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Pooling Cryo and Re-freezing


JLF

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I am looking for information on thawing and pooling Cryoprecipitated AHF, then re-freezing it. We are not a donor center so pooling prior to processing the component (freezing for the first time) is not an option. I am interested in a procedure and a validation protocol for doing this because I have never been involved in this type of process. :confused:

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I am from a large facility with a very active trauma center, more OR's than I can count and 10,000+ births a year.

Once you've gone through a case that uses 10+ pools of cryo you can see how this would be a big help.

I am not aware of any info on how to do this, I have heard of a few facilities that have done it.

I think this would be very costly to validate too. I tend to be a little too conservative when it comes to validation.

What I would do is thaw however many are in your pool - 10 for us. Pool it and sample it for QC. Then I'd freeze, thaw and resample it.

I'd simply use the sample results times the number of units to see if it met QC.

One problem is that after you validate it you'd need to QC it too.

This may be more work than you bargained for, but if you issue a lot of cryo, it might be worth it.

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I agree it would be validation and QC intensive but we are a very large, Level 1 trauma center. I need to explore the possibility of doing this. It may not be worth it. That is why I am looking for someone who has experience with this.

The benefit would be the ability to deliver a cryo pool in 30 minutes. We are always looking for ways to cut delivery time to very critically injured traumas.

I agree it does not take long to thaw and pool but we are a large center and we often have a lot of things going on at the same time. The prime time for critical traumas is weekend nights, the time when we have the least staff available. I have on-call staff, but by the time they arrive we are at least an hour into the trauma.

I would appreciate any ideas. Thanks.

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  • 2 weeks later...

Your rational certainly makes sense. We may transfuse one or two pools per month so that is why I asked the question. I have to agree with Christie, your best option may be to convince your blood supplier to do it. Maybe the best process would be to pool it when the cryo is made from the FFP and then freeze it. That way the freeze thaw cycle would not change. Just a thought.

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  • 4 weeks later...

With a very busy liver program and active emergency room, we find it very helpful to have prepooled cryo on hand-especially for our overnight crew-pooling a cryo while you're crossmatching, thawing plasma, tagging a platelet, (maybe preparing factor 7a) packing coolers and answering the phone is always fun. I can forward you our SOP. FDA did review our validation documents and gave us their blessing to proceed-we routinely keep 15 frozen pools on hand at all times.

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  • 3 weeks later...
Monique, are you still around? I really am anxiously awaiting information on your cryo re-freezing procedure. Could you please e-mail me at <email removed by admin to help prevent spam - this member can be contact by clicking their name and choosing to send them email>
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  • 1 year later...

I am in the process of developing a CRYO Pooled product at my facility and am curious if anyone has received/have SOPs or validation documents they would be willing to share! If so couple you please contact me.

V/r

Steve

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  • 1 month later...

Does anyone know what the expiration of a Thawed Pooled Cryo unit would be if the frozen pool was prepared in a "closed" system? Open prepreparations would surely expire in 4 hours when thawed. But would that be extended to 6 hours if the Frozen Pooled Cryo was prepared by sterile procedure? ICCBBA defines a code for this product.

I can't find a reference for this protocol.

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Community Blood Center of Kansas City (savealifenow.org) offers a frozen pool of 5 cryo. We havent' started using it, but intend to. After thawing the 5-pool, I don't think we will pool 2 5-pools together for a 10pack dose. I think we will just give them the 2 bags to infuse.

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Check with New York Blood Center. I think they do keep pool cryo.

New York Blood Center currently does not supply pooled cryoprecipitate as a product offering. We are considering surveying our customers regarding this product to gauge what the interest level is. There has been a few inquiries.

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  • 4 weeks later...

I am curious if there is any sort of 'industry standard' for the number of cryo's to pool when "pre-pooling". Is each blood center free to do what it wants? Do all pre-pooled cryos get the same ISBT number (E3587), regardless of the number in the pool?

It seems this could get confusing if one center pools 5 and another pools 6 and another decides to pool 10... etc.

I assume there are no CMS HCPC codes for 'pre-pooled' cryo, so these then need to be billed per each unit in the pool. Is that correct?

Linda Frederick

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Very good questions Linda. I would like some answers about how to label cryo as well. I found ISBTcode E5621 that is for frozen pooled cryo from 5 donors. Then I found codes E5599 to E5607 for 2 to 10 units of thawed pooled cryo as well as E3591 for thawed pooled cryo without mention of number of units. Maybe the E5599-E5607 are for when you are doing the thawing and pooling of individual units for transfusion and the E3591 is used when you thaw pre-pooled cryo. The codes that specify the number of units I found on the product list from the ICCBBA site. In Hemtrax, E5621 does not say 5 donors and looks exactly the same as E3587 except for the product code. Also, E5599-E5607 look exactly like E3591 except for ther product codes. You have to enter the volume and # of units in pool for all of them.

I would love to hear from anyone who has this figured out.

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I am too interested in your SOP concerning Re-freezing pooled Cryo. Are you saying that you are thawing and pooling cryoprecipitate and then when it is not used, refreezing the product for use at another time? If so, can you share with me your referenced in standards/technical manual etc, and your procedure on how you perform this task. Are there studies that indicate that refrozen pooled cryo has appropriate concentration of Fibrinogen and Factor8 present? Please direct us to these studies and information?

Thank you.

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  • 5 months later...
With a very busy liver program and active emergency room, we find it very helpful to have prepooled cryo on hand-especially for our overnight crew-pooling a cryo while you're crossmatching, thawing plasma, tagging a platelet, (maybe preparing factor 7a) packing coolers and answering the phone is always fun. I can forward you our SOP. FDA did review our validation documents and gave us their blessing to proceed-we routinely keep 15 frozen pools on hand at all times.

Monique, I am researching the process of pre-pooled cryo. I am interested in your SOP and your validation studies. Could you please forward a copy of your SOP to me? I am also curious to know if you QC'd each individual unit or did you QC the pooled unit? Any help you can offer would be greatly appreciated. Lisa Dewey

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