James O. Westgard

James O. Westgard (born 1941 in North Dakota) is an American chemist, entrepreneur, and educator. He is the creator of the Westgard rules (Verification protocol for which the vast majority of laboratories rely on their quality controls), He won the 2003 AACC Professor Alvin Dubin Award for his outstanding contributions to the profession and the Academy.

James O. Westgard was born in 1941 in North Dakota. He studied at Concordia College in Moorhead, Minnesota, where he received a bachelor's degree in chemistry, MN (1963), and MA (1965) and Ph.D. (1968) degree in analytical chemistry from the University of Wisconsin-Madison. He began his career as a clinical chemist at the University of Washington in 1968 and served as Director of Clinical Chemistry, Associate Director for Laboratory Management, and Associate Director for Quality from 1968 to 1980 at the University of Washington. He is now a professor in the Department of Pathology and Laboratory Medicine, Department of Medicine, and also teaches a course in the selection, evaluation, and control of clinical chemistry methods in the Medical Technology Program.

In addition to being a professor, his intellectual interest also leaned towards the development of method evaluation protocols, making him the first president of the CLSI Protocol Evaluation Area Committee (formerly known as NCCLS). He has published various works in this area between 1970 and 1980, including a monograph on Method Evaluation published in ASCLS.

His most famous work was the "Westgard rules," which led to the multi-norm control procedure applied in validation charts (Levy-Jennings chart). This work in quality management is internationally known and is documented in various books such as Quality Control: Quality Management and Productivity of Analytical Processes, CLIA Final Rules for Quality Systems, Basic Method Validation, Six Sigma Quality and Control Design: Desirable and Necessary Precision Quality Control for Laboratory Measurement Procedures, Quality Assurance: Good Laboratory Practices for Verification of the Intended Quality of Test Results, and Basic Quality Control Practices.

Westgard's main area of interest is in qualitative techniques for analytical quality management and statistical quality control of processes in clinical laboratory tests, as well as performance validation of laboratory test processes. Lastly, in computer and technology tools for practical applications.

His recent research is focused on the development of statistical quality control procedures based on analytical, clinical, or biological quality requirements in laboratory tests. This same research is also focused on the study of imprecision and inaccuracy observed in a measurement procedure and the expected rejection characteristics in relation to different quality control decision criteria and strategies.

These recent investigations could also be applied to the development of improved quality control strategies for the most challenging quantitative analyses in clinical laboratories.

Westgard has received many awards from professional organizations involved in clinical laboratory medicine and science, including:

• 1982 American Association of Clinical Chemistry (AACC) Ames Clinical Achievement and Leadership in Clinical Chemistry Award;
• 1987 Gerulat Award from the New Jersey Section of AACC;
• 1988 Annual Award of the Manitoba Society of Clinical Chemists;
• 1990 Natelson Award from the Chicago Section of AACC;
• 1992 Ciba-Corning Chair from the British Association of Clinical Biochemists;
• 1994 Roman Chair from the Australian Association of Clinical Biochemists;
• 1995 Miriam Reiner Award from the Capitol Section of AACC;
• 1997 Robert Mendelson Award from the American Society for Clinical Laboratory Science;
• 2002 Richard Passey Chair in Clinical Laboratory Quality, Standardization, and Compliance at the University of Oklahoma Health Sciences Center;
• 2003 Alvin Dubin Award for Distinguished Contributions in Clinical Biochemistry from the National Academy of Clinical Biochemistry.
• 2004 National Public Service Laboratory Leadership Award for his career from Lab G2 Institute Washington.
• 2005 Roche Diagnostics Award, British Association of Clinical Biochemistry
• 2005, Outstanding Contribution in Management Sciences from the Division of Management Sciences of the AACC
• 2009, Perry A. Lambird Excellence in Medicine Award, COLA.
• 2010 Havarkate Conference Award for Quality Improvement in the Medical Laboratory (Dutch ECAT Foundation)
• 2012 Van Slyke Award from the New York - Local Section of the AACC

Westgard has published nearly 200 articles, book chapters, monographs, reports, and articles. He has also published about 60 abstracts and made more than 350 presentations at scientific meetings, conferences, workshops, and seminars. The Westgard Website (www.westgard.com) offers more than 400 essays, articles, and lessons on laboratory quality management. Some recent publications include:

• Westgard JO. Basic Method Validation, 3rd ed. Madison WI: Westgard QC, 2008, 320 pp.
• Westgard JO. Right Quality Right: Good Laboratory Practices for Verifying the Intended Quality of Test Results. Madison WI: Westgard QC, 2007, 288 pp.
• Westgard JO, Westgard SA. Today's Clinical Testing Quality: An Assessment of Analytical Quality Sigma Metrics Using Performance Data from Proficiency Testing Surveys and CLIA Criteria for Acceptable Performance. Am J Clin Pathol 2006; 125: 343-354.
• Westgard JO. Six Sigma Quality Design and Control: Desirable and Necessary Precision Quality Control for Laboratory Measurement Procedures, 2nd ed. Madison WI: Westgard QC, Inc., 2006, 338 pp.
• Westgard JO, Westgard SA. Equivalent Quality Tests Compared to Equivalent Quality Control Procedures. Lab Med 2005; 36: 626-629.
• Westgard JO. Clinical Quality vs. Analytical Performance: What are the right goals and target values? Accred Qual Assur 2004; 10: 10-14.
• Westgard JO. Nothing but the Truth about Quality. Madison WI: Westgard QC, 2004, 258 pp.
• Westgard JO. Internal Quality Control: Planning and Implementation Strategies. Ann Clin Biochem 2003; 40: 593-611.
• Crolla LJ, Westgard JO. Evaluation of rule-based autoverification protocols. CLMR 2003; 17: 268-272.
• Westgard JO, Fallon KD, Mansouri S. Validation of IQM.Process Active Process Control Technology. Point of Care 2003; 2: 1-7.
• Westgard JO. Basic Quality Practices, 2nd ed. Madison, WI: Westgard QC, 2002, 320 pp.