A hallmark of a strong quality culture is the concept of continuous quality improvement. At FACT, we embrace that spirit and are always open to opportunities to improve our Standards, our inspection and accreditation processes, and the cellular therapy field as a whole. There are many examples of these types of activities within this newsletter.
We extend our sincerest appreciation to our volunteer Standards Committee members, volunteer inspectors, and accredited organizations for their tireless efforts this year. Two months ago, we published the eighth edition FACT-JACIE Hematopoietic Cellular Therapy Standards. It is always a labor of love. This edition was obviously no exception given the chaos of the past year; however, the committee did not deter from its work to revise and update our Standards. Both inspectors and accredited organizations alike explored the unknowns of virtual inspections. Not only have these inspections gone well, but we have implemented process improvements that have been discovered via the virtual inspection process.
Finally, please identify ways in which you can participate in the many efforts to harmonize industry requirements. You have the direct experience and expertise to leverage decades of lessons learned and accomplishments so that newer cellular therapies can experience the same growth and success as transplant. One such example, applying to be part of the standards working group on industry requirements for apheresis collection, is due by the end of this week.
Catherine Bollard, MD
In my first letter to the FACT community earlier this year, I explained that one of my goals is to continue FACT’s position as the lead promoter for maintaining and improving the quality of cellular therapy for the benefit of patients. The unique collaborative model established by FACT is special, and we are excited to continue advancing this model into new cell therapeutics in clinical trials and in the marketplace.
One of the first steps we are taking is to pursue independent status from FACT’s long-time home, the University of Nebraska Medical Center. This change will allow us to continue to rapidly accommodate progress in the field as we have done in years past. FACT will support the extraordinary growth in cellular therapies, indications, and stakeholders, and becoming independent is one example of our commitment to you.
It is fitting that this change will come to fruition at the time of a milestone anniversary. This newsletter highlights exciting ways we are honoring our 25-year history, including our virtual events that always receive high marks of praise and preparing to publish the eighth edition of the FACT-JACIE Standards. There are examples of accomplishments our volunteers have achieved and collegial advice our programs are always willing to share with each other.
Please join us in celebrating our 25th anniversary and the exciting opportunities ahead for FACT.
Dear Friends and Colleagues,
I am extremely excited to fully introduce myself as your new FACT President in this newsletter. It is truly an honor and privilege to serve in this capacity. For those of you who do not know me, I received my medical degree from the University of Otago, New Zealand and am Board Certified in Pediatrics and Adult/Pediatric Hematology. My background is in cell therapies for cancer and post-transplant viral infections. For the past 20 years, I have investigated the efficacy of virus and tumor specific T cells for the prophylaxis and treatment of viral infection after transplant and cancer respectively. I was formally the Director of the Pediatric Lymphoma program and the co-Director of the BMT QA Program at Texas Children’s Hospital / Baylor College of Medicine (Houston, TX). In 2013, I was recruited to head the new Program for Cell Enhancement and Technologies for Immunotherapy (CETI) and The Center for Cancer and Immunology Research at Children’s National Hospital and The George Washington University (Washington, DC).
Taking over the President role from Dr. Dennis Gastineau as 2021 begins, and at a time that cell therapy is rapidly evolving and expanding to new applications, is extremely energizing for me. Since the inception of FACT, the scope of cell therapy has extended beyond its original application in hematopoietic stem cell transplantation to embrace diverse immune cell therapies and therapies using non-hematopoietic cells in the broad area of regenerative medicine. Technological advances have placed many of these treatments in the “mainstream” or at least within a reach of generalized application. Therefore, I see it as crucial that FACT continues to establish itself as the lead promoter for maintaining and improving the quality of all cell therapies through “peer-developed standards, education and accreditation for the benefit of patients”.
Hence, my vision is to ensure that the unique collaborative model FACT has established continues to be fostered and advanced as new cell therapeutics are developed and/or reach the marketplace. It is critical to support the translational and practical aspects of cell therapy in all its facets. I am therefore excited to work with the FACT community to promote the things that FACT does best to ensure that all cell therapies are administered with the highest quality standards to maximize patient safety. Specifically, as an ISCT Past President and a former Director at Large on the ASTCT (formerly ASBMT) Board, I look forward to continuing to foster FACT’s strong ties with its parent societies as well as enhancing collaborations with other key societies such as the Cord Blood Association (CBA) and the American Society for Gene & Cell Therapy (ASGCT). Further, I see the need to strengthen and initiate partnerships with international accreditation bodies as has been achieved already with our partner JACIE. I perceive that strong collaborations with regulatory agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) will be vital in the next 5-10 years as cell therapy moves far beyond the blood and marrow (BMT) model.
