The FACT-NetCord Standard
The FACT-NetCord International Standards for Cord Blood Collection, Banking, and Release for Administration were developed through a partnership between the Foundation for the Accreditation of Cellular Therapy (FACT) and the NetCord international network of cord blood banks. These standards represent the highest benchmark for quality and safety in cord blood banking worldwide.
The FACT-NetCord standards provide a comprehensive framework covering every aspect of cord blood operations: maternal donor screening and consent, cord blood collection, processing and cryopreservation, testing and characterization, storage, search and selection, release and distribution, and clinical follow-up. The standards also address critical cross-cutting areas including quality management, personnel qualifications, facility requirements, and information management systems.
Accreditation by FACT-NetCord is globally recognized as evidence that a cord blood bank operates at the highest level of quality and safety. It is increasingly required by transplant centres, registries, and regulatory authorities as a condition for accepting cord blood units for clinical use. For cord blood banks, FACT-NetCord accreditation enhances credibility, facilitates international collaboration, and ultimately improves patient outcomes.
Services for Cord Blood Banks
ICMED provides cord blood banks with a tailored suite of consulting services designed to achieve accreditation efficiently and build sustainable quality systems:
- Comprehensive gap analysis: detailed assessment of current operations against all applicable FACT-NetCord standard requirements, producing a prioritized remediation roadmap
- Quality management system development: design and implementation of a complete QMS including quality manual, policies, SOPs, work instructions, and forms specific to cord blood banking operations
- Collection program optimization: review and improvement of maternal consent processes, collector training programs, cord blood collection techniques, and transport logistics to maximize unit quality and yield
- Processing and cryopreservation protocols: development of validated procedures for volume reduction, red cell depletion, cryoprotectant addition, controlled-rate freezing, and long-term cryostorage
- Testing and characterization: establishment of comprehensive testing programs including cell counts, viability assessment, sterility testing, HLA typing, and infectious disease screening
- Information management: guidance on implementing systems that ensure complete traceability from donor to recipient, data integrity, and compliance with reporting requirements
- Staff training and competency: development of role-specific training curricula and competency assessment programs aligned with FACT-NetCord requirements
- Inventory management: strategies for optimizing cord blood inventory diversity, quality thresholds, and storage capacity utilization
Accreditation
Achieving FACT-NetCord accreditation requires meticulous preparation, thorough documentation, and demonstrated compliance across all operational areas. ICMED's structured approach to accreditation maximizes the likelihood of success while minimizing disruption to ongoing operations.
Our accreditation support includes:
- Pre-inspection readiness assessment: a comprehensive review conducted well before the scheduled inspection to ensure all requirements are met and documentation is complete
- Mock inspections: realistic simulation of the official FACT-NetCord inspection, conducted by professionals with deep knowledge of the inspection process and inspector expectations
- Application preparation: assistance in completing the accreditation application, compiling supporting documentation, and addressing any pre-inspection queries from the accrediting body
- Inspection day support: guidance on logistics, staff preparation, and presentation of your quality system during the official inspection
- Post-inspection remediation: rapid and effective response to any findings or observations, including development of corrective action plans that satisfy FACT-NetCord requirements
- Re-accreditation cycles: ongoing support to maintain compliance with evolving standards, prepare for periodic re-inspections, and implement updates required by new standard editions
ICMED's goal is not just to help you pass the inspection, but to build a quality culture that sustains excellence in cord blood banking for the long term. Our experience across multiple international cord blood banks gives us unique insight into best practices and common pitfalls, enabling us to guide your bank to successful accreditation in the most efficient way possible.
