>30 MINUTE RULE

[tbostock]

(Ditto except the FDA forced us change the criteria to 1-6oC because the unit is considerd 'stored' not 'transported' once it has stopped moving from one place to another. (Someday they will fix this unsubstantiated dual temperature requirement.)

Wow...ridiculous since nursing cannot "store" blood. So that would make all of my units trash when they are returned, even if immediately. What a waste. {{{sigh}}}

[bmarotto]

Just tell them to keep those units moving at all times until they hang them.  We issue our units in insulated lunch bags with small cold packs.  Grab that bag by the handle and constantly swing it back and forth.  Yup, that is just as ridiculous as the dual temperature requiement.  Can anyone honestly say when they are receiving blood that the temperature does not exceed 6C?  Unless you are in a cold room when you unpack, pull segments, and log the units in....  

[bmarotto]

Here is a short video about the 30 minute rule. 

 

http://transfusionnews.com/2013/06/30/video-30-minute-rule-for-rbc-temperature-control-may-be-too-restrictive/

[Shelby56]

We also had to change from the 30 minute rule to taking the temps of RBCs and also had to establish a 1-6 C for returned (considered storage) vs 1- 10 C if "in transport". All of the returns which are not in coolers are out of temp when returned within 30 mins and we cannot accept Apheresis Plts at all due to documentation issues regarding their storage while out of our control for periods of time, esp the OR which tends to place items in coolers even with the "room temperature" stickers on them lol. Would love to see more studies regarding the 60 minute return would save alot on wastage.

[Clarest]

It happened to us last week when a unit of packed red blood cells was returned to us. The unit was out of blood bank for less than 30 min, however, the temperature of the unit itself was 14.5C. We checked our provincial standard (in Canada) and it states that the unit can be returned back to inventory if the unit is out of temperature-controlled area for less than 30min, or the temperature of unit is between 1-10C. So, we decided to accept the unit back to our inventory. Any other thought on this practice?

[SMW]

Once you took the temperature and the temperature was outside the acceptable range, it should be a goner.  If you have a validated procedure to defend the 30-minute time frame and did not take the temperature then you might  have been OK.  However, once you have documentation that you have a non-conforming product, it should be considered unacceptable and discarded.

[AMcCord]

Agree, the unit shouldn't have been accepted back into stock. The more stringent requirement under the circumstance is the one you should accept - the temperature, not the time.

[tbostock]

Yes, always the more stringent requirement as AMcCord says above.  The 30 minute "rule" never was a rule at all and is obsolete.

[profbaud]

The "30 minute" rule used to be included in the Technical manual years ago but then was taken out.  If you have CAP accreditation, there is a standard that asks about your return policy.  it must be validated.  So we took several units of red cells over the course of a week and left them on the counter at RT taking the inital temperature and temp every 5 minutes with a calibrated thermometer and discovered the units warm up to over 6 C after 15 min so we updated our policy and sent memos to Nursing and OR about the new rule change.  10 C is too high, that is transport temperature and taking a unit to the floor does not fall under that category.  The unit should not go above your storage temp of 6 C.

[Eagle Eye]

the unit temp was 14.5 so should have been discarded...

[Brenda K Hutson]

We won't take the unit back at that point (> 30 mins. and/or out of temp. range), but do point out to them that they have 4 hours in which to transfuse it; so if they think they can, they should keep the unit; otherwise, send it back to us for discard.

Brenda Hutson

[Auntie-D]

Here's on for you, if someone thaws some FFP and it is accidentally left on the thawer - how long is 'OK'.

[aafrin]

Once thawed FFPs should be transfused within 24 hours. After that they have to be discarded. Thawed FFPs have to be stored at 2-6C.

[Auntie-D]

Aafrin - I don't mean that. If the plasma is left on the thawer (at 38oC) for an hour and a half is it classed as 'cooked'? If so, how long over the thaw time is considered acceptable? If not, how long can it stay on the thawer before it needs to be wasted.

 

We threw the bags away - unfortunately they were 2 MB treated ones priced at £180...

[Malcolm Needs ☆]

I know that this will be of little use to anyone living outside of the UK (unless they can get funding), but Dr. Rebecca Cardigan, NHSBT Head of Component Development, will be giving a lecture entitled, "The 30 minute rule; myth or reality?" between 09.00 and 09.30 on Tuesday 29th September 2015 at the IBMS Congress in Birmingham if anyone wants to come along and get the latest information.

[Auntie-D]

I'd love to come but I bet I won't get a chance (again). I never get to go on anything interesting - I got to go to the coagulation NEQAS once, that was a laugh a minute... **Stomps feet and has a paddy at not being able to go to anything interesting**

[mollyredone]

We do as Brenda does.

[kirkaw]

I am interested in the 'overcooked' plasma issue too. I was taught in school (>20 years ago) that it was better to massage the last ice crystals out of a unit of plasma rather than let it get too warm when thawing. What is current philosphy on this?

 

As for the 30-min. rule, there was a talk on this at the AABB annual conference and there was a lot of science presented but a lot of people argued that the studies did not correspond to 'real life' scenarios. At our hopsital, we still adhere to the 30 min rule and/or take the temp of the unit before returning it to inventory.

[Joanne P. Scannell]

Ok, so perhaps once out of temp for an hour does 'no harm', how about twice, three times, four times, etc.

 

And I disagree with the unit staying within temperature for up to 60 minutes (were these in the days of 'whole blood'?).  We take the temperature of returned units and I have yet to see one last longer than 15 minutes 'out there in the unlimited unknown environments'.
 
Nevertheless, the very bottom line is: So what do you tell the FDA (or AABB or CAP) Inspector when they cite the 'store at 1-6oC, transport at 1-10oC' regulation?

[Auntie-D]

1-6? That's a very fine line between OK and frozen... In the UK we use 2-6

[profbaud]

The nursing policy should say that the unit must be transfused within 4 hrs, so if there is a delay in starting the unit, they know it still must be finished within 4 hrs of receiving it on the floor.  There is no more 30 min rule in the AABB Technical manual and in fact if your laboratory is accredited by College of American Pathologists [CAP], one of the checklist questions deals with return units and reissuing.  What ever time you decide must be validated because inspectors ask to see documentation.  When I did the validation for our hospital BB [300 bed], we found that after 15 min, the blood warms above 6 C so we changed our time to 15 min unspiked.