Busy agenda—sad farewell

Medical Laboratory Observer, March, 2007 by C. Anne Pontius

The Clinical Laboratory Improvement Advisory Committee (CLIAC) met in Atlanta, Feb. 14-15, 2007, to discuss agency updates, genetic-testing laboratory regulations, point-of-care testing, and rapid HIV testing. The meeting started somberly with the announcement and recognition of the death in February of longtime Food and Drug Administration (FDA) employee and industry friend, Joseph Hackett, PhD, associate director of the Division of Clinical Laboratory Devices.

The minutes and presentations from this CLIAC meeting will be posted on CDC's website at www.phppo.cdc.gov/cliac/default.aspx. The next meeting is scheduled for Sept. 5-6, 2007 in Atlanta at the CDC.

CDC news

Julie Taylor, PhD, provided the Centers for Disease Control and Prevention (CDC) update including the announcement of its upcoming 2007 Institute on Critical Issues in Laboratory Practice to be held Sept. 23-26, 2007, at the Westin Atlanta Perimeter North, the fifth meeting in a series. Keynoting is Brent C. James, MD, executive director of Intermountain Health Care Institute for Healthcare Delivery Research. The current plan is to Webcast the general session.

FDA plans

Steve Gutman, MD, director of the FDA Office of In Vitro Diagnostic Devices Evaluation and Safety, announced that the Waiver Guidance is completed in its final version, and will be followed by a plan to present draft regulations. The publication includes concepts to address the tension between value of access and performance, and has stronger risk-management sections. Two other guidance documents have been published for analyte specific reagents (ASR) (not new but explanatory) and in vitro diagnostics multivariate index assay (IVDMIA) (a new interpretation of existing regulations and laws).

CMS update

Judy Yost, director, Division of Laboratory Services, Center for Medicaid and State Operations, Centers for Medicare and Medicaid Services (CMS) provided the agency update. The cytology proficiency testing (PT) recommendations from CLIAC are being pushed through an expedited clearance process for publication in the Federal Register. Public comments, along with committee-member concerns, question the length of time it takes to get recommendations into regulations, but Yost says that is what assures the public of good regulations.

A major initiative of the Secretary of Department of Health and Human Services, Michael O. Leavitt, is the electronic health record (EHR) of which the laboratory will be a prototype. CMS is working with attorneys to retain the integrity of CLIA and incur minimal burden for vendors and laboratories via policies or creative solutions, where possible.

Although the genetic-testing (GT) specialty regulations have been abandoned, oversight of GT continues to be a CMS focus with plans to develop survey options, educate labs, collect data, and collaborate with genetic-testing community, government agencies, and other experts to facilitate design of PT and quality-control (QC) options. Yost explained how current CLIA rules cover what is needed for GT. To strengthen oversight of genetic testing, CMS recognizes the need to effectively implement current CLIA rules. CMS checks on a current list of GT laboratories to verify they are adhering to CLIA rules.

As much as the CLIAC committee would like to see specific genetic-testing CLIA requirements, it is beyond its scope to address the following GT issues: clinical validity; direct-to-consumer; informed consent; genetic counseling; tests (i.e., gender) that do not assess health; and ethical, legal, and social issues. CMS can heighten PT-surveyor awareness and train them to examine specific issues unique to GT and to collect GT laboratory-performance data. CMS also intends to have an ongoing collaboration with advisory groups, experts, CDC, FDA, and other interested parties to develop GT standards with CLSI, and educate GT laboratories.

Once approved, CMS is likely to adopt the Clinical and Laboratory Standards Institute (CLSI) Evaluation Protocol-23 (EP23) to beef up its CLIA Equivalent Quality Control (EQC) options. This provides custom guidance for alternative QC protocols for labs which takes into consideration a lab's unique circumstances of patient population, personnel competency, test systems utilized, and environmental issues.

CMS updated its PT policy to mandate condition-level citations for failure of a lab to enroll and/or perform successfully. The current prohibition of referral PT specimens and communication of PT results for PT-listed analytes has been expanded to include analytes that are not listed. Non-compliance with this rule requires automatic loss of CLIA certificate for one year, and the laboratory director cannot oversee a CLIA-certified lab for two years.

Rapid tests impact public health

Barbara Robinson-Dunn, PhD, D(ABMM), CLIAC chair of the the committee's workgroup, presented a comprehensive report on their meeting about the increased use of rapid, direct testing in physician offices and other POCT sites; expanded use of molecular testing in a variety of labs; and assuring quality of rapid and molecular tests. (A rapid test is defined here as one that can be performed in less than one hour.) From workgroup discussions, concerns emerged about the impact of rapid and molecular tests on public health, including the fact that users may not be aware that 1) some rapid tests are screening tests and require confirmatory testing; 2) public-health disease reporting is required; and, 3) specimens or isolates may not be available for submission to public-health facilities. The workgroup accomplished identifying the challenges that exist between the original testing site and those with public-health oversight responsibilities, and this information goes now to CDC groups that deal with public-health issues.