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ICCBBA

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ICCBBA last won the day on January 16

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    www.iccbba.org

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    Female
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    California
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    Information Standards Specialist
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    Kaytee

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  1. Hello Pmanager, ISBT 128 does not preclude the use of an additional label on top of the ISBT 128 label, such as the “Irradiated” label you referenced, as long as it does not obscure/cover any of the ISBT 128 information. I hope this helps! Kind Regards, Kaytee from ICCBBA (Organization that maintains and develops the ISBT 128 Coding and Labeling Information Standard)
  2. ICCBBA

    Exchange Transfusion Product Code

    Hello Steve, You’re very welcome! Also, apologies for the long response below: It looks like you will need to submit a request for a new code to be added to the database to reflect the description you need for your products. If you can verify that the following description describes your final product, you can go ahead and submit a request for this to be added to our ISBT 128 Product Description Code Database via the ISBT 128 Product Lookup Web Application (please note that you need to be logged into the ICCBBA website to use the program). RED BLOOD CELLS|CPD>SAGM/450mL/refg|RBC irradiated|ResLeu:NS|Supernat rem/Plasma added You can also use a code that does not indicate irradiated. In the US, the FDA does not allow coding and labeling a partially irradiated product (e.g., only RBCs were irradiated) as a fully irradiated product. A product description code with the “RBC irradiated” attribute or a non-irradiated code can be used. If you wish, you can request the following description – currently there is no non-irradiated code in our database that reflects the description you provided. RED BLOOD CELLS|CPD>SAGM/450mL/refg|ResLeu:NS|Supernat rem/Plasma added In the meantime, your facility may assign a local code for the description you need until the description is added to our database. The reconstituted red cell guidance (also linked here) briefly mentions using local codes. For more details regarding local codes: section 2.4.3 of the ISBT 128 Standard Technical Specification (ST-001) document and section 3.7 of the Implementation Guide: Use of Product Code [Data Structure 003] - Blood (IG-021) document discusses and provides guidance for using locally assigned codes. If the codes provided above do not fit your needs, please let me know and we can adjust the description accordingly prior to your request submission. Kind Regards, Kaytee
  3. ICCBBA

    Exchange Transfusion Product Code

    Hi Steve, Products for exchange transfusion or “reconstituted” products are encoded as red blood cells with the plasma added attribute. When selecting an appropriated ISBT 128 code for these products all applicable core conditions, attributes, and modifiers still apply. For help with the terminology, section 2 of the ISBT 128 Standard Terminology for Medical Products of Human Origin (ST-002) document contains the current blood component terminology and definitions that is used for ISBT 128 product descriptions. I would be happy to work with you to narrow down the appropriate ISBT 128 product description. If you are able to provide more information about your product, we should be able to determine an appropriate product description code for your product or initiate a request for a new code to be added (if necessary). Please feel free to DM me or contact the ICCBBA office with a description of your processing steps if you wish not to make such information public on these forums. I also see that the reconstituted red cell guidance was shared earlier in this thread – the short document (also linked here) reflects the current thinking on labeling these products in the US. You may need to refer to your national/local authority for any coding/labeling guidance and requirements for such products in the UAE. You may also need to reference your accrediting organization for any additional requirements. Kind Regards, Kaytee from ICCBBA (Organization that maintains and develops the ISBT 128 Coding and Labeling Information Standard)
  4. ICCBBA

    ISBT

    Hello Eva, The thawed codes for E1624 are listed below. I have included the codes for products with a 24 hour expiration and 5 day expiration, in case you need both. You can use the ISBT 128 Product Lookup Web Application to look up the full descriptions. 24 hour expiration: E2284 5 day expiration: E2121 The division codes (A0, B0, C0, etc.) would also use the same 5-character thawed Product Description Codes. I also wanted to clarify that the second character of the division code is a “0” (zero), and not the uppercase letter “O”. Section 5 in the Implementation Guide: Use of Product Code [Data Structure 003] - Blood (IG-021) document further discusses division codes. (Please note, you will need to be logged in to view the document). I hope this helps, Eva! Please let me know if you would like some more help with finding additional codes. Kind Regards, Kaytee from ICCBBA (Organization that maintains and develops the ISBT 128 Coding and Labeling Information Standard)
  5. Hello Kerry, I can help you with regards to the coding and labeling of your thawed plasma product. The product must be relabeled with a different ISBT 128 Product Code that can be used for 5 day plasma. If you would like, I can help you find the code you need – just reply with your starting frozen code and I will provide the thawed code and the steps to find it. Since thawed 5 day plasma is not a licensable product, the US License Number must not appear on the label. The FDA registration number would still appear. Sections and 7.8.8, 7.8.10, and 7.8.18 in the United States Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 (IG-002) document provides more detailed coding and labeling guidance for thawed plasma products in the US. Figure 79 in the document provides an example of an updated Product Code portion (lower left quadrant) of the label for thawed plasma - I have attached the figure in this post. I hope this helps! Please let me know if you have any additional questions. Kind Regards, Kaytee from ICCBBA (Organization that maintains and develops the ISBT 128 Coding and Labeling Information Standard)
  6. ICCBBA

    Blood Product Transfusion Form/Labels

    A list of possible label vendors can be found here: https://www.iccbba.org/subject-area/vendors/labeling-blood
  7. ICCBBA

    Volume (Plasma) Reduced Platelet

    If you have access to the 31st edition of the AABB Standards for Blood Banks and Transfusion Services handbook, Reference Standard 5.1.8A is a table that provides the expiration times for a number of blood components (e.g., platelets, RBCs, plasma). This should provide some guidance for the expiration of your volume reduced platelets. Hope this helps! Kaytee
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