Abstract
Clinical biochemistry labs play a key role in diagnosis, triage, therapy monitoring, and patient flow decisions. Ongoing delays and inconsistent test reliability weaken their clinical value and can't be fixed by simply increasing analyser speed. These issues often stem from poorly managed interfaces throughout the entire testing process, including test requests, patient ID, sample collection and transport, accessioning, centrifugation, analysis, validation, and result reporting. Objective: To create a comprehensive quality management framework that shortens diagnostic turnaround time (TAT) while maintaining analytical reliability in clinical biochemistry labs. Methods: A narrative review was conducted using international lab quality standards, consensus guidelines, and peer-reviewed research on TAT, quality indicators, risk-based control, sigma metrics, autoverification, and the entire testing process. Findings: Sustainable progress depends on defining TAT from the user’s perspective, breaking it down into measurable components, redesigning bottleneck-prone pre- and post-analytical steps, and applying analytical controls that align with the method’s risk, clinical purpose, and performance. This review offers an integrated framework that links TAT metrics, risk controls, and quality management system governance throughout the full testing cycle. Conclusion: A high-quality clinical biochemistry lab is not just about speed. It is a well-controlled socio-technical system that produces timely, traceable, clinically interpretable, and analytically reliable results. Quality management provides the governance to improve both speed and reliability simultaneously, rather than trading one off for the other.
Keywords
clinical biochemistry, turnaround time, analytical reliability, ISO 15189, quality indicators, risk-based quality control, total testing process, laboratory quality management, autoverification