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I was wondering if anyone knew of a report that showed incident rate of FDA reportable events per hospital or per other statistic like transfusions, patients, etc...  Just looking for a baseline to see how our facility compares to others. I have searched and reached out to other facilities and haven't had any luck. Thanks in advance.

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Many variables there, might be hard to compare.

We transfuse about 35k products a year and have a small donor center.  We send FDA 50 - 75 reports a year. 

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There's an annual BPDR summary for BB/TS from the FDA, looks like 2016 is the most recent available at: https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/ucm129757.htm

1,956 BPDRs from Transfusion Services in 2016, a majority being QC and distribution related, not documenting issue in the computer system is typically the #1 reason.

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Just out of curiosity and in your experience - do you think most establishments report errors to the FDA or not? 

 

 

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On 2/23/2018 at 6:59 AM, AMcCord said:

I'm betting there are many events not reported to the FDA. I think that there are lots of folks that are not aware of the reporting requirement.

Ann, on the flip side I bet there is a lot that gets reported that doesn't need to be reported for fear of getting caught not reporting something.  Unless the FDA has improved their information in the past few years, a lot of what they say leaves a great deal of room for interpretation.  :confuse:

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23 hours ago, John C. Staley said:

Ann, on the flip side I bet there is a lot that gets reported that doesn't need to be reported for fear of getting caught not reporting something.  Unless the FDA has improved their information in the past few years, a lot of what they say leaves a great deal of room for interpretation.  :confuse:

@John C. Staley, this may be true, but the FDA does actually review each file.  They notify us a couple fo times a year that an event is not reportable.  

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Cliff, I'm glad to hear things have improved since the last time I submitted anything to them many years ago.  I remember my first FDA inspector had just came from a meat packing plant and the only thing he knew about blood banks was his check list.  The last one I had was actually an SBB.  I was excited to see they were making an effort to do it right.   

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I've found that the folks involved with the online BPD reporting seem to know what's what. My communication with them has been courteous, helpful and informative.

My long ago experience with inspections was not so positive - as you say, you seemed got someone who didn't appear to know much about Blood Bank at least half the time. I swear that our very last FDA inspection was by an English major. She told us we were doing things wrong that we had changed with specific instructions from the previous inspector (who was from the pharmaceutical side of things). When we got that last report, it looked like it wasn't even written about our facility. Our medical director said "that's it! we are done with collecting autologous units" so that we could say adieu to the FDA inspections.

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I have to second that my experience with the FDA employees handling BPD reporting was very positive. They do review, delete, and explain if they don’t find it to be a deviation.  However, I am not sure how many facilities report them. In 2014, a new Lab Director who had been a director at several hospitals in the area told me to stop reporting BPDs because a QA tech at one of her hospitals said they are not required in transfusion services. I showed her it had been required since 2000.  

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The folks handling BPDRs are different people than the inspectors, I don't think anyone does both.  My/our groups interactions with BPDR submissions have been very positive, sometimes we're told it's not actually reportable, sometimes they tell us they changed the classification code.  I've also had positive interactions writing in to ask if a situation is reportable (I switched from QA support of BBTS to HCTP a year or so ago, so have had a LOT of questions. Rather different on the HCTP side).

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On ‎2‎/‎22‎/‎2018 at 3:43 PM, R1R2 said:

Just out of curiosity and in your experience - do you think most establishments report errors to the FDA or not? 

 

 

I gave a talk at a seminar on this once many years ago.  I KNEW many of my peers were not reporting things that I was reporting (things that clearly were supposed to be reported).  They would try to make it sound like they didn't think it fell into that category, but I knew they knew better than that.....it was a choice. My comment to them was that "we all know that there are a lot of types of errors we could make, and the FDA would never know unless we reported it (for example, let's say you sent out a non-irradiated unit and it was caught by nursing......even so, when it is returned, it is FDA Reportable because the Blood Bank did not catch it.....but how would the FDA ever know that occurred unless perhaps Nursing wrote an occurrence against the lab)?  It is a system largely based on honesty and integrity.  So one time, I asked an FDA Inspector, are you more concerned about places that report a lot of BPDRs, or those who report none?  Of course a LOT cannot mean a LOT.....but they were more concerned about those that never reported in that as we all know, EVERYONE makes mistakes.

Brenda Hutson, MT (ASCP)SBB

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can some one post a link or form for all users here?

there are two forms right? correct me if i am wrong...BPDR and adverse event?

Thanks

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5 hours ago, Eagle Eye said:

can some one post a link or form for all users here?

there are two forms right? correct me if i am wrong...BPDR and adverse event?

Thanks

It's very easy (and preferred by FDA) to do it online.

https://www.accessdata.fda.gov/scripts/cber/CFApps/Login/Index.cfm?CFID=40907533&CFTOKEN=d53320b604cd5b33-CA2F5DED-DE8D-E592-8495BFDE2A8C4673

The form can be found here:

https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/default.htm

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