26th Ed. 5.1.8.1.2.1

[davisco]

Is putting a pool of thawed cryo on your counter waiting for the floor/OR to come and pick it up considered "storage in an open storage area" in anyone's opinion? And for those of you without temperature monitoring systems capturing your room temps, do you document your room temps every 4 hours? Looking for some opinions.:surrender

[Deny Morlino]

To answer the room temp question, yes we monitor every 4 hours. As small as we are we do not routinely keep platelets on hand. We monitor every 4 hours while we have them rotating. Have considered a constant temperature chart for room temp but have not been able to cost justify it as of yet.

[adiescast]

We actually put our pooled cryo into the platelet incubator while we are waiting for the transporter to pick it up. If we did put it on the counter, that would be "open storage" and would require an initial and every 4 hour temperature reading (although your cryo pooled in an open system would be expiring as you took the first reading anyway).

[Lcsmrz]

I think it would depend how long the thawed cryo would sit at RT.

We use a >30 min time period as significant for everything, just for consistency. Under 30 mins of room temp storage would be OK at our facility without monitoring; over 30 mins would require documentation that RT was within limits.

As with everything blood bank, you could carry this to an extreme: do you monitor the temp during transport to the floor and in the patient room before allowing a return to the Blood Bank? -- we woudn't even consider doing that, unless forced to by the FDA. What about the RT in the components, labeling or crossmatch area, when units might sit for more than a minute or two outside the refrigerator? And ad nauseum ...

[bbbirder]

We have a room temperature thermometer because we store albumin and tissues at room temp. But we only check it once/day... I seem to remember that only once/day is acceptable in the regulations for tissues anyway.

Plus, pooled cryo expires in 4 hours.

I agree with the other posters, this can be carried to an extreme.

[vilma_mt]

I doubt that anyone in blood bank allows thawed/pooled cryo to sit for more than 1 hour. They're easy to thaw and pool. The product is thawed and pooled for immediate tranfusion only. Do not use the word 'storage' while it's waiting to be picked up.This is not the same as platelet....Blood Bank stores Platelet and waits for physician's order Besides, it expires within 4 hours same amount of time given for any product released for transfusion.

[velliott]

We record room temperature once daily but we have thermometers that store the min / max for the past 24 hours. You know there is cryo that is already pooled and all you have to do is thaw it.....would the expiration for that be 24 hours, since you're not pooling?

[vilma_mt]

We record room temperature once daily but we have thermometers that store the min / max for the past 24 hours. You know there is cryo that is already pooled and all you have to do is thaw it.....would the expiration for that be 24 hours, since you're not pooling?

It's 6 hours (single donor or pre-pooled prior to freezing)....4 hours after pooling.

(Circular of Information

for the Use of Human Blood and Blood Components)

When using the word 'storage', pertaining to any blood product, temperature needs to be monitored/recorded every 4 hours.

Edited April 15, 2010 by vilma_mt

[BBK710]

We actually put our pooled cryo into the platelet incubator while we are waiting for the transporter to pick it up. If we did put it on the counter, that would be "open storage" and would require an initial and every 4 hour temperature reading (although your cryo pooled in an open system would be expiring as you took the first reading anyway).

Adiescast thanks for this reply. I had never given much thought to this issue. Now I have added to our procedure that the thawed/pooled cryo should be placed into the platelet incubator until issued. Don't know why I never thought of this before.

[vilma_mt]

I think it would be ok to place thawed Cryo in a platelet incubator only if the agitator is turned off. Again I will refer to the Circular "Thawed Cryoprecipitated AHF should be kept at room temperature and transfused as soon as possible after thawing......". I think you're more likely be cited for placing Cryo in an unapproved storage environment specially if the agitator is turned on than keeping it on Blood Bank countertop waiting for pick-up. We thaw Cryo for immediate transfusion only and not for any further storage compare this with Fresh Frozen Plasma wherein the word "stored" was used.

[adiescast]

I think it would be ok to place thawed Cryo in a platelet incubator only if the agitator is turned off. Again I will refer to the Circular "Thawed Cryoprecipitated AHF should be kept at room temperature and transfused as soon as possible after thawing......". I think you're more likely be cited for placing Cryo in an unapproved storage environment specially if the agitator is turned on than keeping it on Blood Bank countertop waiting for pick-up. We thaw Cryo for immediate transfusion only and not for any further storage compare this with Fresh Frozen Plasma wherein the word "stored" was used.

I disagree that the agitation would be more of a problem than controlled temperature. Having said that, we do put it on a still agitator because we have multiple agitators and can do that. What harm would gentle agitation do to pooled cryo?

[vilma_mt]

Is putting a pool of thawed cryo on your counter waiting for the floor/OR to come and pick it up considered "storage in an open storage area" in anyone's opinion? And for those of you without temperature monitoring systems capturing your room temps, do you document your room temps every 4 hours? Looking for some opinions.:surrender

This information came from a reliable source who works for the FDA.

Yes they do need to monitor Cryo at room temp while awaiting to be picked up by the floor. CFR 606.122(n)(5).

As for the platelet incubator; the incubator is a controlled environment, so as long as the temp is within the acceptable temp range for thawed Cryo, it’s ok. But rotation while in the platelet incubator is something FDA would disagree with. No regulation given…I would expect it would come under some non-approve method.