Just the FACTs Newsletter – July 2026
Dear Colleagues:
On behalf of FACT Directors, committee leaders and members, inspectors, and our HQ Team, I’m privileged to offer the following updates and comments. I’m confident this issue of Just the Facts will instill and refresh assurance in the hard work and critical thinking of the hundreds of peers and colleagues who work together to advance quality and safety in cellular therapy.
FACT Forward is a phrase increasingly referenced throughout our organization and certainly was top of mind during the recent in-person Board of Directors meeting in Nashville. It represents FACT’s commitment to a) continual improvement in our operations and services, b) advancement of our four strategic initiatives, c) organizational evolution, and d) foresight thinking and planning within the Board. Throughout all these, we continue to invite and value input and feedback from all stakeholders in our field—and are placing renewed energy in doing so. (Never hesitate to contact me or FACT’s CEO, David Schmahl, in this spirit.)
In the coming months, you’ll see a commitment to critically examining and improving the workflow, technologies and systems, and user experiences surrounding the development and publication of our Standards and the administration of our voluntary accreditation pathways. This work will incorporate voices of longstanding stakeholders served by us as well as those that are rapidly emerging.
In a similar vein, we feature spotlights within this newsletter on actions supporting our imperative of helping expand eligible patient access to safe and quality-based cellular therapy closer to home. These are proof points behind our belief that such therapies can and should be safely administered in new settings in addition to historically traditional provider settings.
We all recognize the accelerating speed of the science in our field. It’s our collective duty to do our very best to be at pace with this, to ensure our patients receive the very best possible care. Our patients are the overall driver behind FACT Forward, and I’m grateful for the collective efforts of hundreds of colleagues working together with them in mind.
Sincerely,
Navneet Majhail, MD
FACT President
FACT Reaffirms Commitment to Strategic Imperatives, Supported by Our Core Values
By Kara Wacker, External Relations and Strategy
The year of FACT’s 30th anniversary was the perfect time for the headquarters team to pause its rapid pace of work to celebrate and reflect in Music City. FACT President Navneet Majhail, the Board of Directors, and senior leaders hosted the team in Nashville to provide professional training, reaffirm commitment to our strategic imperatives, and celebrate our accomplishments.
A major focus was rallying around four strategic imperatives established by the Board last year. These imperatives are guided by our dedication to move FACT Forward into the future of cellular therapy:
- Expand Access: Help expand eligible patient access to safe and quality-based CAR T therapies throughout America’s communities.
Overarching Objective: Deliver highly valued, forward-looking services and resources to community oncologists pursuing FACT accreditation as an assurance of quality and safety.
Dedication from our Community CAR T Working Group, Standards Committee, FACT Board, expert reviewers, and headquarters staff resulted in the swift publication of fit-for-purpose Community IEC Standards and the implementation of an associated accreditation program. We continue to support inaugural community-based programs that have applied and will soon announce an initiative to help a “first wave” accelerate their path to accreditation.
- Standards Forward: Critically examine FACT Standards to maximize relevance, minimize redundancy, enhance accessibility, and improve development efficiency.
Overarching Objective: Expert peers work efficiently to produce timely, principle-based Standards that are clear and meaningful to all stakeholders.
Our Standards are the foundation of nearly all FACT activities. As the cellular therapy field evolves, so must our approach to developing and reviewing requirements. The Board has charged the headquarters team with building workflows that ensure Standards remain peer-driven, consensus-based, and focused on safety and quality.
- Accreditation Forward: Evaluate and improve accreditation processes to enhance efficiency and user experience for applicants, inspectors, and staff.
Overarching Objective: Create streamlined workflows supported by user-friendly technology, maximizing efficiency and satisfaction across all participants.
FACT’s accreditation process is intentionally rigorous to protect patient safety and ensure quality care. At the same time, opportunities exist to reduce operational burden and improve turnaround times. Our goal is to make the process as efficient and user-friendly as possible without compromising standards.
