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30 minutes for return blood and blood products

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I did several checks on expired units of red cells. Using a calibrated infrared thermometer (Global Sensors Model AQA1721), I found that the units reached >10 C in as little as 10 minutes when left on the counter at room temperature. This prompted us to start placing the units on refrigerated gel packs during issue. When sending the units to monitored refrigerators, each unit has a Safe-T-Vue temperature indicator placed on it and they are placed in coolers for transport to the refrigerators. If any unit comes back with a red temperature indicator and/or temperature >10 C, it is discarded. Platelets are a little more tricky...as far as I know, there are no temperature indicators that would indicate if the unit went outside the 20-24C range. We will discard any platelet unit that comes back outside that range.

Does this thermometer take outer bag temp? Because when I validated sad t vues the savy bur10 did not change temp until 20 min.

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I have been checking around extensively for an infrared thermometer and I learned a lot. It could be that all the experts out there already know the scoop on infrared thermometers but...

An infrared thermometer reads only the temperature of the outside of the bag.

The best accuracy you can get will be +/- 1C. (Themocouple probes can have an accuracy of +/- 0.5C)

As Mabel said the emissivity is based on reflectivity and needs to be set but it also is affected by color - and we know not all units are the same color.

Right now I am looking at the ThermoTrace Combo model #15038. I am thinking I will initially test units with the infrared function. Then if slightly out of temp, I will retest using the thermocouple. Is there anything more I should be investigating before I purchase one? We perform our own yearly NIST re-calibration of all thermometers and I wonder how well I can get that done with the infrared function.

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Both AABB and CAP until now we are thinking how to resolve this problem they gave us one month to solve this problem.when they read the procedures they found the 30 min . for RETURN Blodd and Blood Products.

This is from the latest aaBB assessor newsletter

The infamous 30 minute rule (again)

The 30 minute rule refuses to go away!! Please remember that if a facility has validated a given time frame for return and reissue of blood components, that it is valid to cite that time frame in their policy and no nonconformance should be written. Likewise, if they take the temperature of a unit when it is returned to ensure the temperature has been maintained no nonconformance should be written. However, if they cite the 30 minute time frame without validation, a nonconformance must be written. We are revisiting the 30 minute rule in the February issue of AABB News.

CAP

TRM.42470 Acceptance Back Into Inventory Phase II

There is a documented process in place for accepting blood/blood components back into

inventory after they have been issued.

NOTE: The process must include steps to verify the integrity and appearance of the container and

maintenance at appropriate temperatures.

REFERENCES

1) American Association of Blood Banks. Standards for Blood Banks and Transfusion Services, Standard Table 5.1.8.A, 24th ed. Bethesda,

MD: AABB, 2006

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We do not check temperatures if RBC/Plasma are returned within 30 minutes. We send all our RBCs and Plasma on ice and they are kept on ice if there is no blood bank refrigerator in that department. They are also returned to on ice. We perform yearly tube system validation where we document temperatures on several products sent to and returned from different locations/hospitals, within 30 minutes.

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We perform yearly tube system validation where we document temperatures on several products sent to and returned from different locations/hospitals, within 30 minutes.

Did you know the pressure and vortex in a tube system can cause degredation of some blood products, espicially immunoglobulins. Anti-D, Kiovig, Octogam, Beriplex, plus others are all reported to show decreased functionality when transported this way.

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Did you know the pressure and vortex in a tube system can cause degredation of some blood products, espicially immunoglobulins. Anti-D, Kiovig, Octogam, Beriplex, plus others are all reported to show decreased functionality when transported this way.

Auntie-D: could you provide a reference for this? We send our RhIg through the pneumatic tube system.

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Terri,

I looked into sending the RhIg through the tube system but cjose not to for a couple of reasons.

1) Transport can cause bubbles in the RhIg solution (obviously not something you want to inject into the patient)

2) The syringe for the RhIg is glass and this is one of the major "Don'ts" associated with our pneumatic tube system.

I did contact the manufacturer for their stance on PTS transport and was told that they do not have a stance on this practice. Decided to err on the caution side with our practice. Just my .02.

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Auntie-D: could you provide a reference for this? We send our RhIg through the pneumatic tube system.

Not sure on references but there is a nationally published list of products that should not be sent via the tube system. Can anyone else help with this?

Policy from Massachusetts...

http://mghlabtest.partners.org/Pneumatic%20Tube%20System%20Guidelines%20Final%201-14-05.pdf

Edited by Auntie-D

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Thanks, Deny and Auntie-D; good points. Since my OB department is 6 floors above me, though, they will want to see hard data before I tell them we can't use the pneumatic tube anymore. If it compromises the level of Anti-D that would concern me a lot.

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I wondered about sending RhIG through the tube system too but I could find no literature about 'not to'. The insert does not state that it should not be shaken or agitated. Can anyone else find supporting info not to tube?

JB

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I wondered about sending RhIG through the tube system too but I could find no literature about 'not to'. The insert does not state that it should not be shaken or agitated. Can anyone else find supporting info not to tube?

JB

I think it is less the shaking and more the pressure that it is subjected to...

