Abstract
Introduction
Establishing and maintaining quality standards in medical laboratories is a significant challenge due to the rapid advancements in analysis techniques and technologies. In Morocco, the “Guide de Bonne Execution des Analyses’’ (GBEA) is the primary regulation framework overseeing quality assurance in laboratories. However, it does not adequately address potential gaps that could compromise patient safety.
Methods
In this article, we compared five quality management systems through normative frameworks in Morocco, France, and the United States to develop an enhanced model adapted to the Moroccan context.
Results
The comparison reveals that the extensive roles and responsibilities of a laboratory director and the inability to delegate tasks to qualified staff members in the Moroccan GBEA pose a challenge to the effective leadership and detection of non-conformities. Adopting the French GBEA, the Clinical Laboratory Improvement Amendments CLIA and the International Standardization Organization ISO 15189 Documentation model that covers all analytical phases, process and procedure reviews, and robust quality control measures could serve as strengths in achieving successful accreditation without compromising the laboratory's technical, administrative, and financial stability. The principles of risk management and safety are increasingly important in the analytical process to ensure ongoing improvement and the safety of both staff and patients.
Conclusions
In this sense, adopting a progressive model, starting with detailed documentation, quality control, staff qualification and adaptation of requirements to the Moroccan context will enable medical laboratories to achieve quality without putting them in administrative and financial challenges while preserving continuous improvement.