Arthur L. Barry, PhD
Retired  

You have been a Professor of Clinical Microbiology for over 50 years. Can you tell me how you first got started in the health care field?
I started my career as a medical technologist. I worked in a clinical laboratory ever since I graduated in medical technology. While I was studying for a Master’s degree and then a PhD, I continued working in clinical laboratories. I was drawn to the health care profession because I wanted to do something to help care for people. Working in a clinical laboratory was a good fit for me.

Prior to your retirement, you were a Professor of Clinical Pathology, Division of Clinical Microbiology at the Oregon Health Sciences University School of Medicine for almost 20 years; and Professor of Microbiology at the University of California for 16 years. Then, in 1982, you founded the Clinical Microbiology Institute (CMI). Can you describe a bit about your work?
I started CMI in order to do the kind of antibiotic research that I always wanted to perform. CMI is almost exclusively involved in testing antibiotics. Before CMI was founded, I was doing some of that type of research in my laboratory at the University of California Davis Medical Center. At that time, no one in the academic world was in the position to exclusively do such testing. That research was always done as part of our job in the clinical laboratory, in addition to teaching responsibilities. In 1982, a group of microbiologists in the United States collaborated to do such studies. CMI was started in order to coordinate such collaborative studies. After starting CMI, we were able to do much of the research needed to support CLSI standards. CMI generated a great deal of the data that were presented to CLSI subcommittees when new drugs were being evaluated, in order for them to establish the interpretive criteria and quality control limits for the next CLSI documents. 

CLSI, founded as NCCLS, celebrates its 40th anniversary in 2008. Can you describe the events that led to the foundation of CLSI?
Forty years—it seems unbelievable. My interest in antimicrobial susceptibility testing (AST) began when I was working on my doctorate dissertation involving standardization of susceptibility testing methods. I then did a two-year fellowship with Dr. John Sherris at the University of Washington. I was there at the time when he was heavily involved in trying to standardize susceptibility tests on a global level. He and Dr. Hans Ericsson got countries thinking about standardized susceptibility testing methods. That was where I was when I got a letter from Dr. Howard Bodeley who was with the California State Health Department and one of the organizers of CLSI. He asked me to propose subject areas for new CLSI projects in development. I wrote back with a long letter because I was so passionate about standardizing AST. I was asked to serve as chairholder on the committee for susceptibility testing. At that time, CLSI was a group of people with good ideas. They were supported by a part-time secretary serving out of a small office in Los Angeles and a very limited budget. I thought that standardizing AST was an appropriate and timely thing to do knowing what was going on in the country. In terms of susceptibility testing, there was absolutely no standardized method that was universally accepted by clinical microbiologists. Everyone was in favor of their own method. It was clear to me that if clinical laboratories were going to compare results, it had to be done by a standard method. The idea behind CLSI was to get a group of people together—from professions, government, and industry—to write their own standards. I thought it was a great idea and that was really what motivated me to get involved. Early in the foundation of CLSI, I tried to find people who were open-minded and who would agree that standardization was necessary. I spent almost two years interviewing people and holding committee meetings to recruit volunteers. We put together a committee representing all the constituency groups. In 1970, Dr. Thomas Gavin obtained a grant that enabled us to meet in one place for three uninterrupted days. We sat down and wrote what became Performance Standards for Antimicrobial Disk Susceptibility Tests (M2). Once the Food and Drug Administration (FDA) supported the method we had outlined in M2, most of the United States acknowledged the value of CLSI. The day M2 was approved and published, the CLSI office had requests for thousands of copies that were circulated all over the world. The M2 document has been developed and updated ever since. CLSI was in a position to continue developing standards for other test procedures.

When CLSI was first started, the initial need for standards was focused on AST. Can you explain CLSI’s impact on AST at that time?
First, there was, and still is, a need for standard methods. If different laboratories are going to communicate, they must use the same method in order to compare results. Second, susceptibility test results must have some meaning in terms of good clinical response for proper patient care. When CLSI was founded, the world was very simple. There were just a few pathogens that we needed to worry about. Now there are all sorts of pathogens that did not even need to be tested in the past. They present their own unique problems in terms of susceptibility testing because they are becoming resistant. Fortunately, the CLSI committee has been very good at picking up future trends and makes sure standard methods are in place if a particular pathogen becomes a problem worldwide. In terms of antibiotics, the original M2 standard had about 20 drugs. Last time I counted, the CLSI standard had about 75 antibiotics. This is an ever-growing and evolving process.

