We are changing our neonatal aliquoting procedures, moving from bags to prefiltered syringes. Per the supplier of our syringe sets, LRC aliquots should be given 24 hour dating and SDPs 4 hours. Other than this direction from the manufacturer, I am unable to locate additional current references/guidance on this topic. I have one old (1996) AABB document that makes a passing reference to RBC aliquots in syringes having a 4 hour limit. Can anyone give any direction on this?

This sounds like straight forward aaBB Standards for product dating of open system products. Look at the chart in the back of Section 5.0, Reference Standard 5.1.8A.

Not that straight-forward, sorry. My fault...I forgot to mention that we are using a sterile connecting device, so we have a functionally closed system. If we were making aliquots into bags with the SCD, the aliquot would retain the primary unit dating. I believe the syringe set manufacturer states the 24 hour limit due to the change in O2 permeability of the syringe. I just want to know if anyone has any independent references on this. Another hospital that I know of applies a 4 hour limit to syringe aliquots created this way, despite the manufacturer recommendation of 24 hours.

We use a 6 hour outdate. No references but mainly a preference. We

have a SCD but felt the potential risk of bacterial growth should limit the syringe time. Our other argument was the syringe is hard plastic and did not have the same characteristics as the original storage bag. For platelets we are also using a 6 hour OD and have validated that with pH and swirling.

For syringe aliquots, we also use the 24 hour exp. for RBCs and FFP, a 6 hour exp. for cryo, and a 4 hour exp. for platelets (aliquoted using a sterile connecting device). I couldn't find any published data on how long these products maintain acceptable viability after being moved into a sterile hard plastic syringe, but it sounds like we are pretty much in line with others. We do a lot of syringe aliquoting since we are a pediatric hospital and everything ordered with a volume of 50 mL or less for patients in NICU or PICU automatically gets aliquoted into a syringe.

We set a 4 hour outdate on the syringes just to be very conservative. We never load the syringe until we receive an order to transfuse. We use syringes that have an inline filter so the nurses don't have to infuse with a filter. We use an SCD to attach the syringe set to the unit and will assign one baby per unit until it is eiather gone or outdates.

The pedi syringe is an unlicensed product therefore the aliquot has a 4 hour expiration.

This came up during an AABB inspection at my facility.

"The pedi syringe is an unlicensed product therefore the aliquot has a 4 hour expiration." What's being an unlicensed product got to do with it? At a blood bank I used to supervise all of our products were unlicensed becasue we didn't ship interstate. Did the assessor have a reference for you or just something they pulled out of their hat?

Syringe aliquotes : we prepare SCD aliquotes for our neonates of RBC,platelets and plasma. We use the 4 Hrs limit for better control and because our viability studies for irradiated RBC's and PC. were done within that timing . However i can not see why not 6 Hrs.We did report to AABB IN 1997.

There are no studies to show viability for longer periods.

DR J.Werch

Medical Director Transf.Service

Ben Taub Gen.

Thank you all for your input, although now the issue appears to be murkier than ever! Appropriate for the kind of day I'm having..haha! Dr Werch, do you have any references you can point me towards regarding the viability studies? I can always be conservative and go with the 4 hr limit; generally we make aliquots immediately prior to use anyway. However, it's always nice to have a little breathing room for those times when things don't go as planned! I was originally hoping to go with the 24 hour manufacturer recommendation; am in the process of trying to obtain information from them regarding the basis for their claim.

The inspector did not quote me a reference.

I should have said unlicensed container that is why the 4 hour expiration time.

I believe that these aliquots would fall under the same guidance as any unit that has been entered. Any refrigerated units (packed cells) that has been entered for any reason is given a 24 hour expiration date. These syringes are like a unit that has been entered, so at our facility we give them a 24 hour outdate.

We also keep the rbc syringes (using a SCD) for 24 hours and the platelets for 4 as the syringe manufacturer suggests. However, it is rare for the rbc syringe to sit for that long as we prepare them as needed. Most are used within several hours. Not sure about that AABB reference regarding an "unlicensed product". I would think that as long as you are not transferring to another facility it is a non-issue. Good luck!