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Abstract
Introduction: A non-conformity is an error in the process from test request to results delivery. They affect the quality of analyses and are often linked to human error. However, in Africa, most laboratories use a manual data management system. Our aim was to assess the superiority of the computerized laboratory system (CLS) over the manual system in reducing non-conformities. Methodology: We conducted a case-control study, from January to April 2024, in four laboratories of the same biosafety level, two of which used a LIS and two a manual system. We matched employees by age, gender and years of experience. We determined the level of knowledge of the software packages. We then compared the proportions of non-conformities between computerized and manual systems using the chi2 test at the 5% threshold via SPSS 26. Results: Out of a total of 98 employees, 41 using a SIL and 47 a manual system, the median age was 37 [30-45] years, with a sex ratio of 0.5M/F in both groups. The majority were technicians (40%) with an average of 7 years' experience. In the total sample, the level of knowledge was unsatisfactory (50%) for the operation of a software package and good (86%) for manual recording. Compared with the manual system, SIL reduced by 30% the proportions of incorrect tube coding, assignment of the same code to several samples and forgotten reagent supply, with p<0.0001, p=0.003 and p=0.017 respectively. SIL reduced the probability of returning non-validated or incomplete results by a factor of ten (p=0.001). Conclusion: These data suggest that the use of an LIS contributes to a considerable reduction in the frequency of non-conformities in our context.
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