An Introduction to the Medical Laboratory, Part 3 (Online CE Course)

(based on 3 customer ratings)

Authors: Julia Clendenin; Paul Fekete, M.D. FCAP
Reviewer: Joshua J. Cannon, MS, MLS(ASCP)^CMSH^CM

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An Introduction to the Medical Laboratory (3-course series)

$75

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This course is the third part of an elementary introduction to the operation of a clinical medical laboratory. It assumes that the learner has little or no background in medical practice or clinical laboratory science. It is ideal for those who desire an introduction to the operation and function of the laboratory and the qualifications and mindset of those professionals who staff it. The course covers federal regulations related to the clinical laboratory and the departments that enforce them. Such regulations include OSHA, CLIA, and HIPAA.

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Continuing Education Credits

P.A.C.E.® Contact Hours (acceptable for AMT, ASCP, and state recertification): 2.5 hour(s)

Approved through 1/31/2026

Florida Board of Clinical Laboratory Personnel Credit Hours - General: 2.5 hour(s)

Approved through 1/31/2026

Objectives

Describe the federal laws that govern clinical laboratories.
Describe the laws' corresponding federal agencies and their role in the clinical laboratories.

Customer Ratings

(based on 3 customer ratings)

Course Outline

Click on the links below to preview selected pages from this course.

Introduction

Introduction to Regulatory Compliance Laws and Agencies

Occupational Safety and Health Act

OSH Act

Occupational Safety and Health Act

Agency that Enforces the OSH Act Regulations

Occupational Safety and Health Administration (OSHA)
OSHA: Standards
OSHA: Workers' Rights
OSHA: Training
True or False: The OSH Act established OSHA within the U.S. Department of Labor.

Clinical Laboratory Improvement Amendments (CLIA)

CLIA

Introduction to CLIA
CLIA: Levels of Testing Complexity
CLIA: Personnel Qualifications
CLIA: Quality Control
CLIA: Competency Assessment
CLIA: Proficiency Testing
CLIA: Inspections

Agencies that Enforce CLIA Regulations

Agencies that Enforce CLIA Regulations
Centers for Medicare and Medicaid Services (CMS)
Food and Drug Administration (FDA)
Centers for Disease Control and Prevention (CDC)
Match the agency with its function.

Health Insurance Portability and Accountability Act (HIPAA)

HIPAA

Introduction to HIPAA
Who HIPAA Applies To
What HIPAA Protects
HIPAA Privacy Rule
HIPAA Security Rule
HITECH Act
The Omnibus Rule

Agency that Enforces HIPAA Regulations

Agency that Enforces HIPAA Regulations
Department of Health and Human Services (HHS)
True or False: The HITECH Act focuses on increased regulations for new drugs or devices.

Summary of Regulatory Compliance

Summary of Regulatory Compliance

References

References

Additional Information

Level of Instruction: Beginning

Intended Audience: This course is intended as an elementery introduction to the regulations related to a clinical medical laboratory. It assumes that the learner has little or no background in medical practice or clinical laboratory science. It is ideal for those who desire an introduction to the operation and function of the laboratory, and the qualifications and mindset of those professionals who staff it. This course would be ideal for those contemplating a career in any clinical laboratory field, sales representatives who will be visiting clients in the laboratory, and need an introduction to provide context for their future sales contacts, and anyone else who has an interest in the field and desires an introduction.

Author Information: Julia Clendenin is a content and graphics developer for MediaLab, Inc. She graduated from Georgia Institute of Technology with a B.S. in Biochemistry and a B.S. in Literature, Media, and Communication.

Paul Fekete, M.D. is the former CEO of MediaLab. He formerly served as Assistant Professor of Pathology at Emory University and was Director of Laboratories for Gwinnett Health System near Atlanta, GA. Dr. Fekete has extensive teaching experience and is the author of numerous journal articles and book chapters. He additionally has extensive experience in instructional design.

Reviewer Information: Joshua J. Cannon, MS, MLS(ASCP)^CMSH^CM received his Bachelor of Science and Master of Science in Medical Laboratory Science from Thomas Jefferson University in Philadelphia, PA. He holds Medical Laboratory Scientist and Specialist in Hematology certifications through the ASCP Board of Certification. He was a professor at Thomas Jefferson University for seven years before transitioning into his current role as Content Developer at MediaLab. His areas of expertise and professional passions include clinical hematology and interprofessional education.