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or subcommittees at the request of HHS, will review and make recommendations concerning: criteria for categorizing tests and review of analytes categorized as moderately complex and highly complex; determination of waived tests; personnel standards; patient test management, QC, QA standards; PT standards; applicability to the standards of new technology; and other issues relevant to CLIA if requested by HHS.
Carey, PhD, acting director of that division, will be the CDC's ex-officio CLIAC
As noted at the last CLIAC
meeting, several laboratories violate the PT regulations by sending PT specimens to reference laboratories and reporting the reference-laboratory's results.
Joe Boone, PhD, CDC, informed CLIAC
that a small workgroup would be formed to update the proposed Morbidity and Mortality Weekly Report document, "Good Laboratory Practices for Ensuring the Quality of Genetic Testing"--recommended at a previous CLIAC
Although CMS stopped the progression to implement a subspecialty for genetic testing, CLIAC
is still focused on ensuring there is appropriate genetic-testing oversight.
The cytology proficiency testing (PT) recommendations from CLIAC
are being pushed through an expedited clearance process for publication in the Federal Register.
Birdsong, MD, Emory University School of Medicine, and former CLIAC
member, presented on the advancements in cytology-testing technology; he believes a four- to five-year lag exists before enough slides will be in the marketplace to adequately perform PT.
Minutes from this meeting will be posted on CDC's CLIAC
website at www.
This was the first meeting for the new CLIAC
Chair Lou Turner, DrPH, who is the director of the North Carolina State Laboratory of Public Health, as well as for new committee members:
16-17, 2005, to hear agency updates and discuss implementation of cytology proficiency testing; CLIAC
workgroup's report on waived testing; and appropriate quality control for microbiology identification systems.
members included Ronald Gagne, MD; Cynthia Johns, MSA, MT(ASCP)SH; Ronald Luff, MD, MPH; Roland Baldes, Jr.