Waived Testing QC when no specific mfg recommendations provided

Hi Richard, I can't speak for state/local regulations, but the CLIA default for QC is 2 levels daily. If the manufacturer doesn't specify, that is the default. 

Kathleen- is the CLIA default for 2 levels daily for non waived only? Or for waived? Mary

That's a good question, Mary! Actually, the 2 levels of QC daily is in the regulations under moderate and high complexity testing. The waived regulations just state to follow manufacturer's instructions. We in the lab have just traditionally followed 2 levels of QC daily for all testing. So I suppose in the case of the manufacturer not providing any specific instructions, it would be up to the medical director to decide what QC to perform. 

Thanks for your comments Mary and Kathleen. This would be for a Waived OTC product and just wanted to get a read on manufacture recommendations that essentially punted the frequency question to the local regs. 

Hi 
Does this OTC test have a waived equivalent?  If it does than you have a jumping off point for a QC program for the test.
Just a thought!