Article 1 In order to standardize the large-scale nucleic acid detection in COVID-19, ensure the detection efficiency and quality, and effectively control the epidemic situation, these measures are formulated in accordance with the provisions of laws and regulations such as the Law on the Prevention and Control of Infectious Diseases, the Emergency Regulations for Public Health Emergencies, the Regulations on the Management of Medical Institutions, the Regulations on the Biosafety Management of Pathogenic Microbiological Laboratories, and the Measures for the Management of Clinical Laboratories in Medical Institutions.
Article 2 _ _ The term "large-scale COVID-19 nucleic acid detection" as mentioned in these Measures refers to the need to carry out COVID-19 nucleic acid detection in some or all people within the jurisdiction, and the detection amount exceeds the daily maximum detection capacity of a single medical and health institution within the jurisdiction, and it is necessary to mobilize more detection forces within or outside the jurisdiction to jointly complete the nucleic acid detection work.
Article 3 Laboratories that carry out large-scale nucleic acid detection in COVID-19 include laboratories of medical institutions and laboratories of disease control institutions with COVID-19 nucleic acid detection qualifications.
Article 4 According to traffic conditions, population and resource distribution of medical and health institutions and other factors, the laboratories that carry out large-scale testing in cities and counties with districts above the municipal level shall be classified and managed.
Article 5 A large-scale testing laboratory shall meet the following conditions:
Medical institutions that have obtained the Practice License of Medical Institutions, or disease control institutions that have obtained the Legal Person Certificate of Public Institutions;
The laboratories of medical institutions shall meet the requirements of the Measures for the Administration of Clinical Gene Amplification Laboratories of Medical Institutions;
Carry out indoor quality control in accordance with the prescribed standards, participate in the interstitial evaluation of laboratory rooms organized by clinical inspection centers or other institutions entrusted by health administrative departments at or above the provincial level, and the results of the last two qualitative evaluations are qualified;
Having the laboratory conditions of biosafety level 2 or above which have been audited and filed by the health administrative department;
It has not received administrative punishment in the past two years and has a good reputation;
Other conditions stipulated by the provincial health administrative department according to the requirements of detection restrictions.
Article 6 _ _ Laboratories undertaking large-scale COVID-19 nucleic acid detection in cities divided into districts and cities at or above the prefecture level shall, in principle, have the ability to detect at least 5,000 tubes a day, in addition to the conditions specified in Article 5.
Laboratories undertaking large-scale nucleic acid detection at the county level in COVID-19 shall, in principle, have the ability to detect at least 1000 test tubes every day, in addition to the conditions specified in Article 5. When the maximum testing capacity in the county is insufficient, other large-scale testing laboratories can be entrusted for testing.
The local health administrative department may, according to the needs of testing work, co-ordinate the assignment of testing tasks to laboratories that do not have large-scale nucleic acid testing capabilities.
Article 7 _ _ According to the Work Plan for Further Promoting the Capacity Building of Nucleic Acid Detection in COVID-19, public * * * detection laboratories and urban detection bases undertake the task of large-scale nucleic acid detection in COVID-19.
Article 8 Large-scale testing laboratories supported by health administrative departments shall comply with the provisions of Article 5 of these Measures. The recipient shall provide necessary transportation, accommodation, site, medical waste collection and disposal conditions for the laboratory to carry out its work, and ensure the timely, smooth and safe testing.
Article 9 A laboratory that intends to undertake the task of large-scale nucleic acid detection in COVID-19 shall apply to the provincial health administrative department, provide written materials in accordance with the prescribed conditions, and ensure that the materials are true, accurate and reliable. It mainly includes laboratory site, personnel, instruments and equipment, testing ability, indoor quality control records and interstitial evaluation results.
Tenth _ _ provincial health administrative departments shall organize relevant professional and technical personnel to review the materials and conduct on-site inspection when necessary. In line with the conditions, "large-scale COVID-19 nucleic acid detection" is added to the supporting documents that have passed the technical review of clinical gene amplification laboratories; Or the laboratory has the ability of large-scale COVID-19 nucleic acid detection through supporting documents and instruments. At the same time, it will be marked on the "National COVID-19 Nucleic Acid Detection Information Platform" for reference in carrying out large-scale nucleic acid detection in COVID-19.
Eleventh _ _ To carry out large-scale nucleic acid detection in COVID-19, the detection capacity can be rapidly improved by temporarily increasing personnel and equipment. The laboratory that intends to undertake the testing task shall submit an application for examination to the provincial health administrative department in accordance with the provisions of the preceding paragraph. After passing the examination, "large-scale COVID-19 nucleic acid detection" will be added to the technical examination certificate of clinical gene amplification laboratory; Or prove that the laboratory has large-scale COVID-19 nucleic acid detection capability through supporting documents and instruments, and indicate the validity period.
