Release of Cord Blood Units that Do Not Meet Post-Thaw Specification Requirements
By Cathy Talmadge, FACT Accreditation Services Supervisor
The NetCord-FACT Standards define post-processing and post-thaw specifications for cord blood units. When a cord blood unit does not meet post-processing specifications, this is an issue that can be dealt with up front prior to storage. However, cases in which post-thaw specifications are not met are more challenging. At that point, the cord blood unit has likely been selected for a patient in need.
The NetCord-FACT post thaw criteria are >70% viability for CD34 cells, >40% viability for CD45 cells, growth for CFU, and verified identity. Release of a cord blood unit that does not meet this criteria requires exceptional release, a process for which FACT-accredited cord blood banks are required to have a policy or procedure (NetCord-FACT Standard B3.1.24). The policy should outline the process to take when a CB unit does not meet predetermined release criteria, including:
- Documenting and investigating the failed criteria, including documentation in the unit record, and
- Reporting the deviation to the requesting transplant program prior to distribution.
Agreements with families for private cord blood storage should outline the bank’s processes for nonconforming cord blood units, and the bank must comply with the agreement.