Assessment of Selected Laboratory Quality Management Essentials in the Haematology Department at a KENAS-Accredited Level 5 Mission Hospital in Kenya

Abstract

Aims: This study assessed adherence to three selected Laboratory Quality Management System (LQMS) essentials—Process Control, Facilities and Safety, and Equipment Management—in the Haematology Department of P.C.E.A Chogoria Hospital, Kenya. Study Design: A descriptive cross-sectional study design with independent and joint assessments was used. Place and Duration: The study was conducted in the Haematology Department of Chogoria Hospital, a KENAS-accredited Level 5 mission hospital in Tharaka Nithi County, Kenya, from February to March 2026. Methodology: Census sampling covered relevant departmental staff, processes, facilities, equipment and documentation. A customised WHO SLIPTA checklist aligned with ISO 15189:2022 assessed 27 Process Control items (71 points), 24 Facilities and Safety items (57 points), and 16 Equipment Management items (37 points). Data were obtained through document review, interviews, observation and physical inspection. Compliance was scored as Yes, Partial, No or not applicable. Inter-rater reliability and Fisher's exact test were applied. Results: Process Control achieved 98.6% (70/71), Facilities and Safety 98.2% (56/57), and Equipment Management 100% (37/37). Agreement ranged from 96.3% to 100% (Gwet's AC1, 0.96–1.00). Minor gaps concerned referral technical consultant procedures and fire detection/alarm systems. Fisher's exact test showed no statistically significant difference across domains (p = 1.000). Conclusion: The department showed high compliance, although targeted corrective action is needed to address the remaining gaps.