C2-1-1实验室风险概论4.41±0.510.115 00.131 30.008 7
C2-1-2实验室主要风险类型4.59±0.510.110 50.151 60.010 0
C2-1-3国内外实验室感染的流行病学4.24±0.560.132 50.109 50.007 2
C2-1-4实验室风险识别方法4.59±0.510.110 50.248 70.016 4
C2-1-5风险预警监测和评估4.59±0.510.110 50.358 90.023 7
B2-2实验室生物安全风险评估4.71±0.470.099 80.333 30.065 9
C2-2-1风险评估的概念4.47±0.510.115 00.160 80.010 6
C2-2-2风险评估的实施4.59±0.510.110 50.508 90.033 6
C2-2-3风险评估的持续改进4.47±0.510.115 00.330 30.021 8
B2-3 实验室生物安全风险控制4.76±0.440.091 80.333 30.065 9
C2-3-1风险控制的概念4.47±0.510.115 00.132 40.008 7
C2-3-2风险控制的原则和策略4.41±0.510.115 00.138 60.009 1
C2-3-3风险控制措施的持续改进4.47±0.510.115 00.363 40.024 0
C2-3-4风险评估报告的编制4.47±0.510.115 00.365 70.024 1
A3实验室设施设备4.18±0.640.152 20.099 6
B3-1生物安全实验室分级与设计要求3.82±0.530.138 50.268 20.026 7
C3-1-1生物安全实验室防护水平的分级4.12±0.700.169 20.204 30.005 5
C3-1-2生物安全实验室设计的规划和布局原则3.65±0.610.166 00.425 90.011 4
C3-1-3生物安全实验室建设及环境相关要求3.76±0.560.149 50.369 80.009 9
B3-2生物安全实验室设施3.88±0.700.179 60.235 50.023 5
C3-2-1实验室生物安全防护基本原理和技术措施4.35±0.610.139 30.279 70.006 6
C3-2-2二级生物安全实验室结构与设施要求3.88±0.600.154 60.228 00.005 3
C3-2-3生物安全实验室设施检测3.59±0.710.198 30.234 60.005 5
C3-2-4生物安全实验室设施运行维护与管理3.65±0.700.192 30.257 60.006 0
B3-3生物安全实验室设备4.24±0.750.177 40.496 30.049 4
C3-3-1实验操作常用仪器设备的操作规范4.94±0.240.049 20.176 80.008 7
C3-3-2关键防护设备的操作规范4.94±0.240.049 20.363 70.018 0
C3-3-3消毒灭菌相关设备的操作规范4.82±0.390.081 50.310 20.015 3
C3-3-4校准(验证)与维护4.12±0.700.169 20.149 30.007 4
A4实验室生物安全基础知识及操作规范4.82±0.390.081 50.331 9
B4-1个体防护装备(PPE)4.94±0.240.049 20.136 50.045 3
C4-1-1 PPE的概念及分类4.71±0.470.099 80.122 10.005 5
C4-1-2 PPE的使用目的及选用原则4.82±0.390.081 50.264 40.012 0
C4-1-3PPE的安全检查及穿脱顺序4.94±0.240.049 20.613 60.027 8
B4-2病原微生物实验操作规范5.00±0.000.000 00.204 10.067 7
C4-2-1病原体实验操作的生物安全基本要求4.88±0.330.068 00.228 90.015 5
C4-2-2感染性材料操作规范5.00±0.000.000 00.329 20.022 3
C4-2-3实验结束后清场、消毒规范操作5.00±0.000.000 00.291 70.019 8
C4-2-4内务管理4.65±0.490.106 00.150 20.010 2
B4-3危险化学品基础知识4.47±0.510.115 00.038 50.012 8
C4-3-1危险化学品定义及其危险性的识别4.53±0.510.113 50.134 10.001 7
C4-3-2危险化学品的购买、保存、使用及风险隐患的防控4.35±0.610.139 30.226 40.002 9
C4-3-3危险化学品库房和技防监控室的管理要求4.00±0.500.125 00.097 40.001 2
C4-3-4常见危险化学品的特性及安全操作规范4.65±0.610.130 30.254 70.003 3
C4-3-5不同类型实验室的标识及应配备的灭火、防护、急救设备4.59±0.510.110 50.287 50.003 7
