Accreditation Statistics

As of January 2, 2024

Cellular Therapy Entities

  • Accredited: 260
  • Applicants: 26

Cord Blood Banks

  • Accredited: 49
  • Applicants: 10

Congratulations to the following organizations for achieving initial FACT accreditation:

  • Houston Methodist Ann Kimball & John W. Johnson Center for Cellular Therapeutics
  • Blood Assurance
  • American National Red Cross, Salt Lake City, Utah HCT/P Program

A complete list of accredited organizations can be found at www.factglobal.org.

FACT Professional Relations Committee Collaborates on Input to Regulatory Agencies in the United States

Posted in :: 2023 Volume 7 :: Monday, December 11th, 2023

Member organizations of the FACT Professional Relations Committee have robust advocacy programs that initiate and respond to legislative and regulatory affairs around the world. They report on their activities on a quarterly basis during committee meetings. Occasionally, there are proposals for which the committee feels concerted efforts are necessary, and the member organizations collaborate to submit comments or express support. The committee worked on two such proposals in the second half of 2023. 

Support for the Life Saving Leave Act (H.R. 3024) 

Be the Match led an effort to express support for the Life Saving Leave Act (H.R. 3024), which ensures bone marrow and blood stem cell donors nationwide have up to 40 non-consecutive, unpaid hours of leave without a risk to their jobs. Most patients in need of blood and marrow transplantation have only one match on the nation’s bone marrow registry, but job-related barriers to donation can prevent patients from receiving the transplant. One of the top-cited obstacles to saying “yes” to being a donor are job-related barriers.  

Many member organizations of the Professional Relations Committee signed on to a statement of support for the Act. Via the statement, the widespread support of this bill was shared through the American Society for Transplantation and Cellular Therapy (ASTCT)’s Day on the Hill on Sept. 14. 

Read more from Be the Match 

Comments in Response to the FDA Proposed Rule on Laboratory Developed Tests 

As reported in a previous article, the Professional Relations Committee has followed efforts to change Food and Drug Administration (FDA) oversight of laboratory-developed tests (LDTs). The FDA currently practices enforcement discretion for these tests, but seeks to phase out the discretion approach and begin requiring approval under medical device regulations.  

The committee thanks everyone who participated in the request for extending the public comment period. The FDA declined this suggestion, and comments were due on December 4. Several member organizations shared their general impressions regarding the proposed rule, and then submitted individual organizational comments to the FDA.  

FACT’s comments expressed appreciation to the FDA for its commitment to public health, stated that the proposed rule broadly combines a diverse number of LDTs into a single approach, and suggested that the current proposal should be revised to apply to large-volume, mass-produced, and direct-to-consumer tests that are IVDs offered as LDTs. This is where the greatest potential risks, and the greatest potential gains, to public health are present. FACT also specifically suggested that general enforcement discretion be continued for LDTs utilized by clinical laboratories at accredited hospitals and health care systems to support the provision of hematopoietic cell transplantation and cell and gene therapy, including post-therapy monitoring tests and off-label use of FDA-approved test kits and devices. These tests are often used in urgent, life-saving situations and utilize innovative techniques to facilitate the delivery of new therapies with new side effects. Narrowing the scope of the proposed rule would mitigate risks to patient access to therapies and continue prompt intervention of side effects. This approach would substantially benefit public health while avoiding a tumultuous phaseout approach for a wide variety of tests in scale and purpose.  

Read the proposed rule 

FACT-accredited programs can rest assured that their interests are well represented; however, the specific input of individual experts cannot be understated. FACT announces situations in which it feels that diverse submissions are necessary to fully explain the impact of proposed legislation and regulations, and we encourage you to take advantage of those opportunities to influence future requirements.  


2023 Call for Committee Volunteers

Posted in :: 2023 Volume 1 :: Thursday, March 30th, 2023

Dear Colleague:

The Foundation for the Accreditation of Cellular Therapy has several committees to help FACT achieve its vision of being the premiere organization setting standards and awarding accreditation to programs in the evolving field of cellular therapy.

Considering your experience and important involvement with the FACT inspection and accreditation process, we invite you to review the charges for the committees with current vacancies and either nominate yourself or a colleague to serve as a committee member. Active inspectors receive priority consideration. All volunteers must be at a FACT-accredited organization unless otherwise specified.

