Nigeria’s dual laboratory regulators complicate ISO 15189:2022 accreditation push

A new review argues that Nigeria’s medical laboratories face a distinctive governance problem as they confront the world’s updated benchmark for laboratory quality: two statutory regulators with overlapping mandates, a decades-long professional dispute over who should head laboratories, and an accreditation system that remains almost entirely voluntary. The analysis, published in Discover Health Systems, examines how this regulatory dualism may complicate implementation of ISO 15189:2022, the international standard for medical laboratory quality and competence that was significantly revised in December 2022.

The standard places leadership-related responsibilities within its structural and governance requirements. Clause 5 addresses the legal entity, laboratory director, laboratory activities, structure and authority, objectives and policies, and risk management. Crucially, the authors note, ISO 15189:2022 is concerned with clearly defined responsibility, authority and accountability for laboratory activities and the management system rather than with prescribing which profession should hold a particular title. In developed health systems, laboratory governance is structured around organizational accountability rather than inter-professional territorial disputes: the United States’ CLIA framework establishes functional qualification pathways for laboratory directors and supervisors based on test complexity tiers, while UK laboratories accredited by UKAS operate under integrated pathology directorate models with defined reporting lines.

Nigeria presents a different picture. Pathology in the country dates back to the colonial era, with early histopathology services at Lagos Island General Hospital in 1893 and expansion in the 1960s as foreign-trained pathologists returned. Medical laboratory science developed later into a structured profession, progressing through legislative milestones including Decree No. 56 of 1968 and culminating in the Medical Laboratory Science Council of Nigeria Act No. 11 of 2003, which established the MLSCN as the statutory regulator of medical laboratories. Pathologists, meanwhile, are regulated by the Medical and Dental Council of Nigeria under the Medical and Dental Practitioners Act.

The review traces the resulting gridlock to conflicting provisions within these enabling Acts. The MDCN Act empowers the council to regulate the operation of clinical laboratory practice in the field of pathology, a rationale grounded in clinical responsibility: pathologists argue that a laboratory is a clinical consultation service whose leadership must integrate laboratory data with patient history and assume legal liability for diagnostic decisions. The MLSCN Act, by contrast, grants the council power to inspect, regulate and accredit medical laboratories, both public and private, and explicitly states that medical laboratories shall be headed by a medical laboratory scientist with cognate experience. This position rests on technical competence, treating the laboratory as a distinct technical facility requiring autonomous management of analytical processes, quality control and operational logistics.

Because one Act regulates clinical laboratory practice while the other regulates medical laboratories, and because the distinction between the two is not clearly defined in law, the dispute has produced a persistent regulatory impasse. The National Industrial Court of Nigeria has issued judgments addressing the statutory scope of medical laboratory scientists and their claims concerning laboratory departmental leadership, but the review finds these decisions have had limited practical harmonizing effect, since they operate within the wider governance framework of teaching hospitals. Many tertiary institutions provide diagnostic services through specialized pathology departments rather than a single medical laboratory department, complicating the practical application of statutory headship, and administrators face a dilemma between adhering to court judgments and maintaining internal clinical governance bylaws.

The professional rivalry is sustained and institutionalized by associations on both sides, principally the Nigerian Medical Association and the Association of Medical Laboratory Scientists of Nigeria, which the review says regularly mobilize membership dues to prosecute protracted jurisdictional litigations. The core areas of friction include headship of laboratories, professional autonomy and recognition, and disparities in remuneration and career progression linked to leadership eligibility. Inter-professional disputes have been associated with industrial actions that can disrupt healthcare delivery, and the authors argue that such conflicts can consume managerial attention and institutional resources that would otherwise support staff training, preventive equipment maintenance, quality improvement initiatives and participation in external quality assessment programmes.

On the question of actual accreditation, the review reports that formal ISO 15189 accreditation in Nigeria remains limited. Available official sources give different counts depending on the scheme and reporting date: the Nigeria National Accreditation System currently lists four active medical testing laboratories, while the MLSCN reported in January 2025 that nine medical laboratories had received accreditation to ISO 15189:2012 and/or ISO 15189:2022 through its Accreditation Service. The authors emphasize that these figures reflect different accreditation schemes and reporting periods, but both indicate limited uptake. Accreditation remains distinct from regulatory inspection and facility registration, and MLSCN guidance describes ISO 15189 accreditation as voluntary, while inspection forms part of the regulatory approval process.

The review is careful to qualify its causal claims. It states that the available evidence does not establish that regulatory dualism directly causes quality management system failure or poor accreditation outcomes; rather, it supports a plausible governance pathway through which ambiguity or fragmentation of authority could hinder consistent implementation, accountability and risk management. Nigeria’s laboratory quality environment is also shaped by infrastructural deficits, unreliable electricity supply, supply-chain constraints, workforce limitations, equipment-related challenges and inadequate or inconsistent financing. The policy challenge, the authors conclude, is better understood as one of policy coherence, implementation, coordination and resourcing rather than an absence of national laboratory guidance or accreditation infrastructure. Comparative evidence from sub-Saharan Africa, including institutional experiences at Ghana’s 37 Military Hospital and Tanzania’s Bugando Medical Centre, indicates that accreditation progress in resource-constrained settings depends on sustained management commitment, defined responsibilities, staff engagement, technical support and sustainable financing.

Among the pathways proposed by the authors are phased accreditation requirements for designated reference laboratories, progressive integration of appropriate quality benchmarks into facility regulation, legislative review to clarify the boundaries between the MDCN and MLSCN mandates, and strengthening of existing coordination mechanisms such as the National Laboratory Technical Working Group rather than creating parallel structures. They recommend implementing these measures as a sequenced programme: immediate strengthening of national coordination, medium-term legislative review and phased accreditation strategy, and longer-term sustainable domestic financing for quality system maintenance. The review was conducted as a structured narrative review with a PRISMA-informed selection process, identifying 423 records and synthesizing 49 sources published between 2000 and 2026, and its authors acknowledge that the heterogeneous evidence base means the review identifies associations and plausible pathways rather than demonstrating causal relationships between regulatory dualism and accreditation outcomes.

Subject of Research: Regulatory dualism in Nigerian laboratory medicine and its implications for ISO 15189:2022 implementation

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

Article References: Basil, B., Myke-Mbata, B. K., & Mba, I. N. (2026). Fragmented leadership and regulatory dualism in Nigeria’s laboratory medicine practice and their implications for ISO 15189:2022 implementation. Discover Health Systems, 5(1), Article 89. https://doi.org/10.1007/s44250-026-00431-x

Image Credits: AI Generated

DOI: 10.1007/s44250-026-00431-x

Keywords: ISO 15189:2022, Nigeria, laboratory medicine, regulatory dualism, MDCN, MLSCN, laboratory accreditation, quality management systems, health governance, pathology, medical laboratory science, sub-Saharan Africa