Application Effectiveness of a Pre-Analytical Quality Management Pathway Based on the Structure-Process-Outcome Model.

Objective: This single-center, before-and-after study applied the structure-process-outcome (SPO) model to pre-analytical quality control to investigate its effect on laboratory testing quality, nursing practices, patient satisfaction, and clinician trust in test results.

Methods: A before-and-after design was conducted in a provincial Class A tertiary hospital. The control group (April-September 2022) and observation group (April-September 2023) each included all laboratory specimens and 550 clinical nurses (from the same wards). The SPO-guided pre-analytical quality management pathway involved forming a multidisciplinary team, establishing a grid management system, implementing a non-punitive reporting system, standardizing specimen collection, and developing a quality management information system. Groups were compared on non-compliant test sample rates, nurses' knowledge, beliefs, and behaviors, operational standardization, patient satisfaction, and clinical doctors' trust. Data were analyzed using t-tests (with effect sizes) and χ²-tests; confidence intervals and multiple-comparison corrections were also applied.

Results: The observation group showed significantly lower rates of non-compliance in sample type, collection container, volume, contaminated blood cultures, and coagulated samples (all p < 0.01, with 95% confidence intervals). Nurses' knowledge (Cohen's d = 0.44) and behaviors (Cohen's d = 1.56) improved significantly. Operational standardization (92.5 ± 3.2 vs 85.7 ± 4.1), patient satisfaction (93.8% vs 87.2%), and clinical doctors' trust (91.2% vs 84.5%) also increased significantly (p < 0.01).

Conclusion: The SPO-based pre-analytical quality management pathway significantly improved non-compliant sample rates, nurses' knowledge and behavior, operational standardization, patient satisfaction, and clinical trust in test results. This approach may serve as a reference for other institutions aiming to enhance pre-analytical quality management.