Hi we are due to have a UKAS surveillance visit, and I believe one of the points that have been raised in other sites is regarding the use of a national standard for anti-D. Apparently after a PMI on an analyser we should be re validating the analyser with a primary standard of Anti-D. The basic QC which we use and which contains an anti-D of 0.05iu/ml is traceable back to a WHO standard.

Any thoughts?

Thanks

Yes - and they're not nice ones!  In my opinion, this is because most of these inspectors are mixing up the qualitative analyses and quantitative ones.  If you are making a quantitative analysis, it might well make sense to carry out a calibration curve using a standard.  For a qualitative test (like in IH) it makes no sense at all.  Having said that, i am sure that all anti-D reagents in the QC kits that everyone receives are in fact calibrated against standard anti-Ds.  Rant rant

Couldn't agree more Anna.

My tip is - if you welcolm them in and use it as a learning exercise you will fare better. Use it as a springboard for positive chage - the inspectors will help you.