As I continue madly trying to revise procedures before CAP shows up:

Regarding the storage/shipping (whatever it is considered now) of Platelets; i.e. for Outpatient locations, OR, ER, etc. So I see reference in Shipping to keep them between 20-24C. Then on page 298 of the 16th Edition of the Technical Manual, it states that "platelets returned to inventory after 30 minutes can be returned if there is swirling."

So what I can't tell then; does it mean that "assuming they were maintained between 20-24C they can be returned if there is swirling," or are they 2 different issues: one for shipping and one for "storage" (i.e. in a cooler with appropriate coolant packs)?

We don't usually put them in a cooler inhouse, but we do for Outpatient Transfusions. I am trying them to decide whether we can accept them back after 30 mins. provided there is swirling, or whether we have to have a means of documenting that they have stayed between 20-24C in the cooler.

Thanks as always,

Brenda Hutson, CLS(ASCP)SBB

Sorry, here I am replying to my own thread again.

Looking at the Standards, it states that for Storage it must be 20-24C "with agitation." In thinking of the FDA changing the interpretation of storage, how would we maintain the "agitation" part...

Transport says "20-24C; as close as possible."

Hmmm ....still confused.

Brenda Hutson, CLS(ASCP)SBB

I'm no expert but from reading the standards I would say that for the return on a unit (of any type product) that has been out longer than 30 minutes you would have to be able to prove that the proper temperature had been maintained the entire time. Just my interpretation!!

I agree with Karen -- this can be achieved by (1) using validated containers, and/or (2) those little temperature dot thingies that indicate if an unacceptable temperature had been maintained.

Also look for an article by Moroff where he studied the impact of temperature deviations and lack of agitation on platelets...specifically "temperatures as low as 18 deg C for up to 24 hours or no agitation for up to 24 hours had no impact on in vivo survivability or function." (we qualify the non-conforming products via Material Review Board within our facility, I have referenced this paper a time or two!). There is also another paper out there that cites lower temperatures and acceptable timeframes for lower temperatures.