Just the FACTs – February 2026 Newsletter
President’s Letter
It is an honor to greet you with the first letter of my tenure as President of the FACT Board of Directors. In my previous role as Vice President, I was fortunate to work alongside Past President Dr. Catherine Bollard and my colleagues to advocate for the role of FACT in cellular therapy and to set the stage for anticipated growth. As we celebrate our 30th anniversary this year, we plan to do our part to continue a culture of quality and safety to help realize the incredible potential of advancing cellular therapy.
In the past year, we have built upon our storied tradition of peer-based standards and accreditation, extending our role in hematopoietic cell therapy transplantation and cord blood banking to the promising developments of global advancement in cellular therapies. The increase in the number and diversity of FACT-accredited programs is a testament of stakeholders’ commitment to provide access to quality cellular therapy to all eligible patients.
Now, we are implementing many of the plans we established in 2025. In this newsletter, we describe several events and resources already made available in the first two months of 2026. Our redesigned website makes information easy to find and understand, and our updated Quality Handbook and educational events provide useful information for those seeking to continuously improve. We will also continue to provide clarification on standards and accreditation requirements in this newsletter. A major focus for this year is going to be the implementation of the new “fit-for-purpose” Community IEC Standards, which is an important step towards ensuring broader access to high-quality care for CAR T-cell therapy recipients.
I’d like to end this letter with a sincere thanks to all FACT volunteer Board members, committee members, and inspectors. The spirit of service you extend to your colleagues helps them provide excellent care to their patients. Thank you to our outgoing Board members for their leadership, and thank you to the many individuals who have taken the first steps to train to be FACT inspectors.
Sincerely,
Navneet Majhail, MD, MS, FASTCT
FACT President
Honoring Outgoing Board Members and Welcoming New FACT Officers
By Catherine Bollard, MD, FACT Past President
This month, the Foundation for the Accreditation of Cellular Therapy (FACT) Board of Directors proudly recognized several outgoing directors and officers whose dedication has advanced FACT’s mission and strengthened the global cellular therapy community. Their collective service has had a lasting impact on quality, safety, and access to life-saving therapies worldwide, and the Board is deeply grateful for their leadership and commitment.
Celebrating 30 Years of Servant Leadership: C. Fred LeMaistre, MD
A founding Board member, Dr. LeMaistre’s three decades of service are woven into the very fabric of FACT. His leadership, vision, and steady guidance have helped shape FACT from its inception into the internationally respected organization it is today.
Board of Directors Service
- Acting Past President (2022–2025)
- Past President (2012–2016)
- President (2003–2011)
- President-Elect (2002)
- Board Member (1996–2001)
Committee Leadership and Service
- Leadership and Nominations Committee
- Clinical Outcomes Improvement Committee
- Grievance Committee
- Quality Management Committee
- Finance Committee
- Cellular Therapy Accreditation Committee
- Immune Effector Cell Task Force
- New Business Development Task Force
Additional Roles
- FACT Clinical Inspector for more than 15 years
- Vice President, FACT Consulting Services, LLC (2017–Present)
“As a FACT community, we have so much to thank Fred for—starting from the very inception of FACT through this new phase of growth and opportunity,” I shared with the Board. “Fred has been an incredible partner during my five-year tenure as President. I learned so much from you and am deeply indebted for your unwavering support. Thank you for 30 extraordinary years of service and leadership.”
Dr. LeMaistre reflected on his time with FACT, stating,
“It has been a privilege to work alongside FACT colleagues to help ensure that patients have access to the highest-quality cellular therapy programs.”
Recognizing Additional Outgoing Board and Committee Leaders
Carlos Ramos, MD
Board of Directors
- Board Member (2020–2025)
- Executive Committee Member (2023–2025)
- Treasurer (2023–2025)
Committees
- Finance Committee (2023–2025)
- FACT–Center for International Blood and Marrow Transplant Research Data Audit Committee (2017–Present)
Inspector
- FACT Clinical Inspector for more than 13 years
“Thank you for your tremendous service—especially during these five pivotal years on the Board,” I noted. “Your leadership during a time of transition, growth, and expanding global impact has been invaluable.”
Dr. Ramos shared,
“Serving on the FACT Board of Directors and acting as Treasurer has been a deeply rewarding professional experience. FACT’s mission and the dedication of those who advance it continue to inspire me. Collaborating with colleagues across the cellular therapy and transplant communities has reinforced the shared purpose that defines this organization. I am grateful for the opportunity to contribute to FACT’s strategic direction and sustained growth.”
