Faculty

James O. Westgard, Ph.D.; Sharon Ehrmeyer, Ph.D.;

James O. Westgard, Ph.D.

Responsibilities in the Graduate Certificate Program

Dr. Westgard and Dr. Ehrmeyer share responsibilities for the development and implementation of the Graduate Certificate in Quality Management for Clinical Laboratory Scientists. Dr. Westgard has been instrumental in prototyping some of the course materials and continuing education courses on his own website (http://www.westgard.com). He is the author of a continuing education course in "Quality Control Planning" that were provided via the Internet by AACC (American Association for Clinical Chemistry) for 15 ACCENT credits. Another course in "Basic QC Practices" was provided through ASCLS (American Society for Clinical Laboratory Science) for 15 P.A.C.E. credits. These initial experiences in developing online courses were critical in establishing the Internet as the medium for the Graduate Certificate in Quality Management, where Dr. Westgard is the primary author of materials for three of the courses.

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 has in the past served as Program Director. He is also a co-founder and principal in Westgard QC, Inc.

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 1997, he completed 30 years of service with the University of Wisconsin.

Scientific interests

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 chaired the NCCLS working group on Quality Control that developed 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 was the 1982 recipient of the AACC's Ames Award for scientific achievement and leadership in clinical chemistry, the 1987 Gerulat Award from the New Jersey Section of AACC, the 1988 Annual Award from the Manitoba Society of Clinical Chemists, the 1990 Natelson Award from the Chicago Section of AACC, the 1992 Ciba-Corning Lectureship from the British Association of Clinical Biochemists, the 1994 Roman Lectureship from the Australian Association of Clinical Biochemists, the 1995 Miriam Reiner Award from the Capitol section of AACC, the 1997 Robert Mendelson Award from the ASCLS. The 2002 Passey Lectureship from the University of Oklahoma Health Science Center, and the 2003 Alvin Dubin Award from teh National Academy of Clinical Biochemistry.

Recent publications

Westgard JO, Falon 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, 2002, 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 combination 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 measurement processes. Madison, WI: Westgard QC, Inc., 2001,296 pp.

Goldschmidt HMJ, Brandslund I, Vogt W, Westgard JO, Voipio-Puikki LM, Pequeriau N, DeBievre P, Ehrmeyer S, Libeer JC. The EFQM management model for TQM applied to laboratory medicine. Accred Qual Assur 2001; 6:388-395.

Westgard JO. Basic Planning for Quality. Madison, WI: Westgard QC, Inc., 2000,272 pp.

Tomar R, Westgard J, Eggert E. Quality Reengineering in Health Care: The Clinical Laboratory at the University of Wisconsin Hospital and Clinics. Chicago, IL: ASCP Press, 1999, 160 pp.

See also http://www.westgard.com for educational and training materials that have been developed to support applications in analytical quality management.

Sharon S. Ehrmeyer, Ph.D.

Biographical information

Dr. Ehrmeyer is a Professor in the Department of Pathology and Laboratory Medicine at the University of Wisconsin Medical School and Director of the undergraduate Clinical Laboratory/Medical Technology Program, where she teaches courses in clinical chemistry and laboratory management and education.

Dr. Ehrmeyer received her BS degree in medical technology and Ph.D. in pathology from the University of Wisconsin-Madison. Her MS degree in medical technology education and administration is from the University of Wisconsin-Eau Claire. She has been associated with the University of Wisconsin-Madison CLS program since 1976.

Scientific and research interests

Education. Dr. Ehrmeyer has an ongoing interest in improving undergraduate education and providing continuing education for laboratory professionals. She has coordinated and developed several courses to facilitate the retraining of inactive medical technologists for reentry into the workplace and continues to plan and present workshops and seminars both nationally and internationally in a variety of areas to update practicing professionals.

Proficiency testing. Dr. Ehrmeyer has collaborated with Dr. Ronald Laessig, director of the State Laboratory of Hygiene, to better define the role of inter-laboratory proficiency testing in assessing intra-laboratory quality. This research has lead to a better understanding of the ability of proficiency testing to evaluate laboratory quality including why good laboratories sometimes fail and bad laboratories often pass proficiency testing. Some of the concepts of these studies have been incorporated into the current Clinical Laboratory Improvement Amendments (CLIA'88) mandated proficiency testing requirements.

