Article(id=1321170756243927703, tenantId=1146029695717560320, journalId=1319373219989389464, issueId=1321170720168726830, articleNumber=null, orderNo=null, doi=10.11847/zgggws1147228, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1740499200000, receivedDateStr=2025-02-26, revisedDate=1743609600000, revisedDateStr=2025-04-03, acceptedDate=1747584000000, acceptedDateStr=2025-05-19, onlineDate=1792921254454, onlineDateStr=2026-10-25, pubDate=1754755200000, pubDateStr=2025-08-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792921254454, onlineIssueDateStr=2026-10-25, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792921254454, creator=13701087609, updateTime=1792921254454, updator=13701087609, issue=Issue{id=1321170720168726830, tenantId=1146029695717560320, journalId=1319373219989389464, year='2025', volume='41', issue='8', pageStart='897', pageEnd='1024', issueExtLink='null', onlineDate='null', pubDate='1754755200000', pubDateStr='2025-08-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792921245852, creator='13701087609', updateTime=1792921245852, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=897, endPage=901, ext={EN=ArticleExt(id=1321170756688523928, articleId=1321170756243927703, tenantId=1146029695717560320, journalId=1319373219989389464, language=EN, title=Construction of an evaluation index system for biosafety supervision in pathogenic microbial laboratories, columnId=1321170720936284464, journalTitle=Chinese Journal of Public Health, columnName=Special Report – Enhancing Biosecurity Development, runingTitle=null, highlight=null, articleAbstract=
Objective

To establish a biosafety supervision evaluation index system for pathogenic microorganism laboratories, assess the implementation and effectiveness of laboratory biosafety supervision by municipal/district-level health administrative departments, and provide references for innovating regulatory evaluation methods, identifying weaknesses in administrative management, and optimizing laboratory biosafety supervision.

Methods

After constructing the primary evaluation index system, Delphi qualitative interview were conducted among 20 authoritative experts and scholars engaged in laboratory biosafety to screen the indicators from November 2024 to January 2025. The weights of the selected indicators were calculated using hierarchical analysis.For the two rounds of expert consultation, the response rates were 100% with authority coefficients of 0.940 and 0.913, respectively. The Kendall harmony coefficient for the first round was 0.431, with statistical testing confirming consistency among expert scores (P < 0.01), indicating reliable selected indicators within the system.

Results

The final index system comprised 3 first-level indicators (regulatory system, regulatory process, and regulatory outcome, with weights of 0.547 3, 0.297 8, and 0.155 0, respectively), 9 second-level indicators (with organizational team, institutional development, and funding situation having the highest weights at 0.249 7, 0.186 3, and 0.111 2, respectively), and 30 third-level indicators (with the biosafety expert group having the highest weight at 0.101 2, followed by personnel function coverage and overall safety management system, both weighted at 0.089 9).

Conclusion

This study established an evaluation index system for biosafety supervision in pathogenic microorganism laboratories based on the SPO model, addressing a critical gap in administrative department assessment tools. The developed index system enables comprehensive and accurate evaluation of laboratory biosafety supervision through systematic and operational indicators. When applied across the four key stages of planning, implementation, inspection, and feedback, this system promotes a shift from reactive responses to proactive prevention and control measures, ultimately enhancing laboratory biosafety.

, authors=Wei SHI, Sisi LI, Jing LI, Shuang SHI, Chihong ZHAO, authorsList=Wei SHI, Sisi LI, Jing LI, Shuang SHI, Chihong ZHAO, authorCompany=null, correspAuthors=Chihong ZHAO, authorNote=null, correspAuthorsNote=
ZHAO chihong, E-mail:
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目的

构建病原微生物实验室生物安全监管评价指标体系,评估市(区)级卫生行政主管部门实验室生物安全监管工作开展情况和效果,为创新监管评价方式,发现行政部门管理的薄弱之处、优化实验室生物安全监管提供参考依据。

方法

于2024年11月—2025年1月选取20名从事实验室生物安全工作并具有权威性的专家学者,运用德尔菲法构建并筛选指标体系,通过层次分析法确定指标权重。2轮问卷回收率均为100%,专家权威系数(Cr)分别为0.940和0.913。第1轮函询专家意见协调系数(0.431)表明专家评价结论一致性强,评价结果可信。

