Out of temp blood

[shelleyk482]

Opinions needed please, our blood refrigerator went to 9' C before the techs moved the blood products to an alternated refrigerator- is this blood still acceptable since it was below the 10'C shipping temperature or do I need to discard it since it was allowed to remain above the 6'C storage temperature for approximatel 2 hrs?

[Franklyn]

I would document it as a procedural exception and get my medical director to approve it. 9 degrees C for two hours is within the 10 degree threshold for transport and 2 hours is not a very long time.

I wish the FDA would either expand the storage limits for RBCs to 0 to 10 deg. C or limit it to 1-6 deg. C as the current standard is confusing and, in my opinion, not based in fact. If a unit can be at 1-10 for 8 hours on a plane, truck or train, why cannot it not sit in my refrigerator at the same temp for the same time period?

[sshel55]

You could also submit a request for a variance from FDA, especially is this was your entire inventory.

[Lcsmrz]

You don't mention if you're a transfusion service or a blood center. I know, I know, it doesn't make a difference, but in a non-registered hospital, a Medical Director is allowed more professional judgement than in a licensed facility.

In the latter, I would discard the entire inventory ...

[Franklyn]

Very Good point! I am at a registered (not licensed) facility and my answer was, obviously from that perspective. I imagine it would really sting to loose your complete inventory considering how much all the products on the shelves are worth...

[David Saikin]

I am curiouis . . . did not your alarms trigger prior to 6C? If yes, does your procedure allow for product to remain in the ref or should it not have been moved prior to the increasing temp closing in on 10C? The feds would say you need to discard product. What will you do if a patient transfused with any of these products has a reaction? There appear to be a few system failures in this scenario that require resolution . . .

[shelleyk482]

David,

Yes, we had a major breakdown in SOP. When the alarm went off at 5.5'C the tech silenced it and went on working. He did this numerous times over the next couple of hours. His explanation was that at the last place he worked, the blood didn't have to be moved until the refrigerator hit 10'C; he never bothered to check our SOP. We are posting the procedure on each of the storage units and will be retraining all staff at the next department meeting.

Even though we are not a licensed or a registered facility, we did end up destroying all of the product stored in that refrigerator.

Thanks to everyone for the input and thoughts.

[bmarotto]

This defies all logic as far as I am concerned. We can have blood shipped to us from across the country and if it arrives at 9C we happily accept it into inventory. Why should blood in a monitored storage unit that happens to reach 9C for a short period be any different (other than the feds say so)? Granted, we should maintain blood at the optimal 1-6C range but in the event of a refrigerator malfunction, it is not always possible to move the blood immediately. For example, if there is only one tech on duty and he/she is providing blood products for a trauma or GI bleed. Would you want the tech to stop and transfer all the blood instead of supporting the patient in emergent need of products?

I consider discarding my entire inventory, or even a significant portion of it, as being more of a risk to patient care than using blood that reached 9C for a short time. I am neither advocating nor condoning ignoring temperature alarms or waiting until blood reaches 9C before moving it. Certainly if SOP was not followed you document why and retrain if indicated. I would rather take a hit from the feds than risk not having an adequate amount of blood on hand.

Maybe we should put our refrigerators on casters and if one malfunctions just wheel it to a good refrigerator and transfer the blood. Then document that the first refrigerator was a transport unit.

[redstaff2003]

david,

for how long did the ref went out of range?...a retraining in blood cold chain would help your staff in this matter. probably you have considered the condition of the stored blood units before disposing like checking for hemolysis. what do you think?

in our center if we suspect that a hemolysis had occured in the blood unit we consider in disposing the unit.

actually the manual of the WHO doesnt state that if the process blood went beyond 6c consider disposing.

[Trek Tech]

At a previous place of employment I had a similar situation...the alarm sounded on the fridge, digital readout was 5.5 degrees. Tech called maintenance...maintenance lowers temp on fridge...2 hours later...same alarm...tech called maintenance...maintenance lowered temp on fridge. When I walked in at 0600 the tech told me what had been transpiring all night. Digital readout was 3.0. My first question was "What did the thermometer inside of the fridge read?" You guessed it..the entire inventory (auto's included) had been at ZERO degrees for who knows how long. The probe had failed and the tech never checked an actual thermometer. 120 units of blood... gone. Intensive retraining and Root Cause Analysis ensued. A copy of the procedure and step by step guide to documentation is now posted on that refrigerator and all of the refrigerators at my new place of employment.