Sorry...one more cooler validation question

[Brenda K Hutson]

So, I was looking back through some of the posts, trying to get a sense of something that concerned me when reading it. My practice everywhere I have worked is to send blood in validated coolers with temperature monitors attached (usually Safe-T-Vue). The cooler was only allowed to be out for the validated period of time, regardless of what the temp. monitor looked like if returned after that time. I have seen a number of responses regarding the documentation of temps. every 4 hours. Now of course I do that with all of my equipment in the Lab (we have a continuous monitoring system with charts that can be installed as a back-up if needed), but I have not felt the necessity (even from a regulatory standpoint) to do this with coolers, provided I follow those 2 points (cannot be out longer than validated time, and must come back with an acceptable temp. monitor).

So, can anyone tell me (with reference to regulations if possible), whether it is requried "in addition," to document the temps. every 4 hours (provided your validation time is > 4 hrs.)?

Thanks,

Brenda Hutson, CLS(ASCP)SBB:confused:

[shelleyk482]

My personal feeling is that with using the temperature indicator and a validated cooler, you are taking the temperature continuously and since the indicator is nonreversible, if it's still in range when the unit is returned its pretty conclusive that the cooler was in range at the 4 hour time period. So, if you document that the unit was at an acceptable temperature at release and still at an acceptable temperature at return (using the irreversible temperature indicator), you have met the requirements for monitoring the temperature of the cooler for the period of time that the unit was in the cooler.

[amyhlandry]

I have done much research on the matter since we were cited during our inspection this year. I recommend checking the Ask the FDA session from 2008. Question 10 tells you what the FDA determines to be "temporary" storage and then refer to the AABB standard 5.1.8.1.2- that says that the temperature shall be continuously monitored or taken every 4 hours.

[QRISTOFIR]

So, I was looking back through some of the posts, trying to get a sense of something that concerned me when reading it. My practice everywhere I have worked is to send blood in validated coolers with temperature monitors attached (usually Safe-T-Vue). The cooler was only allowed to be out for the validated period of time, regardless of what the temp. monitor looked like if returned after that time. I have seen a number of responses regarding the documentation of temps. every 4 hours. Now of course I do that with all of my equipment in the Lab (we have a continuous monitoring system with charts that can be installed as a back-up if needed), but I have not felt the necessity (even from a regulatory standpoint) to do this with coolers, provided I follow those 2 points (cannot be out longer than validated time, and must come back with an acceptable temp. monitor).

So, can anyone tell me (with reference to regulations if possible), whether it is requried "in addition," to document the temps. every 4 hours (provided your validation time is > 4 hrs.)?

Thanks,

Brenda Hutson, CLS(ASCP)SBB:confused:

I am with you on this one Brenda. If you have validated your Safe-T-Vue indicators to show that they indeed function as expected and you have also validated your transport coolers for a specific time, using the Safe-T-Vue indicators and returning coolers within their validated "keep cool" times suffices and meets that requirement to continuously monitor temps at least every four hours (strictly my opinion). If the indicator will tell you at any time if a unit was exposed to unacceptable temperatures, why isn't that considered continuous monitoring especially when it has been validated to function as expected.

My question to everybody though (since we are just now trying to start using indicators for the first time) is do you perform any form of checks/QC on new lots of indicators before use?

Thanks

Chris

[Brenda K Hutson]

I am with you on this one Brenda. If you have validated your Safe-T-Vue indicators to show that they indeed function as expected and you have also validated your transport coolers for a specific time, using the Safe-T-Vue indicators and returning coolers within their validated "keep cool" times suffices and meets that requirement to continuously monitor temps at least every four hours (strictly my opinion). If the indicator will tell you at any time if a unit was exposed to unacceptable temperatures, why isn't that considered continuous monitoring especially when it has been validated to function as expected.

My question to everybody though (since we are just now trying to start using indicators for the first time) is do you perform any form of checks/QC on new lots of indicators before use?

Thanks

Chris

I do not perform QC on the Safe-T-Vue Indicators (I use the document they send). However, one place I worked at previously, did perform QC (but I did not really feel like the method they used was valid). So, I too would be interested in knowing:

1. For those who use Safe-T-Vue Monitors, do you perform your own QC of the monitors (in addition to the document

that comes with them)?

2. If the answer to #1 is YES, can you explain what you do to perform this QC?

Thanks,

Brenda Hutson, CLS(ASCP)SBB

[lwalton]

Are you using Safe-T-Vue 6 or 10? And how did you validate them? We tried using the Safe-T-Vue 6 but didn't like them in practice, although I love them in theory! Thanks.

[Brenda K Hutson]

Are you using Safe-T-Vue 6 or 10? And how did you validate them? We tried using the Safe-T-Vue 6 but didn't like them in practice, although I love them in theory! Thanks.