结果

最终形成了包含3个一级指标:监管系统(0.547 3)、监管过程(0.297 8)和监管结果(0.155 0),9个二级指标:其中组织队伍(0.249 7)、制度建设(0.186 3)和经费情况(0.111 2)权重最高,30个三级指标:其中生物安全专家组(0.101 2)权重最高、其次是人员职能覆盖度(0.089 9)与安全管理总制度(0.089 9)的评价体系。

结论

本研究基于系统论SPO模型构建了市(区)级卫生行政部门生物安全监管评价指标体系,填补了评价行政部门生物安全监管工作的工具空缺。本指标体系凭借系统、可操作的指标条目,能较为全面、准确地评价实验室生物安全监管工作效果,并应用于规划、实施、检查、反馈四个关键阶段,推动监管从被动响应转向主动防控,进一步保障实验室生物安全。

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施唯(1999—),硕士,研究方向:公共卫生

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赵赤鸿,E-mail:
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Basic information about the experts

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基本特征分组人数构成比/%
性别男1050.00
女1050.00
学历本科525.00
硕士735.00
博士及以上840.00
工作年限/年≤9840.00
10~<19315.00
20~<29735.00
≥30210.00
职称中级职称210.00
副高级职称735.00
高级职称1155.00
单位性质卫生健康委员会630.00
疾病预防控制中心630.00
科研机构840.00
是否为生物安全专家委员会成员是1365.00
否735.00
是否参与生物安全督导工作是1995.00
否15.00
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专家基本情况

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基本特征分组人数构成比/%
性别男1050.00
女1050.00
学历本科525.00
硕士735.00
博士及以上840.00
工作年限/年≤9840.00
10~<19315.00
20~<29735.00
≥30210.00
职称中级职称210.00
副高级职称735.00
高级职称1155.00
单位性质卫生健康委员会630.00
疾病预防控制中心630.00
科研机构840.00
是否为生物安全专家委员会成员是1365.00
否735.00
是否参与生物安全督导工作是1995.00
否15.00
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Evaluation index system for biosafety supervision in pathogenic microbial laboratories

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一级指标均值变异系数二级指标均值变异系数三级指标均值变异系数
A1 结构评价4.900.06B1-1组织队伍4.750.12C1-1-1人员职能覆盖度4.800.09
C1-1-2人力综合素质指数4.100.22
C1-1-3生物安全工作年限3.650.20
C1-1-4生物安全专家组4.150.16
B1-2制度管理4.850.08C1-2-1安全管理总制度4.700.12
C1-2-2备案制度4.500.15
C1-2-3培训制度4.350.17
C1-2-4督导制度4.600.15
B1-3经费管理4.350.20C1-3-1资金边际增长率4.200.20
C1-3-2经费支出分布4.300.20
C1-3-3经费执行率3.900.29
A2 过程评价4.750.09B2-1实验室备案管理4.650.13C2-1-1备案指标完整度4.550.15
C2-1-2备案要求范围4.100.21
C2-1-3平均审批周期4.100.19
B2-2实验室培训考核4.700.12C2-2-1年培训人天数4.000.23
C2-2-2培训内容全面性4.400.19
C2-2-3培训激励手段3.850.19
C2-2-4师资队伍建设情况4.250.19
B2-3实验室督导检查4.850.08C2-3-1督导计划完整性4.650.13
C2-3-2督导内容全面性4.600.13
A3 结果评价4.700.10B3-1主动管理效果4.750.14C3-1-1培训单位覆盖率4.400.17
C3-1-2培训人员覆盖率4.450.20
C3-1-3督导单位覆盖率4.500.20
C3-1-4检查率4.400.16
C3-1-5责令整改率4.350.17
C3-1-6整改复核率4.600.15
B3-2被动反馈效果4.550.15C3-2-1备案单位覆盖率4.450.17
C3-2-2备案率4.500.17
C3-2-3培训合格率4.400.16
C3-2-4培训满意度4.200.21
), ArticleFig(id=1321170761163846335, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1321170756243927703, language=CN, label=表2, caption=

