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Ensuring Proper Storage and Temperatures for the Blood Bank

By: O.J. Bradshaw, MLS (ASCP)  

Laboratory Specialist

Posted: July 3, 2025

Your laboratory blood bank must have a defined system for storing blood and blood products, and adequate refrigerated space for its needs. The storage system includes: 

  1. Areas for available, crossmatched, quarantined, expired, autologous, and directed units. 
  2. Space for different blood types and groups. 
  3. Space that avoids contamination or exposure to hazardous materials. 
  4. A clean and orderly environment to prevent mix-ups. Expired and unacceptable blood is segregated from the routine inventory.  
  5. Space for reagents.  

Regular, documented inspection of storage temperatures for blood, blood products, and blood bank reagents is essential. Laboratories must adhere to all storage temperatures provided on the blood product label. FDA guidelines for blood and blood products storage are found at 21 CFR 610 and 21 CFR 640.  

Acceptable temperature range examples      
  • Whole blood, RBC, and thawed plasma (1-6 °C)  
  • Platelets and thawed Cryo (AHF) (20-24 °C)   
  • Fresh frozen plasma, plasma frozen within 24 hrs. after phlebotomy and Cryo (AHF) (-18°C)   
  • Most blood bank reagents (2-8 °C)  

Can reagents and RBC be stored together? Yes, but the range of the refrigerator MUST be adjusted to accommodate both. For example, packed RBC and blood bank reagents in the same refrigerator would require a range of 2-6°C to store both safely. The alarm lower limit may be 2.2°C and the upper limit 5.8°C to allow for corrective action before an unacceptable temperature is reached.    

Temperatures must be continuously monitored by a recording thermograph or central monitoring system that is checked for proper functioning at least daily. The charts or central monitoring system must be retained to document that temperatures are maintained within the FDA’s acceptable limits.  

An audible alarm should be set to activate under conditions that will allow corrective action to be taken before a low or high temperature limit is reached in the storage unit.  

The laboratory should document all corrective actions taken for any temperature deviations.  

Verification of the alarm settings for refrigerators can be done by placing the actual temperature probe in room temperature water for the upper limit check and ice water to verify the lower limit. 

The frequency of alarm checks should be based on your accreditation organization and manufacturing requirements.  

 
Best practices for storage
  • Adhere to your accreditation organization’s requirements and your organization’s policies/procedures.
  • Organize all items in storage to prevent any discrepancies.
  • Keep documentation of temperature and alarm checks readily available.
  • Verify that temperatures and alarm settings are correct.
  • Plan appropriately for a power outage or equipment downtime: An emergency generator, a continuously monitored unit, or validated coolers. (Storage units that are not continuously monitored must have temperature documentation every four hours.)
  • Platelets stored outside a continuously monitored incubator should have their temperature recorded every four hours (20-24°C).
  • Activated alarms are responded to 24/7, including weekends and holidays. If your organization is not staffed 24/7, the alarm must notify a responsible party.
  • Non-defrosting freezers and refrigerators are used.


Read more articles about Clinical Laboratory Accreditation here.