The National Health Commission plans to stipulate that the new coronavirus samples should be stored in a centralized manner by designated institutions
Published:
2020-05-12
Source:
医药网
Author:
According to the website of the National Health and Health Commission, the National Health and Health Commission recently drafted the "Notice on Laboratory Biosafety Supervision and Management in the Normalization of New Coronary Pneumonia Epidemic Prevention and Control (Draft for Comment)". The draft requires that for laboratory-tested biological samples of the new coronavirus that need to be preserved, an institution with preservation conditions should be designated as soon as possible to preserve them in accordance with the principle of relative concentration, or they should be sent to the national bacterial (virus) species preservation center for preservation; , the relevant institutions shall promptly destroy them in accordance with the relevant requirements of medical waste and biosafety.
According to reports, with the normalization of the prevention and control of the new crown pneumonia epidemic, in order to solidly promote the work related to epidemic prevention and control, and further strengthen the supervision and management of laboratory biosafety, in accordance with the "Law of the People's Republic of China on the Prevention and Control of Infectious Diseases", "Pathogenic Microorganism Laboratory Biosafety" Management Regulations and other laws and regulations, the National Health and Health Commission puts forward the following requirements for the supervision and management of laboratory biosafety:
First, strict requirements for new coronavirus experimental activities. According to the transmission characteristics, pathogenicity and clinical data of the new coronavirus, the new coronavirus (SARS-Cov-2, hereinafter referred to as the new coronavirus) is managed according to the second type of pathogenic microorganisms.
Local health and health commissions are requested to strictly require all biosafety laboratories to carry out relevant experimental activities in accordance with the following protection requirements: new coronavirus virus culture and animal infection experiments should be carried out in laboratories with biosafety level 3 and above; operation of uncultured infectious materials It should be carried out in the biosafety second-level laboratory, and the personal protection of the biosafety third-level laboratory should be used; the operation of inactivated materials should be carried out in the biosafety second-level laboratory; other operations such as molecular cloning do not contain pathogenic live viruses , which can be carried out in a biosafety first-class laboratory.
The second is to do a good job in the guarantee and standardized management of biosafety services in nucleic acid testing laboratories. According to the "Biosafety Guidelines for Novel Coronavirus Laboratories" (Second Edition), nucleic acid testing for the new coronavirus should be carried out in a biosafety second-level laboratory, and the personal protection of a biosafety third-level laboratory should be used.
Local health and health commissions are requested to actively connect with biosafety laboratories undertaking new coronavirus nucleic acid testing, do a good job in record management, strengthen technical guidance and active services, and provide strong guarantees for improving the new coronavirus nucleic acid testing capabilities within their jurisdictions; The safety laboratory regulates the operation process of new crown sample testing, and actively organizes and conducts training in experimental operation technology, personal protection, testing sample disposal, etc., to enhance the biological safety awareness of nucleic acid testing personnel, and ensure the safety of testing personnel and the surrounding environment.
The third is to strengthen the supervision of high-level biosafety laboratories. All provincial health committees should guide all high-level biosafety laboratories within their jurisdictions to do a good job in biosafety management, strictly follow the "Regulations on Biosafety Management of Pathogenic Microorganism Laboratories" and the requirements of relevant technical specifications, and conduct relevant experimental activities within the scope of approval. .
Fourth, strengthen the management of new coronavirus strains and related samples. Local health and health commissions must strictly manage the new coronavirus strains and related samples in accordance with laws and regulations to ensure safety.
In terms of transportation of virus strains and related samples, the transportation of new coronavirus strains and potentially infectious materials should be managed in strict accordance with the "Regulations on the Administration of Transportation of Highly Pathogenic Pathogenic Microorganisms (Virus) Species or Samples that Infect Humans". Provincial health and health commissions should strengthen the supervision and management of virus strains and related sample storage units, and strictly prevent and prevent unauthorized transportation. All provincial health and health commissions are requested to handle the intra-provincial transportation of new coronavirus strains or vaccine strains using new coronavirus as the parent virus from relevant laboratories and bacteria (virus) species preservation units at all levels to other laboratories or units. When going through the permit formalities, promptly provide the information such as the items to be transported, the originating unit, the receiving unit, the planned transportation time, the transportation quantity, and the purpose, as well as the copy of the transportation permit certificate and other materials to the Science and Education Department of our commission.
Regarding the preservation and destruction of relevant samples, the provincial health and health committees should timely study and judge and put forward opinions on the disposal of biological samples for laboratory testing of the new coronavirus according to the needs of epidemic prevention and control and relevant requirements of laboratory biosafety. For those that really need to be preserved, an institution with preservation conditions should be designated as soon as possible to preserve them in accordance with the principle of relative concentration, or they should be sent to the national bacteria (virus) species preservation center for preservation; for those that do not need to be preserved, the relevant institutions shall follow the rules of medical waste and biological safety. Relevant requirements for timely destruction.
Regarding the isolation and preservation of virus strains, all provincial health and health commissions are requested to urge all high-level biosafety laboratories within their jurisdiction to report the newly isolated new coronavirus strains to the Science and Education Department of our commission as soon as possible. All localities should guide all high-level biosafety laboratories to manage experimental data and strains. Within 90 days after the isolation of the new coronavirus strain, apply to the National Bacteria (Virus) Species Collection Center for preservation, and promptly after completing relevant experimental activities The new coronavirus strain is sent to the depository for preservation.
Fifth, strengthen data security management. Local health and health commissions should strengthen data security training for relevant personnel, enhance security awareness, and guide relevant institutions to strengthen information management of new coronavirus strains and samples, and prevent the leakage of sensitive information such as patients' personal privacy.
Sixth, strengthen laboratory biosafety supervision. Provincial health and health committees should strengthen organizational leadership, improve laboratory biosafety supervision capabilities, strictly perform localized supervision duties, carry out laboratory biosafety supervision work in accordance with the principles of localization and classification, and strengthen the supervision and inspection of new coronavirus experimental activities. , to guide relevant institutions within the jurisdiction to strengthen biosafety management, carry out experimental activities in accordance with laws and regulations, prevent laboratory leakage or personnel infection, and ensure laboratory biosafety is foolproof.
Related Information
2022-06-30

2022-06-30

2022-06-30
