Jump to content

Featured Replies

Posted
comment_62578

Hello everyone,

 

It was discovered during a monthly audit that tach and timer testing was not done for our serofuges during the quarterly timeframe.  The audit was done late so this omission was not discovered until about 2 months after the testing should have been done.

 

All implicated serofuges were immediately removed from service upon discovery.

 

Is this reportable to the FDA?

  • Replies 4
  • Views 2k
  • Created
  • Last Reply

Top Posters In This Topic

Most Popular Posts

  • David Saikin
    David Saikin

    If you finally did them and the settings hadn't changed then there is no compromise of testing which would affect the purity, potency, . . . and I would not report this. If, however, there were major

  • Assuming that the serofuges in question refer to ones used for pre-transfusion testing of patient specimens, I would not report this to the FDA. FDA reportable events are ones that may have affected t

  • David Saikin
    David Saikin

    FDA reportables include more than blood product issues. Granted, they are the main focus. . . But - check the Biological product deviation reportables.

comment_62645

If you finally did them and the settings hadn't changed then there is no compromise of testing which would affect the purity, potency, . . . and I would not report this. If, however, there were major changes in the rpms or timer (if it is digital you don't need to check the timer), then, in my opinion, you would have a reportable event AND would probably have to repeat any testing done in the interval that was missed (which would be rather difficult I imagine).

Just my opinion.

comment_62665

Assuming that the serofuges in question refer to ones used for pre-transfusion testing of patient specimens, I would not report this to the FDA. FDA reportable events are ones that may have affected the safety, purity or potency of a distributed blood product. This applies both to transfused products and products that were in control of the BB/TS at the time of the deviation. I do not think your situation applies. Granted, the safety, purity or potency of the product may have been affected if you mistyped a patient due to improper centrifugation, but I think that's a stretch.

comment_62674

FDA reportables include more than blood product issues. Granted, they are the main focus. . . But - check the Biological product deviation reportables.

  • 2 weeks later...
  • Author
comment_62857

Thanks so much for the responses! I always feel better after posting on this forum :-)

Create an account or sign in to comment

Recently Browsing 0

  • No registered users viewing this page.

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.