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In the United States, the Clinical Laboratory Improvement Amendments (CLIA) of 1988, as modified by the final CLIA Rule, requires the testing of two levels of control (one normal and one abnormal) each day the test is performed. This requirement applies to all non-waived tests, unless the Centers for Medicare and Medicaid Services (CMS) approves an equivalent quality testing procedure as specified in Appendix C of the State Operations Manual.
In other words, if testing patient samples for potassium on Wednesday, the laboratory must test at least one normal and one abnormal potassium control product on Wednesday, unless CMS has approved an equivalent QC procedure. Blood gas testing is slightly different.
For instruments verifying calibration internally, a laboratory in the United States must run one control every eight hours and use a combination of materials including low and high values on each day of testing.
If the instrument does not verify calibration internally, a laboratory must test these same controls with each patient sample.
Note: As with any government regulation, these requirements can change.
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