Back to monitoring 1-6C in coolers

[Brenda K Hutson]

Hello again...

Last year we had many discussions regarding the move towards blood sitting in coolers, waiting at a location for a transfusion (i.e. OR; Outpatient Transfusions), as storage, not shipment (thus requiring the temp. be between 1-6C). So, it is my understanding that where we are with that now is: The FDA has in fact stated that it is to be considered storage (and kept at 1-6C) and the AABB is trying to "push back" a little? Of course for now, if the FDA states you "must" do this, then we must...

So, back what for "me" is the biggest problem; temp. monitors for 1-6C. Part of our discussion also discussed ways to assess the temperature in the coolers (Safe-T-Vue Monitors; Hemotemp II Monitors; monitoring the cooler temp. instead of the unit). I personally do not like the Hemotemp Monitors (I find them difficult to interpret).

I have found coolers that are good at maintaining that tight temp. for a long period of time. And much to my surprise, I did not experience problems with Safe-T-Vue 6 monitors turning red while trying to apply to the units (or after storage).

For me, the BIG issue is still the fact that the Safe-T-Vue 6 monitors must be pre-applied in the refrigerator for 1 hour prior to activation. This is a huge logistical problem. It is fine for units of blood ordered "prior" to OR and for known Outpatient Transfusions at a specific date/time. However, the problem comes when the OR needs additional units or when blood in a cooler is needed urgently anywhere, etc.

Does anyone have any GOOD NEWS for me?!

Thanks,

Brenda Hutson, CLS(ASCP)SBB

Has

[swede]

We do not pre-apply the monitors to our units. We apply them at the time of issue. We keep them in the refrigerator just like we used to with the 1-10 monitors. We have a tray of cooler packs that we take out and place on the counter. We keep the units on the cooler packs while we apply one monitor at a time. Then we immediately place the units in the cooler or in a transport box (with a cooler pack for transfer to an OR refrigerator). Blood either remains in a cooler (in ED or in L&D) or goes in a rubbermaid box with a cooler pack straight to the OR monitored refrigerator.

We validated this method and have had very little trouble with the monitors turning red; we too thought they would be very touchy, but they have turned out not to be.

Good luck!

[M_Allan]

I think, swede found a good way to be able to use the monitors straight away, by storing them

on " working temperature ", so they can be used immediately.

One of my concerns with, lets call them " sentinels ", like Safe-T-Vue and Hemotemp, is, that there is no data collection or traceability that can be filed.

The other one is, the low temperature limit, that is not indicated by certain "sentinels". So how can we

prove that units have not gone below a certain temperature.

If this would be 100% FDA proof, you might as well put a Safe-T-Vue or what ever, in every one of your fridges, and as long as they indicate "white", your Units are fine, and you do not need an expensive monitoring system?!

To my opinion, the best way of monitoring transport, is with a small electronic logger, that logs time and temp, and where the data can be filed with the rest of the monitoring data, so to create a waterproof

traceability route.

Correct, the loggers can be stored in a fridge, to achieve fast correct readings when placed in a cooler box, and prevent unnecessary out of range readings.

[adiescast]

My understanding is that when the cooler is validated to maintain 1-6 C, you do not actually have to have indicators on the units to support that. You do have to take 4 hour temperatures (or continuous logging as already suggested). We use the Safe-T-Vue indicators not for storage confirmation, but for the very likely possiblity that an individual unit may be removed from the cooler for a period of time. On removal from the cooler, you are now in a "shipping" situation and not a "storage" situation, so the requirement changes back to 1-10 C and the Safe-T-Vue 10 is an adequate indicator. If the unit was removed from the cooler and exceeded 10 C, this should detect it. If you get the cooler back and take the temperature in the cooler and it is 1-6 C, you can say that units that remained in the cooler were stored at the correct temperature. Any unit that was removed from the cooler and returned whose indicator remained white can be said to have been stored at 1-6 C and not exceeded 10 during its sojourn from the cooler.

[Shadya]

We are working on finding a way to document temperatures of fresh stem cell product during manipulation.

Does anyone have some suggestions of some small temperature data loggers that would track the actual blood bag temp without breaking its integrity? What products have you found that work well.

Thanks!

