Just the FACTs 2023 Volume 5
President’s Letter
Welcome to the change of seasons, whether it be Fall or Spring, depending on where in the world you reside!! With the season change, it is important for FACT to critically evaluate our momentum for change over this past year. To that end, at our recent FACT Board of Directors meeting, we discussed the tremendous progress that our organization has made regarding several key strategic initiatives. These included (i) new funding initiatives, (ii) infrastructural growth opportunities, (iii) streamlined processes, and (iv) development and delivery of new services. The future of FACT is an exciting one, and we are eager to continue implementing our strategic plan to increase patient access to transplantation and other cell-based therapies.
We are also well on our way to resuming a regular inspection schedule following the COVID-19 pandemic and the related extensions. We express our sincerest gratitude to FACT inspectors for your commitment to our peer-review accreditation process.
The FACT team wants to also express how much we have enjoyed seeing many of you during FACT’s 2023 global Educational Tour and looks forward to announcing our next series of in-person educational events within the next couple of months. In the meantime, please join us for the Quality Management Webinar Series on embracing change when implementing a new service or product in your cellular therapy organization. Change is constant, and, as evident in our field, is critical for sustainability and growth in the ever-broadening cell therapy landscape!
Sincerely,
Catherine M. Bollard, MD
FACT President
FACT Global Affairs Committee Continues Successful International Tour
International efforts to assist with the development of cellular therapy programs and quality systems were in high demand in 2023. The FACT Global Affairs Committee and its several working groups has worked directly with specific regions around the world to address regional needs. We extend a special thank you to our dedicated and generous volunteers Daniel Couriel, Carlos Bachier, and Federico Rodriguez for organizing, educating, and serving as invaluable resources for our global partners throughout Latin America. Accreditation and quality sessions were conducted in conjunction with FACT’s partners during the GATMO Congress in Buenos Aires, Argentina; Mexican Society of Cellular Therapy and Bone Marrow Transplants & Transplantation (SMTT) in Puebla, Mexico; and the Brazilian Society of Cellular Therapy and Bone Marrow Transplantation (SBTMO) Congress in Curitiba, Brazil. FACT also held its inaugural education and training event in conjunction with the ISCT Australia & New Zealand Regional Meeting in Perth, Australia and look forward to this being an annual event.
A Bit About BiTEs and Their Relationship to FACT Accreditation
Utilizing a patient’s immune system to combat cancer is a hot topic in research and in translational medicine, with several therapies now commercially available for use. In 2017, FACT published standards and implemented an accreditation program for immune effector cells (IECs), defined as, “A cell that has differentiated into a form capable of modulating or effecting a specific immune response.”1 This definition includes, but is not limited to, cell-based therapies such as chimeric antigen receptor (CAR) T cells, tumor infiltrating lymphocytes (TILs), T cell receptor (TCR)-modified T cells, therapeutic vaccines, and NK- or B-cell based therapies. Activities related to IECs that are performed at FACT-accredited cellular therapy programs must comply with FACT Standards.
But what about BiTEs? Bispecific T cell engagers are emerging as an efficacious therapy that leads T cells to fight tumor cells.2 FACT-accredited programs are increasingly using them in their own programs but also see oncologists in other institutional departments or in other practices prescribing them. They have an immunological mechanism of action, but they are antibodies rather than a cell-based therapy. Therefore, they are not specifically eligible for FACT accreditation or required to be administered by an accredited program.
When handled on a FACT-accredited unit, BiTEs should be treated like any other drug or antibody: utilizing standard operating procedures, personnel trained to administer them and recognize toxicities, confirmation of correct patient and drug, etc. BiTEs do have toxicities similar to CAR-T cells, such as cytokine release syndrome. When administered by medical staff not affiliated with a FACT-accredited IEC or transplant team, it may be useful for the IEC or transplant team to assist as needed with toxicity management, but this is not required.
Because BiTEs have similar toxicities, experience with them may prepare nurses and other staff with management of CAR-T patients in the future. Utilizing BiTEes experience may assist programs preparing to onboard and seek accreditation for IECs.
1 Foundation for the Accreditation of Cellular Therapy and Joint Accreditation Committee – ISCT and EBMT. FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration (Eighth Edition); 2021.
2 Tian, Z., Liu, M., Zhang, Y. et al. Bispecific T cell engagers: an emerging therapy for management of hematologic malignancies. J Hematol Oncol 14, 75 (2021). https://doi.org/10.1186/s13045-021-01084-4.
Public Reporting of Survival and its Impact on Patient Volumes
Since 2015, FACT Standards have required transplant programs to evaluate one-year survival in comparison to national or international data and submit a corrective action plan (CAP) when survival does not meet the expected range. Allogeneic transplant programs in the U.S. must utilize the annual CIBMTR Transplant Center-Specific Analysis (CSA) report as its comparative data. The FACT Clinical Outcomes Improvement Committee evaluates CAPs against defined guidelines using an established policy. Updates to this policy were announced in 2022.
