Storage vs. Shipping/ Validation

[sgoertzen]

I believe this is the history:

At the 2007 AABB meeting, the FDA inspector at the "Ask the FDA" session said that if a cooler is used for temporarily storing blood, then the FDA would consider that to be a "storage" device and would require the 1-6 C temp limits.

(That is when I changed my temp limits on the coolers from 1-10 C, down to 1-6 C)

At the 2008 AABB meeting, speakers from the AABB stated in variours sessions that if the FDA now considers temporary storage coolers as "storage" and not "transport", then the standards would also apply for taking the temperature at least every 4 hours.

(That is when I changed the expiration on my coolers from 6 hours down to 4 hours so we could take & record the temperature every 4 hours.)

Finally, at this most recent 2009 AABB meeting, speakers from the AABB are now back-pedaling (I think they had some major complaints for the very reasons you state above) and they are now stating that if you have validated your cooler to maintain acceptable temperatures for more than 4 hours, you don't need to record the temperature every 4 hours, but you would need to perform some sort of periodic QC to ensure it is still able to perform at the level it was validated.

(So now I am changing my procedure back to allow the 6 hour expiration of the coolers, but now we will be taking the temp of each returned unit with the IR thermometer.)

I'm still confused about the whole 1-6 C or 1-10 C acceptability limits. Its the same cooler and the same units ... if it is sitting still it must be 1-6 C and if it is moving it can be 1-10 C? That still makes no sense to me.

[Kitty Petershagen]

I found this information regarding storage versus transport:

Volume 12, Number 16

April 28, 2006 AABB Weekly Report

Clarification Offered for Storage Versus Transport of Blood Components in Monitored Coolers

In response to several recent inquiries regarding the proper temperature for blood components during cooler storage or transportation, the association has re-released information from an "Ask the FDA" session at the October 2005 AABB Annual Meeting.

Q: In the following scenarios, when is blood considered to be in transport with a temperature requirement of 1-10° C, and when is blood considered to be in storage with a temperature requirement of 1-6° C?

The two scenarios are:

1. transferring blood in a monitored cooler for inventory between two hospitals in the same system

2. blood sent to surgery or the emergency/trauma area while in a monitored cooler

A: According to Sharyn Orton, PhD, deputy director of the Division of Blood Applications at the Center for Biologics Evaluation and Research (CBER), FDA realizes that the current regulations are not completely clear, noting that two of the regulations actually conflict. Orton points to 21 CFR 600.15(a) "Temperatures During Shipment — Products," noting that blood being transported from the collecting facility to the processing facility should be maintained at a temperature that allows cooling towards 1–10° C. In addition, if blood is being transported from storage and is being shipped somewhere, the blood should be maintained at 1–10° C.

However, blood should be stored at 1–6° C if it is being stored in a temporary location or in a temporary vehicle (i.e., cooler) for the intent or the potential intent of product storage for the life of the dating period. For example, if one is using a cooler to take blood to the operating room because of a lack of refrigeration, that is considered an extension of the storage refrigeration with the possible intent of additional storage time.

When electricity is temporarily out and it is necessary to store components in a cooler, FDA considers this a potential means to store for the life of the product, and the blood should be stored at 1–6° C. Therefore, for 1) 1–10° C would be adequate and for 2), 1–6° C would be appropriate.

[Tadpole]

Has anyone actually seen a change over time in cooler performance with periodic QC? What about insulated cardboard boxes?

I know taking temps on recepit is time worn and accepted, but I have seen data using loggers where the product temperature can go out of range during transport and arrive in range. How can reconcile this?

This concept that if blood goes out of range for even a minute or so it is trashed --- how did that get started? I know pharma does stability studies and uses Mean Kinetic Temperature so that it is the cumulative deviations that matter, not just an instance in time.

[galvania]

Has anyone actually done any studies to see just what changes take place in the suitability of blood if it is at 10°C over different time periods? If so, then it could perhaps form the basis of a sensible ruling. I get the impression that very often with many rules regarding how we have to work in transfusion we are dealing with 'guesstimates' rather than evidence-based decisions

[Brenda K Hutson]

Exactly! This is especially true at our pediatric hospital where issued units come in widely variable sizes. That's why we are opting to just take the temp of each one that comes back before assuming its OK and re-entering it into inventory. I agree that verifying the HemoTemp AND taking the temperature with the IR thermometer is probably overkill (we could skip taking the IR temp if the indicator is OK), but talking with my techs, they would prefer to build a uniform method into the process and use it for everything that comes back. I don't want to give up using the HemoTemps because I don't trust that they won't take a unit out for awhile, warm it up, and then try to sneak it back into the cooler to send back to us.

