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FDA 30 minute rule


MOBB

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We are working with nursing on their blood administration policy and the FDA 30 minute rule came up. Do you require nursing to return blood if not hung within 30 minutes and not in a temp. controlled container?

Our current policy is to waste any RBC returned to the BB, so we encourage them to hang and complete within 4 hours of transfusion if something happens like losing a line. Are we in violation of the 30 minute rule? I tried googling, but didn't see much current information. Oddly, Nursing also seems to be under the impression the 30 minute rule means it can be returned and reissued later.

We are in the process of updating the policy and validating infrared thermometers to allow us to return products if they are within transport temp.

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There is no 30 minute rule, I do not believe there ever has been.  An old AABB Accreditation Requirements Manual referenced it once.  I do not believe anyone supports this any longer.

We validated a time to return products in our organization.  We have recently changed our policy to using a Temp Check to measure each red cell upon return.

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I was thinking it was something older they were referrencing, but I need something more than, "I don't think that applies anymore." Because I tried already tried that :) I also told them RBCs wouldn't be in range at 30 minutes and would need to be temped. To which they wanted a hard number of how long-they seemed irritated when I explained it could vary on number of RBCs to temp of the room to so many factors.

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Agree with all above.  (And I believe there are many older threads here that exhaustively cover this sort of thing regarding units out of monitored storage. )

In general, there are two things that are clear to me: a unit must be transfused within 4 hours of release from monitored storage, and that a unit returned to the blood bank for storage must be documented as being at an acceptable temp.

Scott

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32 minutes ago, SMILLER said:

In general, there are two things that are clear to me: a unit must be transfused within 4 hours of release from monitored storage, and that a unit returned to the blood bank for storage must be documented as being at an acceptable temp.

 

Exactly this. We own the blood, so we make the policy. We give them 15 minutes for returns with the proviso that the unit has not been spiked and the temp is less than 10C (which it usually isn't) or it is not returnable for restock/reissue. If the temp is too high, they are given the option of taking it back upstairs to try to give it within 4 hours of checkout. If the transfusion has been cancelled, we take it and discard it. If we discard it, it becomes an occurrence report that hospital quality and nursing management see.

In actuality, the temp should probably be less than 6C, since that is the required temp for storage. I've almost got my medical director convinced to make blood non-returnable - you've got 4 hours to give it once checked out...period. We do require them to have everything, and I do mean everything in place before they check out a unit, then they have 15 minutes to start infusion. That time is policed by nursing and they are all very aware of it. We waste very very few units of blood because of returns, usually because the patient suddenly decides to refuse or the patient's condition changes very unexpectedly. It's taken us quite a few years to get to this point, but it was worth the struggle. It's pretty well ingrained now.

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We actually take the temperature upon return and if the temperature is greater than 10 degrees it is discarded, doesn't matter if it is returned within  20 minutes. And this was changed after one of our inspections. I don't recall if it was CAP/AABB or FDA.                                                                      

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19 hours ago, MOBB said:

We are working with nursing on their blood administration policy and the FDA 30 minute rule came up. Do you require nursing to return blood if not hung within 30 minutes and not in a temp. controlled container?

Our current policy is to waste any RBC returned to the BB, so we encourage them to hang and complete within 4 hours of transfusion if something happens like losing a line. Are we in violation of the 30 minute rule? I tried googling, but didn't see much current information. Oddly, Nursing also seems to be under the impression the 30 minute rule means it can be returned and reissued later.

We are in the process of updating the policy and validating infrared thermometers to allow us to return products if they are within transport temp.

I don't think you are violating any regulatory requirement to return blood within 30 minutes if they can't start the unit and they still want to transfuse.   I think you are correct in encouraging them to complete within 4 hours instead of returning to BB and almost certain discard by BB. 

Edited by R1R2
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I think the only regulatory violation here would be if a unit was returned and there was no documentation that the temp was acceptable if it went back into inventory.

Like some have mentioned, a unit at room temp for only 10 or 15 minutes is going to be warmer than 10 C.  You can set your acceptable "return limit time" to whatever you choose, just don't forget to check the temp if you are going to re-stock it.  (There are other considerations for units released in a cooler.) 

I think the concept of a return time limit is more to encourage the transfusing RNs to not come for the unit until they are set up to hang it.

Scott

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To further confuse the issue the National Advisory Committee in Canada has now said that as long as the unit of blood is returned within 60 minutes, temperature doesn't matter. This is from the Canadian Society of Transfusion Medicine Standards

5.8.7 Return of Blood Components and Blood Products

5.8.7.1

Blood components may be returned to the TS inventory if the following conditions have been met and documented:

a. visual inspection of the blood component is acceptable

b. the bag is intact, including ports

c. at least one sealed segment of integral donor tubing is attached on red cell components. Alternately, an identified segment must be available to the transfusing site.

d. the temperature of the blood component is acceptable or the blood component has not been out of the controlled environment for more than 60 minutes from the time of issue (per occurrence, not cumulative).10.10.2/10.10.5/11.4.7

We find this standard rather vague. What is the acceptable temperature and what would standards for our Quality Audit (like your AABB audits) consider a controlled environment? From what I have learned this was a very rigorous testing process at extreme high and extreme low temperatures and there was never any bacterial issues if the unit was returned to the refrigerator within 60 minutes regardless of the temperature of the unit upon 'return'.

