FACT INSPECTOR CATEGORIES
CLINICAL CELLULAR THERAPY PROGRAM
Inspector must be a licensed physician and have a minimum of two years experience in cellular therapy product administration.
APHERESIS CELLULAR THERAPY PRODUCT COLLECTION FACILITY
Inspector must have a relevant doctoral (M.D. or Ph.D.), nursing, or biological science degree and have completed formal fellowship training in apheresis or at least one year experience in peripheral blood progenitor cell collection by apheresis as the director, physician, nurse, technician supervisor, or assistant supervisor.
BONE MARROW COLLECTION FACILITY
Inspector must be qualified as either a clinical program inspector or an apheresis collection facility inspector. Inspections of the marrow collection facility performed by personnel without a doctoral degree will be performed in conjunction with the M.D. inspecting the clinical and/or facilities of the same program.
CELLULAR PROCESSING FACILITY
Inspector must hold a relevant doctoral (M.D. or Ph.D.), biological science, or medical technologist degree [B.S, M.T. (ASCP or AMT), CLS (NCA), SBB, etc.] and have at least two years experience as a Processing Director, Medical Director or Supervisor of a Cell Processing Facility.
CORD BLOOD BANK INSPECTOR
Inspector must hold a relevant doctoral (M.D. or Ph.D.) degree and have five years experience in cord blood banking and/or transplantation; or be an active FACT clinical and/or bank inspector experienced with cord blood transplantation.
CORD BLOOD BANK COLLECTION FACILITY
Inspector must hold a relevant doctoral (M.D. or Ph.D.), nursing, or biological science and have at least one year experience as the director or supervisor of a CBB; or be an active FACT clinical and/or collection inspector of a cellular therapy program. JACIE Inspectors are also qualified to inspect CBB collection facilities.
CORD BLOOD BANK PROCESSING FACILITY
Inspector must hold a relevant doctoral (M.D. or Ph.D.), biological science, or medical technologist degree [B.S, M.T. (ASCP or AMT), CLS (NCA), SBB, etc.] and have at least two years experience as a Processing Director, Medical Director, or Supervisor of a Cell Processing Facility or Cord Blood Bank. JACIE Inspectors are also qualified to inspect CBB processing facilities.