Article(id=1320442670724526448, tenantId=1146029695717560320, journalId=1319373219989389464, issueId=1320442616123081022, articleNumber=null, orderNo=null, doi=10.11847/zgggws1147329, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1741276800000, receivedDateStr=2025-03-07, revisedDate=1754236800000, revisedDateStr=2025-08-04, acceptedDate=1756310400000, acceptedDateStr=2025-08-28, onlineDate=1792747665338, onlineDateStr=2026-10-23, pubDate=1767974400000, pubDateStr=2026-01-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792747665338, onlineIssueDateStr=2026-10-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792747665338, creator=13701087609, updateTime=1792747665338, updator=13701087609, issue=Issue{id=1320442616123081022, tenantId=1146029695717560320, journalId=1319373219989389464, year='2026', volume='42', issue='1', pageStart='1', pageEnd='128', issueExtLink='null', onlineDate='null', pubDate='1767974400000', pubDateStr='2026-01-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792747652321, creator='13701087609', updateTime=1792748136930, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1320444648791851086, tenantId=1146029695717560320, journalId=1319373219989389464, issueId=1320442616123081022, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1320444648791851087, tenantId=1146029695717560320, journalId=1319373219989389464, issueId=1320442616123081022, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=83, endPage=88, ext={EN=ArticleExt(id=1320442671156539761, articleId=1320442670724526448, tenantId=1146029695717560320, journalId=1319373219989389464, language=EN, title=Biosafety status of testing laboratories in Hangzhou from 2018 to 2023, columnId=1320427686514770171, journalTitle=Chinese Journal of Public Health, columnName=Survey and Report, runingTitle=null, highlight=null, articleAbstract=
Objective To analyze the current status of biosafety laboratory management in testing institutions in Hangzhou, Zhejiang province from 2018 to 2023, identify weak points in management, and propose strategies to enhance the laboratory biosafety management.
Methods A retrospective analysis was performed to evaluate the on-site biosafety assessment data from laboratories of the testing institutions in Hangzhou from 2018 to 2023.
Results From 2018 to 2023, a total of 125 institutions were inspected. The biosafety indicator compliance rates varied across different years (χ2 = 27.409, P < 0.001). Among the indicators, labeling usage and management had the lowest compliance rate of 63.20%. In addition, significant differences were also found across years in terms of organizational management, facility and equipment, experimental waste management, and labeling usage and management (χ2 = 24.312, 24.417, 21.098, and 16.614, respectively, all P < 0.05). Furthermore, the distribution of laboratory biosafety assessment scores altered across different years (H = 89.843, P < 0.001).
