Quality in point-of-care testing: what drives the system: personnel, regulatory standards, or instrumentation?

Any assessment of the quality of testing at point of healthcare always focuses on three factors: personnel, the effectiveness of regulatory standards governing the processes, and the capabilities of the analytical instrumentation. Even a casual evaluation of the environment surrounding today’s point-of-care testing suggests that a new quality paradigm is emerging. Focusing only on the analytical process, state-of-the-art instruments currently in routine use demonstrate, de facto, that the responsibility for traditional quality attributes—accuracy (traceability), precision, reliability, quality control, data interpretation, etc.—now are fully in the hands of the manufacturer. However, in the US all testing, including point-of-care testing, must continue to meet regulatory quality-assurance mandates including quality-control practices. In January 2003 the US government published the “Final Rule” under the Clinical Laboratory Improvement Amendments that introduced new quality-assessment requirements, including equivalent quality control, for analytical processes. The concept of equivalent quality control applies to instruments employing internal and/or procedural controls, an area currently dominated by point-of-care test systems. While manufacturers, personnel and regulators all continue to drive aspects of the quality of point-of-care testing, with the Final Rule incorporating a total quality management-based approach, the laboratory director is given some novel quality-control options. While the director retains full responsibility for guaranteeing that results of appropriate quality are provided to clinicians, the manufacturer can assume responsibility for daily, routine quality control, when the director approves, using one of three equivalent quality-control options for a test system.