Agenda items for the CLIAC meeting included a discussion of the “Appropriate Quality Control for Diverse and Evolving Test Systems, including Microbiology Identification Systems,” a CLIAC workgroup report on “Good Laboratory Practices for Waived Testing,” disclosure statements by CLIAC members, and federal agency updates from the Food and Drug Administration (FDA), the Centers for Medicare & Medicare Services (CMS), and the Centers for Disease Control and Prevention (CDC).
Appropriate Quality Control for Device and Evolving Test Systems, including Microbiology Identification Systems
CLIA regulations require the laboratory to check each batch, lot number, and shipment of reagents, discs, stains, antisera and identification systems for positive and negative reactivity and graded reactivity, if applicable. CLIA also defines ID systems as “systems using two or more substrates or reagents, or a combination.” The need to test each reaction in a microbiology ID system for positive and negative reactivity has been questioned by clinical microbiologists and the manufacturers of microbiology identification systems, who have asked CLIAC to address this issue.
CDC staff, Rhonda Whalen, discussed the problem from the perspective of present and future quality control requirements for diverse test systems and the need for some flexibility in the current CLIA regulations. Freddie Poole presented the FDA’s perspective on the regulations addressing the quality control of microbiology identification systems. Nancy Anderson, from the CDC, addressed the more specific issue of quality control requirements for microbiology identification systems. Currently there are fifty-six identification panels, produced by six manufacturers, containing two to ninety-five substrates/reagents per panel that may require from four to eight organisms to perform the CLIA required QC. Ms. Anderson pointed out that any change to the current CLIA QC requirements must apply to all current and future test systems. After public comment from David Sewell of ASM and representatives of microbiology test system manufacturers (Becton-Dickinson, Biomerieux, and Dade), CLIAC instructed CDC to collect QC performance data on microbiology test systems and report to CLIAC at a future meeting. CDC asked ASM to work with them and other involved federal agencies to develop a survey to gather and analyze QC performance data for all bacterial and yeast ID systems (automated, semi-automated, and manual) from a cross section of microbiology laboratories.
CLIAC Workgroup Report
Jared Schwartz presented the findings of the CLIAC workgroup charged with developing guidelines for “Good Laboratory Practices for Waived Testing.” The report is an excellent summary of good laboratory practices that apply not only to waived testing but all laboratory testing.
Update from the Food and Drug Administration
Jean Cooper from the FDA provided an update on the reorganization of the Office of In Vitro Diagnostics. Currently, one organizational unit in the FDA regulates all In Vitro Devices throughout the Total Product Life Cycle (TPLC) of the device. The FDA is also implementing electronic applications and compliance reporting, publishing a guidance document on waived testing this summer, and continues to develop policy addressing analyte specific reagents (ASRs) and home brew tests.
Update from the Centers for Medicare & Medicaid Services
CMS staff, Judy Yost, reported on the 2004 survey of 1,742 laboratories holding a Certificate of Waiver (COW). Analysis of the data indicates improvement from previous surveys but as in previous surveys, the major deficiencies remain a lack of performance of quality control, a lack of having current manufacturer’s instructions and following the manufacturer’s instructions for the waived test, and performance of testing beyond the scope of the COW. CMS announced that it will participate in two upcoming meetings: The Clinical Laboratory Standards Institute’s (CLSI – formerly NCCLS) meeting on the “QC for the Future” and the Partners for Laboratory Oversight’s meeting that will focus on improved information sharing and development of more effective survey protocols.
Cheryl Wiseman from the CMS reported on the implementation of annual proficiency testing (PT) of all personnel who perform gynecologic cytology examinations. According to CMS, each individual (cytotechnologists and pathologists) must enroll in a CMS-approved cytology PT program no later than June 30, 2005, and annually thereafter. Each individual must complete their initial test no later than December 31, 2005, and must pass the proficiency test by December 31, 2006.
Update from the Centers for Disease Control and Prevention
Tom Hearn and Robert Martin from the CDC provided an update on CDC’s “Futures Initiative,” a strategic plan to develop public health and private partnerships to promote health and prevent disease and injury in individuals. Joe Boone reported on the activities of the Institute for Quality in Laboratory Medicine (IQLM). Activity details and a newsletter are available at http://www.iqlm.org.
Complete minutes from the meeting will be available at a later date, at http://www.phppo.cdc.gov/cliac/default.asp.