Key success factors for the implementation of quality management systems in developing countries.

Background: Despite the tremendous progress made in advancing laboratory medicine in low- and middle-income countries (LMICs), inadequate quality management systems (QMSs) remain a problem and barrier to provision of reliable laboratory services in resource-limited settings. Therefore, it is useful to study the experience of medical laboratories in LMICs that have successfully implemented QMS. Aim: This review identified key success factors (KSFs) for medical laboratories in LMICs implementing QMS in accordance with the International Organization for Standardization standard 15189 as a pathway to improving laboratory quality. Methods: Applying Preferred Reporting Items for Systematic Reviews procedures, we conducted a targeted search of studies from LMICs published between 2012 and 2022 to identify KSFs. Thirty-two out of 952 references retrieved were considered relevant and included in this review. Grounded theory was used to extract key features of the included studies to derive KSFs. Results: Ten KSFs for medical laboratories striving to implement QMS were identified and described. These KSFs were integrated to create a model of success for laboratory QMS implementation. The model consists of three underlying factors, namely preparing for change, resource availability, and effective project management, each comprising three separate KSFs. Institutional commitment was identified as the core of the model and is integral to ensuring the quality of laboratory services. Conclusion: Laboratories planning to implement a QMS can benefit from understanding the KSFs demonstrated in this study as this would help them to identify the necessary changes to implement and set realistic expectations about the outcomes of QMS implementation.