Last year was a big one for FACT. While celebrating our 25th anniversary, we committed to remaining a stalwart supporter of quality cellular therapy by adjusting our processes to overcome challenges caused by COVID-19 and announced our independence from the University of Nebraska Medical Center (UNMC) after a 25-year relationship. Read on for a review of a fantastic year!
FACT Began Virtual Inspections in Response to the COVID-19 Pandemic
Following a pause in on-site inspections due to the COVID-19 pandemic, FACT re-initiated accreditation renewal inspections virtually in 2021. By all accounts, the virtual inspections have been successful. The applicant programs were well prepared, the processes were generally effective, inspectors were able to verify compliance with Standards, and both inspectors and program staff continued to learn throughout the process. Although initially developed for virtual inspections, some changes to submission requirements will continue to be part of the accreditation process moving forward. FACT greatly appreciates the hard work of the inspectors and applicants as we transitioned through this challenging time. FACT intends to return to on-site inspections when it is safe and possible to do so.
FACT Announced Plan for Embracing Continued Growth of Organization
In the midst of tremendous growth, FACT announced its plan to pursue independent operational status by the end of 2021. FACT has responded to progress and advancements in cellular therapy during its storied 25-year relationship with the University of Nebraska Medical Center, and future opportunities for the organization motivated the FACT Board of Directors to make this change. As an independent non-profit organization, FACT will have greater freedom to operate in a manner that allows it to rapidly and nimbly make changes as needed to pursue its mission to improve the quality of cellular therapy through peer-developed standards, education, and accreditation for the benefit of patients.
FACT Celebrated its 25th Anniversary
In 2021, FACT celebrated 25 years of working with our colleagues in the field to improve cellular therapy, cord blood banking, and regenerative medicine. Congratulations to all of FACT’s volunteer inspectors, committee members, leadership, accredited organizations, staff, and supporters for making this milestone possible. Although celebratory events were not possible due to the ongoing need for social distancing, the anniversary was celebrated via the virtual workshops, gifts of appreciation to FACT volunteers, and a 25th Anniversary Guest Book.
FACT and JACIE Published the Eighth Edition Hematopoietic Cellular Therapy Standards
The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and its accompanying Accreditation Manual were published on May 17, 2021. The Standards became effective on August 16, 2021.
The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.
The Standards Committee consists of 64 expert members among a Steering Committee and five subcommittees that reviewed clinical, collection, processing, quality, and IEC requirements. These members reside in 14 countries, contributing a truly international perspective to the Standards. Following months of initial reviews and revisions, the committee considered approximately 770 comments, submitted by 78 participants from 20 countries, during the public comment period.
Two Members Appointed to FACT Board of Directors
Two members representing one of FACT’s parent societies, the American Society for Transplantation and Cellular Therapy (ASTCT), joined the FACT Board of Directors for three-year terms (2021-2023). Navneet S Majhail MD, MBBS, MS is the Program Director of FACT-accredited Cleveland Clinic Blood and Marrow Transplant Program. Dr. Majhail served as ASTCT’s President from 2019-2020, and FACT benefits from his continued leadership in this new capacity. Eneida Nemecek, MD is a FACT inspector from FACT-accredited Northwest Marrow Transplant Program at Oregon Health & Science University, Legacy Good Samaritan Hospital and Medical Center and Doernbecher Children’s Hospital. She also serves on FACT’s Clinical Outcomes Improvement Committee.
FACT Inspection & Accreditation Virtual Workshop and FACT-ASTCT Quality Boot Camp Drew Record Attendance
FACT held its second virtual Inspection & Accreditation Workshop on February 4, 2021 and first virtual FACT-ASTCT Quality Boot Camp on February 5, 2021. Over 300 individuals joined each of the live events resulting in record attendance for both the workshop and the boot camp. We express our gratitude to our workshop chairs, Dr. Dennis Gastineau and Dr. Jean Sanders; our boot camp chairs, Dr. Kimberly Kasow and Therese Dodd; the FACT Education and Quality Management committees; our fabulous presenters and facilitators; and, of course, our attendees for their abundance of energy and enthusiasm.
Eighth Edition NetCord-FACT Cord Blood Banking Standards Development Began
The eighth edition of the NetCord-FACT Cord Blood Banking Standards is officially in development under the leadership of FACT’s new Standards Committee Chair, Dr. Nicole Prokopishyn. The Cord Blood Standards Steering Committee kicked off the process on April 22, 2021.
FACT Joined International Organizations to Renew Support of ISBT 128 Coding and Labeling
In light of continuing adaptation to accommodate the rapidly expanding cellular therapy field, FACT joined 14 other organizations to issue a consensus statement reaffirming its support of ISBT 128 as the global standard for terminology, coding, and labeling of cellular therapy products. With a growing list of stakeholders and cellular therapy products, real-world experiences highlight the importance of standardized terminology, globally unique identifiers, and internationally readability to protect patient safety.
FACT Participated in Multistakeholder Efforts to Advance Cellular Therapies
FACT continues to participate in several multistakeholder groups to advance cellular therapies. FACT representatives are members of groups conducted by the Standards Coordinating Body (SCB), Parenteral Drug Association (PDA), and Deloitte NextGen Industry Working Group (IWG). FACT also participated in events such as the NMDP/Be the Match AcCELLerate Summit and the 80/20 Task Force Workshop of ASTCT. Planning also began for the third FACT Regenerative Medicine InterCHANGE, which took place in January 2022.
Hospital Privado Universitario de Córdoba, Programa de Trasplante de Médula Ósea in Córdoba, Argentina was the first to earn a Certificate of Completion for Step One under the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Stepwise Accreditation Program in May 2021. FACT and the Joint Accreditation Committee of ISCT-EBMT (JACIE) established the stepwise approach to globally improve hematopoietic cellular therapy and make transplantation accessible to patients. The FACT-JACIE Stepwise Accreditation Program aims to improve the quality and safety of bone marrow transplantation in lower-middle-income economies (LMIE) through compliance with established standards; creating a framework for quality management, education, and training; and providing a stepwise process towards full FACT-JACIE accreditation.