I

To my opinion, the best way of monitoring transport, is with a small electronic logger, that logs time and temp, and where the data can be filed with the rest of the monitoring data, so to create a waterproof

traceability route.

Correct, the loggers can be stored in a fridge, to achieve fast correct readings when placed in a cooler box, and prevent unnecessary out of range readings.

[LaraT23]

I agree with the cooler validation idea. I use hemotemp II stickers to cover someone taking the unit out of the cooler, trying to hang it and for whatever reason not giving it. Then I know it was not out of the cooler long enough to get out of temp.

[Brenda K Hutson]

We do not pre-apply the monitors to our units. We apply them at the time of issue. We keep them in the refrigerator just like we used to with the 1-10 monitors. We have a tray of cooler packs that we take out and place on the counter. We keep the units on the cooler packs while we apply one monitor at a time. Then we immediately place the units in the cooler or in a transport box (with a cooler pack for transfer to an OR refrigerator). Blood either remains in a cooler (in ED or in L&D) or goes in a rubbermaid box with a cooler pack straight to the OR monitored refrigerator.

We validated this method and have had very little trouble with the monitors turning red; we too thought they would be very touchy, but they have turned out not to be.

Good luck!

Well, I was going to say that I would not do anything that was not stated in the Manufacturer's Insert. However, I just pulled out the insert again and after the paragraph describing how to pre-apply the monitor in the refrigerator for 1 hour prior to activating, it does go on to say that alternatively, "the Safe-T-Vue 6 can be activated immediately after removing the bag or temperature-sensitive product being monitored (with applied Safe-T-Vue) from the refrigerator."

I will try to validate that. I will be "pleasantly surprised" if we do NOT have problems in that even the Safe-T-Vue 10 can be sensitive at times (turn red after closing). I hope we have success as you have.

Thanks for the input; it helps to read the entire insert!

Brenda

[Brenda K Hutson]

I think, swede found a good way to be able to use the monitors straight away, by storing them

on " working temperature ", so they can be used immediately.

One of my concerns with, lets call them " sentinels ", like Safe-T-Vue and Hemotemp, is, that there is no data collection or traceability that can be filed.

The other one is, the low temperature limit, that is not indicated by certain "sentinels". So how can we

prove that units have not gone below a certain temperature.

If this would be 100% FDA proof, you might as well put a Safe-T-Vue or what ever, in every one of your fridges, and as long as they indicate "white", your Units are fine, and you do not need an expensive monitoring system?!

To my opinion, the best way of monitoring transport, is with a small electronic logger, that logs time and temp, and where the data can be filed with the rest of the monitoring data, so to create a waterproof

traceability route.

Correct, the loggers can be stored in a fridge, to achieve fast correct readings when placed in a cooler box, and prevent unnecessary out of range readings.

Not having used a data monitor, I am thinking that it is monitoring the internal temperature of the cooler, not the individual units; is that correct? If yes, it brings me back to where I stand on that: which is, I would never assume that the units are not removed at times and put back in the coolers. In fact, I KNOW it happens (and so much more). You cannot depend on the OR staff to just "assure" you they did not remove the unit(s) when it comes back with a red temp. monitor; it happens. So, any system that does not actually convince me that the units themselves have been kept within an acceptable temp. range, is not one that I will use (but that is just me).

Brenda

[Brenda K Hutson]

My understanding is that when the cooler is validated to maintain 1-6 C, you do not actually have to have indicators on the units to support that. You do have to take 4 hour temperatures (or continuous logging as already suggested). We use the Safe-T-Vue indicators not for storage confirmation, but for the very likely possiblity that an individual unit may be removed from the cooler for a period of time. On removal from the cooler, you are now in a "shipping" situation and not a "storage" situation, so the requirement changes back to 1-10 C and the Safe-T-Vue 10 is an adequate indicator. If the unit was removed from the cooler and exceeded 10 C, this should detect it. If you get the cooler back and take the temperature in the cooler and it is 1-6 C, you can say that units that remained in the cooler were stored at the correct temperature. Any unit that was removed from the cooler and returned whose indicator remained white can be said to have been stored at 1-6 C and not exceeded 10 during its sojourn from the cooler.

