Standards 5.1.8.2.1 says that portable coolers must be validated. Our hospital has policies and procedures that define what constitutes storage and what constitutes transport. My question is this: How often should these portable coolers be validated? Is this something that our institution can define as well?

Just remember - the FDA also has defined transport and storage. If you store blood in your coolers out of the blood bank they have to meet the 1-6C temp for storage NOT the 1-10C for transfport.

I don't think there is guidance as to how often you perform this. In terms of validation, that is done when something is new or changed. Otherwise you are doing verification. We do our cooler verification twice a year...summer and winter. You could do them quarterly like the refrigerators. Quarterly seems to be popular for most equipment checks.

Just remember - the FDA also has defined transport and storage. If you store blood in your coolers out of the blood bank they have to meet the 1-6C temp for storage NOT the 1-10C for transfport.

Thanks for the info David - I actually didn't know this. Would you happen to know where in the CFR this is mentioned?

Jason Hunn, MT(ASCP)SBB

Thank You adiecast!

They don't specifically mention coolers - I contacted my CSO a few months ago when this was a hot topic on this website. That was the response I received. If you use coolers to transport your blood to the OR and then transfer it to a ref then that is transport . . . if the blood stays in the cooler at the site, that is storage.

Thanks for the info David - I actually didn't know this. Would you happen to know where in the CFR this is mentioned?

Jason Hunn, MT(ASCP)SBB

At a large University Trauma center where I worked we verified our cooler validation temps annually.

I just had an AABB Assessment and was told that cooler validations should be performed annually.

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You didn't happen to get a standard # to reference that did you? Many inspectors interject their own interpretation which may or may not bevalid.

I just had an AABB Assessment and was told that cooler validations should be performed annually.

:juggle::juggle::juggle::juggle::juggle:

Sorry David, I don't recall him giving me a reference. By the time we got to that point, I had a massive stress headache and could have missed it.

Karen