OhioHealth’s Blood and Marrow Transplant and Cellular Therapy Program Awarded FACT Accreditation
The OhioHealth Blood and Marrow Transplant and Cellular Therapy program has received internationally-recognized accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT) at the University of Nebraska Medical Center. By demonstrating compliance with the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration, the OhioHealth Blood and Marrow Transplant and Cellular Therapy program has earned FACT Accreditation for:
- Adult allogeneic and autologous hematopoietic progenitor cell transplantation
- Immune effector cellular therapy
- Marrow cellular therapy product collection for administration
- Cellular therapy product collection by apheresis for administration and further manufacturing
- Cellular therapy product processing with minimal manipulation
FACT is an internationally-recognized accrediting body for hospitals and medical institutions offering stem cell transplant and indicates the accredited institution has met the most rigorous standards in every aspect of stem cell therapy. This covers the entire spectrum of stem cell therapy, from clinical care to donor management, cell collection, processing, storage, transportation, administration, and cell release.
FACT-JACIE Standards are defined by leading experts based on the latest knowledge of the field of cellular therapy transplantation. OhioHealth has been found to be in compliance with these rigorous Standards as well as governmental regulations.
“We endeavored to achieve accreditation for our organization because FACT accreditation has evolved into an all-but-necessary qualification to be accepted and competitive in the field of cellular therapy,” said Yvonne Efebera, MD, Medical Director, OhioHealth Blood and Marrow Transplant and Cellular Therapy program. “We believe FACT Accreditation will make patients aware that our facility strives to achieve the highest quality care for cellular therapy treatment programs.”
“We are pleased that OhioHealth has met the requirements of the Foundation and has been granted accreditation,” said Dr. Phyllis Warkentin, FACT’s Chief Medical Officer.
Accreditation is attained through evaluation of submitted documentation and on-site inspection to determine if an organization is in compliance with current FACT standards and the United States Food and Drug Administration’s current rules for Good Tissue Practice. FACT Standards are defined by leading experts based on the latest knowledge of the field of cellular therapy.
About FACT
In December 1994, the International Society for Cellular Therapy (ISCT) and the American Society for Blood and Marrow Transplantation (ASBMT) merged their Standards into a single document covering all aspects of hematopoietic cell therapy (collection, processing, and transplantation). The two societies established FACT in order to develop a voluntary Inspection and Accreditation Program based on the joint Standards. FACT promotes quality medical and laboratory practice of cellular therapy through its peer-developed standards and voluntary inspection and accreditation program.
In 2006, FACT, in collaboration with the Joint Accreditation Committee–ISCT & EBMT (JACIE), developed international standards in the field of cellular therapy. JACIE was founded by the European Group for Blood and Marrow Transplantation (EBMT) and the International Society for Cellular Therapy (ISCT), the two leading scientific organizations involved with cellular transplantation in Europe.
Since 2007, FACT accreditation has been used in determining the U.S. News & World report rankings of transplant centers for the "America's Best Hospitals" and "America's Best Children's Hospitals" list.
The FACT Inspection and Accreditation Program was developed by Dr. Phyllis Warkentin, Chief Medical Officer of FACT, the FACT Board of Directors, as well as the ISCT and ASBMT Regulatory and Standards Committees. The first edition of the FACT Standards was published in September 1996, and the first inspections began in September of 1997 resulting in the first program being awarded accreditation in 1998.
