pstruik

It is true that haemolysis can most easily be seen if the unit is stored in an upright position (note the phrase "most easily" - I am NOT saying that haemolysis cannot be seen if the unit is stored flat), however, more units can be stored in an upright position WITH the expiry date showing, than can be stored with them flat.  If you have to move an upright unit to see an expiry date (or, in the UK, an Rh and K type - available on ALL units), you can easily do so without disturbing the red cell - plasma/SAGM interface, so that haemolysis is still easily seen, particularly as the units are usually in a cardboard box type thing to keep them upright.  This is not so easy if the unit is stored flat and, in addition, it takes up more space in the average blood bank refrigerator, most of which are designed to take upright units.

'Use common sense, and don't lick anything in the lab' - now that's my kind of policy! 

'Use common sense, and don't lick anything in the lab' - now that's my kind of policy! 

I have been biting my tongue, trying not to say anything, but I have just got to!
Kell is the name of a Blood Group System, but the first antigen within the system is named K, and the antibody against it is named anti-K.
Those of you who screen for "Kell" and find negative donations are finding an awful lot of Ko donors (whereas the rest of the world is trying desperately to find some to freeze down), and those of you who are finding all these examples of "anti-Kell" are finding an awful lot of examples of anti-Ku, and in 43 years working in Reference Laboratories, I have only seen one example!

I think I've seen all yours then!!!!!!!!!

The K antigen is the most immunogenic of the Kell Blood Group System antigens because the Thr193Met mutation voids an N-glycosylation site (asparegine 191), exposing a highly immunogenic area devoid of an N-linked sugar, and so I would be amazed if there had not (Lee S, Wu X, Reid M, Zelinski T, Redman C.  Molecular basis of the Kell (K1) phenotype.  Blood 1995; 85: 912-916.).

Agree with Scott. The validation guide from Immucor is very helpful. You will also want to run a sufficient number of samples for each test you plan on using on the Echo to calculate specificity and sensitivity of the new method compared to your old method(s). The more samples you run, the greater validity your stats will have. I chose to run 50 samples for GrpScreen, Ready ID, Extend I, Extend II, Pediatric, and DAT. You should run samples with all ABO types, Rh positive and Rh negative. If you can come up with samples that have weaker backtypes or samples that react more weakly on front type or Rh type - all the better. If you can find a weak D sample or several weak D samples, that would be good. For antibody screens and IDs, the negative samples are just as important as the positive samples. You want to know if the new method is catching antibodies missed by your old method and if your new method is missing antibodies caught by the old method. I tried to round up a good selection of antibody specificities - anti-D (not RhoGAM), -c, -E, -C, -K, -Fya and/or -Fyb, -Jka and/or -Jkb, -S and/or -s. The antibodies can be frozen, though those samples may not work as nicely as fresh ones. I did my antibody ID validation over a fairly lengthy time period because we just don't see that many on a monthly basis, but I did get some good samples that way. If you are going to run different sizes of tubes, validate that. When I was running my samples to validate a specific test I also selected samples in different collection containers. I ran samples in their original EDTA tubes - 7 ml, 4.5 ml and 2 ml plus samples in 12x75 mm test tubes. If you plan on using capillary tubes, use samples collected in those tubes. Whatever your normal work process is or is going to be, replicate that with your validation so you can see how your instrument is going to perform 'real world'.
One major bonus of doing all this is that you will have a very good feeling for how your instrument and the method perform which makes troubleshooting, training and test interpretation easier. Takes time, but its worth it.

I think those who do this would put the compatibility label on the back, so that no other labelling is covered up.  The adhesive used should be tested to ensure that the label does not fall off between the temperatures at which the blood is stored or at the temperature at which the blood is transfused (and, in my experience, it is harder to get the labels off than it is to get a senior member of staff to buy a round of drinks!), but you do have to ensure that the adhesive is of a type that does not leech through the plastic into the unit itself (seriously - there are some that do)!

With all due respect, that means you have either "pulled the wool" over the eyes of an inspector who knows nothing about a blood group serology, or you have been lucky enough to come across an inspector who actually does know something about blood group serology, and realises that this kind of quality assurance of ANY panel (not just the Ortho panel) is nothing more than "smoke and mirrors" - and I am not blaming you for either scenario.

Completely agree.  We have something called "the element of uncertainty" (it isn't "element", but it is something similar) that is required by one of our more officious regulators (not that any of them are less than officious), but we struggle with this because, apart from titrations/quantifications and measuring an FMH, I struggle to think of any tests that we perform that are quantitative, rather than qualitative, which means there is no "element of uncertainty" - as long as your controls have worked, but these numpties stil ask for evidence.  You will be surprised to learn that most of the inspectors for this particular regulator have never stepped foot over the threshold of a transfusion laboratory prior to inspection!!!!!!!!!!!!!!!

This topic keeps popping up periodically and I find it both interesting and frustrating.  My personal view, as stated in previous discussions on the topic, is that what ever you do is little more than smoke and mirrors in an attempt to pacify some regulator.  I'm sure that's also why the manufacturer puts such nonsense in their package inserts. They claim specificity for many antigens yet it is acceptable to confirm the reactivity of a select few!!  I'm sure that can be rationalized but it still makes no sense to me.  

There is no 'good' way to run QC on a panel. In my mind, a better way to control a panel is to look at it and see if it makes sense with the results you get from your antibody screen. However, that doesn't seem to tick the box for QC for an inspector as well as a specific test defined in a policy.
Method comparison is another of those things that we do with questionable results. I run an antibody screen (or ID panel if I can find a patient with a nice antibody and enough plasma to spare) using all the methods we use, get different results from those screens and interpret it as differing sensitivity - something I expect to see. What have I proven by doing it? Nothing much. The results I get are not surprising. Works great for chemistry and hemo but does it give blood bankers information we don't already have/know? I'm still going to use the Echo for my primary method with tube/PeG for backup.
 