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10 hours ago, NicolePCanada said:

To further confuse the issue the National Advisory Committee in Canada has now said that as long as the unit of blood is returned within 60 minutes, temperature doesn't matter. This is from the Canadian Society of Transfusion Medicine Standards

5.8.7 Return of Blood Components and Blood Products

5.8.7.1

Blood components may be returned to the TS inventory if the following conditions have been met and documented:

a. visual inspection of the blood component is acceptable

b. the bag is intact, including ports

c. at least one sealed segment of integral donor tubing is attached on red cell components. Alternately, an identified segment must be available to the transfusing site.

d. the temperature of the blood component is acceptable or the blood component has not been out of the controlled environment for more than 60 minutes from the time of issue (per occurrence, not cumulative).10.10.2/10.10.5/11.4.7

We find this standard rather vague. What is the acceptable temperature and what would standards for our Quality Audit (like your AABB audits) consider a controlled environment? From what I have learned this was a very rigorous testing process at extreme high and extreme low temperatures and there was never any bacterial issues if the unit was returned to the refrigerator within 60 minutes regardless of the temperature of the unit upon 'return'.

Wow. Are there published studies?

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The ambient temperature is the key.  It is a matter of temperature not an absolute time period.  This was explained to me by an AABB inspector.  She did not cite us, but encouraged us to make a change.  We place temperature monitors on all RBC that leave the lab.  If they have not monitor, we will not accept them back.

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On ‎02‎/‎26‎/‎2018 at 11:44 AM, R1R2 said:

I don't think you are violating any regulatory requirement to return blood within 30 minutes if they can't start the unit and they still want to transfuse.   I think you are correct in encouraging them to complete within 4 hours instead of returning to BB and almost certain discard by BB. 

You have to validate how you are going to return released units to inventory.  My studies indicate that the unit reaches 10C in ~15 minutes.  We will accept an unaltered unit back within 15 min of release.  Longer than that the unit is discarded. 

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1 hour ago, David Saikin said:

You have to validate how you are going to return released units to inventory.  My studies indicate that the unit reaches 10C in ~15 minutes.  We will accept an unaltered unit back within 15 min of release.  Longer than that the unit is discarded. 

Just remember that one cannot be sure what sort of conditions the unit was kept  under while away from the blood bank, whether it was away for 5, 15 or 30 minutes.  So a particular unit may or may not be OK to put back into stock, regardless of any validation one has done with units sitting out on the BB bench at a normal room temp.  This is where those little blood safe stickers come in.

Scott

 

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  • 3 weeks later...
On 2/26/2018 at 7:42 AM, AMcCord said:

Exactly this. We own the blood, so we make the policy. We give them 15 minutes for returns with the proviso that the unit has not been spiked and the temp is less than 10C (which it usually isn't) or it is not returnable for restock/reissue. If the temp is too high, they are given the option of taking it back upstairs to try to give it within 4 hours of checkout. If the transfusion has been cancelled, we take it and discard it. If we discard it, it becomes an occurrence report that hospital quality and nursing management see.

In actuality, the temp should probably be less than 6C, since that is the required temp for storage. I've almost got my medical director convinced to make blood non-returnable - you've got 4 hours to give it once checked out...period. We do require them to have everything, and I do mean everything in place before they check out a unit, then they have 15 minutes to start infusion. That time is policed by nursing and they are all very aware of it. We waste very very few units of blood because of returns, usually because the patient suddenly decides to refuse or the patient's condition changes very unexpectedly. It's taken us quite a few years to get to this point, but it was worth the struggle. It's pretty well ingrained now.

How do you ensure they have everything in place prior to issuing the unit? It's very very rare but we do get the occasional, "we forgot consent". 

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All the pretransfusion requirements are built into the electronic transfusion flowsheet, so they have a checklist that has to be completed. This is emphasized during orientation training and during their annual transfusion education. We suggested making them mandatory entries, however nursing service refused because 'that would be setting them up for failure' :blink: Oh well................The flowsheets are reviewed by someone on their end for completion, so there is follow up with the transfusionist. If there is a problem/product return, I review the flowsheet and chart. If there is something missing that should have been there prior to product checkout, we fill out an occurrence report which goes to the appropriate nursing manager and quality. This has improved compliance dramatically - not perfect, but very good.

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