Acceptable temperature range of blood returned thru the pneumatic tube system

[dsylvest]

Hi i'm the quality specialist for my blood bank and i'm trying to determine the correct temperature range a unit of blood should be when returned from the floor at an appropriate time. My supv. claims that it must be 1-6 C and not 1-10 C that i think it should be. The supv belives that when the FDA is speaking of transported blood being between 1-10 C that they mean blood being transported outside the facility. Meaning blood transported from the blood center. I do not agree with this. We would be throwing away a ton of blood products if we follow this protocol. Any suggestions or literature?

Thanks

[SMW]

Hi i'm the quality specialist for my blood bank and i'm trying to determine the correct temperature range a unit of blood should be when returned from the floor at an appropriate time. My supv. claims that it must be 1-6 C and not 1-10 C that i think it should be. The supv belives that when the FDA is speaking of transported blood being between 1-10 C that they mean blood being transported outside the facility. Meaning blood transported from the blood center. I do not agree with this. We would be throwing away a ton of blood products if we follow this protocol. Any suggestions or literature?

Thanks

Your supervisor appears to have the correct interpretation according to the FDA. Below is from the Ask the FDA session at the 2007 AABB Annual Meeting.

"MODERATOR:

Question 16: What are the requirements for evaluating temperature of a unit of red cells returned (unopened) to the Transfusion Service? (Single units rather than units packed in a box for the operating room). Are they evaluated against storage temperatures (1-6° C) or transportation temperatures (1-10° C)?

MS. CIARALDI: What I would like to do is just start off with a little background, a little reminder of a policy that FDA has stated in the past. When red cells are stored outside the blood bank or the transfusion service, they must still be maintained at 1-6º C because they are in a storage activity. The storage usually takes place in a remote refrigerator, although this is happening less and less, a cooler or a shipping box that is qualified to maintain blood at 1-6º C for the maximum possible storage period. So immediately before, or being in a wait state before transfusion, we consider that activity to be storage and the temperature should be 1-6º C. Now in this case here, a single unit is being issued to the floor for immediate transfusion and it does not have the benefit of being transported to the floor within a cooler or a storage container or stored on the floor in a validated or qualified refrigerator. So it is issued from the blood bank or the transfusion service with the intent that it will be administered but it is not. It lays out somewhere on a nurse's stand or receptionist desk and they decide, for some reason, not to give it and it is returned to the blood bank. In this case here, the blood, while it is waiting to be transfused, is still in a storage space and it is not maintained at the required 1-6º C. So when the blood comes back down you would be evaluating whether or not it was properly stored and that would be using the 1-6º C temperature range. Now, looking into the requirements for determining the conditions under which blood can be reissued, we have a regulation, 21 CFR 640.2©. It also says, in addition to the requirement of being maintained at the proper storage temperature any blood that has been removed from a controlled storage environment may only be reissued if the container has remained sealed, the segments are properly attached and the blood has been inspected or observed for abnormal color, physical appearance or any indication of bacterial contamination. If any of these conditions are not met, the blood should not be transfused. We also have in our CFR the requirement to have SOPs and records for this process and the records should include evidence of the inspection and the results of that inspection."

[Deny Morlino]

Very timely reply. I am in the process of validating a new pneumatic tube system, and this was one of the questions I had not resolved as of yet. Thanks for the reference!