Must have banked 500 cord blood (CB) units prior to inspection.
Must be actively collecting and banking.
Must be registered or accredited, and the CB unit licensed, as required by the appropriate governmental authority for the activities performed.
Must have a Cord Blood Bank (CBB) Director, a CBB Medical Director, a CB Collection Director, a CB Processing Facility Director, and a Quality Unit Manager. The Quality Unit Manager must be a different individual from the directors.
The CBB Director must:
Have a doctoral degree in medicine or in a related scientific field.
Have training and a minimum of two (2) years of experience in immunogenetics of transplantation, basic or clinical immunology, immunohematology, basic or clinical hematology, transfusion medicine, blood or tissue banking, or cryobiology.
The CBB Medical Director must:
Have a current medical license.
Have training in hematopoietic cell transplantation or blood or tissue banking.
Must use coding and labeling technologies using ISBT 128 or Eurocode.
Must meet or exceed all current NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration.
Banks that conduct business in a language other than English must translate a minimal set of documents into English prior to the on-site inspection. Refer to the Document Submission Requirements form for cord blood banks.
