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Peer-reviewedCC BY-NC-ND 4.0Blood Advances

Sustaining cell therapy quality through shared responsibility: a call for equitable FACT inspectorate participation

  • Suzanne Birnley1
  • Michele W. Sugrue2
  • Angelica Vivero3
  • Alejandro R. Sica4
  • Elias Kalouche5
  • Daniel Kota6
  • Donna Salzman7
  • Renee Smilee8
  • Ibrahim Ahmed9
  • Arunkumar Modi10
  • Guy Klamer11
  • Phillip Johnson12
3 more authors
  • Joseph Lynch13
  • Phyllis Warkentin1,14
  • Folashade Otegbeye15
15 affiliations
  1. 1Foundation for Accreditation of Cellular Therapy, Omaha, NE
  2. 2Foundation for Accreditation of Cellular Therapy (Inspectorate), Guilford, CT
  3. 3Department of Pathology and Genomic Medicine, Thomas Jefferson University Hospital, Philadelphia, PA
  4. 4Department of Oncology, Montefiore Health System and Albert Einstein College of Medicine, Bronx, NY
  5. 5CReATe Cord Blood & Peristem Cell Bank, Toronto, ON, Canada
  6. 6Ann Kimball and John W. Johnson Center for Cellular Therapeutics, Houston Methodist Academic Institute, Houston, TX
  7. 7Adult and Pediatric Bone Marrow Transplantation and Cell Therapy Program, The University of Alabama at Birmingham, Birmingham, AL
  8. 8H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
  9. 9Division of Pediatric Hematology/Oncology and Bone Marrow Transplantation, Children’s Mercy, Kansas City, MO
  10. 10AdventHealth Medical Group Stem Cell Transplant and Cellular Therapy at Orlando, Orlando, FL
  11. 11Sydney Cord Blood Bank, Sydney Children’s Hospitals Network, Sydney, Australia
  12. 12Queensland Cord Blood Bank at The Mater, Brisbane, Australia
  13. 13Geisinger Medical Center, Danville, PA
  14. 14Department of Pathology, Microbiology, and Immunology, University of Nebraska Medical Center, Omaha, NE
  15. 15Translational Science and Therapeutics Division, Fred Hutchinson Cancer Center, Seattle, WA
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Abstract

This study highlights a critical challenge in the Foundation for the Accreditation of Cellular Therapy (FACT) peer-accreditation system: a growing imbalance between the rising number of accredited and applicant organizations and the limited pool of volunteer inspectors. This imbalance places a disproportionate burden on current inspectors, concentrates accreditation expertise within a small subset of programs, and threatens the efficiency of the peer-review model. The study presents compelling evidence that organizations contributing to the inspectorate gain measurable benefits. These include stronger audit performance in renewal cycles, access to education in quality standards and best practices, and broader professional networks. It concludes with a call to action: accredited organizations should share responsibility and contribute equitably to the FACT inspectorate to maintain the quality and sustainability of the accreditation process.

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Cite

BibTeXRIS
BibTeX
@article{birnley2026sustaining,
  title = {{Sustaining cell therapy quality through shared responsibility: a call for equitable FACT inspectorate participation}},
  author = {Suzanne Birnley and Michele W. Sugrue and Angelica Vivero and Alejandro R. Sica and Elias Kalouche and Daniel Kota and Donna Salzman and Renee Smilee and Ibrahim Ahmed and Arunkumar Modi and Guy Klamer and Phillip Johnson and Joseph Lynch and Phyllis Warkentin and Folashade Otegbeye},
  journal = {Blood Advances},
  year = {2026},
  month = sep,
  doi = {10.1182/bloodadvances.2026019676},
  url = {https://doi.org/10.1182/bloodadvances.2026019676},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - Sustaining cell therapy quality through shared responsibility: a call for equitable FACT inspectorate participation
AU  - Suzanne Birnley
AU  - Michele W. Sugrue
AU  - Angelica Vivero
AU  - Alejandro R. Sica
AU  - Elias Kalouche
AU  - Daniel Kota
AU  - Donna Salzman
AU  - Renee Smilee
AU  - Ibrahim Ahmed
AU  - Arunkumar Modi
AU  - Guy Klamer
AU  - Phillip Johnson
AU  - Joseph Lynch
AU  - Phyllis Warkentin
AU  - Folashade Otegbeye
PY  - 2026
DA  - 2026/09/03
JO  - Blood Advances
DO  - 10.1182/bloodadvances.2026019676
UR  - https://doi.org/10.1182/bloodadvances.2026019676
AB  - This study highlights a critical challenge in the Foundation for the Accreditation of Cellular Therapy (FACT) peer-accreditation system: a growing imbalance between the rising number of accredited and applicant organizations and the limited pool of volunteer inspectors. This imbalance places a disproportionate burden on current inspectors, concentrates accreditation expertise within a small subset of programs, and threatens the efficiency of the peer-review model. The study presents compelling evidence that organizations contributing to the inspectorate gain measurable benefits. These include stronger audit performance in renewal cycles, access to education in quality standards and best practices, and broader professional networks. It concludes with a call to action: accredited organizations should share responsibility and contribute equitably to the FACT inspectorate to maintain the quality and sustainability of the accreditation process.
SN  - 2473-9529
SN  - 2473-9537
ER  -