In order to guide various regions to standardize the large-scale nucleic acid testing of the new coronavirus, ensure the efficiency and quality of the test, and effectively control the new coronavirus pneumonia epidemic, the State Council has organized and formulated the "Large-scale New Coronavirus Nucleic Acid Testing Laboratory" Management Measures (Trial)". On February 20, 2021, the website of the National Health Commission released relevant content of the Measures.
The "Measures" stated that large-scale testing laboratories must have not received administrative penalties within the past two years and have a good reputation; they must have biosafety level two or above laboratory conditions that have been reviewed and filed by the health administrative department.

The "Measures" clarified that if the quality evaluation of the laboratory fails more than two times in a row, and is still unqualified after rectification, the administrative department of health and health will suspend its new coronavirus nucleic acid testing business.

In addition, large-scale testing laboratories that issue false inspection reports will be punished in accordance with Article 49 of the Regulations on the Management of Medical Institutions. Physicians who issue false inspection reports shall be punished in accordance with Article 37 of the Law on Practicing Physicians. The full text is as follows:

Measures for the Management of Large-scale New Coronavirus Nucleic Acid Testing Laboratories (for Trial Implementation) Article 1 is to standardize large-scale new coronavirus nucleic acid testing, ensure testing efficiency and quality, and effectively control the epidemic. According to the "Infectious Disease Prevention Law", "Public Health Emergency Response" The Regulations, the Regulations on the Management of Medical Institutions, the Regulations on the Biosafety Management of Pathogenic Microorganism Laboratories, and the Measures for the Management of Clinical Laboratories in Medical Institutions, etc., formulate these measures.

Article 2 The term “large-scale new coronavirus nucleic acid testing” as mentioned in these Measures means that some or all populations in the jurisdiction need to carry out new coronavirus nucleic acid testing. The amount of testing exceeds the daily maximum detection capacity of single medical and health institutions in the jurisdiction, and more needs to be mobilized in the jurisdiction Or testing forces outside the jurisdiction to jointly complete nucleic acid testing.

Article 3 Laboratories that carry out large-scale nucleic acid testing of the new coronavirus (hereinafter referred to as large-scale testing laboratories), including medical institution laboratories (including medical testing laboratories, the same below) and disease control institutions that have the qualifications for new coronavirus nucleic acid testing room.

Article 4 According to factors such as traffic conditions, population, and resource distribution of medical and health institutions, the laboratories that carry out large-scale testing in cities and counties divided into districts and cities above the city level shall be classified and managed.


Article 5 Large-scale testing laboratories shall meet the following conditions at the same time:


(1) A medical institution that has obtained the "Medical Institution Practicing License", or a disease control institution that has obtained the "Public Institution Legal Person Certificate";


(2) Laboratories of medical institutions shall meet the requirements of the "Administrative Measures for Clinical Gene Amplification Testing Laboratories of Medical Institutions";


(3) Carry out indoor quality control in accordance with regulations, and participate in the inter-laboratory quality evaluations organized by clinical testing centers or other institutions commissioned by health administrative departments at the provincial level and above, and the results of the latest two quality evaluations are qualified;


(4) It has the laboratory conditions of Level 2 or above in biosafety that have been reviewed and filed by the administrative department of health and health;

(5) It has not received administrative punishment in the past two years and has a good reputation;

(6) Other conditions stipulated by the provincial health administrative department in accordance with the testing timeliness requirements.

Article 6 Laboratories that undertake large-scale COVID-19 nucleic acid testing in cities with districts and cities above the city level shall, in principle, have the ability to test at least 5,000 tubes per day in addition to the conditions specified in Article 5.

In addition to the conditions specified in Article 5, laboratories undertaking large-scale nucleic acid testing of the new coronavirus at the county level should also have the ability to test at least 1,000 tubes per day in principle. When the maximum detection capacity in the county is insufficient, other large-scale testing laboratories can be entrusted to carry out testing.

The local health administrative department may, according to the needs of the testing work, coordinate and assign testing tasks to laboratories that do not have the capability of large-scale nucleic acid testing.

Article 7 Public testing laboratories and urban testing bases constructed in accordance with the "Working Plan for Further Promoting the Construction of New Coronavirus Nucleic Acid Testing Capacity" shall undertake large-scale new coronavirus nucleic acid testing tasks.

Article 8 Large-scale testing laboratories that receive support from the administrative department of health shall comply with the provisions of Article 5 of these Measures. The aided area shall provide necessary conditions for the laboratory to carry out its work such as transportation, accommodation, venue, medical waste collection and disposal, etc., to ensure timely, smooth and safe testing.

Article 9 Laboratories that intend to undertake large-scale new coronavirus nucleic acid testing tasks shall apply to the provincial health administrative department, provide written materials in accordance with prescribed conditions, and ensure that the materials are true, accurate, and reliable. It mainly includes laboratory sites, personnel, equipment, testing capabilities, indoor quality control records, and results of indoor quality evaluation.

Article 10 After receiving the materials, the provincial health administrative department shall organize relevant professional and technical personnel to review the materials and conduct on-site inspections when necessary. For those eligible, “large-scale new coronavirus nucleic acid testing” should be added to the certification documents of the clinical gene amplification testing laboratory’s technical review; or through certification documents, documents, etc., that the laboratory has large-scale new coronavirus Nucleic acid detection capability. At the same time, it will be marked in the "National New Coronavirus Nucleic Acid Testing Information Platform" for reference when carrying out large-scale new coronavirus nucleic acid testing in the jurisdiction.