In what ways has CLSI’s role changed over the years, in education and global standardization, particularly in the area of AST?
For many years, the story I used to hear was that NCCLS starts with “N” for “national.” The AST committee now tries to get participation from all areas of global health care. The national standards that were developed were widely accepted in countries that did not have standardized methods, including parts of South America, Central America, Africa, and Asia. They all accepted the CLSI standards as their methods. Some countries had standardized procedures for their nation. The rest of the world uses CLSI standards. If you visit central Africa, the practice of laboratory medicine is altogether different than in the United States. I was encouraged to see CLSI take on the challenge of standards for global use. I think the move to global standards is a good strategy in many different ways. As CLSI has already done with many organizations, it is best to partner with countries in order to develop globally applicable standards.

Why do you think CLSI has become such a well-known, credible resource for globally recognized consensus standards?
I would like to say that CLSI is a well-known, credible resource because the founders did such a wonderful job. But I do not think that is the reason. The reason is the idea behind the way the organization is structured. The process to develop standards involves professions, government, and industry. In other countries, standards are only dictated by the government. CLSI standards are about different experts getting together to determine best practices. I think a lot of people live in this world because of advances in laboratory medicine. Many health care professionals want to contribute to improving quality and enjoy collaborating with colleagues with similar interests.

What, in your opinion, has made CLSI a unique resource for standardized best practices?
The reason CLSI is a unique resource is twofold. CLSI is the only organization of its kind that follows the consensus process for developing standards. But what I am proud of is the system for updating CLSI documents. Having a standard that is written and etched in stone is unrealistic. What I like about CLSI is that they are constantly reviewing their own data and constantly reviewing and changing them to keep them current.

You participated on CLSI microbiology document development committees for almost 40 years. What drove your passion for standards development for so long?
I was driven to make sure what we started continued to grow and thrive. CLSI was an organization where I could contribute professionally and get satisfaction when standards were published and used.

From your involvement in numerous committees, do you have any particular highlights or areas that you like most about CLSI consensus document development?
CLSI is like an organism that is created and grows. It is like comparing a newborn baby to a teenager. It is still the same person. It is difficult to pick one highlight because I’m proud of my role in the development and growth of CLSI. If I had to pick one document, it would be M2. The document has grown and evolved, but the original method was the one that forged the start of CLSI.

From your extensive teaching and writing experience, did you find it important to reference CLSI documents?
Absolutely. I mainly focused on the need for a standardized method. Anyone around the world could implement M2 and reproduce results. For that reason, I think it is critical that the CLSI standardized method was documented and referenced. 

Why is it so important for microbiologists to stay updated on the latest CLSI documents?
For the microbiologist, it is critical to have the most recent document because it has the most updated information. The first M2 standard has grown so much over the years. There has to be a process in place to make sure the most updated versions are used in the clinical laboratory.

Do you feel microbiologists are aware of CLSI standards?
It is clear that the majority of clinical laboratories claim to be using CLSI standards. I am impressed with the large number of laboratories that must have CLSI breakpoints in order to test new antibiotics. When a new antibiotic comes out, laboratories reference the CLSI guidelines. This certainly shows that CLSI is well-recognized. I think all the CLSI documents are well accepted and used in health care facilities.

As a founding member of CLSI, do you have any recommendations about what you would like to see happen within the organization in the future?
I would like to see CLSI expand its global reach as it has already done so well. To expand globally, CLSI must partner and work together with governing bodies in order to facilitate the standards development. It is important to emphasize and understand that CLSI is a voluntary organization, not a legal authority. I think CLSI is going in the right direction. Project development ideas are generated with emerging technologies and the need for standardization continues. It is hard to look into the future and see where the organization will be forty years from now. But CLSI is thriving, M2 is still being widely used, and I am proud of those accomplishments. I look back at my involvement in CLSI as a very positive experience—I have no regrets. The next generation will come on board and will make it even better.