Added note: Based on our most recent FDA inspection, we also are now verifying the acceptability of the packing/transport methods used by our donor center by taking the temperature of units at the time of delivery using the IR thermometer. Our inspector said we didn't need to do it for every delivery, but should probably hit each type of product (RBC, PLT, FFP, CRYO) periodically, so currently, we are doing each one at least once per month.

Ah, now I see that you are from CA. The comment made regarding an Inspector whose "thing" it is to document a representative sameple of each type of product with each delivery (was my opjnion) was in Southern Calif. Ring a bell? But then it sounds like perhaps it is becoming an actual regulation per the FDA at some point? Because again, finding out what regulations (or at least to that Inspector) are by getting cited for something, should not be acceptable. I mean what is the goal? To cite people, or for the Inspectors to try to get their beliefs actully put into the CFR??

Brenda

[jcdayaz]

We abide by the 30 min rule at our facility. I HATE IT!! Nothing burns me up more than having to waste an AHG crossmatch compatible unit negative for a ton of antigens because it was returned to the BB, in say, 35 minutes! UUGGGHHH!!!!

Of course, it burns me up also that they are not infrequently returned because the nurse didn't realize she/he didn't have consent before picking the unit up in the first place!! But, that's a whole different topic...one for my proposed "Stupid things nurses/Doctors do"

[RR1]

I believe that whoever wrote the 'Store at 1-6, Transport at 1-10' rule was a bit narrow sighted.

So, if there is anyone out there who has any control over writing the FDA regulations, can you bring this up at your next meeting please?

I believe that most of these guidelines are derived by the World Health Organization, with various documents stating transport/ storage temperatures etc. If this is the case, what I would really like to know is why is the storage temp in the U.S 1'C to 6'C and in the UK this is 2'C to 6'C (as stated in the WHO doc).

The WHO cold chain doc can be found in the UK Quality section of this forum (see thread : Cold chain).

[Kathy]

Our CV surgery team asked me if it was okay to transfuse a unit of blood with a red temperature indicator (Safe-T-Vue 10). Based on the fact that transfusions must be completed with 4 hours of issue and that the indicators turn red in about 15 minutes when a unit is kept at room temperature, I told them it was fine as long as the transfusion is complete within 4 hours of the indicator turning red. If they don't know when it turned red, it needs to be brought back to the blood bank and discarded. Please correct me if I'm wrong. I'm new to this supervisor thing.

[Joanne P. Scannell]

Ditto! Only we don't use the '30 minute rule' (it cannot be validated), we take the temperature of all returned units to assure they are still within required temperature range. n.b. They don't stay below 10oC (nevermind 6C!) after about 10 min.

I'm thinking that 'special units' should be issued in a small cooler or thermal That way, if the initiation of the transfusion IS delayed, at least that precious blood would be protected.

Hmmm ... I think I will put this in our policy.

Re: Nursing not having their act together BEFORE they call for the units: We will not issue a unit of blood without a 'Blood Bank Release Request' form FILLED OUT AND SIGNED by the infusionist. This form bears a checklist of items that both nursing and the BB decided must be done BEFORE requesting blood issue, e.g. 'Consent Form Signed'. It also bears patient information (name, Hospital #) and what product they are requesting, e.g. Thawed Plasma. So, in theory, we are assured that they are 'ready to go' when we issue the unit.

We abide by the 30 min rule at our facility. I HATE IT!! Nothing burns me up more than having to waste an AHG crossmatch compatible unit negative for a ton of antigens because it was returned to the BB, in say, 35 minutes! UUGGGHHH!!!!

Of course, it burns me up also that they are not infrequently returned because the nurse didn't realize she/he didn't have consent before picking the unit up in the first place!! But, that's a whole different topic...one for my proposed "Stupid things nurses/Doctors do"

Edited July 8, 2011 by JPCroke

[jcdayaz]

Brenda,

I concur completely with you. We use HemoTemp indicators on every unit sent out to OR (typically) in a cooler. The temperature of the units upon return--if they are returned--is documented in our computer. Our coolers are validated for 6 hours safe storage time based on our in-house validations. We will call the OR @ the 4-5 hour time frame post-issue and ask for the return of the cooler to the BB to get fresh cooling packs, frozen packs, etc. We have a dry-erase board upon which we write when whatever cooler was issued so we can all monitor the length of time it has been out.

BTW-I've not heard anything either about a change to the 30-minute rule. If you find anyting out please let me know.

[SMW]

There is/was no 30-minute "rule".........it is an urban legend.

[Brenda K Hutson]

You raise a lot of good point/ideas.

