James O. Westgard. Ph.D., FACB

Biographical Information Dr. Westgard is a Professor in the Department of Pathology and Laboratory Medicine at the University of Wisconsin Medical School and Faculty Director of Quality Management Services for the Clinical Laboratories at the University of Wisconsin Hospital and Clinics. He teaches in the Clinical Laboratory Science Program and is co-director of a new capstone program that offers a Graduate Certificate in Laboratory Quality Management via the Internet. He is also a co-founder and principal in Westgard QC, Inc., a small business that provides tools, technology, and training for laboratory quality management (www.westgard.com).

Some of the WQC staff at the 2000 AACC/ASCLS meeting in San Francisco. Dr. Westgard (at right), Sten Westgard (middle) and Robert Kennedy (left).

A native of North Dakota, he 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 and Associate Director for Laboratory Administration. In February 2003, he completed 35 years of service with the University of Wisconsin.

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 NCCLS. He published extensively in this area during the 70s and 80s, 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, often referred to as "Westgard Rules." His extensive work on quality control is summarized in the book Cost-Effective Quality Control: Managing the quality and productivity of analytical processes, authored with Patricia Barry and published by AACC. He currently chairs the NCCLS working group on Quality Control that is revising document C24-A2 (Internal Quality Control Testing: Principles and Definitions).

He also spent a shorter sabbatical period in 1990 at Odense University Hospital in Denmark where he worked with Dr. Per Hyltoft Petersen and Professor Mogens Horder. His more recent focus on quality planning is an outgrowth of that sabbatical. The development of the theory and approach for QC planning led to the formation of Westgard QC to support the tools, technology, and training to make quality-planning practical in healthcare laboratories.

Research interests

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.

Awards

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.
  

Publications

Dr. Westgard has published 83 peer reviewed papers, 21 papers in proceedings of scientific conferences, 51 chapters, monographs, books and reports; 24 newsletter articles, 4 computer programs, 3 videotapes, 5 internet courses, 2 CD training courses, and 2 patents. He has also published 58 abstracts and made over 325 presentations at scientific meetings, conferences, workshops, and seminars. About 250 lessons, essays, and QC applications are provided on his website at www.westgard.com. Some recent publications include:

• 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 Method Validation, 2nd ed. Madison WI:Westgard QC, 2003, 292 pp.
  
• 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. Six Sigma Quality Design and Control: Desirable precision and requisite QC for laboratory measurment processes. Madison WI:Westgard QC, Inc., 2001, 296 pp.
  
• Westgard JO. Basic Planning for Quality. Madison WI:Westgard QC, Inc., 2000, 272 pp.