Setting the standard with FACT accreditation
The following success stories represent just a few of the hundreds of organizations around the world that have achieved and benefited from FACT accreditation.
Success stories
M.D. Anderson Cancer Center
About M.D. Anderson Cancer Center
M.D. Anderson Cancer Center was created by the Texas Legislature in 1941 as a component of The University of Texas System and is one of the original National Cancer Institute’s designated Comprehensive Cancer Centers.
M.D. Anderson Cancer Center is recognized as No. 1 in cancer care in U.S. News & World Report's annual "America's Best Hospitals" survey, in part due to our FACT accreditation. The Cancer Center is Magnet credentialed with recognized nursing excellence, and it is recognized by the National Marrow Donor Program (NMDP) as a specialized center for matched unrelated donor transplants.
FACT Contribution
The M.D. Anderson Cancer Stem Cell Transplantation and Cellular Therapy Program was one of the first organizations accredited by FACT receiving our first accreditation in January 13, 2000. It is home to FACT organization leaders including Elizabeth J. Shpall, MD, first FACT President, and Richard Champlin, MD, first FACT Vice President.
Since its initial accreditation, the M.D. Anderson Cancer Center Stem Cell Transplantation and Cellular Therapy Program has continuously maintained its accreditation. Many M.D. Anderson Cancer Center Stem Cell Transplantation and Cellular Therapy Program faculty and staff serve on the FACT Board of Directors and committees, and are clinical, collection, and laboratory inspectors, supporting the organization’s values and mission to set a global standard in quality stem cell transplantation and cellular therapy care.
Lessons Learned From the FACT Accreditation Process
The process of FACT accreditation is an important learning and organizational experience for every transplant program. The M.D. Anderson Cancer Center Stem Cell Transplantation and Cellular Therapy Program’s first FACT accreditation required a thorough review of all our clinical, collection, and laboratory practices and policies, using an interdisciplinary approach, integrating processes throughout the program, setting new standards, and refining old ones. FACT accreditation demonstrates M.D. Anderson Cancer Center’s commitment to outstanding quality patient care and compliance with international quality standards.
Lessons are learned with each new set of standards and with each reaccreditation process. Institutional administrative and clinical management are key in successful accreditation and compliance. They have been involved from the beginning in the accreditation preparations and maintenance of our quality management program standards, including infection control, transfusion, laboratory medicine, radiation oncology, and institutional quality management.
Planning and preparation in advance is critical as suggested by the FACT accreditation timeline. The process can take longer than you can think and the more you prepare in advance, the better. Inspection preparation, more importantly continued standard compliance, is best accomplished under the direction of a designated quality person and team, with representatives from the transplant program’s clinical, cell collection, and cell processing groups.
Documentation and organization are key factors. Even with the implementation of the electronic application and inspection checklist, documentation is key during the inspection process. Having the documentation well organized to the standards will make for a smooth inspection.
Quality, Quality, Quality is the new standard. Development and implementation of an excellent quality management program including clinical, collection, and processing is essential. Developing a good quality plan, the document that describes the quality program and addresses all of the key functions FACT includes in the quality management standards section, is key. The quality plan will provide structure to your quality management program.
Don’t forget to contact your FACT accreditation coordinator and reach out to other institutions who have been accredited by FACT for advice and help in preparation.
Our goal is the same, outstanding quality patient care in stem cell transplant.
Additional Information
The Stem Cell Transplantation and Cellular Therapy Program at M.D. Anderson Cancer Center is an adult and pediatric autologous and allogeneic transplant program that began in 1979 and is internationally recognized as a leader in research and treatment. It is one of the largest transplant centers in the world performing hundreds of transplant procedures each year, consisting of an integrated interdisciplinary medical team, a large inpatient unit and multiple outpatient centers. It has one of the largest and most active Apheresis Centers in the world, performing thousands of procedures a year. It has a nationally and internationally recognized advanced Cell Therapy Laboratory (CTL) with a state-of-the-art Good Manufacturing Practices (GMP) facility with class 10,000 suites processing thousands of products a year.
The mission of the Stem Cell Transplantation and Cellular Therapy Program is to utilize hematopoietic cell therapies to eliminate cancer and allied diseases in Texas, the nation, and the world, through integrated quality programs in patient care, research, education, and prevention. The primary goal of the program is to provide cutting edge medical care and improve upon current treatments. Novel therapeutic approaches being investigated at M.D. Anderson Cancer Center often will become the "standard of care" utilized throughout the country and the world.
Disclaimer: The opinions expressed here are solely the views of the writer and do not necessarily reflect the views and opinions of the Foundation for the Accreditation of Cellular Therapy.
