surgery blood bank refrigerator

[LIMPER55]

the HemoSafe looks great! thanks for the information.

[adiescast]

A word about the "coolers as storage" idea: When we had our AABB assessment in 2009, the assessors threw that at us as well. I knew it sounded wrong, (not to mention the fact that our assessment was prior to the effective date of that standard) but at the audioconference for the changes, which unfortunately didn't take place until a few weeks later, Debbie Kessler made it very clear that blood sent to the OR in coolers is "transport", not "storage", as long as the time period doesn't exceed what the cooler is validated for. She said "the cooler is transporting blood out to the OR and back to the transfusion service with a pause in the OR". I made very detailed notes about this so that we could respond to the variance.

The "coolers as storage" ruling comes from the FDA. They are quite clear and insistent that blood sent in coolers to the floor and operating room are "storage" and not "transport." "Transport" is only defined as blood in coolers that is going from one place to another without a pause that includes the potential for opening/removing/replacing contents. So if your cooler went from the blood bank to the OR and the blood was removed and placed in a monitored refrigerator, the cooler would be for transport. If your cooler goes to the OR, sits and is used or not during surgery, and is returned to the blood bank, the cooler is for storage.

[TIrwin]

The "coolers as storage" ruling comes from the FDA.

Do you have a reference for that? It didn't come up at all during our last FDA inspection, which was otherwise quite thorough.

[David Saikin]

I contacted the agency about this issue last week. Blood in coolers in the OR is stationary and therefore not in transit but in storage.

Do you have a reference for that? It didn't come up at all during our last FDA inspection, which was otherwise quite thorough.

[tbostock]

Check your state regs too; for examply NY state considers it storage, not transport. So red cells would have to be 6 degrees or less instead of 10.

[sonyahhead]

You could also install a magnetic lock on the refrigerator door that can only be opened by pressing a button in blood bank. It works well for us. They come get it in blood bank and take it to the refrigerator. They call us, identify themselves and the blood they are placing in the refrigerato, and we open the lock and document the time they placed it. When they want to use it, they call us, identify themselves and the patient, we push the button, and they read us the unit number(s) they are taking. They know their ability to have a refrigerator depends on following the system and that we do not do coolers if they lose their refrigerator privileges.

I'd like to hear more about the magnetic lock system. Who makes the one you use?

[adiescast]

My engineering department put it together with materials that they say are generally available. It is a strong electronic magnet placed on the refrigerator door that is hard wired to a lighted button in blood bank. The button releases the lock and stays lit as long as the door is open. In case of power failure, the magnet fails open.

[macarton]

Our refrigerator in OR is now being used for tissues for transplanting. We stopped using it after one of the docs got a unit out and transfused it without looking at the patient information and gave the unit to the wrong patient. Mary