- Governance & Practices: Ensure FACT’s bylaws and organizational policies remain relevant, transparent, and effectively implemented.
Overarching Objective: Maintain a strategically oriented, inclusive, and transparent organizational structure guided by evolving, principle-based policies.
Organizational evolution is essential as cellular therapy advances and new stakeholders emerge. A task force of FACT Directors is currently proposing updates to our bylaws to support agility and responsiveness moving forward.
Much of these discussions took place in the context of our newly defined core values. At FACT, our work is guided by a shared commitment to advancing the quality, safety, and future of cellular therapy. These values define how we collaborate, serve stakeholders, and uphold our mission.
These values are not only aspirational but already embedded in FACT’s culture. They align directly with our mission and position FACT for continued growth in cellular therapy. As we advance our strategic imperatives, we do so with integrity, collaboration, adaptability, respect, and excellence.
Initial Impressions From the Front Lines of FACT’s Community IEC Standards and Accreditation
By Lauren Capone, RN, BMTCN, Accreditation Coordinator
In November 2025, FACT reached an important milestone toward our strategic imperative to expand patient access to cellular therapies. With the support of the Community CAR T Working Group, comprised of physicians from community- and academic-based health care systems and representatives from collaborating organizations, the first edition of the FACT Standards for Immune Effector Cells in the Community Clinical Setting was published. The Community IEC Standards adapted the FACT-JACIE International Standards for Immune Effector Cells to meet the “fit for purpose” needs of community-based oncology programs. The associated accreditation program was implemented shortly thereafter.
Since that time, six community programs have applied and are progressing toward initial accreditation under this new pathway. We are thrilled to be working with these dedicated clinical providers and staff as they pursue accreditation. Together, we share the goal of expanding patient access to high-quality care closer to where they live. The table below summarizes the progress of Community IEC programs that have either expressed interest in FACT accreditation or are actively pursuing accreditation.
Table: Number of Community IEC Programs Exploring or Pursuing FACT Accreditation
| Exploratory | Assessment | Preparation | Inspection | Responses |
|---|---|---|---|---|
| 5 | 0 | 4 | 2 | 0 |
The work we have done so far with these accreditation applicants have grown our experience in applying standards and accreditation to this new cohort of providers, and we believe outlining our experience will benefit others who are expanding cellular therapies to more places. The following represents shared learning, in Q&A format, as we work to continue making FACT’s accreditation process as clearly understood and navigable as possible.
Where do we start?
We highly recommend contacting us as soon as you begin considering FACT accreditation. There is no cost or obligation to do this. We are here to help you and will seek to learn more about your program and goals and provide guidance. These conversations have proved valuable for helping programs with their decisions on timing, service providers, relevant Standards, potential gaps, resources, and more.
Once you’ve decided to pursue FACT accreditation, request an account in our online accreditation portal to begin. In short, the steps to accreditation are to:
- Confirm eligibility via an online Eligibility Application
- Submit the online, pre-inspection Compliance Application
- Conduct the on-site inspection
- Respond to the Accreditation Report
How do we learn more about what the Community IEC Standards require?
The FACT website contains a plethora of resources to learn about the Standards and quality management in general.
- The Community IEC Accreditation Manual is a great place to start. This document provides extensive guidance:
- Explanations that help with interpreting and implementing the Standards
- Examples and practical considerations for community oncology programs
- Examples of evidence to demonstrate compliance
- Resources to support quality management and patient care activities
- The FACT Quality Handbook contains examples of SOPs, validations, and audits.
- Created by Quality Managers in cellular therapy
- Recommended resource for supporting the development of a Quality Management Program
- The FACT website has been redesigned with new users in mind and includes resources for:
- The FACT Learning Academy includes live and on-demand learning opportunities.
- Webinar recommended for new CAR-T programs: Bringing Cell Therapies Closer to Home: An Introduction to the FACT Standards for Immune Effector Cells in the Community Clinical Setting
- The Self-Assessment Tool is a free resource that helps evaluate compliance readiness for accreditation. A tool is available for each set of Standards including the Community IEC Standards. All Standards-specific tools can be found on the FACT Standards webpage.