Learn more about current committee descriptions, desired expertise, and expectations: FACT Committee Opportunities.

Please submit your interest in serving as a committee member by completing the Committee Volunteer Form by April 7, 2023.

Standards Committees
• Hematopoietic Cell Therapy Committee
• Immune Effector Cell Standards Committee
• Cord Blood Standards and Common Standards*

*Volunteers for Cord Blood Standards and Common Standards Committees will be solicited at the initiation of the standards development process for the next editions of those publications.

Accreditation Committees
• Cellular Therapy Accreditation Committee
• Cord Blood Accreditation Committee

Special Committees and Task Forces
• Education Committee
• Inspector Development Committee
• Quality Management Committee
• FACT-CIBMTR Data Audit Committee
• Immune Effector Cell Task Force
• Clinical Outcomes Improvement Committee
• Regenerative Medicine Task Force
• Technology Committee

The contributions of our volunteer FACT Inspectors and committee members have been invaluable and have resulted in the tremendous success of FACT. Thank you for your dedication and support of this important effort to ensure quality patient care, improve treatment outcomes, and foster continued development in the field of cellular therapy.

Sincerely,


Catherine Bollard, MD
FACT President


Linda Miller, MPA
Chief Executive Officer


FACT Professional Relations Committee Provides a Forum for Sharing Experiences in Challenging Year

Posted in :: 2020 Volume 6 :: Monday, August 24th, 2020

The cellular therapy community is well known for its spirit of collaboration. One testament to the teamwork enjoyed by the field is the FACT Professional Relations Committee. One of the purposes of this committee is to enhance communications with relevant organizations in the field. This year, 13 organizations are members, and each has nominated a representative to meet at least quarterly to discuss any issues that have captured its attention, new initiatives that might be of interest to other organizations, and requests for input or participation.

Catherine Bollard, MD, inaugural committee chair and Director for the Center for Cancer and Immunology at the Children’s National Medical Center, recently transitioned committee leadership after many years of service to Bruce Levine, PhD, Professor in Cancer Gene Therapy at the University of Pennsylvania. Dr. Levine has called special meetings throughout the COVID-19 pandemic to allow organizations to share ideas, provide updates to processes, and ask questions of each other. The benefits of these discussions were the ability to seek advice and learn from each other, communicate changes impacting cellular therapy programs to a wider audience through multiple channels, and establish some consistency among processes. Topics included, among others, training on caring for transplant patients with COVID-19, cryopreservation of unrelated allogeneic products, virtual meetings, and remote inspections.

FACT thanks the following organizations for their participation on the committee and leadership during this challenging year:

  • AABB
  • American Association for Tissue Banking (AATB)
  • American Society for Apheresis (ASFA)
  • American Society for Gene & Cell Therapy (ASGCT)
  • American Society for Histocompatibility & Immunogenetics (ASHI)
  • American Society for Transplantation and Cellular Therapy (ASTCT)
  • College of American Pathologists (CAP)
  • Cord Blood Association (CBA)
  • International Society Cell & Gene Therapy (ISCT)
  • National Marrow Donor Program (NMDP)
  • Standards Coordinating Body (SCB)
  • World Marrow Donor Association (WMDA)

New Volunteer Committee Members

Posted in :: 2019 Volume 5 :: Friday, May 17th, 2019

Annually, FACT distributes a Call for Volunteers to solicit new committee members for its Standing and Special Committees.

The FACT Board of Director strives to have a 20% turnover each year in committee membership to provide new opportunities for those interested in becoming more involved with FACT as well as to interject fresh and innovative perspectives in working groups.

It is always moving to see the numbers of volunteers willing to devote their personal time in light of increasingly busy schedules. Although there are typically not enough positions available to place all volunteers on a committee, we retain the information of volunteers to appoint to committees in subsequent years.

Following are the FACT Committees that had vacancies this year and their new members:


Education Committee

Purpose: To develop education and training programs for inspectors and for personnel at applicant and accredited facilities to promote knowledge and understanding of current standards, create awareness of commonly cited deficiencies, and promote quality in cellular therapy.

  • Nicole Acqui, MD
  • Alex Babic, MD, PhD
  • Guy Klamer, PhD
  • Yogesh Jethava, MBBS
  • Premal Lulla, MD
  • Joseph Lynch, MD
  • Huy Pham, MD, MPH
  • Priti Tewari, MD

Quality Management Committee 

Purpose: Develop and administer programs that maintain high quality in FACT’s organizational operations and in accredited programs.

