What are the barriers to entry for nucleic acid testing organizations? What qualifications are required?

Strict management of the qualifications of testing organizations and personnel, strengthening the daily supervision and management of nucleic acid testing organizations, and strict implementation of the exit mechanism of nucleic acid testing organizations. The State Council recently issued the Notice on Further Strengthening the Supervision of the Whole Chain of Nucleic Acid Testing for New Coronavirus in response to the Joint Prevention and Control Mechanism of the New Coronavirus Pneumonia Epidemic, which puts forward new requirements for the supervision of nucleic acid testing. All localities should strictly manage the qualifications of testing organizations and personnel, attach great importance to source management such as nucleic acid sample collection, and all sampling personnel should be trained and qualified by the health department. The health administrative department should send quality supervisors to each medical testing laboratory that undertakes testing tasks to carry out the whole process of supervision.

Medical laboratories undertaking testing tasks should install video monitoring equipment to record key aspects of the whole process such as sampling, nucleic acid extraction and amplification, and reporting. The image data should be kept for at least one month for future reference. If there? false positives? or? false negative? , the health administrative department should organize an investigation, follow-up and cause analysis of the case to find out the loopholes in the system and prevent the recurrence of the relevant situation. Timely integration of on-site safeguard testing resources into unified management. To grasp the supply and demand of each round of nucleic acid testing, distinguish between the number of people being tested and the number of sampling tubes for a single test, 5 to 1, 10 to 1, 20 to 1, and according to the actual capacity of the testing organization to reasonably match the testing task, to avoid idle testing power or beyond the actual capacity to allocate testing tasks.

Everywhere to implement the nucleic acid testing organization's access and exit mechanism, the establishment of ? red light?

All regions should implement the nucleic acid testing organization access and exit mechanism, set up a? green light? Approval, resolutely implement? Yellow light? Rectification of the yellow light and the red light Red light? Exit mechanism. Those suspected of violating the law and committing a crime will be transferred to the public security organs for investigation of the relevant responsibilities according to law. During the outbreak, localities will try to shorten the approval time for nucleic acid testing organizations. Recently, some local nucleic acid testing enterprises were established less than a month before they began to participate in nucleic acid testing tasks. Local governments responded that this was a green channel for approval during the outbreak. To ensure the accuracy and reliability of nucleic acid test results, the National Health Commission will strictly enforce testing qualification access, strengthen the management of gene amplification testing laboratories, supervise the access of various nucleic acid testing laboratories, strengthen the qualification assessment of technicians, and continuously improve the access registration to ensure that the entering organizations and personnel meet the qualification requirements.