Assessment of Clinical laboratory using WHO AFRO-SLIPTA Quality Standards in a Referral Hospital laboratory in Ghana

Abstract Introduction: The hospital laboratory exists to provide accurate and reliable results to physicians for effective management of patients. The Quality Management System (QMS) in the laboratory must be effective and efficient so that reliable results will be produced for patient care. Quality System Essentials together with International Organization for Standardization (IOS) 15189 are the core components used to establish a QMS in the Laboratory. Laboratory assessments are an effective means to determine whether a laboratory is providing accurate and reliable results and adhering to good laboratory practices. We assessed the Suhum Hospital laboratory to identify gaps in the components of Quality System Essentials. Method: This exploratory study investigated the practice of QMS in Suhum Hospital laboratory, a public district hospital laboratory in Ghana, in January 2016. Data collected comprised activities by laboratory staff during onsite visits and evidence of documentation. Permission to collect data was sought from the Hospital Management and Laboratory Manager. We used the WHO-AFRO laboratory Strengthening Checklist to assess the laboratory. We reviewed the records to verify if the laboratory quality manuals, policies, logs, Standard Operating Procedures (SOPs) were complete, current, accurate, and annually reviewed. Finally, we interviewed staff of the laboratory and clinicians to obtain information to learn their perspective on the laboratory’s performance. Results: The undepartmentalized laboratory is headed by a manager with a staff strength of 13 trained professionals. It receives averagely 100 patient samples daily and runs 30 different tests. The main strengths of the laboratory in terms of Quality System Essentials were information management 15/18 (83%), process control 25/33 (77%), internal audit 6/10 (60%), facilities and safety 25/43 (58%), purchasing and inventory 17/30 (57%). However, equipment management 8/30 (27%), occurrence management 3/12 (25%), documents and records 7/25 (28%), organization and personnel 8/20 (40%), corrective actions 5/12 (42%) and client management 5/17 (29%) required improvement. Conclusion: Findings from the laboratory audit pointed to an overall weak laboratory QMS based on WHO/AFRO laboratory strengthening checklist and rating. Concerted efforts are therefore required to improve the laboratory QMS rating to improve quality of care to clients in all district hospital laboratories in Ghana.