Our country to provide nucleic acid testing services in health care institutions are mainly three categories: the first category, medical institutions. For example, hospitals, maternal and child health centers can provide nucleic acid testing services; the second category, CDC institutions. From the country to the province, to the city, to the county have CDC, can also provide nucleic acid testing; the third category, medical testing laboratories. "Medical testing laboratories are likewise one of the categories of healthcare organizations, which we usually call 'third-party testing organizations.'" Since a third-party testing organization is a medical institution, its approval, calibration and management, like any other medical institution, should be registered and approved in accordance with the relevant provisions of the Regulations Governing Medical Institutions and the Implementing Rules for the Regulations Governing Medical Institutions, as well as the Basic Standards for Medical Testing Laboratories promulgated by us. Approval of the organization is generally set up and approved by the health administrative department at the municipal level and above, following the same workflow and requirements for the approval of medical institutions. In accordance with the basic standards of our medical testing laboratories, we review the setup of their sections, personnel, housing and facilities, zoning layout, equipment, and the corresponding rules and regulations, etc., and after these conditions meet the requirements, we can obtain the "License to Practice in Medical Institutions". "After obtaining the License to Practice in Medical Institutions, the third-party testing organization should also provide testing services in accordance with the approved diagnosis and treatment subjects." If a third-party organization wants to carry out nucleic acid testing, it must comply with the relevant regulations for clinical gene amplification testing laboratories, have conditions of biosafety level 2 and above as well as PCR laboratories, and register for record in the corresponding health and health administrative departments. The personnel engaged in the test, should also be trained and qualified to carry out nucleic acid testing work.
Legal basis: "on the further improvement of the new coronavirus detection during the outbreak of the work of the notice" Article 1 to further strengthen the construction of laboratories, improve the detection capacity
Everywhere to be combined with the new coronavirus outbreak prevention, control and detection needs, to strengthen the construction of laboratories of medical and health institutions. Tertiary general hospitals should be established in line with biosafety standards for clinical testing laboratories at the second level and above, with the ability to independently carry out the new coronavirus detection; CDC agencies at all levels and the conditions of specialized hospitals, hospitals, independent medical testing laboratories should also strengthen the laboratory construction, improve detection capabilities. The relative lack of medical resources, relatively weak testing capacity, epidemic prevention and control pressure of the region, especially land border crossings, to select a strong comprehensive strength of the county-level medical institutions to be focused on supporting the realization of the county medical institutions with nucleic acid testing capacity.