Tennessee Oncology Is First to Earn FACT Accreditation Under New Standards

Tennessee Oncology has become the first community-based oncology program to earn accreditation under a new set of standards for delivering immune effector cell (IEC) therapies, such as chimeric antigen receptor (CAR) T-cell therapy, the Foundation for the Accreditation of Cellular Therapy (FACT) announced September 1, 2026.¹

The practice was accredited under the FACT Standards for Immune Effector Cells in the Community Clinical Setting, 1st edition. According to FACT, the accreditation shows that IEC therapies can be given safely and effectively in community settings, not just at academic medical centers.

"A strategic imperative of FACT is to help expand eligible patient access to safe and quality-based CAR T therapies throughout America's communities," said Navneet Majhail, MD, MS, FASTCT, president of FACT, who added that the organization is working to move other community-based programs toward accreditation.

Standards Built for the Community Setting

A multistakeholder working group developed the Community IEC Standards by consensus, and FACT published them in November 2025. The standards adapt the FACT-JACIE International Standards for Immune Effector Cells to be “fit for purpose” for the services community oncology programs provide, while keeping a 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,” Michael Byrne, DO, FACP, cellular therapy program director at Tennessee Oncology and medical director of cellular therapy at OneOncology, said in the statement.

“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,” Byrne said.

Davey Daniel, MD, chief medical officer of OneOncology, said in the statement that accreditation carries significance beyond a single practice.

“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,” Daniel said.

Distance as a Barrier

FACT said community-based care could reduce travel burdens, improve adherence, and address disparities tied to geography and socioeconomic status. The organization cited research showing that reducing the distance patients must travel to a treatment center can substantially increase the number who receive CAR T-cell therapy.

"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," said David Schmahl, FACT's CEO.

FACT is encouraging other community oncology programs to review the Community IEC Standards and consider pursuing accreditation.

FACT, a nonprofit founded in 1996 by the International Society for Cell and Gene Therapy and the American Society for Transplantation and Cellular Therapy, has accredited 346 programs across 28 countries.

Reference

Tennessee Oncology first to achieve FACT Community IEC accreditation, signaling shift in access to cellular therapies. News release. PR Newswire. September 1, 2026. Accessed September 29, 2026. https://www.prnewswire.com/news-releases/tennessee-oncology-first-to-achieve-fact-community-iec-accreditation-signaling-shift-in-access-to-cellular-therapies-302864620.html