Agenda items for the CLIAC meeting included federal agency updates from the Centers for Medicare and Medicaid Services (CMS), Food and Drug Administration (FDA), and Centers for Disease Control and Prevention (CDC); waived testing; quality control issues related to DTM culture media; workforce shortage issues; the Quality Institute; direct access testing; and, genetic testing.
Centers for Medicare and Medicaid Services
Judy Yost from the Centers for Medicare and Medicaid Services (CMS) reported that the current CLIA enrollment is 180,000 laboratories, including 101,000 physician office laboratories (POLs). Ms. Yost also provided a summary of the final CLIA regulations on quality control and laboratory director requirements (Fed. Regist. 68:3640-3714, 2003). Ms. Yost indicated that the QC rule parallels laboratory workflow (e.g. pre-analytical, analytical, and post-analytical); merges the moderate and high complexity categories into a nonwaived category; reduces QC frequency for some microbiology tests; places new emphasis on quality systems and assessment; provides flexibility to use alternative QC mechanisms; and eliminates the FDA’s QC role. The Laboratory Director portion of the rule requires board certification for Laboratory Directors named on the CLIA Certificate of Accreditation. In addition, Ms. Yost informed the CLIAC that the CMS Surveyor Guidelines will be posted on the website (http://www.cms.hhs.gov/clia) before the end of the year. New educational brochures for POLs will be available in December, 2003.
Food and Drug Administration
Steve Gutman, from the Food and Drug Administration (FDA) provided an update on FDA’s new strategic plan, which emphasizes better efficiency and access for users. Dr. Gutman noted that the quality assurance guideline for the waived OraQuick Rapid HIV Antibody Test is available on the CDC website (http://www.cdc.gov/hiv/rapid_testing/index.htm).
Centers for Disease Control and Prevention
Robert Martin from the Centers for Disease Control and Prevention (CDC) provided the CDC update, and focused his remarks on CDC’s strategic plan, otherwise known as the “Futures Initiative.” CDC hopes to develop its plan through input from its numerous stakeholders.
CDC staff Toby Merlin informed CLIAC that the Gallup Organization conducted a satisfaction survey of governmental advisory committees. Members of the CLIAC reported greater satisfaction from serving on CLIAC than members of other advisory committees.
Once again, the issue of the waiver review process was discussed. Currently, 32,065 test systems have been categorized as waived or nonwaived (moderate and high complexity). Waived test systems (4% of total systems) measure 72 analytes and are exempt from CLIA standards and regulatory oversight. As in past discussions, a major concern of CLIAC regarding waived testing was the need to implement a method to ensure that quality testing occurs during the pre-analytical, analytical, and post-analytical test phases. The Advanced Medical Technology Association (AdvaMed) proposed criteria to be used by the FDA for the waiver process. Following the discussion of AdvaMed’s proposal and public comment, CLIAC recommended that a workgroup composed of representatives from CMS, CDC, and FDA and other interested parties be organized and charged with developing a waiver process that is acceptable to all affected parties. The workgroup will report to the full committee at the next CLIAC meeting in February, 2004.
Joe Boone from the CDC’s PHPPO provided an update to CLIAC on the Quality Institute that took place Atlanta in April, 2003. Under discussion, based on feedback from the meeting, is the development of a national report on the quality of laboratory services, identification of quality indicators for laboratory services, and development of a process for the collection of these data. It was also suggested that the organization’s name be changed to the “Institute of Laboratory Medicine” with a Board of Directors. The next Institute conference is scheduled for October 14-16, 2004.
Quality Control of Dermatophyte Test Medium
CLIAC accepted the recommendation offered by the American Society for Microbiology (ASM) to support the new NCCLS standard requiring the end user to quality control (QC) dermatophyte test medium, because of the medium’s high rate of QC failure when tested by the end user (Arch Pathol Lab Med 127:661-665, 2003). CLIAC contacted ASM for assistance after receiving a request from the dermatology community to except end user QC on DTM culture media. A copy of ASM’s letter was circulated to CLIAC members prior to the CLIAC meeting. To see a copy of the letter, go to index.php?option=com_content&view=article&id=21491.
Laboratory Workforce Shortage
CLIAC received an update on the June 2003 meeting of the Coordinating Council on Clinical Laboratory Workforce (CCCLW). Factors affecting the number of individuals entering the laboratory workforce were identified and CCCLW is developing strategies to enhance recruitment of new applicants.
Former CLIAC member and ASM member, Patricia Charache, provided a summary of the CLIAC’s activities and recommendations to date on genetic testing.
Direct Access Testing
There was a brief follow up report from CDC staff Toby Merlin on Direct Access Testing (DAT), including information on the various state laws that regulate this form of testing. DAT is defined as testing that patient-consumers self-order and pay for out-of-pocket. Approximately 10-15% of hospital and commercial laboratories currently offer direct access testing. At its March meeting, CLIAC members were presented with background information on DAT; to see a summary of the March presentations and discussions, go to http://www.phppo.cdc.gov/cliac/cliac0303.asp#t17
Complete minutes from the meeting will be available in the future at http://www.phppo.cdc.gov/cliac/default.asp.