病原微生物实验室生物安全监管评价指标体系

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一级指标均值变异系数二级指标均值变异系数三级指标均值变异系数
A1 结构评价4.900.06B1-1组织队伍4.750.12C1-1-1人员职能覆盖度4.800.09
C1-1-2人力综合素质指数4.100.22
C1-1-3生物安全工作年限3.650.20
C1-1-4生物安全专家组4.150.16
B1-2制度管理4.850.08C1-2-1安全管理总制度4.700.12
C1-2-2备案制度4.500.15
C1-2-3培训制度4.350.17
C1-2-4督导制度4.600.15
B1-3经费管理4.350.20C1-3-1资金边际增长率4.200.20
C1-3-2经费支出分布4.300.20
C1-3-3经费执行率3.900.29
A2 过程评价4.750.09B2-1实验室备案管理4.650.13C2-1-1备案指标完整度4.550.15
C2-1-2备案要求范围4.100.21
C2-1-3平均审批周期4.100.19
B2-2实验室培训考核4.700.12C2-2-1年培训人天数4.000.23
C2-2-2培训内容全面性4.400.19
C2-2-3培训激励手段3.850.19
C2-2-4师资队伍建设情况4.250.19
B2-3实验室督导检查4.850.08C2-3-1督导计划完整性4.650.13
C2-3-2督导内容全面性4.600.13
A3 结果评价4.700.10B3-1主动管理效果4.750.14C3-1-1培训单位覆盖率4.400.17
C3-1-2培训人员覆盖率4.450.20
C3-1-3督导单位覆盖率4.500.20
C3-1-4检查率4.400.16
C3-1-5责令整改率4.350.17
C3-1-6整改复核率4.600.15
B3-2被动反馈效果4.550.15C3-2-1备案单位覆盖率4.450.17
C3-2-2备案率4.500.17
C3-2-3培训合格率4.400.16
C3-2-4培训满意度4.200.21
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Tbl.3 Weight of indicators at each level of the evaluation system for biosafety supervision in pathogenic microbial laboratories

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一级指标一级指标
权重
二级指标二级指标
综合权重
三级指标三级指标
综合权重
A1 监管系统0.547 3B1-1组织队伍0.249 7C1-1-1人员职能覆盖度0.089 9
C1-1-2人力综合素质指数0.058 7
C1-1-3生物安全专家组0.101 2
B1-2制度建设0.186 3C1-2-1安全管理总制度0.089 9
C1-2-2备案制度0.025 8
C1-2-3培训制度0.028 0
C1-2-4督导制度0.019 2
C1-2-5应急制度0.023 4
B1-3经费情况0.111 2C1-3-1资金边际增长率0.082 3
C1-3-2经费支出分布0.028 9
A2 监管过程0.297 8B2-1实验室备案管理0.081 2C2-1-1备案指标完整度0.046 6
C2-1-2备案范围0.024 1
C2-1-3平均备案周期0.010 6
B2-2实验室培训考核0.087 6C2-2-1年培训人数0.010 9
C2-2-2培训内容全面性0.034 6
C2-2-3师资队伍建设0.042 1
B2-3实验室督导检查0.081 7C2-3-1计划完整性0.016 8
C2-3-2内容全面性0.029 3
C2-3-3督导队伍建设0.035 5
B2-4实验室应急管理0.047 2C2-4-1应急报告率0.034 6
C2-4-2应急报告平均时限0.012 6
A3 监管结果0.155 0B3-1主动管理效果0.131 8C3-1-1培训系统覆盖率0.040 2
C3-1-2培训人员覆盖率0.022 9
C3-1-3督导系统覆盖率0.040 0
C3-1-4检查率比值0.010 7
C3-1-5整改复核率0.018 0
B3-2被动反馈效果0.023 1C3-2-1备案系统覆盖率0.007 5
C3-2-2实验室备案率0.007 0
C3-2-3培训合格率0.006 0
C3-2-4培训满意度0.002 7
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病原微生物实验室生物安全监管评价指标体系整体框架及各指标权重

