The State Council responds to the novel coronavirus pneumonia epidemic
Joint Prevention and Control Mechanism on Issuing to Further Advance the New Coronavirus
Notice of the work plan for nucleic acid testing capacity building
State Council Invention Electricity (2020) No. 22
The people's governments of all provinces, autonomous regions, and municipalities directly under the Central Government, all ministries and commissions of the State Council, and all directly affiliated institutions:
In order to implement the relevant decisions and deployments of the Party Central Committee and the State Council, and do a good job in the detection of new coronavirus nucleic acid, the "Working Plan for Further Promoting the Construction of New Coronavirus Nucleic Acid Detection Capacity" is hereby issued to you. Please implement it carefully according to the actual situation.
State Council responds to pneumonia caused by new coronavirus
Joint Epidemic Prevention and Control Mechanism
August 27, 2020
Further advance the work plan for the construction of new coronavirus nucleic acid detection capacity
The Party Central Committee and the State Council have repeatedly made arrangements to improve the nucleic acid detection capabilities of the new coronavirus.
In order to implement the requirements of the executive meeting of the State Council and the special meeting of the State Council's joint prevention and control mechanism, and to further promote the construction of the new crown virus nucleic acid detection capacity, this plan is specially formulated.
1. Work objectives
By the end of September 2020, the tertiary general hospitals, infectious disease hospitals, disease control institutions at all levels, and at least one county-level hospital in the county will have nucleic acid sampling and testing capabilities.
By the end of 2020, all secondary general hospitals will have nucleic acid sampling and testing capabilities, complete the construction of urban testing bases and public testing laboratories, give full play to the role of independent medical testing laboratories (hereinafter referred to as third-party laboratories), and rationally distribute The regional mobile nucleic acid detection force has formed a rapid response mobilization mechanism, and has the ability to complete population nucleic acid detection in a short time when a local cluster of epidemics occurs.
2. Tasks
(1) Improve daily nucleic acid detection capabilities.
General hospitals above the second level, specialized hospitals for infectious diseases, disease control institutions at all levels, and county-level hospitals with nucleic acid testing capabilities within counties should make full use of existing resources to accelerate the improvement of nucleic acid testing capabilities to meet daily testing needs.
In accordance with the standard of at least 1 per 1 million permanent residents in urban areas above the prefecture level and the principle of filling and filling, all localities rely on tertiary general hospitals to build urban testing bases, and at least 1 urban residents with less than 1 million permanent residents.
The testing capacity of the urban testing base should reach 10,000 copies/day (the copies are calculated as single sample testing, and the people are calculated as mixed sample testing). When an epidemic occurs, it can reach 30,000 copies/day by increasing the frequency.
In principle, the urban testing base only undertakes the tasks of the city where it is located, and guarantees the needs of nucleic acid testing for sporadic epidemics.
It is necessary to strengthen the capacity building of rapid nucleic acid testing and cargo disinfection testing at ports to improve the convenience of customs clearance.
(2) Build a mobile nucleic acid detection force.
1. Build a public testing laboratory.
Taking into account factors such as the distribution of medical and health resources in various regions and geographical transportation, 100 large public hospitals and CDCs across the country will be selected to build public testing laboratories.
Make full use of existing resources and adhere to the principle of “combining peacetime and wartime, filling and filling”. Each public testing laboratory must have a testing capacity of 10,000 copies per day, and be equipped with a mobile shelter laboratory (mobile biological safety secondary experiment Room) and related auxiliary mobile facilities, forming a mobile inspection reserve capacity of 1 million copies/day nationwide.
The construction work is organized and implemented by the province where it is located.
2. Organize the purchase of third-party laboratory nucleic acid testing services.
All localities must actively take measures to guide and promote the healthy development of third-party laboratories in accordance with laws and regulations.
When an epidemic occurs, in accordance with the standards of more laboratories, wide distribution, strong testing capabilities, and high resource mobilization efficiency and the principle of voluntary participation, third-party laboratories are organized to participate in nucleic acid testing through government purchase of services.
The local and third-party laboratories sign a purchase service agreement to specify the testing volume, completion time limit, testing costs, etc., and agree on other related matters.
(3) Establish a district mobile support system.
