Temperature Monitoring of Approved Storage Units

Storage units approved for storage of blood or blood components at the facility must be equipped with a system that monitors continuously and records temperatures at least every 4 hours and with an alarm that sounds if temperature limits are reached.

The facility must notify Vitalant within 24 hours of any occurrence of temperature deficiencies in the storage of blood and blood components and agrees not to return units subjected to temperatures outside the required ranges, unless approved for return by Vitalant.

Documentation of storage temperatures may be required during inspections by regulatory agencies.

• Blood component receipt temperature must be documented.
• Blood and blood products must be stored in approved and labeled storage areas/units.
• Store in an orderly fashion to prevent crowding and to allow air circulation.
• Do not store quarantined components above other components.
• Do not store reagents above blood components.
• Do not overlap platelet bags during storage.
• Store red cells to allow visual observation of hemolysis at the red cell interface.
• Segregate autologous components from allogeneic components.
• Vitalant boldly labels autologous components with positive test results as Biohazardous and may ship such units in special Biohazardous shipping containers. Biohazard-labeled autologous components should be kept segregated from other non-biohazardous autologous components.
• When released to another department, blood components must be maintained within appropriate storage temperatures or returned to proper storage within a specified time if storage is not available and the component is not transfused.

Storage Unit Failures

In the event of a storage unit failure, components must be moved to appropriate alternative storage. If alternative storage is not available with a temperature monitoring system that alarms for out-of-range temperatures, contact Vitalant Hospital Services to discuss alternative storage at Vitalant, the use of Vitalant shipping containers as alternative storage or other suitable solutions.

Please contact your local blood supplier for proper packing instruction for alternative storage.