Six-Sigma quality is defined as 3.4 (or fewer) defects per million opportunities (DPMO). Achieving Six-Sigma quality in a clinical laboratory is extremely difficult. This presentation will show how the presenters laboratory has been able to achieve this level in lost specimens per 100,000 billed units, probably representing the first US laboratory to achieve Six-Sigma quality for any metric, analytic or nonanalytic. What has enabled this to happen is a 20-year continuum of process improvement and automation, especially using robotics and advanced software. Among the automation systems employed at the authors laboratory are an 1100 foot conveyor system that routes barcoded specimens to 8 high-speed sorters, a two story robotic freezer that holds up to 2.3 million specimens, 2 automated thawing & mixing workcells, and other systems, Further, with the invention and validation of an automated camera system that uses optical character recognition (OCR) technology to identify potentially mislabeled specimens, a second nonanalytic metric in the presenters laboratory now has the prospect of also reaching Six-Sigma quality levels. Using these developments as the background, this presentation will describe several activities that participants can undertake in their own laboratories that will improve nonanalytic quality without the major investments in automation that have happened in the presenters laboratory.

Learning objectives: Upon completion of this activity, participants will be able to: (1) define Six-Sigma quality, and (2) list three activities to improve non-analytic quality in ones own lab.