February 7 - 8, 2001 CLIAC Meeting Summary

On February 7-8, ASM members Joe Campos, Dave Sewell, and Alice Weissfeld attended the Clinical Laboratory Improvement Advisory Committee (CLIAC) meeting in Atlanta, GA. The meeting focused primarily on three issues: the shortage of laboratory personnel, the criteria for waiver of laboratory tests, and genetic testing.

Workforce Issues

A report was presented on the meeting hosted by the Coordinating Council for Clinical Laboratory Workforce (CCCLW - formerly the ASCLS Summit on the Shortage of Clinical Laboratory Personnel). The representatives from eighteen professional groups who attended the CCCLW meeting agreed that the shortage of laboratory personnel is worsening. The CCCLW proposed a strategic plan for the collection of data documenting the problem, marketing the profession, recruitment, and financing education. The participating organizations agreed to assume lead roles for the development of components of the strategic plan. CLIAC agreed that the workforce shortage is an important national problem that can affect the quality of laboratory testing and accreditation agencies (e.g. JCAHO) need to be informed of the problem.

Waived Tests

CLIAC discussed at length the criteria for waived tests and the impact of waived tests on patient care. The discussion highlighted the complexity of the problem as seen by the various regulatory agencies, the manufacturers, and the end users. The number and scope of waived products is increasing and will lead to an increase in the number of laboratories that only perform waived tests. For example, Quidel Corporation's Quick Vue influenza test and ZymeTx Inc.'s ZstatFlu influenza test have been waived and we have been told that FDA is evaluating many more infectious disease diagnostics.

Data was presented from a quality assessment survey of laboratories performing waived testing in Washington, Arkansas, and New York. Generally, laboratories performing only waived tests had CLIA deficiencies in the areas of quality control and following the manufacturer's instructions. Fewer deficiencies were observed in locations affiliated with accredited laboratories.

HCFA reported that approximately 75% of 170,000 CLIA laboratories have only a certificate of waiver or PPMP certificate and therefore are not regulated. Generally these laboratories perform less than 10,000 tests per year. Because an earlier study of waived laboratories in Ohio and Colorado indicated that 50% of these laboratories had CLIA deficiencies, the study was expanded to include eight additional states. The preliminary results of this survey indicate a similar percentage of laboratories with CLIA deficiencies. HCFA will present a final report of this study at the CLIAC meeting in May.

The FDA presented its draft guidance document for CLIA waiver criteria as an alternative to the criteria included in the 1995 Proposed Rule (60FR 47534) published in the Federal Register on September 13, 1995. This draft guidance document is seen as an interim review process until a final regulation is accepted. A copy of the guidance document is available on-line and the public will have 90 days to submit comments to the FDA, once the document is officially published in the Federal Register. The draft guidance lists the following criteria that a test must meet to be waived: 1) the test must be simple, 2) the test has insignificant risk of erroneous error, 3) the test is accurate, and 4) labeling (package insert) is consistent with proposed waiver criteria. The test should contain a failure alert mechanism to prevent erroneous results. The FDA interprets "accurate" to mean test performance (i.e. the test performs the same in the hands of untrained users as it does in the hands of laboratory professionals) and not analytical accuracy. CLIAC members suggested that the term "comparability" be used in place of "accurate." Prior to the release of the draft guidance document, FDA conducted a public workshop where ASM provided testimony on this important issue. ASM is also planning to submit comments on the draft document and welcomes input into this process.

Genetic Testing

CLIAC became involved in providing advice on the regulation of genetic testing in 1998. On May 4, 2000 a Notice of Intent (NOI) was published, advising the public that the Department of Health and Human Services will be preparing a Notice of Proposed Rulemaking to revise the CLIA regulations applicable to human genetic testing. A CLIAC workgroup evaluated the NOI comments and presented their recommendations to the full CLIAC. A report was also presented on the meeting of the Secretary's Advisory Committee on Genetic Testing (SACGT). Although there are areas of overlap between CLIAC and SACGT, CLIAC's expertise is in laboratory testing while SACGT is in the medical/social areas of genetic testing. Both groups will provide advice to CDC and HHS on crafting the appropriate CLIA requirements for genetic testing.

Polio Eradication

CLIAC endorsed the eradication of polio worldwide. CDC is preparing to survey laboratories in January 2002 to request their assistance in destroying all materials that may contain poliovirus or request listing on a national inventory maintained by CDC. This issue was discussed with the ASM's Public and Scientific Affairs Board on February 16.

CDC Proposed Quality Institute

CDC proposed that a Quality Institute be formed to discuss the impact of new technology on test quality and outcome. The format would emphasize problem solving and would involve representatives from all areas of healthcare.

Quality Control Update

In 1996, ASM recommended the revision of the frequency of Quality Control specified in CLIA 88. CDC and HCFA agreed with ASM's recommendations and it is expected that the CLIA regulations will be revised sometime in 2003.