Validation of new lots of strips & controls for Accu-Chek Inform II

Hi Tracy -
For new lots of QC, we just run QC 10x each level and make sure results fall within manufacturer ranges (and SD/CV are acceptable of course). For strips, we do QC 2x each level and a minimum of 3 patient checks on the new lot vs current lot and main lab analyzer. 
Erin

Hi Tracy,

The process we use is pretty much the same as what Erin's facility does.  
Good luck!

Jacqueline

Thanks for responding, Erin and Jacqueline. Do you validate the QC and strips on one meter? We run them the new lots on all of our meters in conjunction with our linearity testing. It's a lot of testing at one time! 

We use multiple meters, at least two, to make the process quicker. We do not use every meter though, as we have 150. We only run linearity on new meters and/or if we are troubleshooting. 

We use two meters - one for the old lot of strips/controls and one for the new lot of strips/controls.  We only run linearity on the new lot of strips (and of course on new meters or for troubleshooting).

I use the subset of meters and have a form I fill out.  If you reach me offline I can send you my procedure and forms.  sharon.walker@meritushealth.com

Thanks again for the information, everyone. I'll be contacting you, Sharon, I appreciate it. 

Erin, for the patient checks on the new vs current lot and the main lab analyzer, what % difference do you use do you use for each of the checks? I read elsewhere in the listserv that CAP and CLIA allow 7%, but I can't find that in the standards.  Also, CAP COM.04250 refers to nonwaived instruments/methods. I'm wondering if the meter to main lab analyzer is required by CAP for the Accu-Chek?

Hi Tracy,
For the patient checks, we use 6 mg/dL and/or 10% from CLIA total allowable error (westgard has a bunch of tables under their CLIA & Quality tab). The meter to main lab analyzer is not required for waived Accu-Chek, but we only get two lots per year so we just do them anyway. You would not be out of compliance if you did not do them for new lots. 

Thanks for the additional information, Erin!