Cooler validation/ QC

[Brenda K Hutson]

We QC one of our coolers weekly when sending blood to our sister hospital. We have a blood bag with a dial thermometer it along with a QC form. They record the temperature on receipt and indicated whether or not it was satisfactory. We also place one of the bags in each cooler we send up to surgery. If blood is returned, the temp from the bag is recorded in Meditech. We just went through a very thorough JC inspection and she didn't have any problems with what we were doing.

So does this mean you do not place temperature monitors on the units going to the OR? Do you also have OR document temps. every 4 hours?

Thanks,

Brenda Hutson, CLS(ASCP)SBB

[docbabe99]

Couple of questions regarding the use of coolers (for OR; outpatient transfusions; etc.; now considered storage by FDA):

1. If you have multiple coolers of same type, do you individually validate each one, or can

one be the representative of all (I am in disagreement of this with our QA Coordinator)?

2. Technical Manual "Suggested Quality Control Performance Intervals" states Shipping

Containers for blood transport should be twice a year. Since coolers used in this way now

considered "storage," do we need to do this twice a year?

Thanks:)

Brenda Hutson, CLS(ASCP)SBB

Hi Brenda

Due to past experiences with blood bank and now cord blood banking........

1.if you are using these coolers i will prefer to validate them individually. Have you given them different equipment/ consumable numbers. Work a standard PQ form and use it for them.

2. Yes i would say to the 2nd point as well, since the term long term or short term storage has not been mentioned.

Hope it helps.........since we just went through with our AABB and passed the same.

[jlemmons]

We bought Igloo coolers from Target and validated them just like the ones from Cell Safe. We validated them for six hours but only allow surgery to keep them for 4. If they need the blood longer and can't bring it down, we take another cooler up to surgery and swap out the blood ourselvences. We validate these every six months and place Hemo-temps on all units going to surgery. We record the time and condition of the "flower" on the Hemotemp on our transfusion sheet that comes back with the units. Since we are due to be inspected anytime, I guess we will find out if we are doing it right

[Brenda K Hutson]

We bought Igloo coolers from Target and validated them just like the ones from Cell Safe. We validated them for six hours but only allow surgery to keep them for 4. If they need the blood longer and can't bring it down, we take another cooler up to surgery and swap out the blood ourselvences. We validate these every six months and place Hemo-temps on all units going to surgery. We record the time and condition of the "flower" on the Hemotemp on our transfusion sheet that comes back with the units. Since we are due to be inspected anytime, I guess we will find out if we are doing it right

Just a couple of thoughts:

1. First, we also use Igloo coolers, but I would like to discontinue that. To me, it is a hassle to use bags of ice; plus the

uncertainty of whether staff are packing properly and using the correct amount of ice; I want something more

standardized

2. So along those lines, CellSafe, Credo Series 4OR, etc. I have used other models and have just purchased 2 of the

Credo Series 4OR at the recommendation of others on this website. I have not had a chance to validate them yet.

3. I have used all of the various temp. monitors (including hemo temp). In my experience, the Safe-T-Vue Monitors are

the most reliable and/or easiest to interpret.

4. And speaking of temp. monitors, it is my understanding that the FDA is now considering blood sitting in coolers

waiting for transfusion (i.e. OR; not quite clear yet Outpatient Transfusions in outside locations) to be storage, I am

also going to swtich to the Safe-T-Vue 6 monitors.

Anyway, thanks for your input,

Brenda Hutson, MT(ASCP), SBB, CLS

credo series 4 or

[Judy hedglin]

Brenda, At our facility we have validted all our coolers (same brand) using only two random coolers. I do not think this needs to be done repeatedly if there is a HemoTemp or other temperature indicater placed on the units at issue.

[BloodBank]

I talked to Credo 4 OR and they are coming up with 6 unit capacity cooler which will be available in October and also at AABB New Orleans if any one wants to view. For Level 1 trauma ceter like us, 4 unit cooler is not large enough.

[L106]

Thanks for the info!

[tcoyle]

Would anyone care to share how they perform their validation on coolers? We recently had an inspection and they were a bit critical on our validation stating that how can we prove that red cells coming out of our refrigerator are 6 degrees or less. There are times that we irradiate or divide units so the potential for us to manipulate a unit, then toss it in a cooler (while not at storage temp) is there. Does anyone check temps prior to placing in a cooler? Or how do you perform your validation to capture this senario.

