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Thank You!
Thank you for volunteering your time and expertise as a FACT inspector! Your contributions are critical to promoting FACT’s mission to improve the quality of cellular therapy. We hope you enjoy your experiences: educating and learning from other organizations, networking, traveling, and advancing the field. This Inspector Handbook provides tips in an easy-to-read format and shares the guidelines and wisdom that inspectors and accredited organizations have developed since the inception of FACT.
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Mission & Purpose
FACT’s mission is to improve the quality of cellular therapy through peer-developed standards, education and accreditation for the benefit of patients. We believe a voluntary organization of practicing professionals is best positioned to improve patient care and foster development of the cell therapy field through quality standards and accreditation. This accreditation process must assess both clinical and laboratory practices to include all aspects of cellular therapy, from donor evaluation and selection to patient administration and follow-up.
FACT has been fortunate to recruit excellent inspectors who have undertaken this vital task on a voluntary basis. Without these outstanding individuals, it would be impossible for FACT to experience such success with an excellent reputation.
This handbook is a resource for inspectors, providing a brief background on FACT and practical tips for the inspection and accreditation process. Most of this information comes from the advice of current FACT inspectors and accredited organizations. The collective knowledge of those who have participated in FACT processes provides valuable insight into what contributes to an effective and positive inspection experience.
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History
FACT is a non-profit corporation co-founded in 1996 by the American Society for Blood and Marrow Transplantation (ASBMT) and the International Society for Cellular Therapy (ISCT) to administer a voluntary inspection and accreditation program in the field of hematopoietic progenitor cell (HPC) transplantation. The first edition of FACT Standards was published in this same year.​
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In 2000, recognizing the global impact of cord blood banking and transplantation, FACT partnered with the International NetCord Foundation to develop international standards for cord blood collection and banking. NetCord is an international network of non-profit public cord blood banks created to promote the establishment of high quality cord blood units through study and research worldwide.
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In 2006, FACT jointly published its hematopoietic cellular therapy standards with the Joint Accreditation Committee – ISCT & EBMT (JACIE) to expand its scope to an international scale. JACIE was founded by the European Group for Blood and Marrow Transplantation (EBMT), the leading scientific organization involved with cellular transplantation in Europe and ISCT, a global association driving the translation of scientific research to deliver innovative cellular therapies to patients. JACIE administers a parallel accreditation program and collaborates on international initiatives.
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Today, FACT provides three core services: standards development, accreditation, and education applicable to HPC transplantation, cord blood banking, and other cellular therapies (e.g. immune effector cellular therapy and regenerative medicine). The most remarkable point about FACT’s reputation as the pinnacle of quality in cellular therapy is that it is completely driven by those in the community. FACT’s Board of Directors, committee members, and inspectors are all volunteers from accredited programs. These practicing professionals set the requirements for the field, inspect each other, educate each other, and encourage each other to improve. In an increasingly competitive world, the FACT international community can be proud to say that we are all helping each other. This spirit of collaboration is what truly benefits patients.
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Standards
FACT accredits facilities under four sets of international standards.​
FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration
Applies to hematopoietic progenitor cell transplantation. The requirements apply to all phases of collection, processing, storage, and administration of these cells. For cells collected from umbilical cord and/or placental blood, these Standards apply only to the administration of the cord blood unit.
NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration
Applies to facilities and individuals performing donor recruitment and eligibility determination and cord blood collection, processing, testing, cryopreservation, storage, banking, listing, search, selection, reservation, release, and distribution. They include requirements for cord blood units intended for unrelated and related use.
FACT Common Standards for Cellular Therapies
Promotes quality medical and laboratory practice in a broad range of cellular therapies. The Standards represent the basic fundamentals of cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials. These Standards apply to cells collected from non-hematopoietic sources (e.g., adipose tissue) and cells collected from hematopoietic sources for non-homologous use (e.g., mesenchymal stromal cells for cardiac repair).
FACT Standards for Immune Effector Cells
Applies to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines. The scope of the Standards includes donor selection and management, administration of cells, management of adverse events, and evaluation of clinical outcomes. These Standards are intended to be flexible to accommodate various models of patient care and use of cellular therapy products.
FACT Standards are developed by international teams of experts in the field of cellular therapy and cord blood banking. The Standards Committee sets these requirements by consensus, believing that these at a minimum must be met to achieve quality programs. Standards are updated every three years based on the rapidly evolving field; feedback from inspectors, committees, and staff; and input from related organizations.
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Accreditation
Accreditation is awarded after successful documentation of compliance with the current Standards. Applicants prepare by confirming their eligibility, reviewing the applicable Standards, and establishing compliance with those requirements. To initiate the accreditation process, applicants submit an online eligibility application to the FACT Office. Once an eligibility application has been submitted and is approved by FACT, organizations have 12 months from approval to complete the compliance application. Compliance is determined by evaluation of written documents provided by the applicant organization and observations from an on-site inspection.
Central to all of these efforts is verification of compliance with the Standards by the FACT inspectorate. On-site inspections are carried out by a team of inspectors who are qualified by education and experience, have completed inspector training requirements, and have a working knowledge of the applicable Standards.
As a member of the
FACT inspectorate, you are the face of FACT. FACT inspectors may be all that Applicant personnel ever see of our organization. Conversely, FACT relies on its inspectorate to evaluate compliance with the Standards and to represent its mission.