Since I want to move towards taking temps. on returned unit using an Infrared Thermometer, I have no doubt I will also be wasting more units that I am currently with the 30 min. rule. So putting Antigen Negative Units in a cooler is not such a bad idea.

But I also, like you (and I suspect most others) are frustrated when Nursing sends for a unit when they are not in fact, ready to begin the transfusion. Then after they have spent 35 mins. trying to start the IV, etc., they send the unit back. It is in their SOP to send for blood when they are prepared (pre-vitals; IV; patient consent form; infusion order from MD; etc) yet it continues to occur.

In fact, we had a big meeting last week (Lab Management will Hospital Accounting/ Billing) regarding wasted units, and who should pay for them. Wish there was a way to charge the Nursing Units or Anesthesiologists! Maybe we could make a rule that if someone wastes a unit, they have to donate to replace it (Ha Ha; like that would fly).

Brenda Hutson

Ditto! Only we don't use the '30 minute rule' (it cannot be validated), we take the temperature of all returned units to assure they are still within required temperature range. n.b. They don't stay below 10oC (nevermind 6C!) after about 10 min.

I'm thinking that 'special units' should be issued in a small cooler or thermal That way, if the initiation of the transfusion IS delayed, at least that precious blood would be protected.

Hmmm ... I think I will put this in our policy.

Re: Nursing not having their act together BEFORE they call for the units: We will not issue a unit of blood without a 'Blood Bank Release Request' form FILLED OUT AND SIGNED by the infusionist. This form bears a checklist of items that both nursing and the BB decided must be done BEFORE requesting blood issue, e.g. 'Consent Form Signed'. It also bears patient information (name, Hospital #) and what product they are requesting, e.g. Thawed Plasma. So, in theory, we are assured that they are 'ready to go' when we issue the unit.

[jcdayaz]

I believe that whoever wrote the 'Store at 1-6, Transport at 1-10' rule was a bit narrow sighted.

Obvious storage is in our refrigerators, but what about the boxes we 'store' the blood in while they are waiting (sometimes for hours!) to be loaded onto a truck? Are they 'in storage' or 'in transport'? When they are IN the truck,we clearly see them as 'in transport'. So, I guess the criteria is based on is really 'is it in a moving state?'. Given that, if the cooler is sitting on the ground, it must remain between 1-6oC. If it is being carried somewhere, it can go up to 10oC. (Ummm, what temp check stickers are we using, 1-6 or 1-10 for these?)

Are we all nuts or what!?

Whatever ... the rule should be rewritten for clarity's sake: e.g. RBC's must be maintained at 1-6oC. However, if allowed to warm up to 10oC for longer than X minutes (hours?), then the outdate must be amended to ____ (24hrs?). If allowed to warm up greater than 10oC, it must be discarded. (Interesting that the current rule states we can't reissue it ... why doesn't it state we must discard it? Do YOU store such units in quarantine until they outdate? We don't either.) This is how it is stated for bones ... it's very clear what to do when.

So, if there is anyone out there who has any control over writing the FDA regulations, can you bring this up at your next meeting please?

AMEN! I think to be a Bood Banker you have to be nuts!

[AMcCord]

AMEN! I think to be a Bood Banker you have to be nuts!

Not mandatory, but it sure does help.

[tbostock]

There is/was no 30-minute "rule".........it is an urban legend.

This is true....there is no such thing as the 30-minute rule; it was never a regulation. If anyone still uses this, they should discontinue it and use temperature as the return criteria. And, yes, it will go above 10 degrees pretty quickly...10 minutes or so, so more units will be wasted.

[Brenda K Hutson]

I did not literally mean a regulation stating 30 mins. Even the Technical Manual references 30 mins (as an example). See 16th Edition, pg. 617. Specifically, it states (usually 30 minutes).

I am not saying it should or should not be 30 mins.; rather just stating where I think a lof of us came up with that number in the first place.

Brenda Hutson

This is true....there is no such thing as the 30-minute rule; it was never a regulation. If anyone still uses this, they should discontinue it and use temperature as the return criteria. And, yes, it will go above 10 degrees pretty quickly...10 minutes or so, so more units will be wasted.

[DPruden]

I did not literally mean a regulation stating 30 mins. Even the Technical Manual references 30 mins (as an example). See 16th Edition, pg. 617. Specifically, it states (usually 30 minutes).

I am not saying it should or should not be 30 mins.; rather just stating where I think a lof of us came up with that number in the first place.

Brenda Hutson

I believe there was a study done when blood was still in glass bottles and that is where the 30 minute time frame came from.

