August 2012

Existing CLIA Language Drives PT Enforcement

CEO SUMMARY: Revocation of a lab’s CLIA license as penalty for inadvertent errors in handling proficiency tests (PT) is not a new problem. As explained here, most clinical laboratories have appropriate protocols for handling PT samples. But, when errors occur, the Centers for Medicare & Medicaid Services (CMS), based on its current interpretation of the […]

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CMS and CAP Comment On CLIA PT Matters

Laboratory Compliance / Joseph Burns

CEO SUMMARY: Federal regulators rely on interpretations from administrative law judges (ALJ) for guidance in how to apply the Clinical Laboratory Improvement Amendments (CLIA) as they pertain to proficiency testing (PT) and the issue of inadvertent PT referrals. Representatives of the Centers for Medicare & Medicaid Services (CMS) and the College of American Pathologists (CAP)

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Lawyer Questions CMS Over Inadvertent PT Errors

Laboratory Compliance / Joseph Burns

CEO SUMMARY: In the case of the Ohio State University Wexner Medical Center (OSUWMC) clinical lab, one attorney with long experience in CLIA regulatory matters says that the facts do not support the severe sanctions that CLIA officials may impose on a healthcare organization that is widely-respected nationally. While the lab did commit errors in

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Congress May Respond to Tough CLIA PT Penalties

Laboratory Compliance / Joseph Burns

CEO SUMMARY: For years, severe penalties in cases where a laboratory has inadvertently erred in handling proficiency testing (PT) specimens have been a point of contention between the Centers for Medicare & Medicaid Services (CMS) and the clinical laboratory profession. Two bills proposed in Congress would give CMS more discretion in how it interprets the

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