MLSCN Tightens Regulation To Raise Diagnostic Quality

By Hannah Yemisi

The Medical Laboratory Science Council of Nigeria (MLSCN) has intensified regulatory oversight of medical laboratory services to improve diagnostic quality, patient safety and public health. Speaking recently at the Medical Laboratory Science Regulation Dialogue with the Association of Medical Laboratory Scientists of Nigeria (AMLSN) in Abuja, the Registrar and Chief Executive Officer of MLSCN, Dr Donald Ofili, said that the Council monitors more than 4,000 medical laboratories through 14 state offices, conducts routine inspections, validates diagnostic kits before approval and enforces compliance by sealing non-compliant laboratories. Ofili disclosed that about 30 Nigerian laboratories have attained ISO 15189:2022 accreditation and that the council recently became an Associate Member of the Global Accreditation Corporation Incorporated.

DECISION HIGHLIGHT

The strengthened regulatory regime raises the quality threshold for laboratory practice, increasing confidence in Nigeria’s diagnostic services while tightening compliance requirements for operators.

DECISION MEMO

The most immediate consequence of the initiative is a gradual improvement in the credibility of medical diagnosis, which underpins both healthcare delivery and investment in Nigeria’s health sector. Reliable laboratory results reduce clinical uncertainty, improve treatment outcomes and strengthen disease surveillance.

The regulatory framework also signals a shift from registration-based oversight to performance-based compliance. Through inspections, accreditation, validation of diagnostic products and enforcement against unethical practices, the council is strengthening quality assurance across the diagnostic value chain.

Dr Ofili said that the council maintains a national database of laboratories and undertakes regular inspections to ensure “accurate test results, patient safety and protection of public health.” He disclosed that laboratories found engaging in unethical practices or failing regulatory requirements are sealed until full compliance is achieved, adding that laboratories operated by unqualified personnel are shut immediately they are identified.

Ofili also stated that diagnostic reagents manufactured locally or imported into Nigeria are validated before approval, while post-market surveillance ensures continued compliance. He noted that the council regularly updates professional training curricula to align with evolving global standards.

The National President of the Association of Medical Laboratory Scientists of Nigeria, Dr Casmir Ifeanyi, reinforced the economic and clinical significance of the reforms, stating that “quality laboratory services remain the foundation of effective patient management and disease control,” while calling for sustained collaboration between regulators and practitioners.

DATA BOX

• Supervisory offices: 14
• Medical laboratories monitored: More than 4,000
• Laboratories with ISO 15189:2022 accreditation: About 30
• International milestone: Associate Member, Global Accreditation Corporation Incorporated
• Regulatory tools:
  • Routine inspections
  • Laboratory accreditation
  • Validation of in-vitro diagnostic kits
  • Post-market surveillance
  • Enforcement against unethical practice and quackery
• Recent enforcement action: Statewide inspection in Delta State leading to the sealing of non-compliant laboratories

WHO WINS / WHO LOSES

Who wins

• Patients receiving more reliable diagnostic services.
• Compliant laboratories meeting international standards.
• Healthcare providers relying on accurate test results.
• Investors in quality healthcare infrastructure and diagnostics.

Who loses

• Unlicensed and non-compliant laboratory operators.
• Suppliers of substandard diagnostic products.
• Facilities unwilling to meet strengthened regulatory standards.

POLICY SIGNALS

The federal government is positioning quality regulation as a central pillar of healthcare reform. Greater emphasis on accreditation, enforcement and internationally recognised standards suggests continued movement towards a more accountable and globally competitive diagnostic ecosystem.

INVESTOR SIGNAL

The reforms improve the long-term investment outlook for medical diagnostics, laboratory infrastructure, quality assurance services and locally compliant diagnostic manufacturing. Stronger regulation also enhances confidence among healthcare investors seeking internationally aligned operating standards.

RISK RADAR

Sustaining the reforms will require consistent enforcement capacity, adequate funding for inspections and broader laboratory accreditation. Uneven compliance across states, shortages of qualified personnel and the cost of meeting higher standards could slow implementation, particularly for smaller private laboratories.