But regardless, just to inject a note of logic, blood bankers have been following the "30-minute rule" for decades and I don't think that we were harming patients on a daily basis.

[brobinson]

We validate each cooler that we have once a year. We have some with gel packs and some Credo coolers. We label each cooler with the amount of time that they have been validated for since we sometimes see a variation between cooler types. We have 16 coolers so doing them twice a year would be a full time job for someone and I agree that the Technical Manual is only a guide. We have been repeatedly inspected by AABB and even the FDA recently and they seem to be okay with what we do. We have data loggers that we put inside the coolers with between 2-8 units of red blood cells and/or plasma in order to validate them.

[Eagle Eye]

which datalogger do you use?

[Tadpole]

Unless you subject the box to extreme ambient conditions (worst case testing for your environment) you are not really testing anything by putting a logger in a box.

Common sense on frequency of testing.....

A cooler has EPS surrounded by plastic. The EPS can crack and you would never know without some frequency of testing.

Vacuum panels can leak and loose insulation over time.

PUR is very stable over time and if it is inspected for cracks etc there is not much value in retesting an indivudial box. QC checks during manufacturing are important to detect air bubble etc than can occur and reduce R value.

Etc.

[Barbarakym]

We are still on paper system, not computer. We use coolers internally only. So per AABB these are considered storage and not transport. I validated all before first use. The coolers we use are CREDO which are basically iglo coolers with inserts. We have 2 coolers and 4 inserts. Any insert can be used in either cooler. They were all validated independently.

Ongoing QC we did a paper log (we are not on computer, another local hospital uses insert/cooler as a pair and acceptance (QC) of temperature on return is done by computer, for us we do this manually). QC LOG has patient name/ time dispensed and temp/ time returned and temp/ If inspection went ok? Credo recommends cleaning each time, so this is part of our inspection process.

This has not been looked at by an inspector yet (started this year). Am I missing anything? So far process seems to be working.

I had an extensive talk with AABB last week on this topic.

Each cooler should be validated upon receipt to verify that it can perform as expected.

Each cooler should be QC'd at regular intervals, as defined by the facility, to ensure that they are still in working condition. And the impression I got was this should be done as they are in use (ie ED or OR, not on counter top in TS).

We haven't defined QC yet, I am having a meeting in a few days with representatives from all my hospitals and this is on my agenda. I don't see doing QC more than quarterly but still haven't figured out exactly how I am going to do this. We do visual inspections quarterly now so that is why I am considering temp QC quarterly also. This will be a pain in the rear with 20 coolers but must be done.

[jill]

All of our coolers are validated once per year.

[bxcall1]

We send a thermometer with each cooler. The temp is read and recorded at the time of issue, at the time each unit is taken out of the cooler and if any units are returned the temp is documented at this time as well. I like to think that we are 'validating' the cooler each time they are used.

Nursing also records a visual inspection and date/time of use for each unit used.

Also at issue we check and record a 'visual inspection' of the cooler.

[Auntie-D]

We send a thermometer with each cooler. The temp is read and recorded at the time of issue, at the time each unit is taken out of the cooler and if any units are returned the temp is documented at this time as well. I like to think that we are 'validating' the cooler each time they are used.

Nursing also records a visual inspection and date/time of use for each unit used.

Also at issue we check and record a 'visual inspection' of the cooler.

If the unit is to be transfused this is complete overkill. In the UK if the unit is going to be transfused to that patient then it can be out of temperature for 4 hours - it just cannot be put back in the fridge. A lot of hospitals have not taken this up yet as it is harder to track the time out of the fridge for 4 hours than 30 minutes.

But we need to make things easier for them in an emergency, not harder. To validate the box ever time it is used makes more paperwork for them and more for yourself too. Once every 6 months, with the temeperature actually challenged is sufficient.

We do a 6 monthly check winter check where we leave the box in a bike locker with a data logger in - this is challenging extremes of low temperature. We do this as our blood is transported by van and it takes about 6 hours to reach us. We also do a high temperature validation in the summer where we leave the box on our hot windowsill. In both cases we also use a data logger to record the ambient temperature to ensure there was indeed a challenge.

IMO it's no use challenging the boxes to room temperature - they need to be challenged for the worst case scenario.

[bxcall1]

If the unit is to be transfused this is complete overkill.

Since 90+% of the times we use a cooler the products are going off-site, generally for 6-8 hrs, what recording temps at the transfusion site allows is for us to return the units to inventory if they aren't transfused. Frequently patients don't show for their appointment, or for one reason or another they can't receive all of the units that were requested. By recording temps when the products are packed, on arrival and several times throughout the day we can safely return the units to stock. The assessors like it as well!