The above three people were arrested because the Beijing Municipal Health and Health Commission organized experts to conduct a sample traceability inspection on the negative test results of previous positive cases on May 28th. Through video inspection and viewing the amplification records on the PCR instrument, it is found that the traceability records of Beijing Zhongtong Rambo Medical Laboratory are incomplete and the recording rules are unclear, so it is impossible to provide the original sample flow sheet and the original paper records of the amplification plate. At some time points, the amplified document records are inconsistent with the number of self-reported tests in the laboratory. The illegal mixed tube detection of multi-tube samples seriously violates the quality and safety regulations, which affects the accuracy of the detection results, leads to the untimely discovery and control of people with positive nucleic acid detection, and causes the risk of further spread of the epidemic.
In fact, recently, a large-scale special investigation of nucleic acid testing institutions has been carried out all over the country, and many unqualified institutions have gradually been "excavated".
More than 200 people were ordered to rectify.
Liaoning province is the latest province to release the special investigation results of nucleic acid testing institutions.
On July 4th, official website, Liaoning Health and Health Commission announced that in order to further strengthen the quality supervision of nucleic acid detection, Liaoning conducted investigation and rectification of nucleic acid detection institutions in the whole province from May to June according to the deployment of the comprehensive group of joint prevention and control mechanism and the medical treatment group in the State Council. After investigation, 23 nucleic acid testing institutions were ordered to rectify, and 17 nucleic acid testing institutions suspended their services (of which 3 were ordered to suspend and stopped by themselves 14).
Before Liaoning was published, Qinghai, Anhui, Sichuan, Guangdong, Hunan, Shaanxi, Guizhou, Jilin, Tianjin, Inner Mongolia, Gansu, Beijing and Henan also published special investigations on local nucleic acid testing institutions.
According to the information published in these places, the largest number of nucleic acid detection institutions ordered to rectify is Hunan Province, with the number reaching 103, including 5 third-party laboratories, 4 disease control institutions 14, and the rest are medical institutions, with the number reaching 84.
After Hunan, 47 nucleic acid testing institutions in Sichuan were ordered to rectify, Liaoning ranked third with 23, and Shaanxi ranked fourth. The latter had 19 nucleic acid testing institutions ordered to rectify.
Judging from the list of rectification orders published in various places, there are many disease control institutions and hospitals on the list. For example, Hunan Province, Hunan Provincial Center for Disease Control and Prevention is impressively listed, including Hunan Maternal and Child Health Hospital, Hunan Children's Hospital and other provincial-level 3A hospitals.
For example, in Shaanxi, there are also two disease control institutions on the list, namely zhouzhi county CDC and weiyang district CDC in xi 'an, and tertiary hospitals such as the Affiliated Hospital of Xi 'an Medical College are among them.
In the list of Liaoning ordered to rectify this time, there are two disease control institutions, namely Zhenxing District CDC (Langtou Hospital) and Zhen 'an District CDC, and the rest are hospitals.
There are many A-share listed companies in the list of third-party laboratories ordered to be rectified published in various places. For example, Xi Ankaipu Medical Laboratory, Kaipu Biology (300639. SZ), which appears in the list of rectification in Shaanxi, is another example, Changsha Wei Lan Medical Inspection Institute, a wholly-owned subsidiary of Wei Lan Medicine (30 1060). SZ) also appeared in Hunan's rectification list.
15 companies were suspended or disqualified.
In addition to a large number of nucleic acid testing institutions that have been ordered to rectify, some institutions have been directly suspended or cancelled their nucleic acid testing qualifications, and even their medical institutions' practice licenses have been revoked, with the number reaching 15. Specifically, Beijing and Hunan have the largest number, reaching four, mainly involving third-party laboratories.
Taking Beijing as an example, Beijing Pukang Renrui Medical Laboratory was disqualified from COVID-19 nucleic acid testing; Beijing Jinzhun Medical Inspection Institute, Beijing Zhongtong Rambo Medical Inspection Institute and Beijing Platts Medical Inspection Institute were directly revoked the practice licenses of medical institutions.
It is worth mentioning that in addition to the arrest of three suspects of Beijing Zhongtong Rambo Medical Inspection Co., Ltd. announced today, the suspects related to Beijing Jinzhun Medical Inspection Institute and Beijing Platts Medical Inspection Institute have also been arrested one after another recently.
Nucleic acid detection is a key measure to implement the "four early", realize the general strategy of "external defense against input and internal defense against rebound" and the general policy of "dynamic zero clearing".
On June 2, the Notice on Further Strengthening the Supervision of the Whole Chain of Nucleic Acid Detection in COVID-19 issued by the Comprehensive Group of novel coronavirus Epidemic Prevention and Control Mechanism clearly stated that it is necessary to strictly manage the qualifications of testing institutions and personnel; Standardize the management of sample collection, storage and transshipment; Strengthen the daily supervision and management of nucleic acid testing institutions; Strengthen the supervision of nucleic acid detection institutions in emergencies; Improve the utilization efficiency of nucleic acid detection resources; Strictly implement the withdrawal mechanism of nucleic acid testing institutions.
The nationwide special investigation of nucleic acid detection institutions has undoubtedly further standardized the development of the whole nucleic acid detection industry and contributed to improving the detection quality of the whole industry.
At present, some local health committees have indicated that they will continue to strengthen the supervision of the nucleic acid detection industry.
For example, the Sichuan Provincial Health and Health Commission made it clear that it will continue to urge and guide all localities to strengthen the supervision of medical institutions, disease control institutions and third-party institutions, and accept extensive supervision from all walks of life to ensure the provision of high-quality and efficient nucleic acid testing services.
Shaanxi also said that the next step will continue to urge and guide all localities to strengthen supervision of medical institutions, disease control institutions and third-party institutions, and accept extensive supervision from all walks of life to ensure the provision of high-quality and efficient nucleic acid testing services.