Analytical non-conformities in bacteriology : Incidence and impact

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Siwar Frigui
Salim Ben Jaafer
Yosra Chebbi
Anis Raddaoui
Wafa Achour

Abstract

Introduction: The incidence of analytical non-conformities (NC) is a particularly interesting quality indicator (QI) for evaluating the analytical process in conventional bacteriology. Our aims were to determine the incidence of analytical NC in bacteriology and to assess their impact on the time to results and on the cost.
Methods: We conducted a prospective descriptive study including all samples received at the Laboratories Department of the National Bone Marrow Transplant Centre for bacteriological analysis, over a 5-month period (July-November 2023).
Results: In total, 180 analytical NC were recorded, with an incidence of 56.7/1000 samples and 30.4/1000 technical operations. The number of NC was correlated with both the number of samples (R=0.564; p=0.006) and the number of technical operations (R=0.471; p=0.027). Analytical NC were dominated by incorrect culture (29%), error in antibiotic susceptibility testing (25%) and non-completion of a technical operation (20%). Causes of NC were dominated by the lack of training (28%) and the distraction (22%). Out of 180 analytical NCs reported, 102 had an impact on the
time taken to deliver results (56.7%), estimated at one day in all cases, and 77 had an impact on the cost of reagents (42.8%), estimated at 1056TD during the study period.
Conclusion: This study showed a high incidence of analytical NC in bacteriology, closely linked to the number of samples and technical operations, with a significant impact on the time to results and the cost of analyses.

Keywords:

Non-conformity , Quality , Accreditation , Bacteriology , Management

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