Considering factors such as population, medical and health resources layout, geographical transportation and other factors, the country is divided into 8 areas, and public testing laboratories and large-scale third-party laboratories in the areas are coordinated as mobile inspection teams. Each area forms 500,000— 700,000 copies/day of mobile nucleic acid detection capacity.
See the attachment for the division of regions and the configuration of public testing laboratories across the country.
When a nucleic acid test is required for an epidemic in a relevant place, in principle, it should rely on the detection force of the region and province. If the detection capacity is indeed insufficient and support is required, an application should be submitted to the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council.
The specific support work is coordinated by the National Health Commission, mobilizing mobile inspection teams from the area for support, and mobilizing support from adjacent areas when the area is insufficient or the area is inconvenient to move.
The transportation, accommodation, and testing expenses of relevant personnel in public testing laboratories shall be borne by the recipient places.
The testing capabilities of the dispatched mobile testing team are determined in accordance with the following goals, and the nucleic acid testing of all employees will be basically completed within 5-7 days: if the number of testing is less than 5 million, the daily testing volume will reach 500,000-1 million through mixed sample testing; testing If the number is between 5 million and 10 million, it will reach 1 million to 1.5 million; if the number of testing is over 10 million, it will reach 1.5 million or more.
(4) Strengthen the construction of inspection personnel.
All localities should be equipped with sufficient testing personnel according to the scale of testing laboratories and establish echelons of reserve personnel.
It is necessary to formulate a detailed training program with strong operability, and organize relevant training for medical institutions, CDC and third-party laboratory testing personnel.
The training of currently on-the-job technicians must be completed by the end of September 2020. The additional technicians of the newly built and expanded laboratory must complete the training when the laboratory is completed, so that the organization and personnel are in place at the same time.
To fully organize the mobilization of existing medical and health personnel, each testing laboratory construction unit should optimize the internal staffing and allocate sufficient sampling personnel according to the needs of the testing work.
(5) Establish a nucleic acid detection resource information management system.
On the basis of the current nucleic acid testing information platform, the National Health Commission has incorporated relevant information from various testing institutions with nucleic acid testing capabilities to form a directory of nucleic acid testing institutions.
At the same time, the sampling and testing personnel information of various medical institutions, disease control centers, and third-party laboratories are summarized, and a database of sampling and testing personnel is established.
The catalog of nucleic acid testing institutions and the database of sampling and testing personnel shall be dynamically managed, and the administrative departments of health and health at all levels and related institutions and personnel shall master and manage them according to the corresponding authority.
3. Work requirements
(1) Increase policy funding support and guarantee.
All localities should increase supporting policies and financial support to ensure the construction of related laboratory infrastructure and equipment configuration.
It is necessary to effectively optimize and adjust the structure of fiscal expenditures, and make good use of funds from various channels such as investment in the central budget, special treasury bonds to fight the epidemic, special bonds of local governments, and local fiscal funds.
The CDC is allowed to charge fees based on public hospital charging standards when carrying out nucleic acid testing, and the fees collected will be promptly paid to the state treasury as administrative fees. The CDC's expenses for nucleic acid testing will be included in the budget management according to regulations.
(2) Strengthen the optimization and innovation of testing technology and methods and guarantee the supply of testing materials.
Localities can refer to the relevant technical specifications issued by the Medical Treatment Team of the Joint Prevention and Control Mechanism of the State Council to carry out mixed sample testing.
Low-risk areas can be tested in accordance with 10:1, medium-risk areas can be tested in a 5:1 manner, and high-risk areas and key populations should be tested in a single-sample test based on 1:1.
Pay close attention to the research to clarify the technical conditions for rapid testing without the laboratory and formulate relevant operating guidelines.
Encourage all localities and relevant institutions to develop testing equipment research and development and testing technology optimization, vigorously promote the use of new technologies and new products, and further improve testing efficiency and quality.
According to the testing needs and application scenarios, equipped with testing equipment of different throughput and speed.
The construction units of urban testing bases and public testing laboratories shall do a good job in purchasing and storing testing materials.
All localities should make overall arrangements for the construction of local nucleic acid testing capacity, and support construction units and production enterprises to use the national key medical material guarantee dispatch platform to do a good job in matching production and demand.
