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