Agenda items for the CLIAC meeting included updates from the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Centers for Medicare & Medicaid Services (CMS); presentations about the future of health laboratory practice and future directions in laboratory technology; and interfaces between the laboratory and clinicians.
Centers for Disease Control and Prevention (CDC) Update
Joe Boone presented the CDC update and included information about CDC’s activities with respect to genetic testing. He informed CLIAC members about CDC’s involvement with the “Collaboration, Education and Test Translation” (CETT) pilot program, which is developing models to facilitate the translation of genetic tests from research laboratories to clinical practice. The program was initiated by the National Institutes of Health’s Office of Rare Diseases, in response to Congressional language requesting the NIH to address the development of diagnostic tests for rare diseases. CDC is one of the federal agencies involved in the program. Information about CETT is available at http://www.cettprogram.org.
Dr. Boone also informed CLIAC members about CDC’s work with the Genetic Testing Quality Control Materials Program (GTOC). The program is focused on helping the genetic testing community obtain appropriate and verified QC materials, facilitating and coordinating information exchange between users and providers of QC materials, and, coordinating efforts for the contribution, development, verification and distribution of QC materials for genetic testing. For more information about the program, go to http://www.phppo.cdc.gov/dls/genetics/qcmaterials/
An update was provided on an upcoming 2007 Institute on Critical Issues in Health Laboratory Practice: Managing for Better Health,” being planned by CDC. Topic areas for the institute include management systems, informatics, technology integrated laboratory services and customer expectations. CDC is in the process or forming a steering committee for the meeting. CDC has also contracted with Battelle to produce a report on the status of laboratory medicine which would include the scope and magnitude of the field, factors affecting the delivery and quality of services, impact of regulation and accreditation, performance measures, and workforce trends. Battelle has also been asked to develop a process for identifying best practices.
Furthermore, Dr. Boone informed CLIAC about an upcoming CLIAC workgroup meeting on the impact of rapid and molecular tests for infectious diseases on public health. CLIAC members Barbara Robinson-Dunn and Gerri Hall, in addition to others on CLIAC interested in the topic will be meeting on November 2 in Atlanta to discuss issues including the need for confirmatory testing for some screening tests, state public health reporting requirements, etc.
Food and Drug Administration (FDA) Update
Courtney Harper from FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety provided an update on FDA’s Critical Path Initiative, patient safety initiatives, CLIA related activities, and information on new FDA Guidance documents. Of note is that the Critical Path Initiative has plans to conduct a workshop on rapid infectious disease diagnostics in November 2006. This workshop will focus on approaches to shorten the critical path in new product development and integrating new technology into clinical practice. It will also focus on transitioning new diagnostic tests from the research bench to the laboratory and near-patient settings. More information on the meeting can be found at http://www.fda.gov/cdrh/oivd/news.html#critpath
Harper updated CLIAC members on LabNet, the surveillance program similar to MedSun. The goals of LabNet are to provide more active surveillance of IVDs and to collaborate on mechanisms needed to monitor devices used in hospital laboratories. Pilot labs have been selected and training is under way.
Harper informed the group that the CLIA Waiver Guidance is in its final stages; comments were received and have been incorporated into the updated version which is currently undergoing the Federal clearance process. Furthermore, information on the other recently released Guidance Documents were presented, including the Guidance on Informed Consent for In Vitro Diagnostics Using Leftover Specimens, the Frequently Asked Questions document regarding Analyte Specific Reagents (ASRs), and the Guidance on In Vitro Diagnostic Multivariate Index Assays (IVDMIAs). Comments on the ASR and MIA documents are due December 6. One CLIAC member asked if there could be an extension on the comment period stating the importance of CLIAC review of the documents. An additional note was made regarding the Informed Consent Guidance: per FDA staff, the Guidance is a first step, and a regulation will follow.
Elliot Cowan provided a summary of the March 10, 2006 Blood Products Advisory Committee (BPAC) meeting on “Approaches to validation of OTC home-use HIV test kits.” FDA developed a set of proposed studies and sought concurrence on its three phase study proposal from BPAC. The objectives of the Phase I study are to establish the inherent sensitivity and specificity of the test, and to demonstrate that the test is capable of withstanding operational stress. The Phase I study will be conducted with individuals trained in using the device. The objectives of the Phase II observed study are to evaluate test use in a controlled setting, including the effectiveness and safety of sample collection by untrained potential users, the ability of untrained potential users to perform test properly, the ability of untrained users to read and interpret test results, to evaluate the performance of the test in the hands of untrained users, and the reaction to test results by untrained users. The expected performance rate for sensitivity and specificity is > 95%. The objectives of the Phase III unobserved study are to evaluate the performance of the test in the hands of untrained potential users, evaluate reactions of the study participants to their test results, validate the ability of informational materials to communicate properly and effectively, and to validate the counseling system. The expected performance is > 95%. BPAC voted in favor of all three phases, including the most stringent proposed Phase III studies. Many additional recommendations were made by BPAC members including concerns about the makeup of study participants, the labeling of test kits, instructional materials, etc.
Centers for Medicare & Medicaid Services (CMS) Update
CMS staff provided an update on the CLIA mandated Cytology Proficiency Testing; the cytology PT program began in 2005 and test data from both 2005 and 2006 was reported. Judy Yost, CMS Director of Laboratory Services provided a detailed update on the CMS response to the report released by the Government Accountability Office (GAO) on the CLIA inspection process. Yost also informed CLIAC that its draft proposed rule on genetic testing has been dropped because of a number of concerns raised by the Department of Health and Humans Services, including ethical/social and legal issues related to CLIA law. She stated that CMS will take a different, non-regulatory approach to genetic testing. It will heighten awareness of genetic tests and use its current lab inspection/oversight process to pick up problems and concerns. It will promote educational tools to provide information to laboratories and will also collaborate with FDA and CDC so that comprehensive oversight is achieved.
Future of Laboratory Medicine Presentations
There were several presentations related to the topic of the Future of Laboratory Medicine. CDC staff, Tom Hearn and Joe Boone provided a general overview of the U.S. health care system including its challenges and inefficiencies, and the laboratory’s role in the current as well as the future health care system. Jocelyn Hicks, PhD gave an overview of laboratory medicine, focusing on technology changes and its impact on laboratory practice and staffing issues, as well as its impact on medicine. Two presentations on technological advances in laboratory diagnostics were made, including one by Dr. Cynthia French regarding advanced diagnostics such as microarrays, and one by Dr. Steven Hofstadler on microbial pathogen identification by multiplex PCR and Mass Spectrometry. Dr. Elizabeth Hammond presented information on reporting standardization in pathology, while Dr. Michael Laposata provided patient-specific narratives for laboratory test evaluation. Dr. James Harrison presented information on challenges in clinical communication. Dr. Kathy Hoig provided the background and current status of the new advanced clinical practice doctorate degree and Ms. Kathleen Hansen presented additional information on interdisciplinary roles for clinical laboratory scientists.
The next meeting is February 14-15, 2007. Complete minutes of the meeting will be available at a later date at http://www.phppo.cdc.gov/cliac/default.asp