Hello - wondering how everyone is submitting the annual blood establishment registration for 48 hours LVDS single step method for apheresed platelets?  Our donor center collects apheresed platelets, samples at 48 hours post collection, and submits to our hospital Microbiology department for culture on the BacT Alert.  After the initial culture is found to be negative for at least 12 hours, we label the apheresed platelets to expire on day 7.

How should we register our platelets with the FDA?  Is it line 11 "Platelets" with bacterial testing checked or is it line 13 "Platelets Extended Dating" with bacterial testing checked?  

Or should we not check "Bacterial Testing" since the culture is performed by the Microbiology department?

Many thanks in advance for your assistance.

On 11/4/2021 at 12:12 PM, cgotwo01 said:

 

Or should we not check "Bacterial Testing" since the culture is performed by the Microbiology department?

Who has responsibility for the product?  If it is blood bank you should check off (I thihk).