David Saikin

I use PeG as backup for gel testing.

I have heard from CAP on this question - and I quote: " Mr. Saikin If you are using polyspecific reagent, you are only required to confirm negative results with IgG-coated red cells. C3-coated red cells are only required with anti-C3 reagents are used (sic). The last sentence in the note for TRM.40210 states that if polyspecific reagent is used, the TRM.40200 applies. I hope this helps. Regards, Sarah Fabian, MLS(ASCP)" If you use polyahg, you only need to run IgG check cells to confirm negatives.

I have never seen that interp for polyahg requiring IgG and C3 sensitized cells. It seems to me that the final sentence of referring to TRM.40200 allows the use of the IgG sensitized cells to document the reactivity of your poly reagent. I know I am not the only one who interprets this. I will f/u w CAP on this.

If I was inspecting, I could live with start times only as long as it is part of your MTP protocol. Definitely want to see the unit #s transfused. I think it is too much to expect during these crisis situations to get stop times; usually the rbcs are pushed as fast as they can. Once it calms down, I'd expect the proper documentation.

Your product would have a life of 4 hrs upon thawing. The extreme cold is not bacteriocidal.

there is no need to run the C3 sensitized cells with a positive polyAHG. If the IgG sensitized cells react as anticipated you are done.

You only need to be registered unless shipping interstate.

I also see this on an occasional CAP survey. I can only assume that it is due to the Compl on these cells. Must have a small amount of agglutination/aggregation that the sensitivity of the gel detects.

these are all great study goals. The tech manual and the Harmening book should get you through almost everything.

As an inspector for >20 yrs: unless you are making packed cells, modified WB, splitting unit, drawing donors - I would mark this question as NA. If, as noted above, you had a thawed plasma with a clot - you would note that in your inspection prior to release and deal w it appropriately.

you are surely entitled to your opinion on this. Whatever the FDA's logic, if you deliver and leave your product in a cooler or box or whatever, you are storing the product.

We also use MediaLab. works great - inspectors like the way it works.

If you are registered or licensed, the FDA is entitled to inspect you at their pleasure.

If you took the blood out of the box when it reached its destination it would be transport. If you leave it in the box wherever it is going - storage.

Everyone on the USA should have one. AABB/CAP standards. don't know about JCAHO.