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

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.

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?

 

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

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 ? 

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.

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 ? 

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.

Do you do lot to lot for QC kit? Actually parallel testing for QC, eg. ALBA Q, Confidence QC kit?

On ‎04‎/‎21‎/‎2018 at 10:50 AM, Eagle Eye said:

Do you do lot to lot for QC kit? Actually parallel testing for QC, eg. ALBA Q, Confidence QC kit?

Oh no... you are kidding me?  Does this apply as well?  I never thought of this!

We run our old confidence and new confidence in parallel on the day of expiration date of current lot. (same for ALBA Q).

We run our new confidence when received with reagents QC'd with the current set, stating that all reactions are as expected with reagents that have been QC'd with the current lot.

Am I the only one that thinks that performing lot to lot with  ABLA Q is not required?  

I emailed CAP about this.... and at least for now, looks like we are in the clear!!  Woohoo!

My email :

1) COM.30450 New Reagent Lot Confirmation of Acceptability:
This refers to kits such as a Fetal Screen, but would this also apply to a Reagent QC Kit such as Ortho Confidence?

Response:  Lilly Petkovic, MT(ASCP)SBB
                Laboratory Accreditation Program

The daily QC testing that is being performed with the Ortho Confidence QC satisfies the requirement for COM.30450, "New Reagent Lot Confirmation of Acceptability" as long as the acceptability criteria is defined and the outcome of the results are recorded followed by supervisory review.

 

The daily QC testing that is being performed with the Ortho Confidence QC satisfies the requirement for COM.30450, "New Reagent Lot Confirmation of Acceptability" as long as the acceptability criteria is defined and the outcome of the results are recorded followed by supervisory review.

 

This is the catch , you need to define what is acceptable result and have supervisory review.

On ‎05‎/‎08‎/‎2018 at 11:15 AM, Eagle Eye said:

The daily QC testing that is being performed with the Ortho Confidence QC satisfies the requirement for COM.30450, "New Reagent Lot Confirmation of Acceptability" as long as the acceptability criteria is defined and the outcome of the results are recorded followed by supervisory review.

 

This is the catch , you need to define what is acceptable result and have supervisory review.

Perfect!   We are covered there