Sharma et. al. recently published an article titled, Impact of Public Reporting of Center-Specific Survival Analysis Scores on Patient Volumes at Hematopoietic Cell Transplant Centers.1 The authors evaluated the impact of public reporting of survival on allogeneic transplant volumes. Data show that public reporting is associated with changes in volume, including lower volume at programs that do not meet expected one-year survival as reported in the CSA. There is a plethora of reasons for why this may be the case, and some are briefly listed in the article.
As part of FACT’s process for evaluating CAPs intended to improve one-year survival, the FACT Outcomes Committee generally does not accept refusal to transplant high-risk patients as a blanket corrective action.2 The committee is mindful of how its reviews should not impact patient access to transplant. Furthermore, refusal to treat high-risk patients may not improve outcomes: The CSA uses risk-adjusted methodology, meaning that the expected range of one-year survival already accounts for the level of risk. Attempts to improve outcomes simply by refusing to treat high-risk patients will be ineffective. The program’s level of risk would simply be lower, causing a higher expected range of one-year survival in subsequent reports.
To improve survival, the committee encourages transplant programs to focus on the cause of death. Perhaps preparative regimens are too aggressive or not aggressive enough, certain comorbidities need to be managed, socioeconomic barriers require greater social support to ensure medication compliance, or patients are being referred to the program too late. Addressing these root causes may improve survival while giving patients a treatment option.
Finally, research involving high-risk patients advances the field. If transplant programs were to only transplant the easy cases, no improvements would be made. This is a research-oriented field, and the greatest challenges will improve transplant and make it an option for more patients, not less.
1 Sharma et. al. Impact of Public Reporting of Center-Specific Survival Analysis Scores on Patient Volumes at Hematopoietic Cell Transplant Centers. Transplantation and Cellular Therapy, 29, 8 (2023). https://doi.org/10.1016/j.jtct.2023.05.013.
2LeMaistre et. al. Integration of Publicly Reported Center Outcomes into Standards and Accreditation: The FACT Model. Transplantation and Cellular Therapy, 25, 11 (2019). https://doi.org/10.1016/j.bbmt.2019.06.035
Register Today for QM Webinar Series 12 – Embrace Change: Growing Your Cellular Therapy Services
The theme for QM Webinar Series 12 is Embrace Change: Growing Your Cellular Therapy Services. Each webinar will equip your organization with practical strategies and insights to successfully incorporate a new service or product into your cellular therapy organization while ensuring compliance, optimizing patient outcomes, and driving continuous improvement. Each webinar will consist of a 45-minute live lecture period followed by a 15-minute Q&A session.
Save 15% when you sign up for our 4-pack webinar bundle! This discount allows you to gain access to all four webinars in the series, ensuring you don’t miss a single topic.
By enrolling in the webinar bundle, you’ll:
- Learn proven techniques to incorporate products effectively into your organization.
- Gain valuable insights from industry leaders who have successfully navigated the challenges of integration.
- Network with like-minded professionals and engage in interactive Q&A sessions during each webinar.
Upcoming Webinar
Webinar #3: Written Agreements
Thursday, November 14, 2023 at 8 am PT, 9 am MT, 10 am CT, 11 am ET
Jay Tanna is the Quality Assurance Lead for the Children’s National Health System Blood and Marrow Transplant Program. After this webinar, attendees should be able to:
- Recognize appropriate stakeholders to be involved in the development, review, and approval process of written agreements.
- Identify when a written agreement is necessary based on FACT Standards.
- Determine what should be included within written agreements, including quality indicators.
Previous Webinars – Recording Available
Webinar #1: Facility Needs Assessment & Change Control
Thursday, July 13, 2023
Ed Brindle, MSc, MLT is the Quality Manager for Hamilton Health Sciences, Cellular Therapy and Transplantation. This webinar will help you:
- Acquire knowledge and strategies to drive success in your organization.
- Establish timelines, recognize regulatory requirements, and identify potential metrics.
- Understand the impact of gap analyses and change controls on program processes.
- Gain insights into staffing, training, and product needs for seamless service implementation.
- Evaluate and analyze the benefits of a facility needs assessment.
Webinar #2: Establishing Quality Indicators
Wednesday, September 27, 2023 at 8 am PT, 9 am MT, 10 am CT, 11 am ET
Quality indicators play a pivotal role in assessing performance, identifying areas for improvement, and ultimately achieving outstanding results. This session, presented by Jacklyn Stentz, Director of Quality Improvement at Sarah Cannon Transplant and Cellular Therapy Program, will help attendees:
- Identify key stakeholders for developing indicators
- Define endpoints and develop benchmarks
- Recognize improvements while reflecting on expected outcomes
