Introduction

Extract

According to Harvard economist Michael Porter, the healthcare delivery system should transition to one based on value for patients rather than quality of processes.^1,2 Applied to the clinical laboratory (CL), this proposal seems intuitive until examined closely. The ramifications of such a transition are extensive when first, the distinction between quality and value is considered and then, their definitions reconstructed for CL as a result of that examination.

Traditionally, CL analytic processes have been the focus of quality measurement and improvement efforts. Value has been defined as “maximum quality for minimum cost” and evaluated at the analytic level. Processes are efficient, and therefore valuable, if results are accurate and direct costs (including labor) are low. Traditionally, CL value for patients is consolidated in specimen collection, transportation, analysis, and resulting processes. In this traditional interpretation, the value of CL processes is evaluated through analytic indicators, i.e., quality control, quality assurance, through a standardized quality improvement (QI) program. In this interpretation, quality measures on the testing cycle, to include sample collection, transport and analysis of patient specimens, and the subsequent reporting of these results, are proxies for patient safety. Excepting the collection process, CL patient safety is actually one step removed from patients; patients' specimens are the operational focus rather than patients themselves.