Foundation for the Accreditation of Cellular Therapy (FACT) accreditation is not an easy delegation to achieve, nor to maintain. However, through their exemplary standards of practice (SOPs), Holden Comprehensive Cancer Center’s Stem Cell Transplant and Cellular Therapy (SCTCT) Program has been accredited since 2001, and was once again renewed this year. The accreditation covers autologous, allogeneic stem cell transplant and Immune Effector Cells (IEC), including CAR-T cells and other cellular therapies.
FACT accreditation sets a global standard for high quality patient care in cellular therapies, and while there are 311 FACT-accredited programs in the world (including transplant programs, independent apheresis centers and cell processing labs, and cord blood banks), Holden’s is the only one in Iowa. The FACT Standards manual is over 500 pages of criteria for Clinical Programs (Adult and Pediatric) and Marrow Collection Facilities, which are covered by the SCTCT Program and headed by Director of the Adult SCTCT Program Margarida Magalhaes-Silverman, MD; Pediatric Director Rajat Sharma, MD; and Quality and Assistant Director of the Stem Cell Transplant & Cellular Therapy Program, Rhonda Evans, MSN, RN, OCN, BMTCN. Annette Schlueter, MD, PhD, who is medical director for Tissue and Cellular Therapies and Patient Services Sections, and DeGowin Blood Center and Quality Assurance & Compliance Coordinator Marci Schmatt led the accreditation effort in the DeGowin Blood Center, which is responsible for the stem cell collection and lab processing standard portions, covering the Apheresis Collection Facility Standards and Processing Facility Standards.
The application renewal process was intensive; the SCTCT’s first application was submitted in March of 2023, with program staff not receiving their mandatory site visit and inspection until July of 2024. With the renewal secured, the SCTCT is now accredited from Jan. 22, 2025, to Jan. 22, 2028, signaling to perspective and current patients that patient-first care is of the utmost importance.
“Insurance companies will only approve transplant and cellular therapy at a FACT-approved facility. FACT accreditations show we have a quality program, and informs patients, health insurance companies, and government agencies that we are dedicated to excellence in patient care and laboratory practices,” said Evans. “We are fortunate to have our inpatient and outpatient areas, ASC, Pediatric OR, stem cell collection and processing all in the same location. In addition to all the SOPs we have [to meet FACT requirements], we have a formal quality program that routinely audits, completes process improvements, and monitors patient outcomes.”
In the beginning of the SCTCT’s accreditation, there were 38 SOPs for the clinical program, a number that has grown to 129 in the years since. As the program is recertified every three years, and the 9th Edition of the FACT Standards will be released this summer, the program will have to continue to strive for the best practices possible to maintain the designation and offer quality care to Iowans.
Silverman extends her thanks to the entire SCTCT program and everyone involved in this process, who helped achieve re-accreditation through their hard work, help, and commitment to quality care.