Abstract:

Objective: To assess the impact of the Strengthening Laboratory Accreditation Administration (SLMTA) program interventions on strengthening quality management in tuberculosis laboratories. Methods: Three laboratories (randomly numbered 1, 2, and 3) in Baoshan, Nanjing, and Chengdu were selected as pilot laboratories according to the selection criteria and voluntary declaration principle. Intervention measures, including training, communication, improvement actions, etc., were implemented in three pilot laboratories (baseline, intermediate, and terminal phases), followed by field assessment using standardized checklists at different phases. The differences in assessment results were analyzed by 12 quality system element. Results: At baseline assessment, the average score rate of three laboratories was (43.17±2.48) %, with 0 star for each laboratory. In the mid-term assessment, the average score rate of the three laboratories was (70.19±4.16) %, with laboratories 1 and 3 achieving 2 stars and laboratory 2 achieving 3 stars. At the final assessment, the average score rate of the three laboratories was (87.88±1.37) %, and all achieved 4 stars. The average scoring rate of the three project laboratories showed significant differences between different project phases (F=165.700, P<0.001). Among the 12 quality system elements, the average score rates of “Documentation and Records” “Organization and Personnel” “Equipment” “Process Control and Internal/External Quality Assessment” “Information Management” “Internal Review” “Management Review” “Internal Review” “Occurrence/Incident Management & Process Improvement” and “Corrective Actions” showed significant difference between baseline and final assessment, increasing from (46.43±0.00) %, (42.42±5.67) %, (43.31±8.07) %, (52.09±3.90) %, (71.35±5.42) %, (2.22±3.14) %, (25.00±13.61) % and (21.05±15.49) % at base line assessment to (83.33±1.68) %, (87.88±11.34) %, (93.66±0.40) %, (88.55±2.95) %, (89.81±0.48) %, (91.11±12.57) %, (88.89±10.39) % and (78.95±0.00) % at final assessment, respecively (t=31.010,P=0.001; t=10.010, P=0.010; t=9.108, P=0.012; t=9.709, P=0.010; t=4.559, P=0.045; t=11.090, P=0.008; t=4.600, P=0.044; t=5.284, P=0.034). Conclusion: SLMTA project implementation helps to improve the quality management of Tuberculosis laboratories, indicating that the intervention measures in the project can be more widely implemented in China.

Key words: Tuberculosis, Laboratories, hospital, Management quality circles, Quality control, Evaluation studies