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Transport or Storage?

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Is blood sent to the ED for traumas considered transport or storage? I thought it was storage since it might sit bedside up to 4 hours, but I'd read in another pathlabtalk thread that the FDA and AABB now said it was transport. I've been googling, but can't find any references to support it as transport. Our blood supplier said anything less than 24 hours is transport, but they haven't sent references yet either.

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It is up to your site to define what you are calling this (transport or storage) in an SOP and then follow the correct temps for what you defined.  As long as it is defined in a written procedure and you follow that procedure, regulatory agencies are happy.

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Posted (edited)

This was a hot topic about 2 yrs ago.  The FDA came out and said that storage in blood boxes/coolers is considered storage NOT transport.  AABB/CAP might be mollified, I don't think the feds will think twice about a 483.  Unless you are putting the product in a BB refrig.

Check out posts from Feb, 2016

Edited by David Saikin
went looking for history posts on this topic.

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There is a transcript of the Ask the FDA and CLIA session from the 2017 AABB Annual Meeting that addresses this topic. It is available now at AABB.org. FDA defined that situation as storage.

 

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On ‎6‎/‎13‎/‎2018 at 11:11 AM, David Saikin said:

This was a hot topic about 2 yrs ago.  The FDA came out and said that storage in blood boxes/coolers is considered storage NOT transport.  AABB/CAP might be mollified, I don't think the feds will think twice about a 483.  Unless you are putting the product in a BB refrig.

Check out posts from Feb, 2016

True, David.  FDA in action: We got cited during an inspection a few years ago and had to switch our Auxiliary Blood Box (aka Cooler) temperature limits from 1-10C to 1-6C.  Someday, they will straighten this out (why the two limits?), but until then, we are stuck with it ... here in the US, anyway.  What is the rest of the world doing?

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This started being a hot topic 10 - 15 years ago.  It started in the AABB and they were fine with calling the coolers transport but then the FDA got involved and their stance was that it was storage and to my knowledge they have not varied from that stance.   That was when I started looking into the "vending machine" blood band refrigerators for the OR.  Sadly they were too expensive for our penny pinching administration so the OR had to be satisfied with blood delivery via pneumatic tube that was measured in seconds!  They were devastated!  :devilish:

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On ‎6‎/‎13‎/‎2018 at 11:04 AM, Marianne said:

It is up to your site to define what you are calling this (transport or storage) in an SOP and then follow the correct temps for what you defined.  As long as it is defined in a written procedure and you follow that procedure, regulatory agencies are happy.

I have to disagree with the presumption that as long as you are following what is in your SOP, you are fine.  The SOPs still have to be accurate.

Just sayin.......

Brenda

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Posted (edited)

I was going to ask if distance traveled had anything to do with this distinction, transported or stored. But it is actually the container that is being transported and the blood is stored within this container. If the container is sealed such that the stored blood is not in any contact with the elements then the stored blood would be good until it's expiration provided the temp is maintained in this container. I think that the container's ability to maintain the appropriate temper for a given time and the time it takes to travel a given distance is probably where the question of transport and storage originates. But the temperature maintenance is a container issue and not the units of blood "stored within."

If a pregnant woman travels a given distance can we think that the fetus she is carrying is transported or stored?

 

Edited by rravkin@aol.com

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17 hours ago, rravkin@aol.com said:

I was going to ask if distance traveled had anything to do with this distinction, transported or stored. But it is actually the container that is being transported and the blood is stored within this container. If the container is sealed such that the stored blood is not in any contact with the elements then the stored blood would be good until it's expiration provided the temp is maintained in this container. I think that the container's ability to maintain the appropriate temper for a given time and the time it takes to travel a given distance is probably where the question of transport and storage originates. But the temperature maintenance is a container issue and not the units of blood "stored within."

If a pregnant woman travels a given distance can we think that the fetus she is carrying is transported or stored?

 

The FDA's decision may have to do more with the level of control.  Donor Centers are inspected directly by the FDA, whereas surrogates (AABB, CAP, etc.)  inspect hospital transfusion services.  As John C. Staley stated "This started being a hot topic 10-15 years ago."  While Transfusion Services continue to challenge the FDA interpretations, Donor Centers don't!

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We are controlled, to a greater or lesser extent, by regulators as to what we can/cannot do.  Talking with donor center personnel over the years, they have no 'wiggle-room' when it comes to compliance with FDA regulations.  Transfusion Services inspections that are conducted by FDA surrogates are not nearly as stringent. Transfusion Services have the option to select a regulator (AABB, CAP, JCAHO, HFAP), Donor Centers have no choice.

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On ‎06‎/‎23‎/‎2018 at 6:42 PM, rravkin@aol.com said:

I was going to ask if distance traveled had anything to do with this distinction, transported or stored. But it is actually the container that is being transported and the blood is stored within this container. If the container is sealed such that the stored blood is not in any contact with the elements then the stored blood would be good until it's expiration provided the temp is maintained in this container. I think that the container's ability to maintain the appropriate temper for a given time and the time it takes to travel a given distance is probably where the question of transport and storage originates. But the temperature maintenance is a container issue and not the units of blood "stored within."

If a pregnant woman travels a given distance can we think that the fetus she is carrying is transported or stored?

 

If you took the blood out of the box when it reached its destination it would be transport.   If you leave it in the box wherever it is going - storage.

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On ‎06‎/‎25‎/‎2018 at 11:56 AM, Dansket said:

We are controlled, to a greater or lesser extent, by regulators as to what we can/cannot do.  Talking with donor center personnel over the years, they have no 'wiggle-room' when it comes to compliance with FDA regulations.  Transfusion Services inspections that are conducted by FDA surrogates are not nearly as stringent. Transfusion Services have the option to select a regulator (AABB, CAP, JCAHO, HFAP), Donor Centers have no choice.

If you are registered or licensed, the FDA is entitled to inspect you at their pleasure.

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9 hours ago, David Saikin said:

If you took the blood out of the box when it reached its destination it would be transport.   If you leave it in the box wherever it is going - storage.

David, I am not sure if there is a difference between transported and delivered, outside of potential semantics. If a package is delivered it was certainly transported. But I think that the FDA's thinking is based on the stored conditions during the transport; thus taking the transport part of the equation out of consideration. If you are familiar with the convenience retail chain, Wawa, one of their limitations on expansion is the safe storage of perishable products being delivered directly from their farm to surrounding stores. With advancement in storage capability they are able to expand; but notice that Wawa is only present on the east coast and not the west coast. This is because of the limitations on storage capability during transport. I believe that this may be the FDA's logic when addressing packed red blood cells. 

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you are surely entitled to your opinion on this.  Whatever the FDA's logic, if you deliver and leave your product in a cooler or box or whatever, you are storing the product.

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On 6/29/2018 at 9:08 AM, David Saikin said:

you are surely entitled to your opinion on this.  Whatever the FDA's logic, if you deliver and leave your product in a cooler or box or whatever, you are storing the product.

Agree. I have also heard this straight from the FDA at a question and answer session at AABB. The answer was quite explicit - storage.

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I think that this has a lot to do with intent. If the intent is to hold the blood until it can be transfused, then it is storage. If the intent is to move the product from one place to another, then it is transport.

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