Conclusions Hangzhou has made continuous progress and demonstrated a high level in the laboratory biosafety management of testing institutions. However, there are still notable deficiencies in areas such as laboratory waste management, the use of labels, and organizational management.
, authors=Fang DONG, Bin CEN, Weiwei HU, Shichuan LIU, Tao LIU, Tianxiao DUAN, Xihui HUANG, Ya LI, authorsList=Fang DONG, Bin CEN, Weiwei HU, Shichuan LIU, Tao LIU, Tianxiao DUAN, Xihui HUANG, Ya LI, authorCompany=null, correspAuthors=Bin CEN, authorNote=null, correspAuthorsNote=
, copyrightStatement=Copyright © 2026 Chinese Journal of Public Health. All rights reserved., copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1320442672016372082, articleId=1320442670724526448, tenantId=1146029695717560320, journalId=1319373219989389464, language=CN, title=2018—2023年杭州市检测实验室生物安全现状, columnId=1320427686770622717, journalTitle=中国公共卫生, columnName=调查报告与分析, runingTitle=null, highlight=null, articleAbstract=
目的 分析2018—2023年浙江省杭州市检测机构生物安全实验室管理现状，识别管理薄弱环节，提出改进策略，以提升实验室生物安全管理水平。
方法 采用回顾性分析方法，对2018—2023年杭州市检测机构实验室生物安全现场评价数据进行分析。
结果 2018—2023年共检查125家单位，各年度间生物安全指标符合率差异有统计学意义（χ2=27.409，P<0.001）。其中，标识使用和管理指标符合率最低，为63.20%。组织管理、设施设备、实验废物管理及标识使用和管理指标在不同年份间差异均有统计学意义（χ2=24.312、24.417、21.098、16.614，均P<0.05）。各年度间实验室生物安全评价得分的分布差异有统计学意义（H=89.843，P<0.001）。
结论 杭州市检测机构实验室生物安全管理近年来持续进步，整体水平较高，但在实验废物管理、标识使用和组织管理等方面仍存在明显不足。
, authors=董芳, 岑斌
*, *, 胡薇薇, 刘诗川, 刘涛, 段恬筱, 黄希汇, 李亚, authorsList=董芳, 岑斌, 胡薇薇, 刘诗川, 刘涛, 段恬筱, 黄希汇, 李亚, authorCompany=null, correspAuthors=岑斌, authorNote=
董芳（1992—），主管技师，硕士，研究方向：病原微生物实验室生物安全管理
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Overview of various testing institutions in Hangzhou (2018–2023)
, figureFileSmall=null, figureFileBig=null, tableContent=
| 年份 | 单位数/家 | 药企 | 食企 | 化妆品 | 医学检验机构 | 医疗器械公司 | 生物技术公司 | 疾控机构 | 食药监 | 出入境 | 采供血 | 质监机构 | 第三方检测 |
|---|
| 2018 | 241 | 49 | 7 | 4 | 28 | 26 | 90 | 15 | 3 | 2 | 2 | 6 | 9 |
| 2019 | 269 | 46 | 12 | 4 | 36 | 40 | 92 | 15 | 4 | 2 | 2 | 6 | 10 |
| 2020 | 326 | 56 | 10 | 3 | 44 | 38 | 125 | 15 | 5 | 2 | 2 | 6 | 20 |
| 2021 | 365 | 62 | 11 | 2 | 47 | 36 | 154 | 15 | 5 | 2 | 2 | 7 | 22 |
| 2022 | 391 | 54 | 12 | 3 | 63 | 46 | 161 | 14 | 6 | 2 | 2 | 3 | 25 |
| 2023 | 420 | 60 | 10 | 3 | 71 | 41 | 181 | 14 | 6 | 2 | 2 | 3 | 27 |
), ArticleFig(id=1320442684016275886, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442670724526448, language=CN, label=表1, caption=
2018—2023年杭州市各类检测机构总体情况
, figureFileSmall=null, figureFileBig=null, tableContent=
| 年份 | 单位数/家 | 药企 | 食企 | 化妆品 | 医学检验机构 | 医疗器械公司 | 生物技术公司 | 疾控机构 | 食药监 | 出入境 | 采供血 | 质监机构 | 第三方检测 |
|---|
| 2018 | 241 | 49 | 7 | 4 | 28 | 26 | 90 | 15 | 3 | 2 | 2 | 6 | 9 |
| 2019 | 269 | 46 | 12 | 4 | 36 | 40 | 92 | 15 | 4 | 2 | 2 | 6 | 10 |
| 2020 | 326 | 56 | 10 | 3 | 44 | 38 | 125 | 15 | 5 | 2 | 2 | 6 | 20 |
| 2021 | 365 | 62 | 11 | 2 | 47 | 36 | 154 | 15 | 5 | 2 | 2 | 7 | 22 |
| 2022 | 391 | 54 | 12 | 3 | 63 | 46 | 161 | 14 | 6 | 2 | 2 | 3 | 25 |
| 2023 | 420 | 60 | 10 | 3 | 71 | 41 | 181 | 14 | 6 | 2 | 2 | 3 | 27 |
