TAG:
clinical laboratory improvement amendments
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…
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 &…
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…
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…
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…
NYSDOH Shuts Hospital Lab In Queens, New York
CEO SUMMARY: When the New York State Department of Health closed the laboratory at 173-bed Peninsula Hospital Center in New York City on February 23, it became national news. State inspectors issued a nine-page list of deficiencies in the lab, including problems that could affect patient …
CDC Seeks to Identify Best Laboratory Practices
CEO SUMMARY: To advance the goal of enhancing the practice of laboratory medicine, the CDC has organized two teams of laboratory experts. They will study best practices and proficiency testing in medical labs nationwide. Such approaches as lab standards, voluntary reporting of adverse eve…
CURRENT ISSUE
Volume XXXI, No. 6 – April 29, 2024
Laboratory managers will want to note that The Dark Report itself was targeted by the fraudsters who hit Change Health in a cyberattack. Also, one lab has some innovative methods of combatting the chronic staffing shortage, including hiring college graduates and students.
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