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.
