Why FACT Accreditation Still Matters for CAR T-Cell Therapy

In "Why FACT Accreditation Still Matters for CAR T-Cell Therapy," the discussion turns to why FACT accreditation for CAR T-cell therapy access has held up over 25 years.

Dr. Porter opens by affirming that FACT accreditation's original rationale for CAR T-cell therapy still holds up, in a general sense, after more than 25 years. He describes FACT as the field's own accrediting body, developed and run by peers who set standards for these therapies, and credits it with ensuring the high-quality care that underlies improved safety and outcomes.

He walks through why the infrastructure demands are so extensive. CAR T-cell therapy is neither bone marrow transplant nor a standard drug therapy, he explains; it is a detailed, complicated, and risky process spanning patient selection, cell collection, processing, freezing, shipping, receiving, thawing, and ongoing patient management. That complexity, Dr. Porter argues, requires comprehensive infrastructure at the program level, not just expertise from the treating physician. FACT mandates planning, forethought, and continued assessment of quality, safety, and efficacy, which he says improves outcomes and gives health systems and physicians real accountability.

Dr. Porter also acknowledges FACT's origins in blood and marrow transplant, historically concentrated at large academic and tertiary hospitals whose standards shaped the accreditation. FACT has recognized that cell therapies now belong in the community as well, and has revised its standards accordingly to be more accessible to community sites without sacrificing the quality and safety that drive good outcomes. He describes this as giving programs a clear baseline for what a high-quality operation requires.

Asked whether FACT is the only path, Dr. Porter is candid: it happens to be the accrediting body the field has used, and while other quality mechanisms could work, FACT brings a 25-plus-year track record. Whatever mechanism a program chooses, he says, the community must hold itself to high-quality, safe standards.

In "What FACT Accreditation Requires and Whether It's Necessary," the panel weighs what FACT accreditation actually requires against whether it should remain a gate to access.