In closing, I would also like to take this opportunity to profoundly thank Dennis Gastineau for his dedication and commitment to FACT over his tenure. Thank you, Dennis, for all your hard work over this time and I look forward to continuing to work with you in your Past President role!
Finally, as a New Zealander who has worked in Australasia, Europe, South Africa, and the US, I hope I can provide, as your President, a genuine international perspective. I look forward to serving FACT and working with the entire FACT community to the very best of my ability.
Inaugural Letter from FACT’s New President: Catherine M. Bollard, MBChB, MD, FRACP, FRCPA
Dear Friends and Colleagues,
I am extremely excited to introduce myself as your new FACT President. It is truly an honor and privilege to serve in this capacity. For those of you who don’t know me, I received my medical degree from the University of Otago, New Zealand and am Board Certified in Pediatrics and Adult/Pediatric Hematology. My background is in cell therapies for cancer and post transplant viral infections, and for the past 20 years I have investigated the efficacy of virus and tumor specific T cells for the prophylaxis and treatment of viral infection after transplant and cancer respectively. I was formally the Director of the Pediatric Lymphoma program and the co-Director of the BMT QA Program at Texas Children’s Hospital / Baylor College of Medicine (Houston, TX). In 2013, I was recruited to head the new Program for Cell Enhancement and Technologies for Immunotherapy (CETI) and The Center for Cancer and Immunology Research at Children’s National Hospital and The George Washington University (Washington, DC).
Taking over this role from Dennis Gastineau as 2021 begins, and at a time that cell therapy is rapidly evolving and expanding to new applications, is extremely energizing for me. I therefore look forward to outlining my 5-10 year vision for FACT in the next newsletter. I would, however, like to take this opportunity to profoundly thank Dr. Gastineau for his dedication and commitment to FACT over his tenure. Thank you, Dennis, for all your hard work over this time and I look forward to continuing to work with you in your Past President role!
Many firsts in 2020, and much to leave behind! But one “first” is the ISBT 128 labeling standard for cells collected for further manufacture. While voluntary for manufacturers, I would strongly encourage everyone to request of manufacturers that they comply with ISBT 128 labeling standards as they will contribute to the safety of our patients and to the efficiency of our laboratories, collection groups, and electronic records. If we all speak with the same voice perhaps headway will be made.
Our virtual accreditation task force continues to refine the process for virtual inspections, which we plan to begin soon. As other accrediting bodies perform virtual inspections and we all have more experience with virtual meetings, I think the overall process will not be that different. But we all look forward to the day we can do in-person inspections again, as nothing replaces the direct interactions and the ability to make new friends and acquaintances.
As we face the biggest peak yet of COVID-19 infections and the pressure at work increases, the importance of taking care of yourself away from work increases, too. Please stay safe—there is a light at the end of the tunnel – not an oncoming train, but vaccines with a level of efficacy that is truly remarkable. Happy Holidays with your friends and families!
Momentous things are happening! First, go vote if you are a US citizen, and, second, we are well into the process of initiating virtual inspections. Sharpen your voting pencils and also your quality pencils (oh, quality people don’t like pencils, so fill your ink pens) and polish off final preparations for inspections.
The process and exceptions are outlined in this newsletter. Read carefully, accredited programs and first-time applicants. We will be starting soon with a secure online process. We know this will be a lot of work for some people, and others may already have electronic systems that will facilitate the process. I know that the inspectors and programs alike will execute this as thoroughly as the in-person inspections.
Speaking of virtual meetings, our first-ever virtual applicant training meeting in September was very successful with over 160 participants from around the world and across attendant time zones. It was really a 24-hour meeting, and the questions were frequent and good—we kept the speakers busy.
It’s great to get started again, and while infections are unfortunately soaring, I think we have a way to handle this part of business again. In the meantime, wear masks at home and at work and keep each other as safe as possible.
