Course Code: REL-ACU-0-CLTKC
Hours: 1.75
Type: Online Course
Content Expiration Date: 12/31/2024
Learning Objectives:
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
Instructor: Leonard Levin, MS, MBA, RM(NRCM), M(ASCP)
Mr. Levin obtained his BS degree in Biochemistry from Albright College, MS degree in Microbiology & Immunology from Temple University, and MBA in Finance from LaSalle University. He worked in nine hospital clinical laboratories for 38 years, including seven years as a microbiology supervisor and 28 years as a laboratory administrative director. Additionally, he worked as an assistant editor for a biology reference publication and editor-in-chief of an AIDS newsletter. He is currently a freelance scientific writer and laboratory management consultant.
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.
Target Audience:
The target audience for this course is: Certified Medical Assistants; Clinical Laboratory Personnel; in the following settings: Acute Care Facility.
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All courses offered by Relias Learning, 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.
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.
Course Delivery Method and Format
Asynchronous Distance Learning with interactivity which includes quizzes with questions/answers, and posttests.