On February 8-9, ASM Professional Affairs Committee member, David Sewell and ASM staff Suzy Leous attended the Clinical Laboratory Improvement Advisory Committee (CLIAC) meeting in Atlanta, GA. CLIAC is comprised of twenty members who have clinical laboratory expertise, including Kimberle Chapin, Barbara Robinson-Dunn, and Jared Schwartz, who are also members of ASM.
Agenda items for the CLIAC meeting included updates from the Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), and Centers for Disease Control and Prevention (CDC); updates on the implementation of cytology proficiency testing of individuals and the Coordinating Council on Clinical Laboratory Workforce report; presentation of the ASM survey of laboratories on the QC performance associated with commercial systems used for the identification of bacteria and yeasts; and a discussion on “Enhancing Connectivity between Public Health and Clinical Laboratories.”
Food and Drug Administration Update
Steven Gutman, from the FDA, reported that the final draft of the Waiver Guidance document is expected at the end of 2006. At that time the FDA will move forward with a Proposed Rule. The FDA has cleared the CDC PCR assay for Influenza A H5 and continues to work on the proposal addressing the use of “leftover” clinical specimens without requiring informed consent. Elliot Cowan provided a summary of the November 3, 2005 Blood Products Advisory Committee (BPAC) meeting on “Approaches to validation of OTC home-use HIV test kits”. This issue will be addressed again at the 3/10/06 BPAC meeting.
Centers for Medicare & Medicaid Services Update
Judy Yost, from CMS, provided an update on CLIA statistics (number and type of laboratories), the “Partners in Laboratory Qversight” project, Automated Complaint Tracking System (available March, 2006), the Certificate of Waiver labs study, and “QC for the Future”. The Clinical and Laboratory Standards Institute (CLSI) anticipates publication of Principles for Validation of Manufacturer’s Quality Control Recommendations, EP22-P in December, 2006 and has authorized work on a companion document on laboratory equivalent QC protocols. Cheryl Wiseman, from CMS’ Survey and Certification group, updated CLIAC on the cytology proficiency testing program.
Centers for Disease Control and Prevention Update
Rima Khabbaz discussed the reorganization effort at CDC which places the laboratory systems in the National Coordinating Center for Infectious Diseases. Sharon Granade updated the committee on marketing of Good Laboratory Practices for Waived Testing (MMWR Vol 54/RR-13, 11/11/05) and Devery Howerton presented the process for revising regulations for cytology proficiency testing.
Update on the ASM Survey of QC Failures with Microorganism Identification Systems
David Sewell presented the results from 1000 surveys sent to random laboratories that perform bacteriology and mycology tests. The response rate was approximately 30%. A total of 9886 lots were tested, 912 lots failed QC (905 were QC organism failures) and 7 lots were replaced by the manufacturer (system failure). The failure rate was less than 1% for systems used to identify gram-positive bacteria, anaerobic bacteria, and yeast. No failures were reported for the gram-negative bacteria or the Neisseria/Haemophilus identification systems.
Coordinating Council for the Clinical Laboratory Workforce Update
Joeline Davidson updated CLIAC on the activities of the CCCLW which include becoming a resource for issues involving the laboratory workforce shortage, targeting groups to whom information is communicated, increasing the visibility of laboratorians, promoting careers in laboratory science, and supporting efforts to increase the number of training programs. Robert Martin (from CDC) provided additional resources that can be used to encourage students to pursue a career in laboratory science. This material is available at http://medlabcareers.msu.edu or firstname.lastname@example.org
Following the discussion on the clinical laboratory workforce, David Sewell provided a statement to CLIAC members to announce the availability of ASM’s Final Benchmarking Survey Report.
Enhancing Connectivity between Public Health and Clinical Laboratories
CDC initiated this topic by detailing efforts to improve communication between the public and private laboratories. Other speakers addressed the role of public health laboratories, emergency preparedness connectivity, outbreaks and public health responses, the role of public and private laboratories in foodborne disease surveillance, the role of public health laboratories in determination of the effect of toxicants on health, and the need for cooperation between public and private laboratories in the diagnosis and surveillance of influenza infections.
Complete minutes of the meeting will be available at a later date at http://www.phppo.cdc.gov/cliac/default.asp