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clia

September 27, 2021 Intelligence: Late-Breaking Lab News

Following the opening of her criminal trial in a Silicon Valley courtroom in recent weeks, Elizabeth Holmes—the disgraced ex-Founder and CEO of Theranos—continues to be the subject of news headlines. Federal prosecutors are calling witnesses to testify. Much of this testimony includes anec…

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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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Interesting New Surprises for Lab Leaders

Unexpected and surprising things continue to happen in the clinical laboratory industry. You might consider that to be one unifying theme to the intelligence briefings we present in this issue of The Dark Report.  For example, a…

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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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CAP Loses CLIA Accreditation Clients to Joint Commission

This is an excerpt of a 1,790-word article in the January 19, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA …

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2021 Opens with a Major Story … and It’s Not COVID!

On the pages that follow, you will learn about a major story in the clinical laboratory…

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CAP Loses Accreditation Clients to Joint Commission

CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA laboratory accreditation services away from the College of American Pathologists and to The Joint Commission. These shifts from one accrediting body to another will involve hu…

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Understanding Differences Between 2 CLIA Accreditors

MAJOR CHANGES ARE HAPPENING IN THE COMPETITIVE MARKET for CLIA accreditation of hospital laboratories. Some health systems representing hundreds of hospitals have shifted from using the College of American Pathologists (CAP) to using The Joint Commission (TJC) to meet the accreditation …

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CMS Sends Cease/Desist Letters to Labs Lacking CLIA Certificates

CLINICAL LABORATORIES DOING COVID-19 TESTING and lacking the proper CLIA certificates to do so are receiving cease-and-desist letters from the federal Centers for Medicare and Medicaid Services (CMS).  The first letters were sent on Aug. 12 and le…

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FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says

This is an excerpt of a 2,029-word article in the August 24, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implic…

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