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Melissa Willcock

ISBT 128- labeling help!

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I have been given the task of making us ISBT ready. We do not have a technical supervisor not do we have a manager who is strong with Blood Bank knowledge- so I am struggling here!

We have conflicting information. We prepare neonatal syringes for all components and perform the normal thawing/pooling plasma, cryo, etc. The way I interpret the AABB regs, for all of those products we must relabel with ISBT labels that are barcode readable. This would include product code, unit number (neonatal syringes), expiration date, and modifying facility ID number. Is this correct?

Can anyone tell me about the HemaTrax system? We have looked at purchasing it, but obviously the cost is huge and I do not know enough about what is required to know if we need this or not. I'm not even sure what labels it will print. We would prefer to purchase this as opposed to a different stand alone system as we currently use Mysis 6.2 and it is supposed to be interfaced with vers. 6.3.

please help me understand! :confused:

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You must be registered with ICCBBA in order to print labels for aliquots and pools. See www. iccbba.com if not already registered with them. Most LIS vendors are using the Digitrax system to print labels for them.

I suspect Mysis has an ISBT group already formed to address conversion issues. Jump on their web site to find it. We Meditech users have our own group for ISBT discussions.

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We Meditech users have our own group for ISBT discussions.

Is this a formal discussion group. We haven't really looked at it to far yet (we don't prepare anything, our IS support says we shouldn't have a problem entering the new barcodes supplied by our Canadian Blood Services). If possible it would be nice to see your Meditech discussion threads for when we get closer.

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Larry, is there another Meditech ISBT group that I don't know about or are you referring to our little email club? :)

The big issues for Meditech users in ISBT are about aliquots and modifying aliquots (like irradiating them). Also, every possible source (collecting facility) whose units you might get must be entered in your source dictionary. If your supplier doesn't import much, you are lucky. There are many many functions that they now need to change to dealing with product groups instead of product codes, but they haven't yet.

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Mabel:

Just our social club. Being new to Meditech, I've gotten some gems from the emailings ...

Larry

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Melissa,

I can help answer any questions that you may have in reference to the labeling software, labels either pre-printed on blank.

Dave

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Sunquest Blood Component Prep will not have interfaced labels with DigiTrax(HemaTrax) until version 6.3.1 which has not yet been submitted to FDA. We are on v 6.3.0 and we are printing labels on the HemaTrax standalone system. We have two printers , one for full face labels for the aliquots and one for the bottom half labels for thawed and irradiated products. If you want to print labels while your Sunquest system is down you will still need the stand alone system or you will have to buy preprinted labels.

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Looking back at the orginial question: Yes, FDA in 21 CFR 606.121 © (13) requires machine readable (bar codes) for certain information: This includes ABO/Rh, product code, unit number and a facility ID. AABB requires that after May 1, these bar codes be ISBT 128.

You do NOT have to bar code more than one facility ID. It's generally the collection facility information that is bar coded. If they are using an ISBT 128 unit number (called Donation Identification Number in ISBT 128 terminology) the facility ID is embedded in that bar code. If you make up aliquots, you should be retaining the original unit number which has the facility embedded. Therefore, you don't need to bar code your own facility ID.

If you pool a product, you must assign your own unique pool number. Again, if you're using ISBT 128, your facility ID will be in this bar code, meeting the FDA requirement. If you are not using ISBT 128, you are correct, you would have to have an additional bar coded facility ID.

For thawed plasma and cryo, you do not need to do any re-labeling--other than change the expiration. Using the original product code bar code, even though it's for the frozen product, is perfectly acceptable in the US. You don't have to bar code the expiration date. In fact, as long as it's legible and indelible, you can hand write or rubber stamp it on the label.

I know everyone is finding this transition to ISBT 128 very frustrating, and I hear a lot of frustration directed at vendors. I'd just like to say a word on their behalf. This is new to them, too. They have worked very hard to understand the ISBT 128 standard and prepare their products. However, it's a complex standard as you know and software writers have learning curves, too. It's just so easy to have overlooked one important page or paragrpah, or even just one phrase on an example label. I know from the calls to our office that the vendors are trying very hard--just as you are. So, I guess I'm just saying we're all in this together. : )

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We are not FDA inspected (we are a private lab) but one of the hospitals we serve irradiates blood for their patients in their Radiation-Oncology center, so they are FDA registered.

When rewriting their protocol when converting to ISBT, I was under the impression that they would no longer need to add a barcoded facility ID label. Just to be sure, I contacted their FDA inspector. She said that they did still need to add a barcoded facility ID label to products they irradiate, place it in the lower right below the ISBT expiration, mark out the original license number, and, of course, change the product code and expiration (when indicated).