On what are you basing your comment that "once you remove the unit from the cooler, you are back to shipping instead of storage?" I don't see what someone in an OR, taking a unit out of a cooler and then replacing it, has to do with "shipping." My understanding is that if that cooler is at a location waiting for possible transfusion (i.e. OR or Outpatient Transfusion), that it is in storage; period. I don't think I would feel comfortable coming up with any kind of variations of that; but that is just me.

Thanks for the input,

Brenda

[RR1]

Just 'throwing ideas around'- is there any reason why you couldn't place a pre-cooled maximum/ minimum digital thermometer into your cooler box on packing, and request that the OR staff check and record this temp every 2-4 hrs, or the lab checks this on return?

[Brenda K Hutson]

Just 'throwing ideas around'- is there any reason why you couldn't place a pre-cooled maximum/ minimum digital thermometer into your cooler box on packing, and request that the OR staff check and record this temp every 2-4 hrs, or the lab checks this on return?

Again, that is just checking that the temp. of the cooler itself is within range (and for a validated cooler, that would not be the big concern to me). After 6 Institutions and 26 years, I have seen and heard more "stories" about things going on in OR Rooms than I would have cared to know! I also discussed this with the Pathologist of our Donor Facility (who used to be a Pathologist at the large Medical Center associated with it where I worked previously). She is with me on that: we absolutely would not assume that blood was not being removed (for some period of time) and then returned to the cooler, especially if it is a bad case.

Brenda

[M_Allan]

Dear Brenda,

I am in the temp. monitoring field QA/PQ/SOP's for many years, and I know, it is really hard

to come up with a perfect, water(blood)-proof, solution.

Units are handled more then once, and only the SOP for handling will guarantee the units

being in range. during handling.

To my opinion, there should be no difference between storage or transport in regards to temp. monitoring.

I do agree, that a color indicator on the units is a good solution to show that a unit has been out of

range. Bulletproof. But an indicator does not prevent it from happening.

Delivering units, to find out that the dots are red is rather frustrating.

Also, if a fridge, freezer or box is validated, this does not automatically mean, that they are infallible.

That is why we have monitoring systems. Continuous monitoring will also show defects before they

brake down completely, and prevent the worst.

As you mentioned, the things that happen in O.R. , the question is, how far the responsibility goes

for the Bloodbank.

Once delivered in good order, it is up to the recipient how they handle the units to my understanding.

But, I think, that these issues will keep us busy for the next hundred years.

Marc

[M_Allan]

Hello Shadya,

With manipulation, do you mean transport / storage ?

Marc

[adiescast]

As you mentioned, the things that happen in O.R. , the question is, how far the responsibility goes

for the Bloodbank.

Once delivered in good order, it is up to the recipient how they handle the units to my understanding.

But, I think, that these issues will keep us busy for the next hundred years.

Marc

The reason it is our problem is that we have to decide whether to accept the unit back into inventory for re-issue to that patient or another within the remainder of the original dating period.

Brenda, what criteria do you use for accepting units (issued without coolers) returned from the nursing areas (1-6 vs 1-10)? Or do you accept returns from nursing areas? I based my statement that 1-10 is OK for units removed from storage in a cooler because that is what we use to accept units returned from the nursing areas.

[M_Allan]

Adiescast,

You are right, that changes the situation a lot, and makes tracebility a lot more difficult.

[Jody]

The reason it is our problem is that we have to decide whether to accept the unit back into inventory for re-issue to that patient or another within the remainder of the original dating period.

Brenda, what criteria do you use for accepting units (issued without coolers) returned from the nursing areas (1-6 vs 1-10)? Or do you accept returns from nursing areas? I based my statement that 1-10 is OK for units removed from storage in a cooler because that is what we use to accept units returned from the nursing areas.

Adiescast- Do you take the temp on every returned unit or use the 30 minute rule?

[Eagle Eye]

Adiescast- Do you take the temp on every returned unit or use the 30 minute rule?

We just changed our policy and we need to take temperature of every unit...including returned within 30 mins. Unless we can validate the system that shows that temp. doesn't go above 6C until XX mins.

[adiescast]

Adiescast- Do you take the temp on every returned unit or use the 30 minute rule?

Sorry, I had posted that on another thread. We currently use the 30 minute rule for all locations except the trauma bay (they are not permitted to return blood because of their high room temperature). I plan to go to taking temperatures because I heard at the last AABB meeting that the Standard was based on temperature exclusively.