Meet the FACT
Inspectors
Meet the FACT Inspectors who are improving cellular therapy worldwide
The FACT inspectorate includes volunteer experts from around the world who are dedicated to quality cellular therapy.
Inspector Insights
Scott Koepsell, MD, PhD
Scott Koepsell, MD, PhD, Medical Director of Apheresis and the Biologics Production Facility and Vice Chair and Professor, Department of Pathology, Microbiology, and Immunology, at the University of Nebraska Medical Center in Omaha, Nebraska, shares his insights regarding the benefits of serving as a FACT Inspector.
Abba Zubair, MD, PhD
Dr Abba Zubair is the former Medical Director at Blood and Marrow Transplantation Program of Mayo Clinic and Nemours Children’s Clinic and Wolfson Children’s Hospital located in Jacksonville, Florida.
Michele Sugrue, MS, MT(ASCP)SBB
In 1997, the first book in the Harry Potter series was published in the United Kingdom. It was at that time, shortly after preparing for our program’s first “FAHCT” inspection, that I considered serving as an inspector.
Patrick J. Hanley, PhD
Patrick J. Hanley, PhD, is the Laboratory Facility Director for cellular therapy and stem cell processing at Children's National Health System. In addition to GMP regulations, Dr Hanley is interested in improving outcomes after stem cell transplantation, including bone marrow transplant and cord blood transplant.
Scott Koepsell, MD, PhD
Scott Koepsell, MD, PhD, Medical Director of Apheresis and the Biologics Production Facility and Vice Chair and Professor, Department of Pathology, Microbiology, and Immunology, at the University of Nebraska Medical Center in Omaha, Nebraska, shares his insights regarding the benefits of serving as a FACT Inspector.
FACT Inspector for 8 Years | Collection & Processing
A Career Built Around Cellular Therapy and Patient-Centered Care
Scott Koepsell’s fascination with cellular therapy began during his residency at the University of Nebraska Medical Center, where he witnessed firsthand the impact of hematopoietic transplantation on patients with lymphoma.
He was fortunate to train alongside Dr. Phyllis Warkentin as she established a state-of-the-art cellular therapy and GMP laboratory at UNMC. That experience helped shape his career path and ultimately led him to the University of Minnesota, where he completed a fellowship with Dr. Dave McKenna during the emergence of CAR-T therapy.
Returning to Nebraska allowed Scott to pursue what he describes as a “dream come true”—working every day in cellular therapy.
One of his proudest professional accomplishments came in 2018, when he was asked to build UNMC’s own apheresis program from the ground up. Working with a quality manager, nursing staff, and support staff, he developed the program from its foundation through its initial FACT accreditation on February 5, 2020.
For Scott, the work has always centered on one thing: the patient.
“Our job is to make sure everyone on the team is passionate about their work because there is a patient depending on us.”
Becoming a FACT Inspector
Scott became a FACT Inspector after being tasked with establishing UNMC’s apheresis collection program. He wanted to better understand FACT requirements and use that knowledge to help his own program succeed.
Eight years later, inspection has become much more than a way to understand standards.
Scott particularly enjoys meeting cellular therapy professionals around the world and learning from the different ways programs deliver care. His FACT experiences have also led to lasting friendships and professional opportunities.
He has served on FACT’s Immune Effector Cell Task Force and volunteered as faculty for accreditation workshops and inspector trainee workshops.
Seeing Cellular Therapy Around the World
Ask Scott about his favorite part of an inspection, and his answer is immediate: the facility tour.
He is fascinated by the many different configurations programs use to provide the same services—and what those differences can teach an inspector.
His most memorable inspections have been in India, where the scale, approaches, and challenges differed significantly from those he had experienced in the United States.
Seeing cellular therapy in a global setting challenged some of his assumptions and reinforced the value of FACT’s international community.
Scott hopes that FACT will continue to expand accreditation globally, bringing the benefits of shared standards and quality improvement to more programs around the world.
An Inspector Who Leads With Conscientiousness
If his fellow inspectors were asked to describe him in one word, Scott hopes they would choose “conscientious.”
For Scott, that means knowing the details, conducting a thorough inspection, and doing so with courtesy and thoughtfulness.
His advice to new inspectors reflects that same philosophy:
“The programs you inspect dedicate an enormous amount of time and effort to their preparation. Please match that commitment by thoroughly preparing for your visit.”
He encourages inspectors to become familiar with the documents available in the Portal before arriving. Thorough preparation not only makes an inspection more efficient—it demonstrates respect for the program and the work it has invested in the accreditation process.