B4-4病原微生物菌(毒)种及样本的使用、保存与管理4.88±0.330.068 00.192 80.064 0
C4-4-1病原微生物菌(毒)种及样本的管理与要求4.65±0.490.106 00.615 40.039 4
C4-4-2病原微生物菌(毒)种及样本的采集4.71±0.470.099 80.384 60.024 6
B4-5感染性物质运输4.59±0.510.110 50.083 20.027 6
C4-5-1感染性物质运输的分类4.53±0.510.113 50.263 20.007 3
C4-5-2感染性物质运输的包装、标记和标签要求4.47±0.620.139 60.439 80.012 1
C4-5-3感染性物质的运输审批及运输流程4.24±0.560.132 50.297 00.008 2
B4-6消毒灭菌4.82±0.390.081 50.177 00.058 8
C4-6-1消毒灭菌的概念、方法和原理4.53±0.510.113 50.117 60.006 9
C4-6-2消毒剂和消毒方式的选用原则4.76±0.440.091 80.219 90.012 9
C4-6-3实验室常用消毒灭菌方法及规范操作4.88±0.330.068 00.366 10.021 5
C4-6-4实验室消毒灭菌效果检测及规范操作4.76±0.560.118 10.296 40.017 4
B4-7实验室废弃物处置4.76±0.440.091 80.167 90.055 7
C4-7-1废弃物的分类4.53±0.510.113 50.141 70.007 9
C4-7-2废弃物处置的概念及原则4.41±0.510.115 00.157 60.008 8
C4-7-3废弃物收集、处置、转运及暂存的规范操作4.88±0.330.068 00.700 80.039 0
A5实验室安全运行与管理4.18±0.640.152 20.241 7
B5-1实验室生物安全管理体系运行和改进4.12±0.600.145 60.192 90.046 6
C5-1-1生物安全管理体系概论4.12±0.490.117 70.087 10.004 1
C5-1-2生物安全管理体系文件及编写4.24±0.560.132 50.196 20.009 1
C5-1-3生物安全管理体系的运行与持续改进4.24±0.560.132 50.203 90.009 5
C5-1-4安全计划的制定与实施4.18±0.530.126 60.190 60.008 9
C5-1-5安全检查方案的起草与实施4.12±0.600.145 60.161 80.007 5
C5-1-6内部审核和管理评审方案的起草与实施3.94±0.430.108 90.160 50.007 5
B5-2实验室备案、审批3.53±0.720.203 10.140 50.034 0
C5-2-1新疆维吾尔自治区病原微生物实验室备案管理办法4.12±0.700.169 20.377 20.012 8
C5-2-2 二级实验室备案流程和要求3.59±0.620.172 10.305 20.010 4
C5-2-3实验室备案的监督管理3.59±0.620.172 10.317 50.010 8
B5-3实验室人员与健康管理4.47±0.620.139 60.214 40.051 8
C5-3-1实验室人员管理的一般要求4.41±0.620.140 10.104 40.005 4
C5-3-2人员培训考核及评价4.24±0.660.156 60.251 10.0130 0
C5-3-3健康监护4.35±0.700.164 40.198 30.010 3
C5-3-4暴露后的处置程序4.88±0.490.099 40.446 30.023 1
B5-4实验室安全保卫3.88±0.700.179 60.129 10.031 2
C5-4-1实验室安全保卫管理制度4.18±0.530.126 60.140 20.004 4
C5-4-2实验室信息安全与人员安全4.35±0.490.113 30.289 90.009 0
C5-4-3实验室安全保卫突发事件的应急预案与现场处置4.65±0.490.106 00.409 10.012 8
C5-4-4反恐怖教育培训4.24±0.560.132 50.160 80.005 0
B5-5应急措施与现场救治4.76±0.560.118 10.323 10.078 1
C5-5-1实验室意外事件、事故的分类及原因4.53±0.510.113 50.109 30.008 5
C5-5-2实验室意外事件、事故案例分析4.41±0.510.115 00.325 20.025 4
C5-5-3实验室生物安全事件的应急处置与现场救治4.82±0.390.081 50.565 50.044 2
), ArticleFig(id=1241821867435164445, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241676523216884537, language=CN, label=表4, caption=

