Milestone highlights new model for delivering life-saving treatments closer to patients while maintaining rigorous quality and safety standards

OMAHA, Neb., Sept. 1, 2026 /PRNewswire/ — The Foundation for the Accreditation of Cellular Therapy (FACT) announced that Tennessee Oncology has become the first community-based oncology program accredited under the FACT Standards for Immune Effector Cells in the Community Clinical Setting, 1st edition.

This milestone is a significant step toward addressing patient access to life saving cellular therapy and demonstrates that high-quality delivery of immune effector cell (IEC) therapies—such as CAR T-cell therapy—can be achieved safely and effectively in community oncology settings, bringing care closer to where patients live.

“A strategic imperative of FACT is to help expand eligible patient access to safe and quality-based CAR T therapies throughout America’s communities,” says Dr. Navneet Majhail, FACT President.  “We’re very impressed with Tennessee Oncology’s leadership and entire team, and are taking steps to accelerate other community-based programs toward the same end.”

The FACT Community IEC Standards, developed through consensus of a multi-stakeholder Working Group and published in November 2025, adapt the FACT-JACIE International Standards for Immune Effector Cells as “fit for purpose” to the services provided by community-based oncology programs while maintaining a strong foundation in quality and patient safety.

“Tennessee Oncology is incredibly proud of the high-quality care we provide to our patients every day. Becoming the first community oncology practice to earn FACT accreditation is significant and reflects our unwavering commitment to advancing clinical research and delivering the highest standard of care to patients receiving cellular therapy. We are proud to reach this historic milestone and grateful to our leadership, hospital colleagues and FACT for their collaboration and support.  We also appreciate FACT’s partnership in working collaboratively with community oncology physicians to develop the first set of fit-for-purpose standards for community-based cellular therapy programs,” says Michael Byrne, DO, FACP, Cellular Therapy Program Director, Tennessee Oncology, and Medical Director, Cellular Therapy, OneOncology

Expanding on this, Davey Daniel, MD, Chief Medical Officer, OneOncology, says, “Tennessee Oncology’s FACT accreditation is a milestone for community oncology.  It proves that high-quality CAR-T delivery is achievable outside the academic setting in a clinic-based model which is essential for the patients we serve who depend on access close to home. We’re grateful to FACT for their commitment to fit-for-purpose standards in the community practice setting, and we look forward to supporting four additional OneOncology practices as they pursue accreditation.”

Expanding access through community-based care models has the potential to reduce travel burdens, improve patient adherence, and address disparities tied to geography and socioeconomic status. Research shows that reducing distance to treatment centers can significantly increase the number of patients who receive CAR T-cell therapy, underscoring the importance of bringing care closer to patients.

“FACT is committed to expanding patient access and working with community oncology programs to ensure that care happens safely and with quality at the forefront,” adds David Schmahl, FACT CEO. “This first accreditation demonstrates what is possible when innovation in care delivery is paired with professionals that are passionate for patient safety and rigorous quality standards.”

FACT encourages community oncology programs and stakeholders across the healthcare ecosystem to explore the Community IEC Standards and consider accreditation as part of a broader effort to expand access to cellular therapies while maintaining the highest levels of quality and patient safety.

About FACT

The Foundation for the Accreditation of Cellular Therapy (FACT) advances quality and safety in cellular therapy by setting internationally recognized standards and fostering excellence through accreditation and education. By partnering with healthcare organizations and experts worldwide, FACT builds trust in emerging therapies, strengthens quality systems, expands patient access to life-changing cellular therapies, and improves outcomes for patients. FACT is a nonprofit corporation co-founded in 1996 by the International Society for Cell and Gene Therapy (ISCT) and the American Society for Transplantation and Cellular Therapy (ASTCT) for the voluntary inspection and accreditation in the field of cellular therapy.

The number of FACT accredited programs continues to grow around the world. There are 346 accredited programs across 28 countries. These programs are served by a volunteer inspectorate of 249 cellular therapy experts. Learn more at factglobal.org.

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SOURCE Foundation for the Accreditation of Cellular Therapy