Nova StatSensor Strip Creatinine Lot to Lot

As a relative newly POC Coordinator, I have struggled with the Creatinine meter. This is my interpretation of the regulations + CAP requirements:
1. COM.30450 New Reagent Lot - new reagent lots are checked against previous lots OR with suitable reference material. Lot to lot is not REQUIRED.
2. Nova REQUIRES a correlation study for each new lot of creatinine strips from the meter to your Chemistry analyzer (20 - 30 samples!). 
So I verify QC is acceptable on the new lot and perform the often challenging correlation. I use the correlations for my semi-annual method comparison and pray that I don't get more than two lots a year (small hospital, relatively low usage).

Thank you Tracy, We are having a hard time correlating results over 1.2 on the Nova meters with our Chem analyzer. 

Me too. I submitted results that I was sure would be rejected, but they were not. As you know, you send it to Nova and they assess whether an off-set is needed.

Yeah, when our data isn't good, they still accept it and say its up to our pathologist. It is very different. 

Are you using the updated ADLM Criteria= If <1.2mg/dL, acceptability =+/-0.2mg/dL, if >/=1.2mg/dL acceptability =20%?

We had evaluated the StatSensor for creatinine several years ago. Because our measurement of interest was 1.7, we also were not able to correlate with the lab. As a result, we do not use the device for Radiology creatinine, we use a different waived creatinine.

What are you using Kathleen? We were told last year that Nova is supposedly coming out with a waived creatinine meter in the near future.

We use the i-STAT creatinine.