My apologies ahead of time in that I know this has been discussed in previous threads (just can't locate it quickly right now).

I believe that historically we have all stipulated a set time-frame (often 30 mins.) in which we would take back blood products issued to a Nursing Unit and returned. But I think that somewhere in the back of my mind, I also recall a discussion to the effect of the FDA stating that this is no longer acceptable; that we should be determining the actual temperature upon return (which then brought in the discussions about the best methods to accomplish this; i.e. an Infrared Thermometer was mentioned by several people).

Questions:

1. Does anyone recall these specific discussions (under which category; approx. dates; etc)?

2. Is this an actual FDA requirement at this point (or in the immediate future)? If yes, please provide the

reference.

Thanks,

Brenda Hutson, CLS(ASCP)SBB

There has never been an AABB Standard that allowed for 30 minutes, nor do I believe the FDA ever had a ruling allowing it.

There was a very old AIM (Accreditation Information Manual) citation that described this - so technically it has never been approved.

We do not measure the temp of any returned products, we validated that RBC's returned within 30 minutes were acceptable for re-issue.

Right; the AABB just said we needed to have a Policy and gave an example of 30 mins. However, what I seem to recall from "at least" one other thread was that the FDA was now saying that we had to actually take the temperature of units returned (not units in coolers with temp. monitors; but rather those that were picked up for a Nursing unit and returned). If that is an actually requirement by the FDA (either recently, or in the near future), I am trying to find that reference.

Thanks,

Brenda Hutson

If I remember correctly it is/was the AABB Standards that says blood returned to the transfusion service must meet certain criteria for reissue and one of the criteria is that the temperature of the blood must be less than 10oC. There were other criteria as well.

Cliff, I would really like to see your data that shows blood returned at 29 minutes is <10oC. Most, if not all, of the blood we had returned at >15 min was well over 10oC. Was your validation for blood in coolers or just sent out exposed to room temp? We took the temp of every unit returned not in a cooler. If it was >10oC it was held until 4 hours after the initial issue and then discarded. The nurses were told that if they could get the unit transfused within the original 4 hours we would reissue it. Otherwise it was lost. Luckily we had very few units returned, especially during the short time I was allowed to charge the nursing unit for units wasted because of their incompetence. (That didn't last long, the lab director didn't want to upset the nurse managers and the VP over both didn't like what it showed on his nurses budgets!!)

We do not take the temperature of the units returned in coolers for 2 reasons:

1. We put irreversible temp. monitors on all of the units going into coolers

2. We validate the coolers annually

As far as the 4 hours to transfuse; we have had a policy that blood must be returned within 30 mins. to be accepted back into the Transfusion Service (though this is the question at hand). If Nursing sends for the blood before they were ready (i.e. IV site ready; etc; which they shouldn't be doing) and they want to return it to be given later, my policy is:

1. If it has been < 30 mins., it can be returned (but I am going to change this once I figure out what is required and/or the standard of practice)

2. If it has been >30 mins., they are told that if they think they can transfuse the blood within 4 hours from the time it was issued from the Transfusion Service, then they should just keep it on the floor and do so; because if they return it to use, we are going to ahve to discard it.

Brenda Hutson

The 30 minute rule has been a subject of much discussion since the introduction of the Blood Quality and Saftey Regulations and the following clarification was given on www.transfusionguidelines.org.uk

Clarification on the "30 minute rule" and reports to SABRE

There has been some uncertainty regarding the requirement for SAE reports which involve units out of cold chain storage.

The "30 minute rule" is the customary limit accepted in the UK as the time allowed out of controlled storage, which if not exceeded, can allow the unit to be replaced back into controlled storage for re-use.

See Joint UKBTS/NIBSC Professional Advisory Committee- Deviations from. 4C temperature storage for red cells: effect on viability and bacterial growth, February 2005

Scenario 1:

Unit taken to ward, decision made not to transfuse and unit returned to the issue fridge. The unit has been out of controlled storage for 45 minutes and is replaced into the issue fridge for re-use.

As the time out of controlled storage is greater than 30 minutes, the pack should not be returned to the fridge and this should be reported as an SAE.

