Management of non-conformities in the pre-analytical phase of the medical analysis laboratory

The pre-analytical phase is a critical step in medical biology analyses, encompassing all stages from test ordering to sample presentation on the analyzer. The aim of this study is to propose a quality management approach for handling non-conformities in the pre-analytical phase of a medical analysis laboratory.

This study investigated various pre-analytical non-conformities in a medical biology laboratory in Casablanca over an 8-month period. To address the primary causes of these non-conformities, we employed several quality tools, including FMECA, Ishikawa diagram, Pareto diagram, and brainstorming. Our work was structured according to the Plan-Do-Check-Act cycle. Excel was used for data processing and diagram creation, while Zotero managed bibliographic references.

Two non-conformities were classified as high-criticality: the first concerned sampling errors (incorrect patient identification and non-compliant labeling), and the second involved non-compliant subcontracting samples. After determining the root causes of these two nonconformities, we implemented corrective actions and achieved a 46% improvement for the non-conforming during sampling and a 49% improvement for the non-conforming subcontracting samples.

After the first PDCA cycle, we achieved a significant improvement in the two non-conformities studied. Using quality tools, we prioritized the most critical non-conformities for immediate action. In addition, other methods enabled us to identify all the potential causes of these two non-conformities, pinpointing those responsible for 80% of their occurrence. A second PDCA cycle will be implemented to further improve the results obtained in the first cycle.