Gerald A. Hoeltge, MD
Head, Section of Transfusion Medicine
The Cleveland Clinic Foundation

Tell me about your professional background.

After graduating from Case Western University in 1971, I trained in anatomic and clinical pathology at the Cleveland Clinic Foundation. After a couple of years in the US Army as a general pathologist, I returned to the Cleveland Clinic in 1977 and have cared for patients here ever since.

You have been with The Cleveland Clinic Foundation (CCF) for nearly 30 years. Please tell me about the work you have done there and your current role.

CCF is a hospital with about 1000 beds. Since 1981, my practice has been limited to transfusion medicine and cytogenetics. For nearly 25 years, I have been managing critical care patients who require transfusions. As the quality officer for the Department of Pathology, I understand the need to maintain laboratory practice consistent with the best available standards and guidelines. The CLSI library is essential for the care and feeding of the quality program here at the clinic. What has kept me at CCF for so long is the opportunity to work in an environment of excellence in patient care, education, and research. There is nothing comparable in the entire state of Ohio. We teach in the medical school and have 36 pathology residents who rotate through the laboratory. We also train specialists in transfusion medicine. From our laboratory we transfuse 100 to 150 patients every day with about 100 000 units of blood and blood components a year. Keeping quality high with all of that activity is quite a challenge. I enjoy that kind of challenge.

You are actively involved in The College of American Pathologists (CAP), among other professional societies. Can you describe a bit about your involvement in professional societies other than CLSI?

I have been involved with the CAP Laboratory Accreditation Program since 1981. Most recently, I chaired the Complaints Committee, which handles about 300 complaints against accredited laboratories per year. In addition to CAP, I am an assessor for the American Association of Blood Banks (AABB); I am on the Board of our local Red Cross in Cleveland; and secretary/treasurer for our state pathology society. In the past, I chaired the Technical Committee on Laboratories in Health Care Facilities for the National Fire Protection Association, a standards development organization very much like CLSI.    

In support of its mission to develop best practices in medical testing and to promote their use, CLSI partners with accreditation agencies, including CAP. In what ways do you feel CLSI documents serve as educational resources for laboratories to meet regulatory and accreditation requirements?

Accreditation and regulatory standards may be thought of as brief, telegraphic documents oriented towards specific objectives. To accomplish a target goal, practitioners must understand the text of the problem that is going to be solved. They must gather the necessary data that fits into his/her situation and structure the necessary forms, training aids, and such. Well-constructed guidelines, like those published by CLSI, simplify that enormous task. If the standard or guideline was developed within the consensus process, then it also defines the standard of care. The programs of CLSI and CAP are aligned to provide useful, credible tools for meeting accreditation and regulatory requirements. At the same time, laboratorians involved in CAP accreditation activities are some of the most active volunteers in CLSI. CLSI provides a forum for regulatory and accreditation agencies to bring difficult issues to resolution through the consensus process.

How long have you been involved in the CLSI consensus development process? What have been the highlights of your involvement in the numerous committees in which you have participated?

My first project began in 1983 as Chairholder on the Subcommittee for Laboratory Waste Management. A decade later found me chairing the Area Committee on General Laboratory Practices. I have been a member of the Board since 1999, and was Treasurer until last year. In my nearly 25 years with CLSI, the most exciting time for me is right now, because as President-Elect I co-chair the Chairholders Council. This is a marvelous opportunity to work with an awesome group of experts and, by extension, all of the volunteers that they manage

How did you first become involved in CLSI?

I think most volunteers at CLSI are introduced to the consensus process because they have personal contact with someone who is an established volunteer. In my case, it was Dr. Tom Gavan. Tom, who was one of my medical school professors, became my colleague when I joined the staff at the Cleveland Clinic. I observed first-hand the professional satisfaction that he derived from participating in CLSI and how it kept his laboratory on the cutting edge. Of course, he later went on to be President of CLSI (or as it was known in those days, NCCLS). 

In April 2006, you were installed as President-Elect on the CLSI Board of Directors. What led you to this position?