I don't know if this is more her interpretation or the official FDA stance on irradiated products.

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I think it would be a good idea to suggest this FDA inspector contact CBER for clarification. CBER is saying that only one facility ID needs to be bar coded.

This information, specifically related to irradiation, can be found on the FAQ (related to labeling) on the AABB website. FDA is responsible for the content of this FAQ so it is an "official" word.

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I know with ISBT 128, we will now be identifying the originial collection facility or my own facility (hospital transfusion service) in the DIN. Is it true that under Codabar, we are supposed to be capturing a facility identifier too?

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Yes. 21 CFR 606.121 © 13 (iii) states that 4 bits of information must be bar coded: Facility Identifier, ABO/Rh, lot number (unit number), and product code. In Codabar, this facility identifier should be the FDA registration number, if you have one. If not, any unique number, such as CLIA number, will work.

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Hello all,

Just wondering about the "modified by" labels I've heard of. If we only thaw/pool and rarely aliquot RBC's, do we need to add a "modified by" label to the product? Does it need to be barcoded?

We have Meditech, and have already purchased and partly tested our Digitrax label printer. (However, we haven't received any sample ISBT labels from our blood supplier yet.) What exactly will happen when we pool plts? Aside from creating a unique pooled unit #, we only have an ICCBBA facility ID, not an FDA one. Will we need to label the pooled product with that #? Will it need to be barcoded?

And later I'll ask about what to do during a computer downtime... :confused:

Thanks for any help you can offer...

Heather

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For an ISBT 128 label printing system about one-half the cost of Hema-Trax, try Computype's Demand-128 LPS. www.computype.com/128LPSdemo. Toll-free number is 800-328-0852; ask for Inside Sales.

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To answer a couple of the questions above: If we only thaw/pool and rarely aliquot RBC's, do we need to add a "modified by" label to the product? For pooling and aliquoting, yes.

Does it need to be barcoded? Yes. FDA requires that the Donation Identification Number, the ABO/Rh, the product code and the facility ID be bar coded (but not expiration date). The facility ID is part of the donation identification number in ISBT 128, so that's 3 bar codes. In Codabar, the facility ID must be bar coded separately. One thing to remember--only one facility must be bar coded on the label. So, if your blood supplier's ID is bar coded (within the unit number or elsewhere), you do not have to bar code your facility when you modify a product. The modifying facility ID would only have to be present as text.

What exactly will happen when we pool plts? Aside from creating a unique pooled unit #, we only have an ICCBBA facility ID, not an FDA one.

FDA accepts the ISBT 128 Facility Identification Number (FIN) as a unique identifier. The ISBT 128 Donation Identification Number includes this FIN, and meets the FDA requirement for a bar coded facility identifier when the unit number is bar coded. (In Codabar, the FDA registration number, CLIA number, or your ISBT 128 number may be used.) When you say you will assign a unique pool number, is that in the ISBT 128 format? That is, includes your facility ID-- For example W0000 08 123456?

Will we need to label the pooled product with that #? Yes.

Will it need to be barcoded? Yes.

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Do these FDA regulations apply to Blood BAnks that are not registered with the FDA?

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Thank you so much! Your response was quite informative.

Yes, we will be assigning a pool # in ISBT format. So, in anticipation of a computer downtime, we'll be ordering pre-printed barcoded facility ID #'s out of the range that our Meditech computer # reel would assign.

Does anyone know where can I get "Modified by:" labels? I haven't come across them in any of my investigations so far (i.e. Digitrax labels, Shamrock labels, and St John Labels).

Thanks!

Heather

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Since the "modified by" labels need not be barcoded, why not print your own on standard Avery label stock? Even those that don't accept David Pollock's answer about the adhesive could make them small enough to fit on the lower right quadrant of the existing label so they would not be in contact with the bag plastic. You just need to make sure they stay stuck under the conditions of use.

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I will be printing on demand ISBT 4x4 labels and my computer system asks me to enter the new pool DIN. I am having a hard time figuring out how to manage this. I need to be sure the next user chooses the next pool number in the sequence. If I create a list with each unit being crossed off when used, there is the chance that someone will not cross off after use. I also do not like depending on a paper list. Any suggestions?

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What if your LIS does not generate pool (or split ) numbers in ISBT format?? Sunquest 5.3 generates P#'s and Slash/numbers and if we try to insert our own pool # in ISBT format the software will not accept it (must start with a 'P' and have no other letters).:confused:

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