Cooler for storage - how to define acceptance for reissue?

[Kathy]

I received an AABB deficiency because my coolers that go to the ER (which has no monitored blood bank refrigerator) are listed (by me) as being for temporary storage but we send them out with Safe-T-Vue 10 and will accept units back as long as the temperature has not exceeded 10 degrees. The inspectors said that we need to use the 6 degree rule for them and I have to respond to this deficiency. It would be easy to use the Safe-T-Vue 6 and say we will only accept the units back if they haven't turned red and/or the temp does not exceed 6 degrees. In practice, that doesn't make a whole lot of sense. The coolers are only validated for that temperature range for 5 hours and we make sure they come back before the 5 hours are up. I would have a difficult time throwing away a unit of blood with a temperature of 8 degrees just because it wasn't in motion during the time it was away from the blood bank, but it looks like my inspectors are asking me to do just that.

How do you deal with this regulation? Maybe some sort of continuous monitoring device in the cooler?

[bmarotto]

This is one of those that has me seeing red. So a unit can be issued to a floor an returned at 9C and be acceptable but if it comes back in a cooler at 7C you discard it. I like your "in motion" statement. Maybe we should have things like baggage claim carousels installed to keep transporting the coolers round and round until they are used or returned.:nana:

[David Saikin]

The FDA has stated to me first hand that blood in coolers is storage, not transport . . . has to be maintained at 1-6C. I know it doesn't make sense but that is the regualation - not worth getting cited from the feds.

[Dr. Pepper]

I agree with the others about the 6o/10o double standard, particularly since the AABB used to say (as of my inspection last year) that coolers to the OR were considered shipping, not storage. The problem with the continuous device in the cooler is that it doesn't address someone taking the units out of the cooler for, say, 45 minutes, then putting them back in, which the Safe-T-Vues would detect.

I would say go with the Safe-T-Vue 6s (although I do love the baggage carousel idea). As for the 5 hour limit on the coolers, (1) that should be adequate time to use the blood or not use the blood and (2) no matter where it's stored, doesn't the AABB want you to take the temp every 4 hours anyway? How do you do that? We have labels on ours to return the blood within 4 hours if unused.

[BankerGirl]

I agree with the above statements. It drives me crazy that blood can sit in a validated shipping box for 24 hours on ice without any temperature monitoring and be acceptable at a receipt temperature of 9 degrees, but blood with temperature monitors in our validated coolers can't get above 6. This is a case when common sense does not prevail, and I had to bite the bullet and switch to 6 degree indicators, as well. As far as the temperature monitoring issue goes, the units in the cooler are being continuously monitored by the Safe-T-Vue monitors, so 5 hours should be acceptable. My inspectors have never indicated that temperature monitoring was an issue.

[Dr. Pepper]

As far as the temperature monitoring issue goes, the units in the cooler are being continuously monitored by the Safe-T-Vue monitors, so 5 hours should be acceptable. My inspectors have never indicated that temperature monitoring was an issue.

Alas, BankerGirl, my AABB inspector specifically quoted standard 5.1.8.1.3 and said that it applied to coolers and temporary storage and that someone had to take and record the temperature in a cooler every 4 hours. Again, the storage vs. shipping issue.

[Kathy]

I called AABB today and was told to refute the deficiency. She told me that this is a hot topic and that they need to educate the inspectors better. She said that we are complaint with the regulation, having validated the coolers at 1-6. She wouldn't expect us to discard a unit that was 7-10 degrees because that could happen during a brief removal to check the unit tags. I would like some clearer direction from the FDA, CAP, and AABB on this issue based on some good research that tells us how long we can keep the products at 7-10 degrees.

