Storage areas for blood components must operate within a specified temperature range and should provide adequate space and suitable lighting, and be arranged and equipped to allow dry, clean and orderly storage.
Good manufacturing practice requires that components of different status are appropriately identified and effectively separated.
Recognised status categories are noted below.
Procedures should ensure that untested components are not quarantined with components which have produced, or are likely to produce, repeatably reactive results in mandatory microbiological screening tests.
Secure and exclusive quarantine storage should be available for known biohazard material awaiting disposal (see section 6.8.2).
Components which do not comply with the specification for mandatory tests or are otherwise unsuitable for transfusion should be categorised as non-conforming. Normally, such components would be discarded. However, if they are to be issued for therapeutic, reagent or research use, a concessionary release procedure must be used (see section 6.10).
Components that have been returned from areas outside the direct control of the blood supplier should not normally be returned to stock.
Components that have been returned to the blood supplier with substantive evidence that they have been stored appropriately and within specification, should be held securely pending possible reinstatement to stock by a designated person.
Only those components which have been deemed satisfactory for issue by a designated person should be held in stock (see section 6.9).
Appropriate security and status labelling of component storage areas are essential.
A current inventory should be maintained of components in each storage category/area.
Areas/equipment in which components are to be stored should be validated before their introduction into routine use and checked for calibration to a documented schedule thereafter.
A permanent, continuous record of storage temperatures should be made, reviewed and stored. There should be a log of alarm events that describes the corrective actions taken.
Written procedures must be established for the storage of blood components. These should include the following: