From Accreditation to Excellence: Understanding CAP, CLIA, and Quality Systems in Clinical Laboratories

Ensuring quality and compliance is at the core of every successful clinical laboratory. This webinar brings together CAP expert Daniel and Christie, QA leader from Burning Rock, to explore the essential components of laboratory accreditation and quality management. The discussion will cover key aspects of CAP accreditation, insights into the U.S. regulatory landscape including CLIA, and practical strategies for building and maintaining an effective Quality Management System (QMS). Join us to gain a deeper understanding of how regulatory frameworks drive laboratory excellence and how global laboratories can align with international quality standards.

Learning Objective: 

• Understand the core principles and evaluation criteria of CAP accreditation
• Explore the U.S. regulatory framework for clinical laboratories
• Apply practical strategies to build and sustain an effective Quality Management System (QMS)

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Presentations

Daniel Chen M.D., Ph.D.

US Clinical Laboratory Regulations CLIA & CAP Focused on Molecular Testing (NGS): Relevancy to international labs.

•What is CLIA laboratory?
•What is College of American Pathologists (CAP) Accreditation?
  -Quality Management System (QMS) 
  -Precision Medicine
  -Validation requirements
•What are the potential utilities of CLIA/CAP certification for labs?
  -Standard, recognition, pharma/clinical trial service

Christina Brown CGMBS, MB(ASCP)

Navigating the US Regulatory Landscape, CAP, CLIA and an effective QMS

Christina's presentation will underscore the critical importance of establishing and maintaining a robust Quality Management System (QMS) that fosters continuous compliance and drives excellence in quality management. The session will provide a comprehensive examination of the fundamental components of an effective QA framework designed to ensure the consistency and integrity of daily operational practices. Christina will also address best practices for CAP inspection preparation and internal auditing, drawing upon her extensive expertise as both an auditor and Quality Manager. Furthermore, she will analyze the essential function of CAP checklists within the broader structure of QMS governance and management.