Volunteer Focus
W. Gregory Miller, Jr., PhD, Professor of Pathology, Virginia Commonwealth University

You have held various positions at the Virginia Commonwealth University, and VCU Health System. Can you briefly describe your professional background?
I came to VCU in 1977 after two years as Director of Clinical Chemistry in a community hospital.  I started as an Assistant Professor and Assistant Director of Clinical Chemistry.  I followed the usual progression in academic laboratory medicine and had the privilege to contribute to the training of a number of doctoral and postdoctoral clinical chemists who are now in various positions around the country.  Eventually I was promoted to Professor and have had several administrative responsibilities in the Pathology Department at VCU Health System. My active involvement in other professional organizations outside of CLSI includes:  Board of Editors for Clinical Chemistry; Chair of the National Institutes of Health, National Kidney Disease Education Program, Laboratory Working Group; Consultant, College of American Pathologists, Chemistry Resource Committee; Member, American Diabetes Association, Insulin Assay Standardization Work Group; Member of the Steering Committee of the National Glycohemoglobin Standardization Program; and Member of the International Federation of Clinical Chemistry and Laboratory Medicine:  Committee on Reference System of Enzymes, Working Group for Standardization of Thyroid Function Tests, and Working Group for Glomerular Filtration Rate Assessment.

Currently, you serve as the Director of Pathology Information Systems, Co-Director of Clinical Chemistry, and Director of the Pathology Quality Management Program at VCU and VCU Health System. What type of work do you do in each of these positions?
For Pathology IS, I provide management and coordination of all IT services for the department, and liaison to the hospital IT services group, and to the IT clinical advisory group.  IS services include anatomic and clinical pathology laboratories, research databases, website, etc.  In Clinical Chemistry, I am responsible for technical and clinical management of the laboratory services.  I coordinate the quality management program for the department and chair the clinical pathology review committee.

In your professional experience and daily work, do you find CLSI guidelines important resources?  
Yes, they are used by all areas of pathology, because they provide practical guidance on how to do the various tasks that are necessary to provide quality laboratory services. For example, we recently introduced some new equipment in the laboratory and we referenced CLSI documents EP15, User Verification of Performance for Precision and Trueness; EP9, Method Comparison and Bias Estimation Using Patient Samples; and C28, How to Define and Determine Reference Intervals in the Clinical Laboratory. Many of the documents are particularly helpful for method validation purposes when we bring new equipment into the laboratory, and for various aspects of laboratory operation. Wherever a CLSI standard or guideline exists, the laboratory in which I work follows it because of the consensus value that CLSI documents bring to the table. You know that if you follow the documents, you are performing the work correctly.   

You have been involved in CLSI for more than 20 years, including participation in the development of consensus documents as a chairholder and committee member. What first sparked your interest in CLSI? 
My first experience was as a member of the EP7 interference testing subcommittee.  A colleague of mine, Neil Greenberg, PhD, Manager, Regulatory Affairs, Ortho-Clinical Diagnostics, Inc., with whom I trained, invited me to become involved in the guideline development.  I was impressed by the process to develop a consensus standard and the cooperation between industry, professions, and government contributors that has been the cornerstone of CLSI.

In your CLSI standards-development experiences, are there any notable documents or resolved consensus issues of which you are particularly proud?
I feel that all the documents have value, and they all fit together in the path of workflow concept to address different components of quality in laboratory service.  I have been involved in some consensus challenges with some documents and have been gratified that the consensus process works very successfully, if not always as rapidly as might be ideal.

What changes have you seen in the development of standards both nationally and globally? And, what do you see as the pulse points for standards development in the future?  
When I entered laboratory medicine, the focus was on national standards, which led to a variety of different national standards for the same service that eventually needed to be reconciled.  The practice of laboratory medicine has become global in the past decades.  Clinical practice guidelines based on outcomes are being applied more uniformly around the world and have become more dependent on international collaborative clinical trials.  Standardization of laboratory test results continues to be critical for successful application of clinical guidelines on a global basis.  Understanding ethnic and geographic differences in laboratory values and how those differences influence clinical guidelines will become a more prominent component of clinical trials.  Many of the laboratory procedures provided by the in vitro diagnostic (IVD) industry are used internationally.  It will continue to be important for both quality and economy that global practices become more uniform and that laboratory test results become more transportable.  Standards that enable global harmonization for clinical practice guidelines will continue to become more important. A key objective for CLSI is to develop guidelines that have value and are used beyond the borders of North America. By recruiting global participants on the subcommittees, a broader perspective is achieved and the practical value of documents is increased. CLSI documents describe the “how to” and provide implementation techniques that bring a strong, practical bent. I see this unique element as the place where CLSI and its documents will continue to positively contribute in the future.

At the recently held 2006 CLSI Leadership Conference, you were initiated for a two-year term as Treasurer. What led you to this leadership role in the organization?  
I suppose the inability to say “no”–more properly stated as the inability to turn down an opportunity to contribute to the advancement of clinical and laboratory standardization.  It will be a new challenge to contribute to the overall direction and management of the organization.

What continues to drive you to stay actively involved in CLSI? 
Belief in the value of the consensus process to produce practical standards and guidelines, and the very talented people that are involved in CLSI activities.

As Treasurer, what do you see as the primary financial issues or topics that you would like to address during your tenure? 
Fortunately for CLSI, the staff are very talented at financial management, and the organization is financially solid.  My role will be to facilitate the finance committee oversight to maintain that condition.  A major investment, that is already underway, will be to improve the IT infrastructure to enable efficient virtual meetings and committee interchange, because physical meetings will become more difficult and expensive as global participation increases.  It is important to avoid under-investment, which can lead to inadequate value for the investment.  New sources of revenue, based on new standard- and guideline-development opportunities, will need to be explored.

What do you see as a path forward for CLSI? More specifically, do you have any particular suggestions for what you would like to see happen in the organization now or in the future? 
CLSI will continue to have influence and value as long as the consensus process and the requirement for independent review of documents are preserved.  The area committees provide an excellent resource for brainstorming and identifying new needs or service areas for standards development. Cooperation with other organizations will continue to be important to foster global participation and respect.