Pat Distler

Yes, you are correct! Some of the logic behind this: It's like washed red cells: No matter what Red Cell product you start out with (CPD, CPDA-1, CPD>AS3, etc.), if you wash it in an open system, it converts to the same washed red cells product code with the same 24-hour outdate. ISBT 128 describes "what's in the bag" not what it started out. So, if you extend the dating of plasma to 5 days, you have a thawed plasma regardless of whether it started out as FFP, Plasma frozen within 24 hours of phlebotomy, or the newest type of plasma: Plasma held at room temperature up to 24 hours and frozen within 24 hours of phlebotomy. It actually makes it a little easier, I think.

This is mentioned on page 34 of a document called, Use of Product Code Data Structure [003] - Blood, which is found on the ICCBBA website (go to the ICCBBA website home page, then Tech Library, then ICCBBA documents, then Blood Documents, then select the second document down). In an example of how to handle a divided product, it states, "For example: Red Blood Cells from a volunteer donor have the Product Code E0164V00. If you perform a single first level division, the resulting aliquots will be E0164VA0 and E0164VB0. If you further divide product E0164VB0 into three syringe aliquots (an open system), the resulting second level subdivisions will be: E0158VBa, E0158VBb, and E0158VBc. Notice that the Product Description Code changed from E0164 to E0158 because the "Open System" attribute was added. See Figure 7." So, yes, the information you received from your blood supplier is correct. It is important to code the product as "open system" because the expiration date will change to 24 hours instead of the original outdate of the product (vs. a divided product made in a closed system which will retain the original expiration date). Computer systems can be set up to assign the shorter expiration date to an "open system" product, but only if the product description code changes.

As you noted, E4550 was retired, and you also noted the difference between the ">" and the "─". All you need is a little history! Originally ">" was for whole blood derived, and "─" was for apheresis derived red cells. Then we decided "Apheresis" was already part of the name of an apheresis red cell and we didn't need twice as many codes. So, we retired all the "─" codes (when we developed a method of retiring codes in 2008).

Linda is correct. If you thaw and use FFP (or Plasma, Frozen Within 24 Hours After Phlebotomy) within 24 hours, all that is required is changing the expiration date and time. This can be a handwritten change. If you opt to, you can re-label it as THAWED FRESH FROZEN PLASMA (or THAWED PLASMA, Frozen Within 24 Hours After Phlebotomy). But changing the product code is entirely optional. If you extend the dating to 5 days, however, it is a different product (no longer has the same level of labile clotting factors). This new product, THAWED PLASMA, requires re-labeling with a new product code and appropirate expiration. Reading back through this thread, I think everyone has it right--I think there may just be some confusion on what is meant by THAWED PLASMA. I think this term is used by some to describe Thawed FFP or Thawed Plasma, Frozen within 24 hours after phlebotomy. ??

There are several sources for this information on the ICCBBA website. You may want to start with a document called Standard Terminology for Blood, Cellular Therapy and Tissue Product Description Codes (http://www.iccbba.org/standardterminology.pdf) This describes the terminology used in ISBT 128 codes. Chapter 3 is for Cellular Therapy and Chapter 4 is for tissues. In the database, all cellular therapy (stem cell) codes begin with the letter S; all tissue codes begin with the letter T. (Blood codes, as you probably know, begin with E). To understand the databases and labeling issues, there are two documents that would be helpful. One is Product Code Structure and Labeling - Cellular Therapy and the other is Product Code Structure and Labeling - Tissues. If you are in the US, you will want to look at the US Consensus Standard for the Uniform Labeling of Cellular Therapy Products using ISBT 128 (http://www.iccbba.org/usconsensusstandard_cellulartherapy.pdf ) Feel free to call or email the ICCBBA office with any questions you may have. Check our website for specific contact information (or email me through Blood Bank Talk private message).

There are codes for Thawed Pooled Cryoprecipitate. Depending on if it's prepared in an open system or not, the codes are:: E3591 Thawed POOLED CRYOPRECIPITATE|None/XX/rt E3592 Thawed POOLED CRYOPRECIPITATE|None/XX/rt|Open Codes for frozen pooled cryo are: E3583 POOLED CRYOPRECIPITATE|None/XX/<-30C E3584 POOLED CRYOPRECIPITATE|None/XX/<-30C|Open If you get prepooled cryo and thaw it, you only have to change the expiration date/time on the label. This can be a hand written correction, as long as it's in indelible ink and legible.

There is no requirement to re-label a thawed product if the only change to it is thawing, whether the labeling is Codabar or ISBT 128. For example, if you thaw and FFP and use it within 8 (or 24) hours, only the expiration date needs to change. If you extend the dating to 5 days, then it becomes PLASMA instead of FRESH FROZEN PLASMA. Then, you have changed the product (beyond thawing it) and you do have to change the product code label. (For facilities that want to use thawed codes in order to allow the computer to control expiration date/time, then using the thawed codes available with ISBT 128 is fine.) For the two products in question: PLASMA, CRYOPRECIPITATE REDUCED: If this is how the frozen product is labeled, and you just thaw it, you may just change the expiration date and time. POOLED CRYOPRECIPITATED AHF: Again,if this is how the frozen product is labeled, and you just thaw it, you may just change the expiration date.