We are using the Safe-T-Vue 6 for in-house coolers (OR; ER) and the Safe-T-Vue 10 for Outpatient Transfusions (for which we have multiple facilities. The reason we use both is:

1. As I understand it, the FDA now considers blood sitting in a cooler "just in case," (i.e. OR), to be short-term

storage. Therefore, you are required to maintain the blood at 1-6C. The Blood going out in coolers for Outpatient

Transfusions, are just in-transit for a transfusion to take place (although the reality is, if multiple units were ordered,

you still have something sitting there in a cooler; the only difference being it is a "sure" transfusion vs. OR). At least

that is what "I" have understood of the new requirement (which in all honesty, is still foggy to me).

2. And the other reason we use 2 is that currently, we are using 2 different types of coolers for each of those patient

populations (only now switching over). Historically where I work, they used Coleman coolers with bags of ice. I

have to admit, this is the first place I have worked in my 26 years that uses bags of ice (and no disrespect to

others of you that do, but I really don't like that; it is obviously almost impossible to standardize how much ice to

use, requires a ready source of ice, and is messier). I was very concerned about being able to use the Safe-T-

Vue 6 because the Safe-T-Vue 10 already seemed rather sensitive at times in the application. So, I ordered a

different type of cooler (Credo; mentioned on this website as well as another local hospital I used to work at) that

seemed to keep cold temps. over a long period of time. So, I purchased 4 of them (for now, 2 for us and 2 for the

hospital we just purchased), just for OR (I am at a 400 bed community hospital and they don't tend to ask for blood

in coolers all that much). We have had NO problems with the Safe-T-Vue 6 with those coolers. We still use the

Coleman Coolers with ice for our Outpatient Transufsions (which we have a lot of) but I want to switch to either

Credo for everything, or CellSafe (or something along those lines) for our Outpatients.

Anyway, that is more than you asked for...

Brenda Hutson

[L106]

Brenda -

In my heart, I agree with you, but this is the original difference of opinion that started this whole cooler issue. Difference sources will tell you different interpretations, but many are hearing that FDA's definition of "transferring" blood means "shipping to another facility." FDA is giving many of us the impression that sending blood in a cooler to our Out Pt facility across the street means that the blood is being "temporarily stored" until it is transfused within your entity.

Don't shoot me....I'm just stating that this is what we are all arguing about: "Transferring" vs. "Temporary Storage."

[Brenda K Hutson]

Brenda -

In my heart, I agree with you, but this is the original difference of opinion that started this whole cooler issue. Difference sources will tell you different interpretations, but many are hearing that FDA's definition of "transferring" blood means "shipping to another facility." FDA is giving many of us the impression that sending blood in a cooler to our Out Pt facility across the street means that the blood is being "temporarily stored" until it is transfused within your entity.

Don't shoot me....I'm just stating that this is what we are all arguing about: "Transferring" vs. "Temporary Storage."

No, not at all! I'm sorry if I left the impression that I actually HAVE A CLUE what the specific requirement is with this storage vs. shipping. I have seen many interpretations and it is still a struggle. Once I get coolers that are more reliable than coleman coolers with bags of ice, I will probably switch to all Safe-T-Vue 6 monitors to make it uniform. Then I don't have to worry about making the wrong conclusion about the FDA Regulation.

Brenda

[EdSharpless]

At the 2009 AABB Ask The Standards Committee session the AABB has taken the position that blood sent to the OR in coolers is transport, not storage or temporary storage. AABB also changed the language regarding every 4 hour temperature monitoring, stating that the cooler needs to be validated for the time and temperature of its use. This entire transcript may be found at our website: http://www.williamlabs.com/Vuepoint-Feb2010.html

Ed Sharpless, William Laboratories

[Brenda K Hutson]

At the 2009 AABB Ask The Standards Committee session the AABB has taken the position that blood sent to the OR in coolers is transport, not storage or temporary storage. AABB also changed the language regarding every 4 hour temperature monitoring, stating that the cooler needs to be validated for the time and temperature of its use. This entire transcript may be found at our website: http://www.williamlabs.com/Vuepoint-Feb2010.html

Ed Sharpless, William Laboratories

But I believe it is the FDA that has changed the requirements. It is my understanding that the AABB is "pushing back" against the new tighter restrictions of the FDA. Unfortunately, they do not always agree with each other, which makes it difficult for us to know what we are "really" required to do (and for which we would get cited by one or both agencies, if we don't).

It is like the question that keeps going round and round with regard to the expiration of pre-pooled (then thawed) cryoprecipitate. Last year, I found that the Technical Manual actually contradicted itself (one place said 4 hrs. and another said 6; even the AABB regulatory expert I contacted was then confused). And the wording used by the FDA was not clear. Now, the wording in the most recent FDA Ciircular of Information seems to me to be clear (6 hours if a sterile connecting device was used in the pooling process); and yet, there are others on this website who interpret that differently.

I personally vote for:

1. Consistency between the regulatory agencies (when they are addressing the same issue)

2. Straight forward instructions that don't lend themselves to so many interpretations.

Just my wish list...(Who's with me?!!! as they say on Extreme Home Makeover)....

Brenda Hutson, CLS(ASCP)SBB

[BBK710]

Brenda,

Are you putting the Safe-T-Vue 6 on the blood bag at least an hour prior to packing the cooler?

If not is it working ok? Most of the time we don't know an hour in advance when the OR would like blood sent in the cooler.