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This refers to New Lot Confirmation and Acceptability.  It states that "New reagent lots and shipments are checked against previous reagent lots or with suitable reference material before or concurrently with being placed in service. " Currently, we perform Lot to Lot Testing for the Fetal Screen Kits only.  Is anyone interpreting this CAP question to also be applied to Commercial Reagent QC Kits??  Do we now need to perform Lot to Lot Testing on those also?

Thanks,

Brenda Hutson, MT(ASCP)SBB

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It is my understanding that they are moving in the direction of lot to lot testing. This is to ease you into it. Basically if your SOP now states that new lots of reagent have appropriate QC results before being put into use, that should cover it. BUT, we do lot parallel testing on all new lots of reagents that are not diluents or enhancement media. Just to cover ourselves.

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Just a question about that.

How do you account for the variability? Since all of these cellular reagents (antibody screen cells, antibody ID panels) are human derived and each lot has different donors, how do you compare them?

 

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Lily at CAP said it was only for the FS kits and daily QC is fine for everything else.

When I called back in October with my list of questions, I got the feeling she thought we over interpreting many of the items :)

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On ‎02‎/‎25‎/‎2018 at 4:00 PM, MOBB said:

Lily at CAP said it was only for the FS kits and daily QC is fine for everything else.

When I called back in October with my list of questions, I got the feeling she thought we over interpreting many of the items :)

Soooo...  Fetal Screen Kits come with their own positive and negative QC - this is no longer sufficient for a new lot :o

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It is my understanding that CAP requires Lot to Lot on Fetal screen Kits only, not commercial reagents since it is not a kit.  You must compare the old QC with the new lot of reagents and the New QC with the old lot of reagents before use.  Kit tests in the rest of the lab are handled the same way per CAP.

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On 4/5/2018 at 7:19 PM, BloodBanker80 said:

Soooo...  Fetal Screen Kits come with their own positive and negative QC - this is no longer sufficient for a new lot :o

Not for lot to lot testing. You want to prove a positive on the old lot is positive with the new lot and the same for negatives. You don't have to use the QC from the old lot with the new lot-you could use a known negative and positive depending on how your policy is written.

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