I am really struck by the universal importance of hope in the setting of information (read truth), and I encourage you to read the article by Dina Becirovic, one of FACT’s Accreditation Coordinators. And when we think about giving our patients the best chance, Louis Pasteur is credited with “chance favors the prepared mind”—and prepare we must, for it is our preparation and systems that give complex care the best “chance” of success.
We celebrate Apheresis Awareness Day today (as I write this) and recognize World Marrow Donor Day, thanking the thousands of unselfish donors giving so others may have a better chance. Our apheresis teams are busier and busier, and donors of all kinds are needed for our ever-expanding population of transplant-eligible individuals.
Don’t forget to register and participate in our virtual workshop next week! Be sure to take advantage of the new way to network: upload a photo and information about yourself and send messages to other participants. I have a feeling we will do this more even when in-person meetings resume.
I know as another month has gone by you all have had one more month of handling the stresses of this reality. Child care challenges, two people working from home competing for the same space, internet speed, and airspace! Not to mention the irony of health-care workers furloughed during a health-care crisis, and the obvious stresses that induces. So, recognizing this, take a minute, breathe, and find an hour for yourself this week (I’d suggest more, but I have grandchildren three and under, so I know the odds of more than an hour are small). Without you the patients don’t get better. And one last request, think about and do whatever you can for everyone up and down the West Coast who have lost so much.
You have a week to get your comments in for the eighth edition FACT-JACIE Standards and the second edition IEC Standards. If you see issues, please submit your suggestions.
While many states in the U.S. still have rising COVID case numbers, others are showing clear signs of decreasing. Australia and New Zealand are working on more localized outbreaks, and, if there is anything to learn from New Zealand, it is that we are all in this together. The world is so small that everyone must do their part to care for each other.
See the article about the Professional Relations Committee on ways to help each other through these unusual times, and be sure to take advantage of all the educational events. A good way to keep everyone in your program up to the 10 hours of annual education!
As caregivers, I don’t need to tell you to take good care of everyone else, but take some time today to do two things: think of someone you haven’t spoken to in a while and make that contact; and consider one thing to be thankful for. I’ll start the second part: I’m thankful to be sitting next to my spouse of 44 years having just returned from a bicycle ride in the north woods of Wisconsin. What’s yours?
Hello colleagues—as COVID becomes a marathon with no real end in sight, and Zoom and Skype are as personal as we get (and our conference rooms are all being used for social distancing), we all look for the pace and combination of communication techniques that allow us to remain in touch with one another beyond our purely professional relationships. The silver lining has been a tendency to try harder to communicate and talk to those we have always meant to call, and I urge each one of you to choose one of your friends this week to call, FaceTime, Zoom, or any way to be in touch and reduce the isolation they might feel and in so doing reduce your own.
We mourn the passing of one of the pioneers of our discipline, Roger Herzig, who was attending on his transplant service. Dr. Herzig was loved by his patients, his program colleagues, as well as colleagues around the world. We all send condolences to his wife and family.
We invite you to a virtual workshop for inspection and accreditation, and the Education Committee is working hard optimizing the virtual experience for you. And don’t forget to look at the 8th Standards and send in your comments by the end of August.
Our community has continued to provide transplant services to patients needing them, and volumes of transplants are remaining remarkably high with all the competing demands on hospital resources—tell each other how much you appreciate the creativity and dedication continuing such complex care, I know our patients feel the same.
I’m grateful to see so many colleagues working so hard in these times, but try to give yourselves a break and a little time to reflect on what you are grateful for.
Dennis Gastineau, MD
First, may I recognize the fatigue everyone has by now, especially as we (at least in the United States and some European countries) are facing a rise in the number of COVID-19 cases again just as we try to reopen transplant services to our patients who so badly need them. Second, may we have kindness in our hearts as we strive for a just world, and the joint statement by FACT, ASTCT, CIBMTR, ISCT, and EBMT acknowledging and condemning racism is a step in that direction. As we pursue our daily activities may we see all people and situations through a new lens.
I think the ISCT meeting was very successful, even more remarkable because of the pivot from an in-person meeting to the new format in such a short time, and may be a sign of the future as we figure out how to communicate with one another, especially for people who have risk factors for complications of COVID infections.
Even as we physically distance, keep in touch with everyone, particularly family and loved ones, please wear masks (I’m preaching to the choir, but choir is one of the risky activities . . .) to protect one another.
