A Framework for Standardizing Point-of-CCare Hematology Testing QC

Thesis Abstract

Point-of-care hematology testing is increasingly deployed in diverse clinical settings, but variability in quality control (QC) practices threatens result reliability, patient safety, and clinical decision-making. This study addresses the gap by developing a robust framework for standardizing QC across point-of-care (POC) hematology testing, with emphasis on harmonizing pre-analytical, analytical, and post-analytical processes to ensure consistent performance and tracability. The aim is to formulate a theoretically grounded and practically implementable framework that improves accuracy, precision, and comparability of POC hematology results across diverse healthcare environments. Specific objectives are (i) to identify critical QC determinants in POC hematology workflows through a multi-country needs assessment; (ii) to synthesize concepts from total quality management (TQM), Six Sigma, and the Theory of Constraints to construct an integrative standardization framework; (iii) to operationalize the framework into measurable QC indicators, benchmarks, and governance structures; (iv) to validate the framework via pilot testing in three hospital networks with varied resource levels; and (v) to propose an implementation roadmap including training, auditing, and continuous improvement mechanisms. The study employs a mixed-methods design comprising three phases. Phase 1 uses a cross-sectional survey of 24 healthcare facilities spanning urban, peri-urban, and rural contexts to map current QC practices, equipment types, and operator training. Phase 2 develops the framework through a synthesis of qualitative interviews with 40 stakeholders (clinical laboratorians, clinicians, and point-of-care operators) and a Delphi panel of 12 international experts to achieve consensus on core QC components and performance targets. Phase 3 tests the framework in 12 pilot sites over 12 months, collecting quantitative data from 10 key performance indicators (KPIs) per site, including linearity, precision (within-run and between-run), bias, coefficient of variation, fail rates, false-positive/false-negative rates, and time-to-result metrics. Data collection instruments include standardized QC checklists, instrument calibration logs, user competency assessments, and a validated survey instrument adapted from ISO 22870 and CLSI guidelines. Validity is established through expert review and pilot testing; reliability is assessed with Cronbach’s alpha for survey items and inter-rater reliability for observational checks. Quantitative analyses will employ regression models to relate QC indicators to clinical decision accuracy, repeated-measures ANOVA to assess performance over time, and control charts to monitor process stability. The qualitative component will utilize thematic analysis of interview transcripts to elucidate contextual factors influencing QC adoption, with triangulation against survey results. A metamodel integrates quantitative findings with qualitative themes, aligning with the Theories of Planned Behavior and Normalization Process Theory to illuminate adoption dynamics. Ethical approval will be secured from relevant institutional review boards, with informed consent obtained from all participants and data anonymization ensured. Expected findings include (a) a set of core QC domains for POC hematology (pre-analytical handling, instrument calibration, internal QC, external quality assessment, data management, operator competency, and governance), (b) standardized QC targets and decision rules harmonized with international guidelines, (c) an evidence-based, scalable framework ready for adaptation across resource settings, and (d) practical barriers and enablers to implementation identified across contexts. The study anticipates that facilities implementing the framework will demonstrate improved precision (average within-run CV reduction by 15%), reduced overall QC fail rates by 20%, and shorter time-to-result without compromising result integrity. The contribution to knowledge lies in delivering a transferable, theory-informed, and empirically validated framework for standardizing QC in POC hematology testing, bridging the gap between guideline prescriptions and field performance. It advances the literature on health technology assessment of POC diagnostics by integrating TQM, Six Sigma principles, and implementation science theories to produce a pragmatic, auditable, and sustainable QC model. Practical implications include a ready-to-implement toolkit comprising prescribed QC protocols, audit templates, competency matrices, and an implementation roadmap tailored to varying resource environments. The study concludes that standardization of QC in POC hematology is feasible and beneficial when supported by a coherent governance structure, continuous data-driven improvement, and consideration of local workflow realities. Recommendations emphasize stakeholder engagement, ongoing training, interoperability of data systems, and periodic revalidation of QC benchmarks to sustain quality improvements and enhance patient safety.