NAN47 Posted February 25, 2015 Share Posted February 25, 2015 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 Link to comment Share on other sites More sharing options...
galvania Posted February 26, 2015 Share Posted February 26, 2015 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 Malcolm Needs and pstruik 2 Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted February 26, 2015 Share Posted February 26, 2015 Couldn't agree more Anna. Link to comment Share on other sites More sharing options...
Auntie-D Posted February 26, 2015 Share Posted February 26, 2015 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. Eoin 1 Link to comment Share on other sites More sharing options...
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