Notice on Further Strengthening Laboratory Biosecurity Oversight and Management in the Normalization of Epidemic Prevention and Control

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各省、自治区、直辖市及新疆生产建设兵团卫生健康委,从事新冠病毒实验活动的各相关机构:

目前新冠肺炎疫情防控已进入常态化,为进一步加强常态化下的实验室生物安全监管,我委拟定了《国家卫生健康委办公厅关于在常态化新冠肺炎疫情防控中的实验室生物安全监督管理的通知(征求意见稿)》(见附件)。 现将材料印发给你们,请认真研究,并将修改意见于2020年6月11日前反馈我委科教司。

Contact Person: Liu Cheng, Liang Bing; Science and Education Division of the National Health Commission

Phone:010-68791377、68791690

Fax:010-68792588

Email: liangbing@nhc.gov.cn

May 11, 2020

Attachments:

Notice of the General Office of the National Health Commission on Further StrengtheningOversight and Management of Laboratory Biosecurity in the Normalization of Epidemic Prevention and Control

To the health commissions of each province, autonomous region, directly-governed municipality, and of the Xinjiang production and construction corps.

随着新冠肺炎疫情防控进入常态化,为扎实推进疫情防控相关工作,进一步加强实验室生物安全监督管理,根据《中华人民共和国传染病防治法》、《病原微生物实验室生物安全管理条例》等法律法规,现就做好实验室生物安全监督管理工作提出如下要求:

1. Strict requirements for Covid-19 experimental activities

根据新冠病毒传播特性、致病性和临床资料,新型冠状病毒(SARS-Cov-2,以下简称新冠病毒)按照第二类病原微生物进行管理。 请各地卫生健康委严格要求各生物安全实验室按照以下防护要求开展相关实验活动:新冠病毒病毒培养、动物感染实验应当在生物安全三级及以上实验室开展;未经培养的感染性材料的操作应当在生物安全二级实验室进行,同时采用生物安全三级实验室的个人防护;灭活材料的操作应当在生物安全二级实验室进行;分子克隆等不含致病性活病毒的其他操作,可以在生物安全一级实验室进行。

II. Complete service guarantees and regular management for biosecurity in nucleic acid testing laboratories

依据《新型冠状病毒实验室生物安全指南》(第二版),新冠病毒核酸检测应当在生物安全二级实验室进行,同时采用生物安全三级实验室的个人防护。 请各地卫生健康委积极主动对接承担新冠病毒核酸检测的生物安全实验室,做好备案管理工作,加强技术指导和主动服务,为提升辖区内新冠病毒核酸检测能力提供有力保障;各地要指导各生物安全实验室规范新冠样本检测操作流程,积极组织开展实验操作技术、个人防护、检测样本处置等方面的培训,提升核酸检测人员生物安全意识,保障检测人员和周围环境安全。

III. Strengthen oversight of high-level biological security laboratories

The provincial-level health commissions should guide all high-level biosecurity laboratories in their jurisdiction to do a good job of biosecurity management, and should carry out related experimental activities within the approved scope in strict accordance with the "Regulations on Biosecurity Management for Pathogenic Microbe Laboratories" and related technical specifications.

IV. Strengthen the management of new coronavirus strains and related samples

Local health commissions should strictly manage relevant strains and samples of the novel coronavirus in accordance with laws and regulations to ensure safety.

1.Transport of strains and related samples. The transportation of novel coronavirus strains and potentially infectious materials shall be managed strictly in accordance with the "Provisions on the Transport of Highly Pathogenic Microorganisms (Viruses) Types or Samples that Could Infect Human Beings". The provincial health commissions should strengthen the oversight and management of units preserving virus strains and related samples, and strictly prevent and put an end to instances of unauthorized transportation. When handling formalities for permits for intra-provincial transport of novel coronavirus strains or vaccines using the novel coronavirus as the source virus between relevant laboratories or units for the preservation of bacteria (virus) species and other laboratories, all provincial health commissions are asked to please promptly provide the science and education division with information such as the items to be transported, the originating unit, the receiving unit, the time of transport, the quantity and use of the transported items, and photocopies of the transport permit and other materials.

2. Preservation and destruction of related strains. As needed for epidemic prevention and control and the requirements of laboratory biosecurity, the provincial health commissions should promptly research. assess, and put forward opinions on the disposal of biological samples from novel coronavirus laboratory testing. Where preservation is truly necessary, institutions with the capacity for preservation shall be designated for as quickly as possible to carry out preservation in accordance with the principle of relative concentration, or designate transport for preservation at the National Bacteria (virus) Species Preservation Center; Where preservation is not necessary, the relevant institutions are to promptly destroy them in accordance with the relevant requirements for medical waste and biological safety.

3. Isolation and Preservation of Viral Strains. The provincial health commissions are asked to please urge all high-level biosecurity laboratories in their jurisdiction to report newly isolated coronavirus strains to the science and education department of our Commission at the first possible moment. 各地要指导各高等级生物安全实验室做好实验数据与毒株管理工作,在分离出新冠病毒毒株后90天内,向国家级菌(毒)种保藏中心申请保藏,完成相关实验活动后及时将新冠病毒毒株送交保藏机构保藏。

V. Strengthen data security management

Local health commissions should strengthen training on data security for relevant personnel, increase security awareness, guide relevant bodies to strengthen the management of information on novel coronavirus strains and samples, and prevent the disclosure of sensitive information such as patients' personal private information.

VI. Strengthen oversight of laboratory biological safety

各省级卫生健康委要切实加强组织领导,提升实验室生物安全监管能力,严格履行属地化监管职责,按照属地化、分级分类的原则开展实验室生物安全监管工作,强化新冠病毒实验活动监督检查,指导辖区内相关机构加强生物安全管理,依法依规开展实验活动,防止实验室泄露或人员感染,确保实验室生物安全万无一失。

Contact Person: Division of Science and Education; Hao Yanzhe, Liu Cheng

Telephone:010-68792224,68791377

General Office of the National Health Commission

May 11, 2020

 

 

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