From Heather DeVries, Indiana University: I’ll make this one short and sweet…how many samples should be used in a cumulative summation study?
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.
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?