How irregular nucleic acid testing organizations make it to the qualified list

In January 2021, the Beijing Municipal Commission of Health released the "List of Healthcare Institutions Providing New Coronavirus Nucleic Acid Testing Services in Beijing", which said that the number of institutions in Beijing with the ability to test nucleic acids has reached 252, and that they can provide new coronavirus nucleic acid testing services for both groups and individuals by appointment.

In February this year, the Beijing Municipal Health Commission said that in order to further strengthen the supervision of third-party testing organizations and facilitate the public's understanding of information related to third-party nucleic acid testing organizations, it will regularly publish a list of organizations in the city that comply with relevant laws and regulations and are qualified in quality evaluation. This is in addition to such as hospitals, maternal and child health centers and other medical institutions in addition to third-party testing organizations. From the Beijing Municipal Commission of Health published in February, March and April to audit the list of qualified institutions, these three months qualified institutions are 71, 70 and 66 respectively.

The State Council's Comprehensive Group on Joint Prevention and Control Mechanisms for Responding to the New Coronavirus Pneumonia Epidemic, issued on February 17, 2021, stipulates that when a local or entire population within a jurisdiction needs to be tested for the new coronavirus nucleic acid test, and the volume of the test exceeds the daily maximum capacity of the single healthcare institution within the jurisdiction, it is necessary to mobilize additional or extra-jurisdictional testing capacity within the jurisdiction,*** with the same to complete the nucleic acid testing work. Laboratories carrying out large-scale new coronavirus nucleic acid testing should meet the following conditions: have a biosafety level 2 or above laboratory conditions that have been audited and filed by the administrative department of health and health, and have not been subjected to administrative penalties in the past two years, and have a good reputation.

However, according to the "China Economic Weekly" reporter query the Beijing Municipal Health Commission announced the audit of the list of qualified institutions, Beijing Jinzhun medical testing laboratories, Beijing Huatai Yikang medical testing laboratories, Beijing Yuanyi medical testing laboratories, Cayudi medical testing laboratories (Beijing), are ranked among the qualified institutions in February, March and April this year. However, these organizations in the past two years (after April 2020) have been the record of administrative penalties.

As mentioned earlier, Beijing Jinzun Medical Laboratory Company Limited accident, is not the first time.

In January of this year, Beijing Jinzun Medical Testing Laboratory Co. Ltd. was fined by the Beijing Haidian District Health and Health Commission for appointing non-health technicians to work in medical and health technology.

Beijing Huatai Yikang Medical Testing Laboratory, the serial number on the list of qualified organizations audited in February, was No. 29, No. 53 in March and No. 52 in April. The organization was fined 431,100 yuan in June 2021 as an administrative penalty by the Beijing Daxing District Market Supervision Administration for violating the Regulations on Supervision and Administration of Medical Devices.

On March 7 of this year, Beijing Yuan Code Medical Testing Laboratory was fined 250,000 yuan in an administrative penalty by the Beijing Chaoyang District Market Supervision Administration for violating the price law.

Cayudi Medical Testing Laboratory (Beijing) Co. Ltd. on March 18 this year, on the other hand, was administratively punished by the Health and Wellness Committee of Fengtai District, Beijing, for failing to separate medical waste by category in special packages.

Beijing Aina Medical Testing Laboratory has been a qualified organization audited by the Beijing Municipal Health Commission since March. On May 11 this year, it was listed on the business exception list by the Beijing Haidian District Market Supervision Administration because it could not be contacted through its registered residence or place of business.

On May 9, at a press conference on the prevention and control of the new Crown pneumonia outbreak in Beijing, Li Ang, deputy director of the Beijing Municipal Commission of Health, informed that in the recent flight supervision and inspection, it was found that there were problems with individual nucleic acid testing organizations in terms of untimely delivery, inaccurate reporting, and unstrict laboratory management. In response to the problems, the relevant departments required the agency to suspend practice and stop undertaking new coronavirus nucleic acid testing business.

Previously, Hefei and Tianjin have exposed unqualified testing organizations.

On April 23, the Hefei Epidemic Prevention and Control Emergency Response Command notified the two nucleic acid testing laboratories of warnings and suspension of cooperation. The briefing said that on April 22, Hefei and Hefei medical testing laboratories, Hefei Novel Medical Testing Laboratory, in the Shushan District area of nucleic acid testing, overcapacity to undertake testing business, serious more than the promised time to issue test reports, affecting the city of Hefei on the outbreak situation in a timely manner research and judgment, and more seriously, has occurred many times before a similar situation, and some of them also several times to issue a "false-positive "report, seriously interfering with the overall situation of epidemic prevention and control in Hefei. The above two laboratories to give a warning, immediately suspend the two laboratories in the city of Hefei within the scope of the cooperative business, the city's counties (cities), development zones and municipal units should be immediately in accordance with the requirements of the strict implementation. Hefei City, also said that in the future, regardless of which testing organizations, if similar circumstances, all according to this treatment.

Earlier, on Aug. 24, 2020, the Tianjin Municipal Health Commission said that in order to continue to promote the work related to the new coronavirus nucleic acid test and to improve the testing capacity, the new Tianjin Lianhe Medical Testing Laboratory provided the public with the new coronavirus nucleic acid test service. About 20 days later, the Tianjin Municipal Health Commission announced that Tianjin Lianhe Medical Laboratory due to internal problems, applying for the cancellation of its new coronavirus nucleic acid testing qualification. 3 months later, the Tianjin Municipal Health Commission announced the cancellation of the Dean Dexion Medical Laboratory nucleic acid testing qualification.