FDA Reportable

[djengen]

We have just recently had a transfusion of RBC completed with no order to transfuse from the Physician. Is this reportable and do I use the BPD form to report?

This is the first time I have encountered this dilema and am having a hard time finding a definative answer.

[David Saikin]

I do not think so - BUT it should be an in-house quality issue. You have not impacted the potency, purity, ad nauseam of the component so it is not a BPD.

[DOGLOVER]

I do not think it is reportable as it was not a Blood Bank error.Nursing may need to report to someone, depending on the state you are in. They certainly need to do a root cause, but as long as the BB issued appropriately (issue slip from the floor, or whatever you call it) then you are really not involved.

[tbostock]

Many Blood Banks are now being held responsible by inspectors for the physician's order, even though it's really not a Blood Bank reg. Some Blood Banks are requiring to be faxed the physician order, some have the nurse bring the order with them when they pick up the blood, and ones that are on EMR are either checking the computer for the order, or getting a printout. We went live with our EMR last year, and when the physician orders 2 units, we get the printout and we coordinate the order with how many we issue. Works very well.

This may be an opportunity to try one of these to make sure it doesn't happen again.

[Eagle Eye]

Was it indicated though? Do you check transfusion appropriatness in BB? For us if there is no order in blood bank we do not issue the products. We do not require actual physician order in BB we need to have request, or phone order documented with physician in BB. When we recieve order we check for appropriatness. This way we have catch errors when we receive a pick up slip with different patient name. We would check the order in BB, if no order, we call the floor and the nurse would say oh I stamped different patient name. It works very well.

[SMILLER]

Simular to that above, we check approriateness at the time of issue. Requisition forms must include indication, such as low Hgb, OR holds, low Plt, etc. In most cases, we require that the actual Hgb or INR or whatever is on the form before we issue. This is writtento in our BB policy (and nursing) so if we fail in this, we get cited. I am not sure who has cited us for missing info in the past--FDA or JCAHO or both, but inspectors habve checked this because its in our procedure.

Of course, we have to have an order put through the hospital's ordering system in the first place. Exceptions being for Massive Transfusion Protocols or calls for a cooler to be packed for OR. Both situations are covered by pathologist-approved policies that allow us to order the products and/or tests directly from BB.

Scott

[MEG]

It is not an FDA reportable. You can and will be cited by the AABB and Joint if it is discovered. This is my recommendation: I would write it up as a non conforming event. This way it shows that you realized there was an issue and took steps to prevent it occurring again. You should also have an internal hospital Quality/Risk Department that these issues are reported to. I would do that as well. See AABB standard 5.11.1.1, 5.25.5 and 5.27.1. Hopefully, this will help.

[Brenda K Hutson]

I also do not believe it to be Reportable. The Blood Bank did not wrong. I have even seen instances where we did have a Transfusion Order; and a Transfusion took place; but it was based on erroneous CBC results which were based on Nursing drawing above IV lines that were not shut off! That is a serious error in my mind; and one that could have grave consequences for a patient with volume issues; but even that I do not would be a BPD in that the Blood Bank would not have made an error (and it is US that they are after when it comes to BPD Reporting).

Brenda Hutson, CLS(ASCP)SBB