The Clinical Laboratories Improvement Act (CLIA) provides the federal government’s regulations for all clinical laboratories in the U.S. This course describes all the components of the CLIA regulations, including accreditation requirements, lab test classifications, the lab inspection process, personnel requirements for the various roles in the clinical laboratory, and laboratory quality assurance.
This program has been granted prior approval by the American Association of Medical Assistants (AAMA) for 1.75 general continuing education unit(s) (approval Administrative/Clinical/General). Granting approval in no way constitutes endorsement by the AAMA of the program content or the program provider.
Florida Board of Clinical Laboratory Personnel (CEBroker Provider #: 50-290)
Tennessee Medical Laboratory Board (CEBroker Provider #50-290)
Louisiana Board of Medical Examiners - Clinical Laboratory Personnel (CEBroker Provider #50-290)
Relias LLC is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program.
About This Course
Section 1: Introduction
Section 2: The Evolution of CLIA ‘88
Clinical Laboratories Improvement Act of 1967 (CLIA ‘67)
Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88)
Federal Infrastructure for CLIA
Section 3: CLIA ’88 Requirements and Guidelines
CLIA Certification Requirements
Section 4:Test Complexity and Personnel Requirements
Test Complexity Categorization
Waived Testing and Point-of-Care Testing
Moderate Complexity vs. High Complexity Testing
Other CLIA Terms Related to Test Complexity or Waived Testing
Section 5: CLIA Inspection Checklist
Interpretive Guidelines for Laboratories
Regulatory Compliance Decision
Section 6: Laboratory Medicine Best Practices (LMBP)
The LMBP Initiative
Section 7: Individualized Quality Control Plan (IQCP)
Development of an IQCP
Section 8: Updated CLIA Information
How to Keep Current on CLIA
Section 9: Clinical Vignette
Preparing for a CLIA Survey
Section 10: Conclusion
Leonard I. Levin, MS, MBA, RM(NRCM), M(ASCP), has a BS in biochemistry, MS in microbiology and immunology, and MBA in finance. Disclosure: Leonard I. Levin, MS, MBA, RM(NRCM), M(ASCP) has no Relevant Financial or Non-Financial Relationship with ineligible companies to disclose.Staff Writer: Catherine J. Swift, MT(ASCP)
Catherine Swift, MT(ASCP) is the clinical laboratory science editor for Relias Learning. She has a Bachelor of Arts in English from Hastings College and a Bachelor of Science in Medical Technology from North Colorado Medical Center. She has experience working in hospital laboratories, clinic laboratories, and research experience in microbiology as well as clinical research trials involving patients and various drug therapies for osteoporosis, endometriosis and bone density at Creighton University School of Medicine. Disclosure: Catherine J. Swift, MT(ASCP) has no Relevant Financial or Non-Financial Relationship with ineligible companies to disclose.
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