Augusta University Medical Center’s Bone Marrow and Stem Cell Transplant Program has again received accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT).
The AU Health program undergoes a thorough audit every three years to maintain this internationally recognized accreditation. It received initial FACT accreditation in 2009.
“If you’re a FACT-accredited center, you’re following really high standards for quality,” said Dr. Vamsi Kota, director of the program. “These days, without having a FACT accreditation, it’s very hard to even perform a transplant.”
Every aspect of the patient experience is inspected, “from the parking garage to the room” because transplant patients have low immune systems and are more susceptible to infections, said Molly James, Bone Marrow Transplant (BMT) Data Coordinator.
The rigorous process of inspection includes observing and reviewing all aspects of the stem cell therapy, from clinical care to donor management, including cell collection, processing storage, administration, transportation and cell release.
On the cell collection and storage side, the blood bank must demonstrate excellent manufacturing practices, prove adherence to standard operating procedures and demonstrate the competencies and continuing education of its staff, said Sheila Tinsley, manager of clinical lab operations.
“You have to show continuing good manufacturing practices that your standard operating procedures are followed and up to date, that you can show continued education
This is the first year the inspection includes the program also includes CAR-T (chimeric antigen receptor T cell) therapy.
CAR-T is a newer therapy for treating cancer that is currently approved for lymphomas.
“It’s where we take out the patient’s white cells and essentially teach them how to target a particular protein on a cancer cell,” said Kota, who is also an associate professor of medicine at the Medical College of Georgia at Augusta University. “So when we reintroduce these cells back into the patient, they are now programmed to go after those cancer cells.”
Tinsley said because they’re creating a blood product, her laboratory is closely monitored and falls under several regulatory agencies including the Food and Drug Administration. FACT accreditation demonstrates that an institution has policies and procedures in place for safe transplants to ensure the best possible outcomes for the patient.
AU Health has the only Bone Marrow Transplant program in the region. Other distinctions include Center of Excellence recognitions from Blue Cross/Blue Shield, Humana, Cigna and Optima.