Barriers to Implementation of Quality Management Systems in Laboratories: Lessons from the Southern Africa TB Health Systems Project

ABSTRACT The laboratory plays a critical role in the diagnosis and management of diseases. To ensure reliability, laboratories implement Laboratory Quality Management Systems (LQMS) and accreditation. Performance of 11 laboratories from 4 countries was monitored over 3 years using the World Health Organization/Regional Office for Africa Strengthening Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) process and a survey on perceptions of staff to identify barriers to implementation of LQMS. The mean SLIPTA score increased from 178 to 233 between 2017 and 2019, respectively. The 67 surveyed staff rated staff commitment (88%), staff knowledge of LQMS (78%), and management (84%) as adequate and staffing (60%) and financial resources (55%) as inadequate. Factors associated with achieving at least a 20% change in percentage score were: staff knowledge of LQMS odds ratio (OR) = 0.06, 95% confidence interval (CI): 0.004–0.80; P = .034, management knowledge of LQMS (OR = 0.22, 95% CI: 0.06–0.80; P = .022), and workload (OR = 3.61, 95% CI: 1.41–9.22; P = .07). There was a significant association between achieving at least 20% change in scores and infrastructure (P = .05), knowledge of LQMS by laboratory staff (P = .01), and workload (P = .07). Knowledge of LQMS by laboratory staff and laboratory management, infrastructure, workload, and management support were potential barriers to the successful implementation of LQMS.