Modification of antigen negative units

[slc7067]

Our Red Cross region is just about to go live with ISBT labeling, and I have one last question about it.  It's my understanding that ARC will print antigen negative information in the very bottom right-hand quadrant, instead of the tie-tags that we used to get.  Except for the fact that it's almost microscopic print, I'm good with this, however, when we irradiate a unit, we print a "product/date and time" label that we place over the bottom half of the label--which will cover up the antigen info on the original.  We've talked about using scissors to snip off the blank part of the label that would cover the antigen info, but at this point, I'm not confident that it wouldn't interfere with the "further processing" statement.  We've also talked about creating an additional, separate sticker that we would place on the unit--something similar to the stickers we currently use to document when we do the antigen testing in-house, but no one likes the idea of covering up the original info on the label.  At this point our Digitrax software doesn't have the ability to print antigen information on labels, so I'm really stumped.  Has anyone out there solved this problem?  Are there FDA considerations that I haven't thought of?

 

Thanks in advance for any suggestions!

 

Sandi

[MAGNUM]

Printing the antigen information on the face label is not used in the US.

[tricore]

 

Printing the antigen information on the face label is not used in the US.

 That is what I thought. Is the ARC going to be the first?

[Mabel Adams]

I think our ARC may print CMV neg info there.  I guess that brings up the same issue.

[DOGLOVER]

check with your vendor. You may be able to buy label stock that the bottom right corner is perforated and stays behind when you peel the label off its backing. I have some, got them by accident and we are using them up. I am not in a Red Cross serviced area so haven't had to deal with this.

[Townsend]

We just saw this same post on our Sunquest list serve. I have verified with our Red Cross IRL Mgr that they WILL be putting the antigen information on the bottom right of the label. I also thought these were not being used in the US, so we hadn't even considered this yet even though we are only a few months away from implementation.

Like Sandy, I think we will continue to use a separate label attached with a tie tag. This is will also make it easier when the nurses are doing the bedside check - the font is so small!!!! Special label stock might be a good idea too, but I hate to get a pricier (custom?) label for something that won't be needed too often. We have the Digitrax labels with the syringe strip on the side and the DIN cutout. Not sure I want to add another pre-perforated cutout to that label.

Ugh, we keep saying that one day when we have made the complete switch to ISBT 128 that everything will be easier. As soon as I say that we find out something else that we will have to "work around". Still trying to figure out Recon. Whole Blood

Stephanie

[tricore]

I added a document to the library that ICCBBA sent to me when I inquired about reconstituted RBCs. I put it under forms.

Cliff, if that isn't the correct place to file please move it.

[Emwilson7]

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Edited May 20, 2013 by Emwilson7

[Malcolm Needs ☆]

Irradiated red cells..pptx

 

I'm not at all certain that I have attached this correctly, but you may be able to see, from this extremely old photograph, that it is still possible to see the antigens listed on the red cell pack, even when the irradiation label is attached.

[AMcCord]

Antigen typing information will definitely be on the bottom right corner of labels for blood from the ARC, below the statement 'Negative for Antibodies to CMV'. Hgb S status will be below the red cell antigen typing information.

 

I recently got a memo from our ARC region strongly suggesting the use of a tie tag for any labels we add to blood products. Have you checked with hospital services in your region to see what they suggest?

[slc7067]

Antigen typing information will definitely be on the bottom right corner of labels for blood from the ARC, below the statement 'Negative for Antibodies to CMV'. Hgb S status will be below the red cell antigen typing information.

 

I recently got a memo from our ARC region strongly suggesting the use of a tie tag for any labels we add to blood products. Have you checked with hospital services in your region to see what they suggest?

Do you mean that your ARC is suggesting tie tags for additional antigen labeling?  Or for all label changes? If you were labeling a syringe of antigen negative red cells, would you make a regular ISBT full face label, then attach a tie tag with the antigen negative information?  If you had to irradiate a full unit of antigen negative red cells, would you cover up the ARC antigen info with your irradiated label,  and add a tie tag?

 

Thanks so much to everyone for the replies!

[Malcolm Needs ☆]

If you had to irradiate a full unit of antigen negative red cells, would you cover up the ARC antigen info with your irradiated label,  and add a tie tag?

 

Slc7067, see the photograph I posted in post 9 of this thread.  You will see from it that you do not need to cover the red cell antigen information.

[AMcCord]

The tie tag recommendation was for the addition of 'stickers' added by hospitals (such as antigen typing and ABO/Rh recheck). Irradiation ? - since you would not be returning a unit you irradiated to the ARC, that's a different story. I would suggest contacting your region's hospital services for more detailed information about label placement for irradiation, but I would think that covering information on the original label wouldn't be a desirable thing to do. The tie tag recommendation is related only to actual units, not syringes.

[Mabel Adams]

What is a "syringe strip"?  This sounds like it could be useful for aliquots.

[Townsend]

Mabel - I am aware of at least two vendors which supply this type of label.  Digitrax and Shamrock both make 4x4 labels where only a strip of the backing is removed.  It is helpful for syringe label prep. if you are using any of the Hematrax printers.  Since you can't load more than one type of label per printer (without making a bunch of adjustments), we use the label with the syringe strip for all of our aliquots.  We just peel the entire label off when we are relabeling a bag.

