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Which scientific paper(s) does your SOP cite to support your practice of adding a second drop of anti-D to a negative (no agglutination) Anti-D test? Which scientific paper(s) does your SOP cite so support your practice of interpreting 1+ agglutination in the Anti-D test as Rh Negative? HFAP in the Healthcare Facility Accreditation Program that has the same deemed status with CMMS as does Joint Commission.

I am not sure about this, but just because the insert describes what a positive result looks like, I do not think that means they are trying to say the interpretation is necessarily positive. That's what your facilities' P&P is for, approved by your pathologist and based on whatever data you want to cite. Scott

We've passed several CLIA inspections within the past 10 years.

I am sorry, but this rather proves to me that the FDA should take more advice, if they are going to claim to be the "be all and end all" in terms of ultimate authority. I, and many people much more expert in the field than me (to name one, Dr Geoff Daniels), would agree with Dr Gandhi that serological ABO typing is far superior to molecular typing, BUT, the same cannot be said for RHD typing, where molecular typing is vastly superior to serological typing (not least because no blend of monoclonal anti-D reagent can detect all weak and partial D types, and no monoclonal anti-D has yet to be found that will not react with a Partial DIII). It is also disappointing that Dr Gandhi is unable to use the internationally accepted terminology for the D antigen. Many, many moons ago, Dr Patricia Tippett, who, you will recall, did the original work on partial D categorisation, which, to a large extent, is still used,not least by the International Society of Blood Transfusion. Patricia pointed out that the correct terminology for the first of the Rh antigens was "D", and certainly not Rh(D). Obviously, Dr Gandhi is one of those who feel they are above and beyond the reaches of those who really know. Turning to Dr Park, I would again say that ABO typing is, almost universally, better done serologically (I doubt anyone would argue with that), but that the molecular testing of the RHD gene and, by inference, the fact that they are far more accurate than is D typing by serological techniques. If this were not so, people with partial D types would not still be making allo-anti-D in the numbers that they are. Similarly to the misuse of terminology by Dr Gandhi, I also note that Dr Park writes, "We use molecular-based testing for a lot of blood bank phenotyping now." Since when has a "molecular technique" in the world of blood transfusion been "phenotyping", rather than "genotyping". This is not just a mistake in terms of "blood grouping terminology", this is a very basic mistake in terms of biological science. This brings me back to my question, do these "experts" make up their rules as they go along, or do they actually take any advice from the experts in the field, who wrote those two papers I cited in my earlier post? I must say that they don't seem to be that "expert" to me.

I believe the FDA is the ultimate authority in the US. CAP, HFAP, Joint Commission and State regulators all act as surrogates for the FDA and are subservient to them.

I have NO idea who are HFAP, but I would say that, whoever they may be, they are complete idiots. Your way of treating the patients as D Negative until proven otherwise (i.e. the patient is D Positive or is Weak D Type 1, 2 or 3) is EXACTLY what is suggested by people who actually know about the subject on both sides of the Atlantic (Daniels G. Variants of RhD – current testing and clinical consequences. British Journal of Haematology 2013; 161: 461-470, and Sandler SG, Flegel WA, Westhoff CM, Denomme GA, Delaney M, Keller MA, Johnson ST, Katz L, Queenan JT, Vassallo RR, Simon CD. It’s time to phase in RHD genotyping for patients with a serological weak D phenotype. Transfusion 2015; 55: 680-689). I have, as I said above, no idea whether this was an HFAP ruling, or the ruling of a rogue inspector from HFAP, but, either way, I would be appealing against the citation, or changing the organisation who inspects my laboratory, if the appeal is rejected. From my point-of-view (and I have a bit of experience) you have done no wrong, but the inspector/inspectors have not got a clue about the Rh Blood Group System, and, in particular, the vagaries of the RHD gene. My own wife is D Negative, and if this lot forced her to be assigned as D Positive on such minimal reactions, I would be suing immediately. Sorry about the rant!

We called the screen positive (went ahead and reported the gel screen) because we wanted the computer to prevent electronic crossmatch if they wanted more blood while that specimen was still good on a later shift that hadn't heard about her and didn't read her comments. We were giving her units negative for the 2 antigens that she lacked (good thing that she was heterozygous for most of our "usual suspects") so we didn't want random units to be issued inadvertently. Also, I read that patients on these drugs sometimes have a drop in H&H at first dosing so I wasn't really willing to go out on a limb and call them compatible and imply that they would have normal red cell survival.

Oh dear, whatever happened to common sense? If you are testing an antibody screen, for example, why do you need a negative control? The majority of your samples will give a negative result. So you know that the negatives are working. But you DO need a positive control to make sure that the reagents are working. similarly, if you have an anti-k reagent, where are you going to get a k-neg cell to use as a control each time (in a normal lab)? For ABO, if you have an A, a B and an O you have covered everything, even the reverse group, as with the A and the B one of the reverse group cells will be negative each time.....