Dennis Gastineau, MD
Hello to a changed world from the last time I wrote to you. As much as I’d like to talk about something else, everything we are doing is affected by COVID-19. You will see a lot of this newsletter deals with cancellations and delays. One silver lining from a programmatic standpoint is the six-month accreditation extension to all programs but that will fly by, I’m sure.
Practice changes are coming fast and the FACT FAQs are being updated frequently by Dr. Warkentin, please note the links for the FDA and always pay attention to the ASTCT for evolving clinical practice guidance. FACT is not determining these practice changes and there are not changes in standards as the practice evolves. The principles that the standards reflect remain the same.
Convalescent plasma is an exciting potential therapy for our patients, and I’m aware that our cell therapy teams have been integrally involved, from collecting plasma to making collection kit components in biosafety cabinets, so kudos to all who are stepping up/stepping outside their roles to help our patients.
Keep physical distancing and remember, just flattening the curve is like your parachute slowing you down, it doesn’t mean it’s time to take off your parachute at 5,000 feet, there’s still a ways to go . . . I’m sure I’m preaching to the choir, but keep your patients, your kids, your grandparents all safe while keeping yourself as safe as possible. To use one more simile, the canoe gets to its destination only if everyone paddles in the same direction. Let’s get our shared canoe through these rough waters paddling together.
Dennis Gastineau, MD
It was great to see many of you at the TCT meetings in Orlando (I didn’t pack a warm enough jacket!) where the solid emergence of cell therapies was in constant evidence. The Quality Boot Camp was another smashing success, as were the applicant and inspector training courses at the FACT Inspection & Accreditation Workshop, and the cellular therapy leadership courses. I had an opportunity to make a presentation on FACT Immune Effector Cell Accreditation to the administrative track, which evoked many questions, some showing the importance of educating our administrative colleagues in the importance of coordinated, comprehensive, quality-driven care to optimize outcomes for our patients and the role community-driven accreditation plays. We had a chance to express our thanks to Mark Litzow for his many years of service on the FACT Board of Directors and as the first FACT Technology Committee chair. You are already missed, Mark! Travel restrictions and meeting cancellations are coming at a rapid pace and paper goods are flying off the shelves as COVID19 cases increase. Our patients would be among the greatest affected—if you are ill take care of yourself and stay home for their sake.
Hand wave from greater than 6 feet—see you soon.
Dennis Gastineau, MD
I am looking forward to seeing everyone at the Tandem, oops!, TCT meetings—some of us take longer to train than others . . . Lots of changes and new events, including a “Mingle with Mimosas” on Thursday for all inspectors to recognize our volunteer force while enjoying a continental breakfast . . . and mimosas! Thank you to everyone for all of your volunteer time, and for everyone else, please consider becoming an inspector. There are more personal and professional benefits from doing inspections than you can imagine.
Once again we are offering leadership training courses, both the original and now advanced courses and of course the Inspection and Accreditation Workshop on Tuesday with a new format. To attend the inspector track you must be pre-approved by the FACT office to be eligible to be an inspector, so register ahead. The Quality Boot Camp session will be on Wednesday to round out 24 full hours of FACT training opportunities at the TCT meeting.
Be sure to pay attention to the online educational offerings, particularly the new Immune Effector Cell Therapy Webinar series, 6 webinars in 2020 by colleague experts in the field.
Last, but certainly not least, remember the FACT Cord Blood Inspection and Accreditation Workshop at the ISCT Annual Meeting in Paris—if that location doesn’t get you there, nothing will. Again, if approved by the office as eligible to be a trainee, that course is free of charge.
Whew! So much to do in Florida, you may not need to bring sunscreen! See you all there!
The recently published book, Best Practices of Apheresis in Hematopoietic Cell Transplantation (Abutalib et. al., 2020), includes a large number of topics relating to the use and performance of apheresis in hematopoietic cell transplantation. The book is described as a practical resource for clinicians ranging from residents to faculty members and other healthcare personnel. The book is available for purchase in its entirety or by individual chapters.
FACT President Dennis Gastineau, MD wrote Chapter Three, FACT-JACIE Standards: Common Citations and How Best to Avoid Them. The chapter on citations focuses on deficiencies found in apheresis facilities during on-site FACT inspections. Dr. Gastineau briefly describes the citations and then suggests methods for avoiding them in future inspections.