I'm still searching for the elusive reference ;)

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We just stopped this practice, (thanks to you all, it was discussed in another thread a month or 2 ago). I checked with our pharmacy; they have a list of products they don't send in the tube. They said with any long chain protein product like immune globulin products or insulin, the turbulance and stop and start can break the chains and lessen its efficacy (they also wonder what's the difference between that and dropping a box or bouncing around in the back of a delivery truck). They also don't tube some products with bags that tend to break easily and are stinky, and cytotoxic products which would pose a decontamination issue if leaking.

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We just stopped this practice, (thanks to you all, it was discussed in another thread a month or 2 ago). I checked with our pharmacy; they have a list of products they don't send in the tube. They said with any long chain protein product like immune globulin products or insulin, the turbulance and stop and start can break the chains and lessen its efficacy (they also wonder what's the difference between that and dropping a box or bouncing around in the back of a delivery truck). They also don't tube some products with bags that tend to break easily and are stinky, and cytotoxic products which would pose a decontamination issue if leaking.

I would think that there would be a huge number if "RHIG failures" if this was true.

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[ATTACH]602[/ATTACH]

Here's what my Pharmacy gave me that they use. Rhogam and Rhophylac are not on there, and I have looked at both package inserts, they say nothing about shaking. Interesting...

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I would think that there would be a huge number if "RHIG failures" if this was true.

I think there's a big difference between "could happen" and "does happen". We happily used the 30 minute return rule for decades without killing dozens of patients who got the reissued units, but now we have to take the temps...........

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We are taking temperatures of rbcs and platelets, but how can we be expected to take a temperture on plasma and cryo when they usually are warm when issued? We planned on still using 30 minutes on the plasma and cryo until there are clearer guidelines. Others' thoughts?

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We are taking temperatures of rbcs and platelets, but how can we be expected to take a temperture on plasma and cryo when they usually are warm when issued? We planned on still using 30 minutes on the plasma and cryo until there are clearer guidelines. Others' thoughts?

We just had an AABB assessment and I asked the assessor that very question. She said that the standard says 1-6o storage, 1-10o shipping, and we should go by those temps, even though it will mean discarding pretty much every returned FFP that hasn't been in the fridge for a while.

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AABB no longer allows this "30 min rule" to apply. They want temps taken anytime a product is returned.

16th ed AABB Tech Manual, page 298 still states "the appropriate transport or storage temperature has been maintained or the component has been returned within a prescribed time frame from issue"...does this not mean a 30 min rule still can apply? It doesn't even state validation must be done on this time frame.

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16th ed AABB Tech Manual, page 298 still states ............

Please remember that the AABB Technical Manual is a TEXTBOOK! A well respected textbook, but nonetheless a textbook. It should not be interpreted or confused with Standards or Regulations. Although the editorial process attempts to screen the contents to be in conformance with the applicable AABB Standards at the time the Tech Manual was edited (which is often significantly before the publication date), sometimes the contents merely convey the opinion of the individual that authored a particular chapter.

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For FFP, I wondered if we should shorten our thaw time so they don't get so warm to start with. We'll see when we turn on the temperature procedure that will go into place soon.

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Recognizing that FFP is often 'issued prior to cooling' along with the focus on the FDA rules about storage/transport temperatures being maintained, here's how we deal with this problem:

First, we determined (with appropriate documentation/validation) how long it takes for FFP to cool down to below 6oC using worst case scenerio, i.e. FFP starts at 37oC. We found that it took around 60 min.

So, I set up a protocol:

- When issuing the FFP, if it has been thawed within the past 60 min, we issue it with the comment 'IPC = Issued prior to cooling' to provide documentation that it went out 'likely warm'.

- If it comes back, it may be accepted back into inventory (refrigerator) if it has been less than 6 hours since thaw time or less than 4 hrs from pool time, whichever applies.

nb Our protocol is to take the temperature of all units that are returned (or the cooler temperature) to assure they are still within acceptable range, but we do not take the temperature of these IPC units because they are not expected to be 1-6oC.

We just had an AABB assessment and I asked the assessor that very question. She said that the standard says 1-6o storage, 1-10o shipping, and we should go by those temps, even though it will mean discarding pretty much every returned FFP that hasn't been in the fridge for a while.

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Recognizing that FFP is often 'issued prior to cooling' along with the focus on the FDA rules about storage/transport temperatures being maintained, here's how we deal with this problem:

First, we determined (with appropriate documentation/validation) how long it takes for FFP to cool down to below 6oC using worst case scenerio, i.e. FFP starts at 37oC. We found that it took around 60 min.

So, I set up a protocol:

- When issuing the FFP, if it has been thawed within the past 60 min, we issue it with the comment 'IPC = Issued prior to cooling' to provide documentation that it went out 'likely warm'.

- If it comes back, it may be accepted back into inventory (refrigerator) if it has been less than 6 hours since thaw time or less than 4 hrs from pool time, whichever applies.

nb Our protocol is to take the temperature of all units that are returned (or the cooler temperature) to assure they are still within acceptable range, but we do not take the temperature of these IPC units because they are not expected to be 1-6oC.

sorry, I couldn't catch the meaning. when you determine the time, is it the time for FFP to change from 37oC to below 6oC? and if it is, is it the thaw time or the pool time?

what is the definition of thaw time and pool time?

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