Huy Pham, MD, MPH
Board of Directors
- Board Member (2019–2025)
Committees
- Cellular Therapy Accreditation Committee (2023–Present)
- FACT–Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) Cellular Therapy Collection Facility Standards Committee (2023–Present)
- Education Committee (2019–2023)
Inspector
- FACT Collection Inspector for more than 10 years
Dr. Pham was recognized for bringing critical expertise from the apheresis community to the Board.
“I deeply appreciate the perspective you brought as the representative of the American Society for Apheresis and the broader apheresis community,” I shared.
Dr. Pham reflected on his service, stating,
“It was an honor to represent ASFA on the FACT Board of Directors for the past six years. This role allowed me to elevate apheresis issues and advocate for collection facilities worldwide. I witnessed firsthand FACT’s significant growth and its leadership in advancing quality and safety across apheresis and cell therapy.”
He added,
“With the introduction of immune effector cell standards into community practice, FACT has worked with external partners to expand access beyond academic centers—helping close disparities and bring life-saving therapies closer to patients. With such strong leadership, I am confident FACT will continue setting the global gold standard for years to come.”
Welcoming New Officers to the Executive Committee
Phillip Johnson, MMedSc(Path)
Hien Liu, MD
As announced in our recent press release welcoming new FACT President Navneet Majhail, MD, FACT is pleased to welcome two new officers to the Executive Committee, further strengthening leadership as the organization continues to grow.
- Phillip Johnson, MMedSc(Path) – Vice President
- Hien Liu, MD – Secretary
FACT looks forward to their continued leadership and service as we advance our mission and expand our global impact.
FACT Operationalizing and Supporting Accreditation of Community IEC Programs
By Kara Wacker, MBA, Strategic Planning Administrator
FACT continues its commitment to increasing patient access to potentially life-saving cellular therapies. An important effort toward this imperative is making FACT accreditation more accessible to community-based providers, and significant progress has been made.
Following publication of the first edition FACT Standards for Immune Effector Cells in the Community Clinical Setting, FACT has operationalized the accompanying accreditation program. The online Compliance Application has been implemented in the online accreditation portal, and trained inspectors for this accreditation program have been selected. In the coming weeks, we will be publishing the Community IEC Accreditation Manual, which is a guide that explains the intent of the Standards, describes evidence requested by FACT, and provides examples of compliance.
FACT is also providing support to programs that have applied for accreditation under the Community IEC Standards. Four community-based cellular therapy programs have applied to be the inaugural cohort of providers accredited under these Standards, with several others initiating dialogue and expressing interest.
“We are thrilled with the reception of our new Community IEC Standards and accompanying accreditation program,” says Suzanne Birnley, FACT Director of Operations. “We have heard nothing but positive feedback about the fit-for-purpose nature of the Standards.”
As community-based programs pursue accreditation, FACT continues to collaborate with multiple stakeholders to continue discussions and dialogue related to improving patient access to cellular therapies. We welcome continued feedback on the Community IEC Standards and will update them as necessary to maintain their tailored purpose.
Tissue Collection and Accreditation: What Programs Need to Know
By Suzanne Birnley, MS, MBA, Director of Operations
With the publication of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Ninth Edition, and FACT-JACIE Standards for Immune Effector Cells, Third Edition, questions have arisen regarding tissue collection requirements for licensed products and collection of other tissue for further manufacturing. These questions have fallen into two main categories: the surgical suite and the Medical Directorship. Although Part C includes specific questions about tissue collection, Clinical Programs—not surgery centers—are responsible for providing evidence of compliance. Surgery centers are not inspected for collection of cellular starting material for FDA-licensed products unless they are seeking FACT accreditation for collection.
Surgical Suite:
For licensed products, compliance is typically confirmed through the commercial manufacturer’s authorization of surgery centers in accordance with the FDA-approved Biologics License Application (BLA). As a result, programs generally face little to no additional burden in demonstrating compliance. The Clinical Program will be asked to provide the Certificate of Qualification from the commercial manufacturer.
In contrast, some investigator-initiated clinical trials involve products that are not yet licensed. In these cases, the accredited Clinical Program oversees the surgically collected material and is responsible for verifying that participating surgery centers hold appropriate accreditation. FACT does not intend to inspect or accredit surgery centers that are properly licensed and authorized unless the program voluntarily seeks accreditation for collection at that site.
Medical Director for Other Tissue:
For programs collecting tissues such as tumor-infiltrating lymphocytes (TILs), the Medical Director must be trained in cellular therapy product collection methods or the diseases treated by these therapies. The Collection Facility Medical Director for Other Tissue must be knowledgeable regarding risks and benefits and demonstrate competence in at least one tissue collection procedure—whether for diagnostic, therapeutic, or manufacturing support purposes. If they have not performed collections for manufacturing, they must understand how these procedures differ from those performed for diagnostic or therapeutic purposes.
