CAP TRM.30450

[Brenda K Hutson]

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

[mld123]

I was told by CAP when I contacted them that this applies to Kits only in Blood Bank.  We perform lot to lot on Fetal Screen Kits only, but we do not perform Elutions.  I believe the Elu-Kit would require a lot to lot if you perform that testing.

[David Saikin]

We only do lot to lot on the fetal bleed screen kit. 

[jalomahe]

When I asked CAP about this they stated that for Blood Bank it only applied to kits that come with their own Pos and Neg QC. So Fetalscreen Kit Yes, Elution Kit No.

[Guest]

That has been my understanding also; Fetal Screen yes, Eluate NO.  But the question being raised by some now has to do with the Commercial Reagent QC Kits.  Can I assume that since those were not referenced by any of you, that no one does "Lot to Lot" on those Kits?  I never have.....just following up on what someone else is thinking they might need to do.

Thanks,

Brenda Hutson, MT(ASCP)SBB

[AMcCord]

I do check new QC lots when they come in simply by using the part of my QC procedure that utilizes the reagents in the kit. The new kit is checked against daily use reagents that passed QC with the QC kit in current use. I don't really consider it lot to lot comparison, just making sure that the reagent is acceptable for use.