lehooke1

If the total inventory is only 6 units at a rural hospital, I would stock 4 O Pos and 2 O Neg. I'm not suggesting every hospital should stock only 'O'!

Many years ago, Peter Issitt stated that microscopes should be banned from Transfusion Laboratories (I think it was in the orange edition of his book) except for such tests where cells are being counted (such as the Kleihauer).
Many years after his wise words, I still follow his advice, and have not (yet) been involved in a missed weak antibody that has caused a clinically significant haemolytic transfusion reaction (43 years in the job), and many of those tests were performed in opaque tiles and then, as we "modernised", tube techniques.

I think that after you use them for a long time.....running panels and seeing which "positive" reactions pan out to be something, and which do not; you start to get an "eye" for what is a true positive vs. a few red dots that are not going to give you anything (or, you learn the "look" of a cold agglutinin; rouleaux; warm auto; vs. clinically significant antibodies).  I think it just takes time and experience (going after the questionable reactions long enough to know "when" to go after them)  to feel comfortable (and in the end, you could still be wrong; but there is also a good chance that if it is so weak that you can't decide whether to call it Positive or not, you probably won't find anything anyway).  Just my opinion.
Brenda Hutson, MT(ASCP)SBB

We will not be using the Verax point of issue testing. Our blood supplier will be going to the FDA approved pathogen reduction system, INTERCEPT, by CERUS.

We will not be using the Verax point of issue testing. Our blood supplier will be going to the FDA approved pathogen reduction system, INTERCEPT, by CERUS.

Well, that would make my decision to retire very very easy!

You could also concentrate your 0.8% cells to 3% by using 4 drops of cells, spinning, decanting and adding one drop of saline, then test it in tubes.

As I understand it, you would only need to perform secondary bacterial testing if you plan to extend the life of your platelets. In that case, you would also need to register with the FDA, if you have not already done so.

Dump the labels. This is the 21st century.

We do both of the above ...
1. Test the panel against QC antisera upon receipt, as we do for all reagents; It shows the reagent survived shipment.
2. Record the Lot#/Cell# and antigen types (zygocity) of the cells used for Antigen Typing QC (heterozygous except K)  ... that's periodic enough.

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.  

You do not have to register with the FDA if you are dividing a product into smaller portions.
However, if you are creating something new so the end product is different from the original product THEN you must register with the FDA. An example of something new would be to use FFP and RBC to create whole blood for an neonatal exchange. The end product is not the same as the beginning.
At my last CAP inspection, the inspector insisted that I needed to be registered with the FDA because we thaw plasma to Thawed Plasma with a 5 day expiration. I knew we didn't have to register but I didn't have proof at that time. I found my proof later on the AABB website 2012 Ask the FDA and CLIA Transcript. Question #29 covers the questions of when you are supposed to register with the FDA. I printed the whole transcript and keep it in my file for future need. Hope it is still up on the website.

Registration would not be required.