TreeMoss

Amazingly enough, our last FDA inspector was pretty laid back. I was surprised, to say the least. That inspection was so enjoyable!

We have clear plastic divider racks for our blood bank frig shelves that keep the units upright without having to use holders. The last two frigs we've purchased have not had these racks available -- they have two sides to go across the drawer and two to go from front to back! We just trim down the old racks to fit in the new drawers and hope that they continue to work well. It really helps to view the units when they are upright. It used to be a lot easier to see the expiration dates before we switched to the ISBT128 labeling, but we've adjusted.

Good suggestion -- I'll have to check in to that.

No, we don't have a centrifuge to spin blood down, and our FDA registration doesn't cover that -- although we could update that. Anne

If the units are from our blood supplier (ARC) and we have the correct paperwork with correctly transported units, we will put the units into our inventory and use them. Anything from another supplier gets discarded. ED folks are instructed to bring any blood products transported with a patient directly to the Blood Bank. If necessary, we will issue units as "Uncrossmatched"; otherwise, we collect a new specimen and crossmatch needed units. We will also let the original facility know if we discarded their units.

We will do a pre-darzelex blood type and antibody screen as well as antigen-type the patient for all antigens that we have anti-sera for. When transfusion is needed after the darzelex is started, we will use phenotypically-matched packed cells. If the patient specimens don't come until after the patient has received the drug, we send the specimens to our Red Cross Reference Lab buddies to work up for us. They use the DTT (not DDT!) and antigen-type the patient to provide information for our future use.

I think our major concern here is wastage. However, our recent Level II Trauma inspector said that was probably not a valid reason not to start using whole blood!

Thank you for answering in such an explanatory way, John and Scott. Nothing more needs to be added, in my opinion. Many folks just don't have an understanding of the education level required for our jobs as Medical Laboratory Scientists.

We also add a comment that baby may be re-tested with no charge at the 4-6 month time. Have not yet had anyone come in to take us up on that offer!

We do this test on all Rh (weak D) negative cord blood specimens from babies with Rh negative moms -- just to make sure that it is baby blood and that mom doesn't need RhIG.

The unit was just sitting on the counter.

We do 5 transfusion observations per month as part of our Blood Bank Quality Improvement. There are several CAP items this could fit under -- between TRM.41000 to TRM.41300.

That is definitely what we do here. We do not have what we would need for an autoabsorption, and our ARC Reference Lab folks serve us well.

We did a validation a few years ago where we set a unit on the counter in lab, ICU, and one of the other patient locations. We took the temperature of the unit every 5 minutes. We found that the temperature was within range in all locations tested for at least 30 minutes, so we validated our 30 minute rule.

Yes, you do need to crosscheck the kit. We test the new kit against the old kit -- use the cells from one kit with the anti-sera from the other kit. We just record our results on our regular QC sheet for the FMH Rapidscreen test.