二级生物安全实验室实验操作人员培训体系各级指标权重

, figureFileSmall=null, figureFileBig=null, tableContent=
指标重要性评分(CV权重组合权重
A1实验室生物安全相关制度体系4.35±0.490.113 30.129 0
B1-1法律法规4.47±0.510.115 00.426 50.055 0
C1-1-1中华人民共和国生物安全法4.82±0.390.081 50.417 00.022 9
C1-1-2中华人民共和国传染病防治法4.35±0.610.139 30.149 80.008 2
C1-1-3病原微生物实验室生物安全管理条例4.65±0.490.106 00.297 90.016 4
C1-1-4医疗废物管理条例4.47±0.510.115 00.135 40.007 4
B1-2部门规章4.41±0.510.115 00.221 60.028 6
C1-2-1人间传染的高致病性病原微生物实验室和实验活动生物安全审批管理办法3.94±0.750.189 80.175 40.005 0
C1-2-2人间传染的病原微生物目录4.82±0.390.081 50.408 20.011 7
C1-2-3可感染人类的高致病性病原微生物菌(毒)种或样本运输管理规定4.35±0.610.139 30.250 40.007 2
C1-2-4医疗卫生机构医疗废物管理办法4.24±0.560.132 50.166 00.004 7
B1-3指南、规范和标准4.76±0.440.091 80.351 80.045 4
C1-3-1 Laboratory Biosafety Manual3.94±0.750.189 80.047 50.002 2
C1-3-2实验室生物安全通用要求4.53±0.620.137 70.243 40.011 1
C1-3-3生物安全实验室建筑技术规范3.88±0.600.154 60.113 90.005 2
C1-3-4病原微生物实验室生物安全通用准则4.47±0.620.139 60.206 90.009 4
C1-3-5生物安全柜4.35±0.700.161 40.094 60.004 3
C1-3-6病原微生物实验室生物安全标识4.29±0.690.159 90.082 90.003 8
C1-3-7医疗废物分类目录4.24±0.660.156 60.077 10.003 5
C1-3-8消毒技术规范4.47±0.510.115 00.133 60.006 1
A2实验室风险管理4.76±0.440.091 80.197 8
B2-1实验室生物安全风险识别4.94±0.240.049 20.333 30.065 9
C2-1-1实验室风险概论4.41±0.510.115 00.131 30.008 7
C2-1-2实验室主要风险类型4.59±0.510.110 50.151 60.010 0
C2-1-3国内外实验室感染的流行病学4.24±0.560.132 50.109 50.007 2
C2-1-4实验室风险识别方法4.59±0.510.110 50.248 70.016 4
C2-1-5风险预警监测和评估4.59±0.510.110 50.358 90.023 7
B2-2实验室生物安全风险评估4.71±0.470.099 80.333 30.065 9
C2-2-1风险评估的概念4.47±0.510.115 00.160 80.010 6
C2-2-2风险评估的实施4.59±0.510.110 50.508 90.033 6
C2-2-3风险评估的持续改进4.47±0.510.115 00.330 30.021 8
B2-3 实验室生物安全风险控制4.76±0.440.091 80.333 30.065 9
C2-3-1风险控制的概念4.47±0.510.115 00.132 40.008 7
C2-3-2风险控制的原则和策略4.41±0.510.115 00.138 60.009 1
C2-3-3风险控制措施的持续改进4.47±0.510.115 00.363 40.024 0
C2-3-4风险评估报告的编制4.47±0.510.115 00.365 70.024 1
A3实验室设施设备4.18±0.640.152 20.099 6
B3-1生物安全实验室分级与设计要求3.82±0.530.138 50.268 20.026 7
C3-1-1生物安全实验室防护水平的分级4.12±0.700.169 20.204 30.005 5
C3-1-2生物安全实验室设计的规划和布局原则3.65±0.610.166 00.425 90.011 4
C3-1-3生物安全实验室建设及环境相关要求3.76±0.560.149 50.369 80.009 9
B3-2生物安全实验室设施3.88±0.700.179 60.235 50.023 5
C3-2-1实验室生物安全防护基本原理和技术措施4.35±0.610.139 30.279 70.006 6
C3-2-2二级生物安全实验室结构与设施要求3.88±0.600.154 60.228 00.005 3
C3-2-3生物安全实验室设施检测3.59±0.710.198 30.234 60.005 5
C3-2-4生物安全实验室设施运行维护与管理3.65±0.700.192 30.257 60.006 0
B3-3生物安全实验室设备4.24±0.750.177 40.496 30.049 4
C3-3-1实验操作常用仪器设备的操作规范4.94±0.240.049 20.176 80.008 7
C3-3-2关键防护设备的操作规范4.94±0.240.049 20.363 70.018 0
C3-3-3消毒灭菌相关设备的操作规范4.82±0.390.081 50.310 20.015 3
C3-3-4校准(验证)与维护4.12±0.700.169 20.149 30.007 4
A4实验室生物安全基础知识及操作规范4.82±0.390.081 50.331 9
B4-1个体防护装备(PPE)4.94±0.240.049 20.136 50.045 3
C4-1-1 PPE的概念及分类4.71±0.470.099 80.122 10.005 5
C4-1-2 PPE的使用目的及选用原则4.82±0.390.081 50.264 40.012 0
C4-1-3PPE的安全检查及穿脱顺序4.94±0.240.049 20.613 60.027 8
B4-2病原微生物实验操作规范5.00±0.000.000 00.204 10.067 7
C4-2-1病原体实验操作的生物安全基本要求4.88±0.330.068 00.228 90.015 5
C4-2-2感染性材料操作规范5.00±0.000.000 00.329 20.022 3
