Fragmented leadership and regulatory dualism in Nigeria’s laboratory medicine practice and their implications for ISO 15189:2022 implementation

The ISO 15189:2022 standard establishes a global benchmark for medical laboratory quality and competence, emphasizing clear organizational responsibility, authority, accountability, and patient-centered risk management. In Nigeria, however, jurisdictional overlaps and administrative dualism within professional regulation may complicate the establishment of coherent laboratory governance arrangements. This review examines the implications of fragmented leadership and overlapping professional mandates for laboratory governance and ISO 15189:2022 implementation, highlighting how the regulatory roles of the Medical and Dental Council of Nigeria (MDCN) and the Medical Laboratory Science Council of Nigeria (MLSCN) intersect within institutional laboratory governance. Using a structured narrative review design, we systematically searched bibliographic databases and legal, regulatory, policy, and grey-literature sources published between 2000 and 2026, applying a PRISMA-informed selection process and qualitative thematic synthesis across predefined analytical domains to examine the historical and legislative origins of this dualism and its implications for laboratory governance and ISO 15189:2022 implementation. The study finds that, while ISO 15189:2022 focuses on organizational accountability rather than professional jurisdiction, unresolved regulatory ambiguity may complicate the alignment of leadership, organizational structure, and quality-management responsibilities. These factors coexist with infrastructural challenges, resource constraints, and the voluntary nature of accreditation, potentially limiting wider uptake of ISO 15189:2022 in Nigeria. Furthermore, we identify gaps in policy coherence and coordination within the broader national laboratory quality infrastructure, despite the existence of accreditation mechanisms and national laboratory guidance. Comparative evidence from SSA indicates that sustained laboratory quality improvement and progression toward accreditation depend on institutional leadership, defined responsibilities, staff engagement, technical support, and sustainable financing. We conclude that wider accreditation may be supported by phased requirements for designated reference laboratories, progressive integration of appropriate quality benchmarks into facility regulation, and a coherent national policy framework that clarifies institutional responsibilities while preserving the distinct functions of professional regulation, organizational governance, and accreditation.