Today’s standardization… is the necessary foundation on which tomorrow’s improvement will be based. If you think of ‘standardization’ as the best you know today, but which is to be improved tomorrow… you get somewhere. But if you think of standards as confining, then progress stops. Henry Ford Today and Tomorrow (originally printed 1926) (Productivity Press, 1988)
The Standards are the cornerstone of the JACIE accreditation program. Believing that quality care can only be achieved if both clinical and laboratory issues are effectively addressed, the FACT-JACIE Standards are the only set of requirements that include both clinical and laboratory practices. The Standards currently apply to Hematopoietic Progenitor Cells (HPC) obtained from bone marrow, peripheral blood, and umbilical cord blood.
FACT-JACIE Standards are evidence-based requirements set by international teams of world-renowned experts vested in the improvement and progress of cellular therapy. Standards are developed by consensus within committees consisting of knowledgeable clinicians, scientists, technologists, and quality experts that span the entire continuum of cell manufacturing. International leaders in cellular therapy programs, cord blood banks, and registries serve on the Standards Development Committees. Liaison representation from consumers and regulatory bodies are consulted throughout the development process. This results in detailed, comprehensive Standards that address every aspect of cell manufacturing and administration that impacts the quality of products and therapeutic care.
The Standards are based upon published medical evidence whenever possible. When published data is not available, requirements are based upon accepted scientific theory. The development process includes a period for public review and comment, legal review, and approval by the respective FACT and JACIE Boards.
The 6th edition of the Standards were published on 1 March 2015.
The documents can be downloaded from from the 'Standards' section in the Document Centre.
Edition 6.01 was published on 2 February 2017 to incorporate standards for administration of immune effector cells.
These Hematopoietic Cell Therapy Standards apply to hematopoietic progenitor cells, defined as self-renewing and/or multi-potent stem cells capable of maturation into any of the hematopoietic lineages, lineage-restricted pluri-potent progenitor cells, and committed progenitor cells from hematopoietic sources (bone marrow, umbilical cord blood, peripheral blood, or other tissue source). These Standards also include mononuclear cells, defined as nucleated cells from any hematopoietic tissue source (marrow, peripheral blood, umbilical cord, and placental blood) collected for therapeutic use other than as hematopoietic progenitor cells.
PART A TERMINOLOGY, TENETS, ABBREVIATIONS, AND DEFINITIONS
PART B CLINICAL PROGRAM STANDARDS
B2 Clinical Unit
B4 Quality Management
B5 Policies and Procedures
B6 Allogeneic and Autologous Donor Selection, Evaluation, and Management
B7 Recipient Care
B8 Clinical Research
B9 Data Management
PART CM MARROW COLLECTION FACILITY STANDARDS
CM2 Marrow Collection Facility
CM4 Quality Management
CM5 Policies and Procedures
CM6 Allogeneic and Autologous Donor Evaluation and Management
CM7 Coding and Labeling of Cellular Therapy Products
CM8 Process Controls
CM9 Cellular Therapy Product Storage
CM10 Cellular Therapy Product Transportation and Shipping
CM12 Direct Distribution to Clinical Program
PART C APHERESIS COLLECTION FACILITY STANDARDS
C2 Apheresis Collection Facility
C4 Quality Management
C5 Policies and Procedures
C6 Allogeneic and Autologous Donor Evaluation and Management
C7 Coding and Labeling of Cellular Therapy Products
C8 Process Controls
C9 Cellular Therapy Product Storage
C10 Cellular Therapy Product Transportation and Shipping
C12 Direct Distribution to Clinical Program
PART D PROCESSING FACILITY STANDARDS
D2 Processing Facility
D4 Quality Management
D5 Policies and Procedures
D6 Equipment, Supplies, and Reagents
D7 Coding and Labeling of Cellular Therapy Products
D8 Process Controls
D9 Cellular Therapy Product Storage
D10 Cellular Therapy Product Transportation and Shipping
D11 Distribution and Receipt
APPENDIX I Minimum Number of New Patients for Accreditation
APPENDIX II Cellular Therapy Product Labeling
APPENDIX III Cellular Therapy Product Labels for Shipping and Transport on Public Roads
APPENDIX IV Accompanying Documents at Distribution
APPENDIX V Changes to Sixth Edition Standards