(3) Do a good job in supervision and management of related laboratories.
All localities should incorporate various nucleic acid testing institutions such as medical institutions, CDCs, and third-party laboratories into the unified management of quality control and quality assessment systems, and do a good job in daily quality control supervision and irregular spot checks.
It is necessary to strengthen the overall coordination of various testing laboratories to ensure that the number of samples received matches the testing capabilities, the testing process is standardized, the testing quality is reliable, and the testing report feedback is timely.
Carry out experimental activities in strict accordance with the "Regulations on Biosafety Management of Pathogenic Microorganism Laboratories" and related technical specifications, strengthen sample management, prevent laboratory leakage or personnel infection, and ensure laboratory biological safety.
(4) Further raise awareness and implement responsibilities.
Timely implementation of nucleic acid testing is a key measure to implement the "four early" requirements, and it is also the basis and prerequisite for regular and precise prevention and control.
All localities must attach great importance to and fulfill their responsibilities, and the joint prevention and control mechanism (leading group, headquarters) of the new crown pneumonia epidemic must strengthen organization and leadership, coordinate the promotion of nucleic acid testing capacity building, and ensure that tasks are completed on schedule and with high quality.
The relevant member units of the Joint Prevention and Control Mechanism of the State Council shall intensify their work and support and guide all regions to improve their nucleic acid detection capabilities.
The National Development and Reform Commission and the Ministry of Finance are responsible for guiding local governments to increase funding for nucleic acid testing capabilities; the Ministry of Science and Technology, the Ministry of Industry and Information Technology are responsible for promoting R&D and production of testing equipment, reagents, and consumables, and organizing and coordinating relevant enterprises to accelerate production to meet testing needs ; The National Health Commission is responsible for providing technical guidance for nucleic acid testing capacity building, and organizing the implementation of area mobile support work; the General Administration of Customs is responsible for the rapid nucleic acid testing and cargo disinfection testing capacity building at ports; the State Food and Drug Administration is responsible for opening green channels and speeding up related equipment, Reagents and consumables review and approval progress; Ministry of Transport, Civil Aviation Administration of China, National Railway Administration and China National Railway Group Co., Ltd. are responsible for coordinating the transportation of relevant personnel and materials.
Attachment: The division of each area in the country and the configuration of public testing laboratories
Area | Coverage | Public testing laboratory |
The first area | Beijing, Tianjin, Hebei Province, Shanxi Province, Inner Mongolia Autonomous Region | Beijing Hospital |
China-Japan Friendship Hospital | ||
Union Hospital of Chinese Academy of Medical Sciences | ||
Beijing University First Hospital | ||
Peking University People's Hospital | ||
Peking University Third Hospital | ||
Beijing Chaoyang Hospital, Capital Medical University | ||
Beijing Center for Disease Control and Prevention | ||
Tianjin Medical University General Hospital | ||
Tianjin CDC | ||
The First Hospital of Hebei Medical University | ||
Hebei Provincial Center for Disease Control and Prevention | ||
The Second Affiliated Hospital of Shanxi Medical University | ||
Shanxi Provincial Center for Disease Control | ||
People's Hospital of Inner Mongolia Autonomous Region | ||
Inner Mongolia Autonomous Region Center for Disease Control | ||
Second area | Liaoning Province, Jilin Province, Heilongjiang Province | The First Hospital of Jilin University |
The Second Hospital of Jilin University | ||
China-Japan Friendship Hospital of Jilin University | ||
Jilin Provincial People's Hospital | ||
Jilin Province CDC | ||
The First Affiliated Hospital of China Medical University | ||
Liaoning Provincial Center for Disease Control | ||
The First Affiliated Hospital of Dalian Medical University | ||
Dalian CDC | ||