C4-2-3实验结束后清场、消毒规范操作5.00±0.000.000 00.291 70.019 8
C4-2-4内务管理4.65±0.490.106 00.150 20.010 2
B4-3危险化学品基础知识4.47±0.510.115 00.038 50.012 8
C4-3-1危险化学品定义及其危险性的识别4.53±0.510.113 50.134 10.001 7
C4-3-2危险化学品的购买、保存、使用及风险隐患的防控4.35±0.610.139 30.226 40.002 9
C4-3-3危险化学品库房和技防监控室的管理要求4.00±0.500.125 00.097 40.001 2
C4-3-4常见危险化学品的特性及安全操作规范4.65±0.610.130 30.254 70.003 3
C4-3-5不同类型实验室的标识及应配备的灭火、防护、急救设备4.59±0.510.110 50.287 50.003 7
B4-4病原微生物菌(毒)种及样本的使用、保存与管理4.88±0.330.068 00.192 80.064 0
C4-4-1病原微生物菌(毒)种及样本的管理与要求4.65±0.490.106 00.615 40.039 4
C4-4-2病原微生物菌(毒)种及样本的采集4.71±0.470.099 80.384 60.024 6
B4-5感染性物质运输4.59±0.510.110 50.083 20.027 6
C4-5-1感染性物质运输的分类4.53±0.510.113 50.263 20.007 3
C4-5-2感染性物质运输的包装、标记和标签要求4.47±0.620.139 60.439 80.012 1
C4-5-3感染性物质的运输审批及运输流程4.24±0.560.132 50.297 00.008 2
B4-6消毒灭菌4.82±0.390.081 50.177 00.058 8
C4-6-1消毒灭菌的概念、方法和原理4.53±0.510.113 50.117 60.006 9
C4-6-2消毒剂和消毒方式的选用原则4.76±0.440.091 80.219 90.012 9
C4-6-3实验室常用消毒灭菌方法及规范操作4.88±0.330.068 00.366 10.021 5
C4-6-4实验室消毒灭菌效果检测及规范操作4.76±0.560.118 10.296 40.017 4
B4-7实验室废弃物处置4.76±0.440.091 80.167 90.055 7
C4-7-1废弃物的分类4.53±0.510.113 50.141 70.007 9
C4-7-2废弃物处置的概念及原则4.41±0.510.115 00.157 60.008 8
C4-7-3废弃物收集、处置、转运及暂存的规范操作4.88±0.330.068 00.700 80.039 0
A5实验室安全运行与管理4.18±0.640.152 20.241 7
B5-1实验室生物安全管理体系运行和改进4.12±0.600.145 60.192 90.046 6
C5-1-1生物安全管理体系概论4.12±0.490.117 70.087 10.004 1
C5-1-2生物安全管理体系文件及编写4.24±0.560.132 50.196 20.009 1
C5-1-3生物安全管理体系的运行与持续改进4.24±0.560.132 50.203 90.009 5
C5-1-4安全计划的制定与实施4.18±0.530.126 60.190 60.008 9
C5-1-5安全检查方案的起草与实施4.12±0.600.145 60.161 80.007 5
C5-1-6内部审核和管理评审方案的起草与实施3.94±0.430.108 90.160 50.007 5
B5-2实验室备案、审批3.53±0.720.203 10.140 50.034 0
C5-2-1新疆维吾尔自治区病原微生物实验室备案管理办法4.12±0.700.169 20.377 20.012 8
C5-2-2 二级实验室备案流程和要求3.59±0.620.172 10.305 20.010 4
C5-2-3实验室备案的监督管理3.59±0.620.172 10.317 50.010 8
B5-3实验室人员与健康管理4.47±0.620.139 60.214 40.051 8
C5-3-1实验室人员管理的一般要求4.41±0.620.140 10.104 40.005 4
C5-3-2人员培训考核及评价4.24±0.660.156 60.251 10.0130 0
C5-3-3健康监护4.35±0.700.164 40.198 30.010 3
C5-3-4暴露后的处置程序4.88±0.490.099 40.446 30.023 1
B5-4实验室安全保卫3.88±0.700.179 60.129 10.031 2
C5-4-1实验室安全保卫管理制度4.18±0.530.126 60.140 20.004 4
C5-4-2实验室信息安全与人员安全4.35±0.490.113 30.289 90.009 0
C5-4-3实验室安全保卫突发事件的应急预案与现场处置4.65±0.490.106 00.409 10.012 8
C5-4-4反恐怖教育培训4.24±0.560.132 50.160 80.005 0
B5-5应急措施与现场救治4.76±0.560.118 10.323 10.078 1
C5-5-1实验室意外事件、事故的分类及原因4.53±0.510.113 50.109 30.008 5
C5-5-2实验室意外事件、事故案例分析4.41±0.510.115 00.325 20.025 4
C5-5-3实验室生物安全事件的应急处置与现场救治4.82±0.390.081 50.565 50.044 2
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二级生物安全实验室实验操作人员培训体系的构建
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张倩倩 1 , 李丽 2 , 赵俊 2 , 刘万里 2
现代预防医学 | 人才培养 2024,51(21): 4027-4032
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现代预防医学 | 人才培养 2024, 51(21): 4027-4032
二级生物安全实验室实验操作人员培训体系的构建
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张倩倩1, 李丽2, 赵俊2, 刘万里2
作者信息
  • 1.新疆医科大学公共卫生学院,新疆 乌鲁木齐 830054
  • 2.新疆维吾尔自治区疾病预防控制中心实验室管理办公室,新疆 乌鲁木齐 830002
  • 张倩倩(1997—),女,硕士在读,研究方向:实验室生物安全

