Hemochron Signature Elite ACT-LR IQCP

Hi Carol,
When it comes to non-waived tests, labs must follow CLIA regulations as well as the manufacturer's recommendations.  Per CLIA regulations, each non-waived test must have at least 2 levels of liquid QC per day of use and per every 8 hours for coagulation tests.  Labs can choose to do less by means of IQCP (individualized QC plan) after proper risk assessment.  I do see your point, but it can only apply to waived tests.  

Good morning Carol. I agree with Don. A part of the IQCP is to assess the risk associated with performing QC at anything other than what CLIA states. For Coagulation testing it is just has Don describes, 2 levels of liquid at 8 hours. The internal QC (electronic) does not count towards that requirement, rather it allows you to go forth with the IQCP. There is a free great resource on how to make an IQCP through CMS. A simple google search will pull it up.