Abutalib, S.A., Padmanabhan, A., Pham, H.P., Worel, N. (Eds.) (2020). Best Practices of Apheresis in Hematopoietic Cell Transplantation. Springer International Publishing. doi: 10.1007/978-3-319-55131-9.
To those of you in the Northern Hemisphere, the days are getting shorter meaning you obviously should be sleeping better—oh, I forgot, we’re transplanters so that’s not allowed. Well, drive carefully in the dark, while all our colleagues down south, enjoy the longer days for more golf—oh, I forgot, we’re transplanters so we probably don’t play golf.
Down to the real stuff, the CIBMTR committee on Infection and Immune reconstitution is doing important work to help us all learn more about post-transplant infections, one of the big opportunities for improvement of patient outcomes. The FDA Cell Therapy Liaison Meeting (CTLM) in March addressed a number of topics, one of which is the collection of MNCs that are then sent to outside companies for manufacturing. The variation of collections (which are really a part of the manufacturing flow, but that is another bone to pick) was raised, both technical issues and the patient issues affecting the cell quantities and therefore product effects was accepted as an important question by the FDA.
Lastly, I invite you to one or more of the FACT activities at the upcoming TCT meetings: The Inspection and Accreditation Workshop and Leadership courses are on Tuesday, February 18th, prior to the opening of the TCT conference, and the Quality Boot Camp is on the 19th, the TCT pre-conference day. On the 20th there will be a gathering for International Delegates hosted by the FACT Global Affairs Committee. We look forward to seeing you at one or more of these in 2020!
Enough for now, I have to go change the battery in my headlamp . . .
Dennis Gastineau, MD
Have you finished your holiday shopping yet? I cannot believe the year has gone by so quickly.
This month’s central theme of data management and its importance is crystalized by the potential penalty of poor CIBMTR audit outcomes and potential impact on accreditation. Why is “just data” so important to accreditation? Well, without correct data, no program or program director can know what is going on in the program beyond gut feel (and we know how that works out . . .). The correct data is not merely to ensure CIBMTR has good data for research, it is so each program can be performing effective ongoing self-analysis for continuous improvement of the care of patients and outcomes. Therefore, it is time to ensure that everyone in the program is participating in the quality of information, from the clinical note, to abstraction, to understanding the questions and categories for CIBMTR. That alone takes a teamwork of providers and data managers.
FACT continues to expand its Regenerative Medicine activities and note the article on Advanced Therapies Week in January.
A big thank you to all who performed their first inspections this year—keep recruiting your colleagues! We have some new programs for supporting and educating inspectors to ensure everyone feels comfortable going out for that first inspection, and resources to access before, during, and after the inspection. Keep it up!
President of FACT
Suddenly the days are shorter than the nights and even in Arizona, the days are getting cooler. The fall Regional Meeting for ISCT was well attended, including non-HPC trial investigators, and the opportunity for networking was welcomed by our technologists. Once again the Quality Boot Camp was extremely popular, a joint effort by FACT and ISCT. It’s yet another reminder that FACT’s parent organizations are both major forces in traditional hematopoietic cell transplantation as well as non-HPC cell therapies. The next opportunity to see this is at the TCT meetings, and you will find the schedule of FACT-related activities at that meeting in this newsletter.
Unlike fall days, cell therapy is definitely NOT cooling down. Job offers abound for those with almost all of the skills that we have in the cell therapy community, from quality to processing to collection and clinical care. This means there is turnover (and some of us are even retiring after 30 or 40 years in the field), and so we need to constantly welcome new colleagues and help them with their education and the philosophy of the best for the patient and constant improvement.
Just like a good cell therapy program, FACT is constantly undergoing self-evaluation, and the board will be meeting for a tune-up of the focus of our strategic plan, as there are so many opportunities coming so quickly, that figuring out what we have the capacity to do and what new projects deserve prompt attention needs to be done more often than every five years.
In addition, we constantly look to volunteers to add to our inspector list, and you will read about Cord Blood Inspector recruitment, but no matter your expertise, FACT can probably use your time and effort, whether in cord blood, bone marrow transplant, or immune effector applications. As we look to the next decade (yes, another one goes in the books soon) we look to a myriad of cell therapy opportunities and activities. Join the ride!
Dennis Gastineau, MD