On January 24, 2003, the Centers for Medicare and Medicaid Services (CMS) published the final Clinical Laboratory Improvement Amendments (CLIA) regulations with an effective date of April 24, 2003. COLA revised their accreditation criteria, Criteria for Quality Laboratory Performance, with an effective date of June 1, 2007. The new CLIA and COLA regulations require that the laboratory verify the manufacturer’s performance specifications listed in their package inserts. The laboratory must verify accuracy, precision, reference range and reportable range for each non-waived test. This bulletin will address the verification of reportable range.
What is reportable range?
Reportable range is the lowest and highest result the test system can accurately report including all the values in between.
When is reportable range verification required?
Reportable range verification is required when a lab replaces a test system or instrument, adds a new test or changes the manufacturer of a test system.
NOTE: This requirement applies to all non-waived test systems put in place on or after April 24, 2003. COLA accredited labs need to meet this requirement beginning June 1, 2007. (more…)