MAY 28, 2014 07:30 AM PDT

How Automation is Required in Order for a Laboratory to Achieve Six-Sigma Quality in Non-Analytic Metrics

  • Scientific Director, Automation & Special Projects, ARUP Laboratories, Professor (Adjunct) of Pathology, University of Utah
      Dr. Charles Hawker is Scientific Director for Automation and Special Projects at ARUP, where he has been for 22 years. Dr. Hawker is also Professor (Adjunct) of Pathology in the University of Utah, School of Medicine. Previously, over a twenty year period, he held various positions in research and development and management at Laboratory Procedures, Inc. (Upjohn) and SmithKline Beecham Clinical Labs. At ARUP he has installed several major automation and robotic systems that have made ARUP one of the countrys most automated laboratories. He is a past president of the Association of Clinical Scientists, the National Academy of Clinical Biochemistry (NACB), and the Clinical Ligand Assay Society (CLAS). In July, 2014 he will received the AACCs highest award: Outstanding Lifetime Contributions to Clinical Chemistry and Laboratory Medicine, and AACCs MSPSD Division award for Outstanding Contributions to Management Sciences and Patient Safety. He has been honored by the Association of Clinical Scientists, Clinical and Laboratory Standards Institute (CLSI), NACB, and the Association for Laboratory Automation. He has chaired automation committees in CLSI and Health Level 7. He is the author of a chapter on clinical laboratory automation in the December, 2007 issue of Clinics in Laboratory Medicine and co-author of chapters in the Tietz Textbook of Clinical Chemistry and Molecular Diagnostics (4th and 5th Editions) and the Tietz Fundamentals of Clinical Chemistry (6th and 7th Editions). He is a frequent lecturer on laboratory automation to national and international audiences. He has three issued patents and has published 43 peer reviewed papers, 14 book chapters or invited reviews, 2 invited editorials, and 47 abstracts. His most recent research efforts have focused on the use of machine vision systems for automated quality inspection of clinical laboratory specimens, particularly the development of an automated camera system that uses optical character recognition (OCR) to identify mislabeled specimens.


    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.

    Show Resources
    Loading Comments...