Quality Management System (QMS) Performance of Medical Laboratories in Secondary and Tertiary Healthcare Facilities in Nigeria: Results of a Multi-Facility Assessment Using the WHO SLIPTA Framework

Abstract Background Quality management systems are critical for accurate, reliable, and safe medical laboratory processes. Compliance with ISO 15189:2022 demonstrates laboratory competence, supports continual improvement, and provides a pathway for national and international accreditation. Inadequate infrastructure, limited human resource capacity, and inconsistent adherence to quality standards limit QMS implementation in many Nigerian laboratories. This study aims to assess the status of QMS implementation in selected secondary and tertiary medical laboratories in Nigeria, identify performance gaps, and highlight areas for intervention. Methods A cross-sectional study was conducted in 60 public medical laboratories, including 10 Global Fund-supported laboratories in Lagos. Using the WHO Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) version 3 checklist, 58 certified QMS auditors conducted assessments across 36 states and the Federal Capital Territory. Data were collected using Kobo Collect and analyzed with SPSS, QGIS, Microsoft Excel, and descriptive statistics. Results Generally, QMS implementation was low. Forty-Seven (78.3%) laboratories achieved 0-star status; 3 (5.0%), 2 (3.3%), 5 (8.3%), and 3 (5.0%) achieved one, two, three, and four stars, respectively. Performance was strongest in Supplier and Inventory Management (56.1%) and Information Management (52.3%). The weakest domains were Assessment (19.4%), Continuous Improvement (22.0%), and Organization and Leadership (26.1%), highlighting major deficiencies in leadership, internal audits, and quality improvement systems. Conclusion Significant system-wide gaps remain in QMS implementation across secondary and tertiary medical laboratories in Nigeria. Strengthening leadership, workforce capacity, structured mentorship, integration of laboratory services, institutional commitment, and coordinated national quality initiatives is essential to improve laboratory quality, reliability, and patient safety while advancing laboratories toward ISO 15189:2022 compliance and accreditation