Cooler validation/ QC

[Brenda K Hutson]

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

[Brenda K Hutson]

Sorry, one more thing I meant to ask in relation to my cooler question above:

If you validate a cooler for a certain period of time, if it is returned "after" that time frame, but the Safe-T-Vue monitors are still white, would you accept them back, or would you not accept them back based on them being out longer than the time for which they were validated?

Thanks,

Brenda Hutson, CLS(ASCP)SBB

[Alternatives]

Hi Brenda, I will answer to the first part of your question. If you have several coolers of same type (same brand, size...etc), you don't need to qualify all of them, only one is enough which will represent shipment you use to do. Qualification will be effective for all your line of coolers if you ship to same destinations, with similar products, range of temp...etc.

Yes you should test them twice a year; this will put in evidence your shipments are always done with an effective method, inside a container able to maintain a specific range of temperature. Also, if you have some specific shipments (in terms of value, products or lengh of transportation, close to your qualification time limit...etc), simply monitor them with data loggers. If you ship outside your hospital, weather is unfortunatelly not a predictable and precise science...

Benoît

[L106]

For us, the "twice a year" validation schedule makes perfect sense. We do the validation during the hotest time in the summer and during the coldest time in the winter.

[Brenda K Hutson]

Hi Brenda, I will answer to the first part of your question. If you have several coolers of same type (same brand, size...etc), you don't need to qualify all of them, only one is enough which will represent shipment you use to do. Qualification will be effective for all your line of coolers if you ship to same destinations, with similar products, range of temp...etc.

Yes you should test them twice a year; this will put in evidence your shipments are always done with an effective method, inside a container able to maintain a specific range of temperature. Also, if you have some specific shipments (in terms of value, products or lengh of transportation, close to your qualification time limit...etc), simply monitor them with data loggers. If you ship outside your hospital, weather is unfortunatelly not a predictable and precise science...

Benoît

But I thought that the FDA now considers blood in coolers, sitting in OR or an Outpatient transfusion location, Storage; not Shipment?? That is why I am having a hard time knowing what applies.

Thanks

Brenda

[Brenda K Hutson]

For us, the "twice a year" validation schedule makes perfect sense. We do the validation during the hotest time in the summer and during the coldest time in the winter.

Ah, good thinking!

Brenda

[Cliff]

Hi Brenda, I will answer to the first part of your question. If you have several coolers of same type (same brand, size...etc), you don't need to qualify all of them, only one is enough which will represent shipment you use to do. Qualification will be effective for all your line of coolers if you ship to same destinations, with similar products, range of temp...etc.

Yes you should test them twice a year; this will put in evidence your shipments are always done with an effective method, inside a container able to maintain a specific range of temperature. Also, if you have some specific shipments (in terms of value, products or lengh of transportation, close to your qualification time limit...etc), simply monitor them with data loggers. If you ship outside your hospital, weather is unfortunatelly not a predictable and precise science...

Benoît

I don't know if I agree with these statements.

We use Igloo coolers with a corrugated plastic insert (custom made). We have about 50 coolers and replace them on a regular basis. They are used a lot.

When we validate them, they don't all pass. Some maintain temp better than others. So if we were to validate just the method, then it might mislead us in thinking they were all good (or all bad).

As for twice a year, what are you proving by doing that? That the one that you validated still works and represents all of them? What if one has a crack in it but you didn't pick that one for the validation. Is it still good?

I wish there were some good guidance on issues like these. We all want to do the right thing, but we all also fear hearing an inspector say that what we did is not enough, and their unfounded advice is to do more.

[sgoertzen]

We use the Cell Safe Igloos and we have validated all of them, and we revalidate all of them every couple of years. We always find one or two that don't pass that must have warped a bit or something from the last time they were validated and need to be replaced. As for QC'ing them at least twice a year, we use a thermometer inside each igloo and HemoTemp indicators on every product placed in an igloo, so every time a product comes back to us and the temperature and HemoTemp is OK or not OK, I would consider that "QC'ing" the storage ability of the igloo and the acceptability of the product. If an igloo comes back after the igloo expiration time, the HemoTemp and internal igloo temperature are used to determine whether the product should be placed back into inventory or be discarded.

The big issue now is the AABB requirement for temperatures to be monitored and RECORDED every 4 hours for any storage device. Now that an igloo is considered a "storage device" instead of a "transport device", this means igloos need their temp taken at least every 4 hours. Our igloos are all validated to maintain temperatures between 1-6 C for 6 hours, but we have shortened their expiration period to 4 hours, since someone/something needs to record the temperature of the igloo every 4 hours. We either had the option to buy a temperature data logger for each igloo (and we have many) or change our policy and make them bring the igloo back to us at 4 hours (we can't trust them to take temps every 4 hours in SURG or in the ED or on the floors). We opted for the latter. If they need it longer, we take the internal temperature of the igloo, re-ice it, and give it back to them. We log all of this information on an Igloo Log.

