The Clinical Laboratory Improvement Advisory Committee (CLIAC) met in Atlanta on Sept. 22-23, 2004, and welcomed new members: (1) Joeline Davidson, MBA, MT(ASCP), CLS(NCA), West Georgia Health Systems in LaGrange; (2) Patrick A. Keenan, MD, University of Minnesota in Minneapolis; (3) Dina Mody, MD, Methodist Hospital in Houston; (4) Lou Turner, Dr PH, NC State Laboratory of Public Health in Raleigh; and (5) Thomas Williams, MD, Nebraska Methodist Hospital in Omaha. Outgoing CLIAC members included Ronald Gagne, MD; Cynthia Johns, MSA, MT(ASCP)SH; Ronald Luff, MD, MPH; Roland Baldes, Jr., PhD; and Alice Weissfeld, PhD.
FDA activities
Jean Cooper, MS, DVM, division director, chemistry and toxicology devices, OVID, Food and Drug Administration (FDA), updated agency activities relevant to new CLIA-waiver criteria by incorporating recommendations for requirements resulting from a collaborative work group of CLIAC, industry, and government. Tests must be simple and easy to run with no specimen manipulation; labeling must be clear; and tests must include quick-reference instructions, pictures and/or other methods to aid users. Manufacturers will need to do more scientifically based flex studies. Subjects in the studies will be intended users rather than lay individuals. The FDA's strengthening of standards will demand, for both quantitative and qualitative tests, more stringent statistical analysis of the studies to ensure tests are sound and perform as intended by manufacturers' claims. The FDA asked for comments on the not-yet-finalized total acceptable error limits; while the agency recognizes the final rules may not be perfect, it anticipates publication in the Federal Register by year's end.
Update of COW surveys
CLIAC Chairman, Dr. David Sundwall, clarified that the 2002 raw certificate-of-waiver (COW) data presented in February 2004--once validated--showed fewer immediate-jeopardy labs than initially suspected (see MLO's 'CLIAC update,' March 2004, p. 9). The Centers for Medicare and Medicaid Services (CMS) awaits the evaluation of 2003 data to determine the level of action for COW labs. Based on 2003 COW data evaluation, the CDC intends to publish the results, along with 'good laboratory practice' guidelines, in the September 2005 Morbidity and Mortality Weekly Report. For the non-waived laboratories, four CMS brochures provide guidance to interpret new CLIA QC rules at www.cms.gov/clia under 'CLIA Updated Regulations Brochures.'
Nonregulatory approaches
CLIAC members learned about nonregulatory approaches (i.e., ISO standards, Six Sigma) the industry has taken to improve lab services, and how accreditation agencies determine their requirements. In-depth presentations came from association, reference lab, and individual experts. As stated by the Centers for Disease Control and Prevention (CDC) representative, government is slow to approve and implement quality standards; therefore, it is necessary to consider other resources that impact the quality of lab services. Upgrading a quality-assurance program by adding ISO and/or Six Sigma requires new lingo, new statistics, and numerous costs. While labs that have implemented quality measures over and above CLIA requirements have experienced a generous return on investment, most CLIAC members agreed that quality is a difficult sell to administrators and a harder sell to government. CLIAC members questioned what actions could be taken to improve the habits of physicians who utilize lab tests. Dr. Joe Boone commented that perhaps the upcoming Institute for Quality in Laboratory Medicine (IQLM) meeting will result in the combination or alignment of performance measures with reimbursement--a possible avenue to motivate physicians to improve utilization to better serve the public.
CLIAC members indicated that lab quality-improvement issues may encourage participation in the meeting, scheduled for April 28-29, 2005. The IQLM mission is to promote improvements in lab testing and services to benefit the public health. Its objectives (see MLO's 'Washington Report,' July 2004, p. 56) are to:
* create an independent public-private partnership that speaks broadly for lab medicine;
* demonstrate the lab's role in systematic improvements in healthcare;
* promote evidence-based lab practices that lead to improvements in quality, effectiveness, and safety;
* provide a forum for collaboration for lab and clinical partners in healthcare;
* support research in design and delivery of effective lab services;
* develop and promote the best indicators for measuring quality of lab services;
* develop sentinel networks of labs that provide regular, factual, information on the state of lab practice;
* present a driving force for continuous quality improvement in lab tests and services; and
* recognize best practices in lab medicine.
By C. Anne Pontius, MBA, CLS(AMT), MT(ASCP)
C. Anne Pontius is a member of MLO's editorial advisory board and president of Laboratory Compliance Consultants in Raleigh, NC.
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As has been the history of MLO's 'Washington Report,' this space has been devoted in 2004 to keeping readers abreast of ongoing issues and new legislation affecting the clinical laboratory and its professional managers and technicians. If there is a particular legislative question or a legislative topic of special interest to your organization, please e-mail: washingtonreport@mlo-online.com.
