TAG:
clia certificate
Theranos Saga Just Keeps Getting More Intriguing
This is an excerpt from a 400-word article in the May 2 issue of THE DARK REPORT. The complete article is available paid members of the Dark Intelligence Group. …
Labs React with Criticism to Proposed ADLT Rule
CEO SUMMARY: Some in the lab industry had high hopes that passage of the Protecting Access to Medicare Act (PAMA) last year would favorably resolve a number of important issues. However, those hopes were dashed following the September 25 release by CMS of a proposed rule setting out how i…
Did Theranos Turn Over its CLIA Lab Director?
PROBABLY NO SINGLE LAB INDUSTRY STORY OF THE PAST 24 MONTHS has generated a higher level of curiosity among pathologists and lab administrators than that of Theranos, the Palo Alto, California-based company that regularly claims it has the technology, the business model, and the low price strategy ne…
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 …
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…
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…
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…
Inadvertent PT “Errors” Trigger CLIA Sanctions
CEO SUMMARY: Despite taking appropriate steps to complete proficiency testing (PT), in recent years an unknown number of labs were determined to be in violation of CLIA requirements. Federal regulators are enforcing penalties ranging from suspension of the labs’ licenses to transition t…
Medi-Cal Hits Pathologist For $6.4 Million Payment
CEO SUMMARY: Once again, government health bureaucrats are overreaching in their efforts to reduce spending and collect money from any source. A California pathologist has been hit with a Medi-Cal demand for $6.4 million in repayments, simply because he served as laboratory director for t…
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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