| Objective:To construct a filing and evaluation system of biosafety level 2 laboratory and apply it to an empirical study of biosafety level 2 laboratories in the Urumqi region,in order to provide a reference basis for improving the biosafety capacity of laboratories,and then to systematically evaluate the development of biosafety level 2 laboratories and the overall biosafety situation in the region,and to further optimize the safety management of biosafety laboratories.Method: Based on the definition of the basic meaning of "biosafety" in the Biosafety Law,following the "risk protection principle" for the control of external risks in laboratories and the "risk prevention principle" for the control of internal risks in laboratories,the framework of the evaluation system was designed based on the Biosafety Law,the Regulations on the Administration of Biosafety in Pathogenic Microbiological Laboratories,the General Requirements for Laboratory Biosafety(GB 19489-2008)and other regulations and standards,combined with the actual filing situation of biosafety laboratories in Urumqi.The Delphi expert consultation method was used to conduct two rounds of correspondence to determine the indicator system;the hierarchical analysis method(AHP)was used to construct the judgment matrix,and the matrix was input to yaahp12.6 software for consistency testing and weight calculation to finally determine the indicator weights.The data were analyzed and collated using Excel 2019 and SPSS 20.0.The reliability of the results was evaluated by the expert positivity coefficient,the expert authority coefficient and the degree of coordination of expert opinions.The empirical study adopted a convenience sampling method to select BSL-2 in the Urumqi area as the subjects of the empirical study,and organized on-site inspections by experts from the Expert Committee on Biosafety Laboratory Filing.Count data were expressed as relative numbers,measurement data were expressed as ?± ,and one-way ANOVA was used for comparison between multiple data groups.The test level was α = 0.05,and P<0.05 was considered a statistically significant difference.Results:(1)The questionnaire recovery rate in both rounds was 100.00%,the authority coefficient of experts was >0.7,and the value of Kendall’s harmony coefficient(W)was high and statistically significant,indicating that the degree of experts’ positivity,authority and coordination of opinions were all high,and it was finally determined that the filing and evaluation system of biosafety level 2 laboratories contained three primary indicators,such as safety protection(A1),operation and management(A2)and system construction(A3),12 secondary indicators and 44 tertiary indicators.(2)As a result of the empirical study,the eight CDC-affiliated biosafety level 2laboratories scored a maximum of 99.047 and a minimum of 94.692,with an average score of 96.607;the 12 medical institutions’ biosafety level 2 laboratories scored a maximum of98.678 and a minimum of 88.937,with an average score of 94.781.Except for one medical institution whose laboratory scored 80-89 and was considered good,all the other 19 laboratories belonging to the institutions participating in this evidence-based study scored above 90 and were considered excellent.Using the institution as the independent variable and the laboratory score as the dependent variable for analysis,there were statistically significant differences between institutions in terms of total score,institutional construction in the primary indicators,laboratory facilities,organizational management,safety management system documentation and emergency disposal management system in the secondary indicators,and labelling system,safety inspection,equipment and bench disinfection,laboratory records and hazardous substance spill handling in the tertiary indicators,P < 0.05.Conclusion:(1)The results of the expert positive coefficient,authority coefficient,expert opinion concentration degree and coordination coefficient of this filing and evaluation system all show good,with good scientific and reasonableness,which play a good role in promoting the construction of laboratory biosafety capacity in the region.(2)The results of the empirical study show that there are differences in the biosafety levels of biosafety level 2 laboratories in different institutions in the Urumqi region,and it is recommended that the training of laboratory personnel should be further strengthened,the investment in laboratory facilities and equipment should be increased,and the laboratory management system should be strengthened. |
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