), ArticleFig(id=1320442684112744879, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442670724526448, language=EN, label=Tab.2, caption=
Basic information on laboratories in inspected testing institutions in Hangzhou (2018–2023)
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| 年份/年 | 单位数/家 | 备案实验室数/个 | BSL-1实验室数/个 | BSL-2实验室数/个 | 尚未备案或备案不成功实验室数/个 |
|---|
| 2018 | 20 | 18 | 3 | 15 | 2 |
| 2019 | 20 | 42 | 6 | 36 | 7 |
| 2020 | 20 | 18 | 3 | 15 | 10 |
| 2021 | 20 | 24 | 2 | 22 | 3 |
| 2022 | 25 | 47 | 7 | 40 | 0 |
| 2023 | 20 | 33 | 2 | 31 | 0 |
| 合计 | 125 | 182 | 23 | 159 | 22 |
), ArticleFig(id=1320442684196630960, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442670724526448, language=CN, label=表2, caption=
2018—2023年杭州市被抽检检测机构实验室基本情况
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| 年份/年 | 单位数/家 | 备案实验室数/个 | BSL-1实验室数/个 | BSL-2实验室数/个 | 尚未备案或备案不成功实验室数/个 |
|---|
| 2018 | 20 | 18 | 3 | 15 | 2 |
| 2019 | 20 | 42 | 6 | 36 | 7 |
| 2020 | 20 | 18 | 3 | 15 | 10 |
| 2021 | 20 | 24 | 2 | 22 | 3 |
| 2022 | 25 | 47 | 7 | 40 | 0 |
| 2023 | 20 | 33 | 2 | 31 | 0 |
| 合计 | 125 | 182 | 23 | 159 | 22 |
), ArticleFig(id=1320442684267934129, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442670724526448, language=EN, label=Tab.3, caption=
Overall results of biosafety evaluation for testing laboratories (2018–2023)
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| 年份 | 评价指标总数/项 | 符合评价指标数量/项 | 符合率/% |
|---|
| 2018 | 900 | 803 | 89.22 |
| 2019 | 900 | 763 | 84.78 |
| 2020 | 900 | 800 | 88.89 |
| 2021 | 900 | 814 | 90.44 |
| 2022 | 1 125 | 1 027 | 91.29 |
| 2023 | 900 | 817 | 90.78 |
| 合计 | 5625 | 5024 | 89.32 |
), ArticleFig(id=1320442684347625906, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442670724526448, language=CN, label=表3, caption=
2018—2023年检测实验室生物安全评价结果总体情况
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| 年份 | 评价指标总数/项 | 符合评价指标数量/项 | 符合率/% |
|---|
| 2018 | 900 | 803 | 89.22 |
| 2019 | 900 | 763 | 84.78 |
| 2020 | 900 | 800 | 88.89 |
| 2021 | 900 | 814 | 90.44 |
| 2022 | 1 125 | 1 027 | 91.29 |
| 2023 | 900 | 817 | 90.78 |
| 合计 | 5625 | 5024 | 89.32 |
), ArticleFig(id=1320442684414734771, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442670724526448, language=EN, label=Tab.4, caption=
Compliance status of evaluation indicators for laboratory biosafety in testing institutions (2018–2023)
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| 评价指标 | 2018年 | 2019年 | 2020年 | 2021年 | 2022年 | 2023年 | 合计 | χ2值 | P值 |
|---|
| 组织管理 | 300（88.67） | 300（80.33） | 300（88.67） | 300（88.33） | 375（92.53） | 300（88.33） | 1 875（88.00） | 24.312 | <0.001 |
| 设施设备 | 140（87.14） | 140（81.43） | 140（80.00） | 140（86.43） | 175（91.43） | 140（96.43） | 875（87.31） | 24.417 | <0.001 |
| 菌（毒）种和样本管理 | 100（92.00） | 100（92.00） | 100（98.00） | 100（93.00） | 125（96.80） | 100（97.00） | 625（94.88） | 8.020 | 0.155 |
| 实验废物管理 | 40（67.50） | 40（60.00） | 40（90.00） | 40（92.50） | 50（86.00） | 40（80.00） | 250（79.60） | 21.098 | 0.001 |
| 日常管理 | 60（98.33） | 60（98.33） | 60（98.33） | 60（100.00） | 75（92.00） | 60（98.33） | 375（97.33） | 7.297 | 0.099 |