When evaluating the Medical Director for Other Tissue, FACT expects the individual to meet the experience requirements in Marrow, Apheresis, or Other Tissue. FACT does not require the Medical Director to have experience in all categories; experience in one area is sufficient, provided certain responsibilities and tasks are appropriately delegated.
For example, an individual who qualifies as an Apheresis Collection Facility Medical Director may also serve as the Other Tissue Medical Director and delegate the actual tissue collection to a qualified individual. However, the Medical Director would retain responsibility for oversight of the tissue collection process and the quality management program. If responsibilities are delegated, FACT expects the program to maintain a policy or Standard Operating Procedure (SOP) that clearly defines:
- The duties the Collection Facility Medical Director for Other Tissue may delegate.
- The required qualifications of the individual performing each delegated task.
- Confirmation that the Collection Facility Medical Director for Other Tissue retains ultimate responsibility for all delegated activities.
Introducing the Third Edition of the FACT Quality Handbook
By Heather Conway, CQA(ASQ), Quality Manager
We are excited to announce the release of the FACT Quality Handbook, Third Edition—a comprehensive, practical, and updated resource designed to support your quality management efforts across FACT-accredited programs.
This new edition includes three all‑new chapters:
- Root Cause Analysis
- Good Documentation Practices
- Preparing for an Inspection
Each chapter features:
- A curated list of citation examples related to the topic and the required response.
- Real examples to guide your approach.
With over 60 new examples, plus a new glossary of terminology, definitions, and abbreviations, this edition is our most robust version yet.
The FACT Quality Handbook remains one of our most valuable tools for strengthening program quality, reinforcing accreditation readiness, and supporting continuous improvement.
Thank you for your continued commitment to excellence and quality in cellular therapy and cord blood banking.
Acknowledgements
This edition would not have been possible without the dedicated work of past and present members of the FACT Quality Management Committee, who contributed their expertise, insights, and time to its development.
We also extend our sincere appreciation to the organizations that generously shared examples, enabling us to provide meaningful examples that enhance learning and applicability.
FACT’s New Website Designed with Stakeholders in Mind
By Kara Wacker, MBA, RAC, Strategic Planning Administrator
We are pleased to announce the launch of our newly redesigned website! Visit www.factglobal.org to check it out.
The new and improved FACT website was designed with stakeholders in mind —making it easier than ever to find the information, education, and resources needed to achieve standards and accreditation for quality cellular therapy and patient safety.
Major initiatives for the website focused on enhanced accessibility, streamlined navigation, and a thoughtful reevaluation of content to better support patients, providers, and community members. Our goal was to make the website clear, consistent, accessible, efficient, and empowering.
We hope the redesign reflects the continuous improvement and value that FACT brings to the cellular therapy field. Features include:
Information at Your Fingertips
The new website is designed to be streamlined and efficient. All information on the website can be found at the top of your screen in the utility bar and page menus. Short on time and need to find something quick? Simply utilize the search function for a robust list of relevant webpages.
FACT Tools Available Right Away
The website is a one-stop shop with all our online resources, including the accreditation portal, list of accredited organizations, learning academy, store, and consulting services. No need to bookmark multiple URLs or perform several clicks to get to these resources – they are now all present in the utility bar.
Actionable Links at All Times
Three of the main actions performed on our website are accessing the Standards, seeking information on becoming accredited, and applying to be an inspector. Links to pertinent information about these three are always available – no matter what page you are on are how far you have scrolled.
Consistent Navigation
There is no second-guessing where information is provided on the website. The main navigation menus have drop-down menus that provide a visual path to the details you need. Users exploring the website to learn more about FACT can start from the beginning and use the navigation links at the bottom of each page to guide you to the next.
User Friendly Interface
Grounded in User-Centered Design (UCD) and tested with Web Content Accessibility Guidelines (WCAG), the redesigned look and feel employs visually contrasting elements, scannable information, plain language, and iconography to decrease cognitive load while still increasing knowledge.
Ability to Do More – Send Us Your Feedback!
The launch of this newly designed website is just the beginning. We have plans for many more resources to make readily available to you via our site.
We want your feedback! After you peruse the site, please let us know what you like, and what could be improved, by emailing us at fact@factglobal.org.
