Behind the investigation of two nucleic acid testing institutions in Beijing: How to ensure "price reduction without quality reduction"?

　　Sino-Singapore Jingwei Wang Yuling

　　On the 27th, according to the Beijing Disciplinary Inspection and Supervision Network, Yang Daqing, deputy director of the Beijing Fangshan District Health Committee, Jin Changhao, chief of the medical and political department, and Xing Man, the third-level chief member of the medical and political department, were involved in the medical examination of Beijing Pu Shi. In the process of supervision and management of the room, he was suspected of serious violation of discipline and law, and is currently undergoing disciplinary review and supervision investigation by the Fangshan District Commission for Discipline Inspection and Supervision.

　　On the same day, according to the Ping An Beijing official account, Beijing Jinzhun Medical Laboratory had suspected illegal and criminal acts during the nucleic acid detection process. Actively cooperate with the investigation.

　　So, what exactly did the above two nucleic acid testing institutions do?

What kind of punishment will be faced?

For third-party nucleic acid testing laboratories, how are the current regulatory responsibilities performed?

What is the reason?

　　On May 21, the Beijing Fangshan District government website updated an administrative penalty: Because the original test data was significantly less than the number of samples tested, Beijing Pu Shi Medical Laboratory Co., Ltd. was revoked by the Fangshan District Health Commission's "Medical Institution Practicing License". ".

　　It shows that on May 14, 2022, the supervisor found that the original test data of Beijing Pushi Medical Laboratory Co., Ltd. at 315-323, 3rd Floor, Building 1, No. 9, Guangyang Street, Fangshan District, Beijing, was significantly less than the number of samples tested.

　　Some third-party nucleic acid testing laboratory personnel told Sino-Singapore Jingwei that for Pushi Medicine, the high probability is that the amount of samples received is too large and the testing throughput is not enough.

The Beijing Municipal Health and Health Commission has high requirements on the efficiency of testing institutions, requiring testing institutions to issue inspection results within 24 hours, so they "take the risk".

　　Dr. Liu from the laboratory department of a tertiary hospital explained to Sino-Singapore Jingwei that, in fact, for nucleic acid testing institutions, the calculation of the maximum daily testing volume needs to rely on the core equipment PCR amplification instrument. It takes the longest time, so the theoretical daily maximum detection capacity of the PCR instrument can be calculated when it is running at full capacity.

Generally, when running at full load, the daily detection capacity of each PCR instrument can basically reach 1000 tubes.

That is, if the number of amplification instruments in a nucleic acid testing institution is fixed, then the theoretical maximum number of detection tubes is also fixed.

　　Regarding Jinzhun Medicine, on the afternoon of the 27th, Pan Xuhong, deputy director of the Beijing Municipal Public Security Bureau, announced that since April 25 this year, "Beijing Jinzhun Medical Laboratory Co., Ltd." has illegally collected samples from multiple districts in order to seek illegal economic benefits. The nucleic acid samples of "5 mixed with 1" and "10 mixed with 1" were tested by multi-tube mixed testing. The samples were artificially diluted, which affected the accuracy of the test results and was suspected of obstructing the prevention and treatment of infectious diseases.

　　Dr. Liu interpreted Sino-Singapore Jingwei, first of all, to distinguish between mixed sampling and mixed detection.

On the basis of mixed sampling, if mixed detection is carried out, it will cause a certain dilution of the sample. For example, when sampling itself, it is "5 mixed 1", and then mixed testing of 3 tubes and more becomes "15 mixed 1". "Even "20 mixes 1" "25 mixes 1".

In the case of sample dilution, it may be lower than the minimum detection limit of the new crown nucleic acid detection system, which in turn affects the detection rate.

How will I be punished?

　　What penalties might the two nucleic acid testing laboratories face?

　　According to the Fangshan District Government Administrative Penalty Letter, the health and health department has revoked the "Medical Institution Practicing License" of Pu Shi Medical Laboratory, and the market supervision department has filed a case for investigation.

According to the Ping An Beijing WeChat account, according to the clues of the case transferred by the health and health department, the public security organs filed a case for investigation on suspicion of obstructing the prevention and treatment of infectious diseases

.

　　Regarding Jinzhun Medicine, according to the health Haidian WeChat public account on the 27th, the Beijing Haidian District Health and Health Commission issued a notice saying that the Beijing Jinzhun Medical Laboratory had suspected illegal and criminal acts during the nucleic acid detection process. The Health Commission has filed a case for investigation and stopped the practice of the institution in accordance with the law.

Its

, and the case is under further investigation.

Huang Mengqi, a lawyer from Beijing Zhongwen (Shanghai) Law Firm, analyzed Sino-Singapore Jingwei that, in fact, the severity of the incident between the two nucleic acid testing institutions was different.

For Piao Shi Medicine, the report stated that the original test data was significantly less than the number of samples tested. This behavior may lead to many samples showing "false negatives" without testing, and "positives" can continue to flow freely, resulting in the continued existence of the epidemic. the possibility of transmission.

　　"From a legal perspective, both of their actions are suspected of obstructing the prevention and treatment of infectious diseases. According to Article 330 (5) of the Criminal Law, the people's governments at or above the county level and disease prevention and control institutions have refused to enforce the Law on the Prevention and Control of Infectious Diseases. The proposed prevention and control measures may be involved in the crime if it causes a Class A infectious disease and if it is determined according to the law that a Class A infectious disease prevention and control measure spreads or there is a serious danger of transmission. Deliberately issuing a 'false negative' report may be suspected of the crime of providing false certification documents, or if the relevant personnel are seriously irresponsible and the issued certification documents are materially inaccurate, they may be suspected of the crime of issuing major inaccuracy of certification documents.

