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. Due to the updated CLIA regulations, COLA updated their accreditation criteria, Criteria for Quality Laboratory Performance, with an effective date of June 1, 2007. Since the release of both regulations, Vital Diagnostics has received numerous questions regarding the calibration and calibration verification requirements. The intent of this Technical Bulletin is to define calibration and calibration verification, explain the requirements and provide some insight into implementation.
What is calibration?
Calibration is the process of testing and adjusting an instrument or test system to establish a correlation between the measurement of the substance being tested and the actual concentration of the substance……(Read More Here)