Volunteer Focus
Bruce H. Davis, MD, President, Trillium Diagnostics, Scarborough, Maine; Associate Director of Clinical Research, Maine Medical Center Research Institute, Scarborough, Maine; Director of Hematopathology, US Labs, Irvine, California

Tell me about your professional background.
I am trained as a hematopathologist, board certified by the American Board of Pathology. I’ve worked both in academics, having faculty positions at Upstate Medical Center and Dartmouth Medical School, and in private practice. I have started my own company recently, Trillium Diagnostics, where I manufacture diagnostic products based upon my research and consultation with medical device manufacturers; so, I’ve seen all aspects of the business. My involvement in professional organizations other than CLSI includes the American Society of Hematology (ASH), American Society for Clinical Pathology (ASCP), and the College of American Pathologists (CAP), where I’ve been active on several committees for over nine years. I was a participant on the CAP Hematology Resource Committee in charge of surveys for instrumentation and the associated proficiency testing. In addition, I am active within both the Clinical Cytometry Society (CCS), being Past President and serving on the Council for many years, and the International Society for Laboratory Hematology (ISLH), which I co-founded and for which I’ve organized meetings for about a decade. I am also active within the International Council for the Standardization in Haematology (ICSH).

Why did you choose to pursue a career in the medical industry?
Well, it’s actually a funny story. I originally wanted to be a veterinarian. One summer, I held a job at a biochemistry research laboratory at University of Connecticut Medical School, where subsequently I went to medical school. At that point, I became uncertain about what career I wanted to pursue. My best friend’s father naively said, ‘You should go to medical school because with that degree you can do anything.’ This was actually true with regard to both practicing medicine or doing research. But, it did rule out ever becoming a veterinarian. Most times, I don’t regret the decision.

As one of the world’s leading flow cytometrists, what organizations seek your expert opinion?
I do a limited amount of expert legal testimony, particularly when it involves flow cytometry as a diagnostic modality. Occasionally, I’m invited to participate in European societies, such as the European Working Group for Cell Analysis, and have made presentations to the British Society for Haematology.  I also serve as a consultant to several of the major manufacturers of flow cytometry products and hematology instrumentation.

How long have you been involved in the CLSI consensus development process?
I think it has been almost 20 years that I’ve participated as a volunteer for CLSI. My involvement in CLSI began when I was invited to take part in the development of the first reticulocyte document (H44). Then I was asked to serve as chairholder for the subcommittee writing a document on fetal red cell detection (H52).  Next, I was invited to be a member of the Area Committee on Hematology, then vice-chairholder, and finally chairholder.

So, now you serve as Chairholder of the Area Committee on Hematology. What prepared you for this role?
Really, I think it was both contributing to the development of several CLSI documents and participating in other consensus activities, and through my involvement with professional associations and societies such as the CCS, as well as ISLH and ICSH. 

What continues to motivate you to devote your valuable time to the CLSI standards development process?  
Standards can be a two-edged sword; there must be a balance. My motivation is the desire to make sure the standards documents are helping people in the laboratory rather than shackling them, as well as educating laboratory personnel on the preferred practice patterns.

Do you feel CLSI documents are helpful resources for professionals in your field in day-to-day practice?
Yes, I do. I will be especially proud of the newest editions of the two flow cytometry documents (H42 and H43) that are now being developed. They will be particularly helpful and useful.

In what ways do you feel these documents will be helpful?
In terms of being a resource, describing the preferred ways of performing certain activities, and providing guidance to laboratories that don’t have the same experience as the people that write the documents.  So, it is a good way to create a useful educational tool that isn’t an 800-page textbook. The documents are concise, yet very practical for the laboratories to be sure that they are performing consistently by following guidelines set out by experts in the field.

What advances have you seen that have increased the need for standardized procedures and guidelines? 
I think any time you introduce new technology, there is always a question about its appropriate use. So, both in the areas of flow cytometry and molecular testing, which are relatively new technologies, I see a need for guidance documents. Of course, for pathologists of my generation, these technologies didn’t exist when we were in medical school, even during residency.   

How do you continue to educate yourself about new technologies?
Certainly, reading the literature and going to meetings are the two best ways to stay current. The other is just staying active within my specialty and keeping in contact with colleagues from around the world—asking them what they know, what’s new. Also, I consult with several medical device manufacturers. This is a way for me to learn about and see products before they are actually out in the marketplace. By interacting with the scientists and engineers that are putting the devices together, I get an innovative perspective.

You are cited in numerous journals, have written many articles, and have an extensive background as an invited speaker. Do you often find it important to reference any particular CLSI documents in your presentations?
Sure. I think the documents are particularly important to cite as related documents for review articles that I am putting together. As I say, the CLSI documents are a nice, succinct review.  

What, in your opinion, are the important issues being faced in the development of global and harmonized standards?
Well, I think one of the biggest challenges is breaking down the traditional parochial barriers, if you will. For instance, CLSI in its origin was NCCLS, but is still viewed by some people around the world as a ‘North American organization.’ It is the challenge of trying to get people to work together and recognize the advantage of buying into one organization providing the standardized document.

Do you think the efforts CLSI is making, by harmonizing documents, and changing the organization name, help to forge the ground for people around the world to recognize the goal of working together?
I think those efforts certainly help. I am hoping that CLSI’s name change, as well as the consideration by the CLSI Board of Directors to expand efforts to hold Area Committee meetings in Europe and in conjunction with international meetings, and to recruit people outside the US, will positively contribute to the acceptance of CLSI as a global organization.

Do you think technological advances, such as the Internet, video conference calls, and webcasts, promote the increased involvement of global CLSI volunteer participants?
I think these advances can help quite a bit. I’ve made it an objective, within the Area Committee on Hematology, to recruit a much broader non-American representation on the document groups that are formed. In that process, I’ve seen that the ability to send a document via the Internet facilitates working across time zones. Conference calls, and hopefully video conferencing in the future, can make all of the necessary communication much easier and more practical.

Do you have any other recommendations for what you would like to see occur within CLSI either in the area of hematology or within the organization in general?
CLSI has set a very good agenda and course. Going forward, I think CLSI should continue to partner with international organizations, and get involved with them. I’ve tried to serve as a catalyst to connect CLSI with ISLH and ICSH. All of these organizations will benefit from working together. Hopefully, CLSI will continue to have success extending these partnerships across all disciplines.

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