Strengthening laboratory quality through risk-based thinking: Implementation challenges and opportunities in Nigeria

Medical laboratories in Nigeria are pivotal for national health security but operate under severe infrastructural deficits and a high disease burden. Traditional Quality Control (QC) methods are prevalent but reactive and fail to address the high proportion of errors occurring in pre- and post-analytical phases. This necessitates a strategic shift toward Risk-Based Thinking (RBT) as mandated by the new ISO 15189:2022 standard to bridge the gap between international requirements and local environmental volatility.

This review assesses the current state of laboratory quality in Nigeria and evaluates the applicability of RBT frameworks (ISO 15189:2022 and CLSI EP23) in resource-limited settings. It aims to identify structural and cultural implementation barriers and propose actionable mitigation strategies.

This comprehensive narrative review utilized a systematic search strategy across PubMed, Scopus, and AJOL covering 2010-2025. Data from 85 identified sources, including 66 studies selected using a defined criticality matrix, were synthesized using the Plan-Do-Check-Act (PDCA) framework operationalized with specific quality indicators to contrast regulatory expectations with operational realities.

The sector is polarized, with elite private and donor-funded public laboratories driving accreditation (representing only 26 facilities or < 0.5% of the sector), while the majority struggle with a punitive blame culture, the "Japa" syndrome workforce crisis, and erratic power supply. RBT frameworks like Parvin's Risk Management Index offer tools to quantify these unique environmental risks and enable targeted resource allocation. Case studies from EL-LAB and HVL, alongside adaptive lessons from the COVID-19 pandemic, demonstrate that RBT facilitates resilience by scientifically validating investments in solar energy and staff competence to mitigate local hazards.

Transitioning to RBT is critical for Nigerian laboratories to move from reactive compliance to proactive resilience. By managing risks like power instability and supply chain volatility, laboratories can effectively optimize scarce resources through data-driven mitigation to ensure patient safety.