Five years on the Executive Committee privileges one with insight into an organization’s strengths, challenges, and opportunities. I never expected to get the chance to preside over CLSI. But, when it was presented, I jumped at it. Who wouldn’t? The volunteers I’ve had the good fortune to meet through CLSI are experts in their fields and tireless. CLSI enjoys a talented staff that pulls the entire process together and makes it all happen. It is an incredible opportunity to be part of the process.

What has sustained your interest in CLSI? And, what continues to motivate you to devote your valuable time in such a highly influential position in the organization?  

If you want to keep your own laboratory among the best laboratories out there, you’ve got to know people who are running the best laboratories. You can’t read about it. You have to be able talk to experts in your field on a first-name basis. The only way to do that is to get involved in organizations like CLSI. CLSI documents are excellent resources that condense clinical laboratory requirements into useful, well-defined pieces. It is actually in the development of the documents where the real enjoyment and fulfillment exists. I think a good portion of every laboratory manager’s practice should be to see what other professionals are doing, and bring back the best ideas to your own workplace. 

Do you see any challenges in the consensus process?

If everyone agreed, you would not need a consensus process. The more constituents disagree, the more you need it. Once you get stakeholders together on any of these important questions, they will advocate for their point of view. At the same time, they will listen to other people’s concerns. That is what the consensus process is all about, finding that middle ground that meets everyone’s needs and is centered where it needs to be—in the best interests of our patients. 

You are cited in numerous journals, have written many articles, and have an extensive background as a formal presenter. Do you find that CLSI documents tie in with your presentations?

Every presentation about quality systems in the laboratory has CLSI themes running through it. You cannot authenticate what you are presenting better than by citing CLSI references. People know CLSI and recognize it as an authority. The questions you get from professionals at these presentations are often questions that CLSI has addressed in its documents. And if there is no standard or guideline in our library on the question, it is a helpful indicator as to what the next generation of CLSI documents should address.

Do you have any primary issues that you are hearing as hot topics for CLSI documents to address? Or, is CLSI already addressing the key issues in the current projects in development?

Some of the current projects in development are addressing issues around quality systems. The main difficulty in providing quality health care is in the handoff of responsibility from person A to person B, and from person B to person C. This includes suppliers, regulators, information systems professionals, and all the various areas where CLSI has documents or projects. Getting all of those providers to work together is really where people are struggling and where you find the most questions. 

Do you feel that laboratories have quality systems in place yet are still faced with the challenge of good communication in the testing process?

Everyone strives to perform his piece of the process perfectly. But, you have to look at the whole system from a much broader perspective to really appreciate where the opportunities for improvement reside. CLSI’s HS1-A2 document (A Quality Management System Model for Health Care; Approved Guideline—Second Edition) looks at the process from a systematic overview. CLSI has a number of documents and products in its inventory based upon HS1-A2, including the new Key to Quality.  Every one of them has useful tools to improve communication.

Do you feel CLSI documents are used by professionals in your field in day-to-day practice?

CLSI standards, guidelines, and reports address real-world problems; however, the documents are only helpful if they are used. I think many people are familiar with a few documents in the CLSI library. If we really wanted to make it easier for people to benefit from CLSI documents, we need to have better ways for them to discover the entire scope of documents that are available to them. That is why a searchable library, such as Infobase, is so helpful. With Infobase, you can find all of the documents that address your particular need very quickly. CLSI is working to improve access to the electronic library with products like Infobase.

In the important leadership role as President-Elect, you will be at the forefront of the future of CLSI. Do you have any recommendations for what you would like to see occur at CLSI now or in the future?

CLSI is here for only one purpose—to improve the quality of medical care. Whether the users of these documents are involved in direct patient care, have responsibility for governmental oversight, or produce the innovations in healthcare delivery, we all have this core responsibility to the patients that we serve. In the years ahead we must keep this patient care perspective. CLSI needs to continue to remember that it is all about patients. With that understanding, CLSI will continue to be a world leader in standards development.

"Volunteer Focus" is an eNews feature that highlights Clinical and Laboratory Standards Institute volunteers from different areas of the healthcare community and describes the contributions they are making to the patient-testing world through CLSI and their daily work.  To recommend a volunteer to be featured in an upcoming issue, e-mail Communications.
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