Course Outline
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- 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
- 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
- Health Insurance Portability and Accountability Act (HIPAA)
- HIPAA
- Agency that Enforces HIPAA Regulations
- Summary of Regulatory Compliance
- 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)CMSHCM 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.
