Chinanews.com, February 20th. The State Council’s Comprehensive Team of Joint Prevention and Control Mechanisms for the Response to the Novel Coronavirus Pneumonia Outbreak has recently issued the "Management Measures for Large-scale Novel Coronavirus Nucleic Acid Testing Laboratories (Trial)" (hereinafter referred to as the "Measures"), since the date of promulgation From implementation.

The “Measures” clarified the conditions that large-scale new coronavirus nucleic acid testing laboratories (hereinafter referred to as large-scale testing laboratories) should meet, including not being subject to administrative penalties in the past two years, and having good reputation; at the same time, it is clear that large-scale testing laboratories should The nucleic acid test results shall be issued within the specified time, and the nucleic acid test results shall be true, accurate, objective and fair.

Data map: The staff carry out testing related work in the laboratory.

Photo by China News Agency reporter Hou Yu

　　The Measures clarify that the large-scale COVID-19 nucleic acid testing referred to in these Measures refers to the need to carry out COVID-19 nucleic acid testing for some or all populations in the jurisdiction, and the amount of testing exceeds the daily maximum detection capacity of single medical and health institutions in the jurisdiction, and the jurisdiction needs to be mobilized More or more testing forces outside the jurisdiction have jointly completed nucleic acid testing.

　　The laboratories that carry out large-scale new coronavirus nucleic acid testing include medical institution laboratories (including medical testing laboratories, the same below) and disease control institutions that are qualified for new coronavirus nucleic acid testing.

　　At the same time, 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 with districts and cities above the city level are classified and managed.

　　The "Measures" proposed that large-scale testing laboratories should meet the following conditions at the same time:

　　(1) Medical institutions that have obtained the "Medical Institution Practicing License" or the disease control institutions that have obtained the "Public Institution Legal Person Certificate";

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

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

　　(4) Possess the biosafety level 2 or above laboratory conditions that have been reviewed and filed by the health administrative department;

　　(5) It has not received any 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.

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

　　At the same time, it is clear that laboratories that undertake large-scale nucleic acid testing of the new coronavirus at the county level should, in principle, have the ability to test at least 1,000 tubes per day in addition to the conditions specified in Article 5.

When the maximum detection capacity in the county is insufficient, other large-scale testing laboratories can be entrusted to carry out testing.

　　The “Measures” clarify that local health administrative departments can coordinate and assign testing tasks to laboratories that do not have large-scale nucleic acid testing capabilities based on testing needs.

　　The "Measures" proposes that when large-scale new coronavirus nucleic acid testing is carried out, 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.

　　The "Measures" emphasizes that large-scale testing laboratories should issue nucleic acid test results within a specified time, and the nucleic acid test results issued should be true, accurate, objective and fair.

　　Those who use personnel who have not been professionally trained and have no training certificate for nucleic acid testing shall be punished in accordance with Article 48 of the Regulations on the Administration of Medical Institutions.

　　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.

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

　　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.

　　The National Health Commission is responsible for the interpretation of the "Measures" and will be implemented from the date of promulgation.