Laboratory Animal and Comparative Medicine ›› 2024, Vol. 44 ›› Issue (2): 202-208.DOI: 10.12300/j.issn.1674-5817.2023.129
• Facilities and Management for Laboratory Animals • Previous Articles Next Articles
Meitong LIU()(
), Zhang CHEN, Zhaoqiang ZHANG, Di FAN, Zhan HU, Hailing MA(
)
Received:
2023-09-25
Revised:
2024-02-02
Online:
2024-04-25
Published:
2024-05-09
Contact:
Hailing MA
CLC Number:
Meitong LIU, Zhang CHEN, Zhaoqiang ZHANG, Di FAN, Zhan HU, Hailing MA. Investigation on Current Biosafety Management Status in Laboratory Animal Institutions in Hunan Province[J]. Laboratory Animal and Comparative Medicine, 2024, 44(2): 202-208.
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URL: https://www.slarc.org.cn/dwyx/EN/10.12300/j.issn.1674-5817.2023.129
调查内容 Survey contents | 按单位性质分 Classified by types of institutions | 按许可类型分 Classified by types of licenses | 合计 Total (n=40) | ||||
---|---|---|---|---|---|---|---|
生物医药公司 (n=21) | 高校/科研机构 (n=11) | 医院/疾控中心 (n=8) | 仅使用的单位 (n=32) | 仅生产的单位 (n=5) | 既生产又使用的单位(n=3) | ||
制定相关管理文件和标准操作规程(SOP) Establish management documents and standard operating procedures (SOP) | 20 (95.2) | 11 (100.0) | 8 (100.0) | 32 (100.0) | 4 (80.0) | 3 (100.0) | 39 (97.5) |
建立本实验室(单位)实验动物突发事件应急预案 Establish emergency response plans with laboratory animals | 18 (85.7) | 11 (100.0) | 8 (100.0) | 30 (93.8) | 4 (80.0) | 3 (100.0) | 37 (92.5) |
有实验动物生物安全应急演练记录 Laboratory animal biosafety emergency drill records | 7 (33.3) | 5 (45.5) | 3 (37.5) | 12 (37.5) | 1 (20.0) | 2 (66.7) | 15 (37.5) |
有实验室生物安全检查记录 Records of laboratory biosafety inspections | 12 (57.1) | 8 (72.7) | 8 (100.0) | 21 (65.6) | 4 (80.0) | 3 (100.0) | 28 (70.0) |
有实验室生物安全风险评估报告 Laboratory biosafety risk assessment reports | 15 (71.4) | 8 (72.7) | 3 (37.5) | 23 (71.9) | 3 (60.0) | 0 (0.0) | 26 (65.0) |
动物来源正规 Laboratory animals with legitimate sources | 21 (100.0) | 11 (100.0) | 8 (100.0) | 32 (100.0) | 5 (100.0) | 3 (100.0) | 40 (100.0) |
建立实验动物尸体及实验动物废弃物管理处置制度 Establish management and disposal systems for laboratory animal carcasses and wastes | 21 (100.0) | 10 (90.9) | 8 (100.0) | 31 (96.9) | 5 (100.0) | 3 (100.0) | 39 (97.5) |
建立实验动物从业人员的体检健康档案 Establish medical examination and health records for laboratory animal practitioners | 20 (95.2) | 11 (100.0) | 8 (100.0) | 32 (100.0) | 4 (80.0) | 3 (100.0) | 39 (97.5) |
人员定期培训并记录 Personnel training records | 18 (85.7) | 11 (100.0) | 8 (100.0) | 30 (93.8) | 4 (80.0) | 3 (100.0) | 37 (92.5) |
建立环境设施消毒制度 Establish environmental facilities disinfection system | 21 (100.0) | 11 (100.0) | 8 (100.0) | 32 (100.0) | 5 (100.0) | 3 (100.0) | 40 (100.0) |
高压灭菌设备维护计划和维护记录 Maintenance plan and records for high-pressure sterilization equipment | 20 (95.2) | 11 (100.0) | 8 (100.0) | 31 (96.9) | 5 (100.0) | 3 (100.0) | 39(97.5) |
高压灭菌器使用记录 High-pressure sterilization equipment usage records | 21 (100.0) | 11 (100.0) | 8 (100.0) | 32 (100.0) | 5 (100.0) | 3 (100.0) | 40 (100.0) |
