An application for ethical approval was made to the Mbagathi Hospital, Health, Wellness and Nutrition Services, Nairobi City County on 15 October 2025. The Mbagathi County Referral Hopsital issued an ethics waiver for the study because the research was undertaken within the framework of the hospital’s accredited laboratory.

Laboratory programmatic data from the SLIPTA tool was used, and no human subject information was collected. Laboratory QMS data were stored and handled with restricted access except for the respective laboratory staff, the hospital superintendent, APHL mentors, and CDC technical advisors.

Between March 2021 and September 2022, the MHL was reorganised to accommodate a molecular section for SARS-CoV-2 testing.The novel molecular section was refurbished to enable a unidirectional workflow and installation of molecular equipment, including a real-time polymerase chain reaction analyser, refrigerated centrifuge, heating block, polymerase chain reaction workstation, freezer, vortex mixer, and autoclaves. Molecular reagents and commodities were purchased and delivered. The staff were trained on using the new test workflows, equipment verification, and QMS consistent with the ISO 15189 requirements.⁵

The laboratory staff were trained by APHL mentors using facility-focused mentorship on laboratory work processes. Staff competency was determined before and after training. A meeting was held for the hospital management team to better understand the need for QMS sensitisation and the hospital management’s commitment. A mentorship schedule was developed that accommodated all 12 quality essential areas for the laboratory to attain ISO accreditation status. The mentorship visits included onsite training on ISO 15189 implementation, risk assessment and risk management, internal audits, method validation and verifications, and customer care services. The mentorship targeted hospital management, laboratory leadership, and laboratory staff. The APHL mentors spent 1–2 weeks every 2 months during the intervention period and worked closely with the quality officer to address the gaps identified during this process. Additionally, the mentors worked closely with the hospital leadership to provide additional resources and for the laboratory staff to develop work schedules that had well-defined, measurable, achievable, and time-bound goals derived from the 12 Quality System Essentials (QSEs) in the World Health Organization Regional Office for Africa SLIPTA checklist.

The APHL adopted QMS and laboratory services sustainability approaches by addressing four key pillars: (1) human resources, (2) financial resources, (3) infrastructure (laboratory workspaces, storage, electricity supply and water), and (4) laboratory information management system. In addition, the interaction between these approaches was assessed and addressed during the mentorship to ensure efficiency and effectiveness. A laboratory Strengths, Weakness, Opportunities, and Threats assessment was conducted by the mentors and outcomes shared with both the laboratory team and the hospital management. Priority areas that required action and commitment from both parties were discussed during feedback sessions. Clear objectives were discussed and included establishing a quality-assured molecular laboratory run by the laboratory staff, improving laboratory quality services beyond the molecular work, and identifying opportunities for laboratory improvement across technical and management-related processes, including the development of lab standard operating procedures.

Various factors were considered to understand the human resource capacity. This included the number of laboratory staff, their skills and specialties (whether utilised or not), the ability of the laboratory staff to manage their time across the various departments, the laboratory leadership structure, and governance capacity to support sustainability.

The laboratory management underwent strategic restructuring to ensure operational continuity and QMS sustainability. This included a multi-tiered leadership hierarchy comprising a laboratory manager, quality officer, and safety officer, each supported by a designated deputy. Significantly, section heads were formally empowered with management and quality oversight responsibilities. This intentional design served as a robust succession plan: By training section heads to act as functional quality and laboratory managers within their respective units, the laboratory eliminated leadership gaps and ensured that technical and quality activities remained uninterrupted, even in the absence of senior management.

The laboratory organogram was communicated to staff, and each staff member’s job description was clear, outlining responsibilities, delegated roles, and reporting lines, bringing clarity in personnel management. The designee for any leadership position was expected to perform at the same level as the primary position holder in terms of service delivery. Occasionally, the laboratory leadership appointed lower-level staff to managerial roles with guidance from the laboratory manager as part of staff capacity leadership mentorship.

Laboratory resource capacity was defined as current, potential, and future capacities and opportunities. Monetary resources included hospital-allocated funding for laboratory operations, alternative financial resources like loans, laboratory revenue collection, and, where feasible, occasional donations from the central government or implementing partners, resources, and a potential resource partner.

Baseline, mid-term, and end-term assessments were performed before, during, and after APHL/CDC’s engagement with MHL. Assessment data were collected using the WHO AFRO SLIPTA checklist version 2.0 (2015) and stored in an Excel sheet 2010 version (Microsoft Corporation, Redmond, Washington, United States), and data on laboratory performance were collected on workload, laboratory revenue, frequency of joint clinical laboratory interface meetings during ward rounds or continuous medical education series, and other performance quality indicators. These data were recorded on QMS tools as part of a continuous laboratory improvement programme, and a summary was captured in an Excel worksheet. The baseline assessment was conducted in March 2021, while the midterm and end-term assessments were conducted in October 2021 and December 2023.

Before mentorship, there was no evidence of QMS implementation. After the mentorship, MHL and the mentor developed and implemented guidelines for technical and management procedures and tools for collecting records, as described in Table 1. Of the total 63 tests performed in the laboratory, 45 (70%) were enrolled in a proficiency testing panel with a consistent performance of > 80% score and were included in the scope of accreditation.

An average score of 46% (n = 127 of N = 275) was recorded during the baseline assessment, which improved to 95% during both midterm and end-term assessments (see Figure 4). Improvements were recorded in QSEs sections: Management review, evaluation, identification of non-conformities, and corrective and preventive actions when comparing baseline and end-term time points (see Table 2).

Overall, baseline performance based on the WHO AFRO SLIPTA scores on QSEs analysed at three time points is presented in Figure 4. At baseline, the laboratory had a score of 127/275 (46%), equivalent to a 0 Star rating; at midterm, 224/275 (81%) points, equivalent to a 3 Star rating, and at the end of term, 260/275 (94%) points, equivalent to a 4 Star rating. Quality management system scores obtained at baseline, compared to midterm and end-term, demonstrated improvement. The MHL achieved ISO accreditation in December 2022; 15 months from initiation of the mentorship process to accreditation is considered a short time compared to other previously accredited laboratories.⁶ However, four areas of the QSE registered low progress in implementation: Information management, equipment management, evaluation and audits, and facility and safety. Laboratory mentorship was then focused on these areas to help the laboratory improve, including strengthening laboratory information systems and equipment interfacing. Overall, there was a statistically significant improvement from baseline to end-term outcomes across the QMS sections (paired t-test, t(11) = 7.47, p < 0.0001).

This capacity was essential for the smooth workflow in the laboratory as it influenced facility safety, accommodation, electricity needs, water, lighting, and safety for both patients and staff. During the intervention period, leaking sinks and broken windows were repaired. Surveillance cameras were installed for safety, and fire extinguishers were purchased and installed in the laboratory premises to ensure fire safety and risk management. The laboratory management ensured that the equipment was functional and serviceable. This led to continuous service provision to patients and other laboratory users through a constant supply of reagents and consumables, ensuring services were always available.