APILM243880241 - CME/CMLE - Overview of the Different Accrediting Bodies-APILM243880241

APILM243880241 - Educational Activity

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This educational commentary by Rebecca Woodford provides a comprehensive overview of the seven U.S. laboratory accrediting bodies that hold deemed status under the Clinical Laboratory Improvement Amendments (CLIA), regulated by the Centers for Medicare & Medicaid Services (CMS). CLIA governs the quality and operation of laboratories testing human-derived materials for disease diagnosis, prevention, and treatment. Laboratories must hold the appropriate CLIA certificate to operate and comply with CLIA standards, but many voluntarily seek accreditation from CMS-approved organizations, called deemed accrediting bodies, which perform inspections and ensure standards meet or exceed CLIA requirements.<br /><br />As of March 2024, over 303,000 laboratories were CLIA-registered, with nearly 16,000 holding accreditation certificates. The major accrediting bodies are the College of American Pathologists (CAP), COLA, and The Joint Commission, with others including the Association for the Advancement of Blood & Biotherapies (AABB), the American Society for Histocompatibility & Immunogenetics (ASHI), the Accreditation Commission for Health Care (ACHC), and the American Association for Laboratory Accreditation (A2LA).<br /><br />Each accrediting body has unique features:<br /><br />- CAP offers the most rigorous, specialty-specific standards developed by practicing pathologists, accrediting over 8,000 labs globally.<br /><br />- COLA focuses on physician office and small laboratory settings, accrediting over 7,000 labs, and is noted for being cost-effective.<br /><br />- The Joint Commission emphasizes operational systems impacting patient safety and quality, using a tracer methodology and accrediting a wide range of labs.<br /><br />- AABB targets blood and biotherapy labs, with internationally recognized quality standards.<br /><br />- ASHI specializes in histocompatibility and immunogenetics labs with a multi-level review process.<br /><br />- ACHC provides accreditation across all testing complexities with a focus on accountability and risk reduction.<br /><br />- A2LA offers internationally recognized accreditation for diverse laboratory types based on ISO standards.<br /><br />Laboratories choose accrediting bodies based on specialty/subspecialty fit, cost, and other operational factors. Accreditation improves compliance, quality, and prestige, facilitating successful CLIA inspections. For more details, contact information for each accrediting organization is provided.

Keywords

CLIA

laboratory accreditation

CMS

Clinical Laboratory Improvement Amendments

College of American Pathologists

COLA

The Joint Commission

AABB

ASHI

ACHC