Posts - Validation

Jun 29, 2019 10:33am
From Maureen (Mo) Tacke, St Luke's Health System: Hi George, our institution is coming to the joyous time of lot roll over in coagulation, and it’s got me wondering... Is our process a little (or a lot) overkill? Current process: Normal ref range studies (20 normals) for PT , PTT , FIB, AT , TT , PC , PS , DRVVT , SCT, APCR , factor VIII, factor IX, VWF activity, VWF antigen Lot to Lot studies (20, spanning the range) for all tests listed above plus D-dimer. Control Studies (assayed controls), 10 runs over a minimum of 5 days.
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Apr 9, 2019 4:49pm
George received this question for our quality assurance experts. When validating a procedure, do you work with a single lot or multiple lots?  
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Apr 2, 2019 7:29pm
Please return to our September 17, 2017 multi-site reference intervals discussion, and in particular to Heather DeVries's comment and question about a combined INR
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Nov 10, 2018 6:26am
Thanks to Ali Sadeghi-Khomami PhD, Precision BioLogic, and Joan Polancic, MS MLS, Denver Health, for the heads-up on this announcemment:
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