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 national cytology proficiency testing program, the Institute for Quality in Laboratory Medicine (IQLM); and proficiency testing for infectious disease agents, publication and marketing the Good Laboratory Practices for Waived Testing Sites Guidelines and appropriate quality control (QC) for diverse and evolving test systems.
Food and Drug Administration Update
Steven Gutman, from the FDA, provided an update on the operations of the Office of In Vitro Diagnostic Device (OVID), reported on a newly released guidance document regarding CLIA waived tests and the establishment of policy addressing analyte specific reagents (ASRs). The draft guidance document on applications for waived tests is available at http://www.fda.gov/cdrh/oivd/guidance/1171.pdf and FDA is accepting comments on the document until December 6, 2005. In addition the FDA is working on a proposal for the use of “leftover” clinical samples without requiring informed consent from the patient and with industry to resolve issues related to testing specimens with ASRs.
Centers for Medicare & Medicaid Services Update
Judy Yost, from CMS, provided an update on CLIA statistics (numbers and types of laboratories), survey of laboratories holding a certificate of waiver (CW), and the “QC for the Future” and “Partners for Laboratory Oversight” meetings. The Clinical and Laboratory Standards Institute (CLSI) convened the “QC for the Future” meeting which included parties interested in QC alternatives on March 18, 2005. A report of this meeting is available on the CLSI website and the presentations are published in Laboratory Medicine 36(10):577-672, 2005. The Partners for Laboratory Oversight group includes accrediting organizations, CMS, CDC, exempt states and states with licensure programs. They met to discuss issues related to accreditation and proficiency testing. An update on the national cytology proficiency testing program was provided by the CMS’ Survey and Certification group.
Centers for Disease Control and Prevention Update
CDC staff, Tom Hearn discussed the events that resulted in the distribution of proficiency samples containing H2N2 influenza virus and the steps being implemented to prevent future errors of this nature. Claire Broome provided an update on the progress of the Laboratory Response Network (LRN) as a multilevel network to provide rapid and critical laboratory capacity for emergency situations. Joe Boone summarized the activities of the IQLM (http://www.phppo.cdc.gov/dls/IQLM/default.aspx), a partnership of the public and private sectors promoting improvements in laboratory testing. IQLM conference highlights from the April 2005 “Recognizing Excellence in Practice” meeting can be downloaded at http://www.medscape.com/viewarticle/506782, after registering with a user name and password. Devery Howerton and Sharon Granade provided an update on the publication and marketing of the Good Laboratory Practices for Waived Testing Sites, a document developed by a CLIAC workgroup. The document will be published in a future edition of the Morbidity and Mortality Weekly Report (MMWR), available at http://www.cdc.gov/mmwr/.
Appropriate Quality Control for Diverse and Evolving Test Systems
Rhoda Whalen, from CDC, initiated the discussion from the perspective of mandated CLIA regulations and the need for flexible guidance from the regulatory agencies to assist laboratories in complying with CLIA regulations in the face of rapidly changing technology. Robert Habig, President Elect, CLSI, provided an overview of the role of CLSI in developing voluntary consensus standards for clinical and laboratory quality control. Luann Ochs, representative for AdvaMed, updated CLIAC on the CLSI consensus document for manufacturers that describes the principles for validation of the capability of control procedures to mitigate identified risks. Greg Miller discussed quality control from the perspective of a laboratory director. David Sewell, representative for the ASM, presented data from a limited survey of laboratories on the QC performance associated with commercial systems used for the identification of bacteria and yeasts. On October 26, 2005, 1000 copies of this survey were mailed to a cross section of randomly selected laboratories. Data from this survey will be collected, analyzed and presented at the February meeting of CLIAC.
Complete minutes of the meeting will be available at a later date at http://www.phppo.cdc.gov/cliac/default.asp