On 2-3 September, ASM staff member Suzy Leous attended the Clinical Laboratory Improvement Advisory Committee (CLIAC) meeting in Atlanta, Ga. Meeting topics were "Laboratory Testing Quality during Public Health Emergencies," "Assessing the Performance and Impact of Waived Testing," and "The Current State of HIV Testing." Representatives from the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Centers for Medicare&Medicaid Services (CMS) provided updates on the origin of novel influenza A (H1N1), epidemiology and surveillance data, antiviral resistance data, information on FDAapproved rapid influenza diagnostics, and short-term CLIA policy changes afforded to laboratories. Representatives from public health and clinical laboratories presented information on H1N1 testing challenges. CLIAC members suggested that guidelines be drafted for various audiences (i.e., laboratorians, health care providers, and consumers) to address issues such as what kinds of H1N1 testing should be performed, when tests should performed, why tests should be preformed, and how to interpret test results.

CMS provided information on its Certificate of Waiver Pilot Project, which has collected data from waived laboratories since 2002. CMS has surveyed 2% of waived labs each year. Through the project, CMS has provided education to waived labs on the CLIA requirement to follow manufacturer's instructions for testing by creating an educational program clearinghouse, producing a best-practices document, and by collaborating with organizations to develop and promote educational materials. Survey results to date indicate that educational visits by CMS to labs with a certificate of waiver have improved test performance. CLIAC members recommended that CMS continue its program and expand it to obtain and assess more detailed information including the tests that are performed in waived laboratories, who is performing the tests, how personnel are trained, and to assess whether manufacturer's instructions are being followed.

FDA presented information on the status of HIV testing and the effort to develop alternative HIV testing algorithms due to evolving diagnostic technologies. Historical information about HIV testing methods was provided, as well as information on the HIV Testing Algorithms Status Report, prepared by the Association of Public Health Laboratories and the CDC. The status report is available at http://www.aphl.org/hiv/statusreport. Data and findings from the report will be discussed at the 2010 HIV Diagnostics conference, to be held 24-26 March 2010 in Orlando, Fla. For more information, please visit the conference website at http://www.hivtestingconference.org.