Sarah Litel-Smith, Manager of Accreditation Services
Andrea Carney, MLS(ASCP)cm, FACT Accreditation Coordinator
Foundation for the Accreditation of Cellular Therapy
Omaha, NE USA
As the fields of cellular therapy and cord blood banking continue to advance, the demand for accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT) has never been greater. Clinical programs, collection and processing facilities, and cord blood banks worldwide recognize the value of FACT accreditation in ensuring high-quality patient care, adhering to rigorous consensus standards, and promoting continuous improvement. The increasing demand reflects a commitment to quality and an understanding that FACT accreditation is not only beneficial but also accessible and attainable for organizations of all sizes and structures.
The volume of initial FACT applicants continues to grow, demonstrating an ongoing trend of institutions seeking accreditation for the first time. The most recent data reflects initial applications from 5 cord blood banks, 25 clinical hematopoietic cell transplantation programs, 3 clinical immune effector programs, and 15 service providers (collection and/or processing facilities accredited independently of a clinical program).
FACT accreditation is not exclusive to large, academic institutions. Many smaller, rural, and outpatient-based programs are successfully achieving accreditation, demonstrating that facilities of all sizes can meet these internationally recognized quality standards. FACT provides extensive resources, educational materials, and expert guidance to help organizations navigate the accreditation process efficiently. Each applicant is assigned an Accreditation Coordinator for ongoing assistance throughout the accreditation process.
Organizations, regardless of structure, benefit from FACT accreditation through enhanced patient care, standardized quality practices, and increased credibility among patients, donors, and stakeholders. Accreditation also streamlines audits and inspections, reinforces a commitment to quality, and fosters collaboration with other accredited institutions. A full list of accredited programs is available at www.factglobal.org/accredited-programs.
As accredited programs continue to expand, FACT remains committed to supporting organizations in ensuring that high-quality cellular therapy and cord blood banking services are accessible to patients worldwide. Whether your program is a large academic center or a small community-based facility, FACT accreditation is within reach, providing measurable benefits for both providers and patients alike.
FACT Accreditation Makes Tremendous Progress Against the COVID-19 Backlog
FACT awarded a record number of program accreditations in January 2025. This milestone underscores the tireless work of FACT staff and dedicated volunteers, who have worked diligently to address the backlog of inspections caused by the COVID-19 pandemic. This backlog had previously delayed inspections, but thanks to the collaborative effort between FACT’s team and volunteer inspectors, the organization has made significant strides in resolving this issue.
A large number of inspections were carried out in November, marking a turning point in the progress toward catching up on these important evaluations. The influx of new and experienced volunteer inspectors played a crucial role in making this possible, allowing FACT to grant renewal and initial accreditation to 20 organizations in January alone. This surge in accreditation represents a significant leap forward, both in the organization’s ability to meet its goals and in ensuring that high-quality standards are upheld in the field of cellular therapy.
Accreditation is not just a formality; it is a rigorous and thorough process that involves a comprehensive review of various facets of operation. These include an analysis of the program’s policies and procedures, a detailed assessment of clinical outcomes, and an examination of data reporting practices. The process also includes an on-site inspection, where evaluators assess the real-world application of the program’s practices to ensure alignment with the Standards. It is through this meticulous process that FACT ensures that accredited programs are consistently delivering the best possible care.
This record-breaking achievement of 20 renewal and initial accreditations in one month is not just a number. It is a testament to FACT’s ongoing commitment to continuously improving cellular therapy, even in the face of challenges. It demonstrates a consistency and adaptability that is critical in such a fast-evolving field.
Looking ahead, FACT remains dedicated to its ongoing mitigation efforts to address the COVID-19 backlog. The organization has set its sights on bringing its accreditation process fully up to date, with plans to be current on all inspections and accreditations by the end of the calendar year. This commitment not only reinforces FACT’s dedication to excellence but also sets the stage for continued success in the years to come.
In celebrating this milestone, FACT reflects on the hard work and collaboration that made it possible. The involvement of volunteers, the expertise of staff, and the support of accredited organizations all played essential roles in making January’s achievements a reality. Moving forward, FACT is excited about the future and is committed to continuing its track record of on-time accreditation.
As 2025 progresses, FACT looks forward to further expanding its impact, continuing its work with both new and returning volunteers, and celebrating more successes. The future of the organization is bright, and its ability to adapt and innovate will continue to drive its success in ensuring the highest levels of care and practice in this vital medical field.
Interested in becoming a FACT laboratory inspector? Join us for training at the ISCT Annual Meeting!
We invite you to APPLY to become a Laboratory Inspector and attend the FACT Laboratory Inspector Training Course held Tuesday, May 6, from 8:00 a.m. to 5:00 p.m., at the New Orleans Marriott Warehouse Arts District, New Orleans, LA, prior to the 2025 ISCT Meeting. This FACT Laboratory Inspector Training Course is for inspector trainees only. Trainees must complete all prerequisites before attending. This course provides trainees with practical, hands-on sessions facilitated by experienced FACT inspectors. FACT inspector trainees learn about technology tools, preparation essentials, common citations, the inspection processes, and what to expect after the inspection.
To apply to become a FACT inspector, please email inspectors@factglobal.org or CLICK HERE to apply.
We hope to see you in New Orleans for our FACT Inspector Training!