Assessment and Optimization of the Pre-Analytical Phase of Biological Tests in the Biochemistry Laboratory at the Charles Nicolle Hospital of Tunis

Abstract

Abstract Pre-analytical phase is important for the quality management system in medical laboratory, given the high rate of non-conformities (NC) (85%), which have serious consequences on the analysis processes. This phase is usually not completely mastered in the clinical biochemistry laboratory. The aim of the study was to evaluate the pre-analytical process in the biochemistry laboratory, according to the medical biology in force: ISO15189 and Tunisian Good Laboratory Practices Guide (GLPG) and to carry out corrective actions to improve its quality in our establishment. The study was carried out in the biochemistry laboratory in Tunis, in the form of an internal audit included in the continuous improvement approach according to Plan, Do, Check and Act (PDCA), so a self-assessment grid was established in accordance with the requirements of normative an regulatory texts (ISO 15189v2012, GLPG). Analysis of the causes of NC identified was carried out using the 5M, and for optimal control of the studied activities, we used the risk management tool: Failure Mode, Effect and Criticality Analysis (FMECA) for a proactive management of the NC. The overall compliance score for the phase was 22.48 %, and the analysis results showed that all the steps were critical and focused essentially on the dysfunction in the management of the documentary system. The lack of awareness and training of personnel were the main failure modes according to their criticality. This methodology allowed us to study the conformity of pre-analytical phase, hence the control of its quality, which will lead to the systematic control of the process of execution of a biological examination.