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New regulation at a glance

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March 2003

The final CLIA QC regulation, published in the Jan. 24 Federal Register and effective April 24, contains a number of clarifications and changes to CLIA rules, as follows:

  • Provides one set of QC standards for nonwaived testing.
  • Reduces QC frequency in most of the subspecialties and specialties, and merges moderate- and high-complexity QC requirements to simplify compliance.
  • Eliminates the prospective FDA review of manufacturers’ QC instructions for compliance with CLIA that was supposed to occur after the end of the QC phase-in.
  • Reorganizes existing requirements to parallel the flow of a patient specimen through the laboratory to help prevent errors.
  • Mandates board certification for new doctoral-degreed directors of high-complexity testing (effective Feb. 24). The regulation grandfathers certain directors with doctorates who are serving or have served as lab directors of high-complexity testing.
  • Requires moderate-complexity laboratories to validate a test system once before testing patients.
  • Implements parallel requirements for each phase of testing (pre-, analytical, and reporting) to review the effectiveness of quality assessments and corrective actions.