Draft Netcord-FACT International Standards for Cord Blood
The Foundation for the Accreditation of Cellular Therapy (FACT) has published the draft eighth edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration for public comment through September 15, 2023.
These comprehensive Standards promote quality medical and laboratory practices throughout all phases of cord blood collection, processing, and banking to consistently achieve quality placental and umbilical cord blood units for administration and to improve patient outcomes. These Standards are applicable to both unrelated donor units and family units and cover 1) collection of cord blood cells, regardless of the methodology or site of collection; 2) screening, testing, and eligibility determination of the maternal and infant donor according to Applicable Law; 3) all phases of processing, cryopreservation, and storage; 4) testing and characterization of the cord blood unit; 5) making the cord blood unit available for administration, either directly or through listing with a search registry; 6) the search process for selection of specific cord blood units; 7) reservation and release of cord blood units for clinical use; 8) transport or shipment of fresh or cryopreserved cord blood units; and 9) clinical follow up. The final Standards will be published in December 2023.
The purpose of this public comment period is to receive your comments and suggestions on this edition of the Standards. The published draft is a redline document intended to highlight the significant changes. Some changes are new standards; however, others are intended to clarify rather than change the intent, or to provide consistency with other sets of FACT Standards. Minor reorganization and clarifications are not tracked.
Instructions for Submitting Public Comments
To review the draft eighth edition of NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, go to Draft Eighth Edition Cord Blood Standards. Comments will be accepted through September 15, 2023
1. Access the comment form at Cord Blood Public Comments Survey.
2. Enter your contact information and comments on the form. Complete all fields to ensure the Standards Committee fully understands your position. Responses are divided into five parts.
3. Submit the form when you are finished. After the form has been submitted, it cannot be changed. However, additional comments may be submitted by completing another comment form. There is no limit to the number of forms that can be submitted.
If you have any questions, please contact Monique Summers, FACT Standards Development Manager at firstname.lastname@example.org or 402-920-7010.