The Latest in CLIA Compliance for Clinical Labs

Why Should You Attend:

All clinical laboratory personnel ranging from directors, scientists to testing personnel are required to meet CLIA standards and therefore must be fully familiar with the federal requirements under which every laboratory must operate. Due to widespread reports of erroneous testing results highlighted by the infamous pap testing mills, Congress enacted CLIA in 1988 to ensure the accuracy reliability and timeliness of patient test results regardless of where the test was performed. There are serious consequences for labs and its personnel which knowingly violate specific CLIA requirements.

In fact, CMS is required to publish annually a registry of labs that have been convicted under Federal and state laws relating to fraud and abuse, false billing, or kickbacks; labs that have had their CLIA certificates suspended, limited or revoked, and labs excluded from Medicare and Medicaid. In addition, the government also lists those persons who have been convicted of violating CLIA requirements as specified in the Public Health Service Act, together with the circumstances of each case and the penalties imposed. The bottom line: no lab or its personnel can afford to knowingly disregard CLIA requirements: ignorance is no excuse.

This webinar will cover essential information you need to know about CLIA including its background; how the program is administered; how tests are categorized; enrollment procedures; and types of CLIA certificates including waiver; provider-performed microscopy; registration; compliance and accreditation; and user fees. In addition, the program will discuss the major quality standards that labs must comply under CLIA as well as other key program elements including surveys and inspections; retention of records; and sanctions.

Areas Covered in the Webinar:

CLIA refers to a federal law regulating labs which set quality standards and other requirements that apply to all personnel and sites performing tests on human specimens to ensure accurate, reliable and timely test results. Among key elements of CLIA regulation to be covered include:

• Program background & overview
• How lab tests are classified
• How to enroll
• Types of certificates: waiver; PMP; registration; compliance & accreditation
• User fees
• Summary of quality standards
• facility administration
• general laboratory systems
• personnel qualifications & responsibilities
• pre analytic, analytic & post analytic systems
• proficiency testing
• quality control
• quality assessment
• specific cytology provisions for labs performing moderate and/or high complexity tests
• Surveys & inspections
• Record retention
• Sanctions
• CLIA resources

Who Will Benefit:

All independent, hospital, group practice, physician office and nursing home labs and other sites performing clinical lab testing requiring CLIA certificates. Employees who will benefit by attending this webinar includes:

• Medical and administrative directors
• Lab scientists
• Office & practice administrators
• Lab managers
• Department & section heads
• Legal and compliance staff

Dennis Weissman
President, Dennis Weissman and Associates LLC

Dennis Weissman is a nationally known independent analyst and thought leaders in the clinical laboratory and pathology sectors for over three decades. Dennis is president of Dennis Weissman & Associates, LLC of Falls Church, VA, a consultancy which provides market intelligence, M&A advisory services, public policy monitoring & advice and business leadership to diagnostic and life science companies and organizations. He has expertise in Medicare and health care reform policies and trends; clinical lab and pathology payment and compliance policies as well as M&A and business issues and direction to diagnostic and life science companies.

Dennis founded and served as publisher of Washington G-2 Reports (now G2 Intelligence) from 1979 through 1999, an information company that reports on and analyzes the U.S. clinical laboratory industry via newsletters, research reports; webinars and live conferences. Prior to G2, he served as Director of the Washington Office of the American Society for Medical Technology (now ASCLS) and before that, Special Assistant to the Deputy Assistance Secretary for Health, U.S. Department of Health, Education & Welfare (now HHS).

Topic Background:

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) apply federal standards to all clinical laboratory testing performed on human in the United States, except clinical trials and basic research. Simply put, all lab testing facilities regardless of where the test is performed are required to meet minimum federal or equivalent standards and cannot legally operate without CLIA certification which is also required for Medicare and Medicaid payment. CLIA defines a clinical laboratory as any facility or site that tests human specimens for health assessment or to diagnose, prevent, or treat disease. This includes all settings including commercial (independent), hospital and physician office labs (POLs). In total, CLIA covers approximately 254,000 laboratory entities with the program funded through user fees from regulated facilities. Primary responsibility for CLIA administration is handled by the HHS Centers for Medicare and Medicaid Services (CMS) in partnership with the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA).

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