Scenario 2:

Unit of red blood cells taken from controlled storage but transfusion not started within 30 minutes. However, clinical decision taken to proceed and unit subsequently transfused within 4 hours of removal from controlled storage. Handbook of Transfusion Medicine (4th edition) states:

Administration Use blood administration set; complete the infusion within four hours of removal from controlled temperature storage (see Table 2)

This is not reportable as an SAE

Scenario 3:

Unit taken from controlled storage, transfusion started within 30 minutes but not completed until more than 4hours after removal from controlled storage

This is not reportable to MHRA as an SAE, as it is a 'clinical' error outwith the remit of the BSQR

A hospital may raise a local incident report due to breach of a local guideline (e.g. where a limit is specified between removal of blood from controlled storage and time of commencing transfusion). This is acceptable, however national guidance (BCSH Handbook) is that transfusion must be 'started as soon as possible and completed within 4 hours of removal from storage'.

there was a article in TRansfusion regarding study on how long does it take for a unit to reach >6 C? It was in last 6 month..I need to look at it then I will post it here...unless someone else gets hold of it before me!!

Of course the 30min rule is based on an adult size pack of red cells and really should not apply to paediatric red cells (50ml vol) used in the UK.

We currently use 30 minutes, but are in the process of transitioning to taking the temp of the unit upon return to fully comply with the "less than 10 degree" regulation. We just purchased a Temp Check, and in the process of validating it, a unit of red cells was returned to us at 27 minutes (met our current criteria for return by 3 minutes). On the Temp Check it measured 13 degrees, so that proved it for me, and the unit was discarded.

If a nurse calls to say that they can't transfuse it immediately, and they still have the unit, we remind them that they have the total 4 hours to get it transfused. If it is returned to us now, it will likely be discarded.

Thank you all for your input. And again, I know this was discussed in at least 1 previous thread and I seem to recall that the FDA was moving in the direction of stating that we had to take the temperature of units returned from the nursing units; not just give some time-frame at which we will take them back. If any of you recall where that thread was and/or have some data to reference, that would be most helpful!

Thanks,

Brenda Hutson

It seems that if we all use more descriptive titles for the threads, we might be able to find them again in the future. As I recently started watching this site more and more, it has become apparent that when the title isn't specific it makes it really hard to pick the subjects we would like to view that are applicable to our situation. Is there a way to re-title the thread that is more specific?

One transfusion service I know has set their HCLL computer system to allow return of units if within 30 min of issue. That was probably based on the policy set in the past based on something common at the time. It is unfortunate that it seems so difficult to find out what we are really supposed to be doing until some inspector cites the lab.

The CAP requires certain things, Joint Commission isn't as specific... not all are inspected by FDA, but we want to follow those rules too...and here we find out about other countries. Is it any wonder that different labs have so many different requirements and processes? No wonder we get stressed out!!

Well said! And I am certainly guilty of improper titles; this thread being a perfect example!!

I was just hoping someone remembered where it was. I have been so swamped that I have not even been able to visit this site for some time.

But I am very grateful to all of you for your time (and hopefully in the near future, I can spend time on the site again, offering my 2 cents).

Brenda Hutson

Brenda,

The thread became quite lengthy but is titled "Return to Blood Bank Policy" and began 3/31/2010. John Staley gave the basis for the 30 minute time frame in post #6 of this thread. Bottom line is several posters began looking for thermometers to perform an instant check at the time of return to determine if the unit was still <10 degrees C at the time of return. Hope this helps!

Thank you very much for locating that!

And I for one will heed the excellent suggestion in this Thread with regard to relevant titles! I also appreciate all of the responses; especially given that I have not had time to visit this website in some time and offer my two cents worth (after all, it is a give and take process). I hope to return regularly soon!

Thanks,

Brenda Hutson, CLS(ASCP)SBB

It seems that if we all use more descriptive titles for the threads, we might be able to find them again in the future. As I recently started watching this site more and more, it has become apparent that when the title isn't specific it makes it really hard to pick the subjects we would like to view that are applicable to our situation. Is there a way to re-title the thread that is more specific?

Good suggestion, done.