[kate murphy]

I have asked both FDA and AABB inspectors to show me the difference in the box that goes to the OR vs the box that is flown cross country with our blood in it. If they can do that, I will monitor 4 hours. However, no inspector has been able to clarify, prove, show me any difference. Either they are all transport, or they are all storage.

That said, I validate each box upon receipt for 72 hours, and QC each box every other month. Not that my boxes stay out 72 hours, but I want to know how they perform. I also put them in hot conditions (a hot stair well) and cold conditions. Number your boxes - do the even numbers one month, the odd numbers the next.

[BloodBank]

1. We have validated all our coolers upon receipt. Also validation was for different time period, 4 hrs, 6 hours, 8 hours and 12 hours at initial validation.

2. We chose 6 hrs. as optimum time although 8 hrs. was still within 6 degrees (storage temp.).

3. Twice a year we perform QC of all coolers for 6 hours.

4. We place thermometer in cooler every time we send cooler to OR. We call OR room at 4 hr. and ask the circulating RN to read the thermometer temp. and we document that in cooler log in Blood Bank.

5. At six hr. time if OR still needs coolar, we exchange the cooler/coolant. Again exchange time and cooler number is documented along with returned cooler temperature.

6. My cell safe coolar's lid latch is breaking down after using for almost 10 years and I need to replace them. I called Cell Safe and they say, those coolars are discontinued and newer ones are thermosafe which is on wheel but I am skeptical about durability of vinyl outer casing.

Any one can tell me which cooler is better. I have cell safe coolant packs that can be used in other coolars? Where can I get Igloo coolars?

[ar_confederate]

We validate the type rather than each cooler and determined the longest time that we could maintain the temperature for the worst case semario (1 unit, packed correctly, iced correctly). For us, it was 8 hours. We inspect and clean each cooler on a regular basis and replace any with damage. The cooler can ONLY be replaced with the same brand and model. We do a quarterly QC check for our shipping of components. Coolers are only used for in-town deliveries but these are checked as well to confirm that the coolers are still providing the proper environment for the components.

As for the question about longer times than validated, we take the temperature of each unit in the cooler and quarantine the units. A product reveiw board evaluates the components and makes the decision to release or discard.

[C Lumbert]

But I thought that the FDA now considers blood in coolers, sitting in OR or an Outpatient transfusion location, Storage; not Shipment??

Thank you for opening this point Brenda.

I have repeatedly read comments that FDA regards the coolers as storage in the patient care department, however, I have not been able to find a reference statement from FDA or from AABB or CAP with that definition.

Can anyone help me locate the reference statement?

I heard that the FDA representative clarified the point in an "Ask the Inspector" session a number of years ago.

Chuck Lumbert

Battle Creek, Michigan

[L106]

I don't know if I agree with these statements.

As for twice a year, what are you proving by doing that? That the one that you validated still works and represents all of them? What if one has a crack in it but you didn't pick that one for the validation. Is it still good?

By performing the validation twice a year (hot summer & cold winter), we are assured that the coolers stay within the acceptable range during our 4-hour time limit. We are sending blood in the coolers to a different building where they transfuse outpatients, so the coolers are exposed to weather and the courier car temperature.

Also, we do validate all of our coolers, not just a representative (as some other posts have mentioned.)

Donna

[clmergen]

I asked these questions of a friend who is an AABB assessor. His QA people asked AABB for clarification. This is the response minus salutations and names etc.

The committee deliberately chose not to get into the battle of words that is defining "transportation" and "storage" in light of how FDA has defined "temporary storage." It might be helpful for you to know that the committee basically meant that whenever products are stored in coolers, the length of validation can exceed the four-hour mark, and that the validation can then take the place of the four-hour check. If you have validated for six hours, you would not need to check the product temperature at the four-hour mark.

I hope this helps. Thanks for your comments about the Standards - I know this issue isn't clearly explained in the book, and we will consider how to improve on the language for the next edition.

[L106]

Thanks, clmergen. This info is very helpful, and I think AABB's wording clearly explains their stand on the matter.

[Brenda K Hutson]

We use the Cell Safe Igloos and we have validated all of them, and we revalidate all of them every couple of years. We always find one or two that don't pass that must have warped a bit or something from the last time they were validated and need to be replaced. As for QC'ing them at least twice a year, we use a thermometer inside each igloo and HemoTemp indicators on every product placed in an igloo, so every time a product comes back to us and the temperature and HemoTemp is OK or not OK, I would consider that "QC'ing" the storage ability of the igloo and the acceptability of the product. If an igloo comes back after the igloo expiration time, the HemoTemp and internal igloo temperature are used to determine whether the product should be placed back into inventory or be discarded.

