LQC lot ranges for Hemochron

We run new lots of QC 5 times to verify the manufacturer control range.  We do not establish our own.  Running 20 times does seem excessive so since not required, we don't do that.

We run new lots 5 times to verify the manuf range.  Establishing our own would probably require far more runs.  Please note, the package insert is just a recommendation. CAP requires us to at least verify the range.  Hope this helps.  

CAP only requires the repetitive analysis for unassayed control material, and DirectChek is assayed so it would only require verifying the range, as the laboratory defines. 
  As most Hemochron users know, achieving acceptable QC values with DirectChek is extremely technique dependent and is often difficult for POC users to attain, even using the manufacturer's range.  A repetitive analysis range defined and set by the POCC would likely result in a much narrower range for the POC staff to have to achieve and quite possibly an impossible goal, or at the very least, lots of wasted QC.  I could not see the value, especially when it has very little bearing on how patient samples are handled.

Our medical director set it so that we run the LQC once upon receipt to verify the results are within the manufacturer's established range. Once placed into active use, we have an entire month of results from a variety of departments to further document performance.

James Beck, so would running controls once upon shipment suffice then? Thank you!

Our urgent care was cited by CLIA for not performing this so we are stuck.  The process is listed in the package insert as a recommendation, so I guess that means requirement in our inspector's opinion.  At this time we have not changed the ranges; not sure how to easily do that, if we have to use configuration manager or not so more work to come on that little project.