通讯作者:

刘万里,E-mail:
Construction of a training system for laboratory operators in biosafety level 2 laboratories
Qian-qian ZHANG1, Li LI2, Jun ZHAO2, Wan-li LIU2
Affiliations
  • School of Public Health, Xinjiang Medical University, Urumqi, Xinjiang 830054, China
出版时间: 2024-11-10 doi: 10.20043/j.cnki.MPM.202408028
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目的

构建二级生物安全实验室实验操作人员培训体系,为提升人员知识水平,规范操作技能,降低实验室意外事件提供保障。

方法

采用德尔菲法对分别来自北京、上海、新疆、福建、安徽、重庆、广州、深圳地区的17名生物安全领域专家进行两轮函询,确定指标体系,应用层次分析法确定指标权重。

结果

两轮问卷回收率为94.44%、100.00%,专家权威系数为0.962、0.944,肯德尔协调系数(W)的值较高(均P<0.01),最终确定培训体系包括5个一级指标、21个二级指标、83个三级指标。

结论

该培训体系结构完整、内容全面,有较强的科学性及可靠性,能为二级生物安全实验室实验操作人员培训及考核提供参考依据。

二级生物安全实验室  /  实验操作人员  /  培训体系  /  权重  /  德尔菲法
Objective

To establish a training system for laboratory operators in Biosafety Level 2 laboratories, aimed at enhancing the knowledge level of personnel, standardizing operational skills, and reducing laboratory accidents.

Methods

The Delphi method was employed to conduct two rounds of consultations with 17 experts in the field of biosafety from Beijing, Shanghai,Xinjiang, Fujian, Anhui, Chongqing, Guangzhou, and Shenzhen to determine the indicator system, while the Analytic Hierarchy Process (AHP) was used to establish the weights of the indicators.

