FDA reportable?

[lindam923]

Do you think this is FDA reportable? I am leaning toward "yes". A patient had a WAA. It was positive in gel, LISS and at 30" saline. Patient has not been transfused since 2005. Our SOP states an absorption needs to be done to rule out clinically significant antibodies. Absorption was not done. Physician signed form for incompatible blood. Two units were dispensed to the patient.

Thanks!

[SMW]

If the physician approved release of the products without the absorptions being performed before the products were released, i.e., pre-approved deviation from procedure, then this would not be an FDA reportable event.

[lindam923]

the physician did approve release of incompatible units, however was unaware the absorption had not been completed.

[Eagle Eye]

if your medical director gave approval based on history(previous panel strength, no transfusion since last work up, medical emergency) and clinician signed emregency release then it is not FDA reportable.

[Lcsmrz]

I would also lean "yes". You issued two units that did not meet your SOP's "special testing" requirement without prior approval for the exception -- you would have not have issued, had you known that absorbtions were not done.

"No harm, no foul" does not apply ...

[shelleyk482]

If this was not a planned deviation from SOP with prior approval by the Medical Director, then my opinion is that this is an FDA reportable.

[QRISTOFIR]

Oh Yes it is a reportable. The key is that if that deviation went undetected until after the units left your custody, there's a discernible chance that something more serious can also slip through your cracks and that's why the FDA wants to know and also how you plan to plug the cracks.

We often find ourselves trying to justify the deviation after the fact or trying to show how innocuous it truly was, but the fact is an error made it past our process controls and we have to fix the WHY and the HOW