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一级指标一级指标
权重
二级指标二级指标
综合权重
三级指标三级指标
综合权重
A1 监管系统0.547 3B1-1组织队伍0.249 7C1-1-1人员职能覆盖度0.089 9
C1-1-2人力综合素质指数0.058 7
C1-1-3生物安全专家组0.101 2
B1-2制度建设0.186 3C1-2-1安全管理总制度0.089 9
C1-2-2备案制度0.025 8
C1-2-3培训制度0.028 0
C1-2-4督导制度0.019 2
C1-2-5应急制度0.023 4
B1-3经费情况0.111 2C1-3-1资金边际增长率0.082 3
C1-3-2经费支出分布0.028 9
A2 监管过程0.297 8B2-1实验室备案管理0.081 2C2-1-1备案指标完整度0.046 6
C2-1-2备案范围0.024 1
C2-1-3平均备案周期0.010 6
B2-2实验室培训考核0.087 6C2-2-1年培训人数0.010 9
C2-2-2培训内容全面性0.034 6
C2-2-3师资队伍建设0.042 1
B2-3实验室督导检查0.081 7C2-3-1计划完整性0.016 8
C2-3-2内容全面性0.029 3
C2-3-3督导队伍建设0.035 5
B2-4实验室应急管理0.047 2C2-4-1应急报告率0.034 6
C2-4-2应急报告平均时限0.012 6
A3 监管结果0.155 0B3-1主动管理效果0.131 8C3-1-1培训系统覆盖率0.040 2
C3-1-2培训人员覆盖率0.022 9
C3-1-3督导系统覆盖率0.040 0
C3-1-4检查率比值0.010 7
C3-1-5整改复核率0.018 0
B3-2被动反馈效果0.023 1C3-2-1备案系统覆盖率0.007 5
C3-2-2实验室备案率0.007 0
C3-2-3培训合格率0.006 0
C3-2-4培训满意度0.002 7
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病原微生物实验室生物安全监管评价指标体系构建
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施唯 , 李思思 , 李晶 , 石爽 , 赵赤鸿 *, *
中国公共卫生 | 专题报道——加强生物安全建设 2025,41(8): 897-901
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中国公共卫生 |专题报道——加强生物安全建设 2025 , 41 (8) : 897 -901
病原微生物实验室生物安全监管评价指标体系构建
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施唯, 李思思, 李晶, 石爽, 赵赤鸿*, *
作者信息
  • 中国疾病预防控制中心,北京 102206
通讯作者:
赵赤鸿,E-mail:
作者简介:

施唯(1999—),硕士,研究方向:公共卫生

Construction of an evaluation index system for biosafety supervision in pathogenic microbial laboratories
Wei SHI, Sisi LI, Jing LI, Shuang SHI, Chihong ZHAO
Affiliations
  • Chinese Center for Disease Control and Prevention, Beijing 102206, China
  • Corresponding Author:
    ZHAO chihong, E-mail:
出版时间: 2025-08-10 doi: 10.11847/zgggws1147228
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目的

构建病原微生物实验室生物安全监管评价指标体系,评估市(区)级卫生行政主管部门实验室生物安全监管工作开展情况和效果,为创新监管评价方式,发现行政部门管理的薄弱之处、优化实验室生物安全监管提供参考依据。

方法

于2024年11月—2025年1月选取20名从事实验室生物安全工作并具有权威性的专家学者,运用德尔菲法构建并筛选指标体系,通过层次分析法确定指标权重。2轮问卷回收率均为100%,专家权威系数(Cr)分别为0.940和0.913。第1轮函询专家意见协调系数(0.431)表明专家评价结论一致性强,评价结果可信。

结果

最终形成了包含3个一级指标:监管系统(0.547 3)、监管过程(0.297 8)和监管结果(0.155 0),9个二级指标:其中组织队伍(0.249 7)、制度建设(0.186 3)和经费情况(0.111 2)权重最高,30个三级指标:其中生物安全专家组(0.101 2)权重最高、其次是人员职能覆盖度(0.089 9)与安全管理总制度(0.089 9)的评价体系。

结论

本研究基于系统论SPO模型构建了市(区)级卫生行政部门生物安全监管评价指标体系,填补了评价行政部门生物安全监管工作的工具空缺。本指标体系凭借系统、可操作的指标条目,能较为全面、准确地评价实验室生物安全监管工作效果,并应用于规划、实施、检查、反馈四个关键阶段,推动监管从被动响应转向主动防控,进一步保障实验室生物安全。

实验室生物安全监管  /  指标体系  /  卫生行政部门
Objective

To establish a biosafety supervision evaluation index system for pathogenic microorganism laboratories, assess the implementation and effectiveness of laboratory biosafety supervision by municipal/district-level health administrative departments, and provide references for innovating regulatory evaluation methods, identifying weaknesses in administrative management, and optimizing laboratory biosafety supervision.

