John C. Staley

My interpretation has always been that the alarm should sound at or before the set point. The set point should be low enough to allow time to move products if necessary. But we are CAP inspected, not AABB.

Well - just to follow up - we approached our Laboratory Compliance team to see what they knew and their response was. "we don't remember, but it was a "BIG DEAL".  We then discussed with the Pathology Medical Director (he was the director when this happened) and he had some insight and suggested contacting the hospital's CLIA person (who was the same person who mad this "decision")
Our Path. Med. Dir. emailed them and - lo and behold - they were perfectly fine with it.......    Needless to say, that email has been sent to compliance and is now added as an attachment in our QP manual so no one can dispute what we all think is correct!
Thanks for letting us know that we weren't crazy in our thought process!
 

It's not uncommon for inspectors/assessors etc to come up with their own interpretations.  Before I would bother making any changes I would certainly do as Neil suggested and go up the food chain for clarification.  Actually, my first inclination would be to ignore this on the chance you never see that inspection person/team again.  If you do need to respond in some manner then "we're looking into it" should buy some time for confirmation.  Best of luck.

 

I'd go up the food chain ladder and consult with this inspector's supervisor. 
Clearly if the lab receives five samples, giving them all to one technologist does not in any way mirror clinical practice, and thus violates the regulations. Thus my initial take on this is that is another extremely bad idea from an inspector who has no idea what they are doing. Sort of the old joke about some physicians:  "Occasionally wrong, but never in doubt."

We used the Sure Tech kit when we were doing Kleihauer Betkes. They offered a 'training book' of KB stain photos, good and bad stains, that included info about troubleshooting the staining process. It wasn't terribly expensive. I found the photos very helpful in getting my eye 'calibrated'. After that I had zero problems hitting the CAP survey results. I tried to use it to educate staff, but I couldn't get them zeroed in - they always overcalled (better than undercalled). I think our major problem was that we did so few patient KBs that it just wasn't possible for anyone else to become proficient. That's when I approached our medical director about switching the test to a send out. We are able to get specimens to our reference lab within 24 hours, usually much less, so it hasn't hindered patient care. I still use the book for student education.

Hi! We are planning to do KB testing for traumas as well. Do you report it as fetal cells positive or negative?

We still do K-Bs for trauma and such to determine if baby is bleeding into mom. No counts, just are there fetal cells or not.
We don't do them to determine RhIG dosage. For that we send positive screens to the local reference lab for flow.

My experience, though it was a while ago, was that during those events the vitals are being monitored constantly whether transfusion is occurring or not.  The documentation may or may not reflect that but it is being monitored.  Personally I think the blood bank/transfusion service should start being in the loop concerning vitals when the crisis is over and transfusions are slowing down or stopping.  Then the vitals will be come relevant.  Just my 2 cents worth.

It is usual for the C+, D- red cells (e.g. r'r) to react with an anti-G more strongly than a C-, D+ red cell (e.g. R2R2), BUT, this is by no means "diagnostic".

As Jsbneg says above, it would be far safer to perform the proper tests, to ensure you have ascertained the correct specificity/specificities.

The attached PowerPoint may or may not help (ignore if it is not helpful).
The G Antigen and Anti G.pptx

I hate to admit it but I don't remember ever hearing about that test in my 35* years in Blood Banking!  I guess you are never too old to learn something new, but remembering it is another story.  Thanks Malcolm.

I know I'm old and been out of the world for a while but I have to ask, what is this DL you are referring to??  

Man you got me good, started searching for anti-O and anti-Q and thought that I missed something big  It's cool, no hard feelings! 
Anti-P sounds much more familiar. 
That's why we don't do DL test ourselves, we don't have time for it.

I was joking about the specificity being between "anti-O" and "anti-Q", in that anti-P, the specificity almost always involved in a case of PCH is a "cold-reacting" IgG anti-P that "fixes" complement (and P is between "O" and "Q" in the Western alphabet).  A pretty poor attempt at a joke, I fully admit!

While I am not saying definitely that it is a case of PCH, the fact that the patient has a suspected AIHA, that the auto-antibody appears to be "cold-reacting", that it is IgG and that it also involves activated complement, strongly suggests that this may be the line to go down as an investigation.

