China News Service, July 13 (Xinhua) According to the official website of the National Health and Health Commission, the State Council's medical treatment team for the joint prevention and control mechanism of the new coronavirus pneumonia epidemic has recently issued the "Handbook of New Coronavirus Nucleic Acid Detection in Medical Institutions (Trial)". The manual requires that the testing capacity of each medical institution should match the number of outpatient visits, inpatient visits, etc., and the amount of collected specimens, to avoid the backlog of specimens, specimen failure, and test results caused by the number of collections significantly exceeding the detection capacity. Slow feedback and other issues.
Data map: People take samples of new coronary pneumonia nucleic acid at the sampling site of Beijing Anzhen Hospital. China News Agency reporter Hou Yushe
The State Council responded to the medical treatment team of the new coronavirus pneumonia epidemic situation joint prevention and control mechanism, in order to further standardize the technical personnel of new coronavirus (hereinafter referred to as new coronavirus) nucleic acid detection, specimen collection, specimen management, laboratory testing, results reporting, etc. This manual was developed to improve the detection quality, improve the detection efficiency, and meet the needs of the new coronavirus nucleic acid detection. The manual is applicable to all medical institutions that carry out the detection of new coronavirus nucleic acid.
In terms of technical personnel, the manual requires that the technical personnel engaged in the collection of specimens for the detection of new coronavirus nucleic acid should undergo biosafety training (qualified training), be familiar with the types of specimens and collection methods, be familiar with the procedures and precautions for specimen collection, and record the specimen information. To ensure that the quality of the specimen meets the requirements, and the specimen and related information can be traced back. Laboratory testing technicians should have college degree or above in related majors or have qualifications for intermediate and higher professional technical positions, and have more than 2 years of laboratory work experience and training certificates in genetic testing. The staff equipped in the laboratory should be suitable for the testing items and the amount of specimens carried out to ensure timely and skilled experiments and report the results, and to ensure the accuracy of the results.
In terms of specimen collection, the manual requires that the detection capacity of each medical institution should match the number of outpatient visits, hospitalizations, etc., and the amount of specimens collected, to avoid the backlog of specimens and specimens caused by the number of collections exceeding the detection ability. Problems such as failure and slow feedback of test results. The manual also stipulates the sampling point settings, staffing and protection requirements, sampling procedures, and collection methods.
In terms of specimen management, the manual sets specific requirements for specimen packaging, specimen submission for inspection, specimen reception, specimen storage, and collection and testing of mixed specimens.
In terms of laboratory management, the manual requires that laboratories carrying out nucleic acid testing should have biosafety level 2 and above laboratory conditions that have been reviewed and filed by the health and health administrative department, as well as laboratory conditions for clinical gene amplification testing. The manual also specifies the requirements for laboratory zoning, main instruments and equipment, and laboratory testing.
The manual also stipulates that for patients with fever and emergency department, report the nucleic acid test results within 6 hours; for general outpatients, inpatients and accompanying persons, etc., in principle, report the results within 12 hours; Generally report the results within 24 hours. The medical institution shall issue a test report for the examinee and inform them of the way of inquiry, and shall not issue a test report for any reason. All medical institutions shall mutually recognize the test results under the regulations of the health administrative department. Medical institutions can use various forms such as paper, express, network or information system to issue nucleic acid test reports, and pay attention to protecting personal privacy. When a positive result of nucleic acid test is found, infectious disease reporting and follow-up epidemiological investigation should be conducted within 12 hours according to relevant requirements.
The manual also specifies the specific contents of specimen safety management, laboratory testing safety management, laboratory medical waste management, laboratory pollution treatment, etc.