Another Cooler Question

[stu]

Hi:

A question was raised (again) today on what temperature whole blood units should be stored at the blood drive and during transport to the BB for processing. I am in recruitment and collections so can use the BBers help on this one

My understanding is that we are supposed to "start the cooling process" toward the 1-6c range and there is (and can not be) any specific temperature. If I place blood collected at 37c into the cooler and check it in 30 minutes it may be 30c or 25c. If I constantly place warm blood into the cooler, then it may never reach that 1-10c range.

I think collected blood, pre processed, is different from storage 1-6c or transport of blood 1-10c.

Thanks.

[L106]

I understand your question, Stu. We collect a few autologous donors one day a week in a room in another area of the hospital. We would put the freshly collected autologous unit in a cooler with a bag of ice, then walk it down to Blood Bank when we had time (ie: maybe 30 minutes later), then place it in the Blood Bank refrigerator.

A few years ago, our FDA inspector cited us because we had no documentation that we had validated the cooler. (I still think it's silly, since there are no temp or time requirements of how fast the blood has to cool down, etc.) So to correct the deficiency, we simply put the bag of ice in the cooler, recorded the temp (ie: usually around 5 C), add the freshly collected warm autologous donor unit, then take the temp in the cooler every 15 minutes. It is expected that the temp will warm up when we add the donor unit, but then the temp should gradually cool down. I considered the validation results for the cooler to be "satisfactory" if the temperature did the logical "warm-up" then gradually cooled down. I did not state any specific temp or time limits, just documented that the ice in the cooler did cool the blood down as expected (but never got colder than 1 C, which of course it never did.) (The inspector was satisfied with this.)

There is probably a better way to accomplish the FDA's intent for this matter, and I would appreciate any suggestions or procedures that anyone would be willing to share.

Donna

[Deb]

Stu,

You are correct - whole blood units collected at a blood drive are indeed different from processed units that need to be maintained at storage temps (1-6C) or transport temps (1-10C) Blood Drive units should be placed in a transport device (i.e., cooler) that is configured with sufficient cooling capacity (i.e., ice/gel packs, etc) that will provide an environment that will cool the units continously "[towards]"

1-6C. We usually get our blood back to the center within 4 hours and the blood is hardly ever cooler than 19 C if it is a full cooler. We validated our process by simulating conditions of a minimal load (1 unit) to a full load (16 units) and tracked the temperature changes over a period of time (that would depend on how long you would need the units to be in the coolers prior to reaching the component lab).

We could demonstrate that we had conditions of continous cooling towards 1-6 C over a 10 hour time period. Some people validate for 24 hours. If you live in a climate that has extreme swings in temperatures you may also want to do a "summer" and a "winter" test to show the cooler can still maintain the cooling capacity.

[NedB]

What you want if for the blood to be cooled towards the target range. There are other considerations - most especially, time. If you are going to make FFP, you need to get the blood into Processing to make the six or eight hour window. The point being not to hold all the blood in one place and try to maintain a cooling but to break up the donations into manageable transportation and processing numbers of units.

[ANORRIS]

I recently purchased a new blood transport cooler for the purpose of transporting blood to the OR. Not for storage, but for transport only. It was validated extensively by the manufactrurer with 67 pages, ugh, of proof. Must I re-validate for AABB? Seems like I would be re-inventing the wheel, but???

[dmpollock]

What brand/model is the cooler?

Thanks

[ANORRIS]

Thermo-Safe 930 Medical Transport Cooler from Thermo-Fischer

[LIMPER55]

these coolers were rejected by our surgery dept--they are covered by a nylon fabric and can not be cleaned

[ANORRIS]

Our OR is OK with this as they wipe it down with a 10-15% bleach solution.

[jcdayaz]

these coolers were rejected by our surgery dept--they are covered by a nylon fabric and can not be cleaned

How frequently do most of you out there disinfect your surgery coolers?

I have always wondered about how others do this. It seems to be a puzzling issue to me as the outside of the bags of products we put in the coolers are certainly not sterile. Our gloves in the BB are not sterile, the hands of the person picking up the blood cooler are not sterile, etc etc. Any thoughts from anyone out there on this?

Thanks in advance.

[ANORRIS]

Not only that, our OR won't accept ARC coolers as they have been outside of the hospital, which I understand, but they will accept styrofoam coolers which they have no idea where they came from or where they have been. Go figure. AND......we see the OR staff all over the hospital in their scrub caps and booties, and they go right back into the or rooms wearing the same ones????