Twelfth large-scale testing laboratories should establish laboratory quality management system and emergency management system, formulate work plans, strengthen material reserves, strengthen personnel technical training, improve emergency response capabilities, and ensure that work can be carried out at any time.
Thirteenth large-scale testing laboratories should receive COVID-19 nucleic acid samples according to their own testing capabilities, so as to avoid problems such as sample backlog, sample failure and slow feedback of test results caused by the number of samples obviously exceeding the testing capabilities.
Fourteenth _ _ personnel engaged in inspection work in large-scale testing laboratories shall be health technicians who have received technical training and passed the examination in accordance with the regulations, and hold the Certificate of Clinical Gene Amplification Inspection Technician. The person who issues the nucleic acid test report shall also have the corresponding qualifications.
Fifteenth _ _ large testing laboratories shall issue the results of nucleic acid testing within the specified time, and the results of nucleic acid testing shall be true, accurate, objective and fair.
Sixteenth _ _ decided to carry out large-scale detection of nucleic acids in COVID-19, all localities should choose relevant institutions from large-scale detection laboratories that have passed the examination according to traffic conditions and detection capacity, and sign an entrustment agreement to clarify the detection quantity, completion time limit and detection cost. , and agree on other related matters.
Seventeenth _ _ large testing laboratory after receiving the testing task, should immediately start the emergency management system, to ensure that personnel, equipment and materials in place in a short time, and immediately carry out the testing work after the sample is delivered.
Eighteenth _ _ large testing laboratories shall, in accordance with the relevant provisions, randomly carry out weak positive and negative indoor quality control for each batch of testing, and regularly participate in the inter-room quality evaluation organized by the state or the provincial level.
Article 19 _ _ Encourage large-scale testing laboratories to install camera equipment in the core work areas of each division. The installation position can clearly record the key process, key parts and operations of the test, and record the whole process of key links such as sample addition, extraction, amplification and reporting in real time. Image data should be kept for at least one month.
Twentieth _ _ during the large-scale COVID-19 nucleic acid detection, the health administrative department shall send quality supervisors to the large-scale detection laboratory to supervise the indoor quality control of the laboratory and make records. When there is a problem, the quality supervisor stationed should report to the health administrative department in time.
Article 21 In any of the following circumstances, the health administrative department will no longer allow a large-scale testing laboratory to undertake testing tasks, and cancel the label of "Large-scale COVID-19 nucleic acid testing" in the Technical Audit Certificate of Clinical Gene Amplification Testing Laboratory: _
When the laboratory conditions change obviously and do not meet the requirements of large-scale testing laboratories;
In the process of quality supervision, it is found that the detection is not standardized, which may affect the detection quality;
Subcontracting samples to other laboratories without authorization;
The backlog of samples exceeds the validity period of sample preservation;
Indoor quality control was not carried out during the test, and ventricular interstitial evaluation was not involved;
Without the consent of the administrative department of health, mixed mining and mixed inspection are carried out without authorization;
Failing to issue a nucleic acid test result within the specified time;
Failing to complete the task of nucleic acid detection within the agreed time limit.
Twenty-second _ _ room quality evaluation is unqualified for more than two consecutive times. If it is still unqualified after rectification, the health administrative department shall suspend its COVID-19 nucleic acid testing business.
Twenty-third _ _ personnel engaged in nucleic acid detection without professional training and training certificate shall be punished in accordance with Article 48 of the Regulations on the Administration of Medical Institutions.
Twenty-fourth 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. Doctors who issue false inspection reports shall be punished in accordance with Article 37 of the Law on Medical Practitioners.
Twenty-fifth _ _ other violations of the Regulations on the Administration of Medical Institutions, the Regulations on the Biosafety Management of Pathogenic Microbiological Laboratories and the Detailed Rules for the Implementation of the Regulations on the Administration of Medical Institutions shall be severely dealt with by the administrative department of health according to law.
Twenty-sixth _ _ the health administrative department fails to determine the testing unit from a qualified large-scale testing laboratory according to the regulations, and all localities should punish the relevant responsible persons according to the law; If serious consequences are caused, relevant responsibilities shall be investigated according to laws and regulations.
Twenty-seventh _ _ these Measures shall be interpreted by the National Health and Wellness Committee.
Twenty-eighth _ _ these measures shall come into force as of the date of promulgation.