Hoxworth Blood Center
About Hoxworth Blood Center
Hoxworth Blood Center Apheresis Collection Facility and its Cellular Therapies Division have been accredited by FACT since 2003. The program values their FACT accreditation and the impact it has had on their program’s continuous quality improvement objectives. Their belief in the accreditation process led then Collection Facility Director, Patricia Carey, MD, and Laboratory Director, Thomas Leemhuis, PhD, to become FACT inspectors.
They both have also served as members of the FACT Cellular Therapy Accreditation Committee. Dr Leemhuis says, “We appreciate the opportunity to contribute to FACT’s collegial, positive approach toward improving the practice of hematopoietic stem cell transplantation and other cell-based therapies throughout the world.”
Hoxworth’s mission is three-fold: 1) to provide exceptional collection and cell processing service to our clinical customers; 2) to facilitate implementation of novel cellular therapy-based clinical trials; and 3) to educate laboratory technologists in the laboratory aspects of cell transplantation. Hoxworth Blood Center offers a graduate program through the College of Allied Health Sciences, Department of Analytical and Diagnostic Sciences that leads to a Master of Science degree in Transfusion and Transplantation Sciences, with either an emphasis in Blood Transfusion Medicine or Cellular Therapies.
Hoxworth Blood Center University of Cincinnati Academic Health Center, University of Cincinnati (U.C.) was founded in 1938, and is one of the oldest community blood centers in the USA. Hoxworth Blood Center’s Apheresis Collection Facility and Cellular Therapy Division serve the Blood and Marrow Transplant Programs at Cincinnati Children’s Hospital Medical Center, Jewish Hospital, Akron Children’s Hospital, and the National Marrow Donor Program; providing comprehensive collection and processing support. Hoxworth is licensed by the U.S. Food and Drug Administration and provides service in compliance with FDA’s cGTP (21CFR 1271) and cGMP (21CFR 211) regulations. All laboratory operations are conducted in either an ISO class 8 or an ISO class 7 clean room, as applicable.
For more information on Hoxworth Blood Center, visit www.Hoxworth.org or call 513-558-1553.
Disclaimer: The opinions expressed here are solely the views of the writer and do not necessarily reflect the views and opinions of the Foundation for the Accreditation of Cellular Therapy.
Hospital Israelita Albert Einstein (HIAE)
About Hospital Israelita Albert Einstein
Hospital Israelita Albert Einstein (HIAE) in Brazil is the first Bone Marrow Transplantation Center in Latin America to receive FACT accreditation. HIAE is accredited for autologous and allogenic transplantation.
Preparing for initial FACT accreditation took the hospital 3 years. To document decisions, medical records, protocols, results, training, data, and registries was an arduous but necessary process. Fortunately, in 2012, the hospital was ready to undergo an on-site inspection from FACT. After the inspection and approval by the FACT Accreditation Committee, HIAE became the first FACT accredited program in Latin America.
The hospital's objective in obtaining accreditation is to provide the best care possible for patients. With FACT accreditation, it is possible to open this path to other transplantation centers that also take good care of Brazilian and Latin American patients. By incorporating technology and quality standards, HIAE fulfills its mission of providing excellence in service. HIAE hopes that in the near future, all national institutions may have the same pride we feel today.
Bone Marrow Transplantation in Latin America
Hospital HIAE started its activities in bone marrow transplantation in 1987, with an autologous transplant. In that same year, the first allogeneic transplantation was performed. In 1997, the transplantation program from unrelated donors began with 2 procedures using cells from umbilical cords obtained from the New York Blood Center. In 1996, the hospital performed the first transplantation procedure in an autoimmune disease patient (refractory autoimmune hemolytic anemia) in Brazil and, since 1999, encouraged by Julio Voltarelli, has been performing transplants for autoimmune diseases with special focus on multiple sclerosis. Today, HIAE performs about 70 cell transplants per year, including auto, allo related and unrelated, umbilical cord blood and haploidentical transplants.
The hospital was founded in 1971 with the mission of providing quality health care, generating knowledge, and promoting social responsibility. In recent decades, an expansion plan doubled the hospital’s service area, expanded social programs of assistance to needy communities, and turned the hospital into a benchmark in organ transplants, in the public sector. HIAE works in close partnerships with governments for health assistance in various regions of São Paulo metropolis. The hospital’s research and educational institute has already trained approximately 130,000 professionals and conducts hundreds of studies annually.
