Over the weekend the overnight shift received a Type and Screen, later the patient received blood. They did get a positive screen, but they were able to rule out all antibodies. When I followed up on the patient, I found out that the patient had history at another hospital in the area, not in our system. When I called the hospital, the patient actually had received blood at that facility earlier this month and had developed Anti-JKb and little c.  Obviously, blood we gave to him was not tested for those antigens. Is that an FDA reportable error? This is first time something like this happened with me as a supervisor. I notified the patient's care team, immediately.  Other than that is there any other documentation I should be doing. I would really appreciate any input from all the experienced folks in this group. TIA

It's been a while for me, but my initial instinct would be to say no.  The safety, purity, and potency of the product were not compromised due to an error (intentional or not) on your part.

Is it your policy to always check to ensure that every patient has not been previously transfused at any hospital and does not have an antibody?  I'm not being facetious, but if it is, then yes, you did not follow your policy.

You can try to find a code for it here, but I don't think you will.  https://www.fda.gov/media/161919/download?attachment

No, not an error.

I would say as long as the rule out was done per policy and appropriately then there is nothing to report.

You can also contact the FDA and ask, I have always found them to be very helpful.

Worst case, report it (again, I don't think it's reportable) and they will reject it and let you know why.  That is safer than not reporting it.

I understand a lot of facilities are reluctant to report, but I came from a large facility and we reported about 50 - 75 events a year and never got in "trouble" from the FDA.

Patient should be monitored for a delayed hemolytic transfusion reaction for about 10-14 days, not necessarily in hospital. Most common signs are fever and progressive anemia. sometimes dark urine or jaundice. Patient education before discharge if earlier than this is essential.

If the screen was positive, what was the result for the Antibody ID?   What is the cause of the positive screen?  Was the blood given to the patient AHG-crossmatched? Usually, depending on the results to the antibody Identification, you would need to issue AHG-crossmatched blood to the patient.  And I think failing to issue patients with demonstrable antibody(ies) with AHG-crossmatched blood is a reportable FDA error.  I could be wrong, but I ran into a similar problem in the past.  

Edited May 31May 31 by SbbPerson
typos and grammar.