, so it is still open to question whether it may constitute these two crimes."

　　How will the sentence be imposed?

Huang Mengqi said that if a unit crime is constituted, the unit, the directly responsible person in charge, and other directly responsible personnel must bear legal responsibility.

Those suspected of obstructing the prevention and treatment of infectious diseases may be sentenced to fixed-term imprisonment of not more than three years or criminal detention; if the consequences are particularly serious, they may be sentenced to fixed-term imprisonment of not less than three years but not more than seven years.

If it is the personal behavior of the relevant personnel, the conviction and punishment will be carried out as a natural person crime.

How to compact the supervision line?

　　Sino-Singapore Jingwei noticed that from the "false positive" controversy of Runda Medical and Hehe Diagnosis, to Jinzhun Medicine and Pushi Medicine, the supervision difficulty brought about by the expansion of nucleic acid testing institutions has increased.

　　According to the data of Tianyancha Professional Edition, there will be 437 new medical inspection-related institutions in 2021, with an annual growth rate of 25.1%, the highest in history.

As of May 27, 2022, 265 medical inspection-related institutions have been established in my country that year, a year-on-year increase of 47.22%.

　　More and more nucleic acid testing institutions are entering the stadium, how do "referees" supervise?

　　Xinhua Daily Telegraph previously commented that the nucleic acid testing business volume is large and there are also interest chains. In this regard, the discipline inspection and supervision department should intervene to conduct a comprehensive and thorough "test" on the qualifications and access procedures of nucleic acid testing institutions, and strengthen supervision. , There must be serious accountability and severe punishment for possible violations of disciplines and laws, so that all participants in the nucleic acid testing affairs do not dare to make trouble.

At present, Sino-Singapore Jingwei has learned from the staff of the third-party nucleic acid testing agency that from the perspective of external supervision, Beijing currently has multiple subjects for the supervision of third-party nucleic acid testing agencies, and the regulatory responsibility is being compacted.

　　Regarding the accuracy of the nucleic acid test results, the staff member told Sino-Singapore Jingwei that the nucleic acid testing laboratory needs to participate in the inter-laboratory quality assessment held by the Beijing Clinical Trial Center from time to time, which has been held four times this year.

　　Guo Yanhong, the supervisory commissioner of the Medical Administration and Hospital Administration Bureau of the National Health and Health Commission of China, previously stated that in addition to the normalization of indoor quality assessment work, the National Health and Health Commission also organizes national clinical inspection centers and provincial clinical inspection centers to conduct inter-laboratory quality assessments for testing institutions. Evaluation, the current inter-laboratory quality evaluation of more than 35,000 laboratories shows that the pass rate has reached 99.7%.

The Beijing Clinical Trial Center is responsible for the accuracy of nucleic acid test results, and the Beijing Municipal Administration for Market Regulation will check the shelf life of relevant medical equipment.

According to the website of the Beijing Municipal Administration of Market Supervision, on April 13, 2022, the law enforcement officers of the Fengtai District Market Supervision and Administration Bureau conducted an on-site inspection of the nucleic acid testing point at the business premises of Beijing Shizhentang Integrated Traditional Chinese and Western Medicine Co., Ltd. The sample preservation solution used has exceeded the shelf life of nearly three months, and as a result, he will be punished according to law, with a fine of 50,000 yuan and confiscation of illegal property.

　　"There is also the Food and Drug Administration, which also has the right to inspect us, mainly to check whether the reagents used are expired, whether the procurement process is standardized, how suppliers are screened, etc." said the above-mentioned staff member.

　　From the perspective of the main body of supervision, the staff told Sino-Singapore Jingwei that the three-party testing institutions that undertake government orders in Beijing will have government personnel stationed, and one institution corresponds to a supervisory expert who is responsible for the supervision of the whole process of nucleic acid testing, including from sample entry to Amplification, entry, etc., laboratory disinfection, etc.

　　The official website of the Beijing Municipal People's Government also elaborated on the on-site supervision mechanism, focusing on the three major links of "collected", "not deteriorating" and "accurate measurement", and strictly managed the whole process of collection, inspection and reporting.

Each district has established on-site supervision working groups. Health supervisors and on-site cadres strictly follow the on-site supervision points and checklists, and conduct daily medical inspection quality control, laboratory biosafety, hospital infection prevention and control, and health supervision and inspection of nucleic acid testing institutions. .

　　It is worth noting that on May 22, the Office of the National Medical Insurance Administration and the Medical Rescue Team of the Joint Prevention and Control Mechanism for Novel Coronavirus Pneumonia Outbreak issued the latest notice, requiring all localities to reduce the number of single-person and single-person tests for the new coronavirus nucleic acid test before June 10. It is not higher than 16 yuan per person, and the multi-person mixed inspection is reduced to not more than 5 yuan per person.

In the case of large-scale screening and normalized testing organized by the government, testing institutions are required to provide services based on a multi-person mixed test of no more than 3.5 yuan per person.

　　Sino-Singapore Jingwei noted that, according to media reports, some nucleic acid testing institutions are "not making ends meet" when prices continue to drop.

At the same time, under the normalization of nucleic acid, many suppliers told Sino-Singapore Jingwei that all the testing and sampling fees for nucleic acid testing are currently paid in advance, and no payment has been received yet.

In this case,

(Sino-Singapore Jingwei APP)

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