Directed/Designated/Dedicated

[n.peters]

We receive Designated Units from our supplier with an ISBT 128 donation type code of “4†and labeled with a “For Designated Recipient Only†Label. The supplier’s policy states that units labeled as Designated Units are eligible for crossover.

Questions:

1. Is the unit correctly labeled with a Donation Type Code “4†or should the unit be labeled with Donation Type “Dâ€.

2. If the unit labeled with Donation Type “4†is crossed over, should it be relabeled since the label states “For Designated Recipient Onlyâ€.

3. If relabeling is appropriate, should it be Donation Type ‘V†or “Dâ€.

4. Our supplier is suggesting we relabel the unit. Is this appropriate since we have not altered the unit.

[DHarts]

This is an issue I have been meaning to bring up for a while. My thought is that an Intended use donation type should never be changed even if crossed over for allogeneic use. However, I can't seem to find this ruling on the ICCBBA website. Pat Distler - we need a ruling here! If a Unit is Designated for Directed Use only, why would you crossover that unit? It would seem to me that you have a conflict that needs to be resolved.

Also, I have read that in the United States, we are not using the Directed encoding in the ABO/Rh barcode. Since the Digi-trax software will change the ABO/Rh to the encoded barcode when Directed is selected, should we be choosing non-specified for ABO/Rh when using this software? I would love it if someone could point me to references for these issues.

Dawn

[Pat Distler]

First, we need to differentiate between a designated unit and a directed unit. A designated unit is one from a donor selected by the collection facility because it has some special value to the recepient--e.g., it's an HLA-matched platelet, or perhaps a cellular therapy product that is carefully matched to the intended recipient. Directed is when the patient has selected his donor (family member, friend, etc.) and asked them to donate a unit of blood. These definitions can be found in the US Consensus Standard, page viii (beginning of the document).

So, 4 in the product code is for a designated donation. Is this how it is being used? This product could logically be crossed over. If it's an HLA-matched platelet, and the intended recipient didn't use it, you would certainly would not want to waste it. (For cellular therapy, even if it could be crossed over, it's unlikely that another patient could use it.)

Relabeling (affixing a new product code) or not is up to you. It is not required--the 4 merely shows a history of having been drawn as a designated unit. However, if you choose to relabel it, a "V" would be appropriate. A "D" (directed) is not appropriate for a unit that was collected as a designated.

Had it been labeled with a "D" for directed, you also have the choice of whether or not to re-label. Again, "V" would be appropirate. Leaving the "D" label merely shows the unit was originally collected as a directed donation.

We are not using "directed, for crossover" codes in the ABO/Rh in the US. This is because it would make the ABO/Rh look very different--and you'd almost have to re-label the ABO/Rh if you wanted to cross it over. Not only is there a risk to overlabeling the ABO/Rh, I interpret 21 CFR 606.121 ( to indicate you shouldn't be obscuring the ABO/Rh of the collection facility. So, to avoid the need to over-label the ABO/Rh, the US chose not to encode "directed, eligible for crossover" into the ABO/Rh. (It can be encoded in the product code, as is discussed in this thread). Other directed types are infrequently used in the US (directed, not eligible for cross-over or directed, biohazard). Because these units cannot be crossed over, it's okay that the ABO/Rh label shows it's intended for one, and only one, patient.

I'm not familiar with this aspect of the Digi-Trax software, and defer this question to Richard Kriozere. Richard?

[DHarts]

Pat,

I'm sure many of us will be grateful for your detailed explaination. You are an amazing resource! I will need to take another look at 21 CFR 606.121 (. This may put a different spin on using full face labels for re-labeling units.

Thank you,

Dawn

[Mabel Adams]

Pat, could you explain Dedicated units as well? Thanks.

[Pat Distler]

Dedicated units are when a donor is allowed to donate more frequently than the usual 8 weeks for whole blood because of the special value of the units to the patient. This is most common when a parent is donating small amounts of blood on a weekly basis for a sick infant. Dad comes in once a week and gives 100 mL, for example. As long as his hematocrit is acceptable (or with medical exception), he donates weekly. His blood is used exclusively for one patient, his child.

The blood might well be eligible for crossover, but you wouldn't want to cross it over routinely. If you did, it might appear as if you were violating the 8-week rule without good cause.

On the issue of 21 CFR 606.121 (. I understand that during the transition from Codabar to ISBT 128, FDA will allow some over-labeling of non-product code information. This is so that facilities can deal with blood suppliers being out of synch on converting (some converting earlier than others). However, this flexibility shouldn't extend to overlabeling an ISBT 128 label with another ISBT 128 label, as was described in the scenario above.

[DHarts]

Thanks again Pat.

Just to be clear. Are you saying that the use of full face labels (labels with all 4 barcodes) will be an FDA violaton if used to re-label ISBT to ISBT modified products? (Example: Thawed plasma where both the product code and expiration will be different)

Should facilities that modify products be opting for quadrant labels instead?

I am curious to hear from sites that are already live on ISBT on how they are handling their labels for modifications.

Dawn

[Pat Distler]

I think we need to pose that question to the FDA, since I'm only interpreting this regulation. I will see what I can find out about their current thinking, but this may take a few days.

[Eagle Eye]

Following is my undersatnding.

I thought we can use full face label for split product.

For modified product we need to change 2nd quadrant(product code). We may opt to change 4th quadrant/expiration date. No need to apply label " processed by" if not shipping out.

[Pat Distler]

I've checked with the FDA and it seems my interpretation of 21 CFR 606.121 ( is a reasonable one. The regulation reads, "The label provided by the collectiong facility and the initial processing facilty shall not be removed, altered, or obscured except that the label may be altered to indicate the proper name and other information required to identify accurately the contents of a container after blood components have been prepared." This allows you to over-label the product information, and the expiration date as needed, but does not really say you can over-label the ABO/Rh. The safe bet on interpreting this is that ABO/Rh of the collecting facility (or initial processing facility) should not be over-labeled.

As I said above, this is for when you over-label an ISBT 128 label with another ISBT 128 label (or Codabar over a Codabar label, for that matter). I understand that flexibility exists when you're dealing with transition issues of having part of your inventory in Codabar and part in ISBT 128.

I also agree with the comment just above this. If you are dividing a product (into a different bag or syringe) you will be using the full 4" x 4" label and it's not an issue of over-labeling the collecting facility's ABO/Rh.