Looking Ahead
Scott is particularly excited about the rapid expansion of cellular therapy beyond traditional oncology.
In a single day, his work has included collecting cells for a CAR-T product, collecting cells for a TCR-T product, and developing a plan to bring an off-the-shelf CAR-T product to a rural cancer clinic for an autoimmune disease clinical trial.
He looks forward to a future in which cellular therapies become mainstream treatments for an increasingly broad range of cancers and diseases.
Beyond the Lab
Away from work and inspections, Scott trades the cellular therapy laboratory for a 40-acre hobby farm, where he raises goats, chickens, and turkeys and tends a large garden.
He enjoys running, reading, and amateur farming—but his favorite way to spend a day off is simply family time.
Why FACT Matters
For Scott, volunteering with FACT is about more than accreditation.
It is about contributing expertise to a global community, continuing to learn from colleagues, and building relationships that extend well beyond an inspection.
“The connections I've built through volunteering with FACT are truly invaluable, both personally and professionally.”
And perhaps that captures the spirit of being a FACT Inspector best: sharing knowledge, strengthening programs, building connections, and ultimately helping ensure that every patient depending on cellular therapy receives the highest quality of care.
Abba Zubair, MD, PhD
Dr Abba Zubair is the former Medical Director at Blood and Marrow Transplantation Program of Mayo Clinic and Nemours Children’s Clinic and Wolfson Children’s Hospital located in Jacksonville, Florida.
Dr Zubair is the past Chair of the Inspector Development Committee and a past member of the FACT Board of Directors. He has 17 years of education and training at Murtala Mohammed General Hospital located in Kano, Nigeria, where Abba grew up. He was awarded Best Intern for Kano State. Dr Zubair also earned a PhD in Tumor Immunology from the University of Sheffield; Post-Doctoral Fellowship and Pathology and Laboratory Residency at the University of Pennsylvania School of Medicine; and a Clinical Fellowship in Transfusion Medicine and Masters of Clinical Science at Harvard Medical School. In 2011, Dr Zubair completed the Quality Academy at the Mayo Clinic. Dr Zubair has also published over 40 peer-reviewed articles.
Dr Zubair has been a FACT Inspector for 14 years and has performed 12 Cellular Therapy and 14 Cord Blood Inspections. Dr Arthur Jones, his chairperson at the time, encouraged him to apply after a successful FACT inspection at their program. Dr Zubair volunteered as a FACT Inspector to keep up-to-date with the FACT Standards.
This has certainly proven effective. Dr Zubair remarks, “Every time I go through the inspection process, it is like going through an entire practice of cell therapy. I get to rehearse and revise each aspect of the program’s activities, both old and new. It helps me remain current because it forces me to read and be up-to-date with current literature in the field.”
“In addition to having greater opportunity to shape the practice of cellular therapy, I benefit by developing friendships with people in my own discipline. There are two kinds of people that I am privileged to meet and establish relationships with including my team members, who join me during the inspection process, and the inspected program’s leadership and supporting staff. We share both professional and personal stories and truly bond together. I learn about many different cultures around the world which expands my network and connections with people in the field,” states Dr Zubair.
His experience as an inspector has contributed to improvements at his program in Jacksonville, Florida. “I observe many ways to meet the same FACT Standard and some programs meet the Standards in a better way than my own program. Every experience makes me a better leader and practitioner,” remarks Dr Zubair.
Dr Zubair is the current chairperson of the FACT Inspector Advisory Committee, a member of the FACT Board of Directors, and member of the FACT Cellular Therapy Accreditation Committee. His leadership qualities have made a great impact on FACT. Dr Zubair sees many benefits of serving on FACT Committees and the Board of Directors. In his view, “Being a member of the FACT Board of Directors contributes to my leadership development which in turn strengthens my career. By being an active participant in FACT activities, I have a greater opportunity to shape the practice of cellular therapy. My contributions help generate new FACT Standards that improve the practice and application of cell therapy in medical practice.”
Dr Zubair states that he believes knowledge is the best gift you can give someone and the giver and the receiver both feel gratified. “Participating in FACT workshops and webinars provides a gratifying feeling that one is contributing to his own professional community.”
Dr Zubair encourages others to volunteer as a FACT Inspector because he truly believes it improves your program practice of cellular therapy and ultimately benefits the patient. Dr Zubair’s advice to new inspectors includes:
Prepare ahead and manage your time during the process
Have an open and positive approach to the inspection process
Stay focused on the Standards—not your own institutional practice
Enjoy the process!