The big issue now is the AABB requirement for temperatures to be monitored and RECORDED every 4 hours for any storage device. Now that an igloo is considered a "storage device" instead of a "transport device", this means igloos need their temp taken at least every 4 hours. Our igloos are all validated to maintain temperatures between 1-6 C for 6 hours, but we have shortened their expiration period to 4 hours, since someone/something needs to record the temperature of the igloo every 4 hours. We either had the option to buy a temperature data logger for each igloo (and we have many) or change our policy and make them bring the igloo back to us at 4 hours (we can't trust them to take temps every 4 hours in SURG or in the ED or on the floors). We opted for the latter. If they need it longer, we take the internal temperature of the igloo, re-ice it, and give it back to them. We log all of this information on an Igloo Log.

Ooh, good point (regarding the issue of coolers now being considered storage, so what about the "monitoring" of those temps.). Please say it isn't so!!

Brenda Hutson, CLS(ASCP)SBB

[Brenda K Hutson]

We validate the type rather than each cooler and determined the longest time that we could maintain the temperature for the worst case semario (1 unit, packed correctly, iced correctly). For us, it was 8 hours. We inspect and clean each cooler on a regular basis and replace any with damage. The cooler can ONLY be replaced with the same brand and model. We do a quarterly QC check for our shipping of components. Coolers are only used for in-town deliveries but these are checked as well to confirm that the coolers are still providing the proper environment for the components.

As for the question about longer times than validated, we take the temperature of each unit in the cooler and quarantine the units. A product reveiw board evaluates the components and makes the decision to release or discard.

Well, I do have a problem with the aspect of taking the temperature of the units upon return, to determine whether they are acceptable to take back into inventory. When I started my current position, there was a time when the OR came for a unit, but didn't ask for it in a cooler. Later, they came for more and asked for a cooler (so we put safe-t-vu monitors on those units). When the cooler was later returned, the initial unit which had gone out without a cooler, was now in the cooler. The staff "tood the temp." and accepted it back into inventory because it was between 1-6C. Well, that would be why we use temperature monitors; because they are irreversible. Who is to say that unit was kept at acceptable temps. the entire time it was out, just because it came back in temp.? So that is no longer a practice here...

Brenda Hutson, CLS(ASCP)SBB

[Brenda K Hutson]

But I thought that the FDA now considers blood in coolers, sitting in OR or an Outpatient transfusion location, Storage; not Shipment??

Thank you for opening this point Brenda.

I have repeatedly read comments that FDA regards the coolers as storage in the patient care department, however, I have not been able to find a reference statement from FDA or from AABB or CAP with that definition.

Can anyone help me locate the reference statement?

I heard that the FDA representative clarified the point in an "Ask the Inspector" session a number of years ago.

Chuck Lumbert

Battle Creek, Michigan

Yes, I was just reading that today (can't recall where how I got the document though). As I understood it, if the cooler was for in-house transfusion, it is considered "storage." If it goes outside of the Hospital, it is considered "shipping." I could have sworn I read something recently though that would have made me think that our Outpatient Transfusion facility, was also now considered storage, but I can't recall where I saw that.

Sorry, I don't have the article at home with me but I will let you know tomorrow.

Thanks for your reply,

Brenda Hutson, CLS(ASCP)SBB

[Brenda K Hutson]

I asked these questions of a friend who is an AABB assessor. His QA people asked AABB for clarification. This is the response minus salutations and names etc.

The committee deliberately chose not to get into the battle of words that is defining "transportation" and "storage" in light of how FDA has defined "temporary storage." It might be helpful for you to know that the committee basically meant that whenever products are stored in coolers, the length of validation can exceed the four-hour mark, and that the validation can then take the place of the four-hour check. If you have validated for six hours, you would not need to check the product temperature at the four-hour mark.

I hope this helps. Thanks for your comments about the Standards - I know this issue isn't clearly explained in the book, and we will consider how to improve on the language for the next edition.

Well, at least it addresses the question of documenting the temps. every 4 hours. However, it still leaves the questions of storage vs. shipping; validate all or validate one; QC on a regular basis, or only initially.

Thanks,

Brenda Hutson, CLS(ASCP)SBB

[sgoertzen]

I would love to say it isn't so, but this was a hot topic at the AABB Assessor Training in Montreal last October. There was some disputing going on between the AABB accreditation "experts", but in the end, they determined that the 4 hour requirement for temp recording goes for all storage devices/areas which now includes igloos as defined by the FDA. I am an AABB Assessor and I came away from that Assessor Training Day with the clear impression that if you don't take temps of your igloos at least every 4 hours, you are not meeting the standard.