You need to carry the 1st and 2nd containers forward into thawed codes: E5548 Thawed Apheresis PLASMA|ACD-A/XX/refg|1st container E5549 Thawed Apheresis PLASMA|ACD-A/XX/refg|2nd container They are no longer FFPs, so you do have to make them "PLASMA". E2684 would be used for 5 day plasma. E2701 cannot be used for 5-day plasma because of the Frozen <24 attribute. This attribute indicates the presence of some labile clotting factors--something that you cannot claim on the label if you use it more than 24 hours after thawing. E2701 must be used within 24 hours of thawing.

Yes, if Apheresis FFP was made in an open system, it should have an "open" attribute. For example: E2146 Thawed Apheresis PLASMA|ACD-A/XX/refg|Open Division codes (7th and 8th positions) can be used for divided plasma. If you want to use container codes, you can request these product codes by using the form on the ICCBBA website (Registered Users Area) Currently, although the "open" is in the product code, it is not required to be in the human readable text. That will change as soon as the draft version of the US Consensus (version 3) is approved by the FDA.

There is a protocol in a very old FDA guideline. It's Appendix A (last few pages) in http://www.fda.gov/cber/gdlns/unilabel.pdf This is rather extensive so you may not want to do this much. However, it's at least something to look at for ideas.

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.

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!!!!!!!

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.

I forgot to mention something important for those creating 5-day plasma. You have to be sure that your blood provider is making their apheresis plasma in a closed system to give it a 5 day outdate. Right now, that isn't very obvious from the labeling--it's just embedded in the product code and not in text on the label. We are changing that to require the words "OPEN SYSTEM" on the label if it applies. But until then, be sure to ask the blood provider. Some apheresis equipment produces plasma in an open system, and it is unsafe to extend the dating on these units to 5 days.

You are correct that if you convert FFP (or Plasma, Frozen <24 hours) into 5-day thawed plasma, you must relabel it to indicate it no longer has the same level of clotting factors that FFP (or Plasma Frozen <24 hours) has. There are two options: Label it as THAWED PLASMA or just PLASMA (the frozen equivalent). It makes more sense to used THAWED PLASMA, even though regulations would permit the frozen equivalent. E2710 is irradiated CPDA-1 plasma. CP2D thawed plasma is E2720. E2121 is Thawed Apheresis PLASMA|ACD-A/XX/refg E2289 is Thawed Apheresis PLASMA|NaCitrate/XX/reg E5642 is Thawed Apheresis PLASMA|CP2D/XX/refg

There is an ISBT 128 code for the thawed version of this product. E6097 is Thawed Apheresis POOLED FRESH FROZEN PLASMA|ACD-A/XX/refg|Open. ACD-A would be an apheresis product, I believe. It's okay to mix anticoagulants. If pooled platelets or plasma contain mixed anticoagulants, the product should be coded as POOLED PLATELETS|NS/XX/20-24 C, or corresponding code for plasma (see the ISBT 128 document called Product Code Structure and Labeling – Blood Components for an explanation on coding). The “NS” in the description indicates that the anticoagulant is not specified in the machine readable information, but must appear in text on the label. The XX indicates the nominal collection volume is not encoded in the bar code, but again may appear in the label text. I'm not sure how you would label a pool of whole blood derived FFP (CPD anticoagulant) and apheresis derived FFP (ACDA anticoagulant). Also, codes for the mixed anticoagulant FFP have not been requested but would be issued by ICCBBA when they are requested.

In response to Reliegos: After the first split, A0 stays A0. The next split becomes: A0 -> Ab Then when the next aliquot comes off, it's A0 -> Ac, The next time, it's A0 -> Ad and so on. When you split a unit, you must indicate it's no longer a full unit. That's why after the first split, the "parent" becomes A0 (divided unit). Thereafter, as long as it is coded as a divided unit, you don't have to change the code on the "parent".

There is a form to request the variance. You must provide specific information. There is information on how to request this variance on the AABB websiste--look on the left hand side of the home page (www.aabb.org), last item and follow the link. The link for the form is on this second page. AABB has granted many requests for variance. You can see the list of facilities who have been given a variance by looking in the same area of the AABB home page and looking for List of AABB-Accredited Facilities with Approved Variances for ISBT 128

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.

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.

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.

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. : )

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.

Yes, David, sounds like you've got it. You need to show the parent unit is no longer a "full" unit so it must get a division code (letter in the 7th position). Thereafter, you'll need to use the 8th position a,b,c, etc. codes to identify the products that are created from this divided unit. And it is independent of the type of container it goes in. The goal here is to ensure you can track every aliquot. There's some flexibility in exactly how you achieve that, but it's best to decide up-front what is best for you, then be consistent. Sorry I missed your question, Cathy. Is this from 450 or 500 mL of whole blood? For 450 mL, E5546 would seem appropriate; for 500 mL (E5537 for irradiated version); for 500 mL E5547 (and E5077 for irradiated).