Methods

After constructing the primary evaluation index system, Delphi qualitative interview were conducted among 20 authoritative experts and scholars engaged in laboratory biosafety to screen the indicators from November 2024 to January 2025. The weights of the selected indicators were calculated using hierarchical analysis.For the two rounds of expert consultation, the response rates were 100% with authority coefficients of 0.940 and 0.913, respectively. The Kendall harmony coefficient for the first round was 0.431, with statistical testing confirming consistency among expert scores (P < 0.01), indicating reliable selected indicators within the system.

Results

The final index system comprised 3 first-level indicators (regulatory system, regulatory process, and regulatory outcome, with weights of 0.547 3, 0.297 8, and 0.155 0, respectively), 9 second-level indicators (with organizational team, institutional development, and funding situation having the highest weights at 0.249 7, 0.186 3, and 0.111 2, respectively), and 30 third-level indicators (with the biosafety expert group having the highest weight at 0.101 2, followed by personnel function coverage and overall safety management system, both weighted at 0.089 9).

Conclusion

This study established an evaluation index system for biosafety supervision in pathogenic microorganism laboratories based on the SPO model, addressing a critical gap in administrative department assessment tools. The developed index system enables comprehensive and accurate evaluation of laboratory biosafety supervision through systematic and operational indicators. When applied across the four key stages of planning, implementation, inspection, and feedback, this system promotes a shift from reactive responses to proactive prevention and control measures, ultimately enhancing laboratory biosafety.

