cthherbal Posted May 23, 2012 Share Posted May 23, 2012 Do I meet the CAP requirement of QC-ing a new test kit (example: Fetalscreen) at the same time as a patient on 1st day of use? Do I have to check the old lot of QC (pos/neg) with the new anti-D reagent in the kit and vice versa? I am thinking of when I worked in hematology and we ran a pos/neg patient with old and new kits (ex: Sed rate, FDP). But at my current facility we don't get very many Fetalscreens so I don't think I could accomplish this, as long as we are not combining kits of different lots?Any input is appreciated... Link to comment Share on other sites More sharing options...
David Saikin Posted May 23, 2012 Share Posted May 23, 2012 I qc my fetal screen using the new anti-D with the old kit controls. This has never been a regulatory problem and I have used these kits for decades. Link to comment Share on other sites More sharing options...
Bill Sinn Posted May 24, 2012 Share Posted May 24, 2012 We only QC the new lot with the new controls that come with the kit. I don't think there is any requirement to do this crosschecking with controls from the old kit. In any case CAP TRM.31350 states "If there are multiple components of a reagent kit, the laboratory uses componenets of reagent kits only within the kit lot unless otherwise specified by the manufacturer."Bill Link to comment Share on other sites More sharing options...
Eagle Eye Posted May 25, 2012 Share Posted May 25, 2012 the day of receipt we run pos & neg controls(from the kit itself) from old lot and new lot (lot to lot release). (we do not interchange component from each kit---because of the CAP). Link to comment Share on other sites More sharing options...
cthherbal Posted May 25, 2012 Author Share Posted May 25, 2012 We only QC the new lot with the new controls that come with the kit. I don't think there is any requirement to do this crosschecking with controls from the old kit. In any case CAP TRM.31350 states "If there are multiple components of a reagent kit, the laboratory uses componenets of reagent kits only within the kit lot unless otherwise specified by the manufacturer."BillI think I agree, Bill. From what I recall, CAP is more concerned with PATIENT results with old, new lots (no significant variation in result with either lot). I remember it being a pain with urine dipsticks doing lot to lot comparisons. If we don't get Fetalscreen tests for several days or a week, the samples are no longer "stable". Plus we hardly see positive fetal screens (maybe 2 a year). Thanks everyone for the input.Colleen Hinrichsen, MT (ASCP) SBB Link to comment Share on other sites More sharing options...
Mabel Adams Posted May 26, 2012 Share Posted May 26, 2012 I have considered lately running the old controls with the new Ortho kit because we have had some times when the positive control is too weak. If we run the old controls while they are still in date and they work fine but the new pos control doesn't, then we know that it is the control failing rather than the reagents failing. In this case, we would be using the old controls as an "unknown" rather than "mixing kits." Link to comment Share on other sites More sharing options...
L106 Posted May 29, 2012 Share Posted May 29, 2012 We only QC the new lot with the new controls that come with the kit. I don't think there is any requirement to do this crosschecking with controls from the old kit. In any case CAP TRM.31350 states "If there are multiple components of a reagent kit, the laboratory uses componenets of reagent kits only within the kit lot unless otherwise specified by the manufacturer."BillSame here.Donna Link to comment Share on other sites More sharing options...
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