Ninth Edition HCT Inspector Test Now Available – Complete by March 23
By Janice Donoghue, FACT Inspector Development Specialist
We appreciate our volunteer inspectors’ commitment to staying up to date and well versed on our Standards, in part by completing an Inspector Test for each new edition of our Standards. We are pleased to announce that the Ninth Edition FACT-JACIE International HCT Standards Inspector Test is now ready for you!
All FACT HCT Inspectors are required to complete this test by Monday, March 23, 2026, and achieve a minimum score of 90% before performing an inspection based on this edition of the Standards.
The Inspector Test is administered by an online testing platform called Team Fabric. Please watch for an email message from info@teamfabric.com with the subject line, “You have been invited to Team Fabric!” Follow the instructions in that email to join the FACT Inspector Team on Team Fabric.
Once logged in, you will find your assigned trainings and tests on your dashboard. There are four tests – Core, Clinical, Processing, and Collection. All inspectors are assigned the Core Test, with additional tests assigned based on your inspection categories.
Thank you for your time and commitment to completing these tests and for your continued service as a FACT Inspector.
If you have questions or do not receive an email message from Team Fabric, please contact inspectors@factglobal.org.
Impressive Group of Volunteers Attended Inspector Training Workshop at Tandem Meetings
By Janice Donoghue, FACT Inspector Development Specialist
FACT hosted a large number of cellular therapy experts for inspector training at the Tandem Meetings of ASTCT and CIBMTR on February 3, 2026. We are thrilled and grateful to the 15 inspector trainees who have volunteered to join the prestigious FACT inspectorate.
FACT inspector training courses provide trainees with practical, hands-on sessions facilitated by experienced FACT inspectors. The trainees learn about technology tools, preparation essentials, common citations, the inspection processes, and what to expect after the inspection.
This training workshop was made possible with the assistance of 7 volunteer inspector training facilitators who worked directly with small groups of trainees during the hands-on activities.
Thank you to the new inspector trainees and the training facilitators for preparing the FACT inspectorate for continuing our tradition of peer-based, collegial inspections!
FACT Hosted Several Events, Kicked-Off 30th Anniversary Celebrations at the Tandem Meetings
By Breann Weishaar, Communications & Design, Senior Associate
The FACT events held prior to the 2026 ASTCT & CIBMTR Tandem Meetings were a meaningful kickoff and celebration of our 30th anniversary. As FACT’s largest presence of the year, the Tandem Meetings provide valuable educational and networking opportunities that keep us informed, current, and connected with colleagues across the cellular therapy field.
FACT hosted three comprehensive education events that welcomed more than 250 participants. Evaluation results showed that 100% of respondents agreed the events clarified and reinforced concepts relevant to their current practice, and 98% would recommend the courses to a colleague.
Monday, February 2
FACT Quality Boot Camp – Agenda
Boot camp hosts and FACT Quality Management Committee members Kimberly Kasow, DO, and Phillip Johnson, MMedSc(Path), opened the session with the announcement of the publication of the 3rd Edition of the FACT Quality Handbook—a highly anticipated resource.
The program featured a balanced mix of presentations and interactive roundtable discussions that encouraged peer-to-peer learning and practical knowledge sharing. This year’s sessions focused on quality systems integration, the interconnectedness of quality management processes, and implementation strategies for cellular therapy programs.
Event Recap Post – View on LinkedIn
Tuesday, February 3
FACT Accreditation Workshop – Agenda
Hosted by Dr. Joseph Lynch, FACT Inspector and member of the FACT Education Committee, the Accreditation Workshop featured 10 presenters sharing real-world accreditation insights. New to this year’s agenda was Learning from the Unthinkable, an interactive case study session exploring lessons from rare but impactful events. Attendees also participated in a live Accreditation Success Stories panel, where representatives from three programs answered questions and shared practical experiences. The workshop welcomed a strong mix of experienced accredited programs and those new to or exploring accreditation.
Event Recap Post – View on LinkedIn
FACT Inspector Training Course – Agenda
Also on February 3, FACT trained 15 inspector trainees from both Clinical and Processing areas. These dedicated professionals are now one step closer to completing their requirements to become FACT Inspectors, helping to strengthen the future of the inspection program worldwide.
Event Recap Post – View on LinkedIn
Thursday, February 5
Volunteer Recognition & Exhibit Hall
On February 5, we connected with and thanked our dedicated volunteers at the FACT Volunteer Recognition Breakfast. Their expertise and commitment remain essential to advancing quality in cellular therapy.
Throughout the week, FACT also participated in the exhibit hall, networking with both familiar and new faces while sharing our 30th anniversary swag.
Join us at future educational events by visiting: https://learn.factglobal.org/upcoming-events