 

Hope this is helpful for you,

Stephanie

[Mabel Adams]

That does help, Stephanie.  We will probably need lower quadrant labels (lower half really) for irradiating and also full labels for syringes so I expect we need at least 2 kinds of label stock.  Or is there a one-size-fits-all label stock that can be full face for syringes  or other aliquots and bottom two quadrants for modified (mostly irradiated) units?

[slc7067]

 

If you had to irradiate a full unit of antigen negative red cells, would you cover up the ARC antigen info with your irradiated label,  and add a tie tag?

 

Slc7067, see the photograph I posted in post 9 of this thread.  You will see from it that you do not need to cover the red cell antigen information.

 

Thanks Malcom, unfortunately, our ISBT labeling requirements involve recreating the bottom half of the label with a new product code and expiration date, as well as the Rad-Sure.

[slc7067]

That does help, Stephanie.  We will probably need lower quadrant labels (lower half really) for irradiating and also full labels for syringes so I expect we need at least 2 kinds of label stock.  Or is there a one-size-fits-all label stock that can be full face for syringes  or other aliquots and bottom two quadrants for modified (mostly irradiated) units?

Our site has 2 printers with 2 kinds of label stock, however if I had it to do over again, I would probably just print the full label on the label stock that has the DIN area perforated for everything.  We're printing product/date labels for units that we irradiate and for the parent unit when we make an aliquot, and we could easily have 2 people doing 2 types of modification at the same time.  With no DIN on the half label, it has to be scrutinized so carefully to make sure we get the right label on the right product, it makes me a little nervous.

[Eagle Eye]

I thought we can not re print Blood Type unless we are collecting facility??? I could be wrong!!!

[Mabel Adams]

As I understand it, we are not supposed to cover the original ABO/Rh label on a bag when we do a modification.  When we aliquot we have to label a blank bag or syringe so would have to print a full face label including ABO/Rh.  The other types discussed above are antigen types of K, E, c etc. that we don't really want to cover up but can't necessarily reprint on our expiration/ modifying facility quadrant label.

 

Maybe we just need a full face label and a pair of scissors!

[Mabel Adams]

Does anyone know if the Digitrax printer software in Haemonetics is being updated to be able to reprint the antigen information when we irradiate a unit that is labeled with it and need to cover the lower right quadrant label with one showing the modifying location?  Is this a Digitrax issue or a Haemonetics issue or both?

[tbostock]

 

I thought we can not re print Blood Type unless we are collecting facility??? I could be wrong!!!

 

Never heard of this; does anyone have a regulation they can quote for this? And would this still apply if my software has a label check function? When we thaw a unit of plasma, the new ISBT label prints, but then the software requires a label check, where you have to scan all quadrants of the label that you're putting on the unit. So blood type is checked against the blood type of the unit that was entered into inventory.

[goodchild]

 

 

Never heard of this; does anyone have a regulation they can quote for this? And would this still apply if my software has a label check function? When we thaw a unit of plasma, the new ISBT label prints, but then the software requires a label check, where you have to scan all quadrants of the label that you're putting on the unit. So blood type is checked against the blood type of the unit that was entered into inventory.

21 CFR 606.121

( The label provided by the collecting facility and the initial processing facility must not be removed, altered, or obscured, except that the label may be altered to indicate the proper name of the product, with any appropriate modifiers and attributes, and other information required to identify accurately the contents of a container after blood components considered finished products have been prepared.

 

What we do for things like thawed plasma:  print off the full face label, cut out the product name/expiration date, and relabel over those sections only so that the information is updated and machine-readable.

[Sandy L]

That does help, Stephanie.  We will probably need lower quadrant labels (lower half really) for irradiating and also full labels for syringes so I expect we need at least 2 kinds of label stock.  Or is there a one-size-fits-all label stock that can be full face for syringes  or other aliquots and bottom two quadrants for modified (mostly irradiated) units?

 

We use Digitrax (Hematrax interface to Cerner Millennium) to print our ISBT labels when we modify.  The labels we purchase from Digitrax are perforated along the 4 quadrants.  We print full face 4X4 inch labels for all modifications.  The labels are easily separated along the perforation lines (and we like them a lot).  If we are changing the product E code and expiration, we use the bottom 2 quadrants only to label.  The rule is NEVER cover up the DIN and ABO/Rh when just changing product and expiration.  We would not want to print only the bottom 2 quadrants in this situation.  We might be modifying multiple units at the same time (e.g. 4 units of thawed plasma) and they might have different E codes and volumes.  You need to have the DIN number to match the correct thawed plasma label to the correct unit, and then tear off the bottom 2 quadrants and label.  If preparing a product in a new container (syringe aliquot or pooled product) then the full face label is used.  Products must go through a Label Verify application following labeling.

[goodchild]

Products must go through a Label Verify application following labeling.

 

Cerner has an application that verifies that all the labels applied to a blood product match the information in the LIS?

 

Does anyone know if Meditech has a similar application that I (we) haven't stumbled across yet? I've always felt uncomfortable that we have no way of verifying full face labels applied to neonatal syringes/divided units because many of our work shifts have only one technologist in the transfusion service.

Edited May 29, 2013 by goodchild