Labeling auto units

[slc7067]

My facility collects autologous units for in-house transfusion only. Our current practice is to create the ISBT label before the collection without the blood type quadrant on a stand-alone ISBT label printer. The phlebotomist places this label on the unit at the time of collection, and later in the blood bank when the unit has been typed, we create a new full-face label, now including the blood type and place it over the original label (we leave the original unit number exposed). Some of the blood bankers are uncomfortable covering up any part of the original label and feel that creating a new label is an opportunity to make an error. They would prefer that we place a blood type sticker on the blank quandrant. Does anyone have any thoughts on this? Any experience with the FDA or AABB concerning a situation like this?

Thanks,

Sandi

[Pat Distler]

The only thing you cannot over-label is the Donation Identification Number [FDA requirement based on 21 CFR 606.121 (]. You indicate you leave this exposed (not over-labeled) so that is good. It is okay to overlabel other things. So the practice you describe is acceptable. Many facilities prefer to do as you describe since (when computer controlled) they can be assured addtional labels (e.g., CMV neg, VOLUNTEER DONOR, facility name and location) have been added when the full 4" x 4" label is applied.

[Eagle Eye]

Pat I thought you can not over-label blood type??

[lcubed]

I was also under the impression that you could not over-label the blood type. We required Digi-Trax to produce new full-size labels for use that were perforated for all quadrants so that we would not over-label the blood type after a change to the unit.

[SMW]

The ABO/Rh label has been over-labeled for years using the Codabar system. Since the expiration date is computer generated/calculated and present on the ABO/Rh label, any time a product was/is modified and the expiration date changed, e.g. to an irradiated product, a new ABO/Rh/expiration date label was/is generated and placed over the previous label (as was/is with the product code label). The label verification process is then completed (electronically) with the new label. This process, other than the location of the information on the final label, essentially has not changed with ISBT.

[lcubed]

I agree about the Codabar part of that, but it was specifically on this forum (BB Talk) that we found the information relating to NOT over-labeling the ISBT 128 ABORh quadrant. Just looking for some specific clarification.

[SMW]

..well since Pat Distler is the Technical Director of ICCBBA and ICCBBA made the rules, it looks like you have your clarification! The only thing you cannot over-label is the DIN. You can choose if you want to re-print and re-label the entire 4x4 label, or you can choose to print and over-label using a 2x4 label, or you can print and over-label portions using a 2x2 label.........as long as the DIN is not overlabeled. Sometimes it's nice to have options.

[Pat Distler]

I'm so sorry!!!! I made to broad of a statement. Per 21 CFR 606.121(, you cannot overlabel the ABO/Rh on the label applied by the collection processing facility. You can overlabel your OWN ABO/Rh--you have the records to support the accuracy of the over-label. I made too broad of a statement when answering a specific question about labeling an autologous unit collected within the person's own facility.

I apologize for the confusion!!!!!!!

[katrap]

As I review ISBT ABO/Rh, I see there are 8 codes for each ABO/Rh, auto only, directed crossover etc. So, since you can only relable the ABO/Rh of your own facility, does this mean that directed and auto units collected at another facility can not be crossed over?

[Pat Distler]

AABB Standards (5.4.4.5) state that autologous units shall be reserved for autologous transfusion. My interpretation of this is that they really shouldn't be crossed over except for unusual (medically justified) reasons. In this case, I think you would have to return them to the collection center for re-labeling (unless it was a dire emergency).

If the collecting facility has labeled the unit for Directed Use Only or Directed Collection/Biohazardous, then it may only be used for the directed patient.

There is an option for Directed, Eligible for Crossover in ISBT 128, but that option is not used in the US because we cannot over-label the ABO/Rh of another facility. In the US, directed units eligible for crossover will have a standard ABO/Rh. They will also have a tie tag (or affixed label) indicating the patient for whom the unit was collected. They may (and may not) also have "directed donation" encoded into the product code. These units may, of course, be crossed over. The choice to use a standard ABO/Rh label on directed units eligible for crossover in the US was made especially because of 21 CFR 606.121 (. The advisory group that made the decision wanted to allow these units to be crossed over without having to return them to the collection facility for re-labeling.

[lcubed]

I appreciate the clarification on this matter. We seem to have actually understood correctly and done the right thing. Thank you Pat.