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.
