Abstract
The quality of microbiological diagnosis depends not only on technical competence but also on the robustness of the laboratory quality management system (QMS). This study assessed the QMS of the microbiology laboratory diagnosing salmonellosis at Saint-Luc General Referral Hospital in Kisantu and described bacterial culture results. A descriptive cross-sectional study was conducted. The QMS audit included 100 criteria distributed across quality domains and scored from 0 to 2. Overall compliance was calculated as the observed score divided by the maximum score. Microbiological data from 931 patients tested between May and July 2026 were analyzed using frequencies, the chi-square test, Fisher’s exact test, and logistic regression. The laboratory obtained 126/200 points, corresponding to 63.0% overall compliance. Reagents and consumables, the analytical phase, and antimicrobial susceptibility testing each reached 100%. The main weaknesses concerned organization and management (12.5%), nonconformity management (0%), and continuous improvement (0%). Among 931 cultures, 103 were positive (11.1%), including 30 Salmonella spp. isolates (3.2%). Age was associated with culture positivity in bivariate analysis (p = 0.030), but no variable was statistically significant in the multivariable model. The laboratory demonstrates encouraging analytical competence but an insufficiently institutionalized QMS. Priority actions should strengthen leadership, document control, quality control, nonconformity management, and continuous improvement.
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