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CLSI’s President’s Message on: Perspectives on Quality: Updates - EP22 and EP23 (CLSI), Accreditation Preparedness (CMS), and IVD Regulation (FDA) Presented during the AACC/ASCLS Annual Meetings and Clinical Lab Expo View the presentations below.

CLSI President Gerald A. Hoeltge, MD and experts from the US Food and
Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS),
industry, and the professions discussed the accomplishments, challenges, and
strategies for advancing quality performance in medical laboratories. Focused on
implementation of laboratory practices, certification of medical laboratories, and
regulation of in vitro diagnostic (IVD) tests. Included updates on the progress of
CLSI's documents EP22 and EP23.

Topics discussed: 

• Perspectives on ensuring quality clinical laboratory performance from CLSI,
  CMS, and FDA experts.
• The scope and issues being addressed during the development of new CLSI
  guidelines EP22 and EP23 focusing on quality control based on risk management.
  Practical values of the guidelines to industry, government regulatory, and medical
  laboratories.
• How to avoid the most commonly cited deficiencies during laboratory accreditation
  inspections.
• FDAs role in assuring effectiveness and safety of IVD tests. 

Speakers & Presentations:

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