On March 11-12, 2003, ASM members Joseph Campos (CLIAC member) and David Sewell (ASM representative) attended the Clinical Laboratory Improvement Advisory Committee (CLIAC) meeting in Atlanta, GA. The Centers for Medicare and Medicaid Services (CMS), Food and Drug Administration (FDA), and Centers for Disease Control and Prevention (CDC) provided updates to the full committee.
Centers for Medicare and Medicaid Services
The Centers for Medicare and Medicaid Services (CMS) provided an overview of the final CLIA regulations published in the Federal Register (68:3640-3714) regarding quality control (QC) and laboratory director requirements. CMS reformatted the CQ regulations to reflect specimen flow through the laboratory (e.g. pre-analytical, analytical, post-analytical); merged moderate and high complexity QC; reduced QC frequency for many microbiology tests; finalized the proposal to require board certification for Laboratory Directors (applies to the individual identified on a CLIA Certificate of Accreditation as the Laboratory Director); placed new emphasis on quality systems and assessment; and provided flexibility to use alternative QC mechanisms. CMS is in the process of drafting CLIA Guidelines, which will be posted on its website (http://www.cms.hhs.gov/clia) in the future.
Food and Drug Administration
The Food and Drug Administration (FDA) presented information about the recently waived OraQuick Rapid HIV-1 Antibody test, including sensitivity and specificity data. FDA informed CLIAC members that the sale and use restrictions found under moderate complexity testing remain in place for the OraQuick test, under the CLIA waived test category. What this means is that only clinical laboratories and/or facilities with a certificate of waiver that meet certain quality assurance requirements may purchase OraQuick. Quality assurance requirements include: planned systematic activities to assure that requirements for quality will be met, and assurance that operators will receive and use the instructional materials. Agents of clinical laboratories-persons who work for the laboratory/facility whether it is high complexity, moderate complexity, or waived, may also perform the test. FDA is currently drafting the package insert to include data from the waived studies, a letter emphasizing the meaning of the purchase agreement, as well as important information regarding quality assurance and the need to confirm all reactive test results with Western blot or Indirect immunoflourescence.
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC) reported that it is developing recommendations on quality assurance (QA) programs for the administration of rapid tests, such as the recently waived OraQuick Rapid HIV-1 Antibody test. CDC hopes to publish the recommendations in the Morbidity and Mortality Weekly Report (MMRW) and will also post the information on the CDC website at a later date.
The Laboratory Response Network (LRN) update was delivered by ASM member, Mike Miller. Dr. Miller highlighted the increasing number of partners (clinical, state, veterinary, agricultural, and military labs) involved in the network and also presented information regarding the modification of the LRN model, which now consists of three levels: Sentinel (formerly Level A), Reference (formerly Levels B & C), and National (formerly Level D) laboratories.
Direct Access Testing (DAT)
The remainder of the meeting focused on a lively discussion of the pros and cons of Direct Access Testing (DAT). The committee heard physician, laboratory, and consumer perspectives as well as comments from various professional organizations and trade groups. All agreed that DAT is part of a system for providing healthcare services to consumers. At a future meeting, CLIAC will decide what role, if any, they should have on the issue of DAT.