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FACT accreditation is tailored to the services provided and accommodates different business models. Accredited programs represent a wide variety of health care institutions – academia, integrated health care systems, and community clinics – in both urban and rural areas. Their scope of service ranges from fully integrated transplantation programs to clinic-based IEC therapy. 

How do new programs get started with the FACT accreditation process? We highly recommend contacting FACT as soon as a program has interest. Programs do not need to be ready to formally apply before contacting us. The FACT accreditation team will learn about the program and then provide specific advice about which Standards apply and how to initiate the accreditation process. The accreditation process includes an eligibility application, online submission of documentation, an on-site inspection, and correction of any identified deficiencies. 

FACT’s Accreditation Supervisors, Sarah Litel-Smith, BSMT (ASCP) and Meghan Quinn, MS, have extensive experience guiding interested programs toward applying for initial accreditation. Once applied, a program is assigned an expertly trained FACT Accreditation Coordinator who will work with the program throughout each step of the process.

Sarah Litel-Smith, BSMT (ASCP) Manager of Accreditation Services 402.920.7014 sarah.litelsmith@factglobal.org	Meghan Quinn, MS Manager of Accreditation Services 402.920.7018 meghan.quinn@factglobal.org

ASTCT Webinar Highlights Value of FACT Accreditation in the Community Provider Setting

On August 21, ASTCT hosted a webinar titled, “FACT Accreditation in the Community Provider Setting.” Led by Cynthia Devroy, Manager of Oncology Business Operations at Northside Hospital Cancer Institute, the goal of the webinar was to highlight the flexibility of the process in different types of provider organizational structures and describe the types of roles and work effort involved in the process. The panel also described the benefits of going through an accreditation process to enable processes to efficiently onboard new cellular therapy products. 

The first panelist was FACT Strategic Planning Administrator, Kara Wacker. After providing a high-level overview of the FACT accreditation process, Mrs. Wacker emphasized that FACT accreditation can be applied to different models of care and described three different examples: an independent community-based clinic providing outpatient CAR T cell therapy, a large integrated program adding satellite or independent practices to its existing accreditation, and a community-based clinic providing TIL therapy. 

The next panelist, Dr. Gary Simmons of Virginia Oncology Associates, described why his community-based clinic chose to become FACT accredited. Dr. Simmons used a very effective metaphor of getting a house ready for market, and explained that the work toward accreditation pays for itself via a program’s quality and safety.

Joan Woeltz, the Quality & Compliance Program Manager of the BMT and Cellular Therapy Cancer Center at Stanford Health Care, served as the third panelist. She described the operational efficiency that FACT accreditation brought to their program. The effort put into the accreditation has helped her program efficiently onboard multiple cellular therapy products and get them to patients faster. 

The final panelist was Dr. Sarah Nikiforow of the Dana-Farber Cancer Institute. Dr. Nikiforow is Assistant Professor of Stem Cell Transplantation, Medical Director of the Cell Manipulation Core Facility, and Technical Director of the Immune Effector Cell Program. She is also co-chair of the ASTCT 80/20 Task Force. Dr. Nikiforow described ways in which FACT accreditation can cover approximately 80 percent of industry requirements for authorized treatment centers and qualified cell collection sites. By leveraging FACT accreditation, industry can achieve synergies at their companies in addition to synergies at programs.

During the Question & Answer session, participants asked a wide variety of questions on topics ranging from FACT Standards to reimbursement. During this portion of the webinar, details were provided about FACT’s efforts to encourage community-based providers to pursue FACT accreditation, including the development of fit-for-purpose standards with the guidance of its Community CAR T Working Group. 

The webinar recording is available free of charge on the ASTCT website. We invite everyone to share this webinar with colleagues to encourage community-based providers to pursue FACT accreditation to provide cellular therapies to patients who would benefit from them.

FDA Removal of REMS Requirements Recognizes Important Role of Risk Management Guidelines and Professional Collaboration

On June 26, 2025, the FDA announced the removal of Risk Evaluation Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell products. The announcement referred to established management guidelines and extensive experience of the hematology/oncology community in managing the risks of these products.

CAR T-cell therapy, a form of individualized cancer treatment using a patient’s own immune cells, has transformed outcomes for patients with certain hematologic malignancies. Since their initial approvals, these therapies have been governed by REMS programs to ensure their safe use in real-world clinical practice.

The FDA’s decision acknowledges the growing maturity of CAR T-cell programs, the accumulation of safety data, and the increasing expertise of treatment centers across the country. FACT accreditation has played a key role in establishing consensus-driven, peer-based standards and quality oversight to promote safe and effective cellular therapy practices.

“The removal of REMS requirements reflects growing confidence in the clinical infrastructure, training, and quality systems that support CAR T-cell therapy,” says Phyllis I. Warkentin, MD, FASTCT, FACT Chief Medical Officer. “We’re proud that FACT-accredited institutions have been instrumental in building that foundation.”

FACT remains committed to maintaining standards in cellular therapy and will continue to support treatment centers through accreditation, education, and collaboration with professional societies. While REMS may no longer be mandated, the responsibility for safe and effective patient care remains paramount. We applaud the FDA’s recognition of the professional field’s collaborative efforts to establish resources to effectively manage adverse events so that these lifesaving therapies can be available to the patients that need them.

Requirements for adverse event management in FACT Standards are minimally impacted by this announcement. “FACT standards for immune effector cells have always included requirements for provider training on risks related to the therapies, availability of appropriate medications, and adverse event management and reporting,” says Joseph Schwartz, MD, MPH, FACT Senior Medical Officer. “FACT-accredited programs will have the expertise and infrastructure in place to manage their patients’ entire cellular therapy process, including adverse event management.”

In addition to its Standards and accreditation program, FACT also contributes to many multistakeholder groups working toward improvement and progress in cellular therapy, including product safety and efficacy and patient access. 

“As FACT and all stakeholders work toward making CAR T-cell therapies become more accessible to eligible patients, it is essential that we ensure patients are receiving optimal care through their entire treatment journey in accordance with peer-developed minimum standards of quality and safety,” said David Schmahl, FACT Chief Executive Officer. “FACT accreditation will continue to serve as a trusted indicator of a program’s commitment to excellence.”

FACT Consulting: Accreditation Support You Can Count On

Feeling the pressure of accreditation? You don't have to do it alone.

FACT Consulting helps programs and facilities just like yours with:

• First-time accreditation
• Adding services or staff
• Inspection preparation
• Correction of inspection deficiencies
• Reducing audit fatigue
• Fast site qualifications for manufacturers

Our consultants know the challenges you're facing—and we know how to solve them. Let's talk through your needs and create a plan that works for you.

Preparation is key. Submit your Needs Assessment Request today or visit the FACT Consulting website for more information.

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Visit FACT Consulting

FACT Consulting is a subsidiary of the Foundation for the Accreditation of Cellular Therapy (FACT) and offers a resource that matches client organizations with experienced consultants who can assist with their specific needs. Our Consulting Menu of Services continues to expand to meet the growing demands of the cell therapy field including in‐depth Quality Management Program review; compliance review of GMP facilities; and assistance in establishing a new Blood and Marrow Transplant program, Immune Effector Cell Therapy program, collection facility, or cell processing facility.