Article 1___In order to standardize the work of large-scale new coronavirus nucleic acid testing, to ensure the efficiency and quality of the test, and to effectively control the outbreak, according to the "Prevention and Control of Infectious Diseases Law", "Emergency Response Regulations for Public **** Health Emergencies", "Regulations on the Management of Healthcare Institutions", "Regulations on the Administration of Pathogenic Microorganism Laboratory Bio-safety", "Measures on the Administration of Healthcare Institutions Clinical Laboratory Management Measures" and other laws and regulations, the formulation of this approach.
Second___The large-scale new coronavirus nucleic acid testing referred to in these measures refers to the jurisdiction of the local or all of the population need to carry out the new coronavirus nucleic acid testing, the amount of testing exceeds the jurisdiction of a single health care institution the maximum daily capacity of the test, the need to mobilize the jurisdiction of the more or outside the jurisdiction of the test force, *** with the completion of the nucleic acid testing work.
Article 3___Laboratories that conduct large-scale neocoronavirus nucleic acid testing include laboratories of healthcare organizations and laboratories of CDC agencies that are qualified to conduct neocoronavirus nucleic acid testing.
Article 4___Based on factors such as transportation conditions, population and distribution of resources of medical and healthcare institutions, laboratories conducting large-scale testing in cities above the prefectural level and counties with districts are classified and managed.
Article V__ large-scale testing laboratories should also meet the following conditions:
Medical institutions that have obtained the "license to practice in health care institutions", or obtain the "Certificate of Legal Person for Institutions" of the CDC;
Medical institutions laboratories should comply with the requirements of the "clinical gene amplification testing laboratories in health care institutions";
According to the regulations Specification to carry out indoor quality control, and participate in the provincial and above health administrative departments commissioned by the clinical testing center or other institutions organized by the laboratory inter-room quality assessment, and the last two quality assessment results qualified;
with the health and health administrative departments to audit the record of biosafety level 2 or above the laboratory conditions;
without being subjected to administrative penalties in the past two years, good reputation;
Other conditions stipulated by the provincial health care administrative department according to the requirements of testing timeliness.
Article 6___Laboratories undertaking large-scale new coronavirus nucleic acid testing in cities at or above the prefectural and municipal levels in the districts should, in principle, have the capacity to test at least 5,000 tubes per day, in addition to the conditions stipulated in Article 5.
Laboratories undertaking large-scale new coronavirus nucleic acid testing in counties should, in principle, have the capacity to test at least 1,000 tubes per day in addition to the conditions stipulated in Article 5. When the maximum testing capacity in the county is insufficient, other large-scale testing laboratories may be commissioned to carry out the test.
Local health and wellness administrative departments may, according to the needs of the testing work, co-ordinate the assignment of testing tasks to laboratories that do not have large-scale nucleic acid testing capacity.
Article 7___Public ****testing laboratories and urban testing bases constructed in accordance with the "Work Program for Further Advancing the Capacity Building of Nucleic Acid Testing for New Coronaviruses" shall undertake large-scale testing of nucleic acid testing for new coronaviruses.
Article 8__ The large-scale testing laboratories that receive dispatch from the health care administrative department for support shall comply with the provisions of Article 5 of these Measures. Recipient shall provide the necessary transportation, accommodation, site, medical waste collection and disposal and other conditions for the laboratory to carry out its work, to ensure that the test is timely, smooth and safe.
Article IX___ to undertake large-scale new coronavirus nucleic acid testing tasks of the laboratory shall apply to the provincial health administrative department, in accordance with the conditions set out in the provision of written materials, and to ensure that the material is true, accurate and reliable. Mainly includes laboratory space, personnel, instrumentation, testing capacity, indoor quality control records, inter-room quality assessment results.
Article ___ provincial health administrative departments receive the material, should organize relevant professional and technical personnel to review the material, if necessary, on-site inspection. Qualified, should be in the clinical gene amplification test laboratory technology audit qualified documents, add "large-scale new coronavirus nucleic acid test"; or through the documents, instruments and other means to indicate that the laboratory has a large-scale new coronavirus nucleic acid test capacity. At the same time, in the "national new coronavirus nucleic acid test information platform" to be identified for reference and use in the jurisdiction to carry out large-scale new coronavirus nucleic acid test.
Article 11 ___ when carrying out large-scale new coronavirus nucleic acid testing, through temporary increase in personnel, equipment and other rapid increase in testing capacity. Laboratory to undertake testing tasks, should be in accordance with the provisions of the preceding paragraph to the provincial health administrative department to submit an application for review. Audit passed, in the clinical gene amplification test laboratory technology audit qualified documents, add "large-scale new coronavirus nucleic acid test"; or through the documents, instruments and other means to indicate that the laboratory has a large-scale new coronavirus nucleic acid test capacity, and indicate the expiration date.