[Brenda K Hutson]

Would anyone care to share how they perform their validation on coolers? We recently had an inspection and they were a bit critical on our validation stating that how can we prove that red cells coming out of our refrigerator are 6 degrees or less. There are times that we irradiate or divide units so the potential for us to manipulate a unit, then toss it in a cooler (while not at storage temp) is there. Does anyone check temps prior to placing in a cooler? Or how do you perform your validation to capture this senario.

One thought I have is that if you happen to use the Safe-T-Vue Monitors (which right now we use the 10 but are going to switch to 6 to meet FDA), the Insert states that the unit must be <4.5 at the time you put the monitor on. And I can tell you from our experience (because we have been struggling with a hot dept. for awhile now, though seems to be fixed finally; wouldn't fix it because we were all hot and dying, but when they heard units were being wasted, then they responded; but I digress), that when the units are warmer than that, it can be difficult to put the monitor on and have it stay white. So, just one idea.

Brenda Hutson, MT(ASCP), CLS, SBB

[macarton]

For surgery coolers, we place a thermometer bag and temperature indicators on each unit. When the cooler comes back we record the condition indicated by the temp sticker on the units and also record the temp of the thermometer bag. Mary

[Townsend]

Has anyone checked out the new edition to Standards (26th edition) on this subject? There were a lot of public comments made during the drafting of the new edition - check them out. The new standard (5.1.8.2.1) reads that "containers (eg, portable coolers) used to transport blood components issued for transfusion shall be qualified and the process validated for the appropriate transport temperature."

I'll be looking for this to come up in New Orleans. Hopefully we'll get some further clarification. Currently, we (a hospital TS, not a blood center) issue blood in the Thermosafe medical transporters if the surgeon requires the blood in the OR room or at the bedside - each unit was validated prior to use. If the blood is simply being transported to the patient care unit for transfusion, it is placed in a ziploc or Igloo cooler and the 10 degree limit applies (usually about 30min, but we do take the temp if returned). We have never validated the Igloo coolers since they are not for storage, but maybe we'll have to!

[tcoyle]

Thanks for everyone's input...My question is, how are you doing your actual validation? We load a temp tale into the cooler (we have off the shelf from Target Rubbermaid) and run this for 8 hours with the equivalent of one unit with the coolets. If we stay within 1-10 degrees, we are good. If it fails, we repeat x 2. If any of those two repeats fail, then we throw the cooler away. We, at this time do not take into account units that may have been manipulated and are now above storage temp. Is anyone taking into account those "warmer" units...?

[L106]

tcoyle - To me, these are two separate issues.

1. One issue that you bring up is the situation where donor units have been manipulated (ie: handled to be irradiated, etc.) and the units are now above storage temp. So, what do you do about those units now? Do you consider them "acceptable" and put them back into the BB refrigerator, then perhaps issue them several hours later? Do you take their temperature, and destroy the units if the temp is above 10 C (or demand that they be transfused within 4 hours?) If they are warmer than 10 C and you are putting them back in your BB refrig, wouldn't it be just as acceptable to put them in a cooler that has been validated? I think whatever your policy is for handling & disposition of "warm" manipulated units, it should be consistant.

2. Your actual validation procedure is a totally different subject. What exactly you need to do will depend on how you are using the coolers. What you are doing is probably fine for you. We are sending blood products (via a courier) to an Out Patient building one block away. So we have to worry about the outside temperature and be concerned if the courier leaves the cooler in the vehicle for any length of time. So, we purchased coolers specifically designed for blood, purchased traceable thermometers, and made up "dummy" bags of 250 mls of water. (We keep the thermometers & dummy bags of water in our blood refrigerators.) For validation, we:

a.) take a unit of expired packed cells out of the blood refrig, put it in the cooler, recorded the temp of the thermometer and put the thermometer on top of the blood, then put the dummy bag of water on top of that and close the cooler.

b.) put the cooler in my car in the parking lot

c.) peek at and record the thermometer temp every 30 minutes for a total of 6 hours. (We consider the acceptable range to be 1-6 C.)

We validate each cooler for 6 hours, but have a policy of storing blood in a cooler for no more than 4 hours. We perform this validation testing before placing a cooler in use, then every 6 months (once in the hot summer and once in the cold winter.) (There is no need to do the "outside" testing if you do not intend to send your coolers outside, of course.)

Also, whether FDA considers coolers to be used as a "transportation device" (acceptable temp range of 1-10 c), or a temporary "storage device" (acceptable temp range of 1-6 C), is the current controversy. We will be anxious to hear what BBTalk poster Townsend reports to us about the subject after the AABB annual meeting in New Orleans. (OK, Townsend.......we're counting on you!!)