Leaderboard

I agree with Scott's assessment. TJC standards for blood bank say that the blood bank should follow AABB guidelines, not necessarily be inspected by AABB. (I should have used the word guidelines, not standards.) I believe that they see AABB as the 'gold standard' that facilities should strive to follow. And of course, the AABB Stds are aimed at meeting FDA requirements. I discovered long ago that if I made sure that I was following AABB standards as closely as I was able to, that I would have little to no difficulty in passing TJC and CLIA inspections. In addition, if I made changes based on new or revised AABB Stds, then I was going to be ahead of the game for new and changed CAP Stds.

We perform Electronic Crossmatch at our facility, and the computer differentiates antibodies as clinically significant or not clinically significant. Even if the antibody is not considered significant, it is set to not allow EXM if the present antibody screen is positive. We don't consider anti-D from a documented, recent RhIG administration clinically significant so as not to brand the lady with an anti-D forever.

CAP has been around since 1960s and TJC commission since 1951, causing lab staff grey hair for many years (in a good way). In the 1990's, CLIA put some bite in inspections because they brought a different type of quality focus into the inspection process, they verify inspections performed by other agencies, like CAP, and they cover labs that were not being inspected - like Drs offices.

Short (facetious) answer: $$$$$$$$$ Long answer - my opinion - Facilities required or choose to follow AABB Standards (and therefore get an inspection) are required to pay for/buy said standards. At the very least, they are "institutional members" that pay an annual membership fee. The AABB Standards are very different from the Technical Manual (in which the universal, public domain procedures reside). I may be wrong, but I think the standards get some kind of tacit approval by the FDA, whereas the TM gets peer-review. Of course, both documents/books are available to anyone for a fee......

How on Earth can one body claim to "own" a procedure, if that procedure is 1) almost universal throughout the world, and 2) if the proper procedure is there to enhance patient safety? It seems absolutely preposterous to me (if I were them, I would be very flattered that people wanted to follow my example/direction, UNLESS of course, they are unsure of what they have written vis-a-vis patient safety and are frightened of being sued if something goes wrong.

In answer to your last sentence Teristella - GOOD LORD YES! Turning to your first sentence, the problem with performing an extended cross-match is that, if, for example, the patient has either sprouted a weak anti-Fya, or worse, has made an anti-Fya in the past (unrecognised), but has not been re-stimulated for a long time. Either the units could both be Fy(a+b+), or one could be Fy(a+b+) and the other Fy(a-b+), and the cross-match may not detect it. This is because the red cells in the antibody identification panel are in a preservative that maximises the expression of the red cell antigens, but NOT the oxygen carrying capacity of the red cells, whereas the red cells in the units are in a preservative that maximises the oxygen carrying capacity of the red cells, but does not maximise the antigen expression of the red cells (and the Duffy antigens are known for deteriorating upon storage (as are the Knops antigens, but they don't matter). So, by cross-matching without performing a panel, you may be missing an anti-Fya, and if the screening cell that is Fy(a+b-) may have come from an individual who has the FYA/FY genotype, if these red cells have come from a donor of the Black ethnicities, but the human immune system is MUCH more sensitive than our tests, so you have a DHTR on your hands. This, however, is purely a personal point-of-view.