TAG:
proficiency testing
Pathologists Benefit from Hospital Lab Consulting
CEO SUMMARY: Deteriorating finances at many rural hospitals and smaller community hospitals is a growing trend. It is also a new consulting opportunity for local pathologists because financially-strapped hospitals often give their labs inadequate working capital and lack the staff needed …
Lab Director Blows Whistle, NY Closes Hospital Lab
CEO SUMMARY: Unable to overcome problems at a rural hospital laboratory caused by the parent hospital’s financial problems and the inability of the hospital to recruit adequate numbers of lab staff, the laboratory director terminated his agreement with the hospital and notified the New …
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 prop…
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 widel…
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 Cen…
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 &…
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 Ce…
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 …
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 b…
June 25, 2012 “Intelligence: Late Breaking Lab News”
Earlier this month, the clinical laboratory at Ohio State University Wexner Medical Center (OSUWMC) was sent a letter by federal CLIA (Clinical Laboratory Improvement Act) officials declaring that the laboratory was in violation of proficiency testing (PT) regulation…
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Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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