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Showing content with the highest reputation on 01/16/2019 in all areas

  1. 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)
    2 points
  2. And you will fix what they cite - no worries. They expect to find things to cite you for, so don't plan on going through the inspection w/o getting nicked for something, Do the best you can, but don't be hard on yourself when you are cited. Look at it as a learning experience and an opportunity for improvement.
    2 points
  3. As an inspector I would be satisfied with this for compliance. It's always nice to see the RadSure label but I do not believe that it is required.
    1 point
  4. 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
    1 point
  5. 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)
    1 point
  6. We check it off on the Maintenance log and document review on the log. Since you cannot run the Echo unless the QC passes and the QC is on the instrument or archive disks, we never felt the need to print off the paper and keep it.
    1 point
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