Reputation Activity
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Pat Distler got a reaction from Maureen in ISBT codes for "Thawed Plasma"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
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Pat Distler got a reaction from slc7067 in Thawed Plasma, frozen within 24 hoursYes, 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.
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Pat Distler got a reaction from GCH LAB RAT in ISBT 128- labeling help!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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Pat Distler got a reaction from GCH LAB RAT in ISBT 128- labeling help!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. : )