Blood gases and critical care measurements. For 10 years, Dr. Ehrmeyer coordinated the Wisconsin pH and Blood Gas Proficiency Testing (voluntary) Survey, in which over 150 laboratories in and around Wisconsin participated. She chaired the NCCLS Committee on pH and Blood Gas Measurements that produced C12-A, Definitions of Quantities and Conventions Related to Blood pH and Gas Analysis; C21-A , Performance Characteristics for Devices Measuring PO2 and PCO2 in Blood Samples; C25-A, Fractional Oxyhemoglobin, Oxygen Content and Saturation, and Related Quantities in Blood; and C27-A, Blood Gas Preanalytical Considerations: Specimen Collection, Calibration, and Controls. She also served on the NCCLS Ion-Selective Measurement Committee--Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method (C29-A2) and A Designated Comparison Method for the Measeurement of Ionized Calcium in Cerum (C39-A). She is currently the sectretary fro AACC's Critical and Point of Care Testing Division.

Laboratory regulations. The impact of laboratory regulations (CLIA, JCAHO, CAP and COLA) on test quality including point of care testing is a continuing interest of Dr. Ehrmeyer. This has lead to the development of The New Poor Man's (Person's) Guide to Meeting the Regulations, co-authored with Dr. Ronald Laessig. The 250-page Guide is updated several times each year and used in workshops sponsored by AACC, NCCLS, ASCLS, CLMA and ASCP as an education training tool to help practicing professionals understand the many, often confusing, testing requirements and develop successful strategies for meeting the regulations. She currently is the Regulatory Affairs editor for the new Point of Care journal.

Awards

In 1996, Dr. Ehrmeyer was named to the University of Wisconsin-Teaching Academy. Additional awards in the last ten years include: the NCCLS Outstanding Educators and Board Service Awards; the Van Hise Outreach, Excellence in Teaching Award from the University of Wisconsin-Madison; the Professional Achievement Educator Award from ASCLS; the Fisher Award for Wisconsin's Outstanding Educator in Continuing Education; the Natelson Award from the Chicago section of AACC; two Professional Achievement Awards --Biochemistry and Lectureship -- from ASCLS; the Medical Technologist of the Year award from the Wisconsin Association for Medical Technology and several Outstanding Speakers awards from AACC.

Recent publications

Ehrmeyer, SS, Laessig, RH: Is CLIA 2003 the Quality Alliance Envisioned between Manufacturers, Laboratory Professionals and Regulatory Agencies? Accreditation and Quality Assurance Journal 8: 2003.

Fallon, KD, Ehrmeyer, SS, Laessig, RH: From Quality Control and Quality Assurance to Assured Quality. Point of Care 2:3; 188-94, 2003.

Ehrmeyer, SS, Laessig RH: POCT 2003: Testing Environment, Regulations, and Technology. Advance for Laboratory Administration 12:4; 28-38, 2003.

Ehrmeyer, SS: Reportable Range: Point of Care 2:1; 71-72, 2003.

Ehrmeyer, SS: Using Creatinine Ratioing of Urinalysis Results to Improve Reliability. MLO 35:26-30; 2003.

Ehrmeyer, SS, Laessig RH: Regulatory Affairs: Proficiency Testing: Point of Care 1:4; 268-270, 2002.

Ehrmeyer, SS, Laessig, RH: A Practical Application: Error Proofing POCT. Accreditation and Quality Assurance Journal 7: 450-454, 2002.

Ehrmeyer, SS: Regulatory Affairs: Quality Assurance: Point of Care 1:3; 180-182, 2002.

Ehrmeyer, SS: Regulatory Affairs: Quality Control: Point of Care 1:2; 104-106, 2002.

Ehrmeyer, SS, Laessig RH: At the Bedside: An Inspection of POCT Issues: Advance 11: 10-12, 2002.

Ehrmeyer SS, Laessig RH, Ancy JJ: Blood Gases, pH, and Buffer Systems, In: Clinical Chemistry, 5th ed (Bishop, Duben-Engelkirk, Fody, eds) Lippincott, Philadelphia, PA,.2003.

Ehrmeyer SS: What Regulatory Guidelines Influence the Practice of Quality Control? In: Basic QC Practices, (Westgard, J, ed) Westgard QC, Madison, WI, 2002.

Ehrmeyer SS: What is Minimum Quality Control? In: Basic QC Practices, (Westgard, J, ed) Westgard QC, Madison, WI, 2002.

Ehrmeyer SS: Urinalysis Regulations, In: Bayer Encyclopedia of Urinalysis, (Renfrew, G, ed) Bayer, Elkhart, IN, 2002.

Ehrmeyer SS, Laessig RH: Compliance Issues -- Laboratory Regulations and Point-of-Care Testing, In: Laboratory Management: Principles and Processes, (Harmening, DM, ed) Prentice Hall, Upper Saddle River, NJ, 2002.

Ehrmeyer SS, Laessig RH: Regulation, Accreditation and Education, In: Point-of-Care Testing: Principles, Management, and Clinical Practice, (Kost, GJ, ed) Lippincott Williams & Wilkins, Philadelphia, PA, 2002.