[R1R2]

Yes Kathy, I would challenge the deficiency. I consider blood removed from a validated 1-6 C cooler "in transport" not "storage" so a Safe T Vue 10 temp indicator should be acceptable. As far as taking temps every 4 hours when blood is in coolers -> there was a little blurb in AABB News a few years ago that specifically stated that validated coolers were exempt from the 4 hour requirement. (I wish I could find the article but I can't)

[cthherbal]

I received an AABB deficiency because my coolers that go to the ER (which has no monitored blood bank refrigerator) are listed (by me) as being for temporary storage but we send them out with Safe-T-Vue 10 and will accept units back as long as the temperature has not exceeded 10 degrees. The inspectors said that we need to use the 6 degree rule for them and I have to respond to this deficiency. It would be easy to use the Safe-T-Vue 6 and say we will only accept the units back if they haven't turned red and/or the temp does not exceed 6 degrees. In practice, that doesn't make a whole lot of sense. The coolers are only validated for that temperature range for 5 hours and we make sure they come back before the 5 hours are up. I would have a difficult time throwing away a unit of blood with a temperature of 8 degrees just because it wasn't in motion during the time it was away from the blood bank, but it looks like my inspectors are asking me to do just that.

How do you deal with this regulation? Maybe some sort of continuous monitoring device in the cooler?

I had problems trying to validate the 1-6 Indcators too, Kathy. They would start turning pink when we put them on the bag. When I called the company they said put them on while blood is still in frige. That seemed to work. If you keep blood out (even in coolers) for mort then 4 hours, you could get data loggers (some of them are very simple and cheap). They look like flashlights but monitor temp continuously so then you plug it in to your computer (it has a USB connection) and you see a nice graph. This is to avoid a nonconformance by AABB that require temperature monitoring at least once every 4 hours.

We keep our coolers out for max of four hours and take the temperature of units returned, regardless of what the temperature indicator says. So I haven't used data loggers but have seen them and they are neat. I think someone said in this post that coolers are exempt from the temperature monitoring. I'd like to see the reference on this as I also was not

aware...

[Kathy]

I did challenge the deficiency, so hopefully all goes well.

We had trouble with the Safe-T-Vue 10 indicators turning pink or red during the issue process, so now we place the units on refrigerated gel packs when we have them out on the counter. I can only imagine how bad the Safe-T-Vue 6 would be.

I do have a datalogger that I use for cooler and refrigerator validation. I really like it, but the program is only on my office computer, so the techs can't use it.

[QCDan]

I'm just wondering how you address this in your SOP. Do you define what is storage and what is transport ? We give out Coolers to our Haemapheresis department for exchange transfusions and call it transport (since they take it from the lab, to their infusion area, take out the units and start transfusing). We qualify our coolers for 8 hours to maintain a temperature 6C or less, and ask for them to be returned within 7 hours. If we send a cooler to a patient floor/cath lab or the OR/ER we call it storage (since they are storing products at the bedside until they are used). We do not check the temperature if the cooler is returned within the 8 hour time frame.

[tkakin]

I did challenge the deficiency, so hopefully all goes well.

We had trouble with the Safe-T-Vue 10 indicators turning pink or red during the issue process, so now we place the units on refrigerated gel packs when we have them out on the counter. I can only imagine how bad the Safe-T-Vue 6 would be.

I do have a datalogger that I use for cooler and refrigerator validation. I really like it, but the program is only on my office computer, so the techs can't use it.

I use the data loggers as well for validation and I am loving them. I have a question about the validation of coolers though. Surgery rooms can get down to 14C. Are you validating your coolers for that low or just at room temp?

[Kathy]

I validated my platelet coolers in a room that was about 16C...worse case scenario for platelet storage in the OR. I didn't do that for red cells because it will never get to 1C anywhere in my hospital, so the red cells would never get below 1C...I am only concerned with a high temperature for them. I have gotten platelet coolers back after spending the night in the OR with temperature indicators showing that the temperature went below 20C, so it was definitely worth doing the validation of those coolers in a cold room.

If the cooler is going somewhere that has a monitored refrigerator and the products will be transferred from the cooler to the refrigerator as soon as it gets there, I call that transport. If it is going somewhere that doesn't have a refrigerator, I call that storage and validated those coolers for 1-6. I don't have an ice machine, so I rely on refrigerated gel packs for transport and Thermosafe coolers for storage.