It is interesting to read the post from clmergen above that quotes clarification from an AABB Standards Committee member that does not jive with what they told us last October. I truly hope that this gets clarified once and for all... hopefully at the AABB meeting in New Orleans coming up in a couple of months. I agree, it is quite ridiculous to use two sets of temp & recording standards for the same exact container: one set if it is being used to transport, and another if it is being used for temporary storage. I would love to go back to 6 hours for my igloos because we validated them for 6 hours, and this 4 hour thing is a lot of extra work for.... what?

[C Lumbert]

Thank you all very much for your input and thanks to clmergen for the statement from AABB. i requested clarification from CAP last spring, since they list storage devices as refrigerators, freezers, and platelt chambers in one question and include coolers in another question. They have not responded.

I do hope more clarification will be provided at the AABB in New Orleans this fall. If an FDA inspector is present, perhaps we might get a documented position to use as reference.

Chuck Lumbert,

Battle Creek, MI

[Brenda K Hutson]

I would love to say it isn't so, but this was a hot topic at the AABB Assessor Training in Montreal last October. There was some disputing going on between the AABB accreditation "experts", but in the end, they determined that the 4 hour requirement for temp recording goes for all storage devices/areas which now includes igloos as defined by the FDA. I am an AABB Assessor and I came away from that Assessor Training Day with the clear impression that if you don't take temps of your igloos at least every 4 hours, you are not meeting the standard.

It is interesting to read the post from clmergen above that quotes clarification from an AABB Standards Committee member that does not jive with what they told us last October. I truly hope that this gets clarified once and for all... hopefully at the AABB meeting in New Orleans coming up in a couple of months. I agree, it is quite ridiculous to use two sets of temp & recording standards for the same exact container: one set if it is being used to transport, and another if it is being used for temporary storage. I would love to go back to 6 hours for my igloos because we validated them for 6 hours, and this 4 hour thing is a lot of extra work for.... what?

So if that is true, we would either need to create a document to attach to coolers so OR (et. al) could document the temp. every 4 hours, or, they would have to return it every 4 hours to replace the ice/cold blocks??

Some "clear" guidance on this (with AABB and FDA in agreement) would be a really nice thing about now.

Brenda Hutson, CLS(ASCP)SBB

[Brenda K Hutson]

1. We have validated all our coolers upon receipt. Also validation was for different time period, 4 hrs, 6 hours, 8 hours and 12 hours at initial validation.

2. We chose 6 hrs. as optimum time although 8 hrs. was still within 6 degrees (storage temp.).

3. Twice a year we perform QC of all coolers for 6 hours.

4. We place thermometer in cooler every time we send cooler to OR. We call OR room at 4 hr. and ask the circulating RN to read the thermometer temp. and we document that in cooler log in Blood Bank.

5. At six hr. time if OR still needs coolar, we exchange the cooler/coolant. Again exchange time and cooler number is documented along with returned cooler temperature.

6. My cell safe coolar's lid latch is breaking down after using for almost 10 years and I need to replace them. I called Cell Safe and they say, those coolars are discontinued and newer ones are thermosafe which is on wheel but I am skeptical about durability of vinyl outer casing.

Any one can tell me which cooler is better. I have cell safe coolant packs that can be used in other coolars? Where can I get Igloo coolars?

Cooler Ideas:

1. See if Lab Safety Supply still carries Thermosafe Transport Containers (similar to Cellsafe)

2. Order Excursion Coolers from Coleman Co., Inc. but will have to use bags of ice; no cold bottles

3. Credo Series 4-OR from Minnesota Thermal Science; new type of Cooler that I have now ordered and will try, at

the suggestion of someone on another Thread:

Brenda Hutson, CLS(ASCP)SB B

[Brenda K Hutson]

Yes, I was just reading that today (can't recall where how I got the document though). As I understood it, if the cooler was for in-house transfusion, it is considered "storage." If it goes outside of the Hospital, it is considered "shipping." I could have sworn I read something recently though that would have made me think that our Outpatient Transfusion facility, was also now considered storage, but I can't recall where I saw that.

Sorry, I don't have the article at home with me but I will let you know tomorrow.

Thanks for your reply,

Brenda Hutson, CLS(ASCP)SBB

Found the Reference: Go online to William Laboratories; Look under subheading Blood Bank Practices with Safe-T-Vue and TRANS-VUE.

Brenda Hutson, CLS(ASC)SBB

[macarton]

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.