R1R2

so, is the employee still around?

PERHAPS weak D was included because a positive weak D would alert you to a possible false positive fetal screen.

"CFR 606.100(c) "All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product". The inspector asserts that testing review must be performed prior to releasing products and since supervisory review is typically performed each morning, any products that were released throughout the day (or night) would not have had their associated testing reviewed prior to release. " I don't think any of our responses helped you with this FDA observation, did they?

In my house, the cake would not make it to the next day.

Agree with TreeMoss. I would check your FDA paperwork and make sure it is correct. I took over a transfusion service and they had registered even though they did not need to register. I changed that right quick.

I know that FDA can visit any hospital but curious as to why they visited you if you only thaw plasma? Do you have an LIS or do you record results on logs?

Was this in reference to daily QC perhaps?

I would think that the freshest irradiated or unirradiated unit you have on hand would be suitable for a baby in a true emergency. A full unit could be issued and tranfusionist would use what they needed and discard. This plan should be discussed with all involved before it happens to make sure everyone is OK with this. Perhaps a procedure should be written as well.

we purchase pooled cryo from the blood center. no more pooling

There is no requirement that the info is read back to a person at time of issue.

I like the way your new supervisor has you performing antibody ID and panels. Why would you continue running full panels after the first if you can start narrowing down the specificity after the first panel and run selected cells? For example, if you suspect the patient has anti e, why run any more e+ cells? Not sure I agree with the DAT if auto control is negative. I think many transfusion services do not do this but I imagine that reference labs do. There may be times when running a DAT is advised when autocontrol is negative but running DATs routinely when an auto control is negative will just take you down a path that will delay blood transfusion IMO

IN the US, a titer is not usually done before transfusing a non group O baby with group O pack cell aliquots. I have only seen one case in which passive anti A was found in a neonate after transfusion of group O pack cell aliquots. There was not patient harm.

No need to take a separate internal temperature providing your digital temp is accurate. You will need to validate your digital readout to NIST and then you are all set.

I have never seen an "extreme case" of antigen blocking resulting in a negative test and I would think that the baby would have a lot of other serological issues that might alert you that this might be going on. Our facility allows newborn weak D testing when the DAT is positive and most of the time the weak D is negative. If you have staff that can understand this process then it might be a good idea.

No you can't but you can run select cells instead of a full panel. You may even skip the antibody screen and go right to the select cell panel.