laboratory biosafety supervision  /  index system  /  health administrative department
施唯, 李思思, 李晶, 石爽, 赵赤鸿. 病原微生物实验室生物安全监管评价指标体系构建. 中国公共卫生, 2025 , 41 (8) : 897 -901 . DOI: 10.11847/zgggws1147228
Wei SHI, Sisi LI, Jing LI, Shuang SHI, Chihong ZHAO. Construction of an evaluation index system for biosafety supervision in pathogenic microbial laboratories[J]. Chinese Journal of Public Health, 2025 , 41 (8) : 897 -901 . DOI: 10.11847/zgggws1147228
自2003年SARS暴发以来,生物安全问题已逐步成为国家安全的核心领域、国际博弈的战略要地和全球治理的重大议题。在此期间,我国先后制定并实施了《病原微生物实验室生物安全管理条例》《GB 19489—2008实验室生物安全通用要求》和《中华人民共和国生物安全法》等法律法规及规范性文件,标志着我国在生物安全领域的理论探索与实践应用迈入全新阶段。病原微生物实验室生物安全(以下简称“实验室生物安全”)作为生物安全中的重要组成部分,是实验人员安全防护与环境保护的主要屏障,已成为发现和应对公共卫生威胁时科学研究、疾病监测与防控的重要条件[1]。2020年,新型冠状病毒感染疫情暴发,我国病原微生物实验室的数量表现出井喷式的增长,截止到2023年11月,全国共备案了34 335个一级实验室和58 205个二级实验室[2],为我国病原微生物实验室的建设及监管工作带来了巨大的挑战。目前国内大部分研究集中于实验室自身的生物安全管理活动评价,少见对卫生行政主管部门的生物安全监管工作的评价。省、市、县级卫生行政主管部门的权责不同,市(区)级卫生行政部门起到承上启下的作用,既是政策措施的核心落地管理层,又承担着对基层工作的监督指导作用,是实验室生物安全监管体系中的重要一环。故本研究聚焦于市(区)级卫生行政主管部门,旨在搭建一套科学、合理的指标体系,以评价市(区)级卫生行政部门实验室生物安全监管工作开展情况与效果。
结合本研究初始指标数量和研究所涉范围,筛选来自卫生健康委员会、疾病预防控制中心及科研机构的20名专家,于2024年11月—2025年1月开展2轮问卷函询。被咨询专家均长期从事实验室生物安全工作,有丰富的实验室管理与实践经验。本研究经中国疾病预防控制中心伦理审查委员会审查批准(编号:202449)。
第1轮专家函询采用德尔菲专家咨询法,筛选并修改指标条目,采用Likert五级评分法评分[3],按重要程度从高到低分别赋值为:5、4、3、2、1。专家基于专业判断修改或删减指标条目,若存在未被涵盖的条目,可通过修订栏增补。专家达成共识后,确立评价体系各层级指标。
第2轮专家函询采用层次分析法,将决策相关要素系统拆解为若干层级(如决策层、准则层、措施层等),各层级以递进式结构逐级分布,每个层级由若干关键要素构成。以Saaty T L[4]提出的相对重要性等级表为基础,采用1~9的标度方法两两比较同级指标的重要性,构建若干判断矩阵,通过群决策法集结专家意见,最终确定指标权重系数。
使用SPSS和yaahp整理并分析数据。通过专家积极系数、专家权威系数和专家意见协调程度3个参数评价第1轮问卷函询结果的可靠性。第1轮问卷函询后确定指标条目筛选准则包括:①专家组的修改意见;②重要性赋值评价均数≥4[5],变异系数<0.25,满分频率>20%[6]。运用yaahp软件,集结专家判断矩阵,开展一致性检验,计算权重,最终确定指标权重体系。检验水准α=0.05。
即问卷的回收率[回收率=(回收问卷总数/发放问卷总数)×100%],该指标表现了专家对研究内容的关注度。2轮专家函询中,每轮次均发出20份问卷,经质量管控后回收20份有效问卷,回收率均达100%,专家参与此项研究的积极度高。
常用来量化专家对问题的权威程度,取决于专家做出判断的依据(Ca)和专家对指标的熟悉程度(Cs)两个因素。Cr=(Ca+Cs)/2,一般认为Cr>0.7为专家的权威程度可靠[5]。第1轮专家函询Cr=(Ca+Cs)/2=(0.940+0.940)/2=0.940,第2轮Cr=(Ca+Cs)/2=(0.940+0.885)=0.913,2次函询Cr均>0.7,表明专家权威性可信。
专家意见协调系数(W)反映专家对所有指标评价的一致程度,用以检验专家意见是否达成共识。W取值范围为0~1,其值越大表示一致性程度越高,当P<0.05时,说明专家评价协调性好[7]。第1轮函询指标体系总体W=0.431,在理想标准0.4~0.5范围内,且P<0.01,表明专家评价结论一致性强,评价结果可取。
参与调查的专家中,有10年以上生物安全工作经验的人占60.00%,作为生物安全专家委员会成员且从事生物安全督导工作的专家13人,占65.00%。
根据现行实验室生物安全管理法律规章和标准规范中对市(区)级卫生行政部门生物安全监管工作的要求,结合实际工作情况,经过多次专家论证,基于系统论SPO(structure-process-outcome)模型初步构建了实验室生物安全监管评价指标体系。该指标体系共3个级别,一级指标3个,包括对结构、过程、结果的评价;二级指标8个,涵盖组织队伍、制度管理、经费管理、实验室备案、实验室培训、实验室督导等方面;三级指标30个,将二级指标进一步细化,落实成科学的、全面的、可操作的具体指标。
根据第1轮专家建议,将“A1结构评价”改为“A1监管系统”,“A2过程评价”改为“A2监管过程”,“A3结果评价”改为“A3监管结果”。
根据第1轮专家建议,新增“B2-4实验室应急管理”指标;将“B1-2 制度管理”改成“B1-2 制度建设”,“B1-3 经费管理”改成“B1-3 经费情况”。