Results

The response rates for the two rounds of questionnaires were 94.44% and 100.00%, respectively, with expert authority coefficients of 0.962 and 0.944. The Kendall's coefficient of concordance (W) was high (all P < 0.01). Ultimately, the training system was defined to include 5 primary indicators, 21 secondary indicators, and 83 tertiary indicators.

Conclusion

This training system is structurally complete and content-rich, demonstrating strong scientific validity and reliability, and can serve as a reference for the training and assessment of laboratory operators in Biosafety Level 2 laboratories.

Biosafety level 2 laboratory  /  Laboratory operators  /  Training system  /  Weights  /  Delphi method
张倩倩, 李丽, 赵俊, 刘万里. 二级生物安全实验室实验操作人员培训体系的构建. 现代预防医学, 2024 , 51 (21) : 4027 -4032 . DOI: 10.20043/j.cnki.MPM.202408028
Qian-qian ZHANG, Li LI, Jun ZHAO, Wan-li LIU. Construction of a training system for laboratory operators in biosafety level 2 laboratories[J]. Modern Preventive Medicine, 2024 , 51 (21) : 4027 -4032 . DOI: 10.20043/j.cnki.MPM.202408028
当今世界正处于百年未有之大变局,随着全球一体化加快,新发突发传染病的发生和传播已经成为世界常态并有加剧趋势[1]。此外,实验室事故发生、恐怖主义猖獗、生物技术谬用、外来物种入侵等生物安全风险事件频发对国家安全构成巨大威胁[2-3]。2019年新冠疫情的暴发,引起全球200多个国家和地区大面积人群感染,再次将生物安全推向风口浪尖,处于社会转型期的中国必定面临生物安全领域的种种挑战[4]。生物安全作为新兴非传统安全已经对国家提出全新挑战。2020年10月17日第十三届全国人大常委会通过《生物安全法》,2021年4月15日起正式施行,该法明确要求从事生物技术研究、开发与应用活动的单位应制定生物安全培训,病原微生物实验室的设立单位要定期组织开展人员培训。由此可见,生物安全实验室作为研究传染性病原微生物的重要场所,建立健全实验操作人员培训体系,对维护国家安全至关重要。
函询结果精确度与专家数量成正比,超过15人以后,函询结果的精确性影响不大[5]。本研究选取来自北京、上海、新疆、福建、安徽、重庆、广州、深圳地区的17名专家进行函询,男性7(41.18%)人,女性10(58.82%)人。见表1
采用电子邮件进行两轮专家函询。Likert 5级评分法进行重要性赋值,5~1表示很重要到很不重要[6]。专家遴选标准:(1)副高级及以上职称;(2)10年及以上专业经验;(3)研究领域为很熟悉或比较熟悉;(4)知情同意并完成专家函询。专家结合工作经验及判断标准对指标修改。两轮函询筛选指标均按照重要性赋值3.5分,变异系数0.25[7]。第一轮函询后,对指标重要性分析,并结合专家建议,经研究小组讨论后修订,形成第二轮函询问卷。专家意见统一后,结束函询,确定指标体系。
AHP是一种定性与定量、主观与客观相结合的系统化、层次化分析方法[8]。基本原理是将一个结构复杂、决策准则多、不易量化的问题分解为若干层级,每一层包含若干要素,若干层级呈现有序的阶梯结构,采用1~9标度法从高向低对指标的重要性两两对比,从而确定各级指标权重[9]
采用Excel 2020和SPSS 26.0整理分析。专家积极性用问卷有效回收率表示[10]。权威程度用专家权威系数(Cr)表示。意见协调程度用肯德尔和谐系数(Kendall W)表示[11]。用层次分析法确定指标权重。检验水准α=0.05。
专家积极系数是指研究中所筛选的专家对本研究配合程度[12]。第一轮函询问卷发放18份,回收问卷17份,回收率为94.44%;第二轮函询问卷发放17份,回收问卷17份,回收率为100.00%,表明专家积极性高,重视并配合本研究。