Article 11 When carrying out large-scale nucleic acid testing for the new coronavirus, the testing capabilities can be quickly improved by temporarily increasing personnel and equipment. The laboratory that intends to undertake testing tasks shall submit an application for review to the provincial health administrative department in accordance with the provisions of the preceding paragraph. For those who pass the review, add "large-scale new coronavirus nucleic acid testing" in the certification documents of the clinical gene amplification testing laboratory technical review; or indicate that the laboratory has large-scale new coronavirus nucleic acid testing through certification documents, documents, etc. Ability, and indicate the validity period.

Article 12 Large-scale testing laboratories shall establish laboratory quality management systems and emergency management systems, formulate work plans, strengthen material reserves, strengthen technical training of personnel, improve emergency response capabilities, and ensure that they can work at any time.

Article 13 Large-scale testing laboratories should receive nucleic acid samples of the new coronavirus according to their own testing capabilities, and avoid problems such as sample backlog, sample failure, and slow feedback of test results caused by the number of samples that significantly exceed the testing capabilities.

Article 14 The personnel engaged in inspection work in large-scale testing laboratories shall be health technicians who have received technical training and passed the assessment in accordance with regulations, and hold the "Clinical Gene Amplification Test Technician Employment Certificate". The person who issues the nucleic acid test report shall also have corresponding qualifications.

Article 15 Large-scale testing laboratories shall issue nucleic acid test results within the specified time, and the nucleic acid test results issued shall be true, accurate, objective and fair.

Article 16 After each locality decides to carry out large-scale COVID-19 nucleic acid testing, it should select relevant agencies from the large-scale testing laboratories that have passed the audit based on traffic conditions and testing capabilities, etc., and sign a commission agreement to specify the testing volume, completion time limit, and testing Expenses, etc., and agree on other related matters.

Article 17 After receiving the inspection task, the large-scale testing laboratory shall immediately activate the emergency management system to ensure that the personnel, equipment, and materials are in place within a short period of time, and the test will be carried out as soon as the sample is delivered.

Article 18 Large-scale testing laboratories shall, in accordance with relevant regulations, conduct weak positive and negative indoor quality control randomly during each batch of testing, and regularly participate in the external quality assessment of national or provincial organizations.

Article 19 Encourage large-scale testing laboratories to install camera equipment in the core work area of each subarea. The installation location can clearly record the key processes, key parts and operations of the test, and real-time recording of key points such as sample addition, extraction, amplification and reporting The whole process of the link. The image data is kept for at least one month.

Article 20 During the large-scale nucleic acid testing of the new coronavirus, the administrative department of health and health shall assign quality supervisors to the large-scale testing laboratory to supervise the laboratory’s indoor quality control and other work and make records. When there is a problem, the quality supervisor dispatched shall promptly report to the health administration department.

rticle 21 If one of the following situations occurs in a large-scale testing laboratory, the health administrative department will no longer allow it to undertake testing tasks, and abolish the “large-scale new coronavirus nucleic acid testing” clinical gene amplification testing laboratory that has passed the technical review certified documents:

(1) When laboratory conditions have changed significantly and do not meet the requirements of large-scale testing laboratories;

2) It is found that the inspection is not standardized during the quality supervision process, which may affect the quality of the inspection;

(3) Subcontracting samples to other laboratories without authorization;

(4) The backlog of samples exceeds the validity period of sample preservation;

(5) Failure to carry out indoor quality control during the testing process or participate in the external quality assessment;

(6) Conducting mixed harvesting and mixed inspection without the consent of the health administrative department;

(7) Failure to issue nucleic acid test results within the specified time;

(8) Failure to complete the nucleic acid detection task within the agreed time limit.

Article 22 If the external quality evaluation is unqualified for more than two consecutive times, and is still unqualified after rectification, the administrative department of health and health shall suspend its development of new coronavirus nucleic acid testing business.

Article 23 Those who use personnel who have not been professionally trained or certified for nucleic acid testing training to engage in nucleic acid testing shall be punished in accordance with Article 48 of the Regulations on the Management of Medical Institutions.

Article 24 Large-scale testing laboratories that issue false inspection reports shall be punished in accordance with Article 49 of the Regulations on the Administration of Medical Institutions. Physicians who issue false inspection reports shall be punished in accordance with Article 37 of the Law on Practicing Physicians.

Article 25 Other violations of the "Regulations on the Management of Medical Institutions", "Regulations on the Biosafety Management of Pathogenic Microbial Laboratories" and the "Detailed Rules for the Implementation of the Regulations on the Management of Medical Institutions" shall be dealt with strictly by the administrative department of health in accordance with laws and regulations.

rticle 26: If the health administrative department fails to determine the testing unit from the qualified large-scale testing laboratories in accordance with the regulations, all localities shall punish the responsible persons in accordance with laws and regulations; if serious consequences are caused, they shall be held accountable in accordance with laws and regulations. .

Article 27 The National Health Commission is responsible for the interpretation of these measures.

Article 28 These Measures shall be implemented from the date of promulgation.