Lot to Lot CAP

[cthherbal]

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...

[David Saikin]

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.

[Bill Sinn]

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

[Eagle Eye]

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).

[cthherbal]

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

I 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

[Mabel Adams]

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."

[L106]

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

Same here.

Donna