CLIAC sets two-year meeting plan
By C. Anne Pontius, MBA, CMPE, MT(ASCP), November 2008
The Clinical Laboratory Improvement Advisory Committee (CLIAC) in Atlanta on Sept. 10-11, 2008, reviewed and discussed the genetic-testing workgroup (GTW) report; testing quality control (QC) through risk management; status of waived testing; and the Food and Drug Administration's (FDA's) potential action to waive a white-blood-count (WBC) device. New chair Elissa Passiment, EdM, CLS(NCA), executive vice president, American Society of Clinical Laboratory Science, and the committee welcomed four new members: Christine Bean, PhD, MBA, MT(ASCP); Julie Gayken, MT(ASCP), CLC(AMT); Linda Sandhaus, MD, MS; and Rosemary Zuna, MD. A tentative CLIAC meeting schedule has been set for two years: Feb. 4-5, 2009; Sept. 2-3, 2009; Feb. 10-11, 2010; and Sept. 1-2, 2010. All CLIAC presentations are or will be available on the CLIAC website http://wwwn.cdc.gov/cliac/default.aspx.
CMS agency coverage
Judy Yost, director of the Division of Laboratory Services at the Center for Medicaid and State Operations at the Centers for Medicare and Medicaid Services (CMS), provided the agency update. The total number of laboratories as of June 2008 stood at 206,940, and includes compliance, 19,412; waived, 126,219; provider-performed microscopy, 38,783; accredited, 16,261; and exempt, 6,265. The CLIA-waived laboratory category continues to be the fastest-growing sector, raising concerns that the United States is heading back to pre-CLIA when the majority of testing facilities in the country were not regulated.
Results of the controversial cytology proficiency testing (PT) indicate improvements for all individuals who provide cytology services. The passing PT scores rose from 67% in 2005 to 89% in 2007 for pathologists without a cytologist. According to Yost, the public should have confidence that there have been improvements in cytology services.
Genetic testing continues to be tracked on CMS' radar. Yost has hired a genetic-testing specialist who participates on the Clinical and Laboratory Standards Institute (CLSI) committees that work on genetic-testing issues. She reiterated CMS' position that CLIA provides sufficient enforcement without having to create a genetic-testing subspecialty.
The list of regulated proficiency tests contains 83 analytes but has not been updated since publication of the original 1992 CLIA regulations. CMS and PT stakeholders meet this month to address how to select analytes for addition or deletion from the regulated PT list. Meanwhile, CMS will promote the use of formal PT when it is available from a PT provider (particularly with the genetic tests).
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. Another disclosed violation is sharing PT results with testing sites before the PT provider cut-off dates. As a result of these continued violations, CMS has created Brochure #8, Proficiency Testing to address compliance with PT regulations, which is available on the CLIA website at www.cms.gov/clia.
The updated CLIA website includes a new service that allows users to look up laboratory demographics. The look-up criteria make it easy to obtain information on a laboratory that performs reference testing. Included in the criteria are CLIA number, name, geography, application type, and/or exempt status. The CLIA Laboratory Demographic Information Report includes the certificate/application type; name and address/CLIA number; telephone; certificate expiration date; and lab testing performed in (type of facility). By the end of the year, CMS plans to complete a pilot program on inspecting/certifying overseas labs that have a CLIA certificate of registration. Currently, no overseas lab facilities have been physically inspected and, therefore, have not been able to obtain anything other than this certificate.
CMS is involved with CLSI in the development of two guidance documents for "Evaluation Protocols." Once finalized, these documents could become additional alternatives to the current CLIA quality-control requirements. CMS has yet to determine if the alternative QC options 1 through 3 will be removed as a result of the new documents.
WBC CLIA-waived device
The 2002 Certificate of Waiver (CW) Project to survey 2% of CW laboratories continues. Follow up in the originally surveyed laboratories indicates improvement, particularly in the requirement to follow the manufacturer's instructions.
Since 1992 until today, the number of CLIA-waived procedures has grown from eight to about 100, which represents more than 1,000 test systems. In that time frame, the CW laboratories' representation changed from 20% to 60% of all laboratories.
The question now is whether or not a WBC performed on an automated system should be CLIA waived. The FDA is responsible for categorizing testing for CLIA purposes. A test system is waived, moderate, or high complexity. Waived tests are considered simple and pose no harm to patients if the lab reports erroneous results. The FDA is examining and considering a test system for waived status that performs a WBC count. A panel, including former CLIAC member, Valerie Ng, MD, was convened in July 2008 to discuss the topic. Ng reported on the panel's conclusions, which included questions related to the pre-analytic, analytic, and post-analytic aspects of waived testing. The panel did not always come to consensus. The report will be available at the CLIAC website. CLIAC weighed in by suggesting more information be gathered, but the panel's overall tone was that there are too many variables with WBC testing to make it safe for the CLIA-waived category. Members, however, did not rule it out.
Genetic-testing workgroup report
The GTW focus was to develop recommendations to CLIAC on good laboratory practices for molecular genetic testing (excluding biochemical and somatic genetic testing, and molecular cytogenetics). The 26-page summary report is a comprehensive table that cites current CLIA requirements with key points and clarifications from the GTW. CLIAC recommended that it be published in the Morbidity and Mortality Weekly Report.
C. Anne Pontius, MBA, CMPE, MT(ASCP), is president of Laboratory Compliance Consultants in Raleigh, NC, and president-elect of CLMA 2007-2009.