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clinical laboratory improvement amendments

CAP Introduces Features to Aid CLIA Inspections

CEO SUMMARY: Clinical labs are changing in multiple ways and the College of American Pathologists regularly revises its CLIA accreditation processes in response to these changes. One such change is the growth in the number of integrated delivery networks that operate multiple hospit…

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CLIA Accreditation Market: More Competitive Now?

CEO SUMMARY: It’s been three decades since compliance with the Clinical Laboratory Improvement Amendments (CLIA) became mandatory. During that time, there has been little competition among the major organizations with deeming status by the Medicare Program to accredit labs to CLIA…

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CMS Shuts Missouri Lab Due to ‘Immediate Jeopardy’

CEO SUMMARY: CMS ordered Gamma Healthcare to close its two labs, revoked the owners’ CLIA licenses, prohibited them from operating a lab for two years, and ordered payment of more than $55,000 in civil penalties. The two lab facilities had been running COVID-19 and other tests for…

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After Two Decades, CMS Wants to Update CLIA Lab Regulations

IN THE FIRST EFFORT OF ITS kIND in more than two decades, the federal Centers for Medicare and Medicaid Services has published a request for information (RFI) in the Federal Register as a first step to revise the CLIA rules it promulgated in 1992. Over the years, CMS has made some m…

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Theranos Now Scrambling To Save What It Can

CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a c…

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ADLT Final Rule Creates Tough Questions for Labs

IT’S GOING TO BE A DIFFERENT AND TOUGHER WORLD for laboratory companies that market proprietary molecular and genetic tests. That’s the opinion of experts who have studied the final rule governing Advanced Diagnostic Laboratory Tests (ADLTs) that the federal Centers for Medicare & Med…

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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. …

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Might Lawsuits Come Next in Theranos Story?

CEO SUMMARY: Recent disclosures in the news indicate that an agreement between Theranos and Safeway has gone sour— after Safeway spent a third of a billion dollars to fulfill its part of the collaboration! Reporting by The Wall Street Journal c…

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Achieving CLIA, ISO 15189 at Same Time with A2LA

CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the America…

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Public Comment Started on FDA LDT Regulations

CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…

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