Issue: Volume XIX No. 11 - August 6, 2012

Time for Congress to Properly Fix CLIA PT Issue

THIS TIME, THE PROVERBIAL CAT MAY BE OUT OF THE BAG when it comes to long-standing dissatisfaction with how federal regulators interpret and enforce CLIA (Clinical Laboratory Improvement Amendments) regulations as they relate to inadvertent errors in the referral of proficiency tests (PT). For many in the clinical laboratory profession, this issue of THE DARK …

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CLIA PT Enforcement Ensnares Top Labs

CEO SUMMARY: Think it can’t happen to you? Think again. Following self-disclosure of inadvertent referrals of proficiency testing (PT) specimens, the laboratory at Ohio State University Wexner Medical Center (OSUWMC) was visited by officials from the Ohio Department of Health and the Centers for Medicare & Medicaid Services (CMS). Following that survey, CMS sent notice …

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CMS Proposes Sanctions Against OSU Laboratory

CEO SUMMARY: As its reward for self-reporting the referral of six proficiency testing (PT) specimens in three years, the laboratory at Ohio State University Wexner Medical Center (OSUWMC) has been told by the Centers for Medicare & Medicaid Services (CMS) that its CLIA license could be revoked, subject to appeal by the laboratory. Here are …

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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

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

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

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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