专家权威系数(Cr)由判断依据系数(Ca)和熟悉程度系数(Cs)的算数平均值组成[13]。Cr≥0.9,表明专家权威性较高[14]。两轮函询的Cr分别为0.962和0.944,表明专家权威性较高,结果可信度高。见表2
Kendall W表示不同专家意见一致性,取值范围为0~1,值越接近1,专家意见一致性越好[15]。两轮函询后,三级指标的W值分别为0.327、0.499、0.352,总体指标的W值为0.372(均P<0.01),表明专家意见协调程度较高。见表3
两轮函询后确定二级生物安全实验室实验操作人员培训体系,包含一级指标5个、二级指标21个、三级指标83个。一级指标权重分别为0.129 0、0.197 8 、0.099 6、0.331 9、0.241 7,二级指标权重为0.012 8~0.078 1,三级指标权重为0.047 5~0.700 1,一致性比率CR<0.10,表明判断矩阵有可靠一致性。见表4
本研究选取来自8个不同省市的17位专家,高级职称占88.24%,硕士及以上学历占94.12%,生物安全领域的工作时间≥10年,专家的地域性及代表性高。两轮函询问卷回收率≥70%,Cr≥0.9,表明专家积极性及权威性较高。经两轮函询后,各指标重要性平均得分>3.5,变异系数<0.25,一致性比率CR<0.10。本研究具有较高的科学性、可靠性。
一级指标中,实验室生物安全基础知识及操作规范(0.331 9)权重最高,说明专家普遍认为首先注重实验室基础知识及操作规范。李志红[16]对100起典型实验事故分析显示,违反操作规程或误操作引起实验室事故原因占比最多。研究表明,实验室事故的发生通常是人的不安全行为导致。因此,操作人员作为经常接触各种病原微生物的载体,加强基础知识及操作规范培训是保障自身安全的前提条件。二级指标中,应急措施与现场救治(0.078 1)组合权重最高,且与三级指标中组合权重最高的实验室生物安全事件的应急处置与现场救治(0.044 2)为从属关系,表明专家认为应急措施与现场救治在该体系中占重要地位。吴文军等[17]学者在常态化疫情防控下对上海市16家疾控中心调查发现仍存在应急人员现场处置能力不足问题。由此可见,实验室生物安全事件的应急措施与现场救治在实验室安全运行与管理中扮演极为重要的角色,应加强应急措施与现场救治的培训。
近年,二级生物安全实验室大规模建设,实验操作人员剧增,其培训问题受到广泛关注。目前,国家卫生健康委科教司明确要求对二级生物安全实验室人员培训,为响应号召,全国陆续开展培训。经培训发现,我国目前针对其培训内容无统一标准,各个地区的培训内容较大差异。2024年中国医学科学院詹宇[18]关于低等级生物安全实验室管理体系指出我国生物安全培训标准不统一等问题。因此,本研究采用德尔菲法和层次分析法构建二级生物安全实验室实验操作人员培训体系,该体系更加系统、科学地对实验操作人员培训,针对性提升生物安全相关知识水平,以期对促进我国生物安全培训能力的建设起到推动作用,为有效防止生物安全事故奠定基础。
本研究构建二级生物安全实验室实验操作人员培训体系对二级实验室实验操作人员人才培养具有广泛的实用性和适用性,符合我国二级生物安全实验室培训教学现状,反映现阶段培训人员各知识纬度掌握情况。主要表现在以下方面:(1)全面指导二级生物安全实验室实验操作人员规范化培训,本研究构建培训内容系统、统一、全面,可为后续二级生物安全实验室人员培训提供参考依据。(2)根据组合权重,可应用于二级生物安全实验室实验操作人员终结性评价。(3)实验操作人员可以参考培训体系内容及其权重,合理分配知识纬度的掌握情况及努力方向。
  • 新疆维吾尔自治区卫生健康青年医学科技人才专项科研项目(WJWY-202348)
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2024年第51卷第21期
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doi: 10.20043/j.cnki.MPM.202408028
  • 接收时间:2024-08-02
  • 首发时间:2026-03-20
  • 出版时间:2024-11-10
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  • 收稿日期:2024-08-02
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新疆维吾尔自治区卫生健康青年医学科技人才专项科研项目(WJWY-202348)
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    1.新疆医科大学公共卫生学院,新疆 乌鲁木齐 830054
    2.新疆维吾尔自治区疾病预防控制中心实验室管理办公室,新疆 乌鲁木齐 830002

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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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