We will be going to ISBT at the end of this month. We RARELY relabel a product so we are not getting any ISBT printers.

My question is if we have to split an RBC unit do we have to have ISBT labels for the split or can we still use our codabar labels? Our computer system can read both.

I eliminated splitting and pooling products from my SOP, so I wouldn't have to buy printers and register with ICCBBA. As I understand it, you have to go with ISBT, but you might be able to buy standard base label to make your own.

You must be registered with ICCBBA to have the rights to generate or use the ISBT128 barcodes. You are required to relabel splits of ISBT labeled units with ISBT labels. You are not required to relabel thawed products, although you can. Check the AABB website for their requirements. To my knowledge, they are the only ones requiring the transition to ISBT128.

IF you are splitting ISBT product, you have to relabel with ISBT barcodes. If you are splitting codabar(ARC units are still codabar), you can use codabar barcodes.

If you are using fresh frozen plasma only up to 24 after thawing you do not have to change product code or expiration date. If you are going to keep up to 5 days you need to to change product code barcode.

You can get preprinted labels from different companies....I do nto know how you are going to get expiration date barcode? we have digitrax and we print full face (4X4) ISBT label for our syringe.

We will be going to ISBT at the end of this month. We RARELY relabel a product so we are not getting any ISBT printers.

My question is if we have to split an RBC unit do we have to have ISBT labels for the split or can we still use our codabar labels? Our computer system can read both.

Remember that the AABB is the only agency (at this time) requiring the use of ISBT 128. The FDA requirement is as follows:

"21 CFR 606.121©(13) states the following information on labels must be machine readable as well as eye-readable after 4/26/2006.

Includes aliquoting,pooling, or relabeling

*Unique facility ID

*BUI (Donor Idenification Number or DIN)

*Product Code

*ABO/Rh

Does not include expiration dates

Does not differentiate between Codabar and ISBT 128"

We are a small hospital and we do not print any unit labels.

Traceability is the most important aspect of unit labelling. Although I found an AABB requirement that stated, if a facility receives a unit with a Codabar label, they MAY elect to use a Codabar OR ISBT 128 label for the DIN, I could not find a statement that said that the FDA required the use of an ISBT 128 DIN if the product was received with an ISBT 128 DIN.

You might want to speak with your blood supplier. We made an arrangement with them that if we requested a product (PC,FP,Platelet pheresis) that we knew was going to be divided for a neonate, they have a label printer available and they send extra barcode readable DIN labels with the product. Also keep in mind that this applies IF the modified product remains at your facility and is not transferred somewhere else.

Remember that when using ISBT 128, the DIN stays the same, and the product code changes. We had our label supplier (Shamrock, www.shamrocklabels.com), create product codes for our aliqouts of PC, FP, and Platelet pheresis that we place on our base label for our aliquot. Shamrock will create any exisiting ISBT 128 label. They are not considered a custom label even if you are the only one requesting it. We also purchased the blood type barcode labels. We kept our cost down by selecting only one product code for each of the three possible prouct types to aliquot. That is because we can trace any aliquot to the parent product.

PC:E0224VA0-E0224VH0

FP:E2701VA0-E2701VD0 (only asked for 4 divisions)

PLT:E3046VA0-E3046VD0 (only asked for 4 divisions)

We also had our computer guru create three labels we place on top of our base label when we make an aliquot:

*Blood Supplier(s) Source information including FDA reg/license

*Our Facility Source information including FDA reg for "furthur processed by"

*Exp. date:______________

I am validating the hematrax printer. Will I have to take in to account the different anticoagulants for each product modified?

Could I just create labels for the modified product, i.e thawed plasma, irradiated blood.

thanks,

es

Yes. Each anticoagulant (plus a lot of other differences) have separate product codes in ISBT. When those products are irradiated, the resulting product likewise has a separate product code. Your supplier should be able to provide you with a list of product codes it will supply and the appropriate irradiated code for each.

Thawed plasma (exp 24 hrs) does not need to be relabeled after thawing as long as you are using it in your own facility.

if you are keeping thawed plasma for 5 days, you need to re label with product code and expiration date. Product code for thawed plasma is different, even different code for each anticogulant used when collecting WB. (eg. CPD, CP2D etc.)

Thank you Mabel,

Can I use the codes from ICCABBA . I do not have the labels to validate from our blood providers only the product description.

Yes. Each anticoagulant (plus a lot of other differences) have separate product codes in ISBT. When those products are irradiated, the resulting product likewise has a separate product code. Your supplier should be able to provide you with a list of product codes it will supply and the appropriate irradiated code for each.

Thawed plasma (exp 24 hrs) does not need to be relabeled after thawing as long as you are using it in your own facility.

Are these the only product codes you receive from your supplier? Or are these the only ones you split?

PC:E0224VA0-E0224VH0

FP:E2701VA0-E2701VD0 (only asked for 4 divisions)

PLT:E3046VA0-E3046VD0 (only asked for 4 divisions)

The reason I ask is because we receive more than one product code for each poduct from our supplier.

We no longer split units. It was not worth the expense of the printer and the validation for 1-2 units per year. That was several years ago and we have not had any complaints. We tell the nursing staff that they have 4 hours to give as much of the unit as possible with the patient safety in mind for the rate of infusion. THey understand that this supercedes a physician order to transfuse over 6 hours.

Just for information purposes Digi-Trax has new smaller, low cost Zebra printers for the blood banks that don't do much labeling. HemaTrax on-demand PC stand-alone software available at a reasonabl price so you can utilize a single blank stock label for all requirements. One of these 4" x 4" labels has been designed with special back split so it can be used either as a full base label or with only section of adhesive exposed for use on syringes.

We no longer split units. It was not worth the expense of the printer and the validation for 1-2 units per year. That was several years ago and we have not had any complaints. We tell the nursing staff that they have 4 hours to give as much of the unit as possible with the patient safety in mind for the rate of infusion. THey understand that this supercedes a physician order to transfuse over 6 hours.

This is what we do and with similar responses from the nursing staff. The few times a physician has requested a prolonged infusion time over the last several years, the nurses informed them it's not allowed and it didn't seem to cause a problem. They don't seem to even ask any more. We rarely transfuse pediatric patients.