TAG:
clia license
2012’s Top Ten Lab Stories Predict More Challenges
CEO SUMMARY: It’s been a year with more lows than highs, when viewed through the lens of THE DARK REPORT’S “Top Ten Lab Stories of 2012.” The end of the TC grandfather clause, new policies for prostate biopsy billing, and a dramatic 52% cut to 88305- TC fees were widely reported. …
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 …
NY Hospital Closed Due to Deficiencies in Lab
CEO SUMMARY: Lab executives and pathologists have long read about the deteriorating finances at many rural hospitals, along with their struggles to recruit and retain enough skilled laboratory staff. Now the closure of the laboratory at 37-bed E.J. Noble Hospital in Gouverneur, N…
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 …
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…
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 …
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…
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…
CURRENT ISSUE
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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