Assessment of compliance with the International Organization for Standardization 15189:2012 requirements in four medical biology laboratories in Bafoussam, Cameroon

The medical laboratory plays a crucial role in patient care, and quality assurance is essential for ensuring the accuracy of results. The International Organization for Standardization (ISO) 15189 standard outlines the requirements for medical biology laboratories. Non-compliance with these standards can lead to serious errors. This study assessed the compliance of four medical biology laboratories in Bafoussam (Cameroon) with the requirements of the ISO 15189:2012 standard, following observations of deficiencies in quality assurance practices. The objectives were to identify dysfunctions and their underlying causes, and to propose recommendations for remediation. The research strategy employed a normative evaluation based on a systemic approach. The organization and operation of the laboratories were analyzed in relation to ISO 15189:2012 standard. The main activities involved conducting a systematic compliance audit, evaluating conformity with the applicable ISO 15189 requirements, and identifying and documenting any non-conformities. The results indicated that the service quality of the studied laboratories varied from one laboratory to another in relation to the ISO 15189:2012 standard, with none achieving the 80% threshold required for conformity. Specifically, the general averages for each chapter of the standard were 46% for management requirements and 51% for technical requirements. The study revealed that the laboratories in Bafoussam exhibit numerous shortcomings. These laboratories need to make substantial efforts to implement corrective actions to meet quality standards, and underlines the need to extend this study to all laboratories in Cameroon for better detection of public health emergencies.