Exchange Transfusion and the Dreaded Bag Label

[Bob M]

Owing to the FDA "bar code readable" requirement when signing out blood products from the lab, how is everyone coping with a neonatologist who requires a 40% Hematocrit unit (for example) in an Exchange Transfusion?

The usual course of events, for most I suspect, is an O Neg, Irradiated, CMV Neg, CPDA Packed Cell diluted to 40% Hct with a thawed AB FFP. If the lab transfers the FFP in to the red cell bag, I am assuming that is "making a product", and would require that the lab have an FDA facility code. It would also require a label printer able to output in both Codabar (for now) and ISBT (for now too?).

Are most of you with NICU's just issuing the units in their original configurations, and letting the NICU combine the products? If so, who in the NICU is performing that task, the MD or the RN? Do you give them a third satellite bag (say 600ml) to combine for the Exchange unit? How does the "combiner" in NICU know how much FFP to add to the Red Cells, and how do they measure that (e.g. scale, syringe, moist finger held to the wind)?

I was thinking that the 600ml Transfer Bag might be a messy proposition for the NICU folks, what with having to stab one unit, pull it out, and stab the second. So Baxter makes a plasma transfer set with a double spike that could cleanly go in to the FFP and the PRBC at the same time. Then, the FFP could be gravity fed to the PRBC unit to get the final Hematocrit. Is this viable, or is there some legal problem with doing this?

Finally, how do you handle the expiration date conundrum? Do you label the units with a 4 hour outdate, knowing they are going to have to enter the bags? And on what unit(s) do you put this expiration information?

There.........................I feel better just getting that off my mind. Thanks for any help (and by the length of this post, you can sure tell I need it!).

[DLCarvalho]

As we gear up to ISBT, I was hoping you could share the resolution to your labeling issue.

[JoyDenver]

For ISBT I created (inconjunction with our blood supplier) a local "D" ISBT codes for the packed RBC and FFP products used in the exchange unit. We modify the original products to the unique "D" product codes then use our computer pooling function to pool the products.

The final Reconstituted Pooled Whole Blood product also has its own Local ISBT code.

Our blood supplier reconstitutes the units for us as we have no way to hyperpack a unit of RBCs ourselves; They supply us with the original unit numbers and product codes of the units used in the pooled unit, then we "pool" the unit in our computer adding our own Facility ISBT DIN to the Exchange unit.

[whbb]

At our facility, we combine the red cells and plasma together prior to issue. We use MEDITECH software, and elected to issue to the floor the reconstituted product. We use the component routine to create reconstituted blood. We manually transfuse the FFP stating the volume transfused plus that it was given as part of the reconstituted blood.

For our product label for ISBT, we were able to work with Shamrock labels to select the appropriate ISBT code to use which they made for us. Shamrock has stated that if there is an ISBT label that we want, as long as we provice the ICCBBA number for it, they will create it for us at the standard label price (not considered custom). Here is what our label says:

E5747V00

RECONSTITUTED

RED BLOOD CELLS

IRRADIATED

LEUKOCYTES REDUCED

PLASMA ADDED

Approx___mL Red Blood Cells

From 500 mL CPDA-1 Whole Blood and

___mL___ ___Plasma

Store at 1 to 6 C

You write the volume of red cells used AND the volume and Blood Type of the FFP used.

[Liz0316]

If your computer system cannot give you a new barcoded unit number when you "make" a new product, you can buy pre-printed labels. Be sure to keep a log.

Also, remember, unless you are AABB, it does not have to be ISBT - just barcode readable for the FDA. And, you don't have to be able to use (computer read) the bar-coded number for the FDA either; it just has to be "bar-code readable.

[DLCarvalho]

Thank you all for your suggestions. You've been most helpful.