I don't want to get you into trouble, but I would suggest that you gently persuade your manager to either read (and take notice of) BSH Guidelines or (or better still, and) contact an NHSBT Consultant to get advice/contact one of the writing group of the Guidelines (medically qualified, if necessary) to save him/her and his/her staff a lot of totally unnecessary work and expense (particularly as his/her budget is provided by British tax payers, of which I am one)!!!!!!!!!!!!!!!!!   

In my opinion, this very much depends upon the underlying pathology.  For example, if the patient has an auto-immune haemolytic anaemia, the chances are very strong that the DAT will be positive before as well as after the transfusion, and that any eluate will be positive with all red cells tested (of normal type).  The chances of detecting a new antibody specificity on the DAT positive red cells under these circumstances is disappearingly small.
Therefore, if the sample is sent to a reference laboratory on a regular basis, your manager will be 1) showing a degree of ignorance that should be surprising, 2) will be upsetting the staff of the reference laboratory, as most have enough to do, without having to perform extra, unnecessary work, and 3) as you are in the UK, will be wasting the tax payer's money (and, as a UK tax payer, I feel very strongly about this).
If, on the other hand, the positive DAT is new, then a reference laboratory would be delighted to help out.
Of course, what your manager could do is to buy his/her own laboratory an elution kit, and train his/her staff to use it!!!!!!!!!!!!!!!!  This may bring the cost of the kits to meaningful results ratio to the overall pathology manager, which could be of interest!

No, and you won't Scott (or, at least, you shouldn't!), because changes in storage affect the serum that allow non-specific uptake of proteins on to the red cells, causing false positive DAT results - something that does not happen (never say never!) with EDTA plasma.

Actually, Ca++, Mn++ and Mg++ ions are all chelated by EDTA, and all of them are required for complement activation through to haemolysis.
The antibodies that gave suspicion as to their specificity by haemolysis (apart, of course, from rip roaring ABO antibodies) were anti-H (from an Oh individual), anti-I (from an adult ii individual), anti-PPKP1 from a pp individual and an anti-Vel.  As no Ca++, Mn++ or Mg++ are present, you will not see haemolysis with these antibodies in any of the tests you mention, however, you will, except in very rare cases, see agglutination.  In some 43 years in, usually, Reference Laboratories (so we saw most specificities), I know of only one case were an anti-Vel was missed in the UK because the anti-Vel was so weak by IAT using EDTA plasma, but was quite strong using serum, and Jill Storry has also described such a case (although I do not have her citation to hand).
I really wouldn't worry about it.  It is just SOOOOOOOOO rare.  It is a bit like a patient with an anti-Wra being given Wr(a+) blood by electronic issue, after a clear antibody screen.  It happens, but you wouldn't abandon electronic issue on such a rare happening.

What makes you?  If it is your computer programme, I would urge that you change your computer programme so that it only makes you when the anti-A1 genuinely reacts at 37oC (pre-warmed, etc).
A computer in the laboratory is there to aid the staff; not to make things more difficult.

UKTLC recommendations are now standards, rather than guidelines.  That having been said, MHRA have said that they will not inspect against these standards per se, however, if they feel that the staffing levels and/or their qualifications may impinge upon patient safety, they will take them into account.

Oh, believe me. this photograph is certainly NOT when I am looking my best!!!!!!!!!!!!!

Thanks to a very generous invitation from the organisers (in particular Phil Hoffman, aka Dr Pepper on this site, and Maddie Josephs, Chair) I will be attending and speaking at the 69th Annual Clinical Laboratory Science Convention - Central New England (ASCLS - CNE) taking place at the Rhode Island Convention Center between May 9th and May 11th 2017.  I will be talking on Wednesday 10th May 2017, giving a lecture entitled, "An In Depth Description of the Kell Blood Group System." and then, after a well-deserved break for the delegates, and for those that can stand it, a second lecture entitled, "King Henry Viii, McLeod Syndrome, Chronic Granulomatous Disease and Kx."
Sorry if this comes across as being "big headed", but I am really excited about coming back over to the USA.    

Anyone would think I'm a pedant!!!!!!!!!!!!!!
Could be an antibody identification panel.

I would tell them 1) to read the package insert, which, I bet, does NOT say it can be used for this purpose, and 2) tell them to contact Ortho about this practice, and I bet Ortho will also tell them that they are playing with fire.
I haven't heard anything quite so stupid for a very, very long time.

To me, it is not a common practice, because I eliminated it wherever I encountered this practice.  Separating serum/plasma for a Reference lab is a separate issue because you are sending them a known problem.
Do you have an example of a problem that occurred in your facility that was directly linked to not separating serum/plasma from a whole blood sample immediately after centrifugation?  Did this problem occur in a known patient or a patient new to your facility?  Does this occur frequently, rarely or is this the only known example?  These are some of the questions I would ask before memorializing the process in a procedure manual.
Unless you have accumulated evidence to support the assertion that separating serum/plasma actually prevents problems frequently encountered in your facility, you have to look to other reasons to justify doing this. 
If this problem occurs in 1/10 patients, I would be doing it.  Otherwise, I view separation of serum/plasma from red cells to be a “solution looking for a problem”.
 

Well, that's me finished.  I am officially retired from work - but not from this wonderful site!

In the UK, I think we generally agree with you (at least, put it this way, our full face protector has been gathering dust - unless an inspection is due - for years now).