Jump to content

Blood Establishment Registration re LVDS 48 hours apheresed platelets

Recommended Posts

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.

Link to comment
Share on other sites

  • 5 months later...

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now
  • Recently Browsing   0 members

    • No registered users viewing this page.
  • Advertisement

  • Create New...

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.