JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

22.13: Release

Prior to HPCs being cleared for issue, all relevant records, including donor records, processing and storage records, and post-processing quality control tests must have been reviewed, approved and documented as acceptable by the individual(s) responsible according to the relevant local standard operating procedures. Responsibility for setting policies for exceptional release and for issuing products on concession resides with the medical director/advisor.

Records must demonstrate that before cells are released the product specification is met and verified according to a written procedure by a person authorised by the Designated Individual.

For clinical use of a product that has not met its specification, exceptional release-specific authorisation must be given by the facility medical director or designee.

For cord blood donations release occurs at two stages:

  • Following completion of testing and donor selection when donations are formally banked and made available for search.
     
  • At issue for transplantation.

Table 22.3 Label content for HPC-C adapted from NetCord-FACT

Label element

Partial label

Label at completion of collection

Shipping container labelling for transport from collection

Label at completion of processing

Label at cord blood unit release

Dry shipper labelling at issue

Unique numeric or alphanumeric identifier

AF

AF

 

AF

AF

 

Proper name HPC, Cord Blood

AF

AF

AF

AF

AF

 

Product modifiers

 

 

 

AC

AC

 

Statement ‘Directed donor’ (directed allogeneic and autologous HPC-C units)

AF

AF

 

AF

AF

 

Collection centre identifier

 

AF

AT

 

 

 

Date of collection

 

AF

 

AC

AC

 

Time of collection

 

AC

 

 

 

 

Name and volume or concentration of anticoagulant and other additives

 

AF

 

AC

AC

 

Recommended storage temperature

 

AT

 

AF

AF

 

Donor name (directed allogeneic and autologous HPC-C units)

 

AF

 

AF

AF

 

Recipient’s name, unique identifier or family (directed allogeneic and autologous HPC-C units) – if applicable

 

AF

 

 

AF

 

Volume or weight of the HPC-C unit at the end of collection

 

 

 

AC

AC

 

Volume or weight of the HPC-C unit at the end of processing

 

 

 

AC

AC

 

Date of cryopreservation

 

 

 

AC

AC

 

ABO group and Rh type

 

 

 

AC

AC

 

HLA phenotype

 

 

 

AC

AC

 

Number of nucleated cells post-processing

 

 

 

AC

AC

 

Gender of HPC-C infant donor

 

 

 

AC

AC

 

Identity of the cord blood bank

 

 

 

AF

AF

 

Statement ‘Properly identify intended recipient and product’

 

 

 

 

AT

 

Statement ‘For use by intended recipient only’ (allogeneic HPC-C units)

 

 

 

 

AT

 

A statement indicating that leucoreduction filters should not be used

 

 

 

 

AT

 

Statement ‘Do not irradiate’

 

 

 

 

AT

 

Statement ‘For non-clinical use only’ (if applicable)

 

 

 

 

AT

 

Biohazard labels – if applicable

 

AF

AF

AT

AT

 

Date of distribution

 

 

 

 

AC

AF

Shipping facility name, address, telephone number

 

 

AF

 

 

AF

Receiving facility contact details

 

 

AF

 

 

AF

Identity of person or position responsible for receipt of shipment

 

 

AF

 

 

AF

Statement ‘Do not X-ray’

 

 

 

 

 

AF

Statement ‘Medical specimen’, ‘Handle with care’

 

 

 

 

 

AF

Statement indicating HPC-C for transplantation

 

 

 

 

 

AF

Shipper handling instructions

 

 

 

 

 

AF

AF = affixed, AT = attached or affixed, AC = ccompanying or attached or affixed