按照筛选标准,删除“C1-1-3生物安全工作年限”“C1-3-3经费执行率”“C2-2-3培训激励手段”3个指标;根据专家建议,删除“C3-1-5责令整改率”,新增“C1-2-5应急制度”“C2-3-3督导队伍建设”“C2-4-1应急报告率”“C2-4-2应急报告平均时限”指标,同时调整8个指标的名称,如将“C2-1-2备案要求范围”改为“C2-1-2备案范围”。
利用yaahp软件构建层次分析模型,分为决策层(病原微生物实验室生物安全监管评价)、一级准则层(A1监管系统、A2监管过程、A3监管结果)、二级准则层(B1-1组织队伍、B1-2制度建设、B1-3经费情况、B2-1实验室备案管理、B2-2实验室培训考核、B2-3实验室督导检查、B2-4实验室应急管理、B3-1主动管理效果、B3-2被动反馈效果)、方案层(30个指标)。在验证20位专家各自的判断矩阵的一致性后,使用判断矩阵集结法将专家意见集结在一起,构建群决策判断矩阵,经计算各矩阵的一致性比例(CR)均小于0.1,通过一致性检验,所得到的权重合理。
研究结果的可靠性是指标体系能否用于实践的前提和基础。本研究函询的专家长期从事生物安全及其监管的工作,熟悉市(区)级卫生行政部门生物安全监管职责与工作内容,具有代表性。第1轮函询中专家积极系数和权威系数均较高,总体一致性好。第2轮函询中,20名专家各自的判断矩阵以及构建的群决策判断矩阵一致性比例(CR)均小于0.1,说明专家达成一致,权重计算结果可信,本研究结果具有可靠性。
建立健全生物安全管理系统是生物安全监管的核心与基石[8]。3个一级指标中,A1监管系统(0.547 3)权重显著高于其他层级,A3监管结果(0.155 0)最低,说明专家普遍认为,在实验室生物安全监管中应更关注制度、组织和资源的基础能力建设。由此可见,实验室生物安全监管在进入科学化、规范化管理的新阶段中[9],需要先有健全的体系,才能保障过程和结果[10]。
二级指标中,属于A1监管系统的B1-1组织队伍(0.249 7)、B1-2制度建设(0.186 3)、B1-3经费情况(0.111 2)3项指标权重较高,此外B2-2实验室培训考核(0.087 6)的权重也相对较高,体现出专家一致认为有效的人员培训是预防生物安全事故发生并保障实验室安全高效运行的重要条件[11]。另外,郑君等[12]人调查发现我国在实验室生物安全培训上存在培训内容不全面、缺少实践设计的问题,詹宇等[13]人同样发现,我国低等级实验室缺乏标准化的生物安全培训的问题。由此可见,系统、全面的人员培训是卫生行政部门提高实验室生物安全监管能力的重要环节。
三级指标中与人力资源相关的指标如C1-1-1人员职能覆盖度(0.089 9)、C1-1-2人力综合素质指数(0.058 7)、C1-1-3生物安全专家组(0.101 2)权重较高,说明专家更重视监管方的人员能力,提示卫生行政部门应注重顶层设计,优化组织架构,明确监管人员职责,确保监管系统的高效运行。三级指标中与经费相关的C1-3-1资金边际增长率(0.082 3)的权重较为突出,表明了生物安全监管持续资源投入的重要性。在对省级行政部门生物安全管理能力的调查中,姜孟楠等[14]人也同样建议为实验室生物安全监管配置专项经费。
本研究通过凝聚权威专家共识,构建了科学、可量化的实验室生物安全监管评价指标体系,弥补了评价卫生行政部门方面的空白。实验室生物安全监管评价指标体系,可在规划、实施、检查、反馈四大阶段发挥作用,不断循环优化,从而使生物安全监管工作效果螺旋式上升。规划阶段,本体系可用于卫生行政部门的自我评价,发现自身监管的薄弱环节,从而有效地调整资源配置,解决传统监管中“重检查、轻预防”的问题。在实施阶段,可将指标体系嵌入监管流程,量化监管效果、优化工作流程;检查阶段,使用本体系可评价各卫生行政部门的实验室监管能力,促使各部门在横向对比中找到差距,不断改进监管策略和措施;反馈阶段,卫生行政部门可通过纵向对比不同时间点的能力表现,分析自身的监管能力趋势变化,及时调整工作侧重点。本体系用于市(区)级卫生行政部门实验室生物安全监管工作的评价,以量化、具体、可执行的指标,推动实验室生物安全监管从被动反馈向主动管理转型,为进一步优化实验室生物安全监管提供支持。
本研究通过构建实验室生物安全监管评价指标体系,系统地整合了监管系统、监管过程及监管结果三大维度,为评价市(区)级卫生行政部门监管工作的开展和效果提供了科学依据。该指标体系创新地填补了卫生行政部门生物安全监管量化评价工具的空缺,通过将其嵌入“规划–实施–检查–反馈”循环,助力监管效能的螺旋式提升。本研究仍存在一些局限,指标体系尚未开展实证研究,其信度和效度有待验证。随着相关研究的进一步深入,该指标体系需在实践中进一步完善,以推动我国实验室生物安全监管体系的标准化与精细化发展。

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doi: 10.11847/zgggws1147228
  • 接收时间:2025-02-26
  • 首发时间:2026-10-25
  • 出版时间:2025-08-10
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  • 收稿日期:2025-02-26
  • 修回日期:2025-04-03
  • 录用日期:2025-05-19
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    中国疾病预防控制中心,北京 102206

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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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