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Friday, September 07, 2007

A little known side of urine analysis

Urine analysis by dip stick is a CLIA waived lab test. What this means is that as long as you follow the manufacturers directions, exactly, you will be in compliance with CLIA'88 regulations and will not need not anything other than a CLIA Waived Certificate to legally do the tests and bill for them. But here is the rub. You must follow the manufacturers directions exactly, because veering from the package insert directions automatically converts your waived lab into a high complexity lab, and you don't want to go there. Below is a description of the QC (quality control) requirements for urine analysis.


  • The package insert from the test strips recommend that QC (quality control) be performed on every new package of test strips.

  • QC, according to the package insert, involves 2 sets of negative controls, and 2 sets of positive controls

  • If you use an automated test strip reader, the manufacturer recommends that, at the very least, QC be performed daily, as above, on all testing days.

  • Each test costs 33 cents (PSS brand) or 50 cents (Bayer Brand), thus daily QC just for UAs costs netween $1.20 and $2.00, or between $370 and $624 per year.

If you don't, then in essence you are converting a waived test to a high complexity CLIA test. Good luck.

Dr Schoor

www.ilabtqm.org.