https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6478205/

DOWNLOAD DOCUMENT: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6478205/pdf/18-0220.pdf

"Abstract:

Experienced, qualified personnel certified to work in high-level biocontainment laboratories contribute to the safe operation of these facilities. China began a training program for laboratory users after establishing its first Biosafety Level 4 laboratory, the Wuhan National Biosafety Laboratory (Level 4) of the Chinese Academy of Sciences. We provide an overview of the content of this training program, which can serve as a reference for developing national norms for high-containment laboratory training.
Keywords: biosafety training, BSL-4, China, high-containment laboratory, laboratory, pathogens, personnel certification, high-consequence pathogens

Over the last 2 decades, numerous infectious diseases, including Ebola, Marburg hemorrhagic fever, Crimean-Congo hemorrhagic fever, Lassa fever, severe acute respiratory syndrome (SARS), avian influenza A(H5N1), Rift Valley fever, and Nipah and Hendra viral diseases, have emerged and re-emerged. These infectious diseases pose serious threats to public health and global economies. For example, 28,616 suspected cases and 11,310 deaths were reported during the large and complex Ebola outbreak in West Africa during 2013–2016 (1). In addition, as the threat of terrorism increases globally, the risk for bioterrorism is expected to increase as well. To prepare for biological threats, scientists must research dangerous pathogens to develop effective methods to prevent, diagnose, and treat the diseases caused by them.

Laboratories are classified into biocontainment levels 1–4, depending on the pathogenicity of microbes investigated. Biosafety Level 4 (BSL-4) laboratories investigate the most dangerous pathogens and have the maximum biocontainment levels. Microbes contained in BSL-4 laboratories pose a significant risk for transmission and are frequently fatal; most have no reliable cure. BSL-4 laboratories provide a safe environment in which laboratory staff can work with and study these highly pathogenic microbes.

After the 2003 SARS epidemic, the government of China initiated a plan to construct a national high-level biosafety laboratory system to prepare for and respond to future infectious disease outbreaks. One of the goals was to build a BSL-4 laboratory that meets the national and international standards for diagnosing, researching, and developing antiviral drugs and vaccines while additionally preserving highly pathogenic BSL-4 agents for future scientific research. Within the framework of the Sino-French Cooperation Agreement on Emerging Infectious Diseases Prevention and Control (2) signed in October 2004, China constructed its first BSL-4 laboratory, the Wuhan National Biosafety Laboratory (Level 4) of the Chinese Academy of Sciences, in 2015. During construction, prospective BSL-4 laboratory staff members visited France, the United States, or Australia for BSL-4 training and capacity building. After 2 years of testing and commissioning, Wuhan BSL-4 laboratory passed a series of assessments, and the China National Accreditation Service for Conformity Assessment certified it as meeting the highest biosafety standard in January 2017 (3). In August 2017, the National Health Commission of China approved research activities involving Ebola, Nipah, and Crimean-Congo hemorrhagic fever viruses at the Wuhan BSL-4 laboratory (4).

The safety and function of a BSL-4 laboratory rely not only on the containment facility and biosafety management systems but also on highly qualified and experienced staff. Many recorded laboratory accidents are related to personnel error. Qualified staff ensure the efficacy and safety of a high-containment laboratory. Developing an appropriate and rigorous BSL-4 laboratory user training system is an essential prerequisite for ensuring the safety of laboratory workers, operations, and the environment (5,6). We designed a training program for BSL-4 laboratory users that follows local, national, and international guidelines and regulations. Our program ensures the safety and security of staff involved in research at the Wuhan BSL-4 laboratory."