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Blood Returned to the lab >10 degrees C


NewBBSup

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I have in my procedures that if blood is returned to the blood bank from the floor and the temp is >10 C that we quaranteen the unit. (For example, lost the IV site.) We change the unit expiration to 4 hours from the original dispense time.  If the floor request the unit back we can issue to that patient IF the transfusion can be completed within 4 hours of the original dispense time.  Does anyone else do this?  My pathologist wants to discard the unit.  My thought is that if they can transfuse within 4 hours, it's ok.  I would appreciate any feedback.

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Your procedures are outdated and I agree with your pathologist.  Once an RBC unit exceeds 10C, it should be discarded per AABB, CAP, FDA.  We discard any returned units that have been spiked or if the outlet port covers have been opened, to that they may not be reissued...   

 

There have been extensive discussions on this website regarding this very issue.

Edited by Dansket
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I see discussions about the 30 min or 10 degree dilemma, but not this particular issue.  I'm not talking about if the unit has been spiked, this it is definitely discarded.  If the unit is issued to the floor and returns say 15 mintues later, the unit is 11 degrees, we change expiration to 4 hours from dispense and quaranteen the unit for only that patient.  Floor can re-request the unit as long and the transfusion can be completed within the 4 hour time frame from original dispense.  The unit never goes back to the general inventory.  They have 4 hours to complete the transfusion. 

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I see discussions about the 30 min or 10 degree dilemma, but not this particular issue.  I'm not talking about if the unit has been spiked, this it is definitely discarded.  If the unit is issued to the floor and returns say 15 mintues later, the unit is 11 degrees, we change expiration to 4 hours from dispense and quaranteen the unit for only that patient.  Floor can re-request the unit as long and the transfusion can be completed within the 4 hour time frame from original dispense.  The unit never goes back to the general inventory.  They have 4 hours to complete the transfusion. 

I believe that this IS allowed, if for that same patient.  But we don't do that, we discard all that come back >10°C.

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Here in the US, according to the FDA CFR640.2c3, we cannot issue a unit that has not been maintained at required temperatures ... we can take it back, but we cannot issue it.  Therefore, I believe it is a violation of this requirement to hold the unit in the BB and reissue it, even if it is for the same patient, even if it is within that 4 hour window.  BTW: The 4 hour limit is for the completion of the transfusion, not the start of it.

 

In addition, the FDA has told us during our most recent inspection that the CDC determined that once issued blood is delivered to the location, it is considered 'in storage', not 'in transport', therefore the 1-6oC temperature restriction applies.

 

Given those restrictions, when an attempt is made to return blood to us and the unit temperature is greater than 6oC, we tell the infusionist to keep it and try to get the transfusion completed within 4 hours of the issue time or we will take it but will have to discard the unit.  They usually opt to keep it ... and they usually get the transfusion accomplished in time.

 

I see no value to re-entering the unit then reissuing it other than to create busy work for everyone, set yourself up for a citation (if you are in the US), and create confusion. 

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We discard the unit.  If the set has been inserted, nursing has 4 hours to complete as much of the transfusion as possible.  For infection control purposes, units that have been entered must be discarded on the floor.

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Interesting... I like that you change the expiry date, but how do you make sure the nurse transfusing the blood gets the unit in before the 4 hour expiry?  I mean, they should know to transfuse all units of blood within 4 hours of issue from the lab.  But, if it is issued at 3 hours from the lab, they only have an hour.  How do you make sure that happens?

 

BTW, we discard all units returned that are >10 ºC.

 

Side question: do the people in the USA use degrees Celsius?  Just dawned on me that I've never seen Fahrenheit on this board!

s

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Interesting... I like that you change the expiry date, but how do you make sure the nurse transfusing the blood gets the unit in before the 4 hour expiry?  I mean, they should know to transfuse all units of blood within 4 hours of issue from the lab.  But, if it is issued at 3 hours from the lab, they only have an hour.  How do you make sure that happens?

 

BTW, we discard all units returned that are >10 ºC.

 

Side question: do the people in the USA use degrees Celsius?  Just dawned on me that I've never seen Fahrenheit on this board!

s

In the US, we use metrics in the lab - Celsius, grams, milliliters, centimeters, etc.  The 'outside world' uses Fahrenheit, pounds, cups, feet, etc. ... even nurses and MDs!  It would be nice to go metric 'out there', too!

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Interesting... I like that you change the expiry date, but how do you make sure the nurse transfusing the blood gets the unit in before the 4 hour expiry?  I mean, they should know to transfuse all units of blood within 4 hours of issue from the lab.  But, if it is issued at 3 hours from the lab, they only have an hour.  How do you make sure that happens?

 

BTW, we discard all units returned that are >10 ºC.

 

Side question: do the people in the USA use degrees Celsius?  Just dawned on me that I've never seen Fahrenheit on this board!

s

 

"How do you make sure that happens?".    This is a quality control function.  We monitor this on a monthly basis and report deviations to the Blood Utilization Committee quarterly.  Nursing Directors sit on this committee.  It is there job to report to their staffs regarding compliance with BBK policies and procedures.

