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product modification labeling requirements...


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I somewhat recently moved from a larger hospital with digitrax ISBT label printer to a smaller hospital without a blood product label printer...
 

When we thaw a unit of plasma, what sort of relabeling is required? We do use barcode scanning for issuing and transfusing, so if we modify the expiration in the computer and then scan the original barcode problems occur at issuing and then at transfusion as they don't match. Currently we have a sticker we put on the unit where we hand-write the thaw date/time and expiration date/time... is that... acceptable?

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Per the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 Version 3.0.0 March 2013 published by ICCBBA, for thawed plasma products or Cryo AHF, thawed plasma products that are used with the 6-24 hour expiration can keep their original product code.  The expiration date and time must be changed and that information does not need to be bar coded.  The original expiration date bar code should be lined thru, date and initialed.  You can then write the new expiration date and time below that.

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You are in a tough situation. Either your facility will need to invest in a digitrax printer to print ISBT labels or you should not modify the component in the LIS, only manually change the expiration date on the face label and document the new expiration after issue and transfusion (or by comment). I do not like the former option. I would insist on obtaining an ISBT label printer if I were in your position. That is the cost of having a blood bank.

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The storage temp does not need to be updated if you are not changing the product code for a plasma that is used in that 6-24 hour window.  If you are extending a unit of plasma to 'thawed plasma' that is good for five days, you'll need to change the product code and expiration date which will then include the new storage temp.

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On 5/9/2023 at 8:18 AM, tcoyle said:

Per the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 Version 3.0.0 March 2013 published by ICCBBA, for thawed plasma products or Cryo AHF, thawed plasma products that are used with the 6-24 hour expiration can keep their original product code.  The expiration date and time must be changed and that information does not need to be bar coded.  The original expiration date bar code should be lined thru, date and initialed.  You can then write the new expiration date and time below that.

Exactly what we do.

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21 hours ago, AMcCord said:

Exactly what we do.

There is one danger in this process, and I have seen it happen. Miscommunication between shifts opens the possibility of an expired unit being successfully issued because the expiration date in the LIS is different then what is manually written on the unit. If you are not changing the expiration in the LIS, you will need some sort of system in place (in policy and practice) that shows you mitigate this possibility. 

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2 hours ago, jayinsat said:

There is one danger in this process, and I have seen it happen. Miscommunication between shifts opens the possibility of an expired unit being successfully issued because the expiration date in the LIS is different then what is manually written on the unit. If you are not changing the expiration in the LIS, you will need some sort of system in place (in policy and practice) that shows you mitigate this possibility. 

Would agree with that. Our software automatically 'thaws' and updates the unit outdate when we product select. Our potential failure point is that the tech who thaws and tags the product fails to change the outdate on the unit face label. 

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28 minutes ago, AMcCord said:

Would agree with that. Our software automatically 'thaws' and updates the unit outdate when we product select. Our potential failure point is that the tech who thaws and tags the product fails to change the outdate on the unit face label. 

Have you thought of thumb screws????????!!!!!!!!!!!!!!!!!!!!

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