What if I still have a question about a specific standard?
It is common to have follow-up questions about specific requirements, including how to interpret a standard, how to comply with it, or what evidence to provide. The resources above will help, and you can contact FACT at any time with questions. Once you apply for accreditation, you will also be assigned a designated FACT Accreditation Coordinator who will be your direct contact for anything you need.
Below are questions that we have commonly received from initial Community IEC accreditation applicants and a brief answer for each. Do you need more information or have questions about any other standards? If so, see the Accreditation Manual for more guidance or contact us via email at fact@factglobal.org or via phone at 1-402-920-7001. We are here to help!
Selected Standards & FAQs
Standard B1.2.1: The Clinical Program shall be licensed, registered, or accredited as required by the appropriate governmental authorities for the activities performed.
Which documents should a Community IEC Clinical Program provide?
Community IEC Clinical Programs that are hospitals, and inpatient units collaborating with Clinical Programs for adverse event management, must be accredited by the Joint Commission, Healthcare Facilities Accreditation Program of the American Osteopathic Association, DNV Healthcare, Inc., or Centers for Medicare & Medicaid Services.
Community-based clinics’ licenses, registrations, or accreditations may be variable because states differ in their regulatory requirements, and what is submitted to FACT may differ from program to program based on local applicable law. When completing the Compliance Application, denote the license, registration or accreditation for the activities the program performs.
Standard B1.3: The Clinical Program shall have a designated team that includes a Clinical Program Director, a designated Quality Manager, and a minimum of one (1) additional physician trained or experienced in cellular therapy. The designated team shall have been in place and performing cellular therapy for at least twelve (12) months preceding initial accreditation.
Do we have to wait to apply for accreditation until the designated team has been in place for 12 months?
You do not have to wait until the team has been in place for the minimum 12 months. Clinical Programs are welcome to apply sooner, and this is a way to expedite the accreditation process. Programs may progress through the process while they are accumulating this length of experience. If the accreditation process is completed before 12 months have passed, FACT will wait to officially award accreditation (i.e., provide the accreditation certificate and list the program on the website) until this milestone is reached.
If a new program has also not met the minimum required number of new patients for initial accreditation (five patients), it may wish to consider seeking provisional accreditation.
Standard B2.1: There shall be a designated inpatient unit of appropriate location and adequate space and design that protects the patient from transmission of infectious agents and allows, as necessary, for appropriate patient isolation, confidential examination, and evaluation.
Does the Clinical Program have to be located within a hospital?
Clinical Programs do not have to be located within a hospital and will often provide services in a clinic. The program does, however, need to have a close working relationship with a collaborating hospital that can manage adverse events of cellular therapies when inpatient care is needed by a patient.
Standard B3: Personnel (Clinical Program Director, Attending Physicians, Advanced Practice Providers/Professionals, Nurses, Pharmacists, Consulting Specialists, Quality Manager, Data Management Staff, Support Services)
Do each of the personnel listed have to be dedicated to cellular therapy as 100% Full Time Equivalents?
No, the personnel do not need to be 100% dedicated to cellular therapy on a full-time basis. Individuals will often fulfill their cellular therapy-related roles in addition to other roles within their organization. The Standards require that individuals be designated for each of these roles and have the required training, education, experience, and competency as outlined in the substandards.
As Clinical Programs grow and serve more patients, there may come a time when full-time personnel are required. The Clinical Program will determine this need, and FACT inspectors will verify adequate staffing during inspections.
Standard B3: Continuing Education
What is required for continuing education?
Several key personnel listed in B3 are required to complete a minimum of 10 hours of continuing education related to cellular therapy and/or their roles in the Clinical Program. There are many ways to meet this requirement, and the Standards are intentionally not meant to be prescriptive. Recognized educational activities include both certified continuing medical education (CME) credits (preferable) and non-credit educational hours, including internal presentations and conferences.
