Dr. Westgard: You certainly have contributed a great deal to the field of analytical quality management. Who were some of your role models/mentors in your early career? Were others in the field supportive of the changes you were trying to implement early on?
James O. Westgard, Ph.D.
Roy Rand, who was at Kodak, was one person who I consider a mentor, though his influence was initially through his articles on standardization in the Clinical Chemistry journal. Later I would talk to him at AACC meetings and other scientific conferences. Another was Roy Barnett, who was a pathologist at Norwalk Hospital. He established method validation as a standard laboratory practice and also was a leader in the area of analytical goals. I later worked with him on the NCCLS committee that he chaired to develop the C24 document on statistical QC. I must admit there were a number of pathologists who were not very supportive of the concept of "total error." At the 1976 Aspen conference on quality goals, I found myself arguing against the leaders in the field. However, I had learned from my major professor how to defend myself (otherwise I would never have gotten out of graduate school) and that training proved valuable throughout my career.
Dr. Westgard, It must be very gratifying to know that you have made such important contributions to the practice of laboratory medicine. I was struck by your astute statement regarding how QC practices have yet to catch up with today's automated instrumentation. Could you describe your vision of what the perfectly controlled laboratory would look like? Also, what should laboratorians be doing to address the variation in patient test results that occurs due to biological variation? In some instances, we seem to focus on achieving an analytical precision that isn't really necessary. Thank you.
James O. Westgard, Ph.D.
I think the main ingredient that is missing in laboratory quality management is "quality" - what is needed and how do you know you are achieving it in everyday operation. We need to make our quality practices quantitative and objective, guided by what is needed for patient care. Until we have quantitative evidence of the quality of our processes, whether pre-analytic, analytic, or post-analytic, quality won't be properly and objectively managed. I personally believe we need to make improvements in all parts of the testing process, including analytic performance. The relative importance of analytic vs biologic variation can be assessed objectively, and when biologic variation is a limiting factor, it will be necessary to obtain multiple tests over time to average out that variation. Such an assessment requires a "clinical quality planning" model to account for the interactions of the possible sources of random and systematic variation. Today's "evidence-based laboratory medicine" needs to deal with this issue if clinical guidelines are to be useful and reliable. So, we need a better framework to understand quality management, then we can figure out how to better implement quality practices. That implementation should make use of technology and automation to make the testing process more systematic and reliable.