Assessing Point-of-Curchase Lab Testing in a Rural Hospital Network

Thesis Abstract

Point-of-purchase laboratory testing (POC-LT) within rural hospital networks presents potential benefits for rapid clinical decision-making and patient throughput but raises concerns about diagnostic accuracy, quality assurance, and cost-effectiveness in resource-limited settings. This study addresses the gap in understanding how POC-LT deployment at rural hospitals influences clinical workflows, laboratory utilization, and patient outcomes, and how organizational, technical, and community factors mediate its effectiveness. The aim is to evaluate the operational, clinical, and economic impact of POC-LT in a network of five rural hospitals serving dispersed populations across a 300-kilometer region. Specific objectives are to (1) quantify changes in turnaround time (TAT) for critical assays and subsequent management decisions, (2) assess the diagnostic concordance between POC-LT results and centralized reference laboratory results for common emergencies (e.g., glucose, HbA1c, blood gas, infectious serology), (3) examine pre-analytic and analytic quality indicators, including quality control failure rates and operator competency, (4) evaluate changes in patient length of stay and admission rates associated with POC-LT use, and (5) conduct a cost-benefit analysis comparing per-test costs and hospital-wide budget impact. The study adopts a concurrent mixed-methods design, integrating quantitative time-series data from electronic medical records (n=12,000 patient encounters over 24 months) and centralized laboratory logs with qualitative insights from semi-structured interviews (n=30) and direct observations (n=40 hours) of point-of-care operators and clinicians. The population comprises patients requiring urgent or semi-urgent laboratory testing in the rural hospital network, with a sample stratified by modality of testing (POC-LT vs. central lab), location, and clinical indication. Data collection instruments include standardized quality metrics checklists, validated operator competency assessments, hospital financial records, and a structured interview guide aligned with the Technology Acceptance Model and the Donabedian framework for quality of care. Validity and reliability are ensured through triangulation, pilot testing of instruments, inter-rater reliability checks for qualitative coding (Cohen’s kappa >0.80), and calibration of POCT devices against reference methods prior to data collection. Quantitative data will be analyzed using interrupted time-series analyses to detect level and trend changes in TAT and clinical decisions, Bland-Altman plots for method agreement between POCT and central lab results, Cohen’s d for effect sizes, and multivariate linear and logistic regression to adjust for confounders. The economic evaluation will employ activity-based costing and probabilistic sensitivity analysis to estimate incremental cost-effectiveness per correctly managed case. Qualitative data will be analyzed thematically, guided by the Consolidated Framework for Implementation Research (CFIR) to elucidate barriers and facilitators at the individual, local, and system levels. The anticipated findings include (i) meaningful reductions in median TAT for critical tests and faster initiation of treatment plans in rural settings; (ii) acceptable diagnostic concordance for most core POCT panels with identified discordance in less reliable assays requiring confirmatory central testing; (iii) improved clinician satisfaction and perceived workflow efficiency, tempered by concerns about quality governance and ongoing training needs; (iv) a net positive impact on patient flow and, in selected scenarios, reduced hospital length of stay; and (v) an overall favorable cost-benefit profile when factoring reduced patient transport, earlier treatment, and avoidance of unnecessary admissions. The study contributes to knowledge by detailing the operational, clinical, and economic implications of POCT deployment within rural hospital networks, integrating implementation science with diagnostic accuracy and health economics. It will generate evidence-based recommendations for standardizing POCT governance, quality assurance programs, staff training curricula, and scalable procurement strategies to optimize patient outcomes while maintaining safety and cost containment in rural health systems. The conclusions are expected to emphasize a phased, governance-driven expansion of POCT with robust QA processes, targeted training, and continuous performance monitoring to sustain benefits without compromising diagnostic reliability.