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

22.12: Labelling, packaging, transportation and temperature controls

The requirements for these are described in the HTA’s Guide to Quality and Safety Assurance for Human Tissue and Cells for Patient Treatment, FACT-JACIE Standards and NetCord-FACT Standards and the requirements for labelling are summarised in Tables 22.2 and 22.3.

 

Table 22.2 Label content adapted from FACT-JACIE

Element Partial label Label at completion of collection Label during processing Label at completion of processing Label at distribution Inner and outer shipping container

Unique identifier of product

AF

AF

AF

AF

AF

 

Proper name of product

AF

AF

AF

AF

AF

 

Recipient name and identifier

AF (if applicable)

AF (if applicable)

AF (if applicable)

AF (if applicable)

AF (if applicable)

 

Date, time collection ends and (if applicable) time zone

 

AF

 

AC

AC

 

Approximate volume

 

AF

 

AC

AC

 

Name and volume or concentration of anticoagulant and other additives

 

AC

 

AC

AC

 

Donor identifier and (if applicable) name

 

AF

 

AT

AT

 

Identity and address of collection facility or donor registry

 

AC

 

AC

AC

 

Recommended storage temperature

 

AT

 

AT

AT

 

Biohazard label

 

AC (if applicable)

 

AC (if applicable)

AC (if applicable)

AC (if applicable)

Identity and address of processing facility

 

 

 

AF

AF

 

ABO and Rh of donor

 

 

 

AC

AC

 

Red blood cell compatibility testing results

 

 

 

AC

AC (if applicable)

 

Statement ‘Properly identify intended recipient and product’

 

 

 

AC

AC

 

Statement ‘Warning; this product may transmit infectious agents’

 

 

 

 

AF

AF

 

Expiration date

 

 

 

AF (if applicable)

AF (if applicable)

 

Expiration time

 

 

 

AF (if applicable)

AF (if applicable)

 

Statement ‘For autologous use only’ or


Statement ‘For use by intended recipient only’

 

 

 

AF (if applicable)


AF (if for allogeneic recipient)

AF (if applicable)


AF (if for allogeneic recipient)

 

Statement ‘Do not irradiate’

 

 

 

AT

AT

 

Statement ‘Not for infusion’ including reason

 

 

 

AT (if applicable)

AT (if applicable)

 

Name and address of receiving institution

 

 

 

 

 

AT

Name and telephone number of contact person at receiving institution

 

 

 

 

 

AT

Statement ‘Medical specimen’

 

 

 

 

 

AT

Statement ‘Do not X-ray’

 

 

 

 

 

AT

Name, address and telephone number of shipping facility

 

 

 

 

 

AT

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