FACT vs Non-FACT Centers: Why Certification Still Shapes CAR-T Outcomes

Why Center Certification Matters in CAR-T Therapy

Emerging real world analyses and health system reports indicate that outcomes following chimeric antigen receptor T-cell (CAR-T) therapy potentially vary significantly depending on whether treatment is administered at FACT-accredited versus non-FACT-accredited centers. These differences present as being driven through variations in toxicity monitoring infrastructure, clinician experience, and post-infusion care protocols.

With the expansion of CAR-T beyond academic centers, certification status is progressively shaping both patient safety outcomes and referral patterns. The expansion of CAR-T therapy beyond academic centers comes with certification status progressively shaping both patient safety outcomes and referral patterns.^1,2

Having a foundational comprehension of these distinctions is critical for pharmacists and health care practitioners with involvement in oncology care coordination, toxicity management, and institutional CAR-T program oversight.

CAR-T Therapy and the Role of FACT Certification

CAR-T therapy is a personalized immunotherapy where a patient’s T cells are collected and genetically engineered ex vivo to recognize and attack malignant cells. Approved CAR-T therapies, such as idecabtagene vicleucel (Abecma; Celgene Corporation) and lisocabtagene maraleucel (Breyanzi; Juno Therapeutics, Inc), demonstrate significant clinical activity in relapsed or refractory hematologic malignancies, particularly amongst patients with limited remaining treatment options.^3,4

Due to CAR-T therapies association with potentially severe immune-mediated toxicities such as cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS), administration is restricted to specialized centers with established monitoring and emergency response capabilities. FACT accreditation establishes standards for institutional readiness, which includes staffing requirements, toxicity management protocols, and post-infusion monitoring procedures.¹

How FACT Certification Influences Safety Infrastructure and Outcomes

Centers that are FACT-accredited are required to maintain structured protocols for patient monitoring before, during, and after CAR-T infusion. Furthermore, this includes standardized grading systems for CRS and ICANS, rapid escalation pathways, and 24-hour access to trained personnel capable of managing acute toxicities.¹

Adverse effects such as CRS and ICANS commonly occur within the first several days to weeks following CAR-T infusion and may progress rapidly without prompt intervention. In evidence-based management strategies, there is an emphasis for early recognition and treatment with agents such as tocilizumab (Actemra; Genentech) and corticosteroids when clinically indicated.² Standardized toxicity management pathways have been associated with more consistent care delivery and improved management of immune-mediated adverse events across CAR-T programs.²

Real-World Outcomes and Patient Funnel Differences

With the expansion of CAR-T therapy into broader clinical practice, data from real-world analyses indicate that institutional experience and care coordination may influence patient outcomes and healthcare resource utilization.⁵ The differences in treatment experiences between centers can be contributed through variability in referral workflows, toxicity monitoring practices, and post-infusion follow-up.

The CAR-T patient funnel includes multiple potential barriers prior to infusion, including referral delays, insurance authorization, leukapheresis scheduling, manufacturing timelines, and coordination of post-treatment monitoring. These logistical challenges may impact both time to treatment and continuity of care, specifically for patients treated outside large academic institutions.^5,6

Accessibility to CAR-T therapy and the feasibility of intensive post-infusion monitoring requirements may also be influenced due to distance from treatment centers. Institutions may face increasing pressure to balance expanded patient access with maintenance of standardized safety infrastructure as additional centers begin offering CAR-T treatment.⁶

FACT accreditation continues to be an important determinant of institutional readiness for CAR-T therapy, influencing toxicity management infrastructure, patient monitoring capabilities, and overall care coordination. With crucial CAR-T therapies such as idecabtagene vicleucel and lisocabtagene maraleucel continuing expansion into real-world clinical practice, differences in institutional experience and certification status may increasingly shape patient outcomes.

For pharmacists and health care practioners, having solid comprehension on these distinctions is essential for supporting safe and effective CAR-T delivery across evolving treatment settings.

References

1. Foundation for the Accreditation of Cellular Therapy. FACT Standards for Hematopoietic Cellular Therapy Products. FACT. Last updated 2024. Accessed May 19th, 2026. https://factglobal.org/fact-standards/

2. Neelapu SS, Tummala S, Kebriaei P, et al. Chimeric antigen receptor T-cell therapy - assessment and management of toxicities. Nat Rev Clin Oncol. 2018;15(1):47-62. doi:10.1038/nrclinonc.2017.148

3. Locke FL, Ghobadi A, Jacobson CA, et al. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol. 2019;20(1):31-42. doi:10.1016/S1470-2045(18)30864-7

4. Munshi NC, Anderson LD Jr, Shah N, et al. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2021;384(8):705-716. doi:10.1056/NEJMoa2024850

5. Riedell PA, Grady CB, Nastoupil LJ, et al. Lisocabtagene maraleucel for relapsed/refractory large B-cell lymphoma: a cell therapy consortium real-world analysis. Blood Adv. 2025;9(5):1232-1241. doi:10.1182/bloodadvances.2024014164

6. Adly AS, Cartron G, Adly AS, et al. CAR-T Cells: Current Status, Challenges, and Future Prospects. MedComm (2020). 2026;7:e70606. Published 2026 Apr 17. doi:10.1002/mco2.70606