In fact, such a concern with quality has lead HIAE to make history in Brazil in the field of quality accreditations. In 1996 and 1997, the institution was accredited by ISO 9001 in the areas of Laboratory, Blood Bank and Intensive Care Unit (ICU), which later spread to other areas. In 1999, HIAE achieved accreditation by the Joint Commission, the first hospital in the world to obtain such certification outside the United States. HIAE is also accredited by CAP (College of American Pathologists), the AABB, the Joint Commission for Stroke (CVA), and Planetree.
Disclaimer: The opinions expressed here are solely the views of the writer and do not necessarily reflect the views and opinions of the Foundation for the Accreditation of Cellular Therapy.
Héma-Québec
About Héma-Québec
The Héma-Québec Public Cord Blood Bank (CBB) was created in 2004 to meet the needs of Quebecers and to contribute to the international effort towards a high-quality global inventory of cord blood units. Since 2008, the bank has witnessed substantial growth in its activities.
Benefiting from a solid partnership with seven hospital centers, the CBB had more than 13,000 units of qualified cord blood in March 2025. The CBB is integrated into an organizational structure that includes, among others, an ASHI-accredited HLA laboratory, a support team for the recruitment of mothers, and a stem cell laboratory responsible for the qualification, processing, and cryopreservation of cord blood units.
FACT-NetCord accreditation is the result of major efforts previously invested by the HLA laboratory to obtain ISO 15189 accreditation in 2009 and ASHI accreditation in 2010. In 2008, senior management at Héma-Québec decided to begin the process of obtaining FACT-NetCord accreditation. A team that included staff from the Stem Cell Donor Registry and the Stem Cell Laboratory, supported by Héma-Québec’s Quality and Standards team, was mandated to pilot this project. This working group began its assignment with a thorough review of all steps of the cord blood banking process―from the registration of future donor mothers to product distribution―to ensure that each step met the standards. The team then implemented all the necessary changes and adjustments.
Adding to the challenges facing the team, the FACT-NetCord accreditation process occurred at the same time the bank was experiencing a major increase in enrollments and in volume of processed products. The installation of a computer system to manage all of the CBB’s activities also added to this hectic period. Facing so many challenges at one time had a silver lining, though. To configure the chosen computer system, Héma-Québec brought together a multidisciplinary team of not only information technology staff but also quality assurance and accreditation specialists, who kept a constant eye on compliance with the Cord Blood Standards.
It is worth mentioning that throughout the process, great support was provided by our accreditation coordinator and that communication with FACT personnel and the inspection team was constructive. With FACT-NetCord accreditation, Hema-Quebec benefits from international recognition and, with personnel serving as FACT inspectors, from the practices of other cord blood banks.
For more information, contact the Héma-Québec Media Line at 514-832-0871.
Disclaimer: The opinions expressed here are solely the views of the writer and do not necessarily reflect the views and opinions of the Foundation for the Accreditation of Cellular Therapy.
University of Utah Blood and Marrow Transplant Program
About the University of Utah Blood and Marrow Transplant Program
The University of Utah Blood and Marrow Transplant Program began at the University Hospital in Salt Lake City in 1990. Since that time the program has continued to grow in scope and currently performs transplants for several other institutions including Primary Children’s Medical Center and Huntsman Cancer Institute. The 3 institutions each have inpatient and outpatient units. A single stem cell laboratory provides services for these programs as well as Intermountain Health Care Transplant Program. In total the programs perform approximately 300 transplants per year, equally distributed between autologous and allogeneic.
Our program has been FACT accredited for over 10 years, representing multiple accreditation cycles. Our approach to the initial accreditation was somewhat disjointed, lacking a single team leader. The 3 distinct areas (clinical, collection, laboratory) worked somewhat independently to implement the standards and gather documentation. We underestimated the time frame and scurried in the final weeks before the inspection to put everything in place. The inspection went well, however, and we were able to identify bottlenecks to help us streamline the process for future inspections. A year prior to the second accreditation process, a team was established that met monthly and then weekly as the inspection date neared. This approach allowed for a more effective preparation process, however, several areas in the standards were identified in which we had been unable to keep updated, specifically standard operating procedures review, quality assurance, and document review. To address these issues, the program created a full-time position for a Quality Assurance Manager for the clinical and collection programs. Designated quality assurance individuals had already been assigned for the laboratory. Currently, compliance issues are addressed on an ongoing basis, minimizing last minute planning, and enhancing the overall quality of the program.
There is program-wide support, from the top down, to comply with FACT Standards and maintain accreditation. FACT accreditation is recognized as a measure of the quality of our program by all faculty, staff, and administrators.
Key points to consider:
Secure support from Program Leaders and Administrators
Designate a full-time Quality Assurance Manager
Commit to compliance on a daily basis
Identify program bottlenecks and work on real solutions