As referenced above, the Community IEC Accreditation Manual has very detailed explanations and examples that may be helpful to Clinical Programs determining how to satisfy this requirement.
Standard B3.5: Requirements for Nurses
What type of training and competency is required?
In addition to the outpatient clinic nurse(s), the hospital/inpatient nurses need documented competencies for the care they administer to cell therapy patients. The substandards outline the subjects that must be included in the training and competencies.
Standard B4.6: The QM Plan shall include, or summarize and reference, policies and Standard Operating Procedures for the establishment and maintenance of written agreements with external parties providing critical services that could affect the quality and safety of the cellular therapy product or the health and safety of the donor or recipient.
What types of external parties need to be included?
The clinical program should consider external parties such as laboratories and pharmaceutical manufacturers, cell collection services if contracted, and any external facility whose activities are not under the control of the Clinical Program Director.
Standard B4.16.1: Feedback shall be obtained from recipients or legally authorized representatives.
What type of feedback is included?
This includes any feedback from patients, patients’ families, and external facilities, including documentation of review of this feedback. A Clinical Program may use the same system used by its overall institution for requesting and receiving feedback as long as it is included in the system and receives and reviews the feedback.
B9: Data Management
Do we have to submit data to CIBMTR?
Although FACT recommends submission of data to CIBMTR (i.e., denoted with the word “should” in Standard B9.2 and its substandards), Community IEC Clinical Programs are obligated to comply with the data reporting requirements outlined by the manufacturers of commercial cellular therapy products or the sponsors of investigational products. These entities, and those that use their products, must comply with data reporting requirements that are part of the U.S. FDA-approved Biological License Applications (BLAs) or Investigational New Drug (IND) applications. Some of these entities do require submission to CIBMTR.
Note that U.S. federal law requires data reporting for genetically modified cellular therapy products, so the collection and reporting of data are not solely FACT requirements.
How do we efficiently complete the pre-inspection, online Compliance Application?
The Compliance Application includes questions related to each requirement in the FACT Standards that are applicable to the accreditation applicant. We encourage programs to prepare for the workload required by the Compliance Application by designating who will be responsible for completing it, and who will support this effort by identifying and providing documentation to upload.
In some cases, it may be feasible to designate and delegate personnel to complete the application; however, in other programs this may not be possible due to limited staff. It is time well spent to have a discussion among team members about where the time can be found to complete the application, including discussions about distribution of workload, how to set aside time needed, and establishing regular check-ins.
The Self-Assessment Tool is not only educational but is a productive planning resource because it contains all the questions that are in the Compliance Application, including each standard. Because it takes time to complete the Compliance Application, programs are encouraged to review the Self-Assessment Tool before FACT creates the Compliance Application. Note that the tool may contain some standards that are not applicable to the services provided by your program, and you can indicate those as “not applicable.”
The Compliance Application is automatically customized by the accreditation portal, which removes questions that are not relevant to an applicant based on responses it enters as it progresses through the Compliance Application. For this reason, while completing the application in the portal, it is beneficial for a program to work through the Compliance Application from beginning to end, rather than jumping between sections.
As you approach the onsite inspection, the Compliance Application can serve as a blueprint for assembling evidence of compliance. Prepare to support your responses in the application with documentation that can be reviewed by the FACT inspector, including related policies and/or examples.
We are grateful for the opportunity to work together toward the shared goal of high-quality patient care in cellular therapies and want to provide programs the best opportunity to complete the application in preparation for a productive onsite inspection.
FACT Introduces New Intermediary Storage Checklist
By Sarah Litel-Smith, BSMT (ASCP), Manager of Accreditation Services
FACT has developed a new Intermediary Storage Checklist in response to the increasing use of temporary storage locations outside the direct oversight of the Clinical Program, Collection Facility, or Processing Facility. The checklist supports review of temporary storage sites—such as pharmacies, blood banks, or laboratories outside the processing facility—that store cellular therapy products between key points in the product lifecycle.
