Pooled frozen cryo

[Cliff]

Does anyone pool and refreeze cryo?

If so, what problems have you run into? Do you perform QC on each product or do you do monthly QC?

[Walter]

The Blood Center of Southeastern Wisconsin (soon to be the Blood Center of Wisconsin) has been preparing pooled cryo for years. They prepare pools of 5 units each, but also make pools of other sizes for certain customers. As far as I know, the pooled cryo isn't licensed, so the products remain in Wisconsin.

[Cliff]

Thanks Walter. We aren't licensed and aren't interested in shipping.

Do you perform QC on the individual units and or the pooled cryo?

[Walter]

I don't work at the blood center, so I don't have firsthand knowledge of their practice. When I worked at Community Blood Center in Appleton, Wisconsin, we QC'd our individual units of cryo by testing pools of 4 units. This practice satisfied both AABB and FDA regulations.

[ChrisH]

Hey Cliff,

Our blood supplier Florida Blood Centers (aka CFBB) also supplies us with 10 packs of pre pooled frozen cryo. I do not know what QC they do, before they ship to us.

But we in the Blood Bank do no QC. Boy does it save us time. We still keep about 9 individual cryo for orders less then 10.

[Colleen]

Cliff,

At the Blood Bank of San Bernardino we pool 8 units of cryo and refreeze the pools. For QC, at the time of pooling, we aliquot off a single cryo equivalent (approximately 20 mL) from 4 units. The aliquots are refrozen and shipped to the ARC for Factor VIII and fibrinogen testing. We also ship 4 single units. The remainder of the QC'd pools are labeled to indicate the potency of 7 cryo units but with 8 donor exposures. Our pools are FDA licensed.

Colleen

[Cliff]

Thanks everyone, these are some pretty good starting points to work off of.

[Nancy Leland]

You have to be registered with FDA to do this. In fact, I don't think you can thaw and refreeze, the pooling has to be done before it is frozen. I would say not to do it unless you file an amendment to your registration. We have just started to get pooled cryo from our supplier.

[Colleen]

With our process, we harvest the single cryo units from frozen plasma units, pool 8 of them, then refreeze the pool within 1 hour of harvesting. So they are pooled prior to freezing. If we thaw single cryo units, then pool them, we do not refreeze the pool.

[Dawn]

I don't think you have to be FDA licensed to thaw/pool/re-freeze cryo as long as you are going to use it yourself and you perform adequate QC.

I wish more blood centers would prepare the pooled frozen product. We would certainly purchase it.

[Cliff]

I guess my concern is as Nancy pointed out, is it allowed to that and refreeze? Is it even a viable product?

I guess the intent is to pool directly from the thawed FFP. Since we don't manufacture cryo here, I suspect this may not be an option for us.