FDA reportable or not?

[RL0121]

Scenario :Missed Anti Fya during initial compatibility testing. No previous antibody hx. Received 1 U (Fya Ag unk at this time). If unit transfused is Fya+ is it FDA reportable or if its neg and patient not transfused with fya+ is it still reportable?

[SMW]

It depends on how/why the antibody was missed.

"The reporting criteria are:

• Either
  

i. Represents a deviation from current good manufacturing practice, applicable regulations, applicable standards, or established specifications that may affect the safety, purity, or potency of that product; or

ii. Represents an unexpected or unforeseeable event that may affect the safety, purity, or potency of that product; and

2. Occurs in your facility or a facility under contract with you; and

3. Involves a distributed blood or blood component."

So if your rules for testing/interpretation were not followed and the testing was performed in your facility and the product left the blood bank, it is reportable. If it was transfused or not or was Fya positive or negative does not change the reporting requirement. The key wording in the guidance is "The decision to report should be based on whether the event had the potential to affect the safety, purity, or potency of a product."

The FDA guicance document provides examples of reportable events and includes (underlining added):

"For

transfusion services

, reportable events may also include:

• Patient samples were mislabeled or collected from the wrong patient, if you used the sample to crossmatch a product that you distributed. This includes samples collected by transfusion service personnel and personnel outside of the blood establishment.
  
• Mistyped or misinterpreted patient samples if the sample was used in crossmatching a product that you distributed.
  
• Immediate spin crossmatch performed when a patient's history or testing requires an indirect antiglobulin test."
  

If it was just that the routine technique and methods you are currently using were performed correctly on a correctly labeled/identified sample but just did not detect the antibody (and could not be detected on the same sample with repeat routine testing), then that is not reportable since condition one was not met.