This shortened, targeted checklist is issued within applicable Cellular Therapy Compliance Applications when an intermediary storage site is identified. It supports review and documentation to confirm that cellular therapy products are secure, maintained at appropriate temperatures, traceable, and managed by trained staff. It also supports evaluation of key processes, including product receipt into storage, release from storage, response to storage alarms, temperature excursions, damaged containers, and leaking product containers.
A key focus of the checklist is chain of custody. Cellular therapy products must be continuously accounted for throughout the product lifecycle, including collection, processing, storage, shipment, transportation, and other points of transfer. Documentation must clearly identify the product’s location, status, and the designated party responsible for the product at each applicable step.
Although the checklist questions are derived from the Processing Standards, they should be answered in relation to the storage services performed by the intermediary storage site. Programs should complete the checklist sequentially in the FACT Accreditation Portal, as some questions include logic that will remove non-applicable follow-up items based on prior responses. Many questions also include an option to indicate when a requirement is not applicable. Programs are encouraged to use the optional comment field to provide brief explanations for the FACT office and inspection team.
When completing the Processing Facility Grid, storage-only facilities are required to complete Table 2: Storage Facility Demographics only. The general processing facility demographics and processing activity tables do not apply unless the storage site performs processing activities.
Some requirements may appear similar to items addressed elsewhere in the Compliance Application, such as chain of custody, chain of identity, internal transfer, personnel safety, and use of personal protective equipment. However, these topics apply across multiple areas of operation and must be demonstrated within the context of the specific service being evaluated.
This checklist reflects FACT’s continued commitment to patient safety, product traceability, and documented accountability across the full continuum of cellular therapy.
FACT Welcomes Many Esteemed Professionals to FACT’s Inspectorate, Continues Training Large Number of Inspector Trainees
By Janice Donoghue, Inspector Development Specialist
We are pleased to welcome many new members to the FACT inspectorate. FACT continues to add new active inspectors—professionals who have completed all training requirements and are now ready to perform on-site inspections independently. These professionals include:
Apheresis Inspectors:
- Dr. Andrea Tiemi Kondo – FACT Inspectorate
- Dr. Walter Linz – Oklahoma Blood Institute
- Dr. Aleh (Oleg) Bobr – University of Nebraska Medical Center / Nebraska Medicine Apheresis Collection Facility
Processing Inspector:
- Teresa Turner – University of Kansas Hospital Cell Processing Laboratory
Cord Blood Inspector:
- Dr. Elias Kalouche – FACT Inspectorate (Dr. Kalouche adds Cord Blood Banking and Cord Blood Collection qualification to his current inspector categories of Cord Blood Processing and HCT Minimal Processing)
We also had the pleasure of conducting FACT Inspector Training at the ASFA Annual Meeting on April 21st. Thank you to these inspector trainees for answering the call to serve their peers and promote safe, high-quality cellular therapy.
Last but not least, we are pleased to announce that our first two Community IEC accreditation inspections will occur in the third quarter of 2026. Current FACT inspectors were selected to serve as the first cadre of inspectors for this new accreditation offering, which includes targeted preparation and consolidated feedback to better support community-based Clinical Programs.
On June 25th, a Community IEC Inspection Preparation Session was facilitated by FACT President Dr. Navneet Majhail, FACT Chief Medical Officer Dr. Phyllis Warkentin, and FACT Director of Operations Suzanne Birnley. This session included:
- An overview of Community IEC programs and inspection considerations.
- Discussion of key differences and nuances inspectors should be aware of when evaluating these programs.
- Expectations and practical considerations for these inspections.
- An opportunity for open discussion and questions.
