The Risk Analysis And Risk Control Of The External Environmental Leakage Of BSL-3 Laboratories

In the new century, in order to deal with the global continuing outbreak of infectious diseases, such as SARS, H5N1, MERS, Ebola, and the threats of malicious use of high-risk pathogens, numerous countries have to strengthen the research of highly pathogenic microorganisms and build a series of high-level biosafety laboratories. As the rising amounts of laboratories, the laboratory biosafety has attracted widespread attention, and there are a few times serious laboratory biosafety accidents in recent years, what caused laboratory personnel exposed to the risk of infection, the surrounding environment contaminated, diseases outbreak, serious economic losses, the social great panic, and waked up biosafety laboratories.Biosafety laboratories construction started late in China, there are 41 BSL-3 laboratories through the authentication until 2014, which have amounts of tasks and heavy load operation, and some is weak in the safe operation and management, the long-term continuous operation of some laboratories reduce the time for maintenance, what virtually increase laboratory biosafety risks. Therefore, it is important for laboratory management to analyze the laboratory biosafety risk factors and establish scientific and effective risk control measures.According to the high-level biosafety laboratories biological agents exposure causes, the laboratory biosafety accidents risk factors can be divided into the following categories: firstly, the personnel exposure and infection in the laboratories, secondly, laboratory external environmental leakage; thirdly, the malicious use or accidental loss of biological agents. Among them, external environment leakage often occurs without notice, and the leakage is always discovered through the investigation or by accidental after the biological agents spread and generate a certain incident, resulting in serious losses.At present, the study of high-level biosafety laboratories at home or aboard, has not carried out systematical research in risk analysis and risk control of the high-level biosafety laboratories external environmental leakage, did not elaborate on its specific risk factors and establish its specific control measures. At the same time, the risk management of biosafety laboratories in China is relatively weak, so the research is of great significance for BSL-3 laboratories maintaining safely.Our team had accumulated experience for a long time in the laboratory management, laboratory microbial sampling, disinfection evaluation in previous studies, formed a series of related operation standards, and researched in risk analysis, risk assessment and risk control of BSL-3 laboratories experimental activities during the period of "11th five-year plan" which clarified its risk and the control methods, and helped BSL-3 laboratories internal activities more safely. Now, through the risk analysis of BSL-3 laboratories external environmental leakage, this research clarifies its risk factors, raises the detecting and monitoring methods, forms comprehensive control measures, and then assists BSL-3 laboratories safety management of laboratories external environmental leakage.This research mainly discusses the risk analysis and risk control of laboratories external environmental leakage, bases on the laboratory leakage accidents "situation" and the experiences in laboratory operation management, analyzes the risk of key parts in laboratory "four circulations" approach that may lead to leakage, makes sure the paths and the specific risk factors of lab highly pathogenic microorganisms external environmental leakage, builds the external environmental leakage detecting and monitoring methods and technical standards, and then puts forward the reasonable comprehensive control measures to help BSL-3 laboratories external environmental leakage management in China.Specific methods and results of the study include: 1. Use FTA to analyze the risk paths and factors of external environmental leakage.Firstly, searching papers in the Pub Med database, the USA CDC website andChina Hownet by using external environmental leakage related keywords to findout leakage accidents reports in the retrieval of literature, as a result, acquiring 45accidents and their leakage paths, reasons and risk factors,and then suming up thethe environmental leakage paths. 2. To specific parse the risk factors in each path that cause pathogen leakage in timeand space order, and analyze the leakage forms and reasons, result in thecomplete fault tree of BSL-3 laboratories external environment leakage. 3. Base on risk factors discovered by risk analysis, to advance now detecting andmonitoring methods about leakage or transform from the accumulation ofdisinfection evaluation methods, specific include:1. Object surface sampling anddetection, 2. Air sampling and detection, 3. Sewage sampling and detection, 4.Autoclave sterilizing effect testing, 5. HEPA testing; 6. The pipe leakage testing. 4. To establish the technical standards of the detecting methods, such as scope,reagents material, sampling and detecting method, results interpretation and soon. 5. Considering the existing conditions in the laboratory, to carry out the evaluationtests to object surface sampling and detection by using e. coli. As a result, itmakes sure that the method can find out the bacteria where contain 101cfubacteria. 6. To carry out the evaluation tests to sewage sampling and detection by usingbacillus stearothermophilus. As a result, it makes sure that the membranefiltration method can find out the bacteria in water which contains 101 cfu bacteria.Then the field test of sewage treatment system shows that the method sensitivitycan carry 100 cfu and the system can not achieve the sterilization.7. According to risk analysis of BSL-3 laboratories external environment leakageand its detecting and monitoring methods, to put forward the risk controlcomprehensive measures of each path for BSL-3 laboratories management.