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I believe most of these tests will fall under 1976-Type LDTs which fall under enforcement discretion. The immunohematology tests that may fall the new rule would be modifications to manufacturers' instructions (i.e., you use the reagent/test in another method, you use a different specimen type or extend the specimen acceptable time limit).

I took my exam in 2017 after going through the NIH SBB program in Maryland. I highly recommend that program to anyone who is looking for in person program. The passing rate after the program for the SBB exam is at 90% for the last 10 years. It is free, you work there and get paid and learn from the best in the industry, and it is in person. I did not study outside the class provided materials and got 630 on the exam. Prior to that I had 6 years of BB leadership experience in the smaller Regional hospitals. I can provide contact info for the program if anyone interested.

My question is, why are you looking at them under a microscope? My transfusion service stop doing that back in the late 80s!

I just answered this question. My Score PASS  

If the test is showing no immediate rouleaux or agglutination due to a "cold reacting" antibody, I'm afraid that I am at a loss to see why anyone would leave the tests to see whether one or the other develops. Rouleaux is clinically insignificant in terms of blood transfusion, and ditto "cold reacting" antibodies, unless they are of wide thermal amplitude (in which case, there would almost certainly be agglutination visible straight away. Why waste reagents and expensive technician's time investigating a clinically insignificant phenomenon?

I believe internal QC or non-patient testing is not covered by the FDA regs. Only tests used to report patient results.

"the presenter stated specifically that NOTHING has been grandfathered. " I think the presenter is mistaken. The FDA specifically noted that the area of rare reagents and cells, and similar testing would not be subject to LDT enforcement. Of course, all the opinions in the world matter not a bit until the FDA actually acts or does not act. I cannot imagine they want to be inspecting every tertiary care hospital and blood center reference laboratory for this purpose. And most of the things we are discussing in the transfusion service and immunohematology lab are not used to provide diagnostic results to practitioners, but rather used for internal resolution of therapeutic decisions. Quite different from your average laboratory test which provides quantitative or semi-quantitative result to physicians and other practitioners who make decisions based upon lab results. Perhaps a nuance, but a real difference. If the FDA insists we validate the use of a potent anti-HPA1 anti-platelet antibody in our decision making, we're out of luck :). Ain't happening. Interestingly, much of what we do in clinical medicine has not been "validated" or subjected to FDA-like regulation. Such as using autologous or allogeneic stem cell transplants, liver transplants, using a stethoscope or looking at a patient's retina with an ophthalmoscope. No validation. No data to speak of at all.

Yup. What Neil said. We do not give RhIg prophylaxis for women of childbearing age if they have received Rh Pos red cells, but will offer it for Rh pos platelets. Once a full unit of red cells is in, it's a lot to mitigate, and if they're getting 1 unit of Rh pos red cells, they're usually getting MTP and many more Rh pos products. Plus, treatment for anti-D in pregnancy has gotten pretty sophisticated, it's certainly not pleasant for mom, but it can be done. The patient has to survive first!

I took my test last week and I pass my SBB. I took it first time. Chris, please do not get upset and please fill out form again. Everything is fresh in your mind right now study little harder and give it a try again. Few tips: Are you good in lab math? Because I know I needed to use my calculator so many times. ALso you need to read your questions..I started reading fast and at first I picked wrong answer and when I read it again I realized that my answer was wrong. Read again and got it right. Chris, on your letter do you have total score/ maximum you can get? I just wanted to figure out my percentage. Thank you. ANd go for it again.