We appreciate the additional time and expertise the following inspectors are dedicating to Community IEC inspections:
- Carlos Bachier, Hospital Auxilio Mutuo Bone Marrow Transplant and Cellular Immunotherapy Program
- Bhagirathbhai Dholaria, Vanderbilt University Medical Center / Veterans Affairs Tennessee Valley Healthcare System
- Helen Heslop, Baylor College of Medicine Stem Cell Transplant Program, Texas Children’s Hospital and Houston Methodist Hospital
- Chitra Hosing, The University of Texas MD Anderson Cancer Center Stem Cell Transplantation and Cellular Therapy
- Premal Lulla, Baylor College of Medicine Stem Cell Transplant Program, Texas Children’s Hospital and Houston Methodist Hospital
- Joseph Lynch, Geisinger Cellular Therapy Program
- Folashade Otegbeye, Fred Hutchinson Cancer Center Cellular Processing Facility
- Alejandro Sica, Montefiore Medical Center Transplantation and Cellular Therapy Program
- Priti Tewari, The University of Texas MD Anderson Cancer Center Stem Cell Transplantation and Cellular Therapy
- Basem William, OhioHealth Blood and Marrow Transplant and Cellular Therapy Program
FACT Standards Committee Kicks Off Review of 9th Edition Cord Blood Standards
By Monique Summers, RN, MSN, MPA, Standards Development Manager
The FACT Standards Committee kicked off its review of the ninth edition of its Cord Blood Standards in Madrid, Spain, in conjunction with the 52nd Annual Meeting of the EBMT and the 2026 WMDA Global Meetings.
During this meeting, the Steering Committee discussed the overall updates to the Cord Blood Standards that may be necessary in response to changes in the field or technology. This initial discussion sets the tone for the review of the ninth edition.
Members of the Steering Committee include Standards Committee leadership and the co-chairs of each subcommittee. Subcommittee chairs and members were selected through review of interested candidates, responses to FACT’s Call for Volunteers, and recommendations received in response to the Cord Blood Survey distributed to the FACT community prior to the kick-off meeting. When developing Standards Committee rosters, expertise is sought across all areas of cord blood banking, including collection, processing, and quality management. Many members have served as FACT inspectors, bringing extensive expertise to the committees.
During the meeting, the Steering Committee reinforced the importance of data-driven decision-making. As committee members propose revisions or additions to the Standards, they are asked to carefully consider relevant academic literature and any applicable data supporting the issue under review. Examples of topics under consideration include revising qualifications for the Processing Facility Director, potential new standards for programs that no longer collect cord blood units, and expectations for third-party storage companies.
Following this meeting, subcommittees began their work in early May. The goal is to have a draft ready for public comment in November 2026.
“As FACT’s Senior Medical Officer, I truly appreciate the time and commitment of each member of the Cord Blood Standards Steering and Subcommittees,” said Dr. Joseph Schwartz. “We are fortunate to work with the best experts in the field and value their time and expertise in the development of the Standards. We look forward to working with them to produce the ninth edition Cord Blood Standards.”
Upcoming FACT Education Events to Mark on Your Calendar!
Access FACT’s flexible education offerings—available live, on-demand, virtual and in-person—to support your ongoing learning and professional development in cellular therapy. Visit learn.factglobal.org to register.
July 16, 2026 – QM Series 14, Webinar #1
Identifying and Understanding the Why of Occurrence Management
This webinar will guide participants through the fundamental purpose of occurrence reporting in strengthening quality systems and patient safety. Attendees will explore how digging into the “why” through root cause analysis, corrective and preventive actions, and continuous monitoring drives meaningful, sustainable improvement in their cellular therapy programs.
July 30, 2026 – Virtual FACT Apheresis Collection & Laboratory Processing Accreditation Workshop
Participants will gain practical strategies for achieving and maintaining accreditation, improving audits and corrective actions, and avoiding common citations to support stronger clinical and data outcomes.
August 19, 2026 – QM Series 14, Webinar #2
Occurrence Management Follow Up: Closing the Loop Effectively
This webinar focuses on turning identified issues into measurable, sustainable improvements. Participants will learn practical strategies for tracking corrective and preventive actions, verifying effectiveness, communicating outcomes, and fully “closing the loop” in their occurrence management process.
September 10, 2026 – Virtual FACT Clinical, Collection, Processing, and Cord Blood Quality Boot Camp
