Purchase any WEBINAR and get
10% Off
CODE: SAVE10
T&C applicable, please referFAQ
Validity : 13th Apr'24 to 23rd Apr'24
The Latest in CLIA Compliance for Clinical Laboratories
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
Overview of the webinar
This webinar will cover essential information you need to know about CLIA including its background; how the program is administered including the responsibilities of various federal agencies; how tests are categorized; explanation of differing requirements applied to waived procedures, moderate complexity tests (including physician performed microscopy procedures) and high complexity tests; 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.
Who should attend?
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 include:
- Medical and Administrative Directors
- Lab Scientists
- Office & Practice Administrators
- Lab Managers
- Department & Section Heads
- Legal and Compliance Staff
Why should you attend?
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) apply federal standards to all clinical laboratory testing performed on humans in the United States, except clinical trials and research. Simply put, all clinical lab testing sites regardless of where the test is performed are required to meet minimum or equivalent standards and cannot legally operate without CLIA certification which is also required for Medicare and Medicaid payment. Likewise, all testing personnel ranging from the bench to the director level are required to meet CLIA requirements and therefore must be fully familiar with the federal requirements under which every laboratory must be certified to operate. Congress enacted CLIA in 1988 to ensure the accuracy reliability and timeliness of patient test results regardless of where the test was performed. including commercial (independent) and hospital laboratories as well as physician office labs (POLs). There are serious legal consequences for labs and its personnel which knowingly violate specific CLIA requirements, The bottom line: no lab or its personnel can afford to knowingly disregard CLIA requirements: ignorance is no excuse!
Faculty - Mr.Dennis Weissman
Dennis Weissman, A nationally recognized, independent analyst and thought leader in the diagnostic field for over three decades, Dennis is President of Dennis Weissman & Associates, LLC, Falls Church, VA, a consultancy which provides market intelligence, M&A advisory services, business leadership and public policy advice 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 & compliance policies as well as business trends affecting the diagnostic sector. Dennis founded and served as publisher of Washington G-2 Reports (now G2 Intelligence) through 1999, an information company that reports on and analyzes the U.S. clinical laboratory industry via newsletters, research reports and conferences. Prior to G2, he served as the Director of the Washington Office of the American Society for Medical Technology (now ASCLS) and before that, Special Assistant to the Deputy Assistant Secretary for Health, Department of Health, Education & Welfare (now HHS).