R1R2

Below is the exact text from the guidelines.    I agree that potentiators added to the reverse group may detect non ABO antibodies in addition to the ABO antibodies but who adds potentiators to reverse group routinely?   One reason that anti c is mentioned may be that reverse group cells are usually Rh neg.   I have seen strong IgG anti c react in reverse group with no potentiators. 
 
 
Other reverse grouping anomalies: Potentiators in the reverse grouping reagents may cause IgG antibodies such as anti-c to be detected in the reverse group.

Might be a rare IgG anti-A1 - you may not see in in the Reverse (presumably IS or buffer-only gel card), but is detected when you do anything with an antiglogulin reagent. You could try doing the Reverse by IAT. The DAT may just be a red herring, but it might represent a weird autoantibody that favors group A cells.

Good 1st question and I don't know.  
For the second, if the reagent is licensed and approved for what you want to use it for I would do QC with current and new reagent and quickie comparison .- say a weak, mid strength and strong reaction on a couple of samples.  The goal would be that the new reagent compares with the current and reaction strengths do not differ by more than 1 (or whatever you decide). 

We would issue with 15 minutes left on the type and screen.  And, per the AABB's 2010 Ask the FDA and CLIA Transcript:
Question 34: The Circular of Information, for the Use of Human Blood and Blood Components, in the Instructions for Use section, item number 13 states: "Transfusion should be started before component expiration and (be) completed within 4 hours." What is the FDA's interpretation with regard to this instruction? For example, is it acceptable to start a component at 23:45 on the expiration date and allow the unit to be transfused for 4 hours (until 03:45 the next morning)?
MS. CIARALDI: Our regulations in 606.122 state that administration should start within four hours of entering the product. To us, this means that transfusion must be started within the shelf life of the unit. The length of time to hang a unit, specified in the Circular of Information, is four hours. We are aware that this may sometimes result in the transfusion ending after the unit has expired; however, we do not object to this practice.

Let's say the specimen is going to expire at midnight, the red cell is still good for a couple of weeks, will you issue the product at 11:45pm knowing they will not infuse it before the outdate of the specimen? Yes, I would issue the product with 15 minutes left on the clock.  
The patient requires a washed platelet.  It only has a four hour outdate from the time you start washing it.  It's going to outdate in 10 minutes, do you still issue it?  Yes.  but transfusion must be started before product expiration per Circular of Information.     Close communication with nursing is important. 
 

There is no required number of samples to use for method comparison.   I would suggest 1 pos, 1 neg for Rh and antibody screen and pick your samples wisely - a nice strong K or anti D to eliminate those pesky (expected) discrepancies between different methodologies and required corrective action.     

There is no required number of samples to use for method comparison.   I would suggest 1 pos, 1 neg for Rh and antibody screen and pick your samples wisely - a nice strong K or anti D to eliminate those pesky (expected) discrepancies between different methodologies and required corrective action.     

Returned blood bags are a risk and an outdated practice IMO.  I have never seen one that didn't leak all over the place, floor, bag counter, fridge, even when placed in a plastic bag.   And then there was the occasional needle to deal with. We save segments. 
 
 

I don't think you are violating any regulatory requirement to return blood within 30 minutes if they can't start the unit and they still want to transfuse.   I think you are correct in encouraging them to complete within 4 hours instead of returning to BB and almost certain discard by BB. 

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.

Thanks Cliff for the link.  Lots of great information.    

Maybe try here?
https://loopsters.org/index.php?/forums/

Same as above. Here is the form I made in case you need it.
l to l to send.docx

I may go to the extreme but when we receive surveys all of the "patients" are registered in the computer and the appropriate tests ordered. The vials can then be labeled with barcoded patient/test labels and can be scanned. I also enter the "donor unit" into our inventory and print donor unit label for the specimen and place the DIN label on the vial. This way everything is done in the computer just as it is with a real patient. When the tech has completed testing they can print their results from the LIS and if need be I can always go back and look at the results.

With your many years of work experience, have you thought about studying on your own and taking the exam? 

We solved that problem by dc'ing the policy that 2 must identify patient and include initials on the tube.

You may want to drop CT ratio since you implemented electronic crossmatch.     Generally, it usually drops close to 1:1 if you are not setting units up in anticipation of usage.    Your computer system will check to make sure that patient is eligible so that is probably not a good monitor.  I can't think of a thing to monitor for electronic crossmatch.

What immediately sprang to mind was, to be honest, get a different Lab Quality Manager if she has to ask you (it's her job, for which she gets paid, after all), but another thing is turn around time for non-complex samples - by that, I mean routine samples, with out-liers containing antibodies (particularly antibodies directed against high prevalence antigens or nasty mixtures).

Are you performing electronic crossmatches?  
 
How about autologous blood use/waste, corrected reports, FDA reportables? 
 

We solved that problem by dc'ing the policy that 2 must identify patient and include initials on the tube.

Yes, what he said.....

agree with pinktoptube

I think upon hire.   Not really a competency, more like training.
 

We validate our coolers for 6C and use 10C Safe-T-Vue's, under the assumption that if the unit is in the cooler, 6C is maintained, if it is out of the cooler it is in transport.  Haven't had any problems with FDA or AABB.  We tried using the 6C Safe-T-Vue indicators, but they changed before we could even issue the products sometimes.

I was not going to say that I promptly threw it in the circular file because I was afraid of being "shamed" for doing so but I threw it in the circular file promptly.