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

Abstract

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.

Harmonization of four biomarkers across nine nationally representative studies of older persons

“…Factors that can affect the comparability of results across laboratories include differences between the standards of performance used by national and international agencies to accredit laboratories (Schneider et al, 2017), differences between accreditation program requirements (AbdelWareth et al, 2018), and the lack of a universal requirement that a clinical laboratory participates in a quality assurance program (Haliassos, 2018; Zima, 2017). Recent activities to reduce the impacts of these issues including regionally adopting common laboratory performance standards (Ndihokubwayo et al, 2016), addressing differences between standards and quality assurance programs (AbdelWareth et al, 2018), and requiring clinical laboratories to be accredited (Tanasiichuk et al, 2023) are expected to improve the compatibility of test results across laboratories. The findings from this biomarker harmonization study highlight the necessity for assay value harmonization not only across studies but also when biomarker data are compared between different waves of the same longitudinal study, which may have made changes in study laboratory and assay methodology over time.…”

Laboratory Surveillance, Quality Management, and Its Role in Addressing Antimicrobial Resistance in Africa: A Narrative Review

“…Effective disease prevention and management relies in accurate and time-efficient laboratory testing for patient care [ 13 ]. Healthcare systems are tasked with continuous quality improvement of patient care and safety [ 14 ]. High-quality microbiological diagnostics are essential for clinicians to make accurate diagnoses, formulate treatment plans, and subsequently monitor treatment effects on their patients [ 13 , 14 , 15 , 16 , 17 ].…”

“…Healthcare systems are tasked with continuous quality improvement of patient care and safety [ 14 ]. High-quality microbiological diagnostics are essential for clinicians to make accurate diagnoses, formulate treatment plans, and subsequently monitor treatment effects on their patients [ 13 , 14 , 15 , 16 , 17 ]. Therefore, in developed countries laboratory diagnostics play a crucial role at every stage of disease management with clinicians relying on it for the diagnosis, monitoring, screening, and prognosis of disease.…”