Clinical Laboratory Testing : Keeping up with CLIA
Hours: 1.75
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.
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.
American Association of Medical Assistants
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
Florida Board of Clinical Laboratory Personnel (CEBroker Provider #: 50-290)
Clinical Laboratory Personnel will receive 1.5000 contact hours for participating in this course.
Tennessee Medical Laboratory Board
Tennessee Medical Laboratory Board (CEBroker Provider #50-290)
Louisiana Board of Medical Examiners- Clinical Laboratory Personnel
Louisiana Board of Medical Examiners - Clinical Laboratory Personnel (CEBroker Provider #50-290)
American Society for Clinical Laboratory Science
Relias LLC is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program.
Discuss what CLIA is and the roles played by the CDC, FDA, and CMS in overseeing its administration.
Explain the qualifications required to perform and/or oversee laboratory testing.
Identify the different classifications of lab testing based on complexity, and
describe CLIA requirements for lab testing and what to expect in a CLIA laboratory inspection.
Describe the process by which the CDC and others work together to define laboratory medicine best practices, and how to prepare an IQCP.
Outline:
About This Course
Section 1: Introduction
Learning Objectives
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
Review
Summary
Section 3: CLIA ’88 Requirements and Guidelines
CLIA Certification Requirements
Proficiency Testing
Cytology Standards
Inspections
Review
Summary
Section 4:Test Complexity and Personnel Requirements
Test Complexity Categorization
Waived Testing and Point-of-Care Testing
Provider-Performed Microscopy
Moderate Complexity vs. High Complexity Testing
Other CLIA Terms Related to Test Complexity or Waived Testing
Review
Summary
Section 5: CLIA Inspection Checklist
Interpretive Guidelines for Laboratories
Regulatory Compliance Decision
Review
Summary
Section 6: Laboratory Medicine Best Practices (LMBP)
The LMBP Initiative
Methods
Review
Summary
Section 7: Individualized Quality Control Plan (IQCP)
Definition
Development of an IQCP
Review
Summary
Section 8: Updated CLIA Information
How to Keep Current on CLIA
Review
Summary
Section 9: Clinical Vignette
Preparing for a CLIA Survey
Section 10: Conclusion
Summary
Course Contributors
Resources
References
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.
The target audience for this course is: Certified Medical Assistants; Clinical Laboratory Personnel; in the following settings: Acute Care Facility.
Asynchronous/Online Distance Learning; please see certificate details for specifics on delivery format.
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All courses offered by Relias, LLC are developed from a foundation of diversity, inclusiveness, and a multicultural perspective. Knowledge, values and awareness related to cultural competency are infused throughout the course content.
Reference herein to any specific commercial product, process, or service by trade name, trademark, service mark, manufacturer or otherwise does not constitute or imply any endorsement, recommendation, or favoring of, or affiliation with, Relias, LLC.
All characteristics and organizations referenced in the following training are fictional. Any resemblance to any actual organizations or persons living or dead, is purely coincidental.
To earn continuing education credit for this course you must achieve a passing score of 80% on the post-test and complete the course evaluation.
If you require special accommodations to complete this module, please contact Relias Customer Support here.
