Comments from some CLIAC
members indicated that this change appeared to be contrary to the origin of CLIA '88, which was in response to poor quality PAP testing.
The document summarizes the findings of multiple surveys of CW sites, and also comprehensively covers good laboratory practices for waived testing--recommended by CLIAC
at previous meetings.
Mody commented that CLIAC
members represent themselves (not institutions or organizations) and must disclose conflicts of interest.
This marked the last meeting for the CLIAC
Chair David Sundwall, MD, and for committee members Cyril Michael Hetsko, MD, FACP; Margaret Mary McGovern, MD, PhD; and Albert H.
Jean Cooper, MS, DVM, division director, chemistry and toxicology devices, OVID, Food and Drug Administration (FDA), updated agency activities relevant to new CLIA-waiver criteria by incorporating recommendations for requirements resulting from a collaborative work group of CLIAC
, industry, and government.
Workgroup on waiver criteria: After the September 2003 CLIAC
meeting, a waiver workgroup was formed--composed of CLIAC
representatives, AdvaMed, federal agencies, laboratory professional organizations, industry stakeholders, and physicians that use waived tests--and chaired by Barbara Goldsmith, PhD, a former CLIAC
A moratorium on the issuance of new waived tests was recommended by CLIAC
in February 1993.
At the time CLIA was written and when CLIAC
was initiated, DNA-related genetic testing was in its infancy and had not yet become a defined laboratory specialty.
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.
In addition to CLIAC
, input also will come from laboratories, PT programs, accrediting organizations, exempt states, the Veterans Administration, Department of Defense, the Food and Drug Administration (FDA), and other government agencies, she says.
There was news recently that in Florida, there is a move to have these clinics monitored via CLIAC
rules rather than by SAMHSA which deals with substance abuse.