Dr Zubair was asked about his distinguished accomplishments and he commented, “I am most proud of being a father of four children. Two have graduated from college, one is working as a software developer, and the other is in medical school. My two younger children are in elementary school.”
Michele Sugrue, MS, MT(ASCP)SBB
In 1997, the first book in the Harry Potter series was published in the United Kingdom. It was at that time, shortly after preparing for our program’s first “FAHCT” inspection, that I considered serving as an inspector.
I felt that being able to visit other programs and observe operations firsthand would not only better expose me to the cellular therapy community and provide an educational experience, but also allow me to contribute to process improvement initiatives at the BMT program at UF Health.
My first assignment was in 1998. While that seems like a lifetime ago, I continue to appreciate the opportunity to represent FACT as much today as I did back in the “20th century.” Since then, my goal is to perform at least two inspections each year, as either a Processing or Apheresis Collection Facility Inspector. Being qualified to perform inspections in both areas provides me an enhanced perspective of the cellular therapy product life cycle—collection, processing, storage, and administration. In the following paragraphs, I share some insights, approaches and “tricks of the trade” that I have learned along the way.
“Before anything else, preparation is the key to success.” —Alexander Graham Bell
The most important preparation tip that I share with inspector trainees is to start the “desk” inspection early in order to allow ample time for thorough review. By planning sufficient time for review, well prior to the date of inspection, an inspector can request further information and clarifications. This ultimately allows for a more efficient inspection. I developed a personal SOP for inspection preparation titled, Preparing to Perform a FACT Inspection, which has undergone many revisions, been validated, and approved by Quality Management and continues to serve as the basis for my approach to inspections.
First, I confirm scheduling and travel arrangements with FACT office staff and the inspection team leader (I provide my cell phone number in case of emergencies). My next step is to review the application in order to understand the services provided, volume of activities, and organizational structure of the applicant program. I print the assigned inspector checklist, which contains applicant responses, and begin a comprehensive review of all documents provided in the application. Often several sections of the checklist can be completed by document review, such as label content requirements and key staff credentialing, well before departing for the applicant site. As I proceed through the checklist and review the QM Plan, SOPs, and other documents; stickers with notations are placed next to Standards requiring further clarification or observation on site. In addition, I develop a written list of questions to have in hand upon arrival on the day of inspection. Preparation is not complete until the entire checklist and all documents have been reviewed. Yes indeed, I am “old-school,” and assemble a three-ring binder containing printed materials to have on hand during the inspection. It resembles a mini version of the original four-inch binders that were sent to inspectors before the accreditation portal was launched. My binder is complete with section dividers, is only one or two inches, and contains only area-specific printed materials. Once at the inspection site, I again work through the checklist and systematically remove the stickers and cross out items on my list. Ultimately, at the end of the day, what remains is a new list of potential citations and/or variances along with commendable practices.
"The best-laid plans of mice and men/Go oft awry." —Robert Burns
As inspectors, we diligently work to prepare for an efficient and well-structured inspection day. Occasionally, schedules fall apart. As such, we must exhibit flexibility and maintain composure and professionalism. Developing a detailed agenda with the inspection team and site coordinator can often avoid poor time management, yet unforeseen factors can impact the best of intentions. Amazingly, more often than not, I have arrived at a facility where no apheresis collections, product processing, or administration procedures have been scheduled for observation. That is when I quickly switch to “mock” procedure mode and work to allow sufficient time to perform a thorough observation. Being prepared prior to arrival on site with the skill set to examine both actual and “mock’” procedures puts the facility site at ease and allows the inspector to perform a complete review
"Without continual growth and progress, such words as improvement, achievement, and success have no meaning.”
—Benjamin Franklin
After hours of preparation and a long day, inspectors will conduct an exit interview with the applicant program staff and institution leadership. I have come to approach these meetings in such a manner to avoid the unexpected and to offer positive feedback. I always make it a point to have discussed all significant potential citations, variances, and concerns with area managers and directors, if available, prior to the exit session. My standard exit session script begins by thanking the staff (by name) for their patience and hard work, no matter how well or poorly the day unfolded. I then reiterate that I have inspected the facility with the “X” Edition FACT-JACIE Standards and that the FACT Accreditation Coordinator will present my report to the FACT Accreditation Committee for review. I share my observations and potential citations and variances to the group with reference to specific examples. I consider it equally important to also describe commendable practices such as process improvement efforts, exemplary SOPs and worksheets, or praiseworthy practices or achievements. As inspectors, we cannot diminish the importance of the exit session, as it can often be what is most remembered of the inspection day’s activities by those in attendance.
