We’re a small lab and have been setting our means and ranges based on the package inserts. It hasn’t been a problem for us, but at a recent local conference a presenter said this was a CLIA violation. What’s the real story and what should we do?

The purpose of QC is to assess the performance (variation) of testing conducted in your laboratory. The QC limits for acceptability are based on the method’s past performance and established by using the observed means and standard deviations (SDs) obtained by your laboratory’s methods through repeated measurements of the controls.

The means and SDs identified in the product insert reflect the variation observed across several different laboratories. These “group” variations typically are larger than what are observed by an individual laboratory. These cause larger SDs and wider control limits, and in your laboratory, will reduce error detection. So the bottom line, is use these values as a guide, but don’t use the means or SDs from the control’s product insert to calculate the control limits for your methodology. If necessary, it is acceptable to use bottle values (as a guide) until sufficient in-house data (at least 20 values) are collected and means, SDs, and control limits can be established.


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