湖北省医疗卫生机构生物安全实验室管理现状与对策

Current situation and countermeasure of biosafety laboratories management in medical and Health Institutions in Hubei Province

目的了解湖北省医疗卫生机构生物安全实验室管理现状,为提升生物安全实验室规范管理能力提供科学依据。方法全省各辖区选取657家医疗卫生机构的生物安全实验室进行辖区内监督检查,从中抽取48家进行省级现场抽查。对结果进行统计,分析生物安全实验室管理现状及存在的主要问题。结果各辖区实验室生物安全管理制度、组织结构、人员培训、设施设备配备符合率达95.00%以上,菌(毒)种及样本管理符合率仅68.95%。省级抽查显示高压灭菌器和生物安全柜定期检测符合率分别为62.50%和47.92%。实验活动准入、意外事故处置与演练、风险评估制度的实施符合率为72.92%。生物安全管理文件的更新、人员定期评价和技术档案建立、菌(毒)种及样本管理等制度的实施符合率分别为64.58%、62.50%和54.17%。结论各辖区监督检查与省级抽查结果基本一致。建议属地化管理关注生物安全制度的执行情况,加强对高压灭菌器和生物安全柜定期检测、实验活动准入、风险评估、意外事故处置与演练,尤其是菌(毒)种及样本管理工作的技术指导与监管力度。

Objective To understand the management status of biosafety laboratories in medical and health institutions in Hubei Province, and provide scientific evidence for improving the standard management capabilities of biosafety laboratories. Methods 657 bio-safety laboratories of medical and health institutions were selected for supervision and inspection within their jurisdictions, and 48 of them were selected for on-site spot checks at the provincial level. The results were statistically processed to analyze the current status of biosafety laboratory management and the main problems. Results The compliance rates of laboratory biosafety management system, organization structure, personnel training, facilities and equipment were all higher than 95.00%, but the compliance rate of bacteria （toxic） species and sample management was only 68.95%. Provincial inspections showed that the compliance rates of autoclaves and biosafety cabinets were 62. 50% and 47.92% , respectively. The compliance rate of the implementation of experimental activity-access, accident disposal and drills, and risk assessment system were 72. 92%. The implementation rates of biosafety management document update, personnel regular evaluation and technical file establishment, management of bacteria （toxic） species and sample were 64. 58% , 62. 50% and 54. 17% , respectively. Conclusions The supervision and inspection of each jurisdiction were basically consistent with the results of provincial random inspections. It is suggested that the localization management should pay more attention to the implementation of the biosafety system. Technical guidance and supervision for the regular inspection of autoclaves, biological safety cabinets, access to experimental activities, risk assessment, and accident disposal and drills should be strengthened, especially for bacterial （toxic） species and sample management.