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In the US, we use metrics in the lab - Celsius, grams, milliliters, centimeters, etc.  The 'outside world' uses Fahrenheit, pounds, cups, feet, etc. ... even nurses and MDs!  It would be nice to go metric 'out there', too!

There have been sporadic attempts to try to introduce more of the metric system into US culture but with very limited success. Once in a great while you'll see road signs that say "Boston 50 miles/80 kilometers", and most rulers have an inch scale on one side and a neglected centimeter scale on the other, but that's about it. Body temperature is 98.6o outside of the lab, kitchen fridges run at 39o. Interesting that hospital labs are about the only metric stronghold.

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I have in my procedures that if blood is returned to the blood bank from the floor and the temp is >10 C that we quaranteen the unit. (For example, lost the IV site.) We change the unit expiration to 4 hours from the original dispense time.  If the floor request the unit back we can issue to that patient IF the transfusion can be completed within 4 hours of the original dispense time.  Does anyone else do this?  My pathologist wants to discard the unit.  My thought is that if they can transfuse within 4 hours, it's ok.  I would appreciate any feedback.

 

I do this.  It only makes sense.  AND it was part and parcel of AABB a few years ago. (maybe more than a few).  The unit was going to hang and get >10C anyway.  The product is not going to be any more deleterious than if it was hanging.  Besides, the stuff is too precious to discard.  I have not had my policy challenged since it was written back in the late 1990's - at least 8 CAP inspections and also FDA.  I believe the original criteria documenting this was in the Accreditation Requirements Manual

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Thank you David for your feedback.  My thoughts exactly.  Unit warms to >10 anyway and the transfusion will be competed by 4 hours from original dispense.  My pathologist heard at a conference that we should not be taking back units >10 even if we will dispense to same patient and complying with the 4 hours rule.  Can' t get her on board with it.  We've now changed our policy to throw the unit away.  Thankfully it doesn't happen very often!  I've also just been through a CAP inspection with this policy in place and no deficiencies found.

Edited by NewBBSup
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Thank you David for your feedback.  My thoughts exactly.  Unit warms to >10 anyway and the transfusion will be competed by 4 hours from original dispense.  My pathologist heard at a conference that we should not be taking back units >10 even if we will dispense to same patient and complying with the 4 hours rule.  Can' t get her on board with it.  We've now changed our policy to throw the unit away.  Thankfully it doesn't happen very often!  I've also just been through a CAP inspection with this policy in place and no deficiencies found.

 

We don't take the unit back.  If they call us because the unit has been issued and the IV is not working, we ask if they can transfuse it within 4 hours of issue.  We make them keep it with them.  If they can't get it transfused within 4 hours we would discard it.

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If I remember correctly, our policy was very similar to Mollyredone's.  They kept the unit on the floor and transfused it up to the end of the 4 hour time limit from issue.  No reason to bring it back and then reissue.  Quarterly I reviewed every transfusion occurring during the month and one of the things I looked for was issue to completion times.  Granted, if this did not occur during the month I reviewed it would not be caught if the 4 hours were exceeded but at some point you need to have a little faith that other people actually attempt to follow policies and they were reminded of the 4 hour limit during the discussion of what to do with the unit initially.:ph34r:

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22 hours ago, John C. Staley said:

If I remember correctly, our policy was very similar to Mollyredone's.  They kept the unit on the floor and transfused it up to the end of the 4 hour time limit from issue.  No reason to bring it back and then reissue.  Quarterly I reviewed every transfusion occurring during the month and one of the things I looked for was issue to completion times.  Granted, if this did not occur during the month I reviewed it would not be caught if the 4 hours were exceeded but at some point you need to have a little faith that other people actually attempt to follow policies and they were reminded of the 4 hour limit during the discussion of what to do with the unit initially.:ph34r:

makes sense too

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There was a session at AABB that was somewhat contentious regarding storage/transport temps, validations, etc. One of the presenters said that they do the exact thing described by NewBBSup.  If I can ever figure out how to retrieve my Sync-to-Slide, I'll verify!  I managed to scribble the session number down:  9108-QE.

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Do blood transfusions still have to start within 30 minutes of leaving the blood bank?

 

If so,

If they have trouble with the IV site and you tell them to keep the unit but finish within the 4 hours do they get penalized for not starting within the 30 minutes?

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12 hours ago, amym1586 said:

Do blood transfusions still have to start within 30 minutes of leaving the blood bank?

 

If so,

If they have trouble with the IV site and you tell them to keep the unit but finish within the 4 hours do they get penalized for not starting within the 30 minutes?

It depends on how their policy is written and how stringent the nursing reviewers are - if they documented issues with an IV (or something else legit), I wouldn't nick them for that. I would, however, make sure the infusion was complete in 4 hours.

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1 hour ago, AMcCord said:

It depends on how their policy is written and how stringent the nursing reviewers are - if they documented issues with an IV (or something else legit), I wouldn't nick them for that. I would, however, make sure the infusion was complete in 4 hours.

Gotcha,   I pull a percentage of transfusion slips every month and my pathologist checks all the info. So, I'd have to check with him I suppose about how lenient we are with those numbers.   

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