有高压灭菌器校准合格证且在有效期内 High-pressure sterilization equipment calibration certificate and within the validity period | 20 (95.2) | 11 (100.0) | 8 (100.0) | 32 (100.0) | 4 (80.0) | 3 (100.0) | 39 (97.5) |
有高压灭菌器灭菌效果监测记录 Sterilization efficiency monitoring records for high-pressure sterilization equipment | 19 (90.4) | 11 (100.0) | 8 (100.0) | 32 (100.0) | 3 (60.0) | 3 (100.0) | 38 (95.0) |
Table 1 Survey results of biosafety management in laboratory animal institutions
调查内容 Survey contents | 按单位性质分 Classified by types of institutions | 按许可类型分 Classified by types of licenses | 合计 Total (n=40) | ||||
---|---|---|---|---|---|---|---|
生物医药公司 (n=21) | 高校/科研机构 (n=11) | 医院/疾控中心 (n=8) | 仅使用的单位 (n=32) | 仅生产的单位 (n=5) | 既生产又使用的单位(n=3) | ||
制定相关管理文件和标准操作规程(SOP) Establish management documents and standard operating procedures (SOP) | 20 (95.2) | 11 (100.0) | 8 (100.0) | 32 (100.0) | 4 (80.0) | 3 (100.0) | 39 (97.5) |
建立本实验室(单位)实验动物突发事件应急预案 Establish emergency response plans with laboratory animals | 18 (85.7) | 11 (100.0) | 8 (100.0) | 30 (93.8) | 4 (80.0) | 3 (100.0) | 37 (92.5) |
有实验动物生物安全应急演练记录 Laboratory animal biosafety emergency drill records | 7 (33.3) | 5 (45.5) | 3 (37.5) | 12 (37.5) | 1 (20.0) | 2 (66.7) | 15 (37.5) |
有实验室生物安全检查记录 Records of laboratory biosafety inspections | 12 (57.1) | 8 (72.7) | 8 (100.0) | 21 (65.6) | 4 (80.0) | 3 (100.0) | 28 (70.0) |
有实验室生物安全风险评估报告 Laboratory biosafety risk assessment reports | 15 (71.4) | 8 (72.7) | 3 (37.5) | 23 (71.9) | 3 (60.0) | 0 (0.0) | 26 (65.0) |
动物来源正规 Laboratory animals with legitimate sources | 21 (100.0) | 11 (100.0) | 8 (100.0) | 32 (100.0) | 5 (100.0) | 3 (100.0) | 40 (100.0) |
建立实验动物尸体及实验动物废弃物管理处置制度 Establish management and disposal systems for laboratory animal carcasses and wastes | 21 (100.0) | 10 (90.9) | 8 (100.0) | 31 (96.9) | 5 (100.0) | 3 (100.0) | 39 (97.5) |
建立实验动物从业人员的体检健康档案 Establish medical examination and health records for laboratory animal practitioners | 20 (95.2) | 11 (100.0) | 8 (100.0) | 32 (100.0) | 4 (80.0) | 3 (100.0) | 39 (97.5) |
人员定期培训并记录 Personnel training records | 18 (85.7) | 11 (100.0) | 8 (100.0) | 30 (93.8) | 4 (80.0) | 3 (100.0) | 37 (92.5) |
建立环境设施消毒制度 Establish environmental facilities disinfection system | 21 (100.0) | 11 (100.0) | 8 (100.0) | 32 (100.0) | 5 (100.0) | 3 (100.0) | 40 (100.0) |
高压灭菌设备维护计划和维护记录 Maintenance plan and records for high-pressure sterilization equipment | 20 (95.2) | 11 (100.0) | 8 (100.0) | 31 (96.9) | 5 (100.0) | 3 (100.0) | 39(97.5) |
高压灭菌器使用记录 High-pressure sterilization equipment usage records | 21 (100.0) | 11 (100.0) | 8 (100.0) | 32 (100.0) | 5 (100.0) | 3 (100.0) | 40 (100.0) |
有高压灭菌器校准合格证且在有效期内 High-pressure sterilization equipment calibration certificate and within the validity period | 20 (95.2) | 11 (100.0) | 8 (100.0) | 32 (100.0) | 4 (80.0) | 3 (100.0) | 39 (97.5) |
有高压灭菌器灭菌效果监测记录 Sterilization efficiency monitoring records for high-pressure sterilization equipment | 19 (90.4) | 11 (100.0) | 8 (100.0) | 32 (100.0) | 3 (60.0) | 3 (100.0) | 38 (95.0) |
