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clia

2021’s Top 10 Lab Stories Highlight Important Trends

This is an excerpt of a 3,075-word article in the December 20, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Much like 2020, the pandemic dominated our new list of the top 10 lab stories for 2021. Beyond…

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2021’s Top 10 Lab Stories Confirm Important Trends

CEO SUMMARY: Much like 2020, the pandemic dominated our new list of the top 10 lab industry stories for 2021. Beyond COVID-19 testing, the virus crept its way into long-term trends, such as pathology jobs and technology innovation. New ways of delivering healthcare will need respons…

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VALID Act vs. VITAL Act: Day of Reckoning for LDTs

TWO DISTINCTLY DIFFERENT BILLS HAVE SURFACED IN CONGRESS, each with the potential to have substantial impact on how laboratory-developed tests (LDTs) are regulated by agencies of the federal government. One bill even creates a new acronym for the lab industry: IVCT for in vitro clinical tests….

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Congress May Soon Act on LDT, IVCT Regulation

CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tes…

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In Theranos’ Trial, CLIA Laboratory Director Has a Starring Role

CEO SUMMARY: Most clinical lab directors understand the risks that come with running a CLIA-licensed lab. Such risks are at the forefront of the criminal trial of Elizabeth Holmes, founder of now-defunct Theranos. During the trial, federal prosecutors and defense attorneys question…

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Congress May Soon Act on IVCT, LDT Regulation

This is an excerpt of a 2,017-word article in the November 29, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Congress is gearing up for a debate on …

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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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