| 标识使用和管理 | 40（72.50） | 40（65.00） | 40（72.50） | 40（77.50） | 50（52.00） | 40（42.50） | 250（63.20） | 16.614 | 0.005 |
| 人员管理 | 140（92.86） | 140（94.29） | 140（88.57） | 140（94.29） | 175（92.57） | 140（96.43） | 875（93.14） | 7.627 | 0.178 |
| 内部审核 | 40（95.00） | 40（87.50） | 40（90.00） | 40（87.50） | 50（98.00） | 40（92.50） | 250（92.00） | 5.367 | 0.373 |
| 管理评审 | 40（100.00） | 40（100.00） | 40（100.00） | 40（100.00） | 50（100.00） | 40（100.00） | 250（100.00） | — | — |
), ArticleFig(id=1320442684494426548, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442670724526448, language=CN, label=表4, caption=
2018—2023年检测机构实验室生物安全各评价项目指标符合情况[项（占比/%）]
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| 评价指标 | 2018年 | 2019年 | 2020年 | 2021年 | 2022年 | 2023年 | 合计 | χ2值 | P值 |
|---|
| 组织管理 | 300（88.67） | 300（80.33） | 300（88.67） | 300（88.33） | 375（92.53） | 300（88.33） | 1 875（88.00） | 24.312 | <0.001 |
| 设施设备 | 140（87.14） | 140（81.43） | 140（80.00） | 140（86.43） | 175（91.43） | 140（96.43） | 875（87.31） | 24.417 | <0.001 |
| 菌（毒）种和样本管理 | 100（92.00） | 100（92.00） | 100（98.00） | 100（93.00） | 125（96.80） | 100（97.00） | 625（94.88） | 8.020 | 0.155 |
| 实验废物管理 | 40（67.50） | 40（60.00） | 40（90.00） | 40（92.50） | 50（86.00） | 40（80.00） | 250（79.60） | 21.098 | 0.001 |
| 日常管理 | 60（98.33） | 60（98.33） | 60（98.33） | 60（100.00） | 75（92.00） | 60（98.33） | 375（97.33） | 7.297 | 0.099 |
| 标识使用和管理 | 40（72.50） | 40（65.00） | 40（72.50） | 40（77.50） | 50（52.00） | 40（42.50） | 250（63.20） | 16.614 | 0.005 |
| 人员管理 | 140（92.86） | 140（94.29） | 140（88.57） | 140（94.29） | 175（92.57） | 140（96.43） | 875（93.14） | 7.627 | 0.178 |
| 内部审核 | 40（95.00） | 40（87.50） | 40（90.00） | 40（87.50） | 50（98.00） | 40（92.50） | 250（92.00） | 5.367 | 0.373 |
| 管理评审 | 40（100.00） | 40（100.00） | 40（100.00） | 40（100.00） | 50（100.00） | 40（100.00） | 250（100.00） | — | — |
), ArticleFig(id=1320442684565729717, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442670724526448, language=EN, label=Tab.5, caption=
Biosafety evaluation results for laboratories of testing institutions in Hangzhou (2018–2023)
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| 风险等级 | 2018年 | 2019年 | 2020年 | 2021年 | 2022年 | 2023年 | 合计 |
|---|
| 低（90～100分） | 11 | 9 | 13 | 19 | 22 | 17 | 91 |
| 较低（80～89分） | 7 | 10 | 6 | 1 | 2 | 3 | 29 |
| 中等（60～79分） | 2 | 1 | 1 | 0 | 1 | 0 | 5 |
| 高（0～59分） | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
), ArticleFig(id=1320442684645421494, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320442670724526448, language=CN, label=表5, caption=
2018—2023年杭州市检测机构实验室生物安全评价结果
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| 风险等级 | 2018年 | 2019年 | 2020年 | 2021年 | 2022年 | 2023年 | 合计 |
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| 低（90～100分） | 11 | 9 | 13 | 19 | 22 | 17 | 91 |
| 较低（80～89分） | 7 | 10 | 6 | 1 | 2 | 3 | 29 |
| 中等（60～79分） | 2 | 1 | 1 | 0 | 1 | 0 | 5 |
| 高（0～59分） | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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