Cord Blood Standards

The major objective of the NetCord FACT Standards is to promote quality medical and laboratory practices throughout all phases of cord blood banking to achieve consistently high-quality cord blood units available to patients for lifesaving treatments. This new edition places emphasis on the minimum standards for both family banking and the procurement of units for unrelated donor use. They comprehensively cover all aspects of cord blood banking: donor selection, cell collection, processing, and release for administration.

Cord Blood Accreditation Process Requirements

The Crosswalk between the 7^th Edition and 8^th Edition is included in the Eighth Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration.

These Standards apply to cord blood units intended for unrelated allogeneic use and to related units collected and stored for allogeneic or autologous use by a donor family. All phases of cord blood collection, banking, and release for administration are included:

• Donor management, including screening, testing, and eligibility determination of infant and maternal donors
• Collection, regardless of the methodology or site of collection
• Processing
• Testing and characterization of the unit
• Cryopreservation
• Storage
• Listing, either directly or through a search registry
• Search, selection, and reservation
• Release
• Distribution to clinical programs, whether fresh or cryopreserved

These Standards only apply to umbilical cord tissue as it relates to samples for testing. Storage of umbilical cord tissue for therapeutic intent is covered under the FACT Common Standards for Cellular Therapies. Standards for the administration of cord blood cells, either allogeneic or autologous, are covered in the Clinical Program section of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration.

These Standards were developed by consensus, based on the best available evidence-based science, placing emphasis on research findings related to clinical outcomes of cord blood recipients. Cord blood banking is an emerging and evolving field. For those areas where there are little or no definitive data on clinical outcomes relating to a particular standard, the Standards Committee weighed the available evidence from preclinical studies and accepted scientific theory.

Previous Edition

Seventh Edition

• Seventh Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration
• Seventh Edition NetCord-FACT Accreditation Manual
• Summary of Changes to Seventh Edition Standards
• NetCord-FACT Sixth to Seventh Edition Crosswalk
• NetCord-FACT Seventh to Sixth Edition Crosswalk
• CB Self-Assessment Tool, Seventh Edition
• CB OneNote Self-Assessment Tool, Seventh Edition
• Document Submission Requirements Seventh Edition – Cord Blood