James O. Westgard. Ph.D., FACB
Profile for Dr. James O. Westgard
Dr. Westgard is co-founder and principal in Westgard QC, Inc., a small business providing tools, technology and training for laboratory quality management. He is also an Emeritus Professor in the Department of Pathology and Laboratory Medicine at the University of Wisconsin Medical School. He spent many years as Faculty Director of Quality Management Services for the Clinical Laboratories at the University of Wisconsin Hospital and Clinics, still teaches in the Clinical Laboratory Science Program, and is co-director of a capstone program offering a Graduate Certificate in Laboratory Quality Management via the internet.
A native of North Dakota, Dr. Westgard obtained a BA degree in chemistry from Concordia College in Moorhead, Minnesota, and Master's and Ph.D. degrees in analytical chemistry from the University of Wisconsin-Madison. He began his career at UW as a Clinical Chemist and served in the past as Director of Clinical Chemistry, Associate Director for Laboratory Administration, and Associate Director for Quality.
Dr. Westgard's early interest was in the development of method evaluation protocols and he served as the first chairman of the Evaluation Protocols Area Committee in CLSI (then known as NCCLS). He published extensively in this area during the 1970s and 1980s, including a monograph on Method Evaluation published by ASCLS. His interest in quality control began in 1976-77 when he was on sabbatical leave at Uppsala University in Sweden where he worked with Professor Carl Henric deVerdier and Drs Torgny Groth and Torsten Aronsson. This work led to the multi-rule control procedure, internationally known as “Westgard Rules.” His extensive work in quality management is documented by several books, including Cost-Effective Quality Control: Managing the quality and productivity of analytical processes, Basic QC Practices, Basic Method Validation, CLIA Final Rules for Quality Systems; Assuring the Right Quality Right: Good Laboratory Practices for verifying the attainment of the intended quality of test results; and Six Sigma Quality Design and Control: Desirable precision and requisite QC for laboratory measurement procedures.
The general area is quantitative techniques for analytical quality management and includes statistical quality control of laboratory testing processes, performance validation of measurement procedures, modeling and simulation for optimization of laboratory testing processes, and computer tools and technology for practical applications. Current work focuses on the development of a computerized process to automate the design of statistical QC procedures on the basis of the analytical, clinical, or biological quality requirements for a laboratory test, the imprecision and inaccuracy observed for a measurement procedure, and the rejection characteristics expected for different QC decision criteria and strategies. Applications of this process are also investigated to develop improved QC strategies for the more complicated quantitative analyses in clinical laboratories.
Dr. Westgard has received many awards from professional organizations involved with laboratory medicine and clinical laboratory science, including the following:
- 1982 American Association for Clinical Chemistry (AACC) Ames Award for scientific achievement and leadership in clinical chemistry;
- 1987 Gerulat Award from the New Jersey Section of AACC;
- 1988 Annual Award from the Manitoba Society of Clinical Chemists;
- 1990 Natelson Award from the Chicago Section of AACC;
- 1992 Ciba-Corning Lectureship from the British Association of Clinical Biochemists;
- 1994 Roman Lectureship 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 Lectureship on Clinical Laboratory Quality, Standardization, and Compliance from the University of Oklahoma Health Science Center;
- 2003 Alvin Dubin Award for Distinguished Contributions to Clinical Biochemistry from the National Academy of Clinical Biochemistry.
- 2004 Laboratory Public Service National Leadership Award for Lifetime Achievement, Washington G2 Lab Institute.
- 2005 Roche Diagnostics Award, British Association of Clinical Biochemists
- 2005, Outstanding Contributions to Management Science, AACC Management Science Division
- 2009, Perry A. Lambird Excellence in Medicine Award, COLA.
- 2010 Havarkate Lecture Award for Quality Improvement in the medical Laboratory (Dutch ECAT Foundation)
- 2012 Van Slyke Award from the New York - Metro section of the AACC
Dr. Westgard has published nearly 200 papers, chapters, monographs, books, reports, and articles. He has also published some 60 abstracts and made over 350 presentations at scientific meetings, conferences, workshops, and seminars. The Westgard Website (www.westgard.com) provides over 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. Assuring the Right Quality Right: Good laboratory practices for verifying the attainment of the intended quality of test results. Madison WI:Westgard QC, 2007, 288 pp.
- Westgard JO, Westgard SA. The quality of laboratory testing today: An assessment of sigma-metrics for analytical quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance. Am J Clin Pathol 2006;125:343-354.
- Westgard JO. Six Sigma Quality Design and Control: Desirable precision and requisite QC for laboratory measurment processes, 2nd ed. Madison WI:Westgard QC, Inc., 2006, 338 pp.
- Westgard JO, Westgard SA. Equivalent quality testing versus equivalent QC procedures. Lab Med 2005;36:626-629.
- Westgard JO. Clinical quality vs analytical performance: What are the right targets 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. Design of internal quality control for reference value studies. Clin Chem Lab Med 2004;42:863-867.
- Westgard JO, Ehrmeyer SS, Darcy PT. CLIA Final Rules for Quality Systems. Madison WI:Westgard QC, 2004, 220 pp.
- Westgard JO, Darcy PT. The truth about quality: Medical usefulness and analytical reliability of laboratory tests. Clin Chim Acta 2004;346:3-11.
- 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 active process control technology. Point of Care 2003;2:1-7.
- Westgard JO. Basic QC Practices, 2nd ed. Madison, WI:Westgard QC, 2002, 320 pp.
- Westgard JO. Electronic quality control, the total testing process, and the total quality control system. Clin Chim Acta 2001;307:45-48.
- Petersen PH, Stockl D, Westgard JO, Sandberg S, Linnet K, Thienpont L. Models for combining random and systematic errors. Assumptions and consequences for different models. Clin Chem Lab Med 2001;39:589-595.
- Westgard JO. Basic Planning for Quality. Madison, WI:Westgard QC, 2000, 272 pp.