New regulation at a glance
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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
- 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.