We didn't perform a DL test routinely by any manner of means (despite being a London based Red Cell Immunohaematology Laboratory).  It was always discussed between our own Consultant (or, at night, weekends or Bank Holidays) by the on-call Consultant, but all of the staff knew how to perform the test, even if they were a lone worker.  We always used to dread being asked to perform such a test as a lone worker, as it took so long to do!

We send both syringes and bags through the tube system.  
We have a special cap that we use for syringes for which it is obvious if someone has taken it off.  That is to prevent partially used syringes from being accepted back into stock.  
That was an issue for all syringes, not just the ones sent through the tube.
 

We do perform both activities.  Since we had already validated the system for transport of all other products, we validated syringes by ensuring that when they were sent they wouldn't leak or break.  We also add a little additional padding to the tubes with syringes to guarantee they are held in place.

We normally used a ratio of 1:1, unless the antibody was particularly weak, in which case we would, on occasions, go up to 4 of plasma/serum to 1 of red cells in NISS (BUT, make sure that such a ratio is written into your SOP).

No AABB standard requires a crash cart.  Donors do not develop anaphylactic reactions, but this type of reaction is why offices or facilities that administer transfusions or IVIgG (and similar products) need to be able to administer epinephrine emergently.  Most of the rest of the stuff in a crash cart would never be needed and certainly not for blood donors.   So no crash cart unless you are administering human blood products or drugs that can cause anaphylaxis. 

I cannot find the reference for which I was looking, and I wonder if (now I am in my dotage) I have mis-remembered and that it was one of a couple of papers stating that IgM ABO antibodies are easier to inhibit than are IgG ABO antibodies.  The references for these are Witebsky E.  Interrelationship between the Rh system and the ABO system.  Blood 1948; 3: 66-79, and Kochwa S, Rosenfield RE, Tallal I, Wasserman LR.  Isoagglutinins associated with erythroblastosis.  J Clin Invest 1961; 40: 874-883.

My apologies.

I would make the argument that the blood was inspected when it was issued to the remote storage unit.  At that point the transfusion service had completed it's obligation.  I am assuming (and we all know how that goes!) that the remoted storage unit has been exhaustively validated and monitored with documentation to confirm my assumption.  As well as any training required for those accessing the remote storage unit.  I'm always more worried about the blood going to the wrong patient in these situations than I am for the quality of the unit.
  Personally I always enjoyed challenging such citations.   

I would make the argument that the blood was inspected when it was issued to the remote storage unit.  At that point the transfusion service had completed it's obligation.  I am assuming (and we all know how that goes!) that the remoted storage unit has been exhaustively validated and monitored with documentation to confirm my assumption.  As well as any training required for those accessing the remote storage unit.  I'm always more worried about the blood going to the wrong patient in these situations than I am for the quality of the unit.
  Personally I always enjoyed challenging such citations.   

I would make the argument that the blood was inspected when it was issued to the remote storage unit.  At that point the transfusion service had completed it's obligation.  I am assuming (and we all know how that goes!) that the remoted storage unit has been exhaustively validated and monitored with documentation to confirm my assumption.  As well as any training required for those accessing the remote storage unit.  I'm always more worried about the blood going to the wrong patient in these situations than I am for the quality of the unit.
  Personally I always enjoyed challenging such citations.   

I did allo-adsorptions on eluates for quite a while and never once detected anything in the adsorbed eluate.  My own experience suggests that it is a waste of time and resources, but others may disagree.

I agree with Malcom - not much value, if any. I, too, have done many such noninformative adsorptions.
In a recently-transfused patient, there is perhaps a very remote chance that (allo)adsorptions on an eluate would reveal a "only on the cells, not in the serum yet" newly formed antibody. This might be important if the clinicians suspect faster-than-normal red cell loss, but it would be very difficult to differentiate from the typical increased red cell demise seen in patients with warm autoantibodies.

How do you get hold of the extremely rare antibody specificities I mentioned (such as anti-Vel) to regroup units sent from, possibly, frozen blood banks, that they have typed as Vel Negative before the unit is sent out?

I second the Echo suggestion. I have had zero issues getting reagents through the whole Covid/supply chain problem period (which is ongoing). We are geographically isolated customers but still receive good support service when we need it.  Pricing for tube reagents is much cheaper when your facility is in the automation pricing tier.