To the health commissions of each province, autonomous region, directly-governed municipality, and of the Xinjiang production and construction corps.
Since the coronavirus epidemic occurred, the entire nation's medical establishments and disease control institutions have quickly implemented the state's relevant requests to carry out nucleic acid testing for the coronavirus, playing an important role in epidemic prevention and control. At present, the gradual resumption of work and production, the continuously increasing stress of importing the virus from abroad, the removal of controls on passage from Wuhan and Hubei, and the definite risk of transmission from asymptomatic carriers, have raised new requirements for coronavirus testing efforts. In some areas, problems such as insufficient laboratory capacity have emerged, making them unable to completely adjust to requirements for epidemic prevention and control. Notice of the following requirements is hereby given as follows so as to further complete efforts on coronavirus testing during the epidemic:
I. Further strengthen the construction of laboratories to increase testing capacity
All regions should summarize the requests for epidemic prevention and control and testing, and strengthen construction of medical institution laboratories. Level 3 general hospitals shall establish clinical testing laboratories compliant with bio-safety level 2 standards or higher, that have the ability to independently carry out novel coronavirus testing; all levels of disease control institutions and qualified specialized hospitals, level 2 hospitals, and independently established medical testing laboratories shall also strengthen laboratory construction and improve testing capacity. In areas where medical resources are relatively scarce, capacity for testing is relatively weak, and pressure for epidemic prevention and control is high, especially at ports of entry, a county-level medical institution with comprehensive strengths should be selected to give priority support, to make it so that medical institutions within the county have nucleic acid detection capability.
II. Put in place recording and entry requirements for laboratories, for testing in accordance with laws and regulations
Coronavirus testing shall be carried out by qualified medical establishments (including independently established medical testing laboratories) and disease control institutions. Medical establishments carrying out pathogen testing shall biosafety level 2 laboratory qualifications or above registered with the health department of a people's government for a districted-city, and meet the requirements of the "Measures on the Administration of Clinical Gene Amplification Testing Laboratories in Medical Establishments" (WeibanYizhengfa (2010) No. 194), and have PCR laboratory capacity Medical testing laboratories shall conform to the requirements of the "Basic Standards for Medical Testing Laboratories (provisional)" and the "Specifications for the Administration of Medical Testing Laboratories" (GuoWeiYifa (2016) No.37); and where medical establishments or disease control institutions entrust medical laboratories with carrying out coronavirus testing, they shall follow requirements and agreements they have signed to clarify the rights and obligations of both parties.
III. Expand the degree of training for medical and health personnel to standardize technical operations
Each region should follow the requirements of the "Technical Guide for Novel Coronavirus Laboratory Testing" (GuoWeiBanYiKong (2020) No. 156) to strengthen technical training and guidance for medical and health personnel to include all medical establishments carrying out coronavirus testing and increase standardization of operations. Ensure that relevant medical personnel are proficient in the standardized specimen collection methods of nasopharynx swabs, pharynx swabs, lower respiratory tract specimens, blood or serum specimens, and stool specimens, and that laboratory testing personnel are proficient in the use of relevant reagents and testing methods to process specimens, so as to reduce the impact on the accuracy and reliability of testing results from problems in technical operations. Laboratory testing personnel should go through strict standardized training, and complete bio-safety protections performing tests.
IV. Strengthen quality control for laboratory testing to increase testing quality
All laboratories shall use testing reagents and sampling swabs that have been approved by the drug regulatory departments, to strengthen laboratories' internal quality control, and normalize the acceptance of national or provincial level clinical inspection and quality control. Provincial administrative departments for health shall organize medical establishments that carry out new coronavirus testing within their jurisdictions to participate in inter-laboratory quality assessment in batches, ensuring each institution participates in at least one inter-laboratory quality assessment and is found qualified. Those that are found not unqualified through inter-laboratory quality assessments are not allowed to carry out coronavirus testing. The National Health Commission's Clinical Laboratory Center should continue to organize inter-laboratory quality assessment work and complete related technical guidance and support. The National Health Commission's Clinical Testing Center has already sent the "Report on the Nation's Coronavirus Nucleic Acid Testing Inter-Laboratory Quality Assessment Outcomes" to each provincial-level clinical testing center, and each medical establish is asked to complete efforts to improve quality.
V. Strengthen bio-safety management in laboratories, and do a good job of disposing of leftover specimens
all regions carrying out coronavirus testing shall comply with the "Regulations on Biosafety Management for Pathogenic Microorganism Laboratories" (State Council Order No. 424), and implement the requirements of the "Biosafety Guide for Novel Coronavirus Laboratories (Second Edition)" (GuoWeiBanKeJiaoHan (2020) No. 70), to truly strengthen bio-safety management. Each provincial-level administrative department for health should put forward opinions on the disposal of remaining biological samples in regional laboratories based on the actual conditions; and medical establishments and disease control institutions should implement entity responsibility and complete efforts on the use, preservation, and destruction of samples.
Comprehensive Group of the State Council Joint Prevention and Control Mechanism for Responding to the Covid-19 Epidemic