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Specimen / Product outdate


Cliff

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What are your issuing policies regarding issuing products with regards to product / specimen outdate?

Let's say the specimen is going to expire at midnight, the red cell is still good for a couple of weeks, will you issue the product at 11:45pm knowing they will not infuse it before the outdate of the specimen?

Let's say you have a specimen that is good for a couple more days.  The patient requires a washed platelet.  It only has a four hour outdate from the time you start washing it.  It's going to outdate in 10 minutes, do you still issue it?

Now think of this with the mindset of issuing hundreds of products a day, so you can't work closely with the nurse who requested the thawed cryo to ensure they infuse it before the 6 hour limit.

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Let's say the specimen is going to expire at midnight, the red cell is still good for a couple of weeks, will you issue the product at 11:45pm knowing they will not infuse it before the outdate of the specimen? Yes, I would issue the product with 15 minutes left on the clock.  

The patient requires a washed platelet.  It only has a four hour outdate from the time you start washing it.  It's going to outdate in 10 minutes, do you still issue it?  Yes.  but transfusion must be started before product expiration per Circular of Information.     Close communication with nursing is important. 

 

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We would issue with 15 minutes left on the type and screen.  And, per the AABB's 2010 Ask the FDA and CLIA Transcript:

Question 34: The Circular of Information, for the Use of Human Blood and Blood Components, in the Instructions for Use section, item number 13 states: "Transfusion should be started before component expiration and (be) completed within 4 hours." What is the FDA's interpretation with regard to this instruction? For example, is it acceptable to start a component at 23:45 on the expiration date and allow the unit to be transfused for 4 hours (until 03:45 the next morning)?

MS. CIARALDI: Our regulations in 606.122 state that administration should start within four hours of entering the product. To us, this means that transfusion must be started within the shelf life of the unit. The length of time to hang a unit, specified in the Circular of Information, is four hours. We are aware that this may sometimes result in the transfusion ending after the unit has expired; however, we do not object to this practice.

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