I recently received my new Thermosafe coolers for validation for my MTP's.  I was able to validate them for a max of 8 units for 6 hours (at 8 hours we started losing the temp).  OR has decided to change the protocol and they want one cooler with RBC's and one with FFP.  How can I validate the coolers for FFP?  The temps tend to vary widely depending on whether you are using one that has sat in the refrigerator for a while or if it is fresh from the water bath.  Do I need to re-validate with FFP or can I state that because it keeps the blood cold we can assume the FFP will maintain as well?  I am so confused as to how to approach this.

 

Thank You!

Christy

You need to re-validate with FFP.  FFP Should be refrigerated at least 2 hrs.

You need to re-validate with FFP.  FFP Should be refrigerated at least 2 hrs.

Interesting...we don't have time to let FFP sit in the refrigerator if we just thawed it for an MTP.  We're just starting to use coolers, only for MTPs.  Wondering the effect of the room temp FFP put in the pre-conditioned cooler with cold red cells.  I'll have to play around with different scenarios for our validation. 

 

Anybody have good ideas how to deal with this?  We will be putting red cells and FFP in the same cooler with a data logger.

I think you will have to put the FFP in a different cooler than the RBCs.  FFP is frequently just too warm to put with RBCs.  You never know what temp the FFP is going to start out at - fresh out of the thawer or stored in the refrig awhile or somewhere in between.  I think the best FFP could be validated for is that it comes back as cool or cooler than it left - nothing else will work if you are thawing at need for O.R.  You could use the BioSynergy, Inc Hemptemp IIs to monitor the return temp, but the "irreversible" temp flower will be worthless if the FFP leaves warm.  We put a one hour return time on FFP and do not convert any returned FFP to Thawed Plasma (we maintain the original 24 hour expiration time) - those would be my only suggestions.  Good Luck

we use separate coolers for FFP & RBC for our MTP cases.

Here's a related question. Does anyone use one of the boxes your blood supplier ships your red cells in to send blood to the ER for trauma cases? If so...have you revalidated the boxes yourself or do you say that the supplier has done that?

We used to use a slightly modified UBS transport box for our in-house transport needs - used them for years and never validated them.  Now we would have to validate them or anything else we chose to use exactly as we have rigorously validated the Credo coolers we do use now.

This topic brings this to mind:

 

"

Question 15: What would be an acceptable return policy for plasma products? Some plasma products are thawed (may be thawed at temperatures up to 37 C) and issued immediately and some are placed at 1-6 C prior to issue. Should separate temperature ranges be established or is it acceptable to have an all inclusive range?

 

MS. FIELDS: FDA does not have any policy guidance or regulation on acceptable return policies for plasma products. We suggest that you work with other groups – AABB, CAP, etc. – to determine how to handle this process at your facility.

 

MODERATOR: Okay, so there is no regulation, no guidance document about it, but possibly some best practices available. Thank you, Lore.

"

 

Taken from http://www.aabb.org/resources/governmentregulatory/Pages/askfdatranscripts2011.aspx 2011 Ask the FDA and CLIA transcript

How long can FFP be out at RT temperature?

 

I would validate with cold FFP otherwise your cooler probably could not validate past one hour.  I wouldn't extend cooler validation time past 6 hours.    After MTP,  I would take the temp of  returned FFP and discard any not within acceptable temp. 

Edited February 21, 201411 yr by R1R2

Our blood supplier validates their boxes and sent us a copy of the validation. They validate in warm weather and cold weather.

What did you use to validate, actual thawed plasma? 

I've heard 'dummy" units of blood.

Are there "dummy" units of thawed plasma?

We keep a small supply of expired red cells and thawed plasma on our quarantine shelf to use for validations.

We do the same thing. And for training new techs things like washing blood/aliquots. Though secretly I long to get rid of our cell washer and my medical director is in support of it.

Edited December 15, 20159 yr by goodchild