For many Nigerians, the medical laboratory is the quiet but critical link between the doctor’s doubt and the patient’s diagnosis. Yet, it is also an area of healthcare where patients often have little idea about who is responsible for ensuring that the laboratory they patronise is competent, properly staffed and capable of producing reliable results.
As we know, the Medical Laboratory Science Council of Nigeria (MLSCN), established by Act 11 of 2003, is the Federal Government’s statutory regulatory body for medical laboratory science. Its mandate includes registering and licensing practitioners, regulating their training, inspecting and accrediting public and private medical laboratories, and regulating diagnostic reagents and chemicals.
So, the problem is not that Nigeria has no regulator. The major question is, how effectively is the existing regulatory framework reaching the thousands of laboratories that Nigerians depend on every day?
A patient can walk into two laboratories in the same city and discover significant differences in the price of the same test. We also know that price variation, by itself, does not necessarily mean malpractice, as laboratories have different equipment, staff structure, locations, reagents, quality systems and operating costs. The regulator’s primary responsibility is therefore not to impose one national price for every test but to ensure that whatever price is charged, the service meets acceptable professional and quality standards.
However, the more disturbing issue is the reliability of results.
Consider the case of a couple preparing for marriage who were asked to undergo medical testing. The woman, who had previously known her genotype status, received a result that appeared inconsistent with her medical history. A second laboratory produced a result that agreed with the first, creating anxiety and raising questions about what had happened.
The lesson is not that either laboratory necessarily produced a wrong result. Rather, a result with potentially life-changing consequences should never be treated as infallible simply because it has been printed on laboratory letterhead. Where a result is unexpected or inconsistent with previous records, professional practice should provide mechanisms for verification, repeat testing and, where necessary, referral to a competent reference laboratory.
This is where Nigeria needs to move from basic regulation to a much stronger quality-assurance culture.
The MLSCN itself has acknowledged the problem of non-compliance. In August 2025, the Council reported inspections in Lagos and Ogun that uncovered unregistered laboratories, poor bio-safety practices and cases in which unqualified individuals were performing diagnostic tests. The Council said some non-compliant facilities were sealed. That is evidence that enforcement is taking place, but it is also evidence that illegal or inadequate practice remains a problem.
Nigeria’s own laboratory guidelines recognise that quality requires more than simply registering a facility. They identify issues including qualified resident medical laboratory scientists, laboratory information systems and regulatory approval.
The ideal situation is what is increasingly regarded internationally as the norm – licensing plus continuous quality management plus independent accreditation plus proficiency testing.
The World Health Organisation identifies ISO 15189 as the international standard specifically designed for medical laboratories. It covers quality and competence and requires laboratories to establish systems covering personnel, equipment, processes and continual improvement.
Britain provides a useful example. UKAS accreditation against ISO 15189 independently assesses whether medical laboratories have the required quality-management systems and technical competence. In the United States, the Clinical Laboratory Improvement Amendments (CLIA) establish federal quality standards for virtually all facilities testing human specimens for diagnosis, prevention or treatment. Laboratories can be inspected, sanctioned and, where necessary, have their certificates suspended or revoked. Importantly, the US system also makes laboratory performance and enforcement information available to the public.
That is the direction Nigeria should pursue more aggressively.
Every licensed laboratory should be easily verifiable by the public, and accreditation status should be displayed and searchable. Inspections should be regular rather than occasional. Results should have proper patient identification and traceability. Laboratories should participate in external quality assessment and proficiency-testing programmes. Equipment should be calibrated, reagents properly controlled and staff competency regularly assessed. Above all, there must also be consequences for repeated failure.
But regulation should not stop at the laboratory door. Courtesy, confidentiality, proper patient identification and careful handling of samples are part of quality healthcare. A laboratory attendant who confuses patients, samples, or tests is not merely displaying poor customer service. Such behaviour can potentially become a patient-safety issue.
Nigeria already has the regulatory institutions and the legal foundation. What is needed now is more visible enforcement, wider accreditation, stronger public disclosure and a culture in which accuracy is valued above speed and profit.
Medical laboratory results can determine whether someone undergoes surgery, starts lifelong medication, receives a blood transfusion, is declared fit for marriage or employment, or is wrongly told that he or she has a serious disease. That is too much responsibility to leave to guesswork.
Nigerians deserve to enter any licensed laboratory with the reasonable confidence that the person collecting the sample is competent, the equipment is fit for purpose, the test is properly conducted, and the result can withstand independent scrutiny.
That should not be an exceptional standard in our nation, but the standard.
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