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Posted: October 29, 2009

Addenda: Nov. 19, 2009

 

Labeling donor units that are Directed Donations

A colleague in Louisiana reports that their blood supplier collects Directed Donor products but designates the intended use and donation type as volunteer. This causes the intended use character in the product code to be "V" instead of "D" but the products are intented to be handled as Directed. Only a tie tag indicates this. Is this considered compliant with AABB/ICCBBA standards? The lack of the "D" forces their computer system (Cerner Millennium) to treat these units as allogeniec and therefore bypass the safeguards built for appropriate handling of these Directed Donor products. What has been the experience at other institutions with the labeling of Directed Donor units?

The following comments have been submitted.

ADDENDA Nov. 19, 2009

  1. A colleague believes this "related" note in the "Frequently Asked Questions" (for the U.S.) on the ICCBBA website might be of interest to the present discussion:

    '6. Am I required to specify in the ISBT 128 product code data structure (data structure 003) whether the unit is autologous, directed, or designated?

    Autologous donations are required to be coded in the product code. Directed or designated units are not required to be coded in the product code. Although it is not mandatory to code directed, or designated units in the product code data structure (data structure 003), it may be in the facility’s best interest to do so for billing purposes. It is also required in the product code data structure is to specify the type of donation (volunteer or paid); FDA does not permit the default value of "0"(not specified) to appear on transfusable products, except for on Recovered Plasma and Source Plasma units.'

    The submitting colleague concludes that between the FAQ on the ICCBBA website and AABB BBTS Standard 5.1.6.3.1 that says labeling must be in compliance with the most recent version of ... ISBT-128, it looks like what they are doing is consistent with the requirements.

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