    • Sylvia Dulan, RN, MSN, MBA, PMP –
    • Kris Michael Mahadeo, MD, MPH
    • Omotayo Fasan, MBBS, MRCP
    • Krista Holcomb

FACT-CIBMTR Data Audit Committee

Purpose: Coordinate the evaluation of transplant center data audits performed by FACT and CIBMTR.

    • Jaskiran Kaur, CQA(ASQ)
    • Linh Sellers, CCRP
    • Hemant Murthy, MD

Technology Committee

Purpose: Enhance, refine, streamline, and improve the efficiency of the accreditation process and educational programs through the continued improvement of Technology and FACT’s online presence.

    • Leon Su, MBA, FCAP, FASCP
    • Shanlong Jian, BS, MS
    • Federerico Rodriguez Quezada BSMT, SBB(ASCP)

The contributions of our volunteer committee members has been invaluable and  has resulted in the tremendous success of FACT. Thank you to all our volunteers for your dedication and support of FACT to ensure quality patient care, improve treatment outcomes, and foster continue development in the field of cellular therapy.


Call for FACT Volunteers

Posted in :: 2019 Volume 2 :: Tuesday, February 12th, 2019

Dear FACT Colleague:

The Foundation for the Accreditation of Cellular Therapy has several committees to help FACT achieve its vision of being the premiere organization setting standards and awarding accreditation to programs in the evolving field of cellular therapy.

In light of your experience and important involvement with the FACT inspection and accreditation process, we invite you to review the charges for the committees with current vacancies and either nominate yourself or a colleague to serve as a committee member.

Education Committee

Purpose: To develop education and training programs for inspectors and for personnel at applicant and accredited facilities to promote knowledge and understanding of current standards, create awareness of commonly cited deficiencies, and promote quality in cellular therapy.

Responsibilities:

– Attend monthly one-hour teleconference

– Develop content for workshop and webinar presentations

– Assess effectiveness of training events and recommend improvements

– Serve as a FACT workshop presenter at various meetings

– Develop content for inspector continuing education

Quality Management Committee

Purpose: Develop and administer programs that maintain high quality in FACT’s organizational operations and in accredited programs.

Responsibilities:

– Attend monthly one-hour teleconference

– Maintain and update the FACT Quality Management Handbook

– Offer a comprehensive schedule of webinars related to quality management activities

– Develop content for quality “boot camps”

– Develop quality metrics for gauging the performance of the FACT inspection and accreditation process, including effectiveness, efficiency, and customer satisfaction

FACT-CIBMTR Data Audit Committee

Purpose: Coordinate the evaluation of transplant center data audits performed by FACT and CIBMTR.

Responsibilities:

– Attend monthly one-hour teleconference

– Develop mechanisms by which CIBMTR and FACT can coordinate audits and inspections of data management processes within transplant centers

– Develop a collaborative approach to evaluate the results of FACT inspections with CIBMTR’s data audit findings to ensure a coordinated response to the transplant center

– Participate in the joint FACT-CIBMTR data review process by assessing programs’ progress on implementing corrective action plans

– Develop education and provide assistance to programs throughout the accreditation cycle to achieve quality improvement in data management

Technology Committee

Purpose: Enhance, refine, streamline, and improve the efficiency of the accreditation process and educational programs through the continued improvement of technology and FACT’s online presence.

Responsibilities:

– Attend quarterly one-hour teleconference

– Suggest ideas to enhance user’s experience using the Accreditation Portal

– Evaluate and review new portal features

– Evaluate new technologies to improve business processes

– Interface with other committees to identify data needs to develop and publish reports

– Evaluate a mobile app option for FACT’s resources such as Standards, announcements, newsletter, and education

Please submit your interest in serving as a committee member along with a description of your qualifications to Linda Miller at lmiller1@unmc.edu by March 1, 2019.

The contributions of our volunteer FACT inspectors and committee members have been invaluable and have resulted in the tremendous success of FACT. Thank you for your dedication and support of this important effort to ensure quality patient care, improve treatment outcomes, and foster continue development in the field of cellular therapy.

Sincerely,

Dennis Gastineau, MD

President

Linda Miller, MPA

Chief Executive Officer