调查内容 Survey contents | 非常了解 Know very well | 一般了解 Know well | 完全不了解 Do not know |
---|---|---|---|
是否知晓国家/湖南省实验动物相关法律法规及行业标准? Are you familiar with national/Hunan laws and regulations on laboratory animals and industry standards? | 15 (30.0) | 33 (66.0) | 2 (4.0) |
是否了解实验动物常见的人兽共患病? Are you familiar with common zoonoses in laboratory animals? | 17 (34.0) | 31 (62.0) | 2 (4.0) |
是否了解实验动物气溶胶的产生及危害? Are you familiar with the production of aerosols and their hazards in laboratory animals? | 18 (36.0) | 26 (52.0) | 6 (12.0) |
是否了解本单位实验动物应急预案或处置程序? Are you familiar with the emergency plan or procedures for handling laboratory animals in your institution? | 27 (54.0) | 21 (42.0) | 2 (4.0) |
如被实验动物抓伤或咬伤,是否知晓如何处理? Do you know what to do if you are scratched or bitten by a laboratory animal? | 39 (78.0) | 10 (20.0) | 1 (2.0) |
如发生医疗废弃物意外流失/泄露/扩散,是否知晓如何处理? Do you know how to deal with the accidental spill/leakage/diffusion of medical waste? | 25 (50.0) | 17 (34.0) | 8 (16.0) |
是否知晓防控病媒生物进入实验动物设施的处理方式? Are you familiar with the management of vector control in laboratory animal facilities? | 28 (56.0) | 17 (34.0) | 5 (10.0) |
如发生实验动物逃逸,是否知晓如何处理? Do you know what to do if animals escape from the laboratory? | 25 (50.0) | 20 (40.0) | 5 (10.0) |
如发生实验动物未知原因大量死亡,是否知晓如何处理? Do you know what to do if a large number of laboratory animals die from unknown causes? | 25 (50.0) | 20 (40.0) | 5 (10.0) |
Table 2 Survey results on biosafety awareness among laboratory animal practitioners
调查内容 Survey contents | 非常了解 Know very well | 一般了解 Know well | 完全不了解 Do not know |
---|---|---|---|
是否知晓国家/湖南省实验动物相关法律法规及行业标准? Are you familiar with national/Hunan laws and regulations on laboratory animals and industry standards? | 15 (30.0) | 33 (66.0) | 2 (4.0) |
是否了解实验动物常见的人兽共患病? Are you familiar with common zoonoses in laboratory animals? | 17 (34.0) | 31 (62.0) | 2 (4.0) |
是否了解实验动物气溶胶的产生及危害? Are you familiar with the production of aerosols and their hazards in laboratory animals? | 18 (36.0) | 26 (52.0) | 6 (12.0) |
是否了解本单位实验动物应急预案或处置程序? Are you familiar with the emergency plan or procedures for handling laboratory animals in your institution? | 27 (54.0) | 21 (42.0) | 2 (4.0) |
如被实验动物抓伤或咬伤,是否知晓如何处理? Do you know what to do if you are scratched or bitten by a laboratory animal? | 39 (78.0) | 10 (20.0) | 1 (2.0) |
如发生医疗废弃物意外流失/泄露/扩散,是否知晓如何处理? Do you know how to deal with the accidental spill/leakage/diffusion of medical waste? | 25 (50.0) | 17 (34.0) | 8 (16.0) |
是否知晓防控病媒生物进入实验动物设施的处理方式? Are you familiar with the management of vector control in laboratory animal facilities? | 28 (56.0) | 17 (34.0) | 5 (10.0) |
如发生实验动物逃逸,是否知晓如何处理? Do you know what to do if animals escape from the laboratory? | 25 (50.0) | 20 (40.0) | 5 (10.0) |
如发生实验动物未知原因大量死亡,是否知晓如何处理? Do you know what to do if a large number of laboratory animals die from unknown causes? | 25 (50.0) | 20 (40.0) | 5 (10.0) |
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