FDA reportable or not

[epfeiffer]

Hi,  I am having a slight disagreement with my manager.  We recently had a trauma that required an MTP.  Initially we complete all the issuing of blood products on paper as our computer system makes releasing uncrossmatched blood very cumbersome in an emergency, especially when we may not necessarily have a name right away.  When I went to review the paper work I found that one unit had been recorded twice (it was not a split), one unit had then been omitted, and two donation numbers were incorrectly recorded.  The units were all released to nursing staff, one unit was transfused and the other two were returned.  I feel this is a reportable error.  He feels that because this is administrative that it shouldn't be reportable.  I am frustrated.

[R1R2]

Was the paper work issued with the units correct?

 

What LIS system do you have?

[epfeiffer]

The paperwork with the units was not correct, it was a carbon to what we issued.  We use Cerner

[Cliff]

I report a lot each year, there really isn't any harm.  FDA is not keeping a tally of how many reports you make and swooping in to grill you about them - just my opinion.

 

From what you reported, I don't think this is reportable.  Did you document everything correctly on the products that left the blood bank?  Was the decision to transfuse based on paper records and were they properly reviewed and was this review documented?

[epfeiffer]

The only way I was able to determine which units left the blood bank for the MTP and trauma pack was by looking at the segments which were appropriately labeled. The nursing record correctly identified all transfused components. None of my records correctly identified the three units in question. The blood is not labeled with a patient name because we often won't have a patient name until after we deliver the blood.

[clumbert]

Although the FDA may not "swoop down" on reporting Transfusion Services, administraters are sometimes reluctant to report errors; possibly in fear of showing up on FDA radar.

My administrative director once told me that, if I reported anything to the FDA, it would affect my position in the company.  I established a policy that required all errors be reported to administration and the blood bank director and they would make the decision to report or not.  I visited my old blood bank after I retired and my replacement asked if I wanted my job back.  I felt sorry for her.

 

MT,(ASCP) retired (thankfully)

[kate murphy]

If the paperwork/unit tag that was attached to the unit, the one the nurses double-check before they transfuse it (usually) did not match the actually unit, then yes, it is reportable. 

Switched tags, even if it's the correct patient, but the wrong unit, is a reportable event. 

And everyone else is correct - the FDA doesn't swoop in!  But when/if they do come, they will want to see your corrective actions, if needed. 

Last FDA inspector here (2014) informed me that they are looking at computer systems, since most places bypass their computers for emergencies. 

[tcoyle]

That is horrible...and so much for transparency. 

[David Saikin]

I agree with Kate - if it is signed out and incorrect it is a reportable event.

[albaugh]

What code level are you on in Cerner?  We have Cerner, too, and issuing units in an emergency, even if the patient is unknown, shouldn't be that difficult. Bypassing the LIS and handwriting a bunch of tags is far more cumbersome.

[epfeiffer]

Albaugh, we have Cerner Milenium, and you may be right it may be just as easy, I just took over and haven't had a chance to investigate.

[R1R2]

I agree with Katie.   It is reportable. 

[Kathy H]

I agree - this is reportable.  The situation must have been quite urgent for the nursing staff to transfuse units that did not match up on the clerical checks.

 

I'd also point out that the FDA finds it quite suspicious if your facility never reports anything.  That can put you it a worse position with them than the things you would have reported.

[Eagle Eye]

What is the RN noted the discrepancy and returned the unit to blood bank?

[Eagle Eye]

What code level are you on in Cerner?  We have Cerner, too, and issuing units in an emergency, even if the patient is unknown, shouldn't be that difficult. Bypassing the LIS and handwriting a bunch of tags is far more cumbersome.

Even in cerner classic you could issue to dummy patient. We used to have -------------- for patient name on the tag for the uncrossmatch units we kept in ER & OR refrigerator because we were issuing units to dummy patient to print the tag with all the information and then we would returned them in the system so they would be available. 

My tech loved it compare to what they had to do when they were all writing manually...

[goodchild]

Although the FDA may not "swoop down" on reporting Transfusion Services, administraters are sometimes reluctant to report errors; possibly in fear of showing up on FDA radar.

My administrative director once told me that, if I reported anything to the FDA, it would affect my position in the company.  I established a policy that required all errors be reported to administration and the blood bank director and they would make the decision to report or not.  I visited my old blood bank after I retired and my replacement asked if I wanted my job back.  I felt sorry for her.

 

MT,(ASCP) retired (thankfully)

 

 

I remember when I first came into my position and began highlighting reportable errors to submit BPDR to the FDA there was a huge uproar throughout the hospital. Prior to my arrival there was an understanding that FDA reports were optional, despite the fact that they've been mandatory for every transfusion service since 2001 (or thereabouts). We had several meetings to review the concept and since then it's kind of old hat.

[kirkaw]

I have to be honest, based on the original scenario, I probably wouldn't have reported this as a BPD. BUT, after reviewing the CFR, I can see how this is a reportable event. Sec. 606.171( says, You must report any event, and information relevant to the the event, associated with the manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding or distribution, of both licensed and unlicensed blood or blood components.

 (1) (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.

In my opinion, the instance described was a labeling issue that could have affected the safety of the product.