Establishing your own control values

[dgelagay]

1. I am trying to establish my own control ranges (Bio rad 1,2,3) What are the steps? What are the supporting documents for CLIA inspector?  Help?

 

2. I have a physician who is questioning our TSH result. The common complaint I get is it was 2.0 two days ago at a different lab how come I get 4.3 two days later in your lab. I looked at the controls, calibration, proficiency results, peer group data... How can I educate or convince him?

 

 

Thank you