History and Future of Efficient Design of Quality Control in Clinical Laboratories

After half a century of development, conventional quality control (QC) theory has begun to approach its practical limits. Classical theories, including power function analysis, multi-rules, and patient risk models, have pushed conventional QC to its near-maximal efficiency. This review discusses this historical development and explores how patient-based real-time QC (PBRTQC) can theoretically drive future improvements in the information age. We focus on the key, yet often overlooked, concept of QC efficiency, defined as the ratio of the capability of error detection (CED) to the cost invested. We conclude that conventional QC is inherently limited by its paradigm, which relies on testing QC materials. This limitation confines QC to a fixed technical efficiency boundary, where recent research is limited to balancing CED and cost. PBRTQC leverages advances in information technology and data analytics to incorporate continuous, patient-derived information that is not restricted by the sampling limitations of QC materials. Integrating PBRTQC with conventional QC will allow the overall QC system to operate beyond the efficiency boundaries inherent to conventional QC paradigms. Laboratories would benefit by adopting this perspective to make optimal decisions when establishing or improving their quality systems with advancements in laboratory information systems and total laboratory automation.