Laboratory quality systems in clinical laboratory practice in Lagos, Nigeria (West Africa): Associated problems and prospects

Abstract

The quality of the clinical laboratory, defined as accurate, reliable and timely reporting of test results, has a direct impact on patient care. As much as 70% of all medical diagnosis relies on laboratory testing. 1,2 The impact of errors in laboratory testing may be immense including delayed diagnosis, misdiagnosis, wrong and inappropriate treatments, treatment complications, fatalities and financial waste. 2,3 The clinical laboratory plays a major role in detection of diseases (screening and confirmatory testing), staging and subclassification of diseases, monitoring of response to therapy, prognosis as well as guiding choice of therapeutic options for best outcomes. The issue of laboratory quality is therefore crucial and requires prompt and continual assessments of its current state and service gaps, followed by appropriate responses for quality improvement.Laboratory quality addresses meeting standards and benchmarks expected in a laboratory practice setting. Laboratory quality centres on reliable testing with negligible or no errors for users and patients. The laboratory quality management system, a management model, looks at the entire system that affects quality of laboratory performance. Its building blocks, otherwise termed quality system essentials, include 12 modules according to the International Organization for Standardization, ISO (organization, personnel, equipment, purchasing and inventory, process control, information management, documents and records, occurrence management, assessment, process improvement, customer service, facilities and safety). 4 Quality cannot be improved without being measured. In a 2013 survey by Schroeder et al, 5 most sub-Saharan African (SSA) countries did not have an internationally accredited laboratory. In Kampala, Uganda, only 0.3% of medical laboratories met international standards. In Nigeria, only two laboratories were internationally accredited to ISO 15189:2012 by May 2013. 5 Lagos (the former capital city) is the most populous state in the Nigerian federation with an estimated population of at least 20 million persons. 6 Anecdotal evidence reveals that private practice delivers over 60% of health care (including laboratory services) in Lagos state. The objective of this project was to test and characterize the state of laboratory quality systems in private clinical laboratory practice in Lagos, Nigeria, identify quality failures and proffer models for improvements. A pilot, cross-sectional survey of private laboratories in Lagos State was conducted. Statutorily, HEFAMAA (Health Facility Accreditation and Monitoring Agency), a parastatal of the Ministry of Health, Lagos State, is responsible for registering and monitoring all health facilities in Lagos State, including medical laboratories. On examining the HEFAMAA directory in October 2017, Lagos had over 2500 registered health facilities including 262 private medical laboratories. There were 158 public health institutions (including research laboratories, tertiary, secondary and comprehensive primary centr...