A simmering internal power struggle within the Ministry of Health over control of donor-funded laboratory services has been linked to the suspension of Kenya’s laboratory accreditation, raising serious questions about governance, professionalism, and accountability at the heart of the health sector.
The Kenya Accreditation Service (KENAS) has suspended the Ministry of Health’s International Organization for Standardization (ISO) 15189 accreditation for laboratory services after the ministry failed to transition from the 2012 standard to the revised ISO 15189:2022 framework.
The suspension affects laboratories managed under the National Public Health Laboratory (NPHL), a critical pillar of Kenya’s disease surveillance and diagnostic capacity.
In a letter to the NPHL Director, Dr. John Kiiru, KENAS Chief Executive Officer Walter Ongeti stated that the laboratory had not complied with KENAS Circular No. 2 of 2023, which outlined the mandatory transition process. As a result, KENAS proceeded to suspend the accreditation with immediate effect.
During the suspension period, the laboratories are barred from referencing accreditation status or using any promotional material bearing ISO marks until compliance is restored.ISO 15189 is an internationally recognised standard that certifies the competence and quality of medical laboratories.
Although the standard was revised in 2022, conformity assessment and accreditation bodies were granted a transition window extending to December 5, 2025.
KENAS maintains that it issued clear guidance on the transition as early as March 15, 2023, communicated through official circulars, meetings, assessments, and online platforms.
According to the accreditation body, the Ministry’s laboratory services failed to adequately respond to these directives.
Behind the technical explanation, however, lie allegations of internal interference and mismanagement.
Multiple sources within the laboratory sector allege that Principal Secretary for Public Health and Professional Standards, Mary Muthoni, interfered with the work of laboratory professionals, disrupting the accreditation process.
Insiders claim that the laboratory services wing was subjected to tight administrative control that undermined technical independence, ultimately contributing to the loss of accreditation.
The sources further allege that the National Public Health Laboratory had effectively been turned into a conduit for discretionary spending, with donor funds allegedly diverted to non-core activities.
While these claims have not been independently verified, they include allegations that procurement decisions at the National TB Reference Laboratory led to the expiry of reagents valued at approximately KSh 600 million.
It is claimed that efforts by quality assurance teams and KENAS to access accurate information were frustrated, limiting oversight and transparency.
Stakeholders within the ministry also point to strained relations between senior leadership and laboratory professionals perceived to uphold strict ethical standards.
Some allege that resistance to professional oversight has resulted in sidelining or targeting of officials who question irregular practices.
Concerns have also been raised about internal correspondence and decision-making processes that, according to senior directors, failed to meet professional standards.
The Ministry of Health has, however, rejected the characterization of the KENAS action as a failure of quality systems.
Under Cabinet Secretary Aden Duale, the ministry has acknowledged the suspension but insists it represents a procedural stage within the transition timeline rather than a withdrawal of accreditation.
In a statement issued through the Directorate of Public Health and Sanitation, the Division of National Laboratory Services said all its laboratories remained compliant with ISO 15189:2012 and continued operating within the transition period allowed by KENAS, pending submission of corrective actions and documentation.
The accreditation dispute coincides with leadership upheaval at the Kenya National Public Health Institute (KNPHI).
In a letter dated January 19, 2026, the Ministry of Health removed KNPHI’s Deputy Director for Laboratory Services, Dr. Leonard Kingwara, from his roles, citing his alleged lack of registration with the Kenya Medical Laboratory Technicians and Technologists Board.
Within the laboratory fraternity, the move has been interpreted as part of a broader pattern of internal restructuring and power realignments linked to the ongoing accreditation crisis.ISO standards are widely regarded as benchmarks for quality, safety, and efficiency across sectors.
While standards such as ISO 9001 focus on quality management and ISO 14001 on environmental sustainability, ISO 15189 is specific to medical laboratories, underpinning trust in diagnostic results that inform clinical care and public health responses.
The suspension of this accreditation, even temporarily, represents a significant reputational and operational setback for Kenya’s public health laboratory system.
As the Ministry works to resolve the compliance issues, pressure is mounting for transparency and accountability, with stakeholders calling for political and administrative leadership to prioritise professional standards over internal power struggles in a sector critical to national health security.
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