It has been an honor and privilege for me to serve as a FACT Inspector. While it requires time and effort outside of my office and personal life, I am convinced that both my home BMT program and I greatly benefit from the experience. I encourage those interested to join the FACT inspectorate.
FACT is very appreciative of Michele's commitment to serve as a Processing and Apheresis Collection Facility Inspector.
Patrick J. Hanley, PhD
Patrick J. Hanley, PhD, is the Laboratory Facility Director for cellular therapy and stem cell processing at Children's National Health System. In addition to GMP regulations, Dr Hanley is interested in improving outcomes after stem cell transplantation, including bone marrow transplant and cord blood transplant.
He currently sits on the Immunotherapy Committee of the International Society for Cellular Therapy (ISCT) and co-chairs its Early Stage Professionals committee. Since 2013, Dr Hanley has been a FACT Inspector and inspects both cellular therapy and cord blood banking processing facilities. In addition to volunteering as an inspector, he is a member of the FACT Cellular Therapy Accreditation Committee and Cellular Therapy Processing Facility Standards Committee.
Dr Hanley shares his insights into why he became an inspector, and the benefits he has gained from this experience.
Becoming an Inspector
I became interested in becoming a FACT Inspector a bit serendipitously. I noticed a FACT Inspector Brochure in Dr Catherine Bollard’s office that listed advantages of being an inspector. What I found appealing was the opportunity to travel to some of the most well-known, cutting edge facilities in the world and learn how they function. How do they train staff? How do they qualify critical reagents and handle inventory control?
After verifying my education and experience made me eligible, I asked Dr Helen Heslop what the first step is to become a FACT Inspector. She directed me to the FACT website and the online inspector application. After completing initial training requirements, I performed my training inspection with Dr Monica Smogorzewska. I found the information obtained through this visit invaluable when we had to develop our own cell therapy facility at Children’s National in 2013. Since my first inspection in 2013, I have performed an average of 2 inspections per year.
Learning from Inspections
I really look forward to learning new information when I perform a FACT inspection. One of the aspects of the inspection process that I’ve found valuable has been the opportunity to visit other facilities and gather new ideas. For example, I trained at Baylor College of Medicine, which is quite a large academic facility. Our facility at Children’s National is significantly smaller and I am always looking for ways to improve our productivity and make more out of the existing space. I am also looking towards the future to identify aspects of various facilities that I would like to include in the new facility we have planned.
Children’s National has its challenges and areas where improvement is needed, which is no different than other FACT-accredited programs. As an inspector, I have the unique opportunity to see (for FREE) how other institutions handle similar challenges and hear from others what works and what does not. The staff at Children’s can usually tell when I’ve been on a FACT inspection because I come back with a list of questions and suggestions based on my recent experience. Recently, after returning from an inspection, I asked for our transient warming validation and where we documented the length of time that the product was out of the freezer.
One experience of mine that was striking was while performing a more-than-minimal manipulation inspection at an institution. The site volunteered to show me its Investigational New Drug (IND) Application for one of its clinical trials. We have our own clinical trials, but to see how another group writes their Chemistry, Manufacturing, and Controls (CMC) section of the IND was fascinating. I walked away quite impressed with the effort they put forth qualifying their critical reagents.
Observing Frequent Deficiencies
One deficiency that I have found to be quite common is D4.14, which states that tests must be validated for their intended purpose. Where most sites fall short is that they use the BacT/Alert or BacTec sterility tests that have been validated for whole blood, but not cell therapy products. Another deficiency that is often overlooked is the expiration date of supplies and reagents—especially ethanol and disinfectants.
A standard that I think is critically important that is often cited is the annual report on the progress of the quality program. I think the majority of groups have regular meetings that meet the standard, but they fail to discuss how well the quality program is working and what the problem areas have been over the past year. Similarly, as more and more programs start to use therapeutic cells (such as donor lymphocyte infusions) or cells under a clinical trial, these protocols are sometimes overlooked and outcomes are not always reported.
Preparing for Inspections
As an inspector, reviewing the documentation as early as possible is an absolute must so that you have the opportunity to request additional information as needed. More and more sites are requesting accreditation for more-than-minimal manipulation, and looking over the documents early provides me with the opportunity to determine what is being extensively manipulated. It also allows me to speak with the FACT Office if needed about whether the program meets the criteria or not.
Another suggestion is to reach out to your peers who are inspectors for ideas. My mentor for my recent cord blood training inspection sent me a list of items for which he wanted to request more information from the bank. When he followed that up with a second checklist, it was a very enlightening moment for me; so much so that I scanned the list and saved it to my desktop (thanks, Ping!).