Article 12 ___ large-scale testing laboratories should establish a laboratory quality management system and emergency management system, formulate work plans, strengthen the material reserves, strengthen the technical training of personnel, improve the emergency response capabilities to ensure that work is carried out at any time.
Article XIII ___ large-scale testing laboratories should receive new coronavirus nucleic acid samples according to their own testing capacity, to avoid the number of samples significantly exceeded the test capacity resulting in the backlog of samples, sample failure, delayed feedback of test results and other issues.
Article XIV ___ large-scale testing laboratories engaged in testing should be in accordance with the provisions of the technical training and assessment of qualified, holding the "Clinical Gene Amplification Test Technician Induction Certificate" of health technicians. The personnel issuing nucleic acid test reports should also have the appropriate qualifications at the same time.
Article XV___ large-scale testing laboratories shall issue nucleic acid test results within the specified time, issued by the nucleic acid test results should be true, accurate, objective and fair.
Article 16___After deciding to carry out large-scale nucleic acid testing for the new coronavirus, each region shall, based on transportation conditions, testing capacity, etc., select the relevant organizations from among the large-scale testing laboratories that have passed the audit, and sign a commissioning agreement specifying the amount to be tested, the timeframe for completion, and the testing fees, etc., as well as agreeing on other relevant matters.
Article XVII___ After receiving the test task, large-scale testing laboratories should immediately activate the emergency management system to ensure that within a short period of time personnel in place, equipment in place, materials in place, samples delivered immediately after the test.
Article XVIII __ large-scale testing laboratories should be in accordance with the relevant provisions of each batch of tests, random weak positive and negative indoor quality control, and regularly participate in the national or provincial organizations of inter-room quality assessment.
Article 19___ Large-scale testing laboratories are encouraged to install camera equipment in the core work area of each sub-district, installed in a location that clearly records the key processes, key parts and operations of the test, real-time recording of the whole process of adding samples, extraction, amplification and reporting of key links. The image data is kept for at least one month.
Article 20___During the period of conducting large-scale new coronavirus nucleic acid testing, the administrative department of health shall station quality supervisors to the large-scale testing laboratories to supervise the laboratory's indoor quality control and other work, and keep records. When problems arise, the assigned quality supervisor shall promptly report to the administrative department of health.
Article 21 ___ large-scale testing laboratories in one of the following circumstances, the health administrative department will no longer allow it to undertake testing tasks, abolish the annotation of "large-scale new coronavirus nucleic acid testing" clinical gene amplification test laboratory technology audit qualification documents:_
Laboratory conditions have changed significantly, do not meet the laboratory's indoor quality control work. Obvious changes in laboratory conditions do not meet the conditions specified in the large-scale testing laboratories;
In the quality monitoring process found that the test is not standardized, which may affect the quality of the test;
Authorized subcontracting of samples to other laboratories;
The sample backlog exceeds the validity period of the sample preservation;
In the testing process did not carry out the quality control of the room, did not participate in the inter-room quality assessment;
Without the approval of the health department of the Ministry of Health and the Ministry of Health and the Ministry of Health and the Ministry of Health. /p>
Without the consent of the administrative department of health and health, unauthorized mixed collection and mixed testing;
Failure to issue nucleic acid test results within the specified time;
Failure to complete the nucleic acid testing task within the agreed time limit.
Article 22___ If the inter-room quality evaluation fails for more than two consecutive times and remains unqualified after rectification, the health care administrative department shall suspend it from carrying out the new coronavirus nucleic acid testing business.
Article 23___The use of personnel without professional training, without nucleic acid testing training certificate for nucleic acid testing work, in accordance with the "Regulations on the Management of Medical Institutions" Article 48 punishment.
Article 24___ issued false test reports of large-scale testing laboratories, in accordance with the "Regulations on the Management of Medical Institutions" Article 49 punishment. Issuing false test reports of physicians, in accordance with the "Practicing Physicians Law" Article 37 penalties.
Article 25___ other violations of the "Regulations on the Management of Medical Institutions" "Regulations on the Management of Biosafety in Pathogenic Microorganism Laboratories" and "Rules for the Implementation of the Regulations on the Management of Medical Institutions", by the health administrative department in accordance with the law, from the strictest to the heaviest treatment.
Article 26___ health administrative departments do not follow the provisions of the large-scale testing laboratories from the conditions to determine the testing unit, the localities shall, in accordance with the rules of law, the relevant responsible person shall be punished; cause serious consequences, in accordance with the rules of law, the relevant responsibility.
Article 27___These measures shall be interpreted by the National Health and Health Commission.
Article 28___These measures shall come into force on the date of publication.