Meet the FACT
Inspectors

Dr Eldridge has been a FACT Inspector for 18 years and has performed 24 inspections. “For the past 18 years, I have enjoyed the satisfaction of participating in FACT activities. When a notice of inspector training was issued back in what now feels like the ‘early neolithic period,’ I volunteered with the hope of gaining some better insight about what would be required for my program to achieve accreditation.

I was definitely able to meet my goal,” explains Dr Eldridge. “I received far more than I expected by gaining access to a group of dedicated experts in hematopoietic cell transplantation with the mission of raising the quality of patient care and science in the field. The opportunity to discuss issues with sharp leaders and the prospect of visiting other facilities to observe how they have addressed needs and solved common problems has been invaluable to my professional growth and directly benefited my program.”

Dr Eldridge is a former Chair of FACT's Standards Committee and is a former member of the FACT Board of Directors. According to Dr Eldridge, “One of the most appealing aspects of FACT as an organization is an openness to listening and soliciting ideas and viewpoints from everyone in our field. Embracing this, I have over the years become involved with various FACT working committees to address evolving needs of our community. This is a real chance to see firsthand how the mission of FACT is implemented from the kernel of an idea to the establishment of standards promoting best practices for cellular therapy. My experiences in serving on the Board of Directors, the Standards Committee, and as an inspector have been the source of much personal pride, especially when I see recognition of the success of FACT in improving the quality of our field from colleagues and patients.”

Dr Eldridge has led over 30 committee meetings, served as a FACT Inspector, and presented on behalf of FACT at the first meeting of the African Blood and Marrow Transplantation Society (AFBMT) in Morocco, the American Society for Apheresis (ASFA) meeting in Chicago, and the International Society for Cell and Gene Therapy (ISCT) meeting in Montréal. Dr Eldridge comments, “Talking with colleagues at FACT educational events and committee meetings is one of the most useful ways I have found to stay current on important topics. In my opinion, service to our patients and community is the underlying inspiration for the goals and mission of FACT. Nothing happens without help, though. When hands have been needed within FACT, I was glad to assist in acknowledgement of the benefits I have garnered.”

Andra Moehring, a previous FACT Standards Development Specialist states, “Regardless of how many emails received or meetings attended, Dr Eldridge always shows a positive attitude. He proves time after time that he is an exemplary leader through his plethora of knowledge and continued guidance on the FACT Standards Committee. As a global ambassador he is responsive, considerate, kind, and fair. I have learned so much from working with him. FACT is lucky to have Dr Eldridge as a volunteer.”

“As a global ambassador for FACT, Dr Eldridge serves as the appointed representative to the Worldwide Network for Blood and Marrow Transplantation (WBMT),” states Linda Miller, FACT Chief Operating Officer. “Through his leadership, Dr Eldridge ensures FACT’s mission of improving quality and safety for patients is shared with our cellular therapy colleagues throughout the world.”

Dr Eldridge concludes, “Personally, and professionally, I have benefited immensely from FACT. I encourage everyone to consider becoming involved in the activities that keep FACT evolving and improving. The organization is only as strong as the people participating.”

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. 

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!).