The First Affiliated Hospital of Harbin Medical University | ||
Heilongjiang Provincial Center for Disease Control | ||
The third area | Shanghai, Jiangsu Province, Anhui Province, Shandong Province | Zhongshan Hospital Affiliated to Fudan University |
Huashan Hospital Affiliated to Fudan University | ||
Ruijin Hospital, Shanghai Jiaotong University School of Medicine | ||
Shanghai CDC | ||
Nanjing Gulou Hospital | ||
Jiangsu Provincial Center for Disease Control | ||
The First Affiliated Hospital of University of Science and Technology of China | ||
Anhui Provincial Center for Disease Control and Prevention | ||
Qilu Hospital of Shandong University | ||
The Second Hospital of Shandong University | ||
Shandong Provincial Hospital | ||
Shandong Provincial Center for Disease Control | ||
Qingdao Municipal Hospital | ||
Qingdao Disease Control Center | ||
Fourth area | Zhejiang Province, Fujian Province, Jiangxi Province | First Affiliated Hospital of Zhejiang University School of Medicine |
Zhejiang Provincial Center for Disease Control | ||
Ningbo Huamei Hospital, University of Chinese Academy of Sciences | ||
Ningbo Disease Control Center | ||
Fujian Provincial Hospital | ||
Fujian Provincial Center for Disease Control | ||
Zhongshan Hospital Affiliated to Xiamen University | ||
Xiamen City Center for Disease Control | ||
The First Affiliated Hospital of Nanchang University | ||
Jiangxi Provincial Center for Disease Control | ||
The fifth area | Henan Province Hubei Province Hunan Province | Union Hospital of Tongji Medical College, Huazhong University of Science and Technology |
Huazhong University of Science Tongji Hospital, Tongji Medical College | ||
Wuhan University People's Hospital | ||
Zhongnan Hospital of Wuhan University | ||
Hubei Provincial Center for Disease Control and Prevention | ||
Xiangya Hospital of Central South University | ||
The Second Xiangya Hospital of Central South University | ||
The Third Xiangya Hospital of Central South University | ||
Hunan Provincial People's Hospital | ||
Hunan Provincial Center for Disease Control and Prevention | ||
First Affiliated Hospital of Zhengzhou University | ||
Henan Provincial Center for Disease Control | ||
Sixth District | Hainan Province , Guangxi Zhuang Autonomous Region , Guangdong Province | The First Affiliated Hospital of Sun Yat-sen University |
Sun Yat-sen Memorial Hospital of Sun Yat-sen University | ||
The Third Affiliated Hospital of Sun Yat-sen University | ||
Guangdong Provincial People's Hospital | ||
Guangdong Provincial Center for Disease Control | ||
Shenzhen People's Hospital | ||
Shenzhen CDC | ||
People's Hospital of Guangxi Zhuang Autonomous Region | ||
Guangxi Center for Disease Control and Prevention | ||
Hainan Provincial People's Hospital | ||
Hainan Provincial Center for Disease Control | ||
Seventh area | Chongqing City, Sichuan Province, Guizhou Province, Yunnan Province, Tibet Autonomous Region | West China Hospital of Sichuan University |
Sichuan Provincial People's Hospital | ||
Sichuan Provincial Center for Disease Control and Prevention | ||
The First Affiliated Hospital of Chongqing Medical University | ||
Chongqing CDC | ||
Guizhou Provincial People's Hospital | ||
Guizhou Provincial Center for Disease Control | ||
The First People's Hospital of Yunnan Province | ||
Yunnan Provincial Center for Disease Control and Prevention | ||
People's Hospital of Tibet Autonomous Region | ||
Tibet Autonomous Region Center for Disease Control | ||
Eighth area | Shaanxi Province Gansu Province Qinghai Province Ningxia Hui Autonomous Region Xinjiang Uygur Autonomous Region Xinjiang Production and Construction Corps | The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine |
The Second Affiliated Hospital of Xi'an Jiaotong University School of Medicine | ||
Shaanxi Provincial People's Hospital | ||
Shaanxi Provincial Center for Disease Control | ||
Gansu Provincial People's Hospital | ||
Gansu Provincial Center for Disease Control and Prevention | ||
Qinghai Provincial People's Hospital | ||
Qinghai Provincial Center for Disease Control | ||
General Hospital of Ningxia Medical University | ||
Ningxia Hui Autonomous Region Center for Disease Control and Prevention | ||
People's Hospital of Xinjiang Uygur Autonomous Region | ||
The First Affiliated Hospital of Xinjiang Medical University | ||
Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention | ||
General Hospital of Xinjiang Production and Construction Corps | ||
Xinjiang Production and Construction Corps Disease Control Center |