Abstract:

Objective: To construct a biosafety management indicator system for clinical testing laboratories dealing with tuberculosis. Methods: Based on the research team’s previous experience in laboratory biosafety management and inspection supervision, a literature review was conducted to collect domestic laboratory biosafety standards, including “WS 233—2017 General Guidelines for Biosafety in Pathogen Microorganism Laboratories”,“CNAS—CL05—2009 Laboratory Biosafety Accreditation Criteria”, and “GB 19489—2008 General Requirements for Laboratory Biosafety”. After internal discussions within the research team, a preliminary pool of candidate biosafety management indicators was developed, and a framework for the system was constructed. Two rounds of external expert consultations were conducted based on this framework, with experts determining inclusion/exclusion of each indicator and evaluating their importance rate. Analytic Hierarchy Process (AHP) was used to calculate weight coefficients of each indicator, ultimately forming a three-level evaluation indicator system for biosafety management in tuberculosis clinical testing laboratories. Results: A total of 15 and 14 expert consultation forms were collected in the first and second round, with response rates of 100.0% and 93.3%, respectively. The first round mainly focused on revising the structure of the indicator system, while the second round involved rating importance of indicators. The authority coefficient of experts in the second round was 0.76, indicating high reliability. The coordination coefficients of indicators at all levels in both rounds were greater than 0.1, and the Kendall’s W consistency test showed that, except for the first-level indicators, all P-values were less than 0.05, indicating good consistency among expert opinions. A practical and operational three-level biosafety management indicator system for tuberculosis clinical testing laboratories was finalized, comprising 5 first-level indicators, 13 second-level indicators, and 44 third-level indicators. Conclusion: A biosafety management indicator system for tuberculosis clinical testing laboratories has been constructed based on scientific theory. It can be used to evaluate the biosafety management level of tuberculosis clinical testing laboratories and guide laboratories to improve management efficiency through regular self-inspections. It also provides a scientific basis for healthcare institution managers to develop management systems and policies.

Key words: Tuberculosis, Laboratory infection, Safety management, Models, organizational