Our clinic laboratory performs a limited amount of testing for some analytes. We meet the CLIA QC requirements by analyzing 2 levels of liquid control each day of testing to assess quality for the tested analytes. For the low volume tests, can we just use the controls’ product inserts range of values?
The purpose of QC is to evaluate the quality of testing conducted in your laboratory. The QC performance 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 control limits identified in the product insert reflect the variation observed across several different laboratories. This “group” variation typically is larger than what is observed by an individual laboratory causing larger SDs and wider control limits, which reduce error detection.
Since the goal of QC is to evaluate the quality of testing in your laboratory, control limits should be established based on the QC data (means and SDs) collected in your laboratory. To begin, it is acceptable to use bottle values until sufficient in-house data (10 – 20 values) are collected and means, SDs and control limits are established.
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