A Conceptual Framework for Standardizing Point-of-Care Testing Quality Assurance

Thesis Abstract

The increasing reliance on point-of-care testing (POCT) in clinical diagnostics has underscored the critical need for standardized quality assurance (QA) frameworks to ensure accuracy, reliability, and patient safety. Despite the proliferation of POCT devices across healthcare settings, existing QA practices are often inconsistent and lack a unified theoretical foundation, leading to variability in test outcomes and compromised healthcare delivery. This study aims to develop a comprehensive conceptual framework for standardizing POCT QA processes, thereby enhancing consistency and quality across diverse clinical environments. The specific objectives include (1) to analyze current QA practices and identify key gaps; (2) to synthesize relevant theoretical models and best practices from laboratory and quality management disciplines; (3) to formulate a novel, integrative conceptual framework tailored to POCT settings; and (4) to empirically validate the framework through stakeholder consensus and pilot implementation. Employing a mixed-methods research design, the study combines qualitative exploratory methods with quantitative validation. The qualitative phase involves semi-structured interviews with 35 laboratory managers, clinicians, and quality assurance officers across public and private healthcare facilities, aiming to explore perceptions, challenges, and existing QA strategies. Thematic analysis, guided by Braun and Clarke’s approach, will identify recurrent themes and inform the initial model components. Concurrently, a Delphi technique involving 20 experts in laboratory medicine, quality management, and healthcare policy will facilitate consensus on the core elements of the framework. In the quantitative phase, a pilot study will be conducted in 10 healthcare facilities with a total sample of 150 POCT operators and supervisors. Data collection incorporates structured questionnaires measuring perceptions of QA effectiveness and adherence, along with observational checklists. Reliability and validity of instruments will be established through Cronbach’s alpha and pilot testing. Data analysis will involve descriptive statistics and inferential tests such as multiple regression analysis to assess relationships between QA implementation factors and testing performance metrics. Structural equation modeling (SEM) using AMOS will be employed to test the proposed framework’s validity and alignment with empirical data. Ethical approval will be secured from institutional review boards, ensuring confidentiality, informed consent, and adherence to ethical research principles throughout the study. The anticipated outcomes include a validated, theoretically grounded framework that delineates critical components, contextual factors, and implementation strategies for POCT QA standardization. The new framework is expected to highlight the importance of integrating quality management theories such as Donabedian’s Structure-Process-Outcome model and the Swiss Cheese Model of System Failures to enhance fault detection and prevention in POCT workflows. It will provide practical guidelines adaptable across various healthcare settings, emphasizing continuous quality improvement and stakeholder engagement. The study’s contribution to knowledge lies in bridging the gap between existing laboratory QA models and the unique operational realities of POCT, offering a contextually relevant, scalable, and evidence-based conceptual tool for policymakers, clinicians, and laboratory professionals. Main conclusions will emphasize the critical role of standardized QA frameworks in improving POCT accuracy, reducing errors, and optimizing patient outcomes. Recommendations will include integrating the framework into national and institutional POCT policies, conducting ongoing training programs, and fostering collaborative quality circles for continuous improvement. Further research avenues will explore longitudinal impacts of framework implementation and adaptation to emerging POCT technologies.