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CMS Shuts Missouri Lab Due to ‘Immediate Jeopardy’

Laboratory Compliance / By Robert Michel

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 about 2,500 nursing homes in 11 states. This …

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July 6, 2021 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

Did the SARS-CoV-2 virus infect people in the United States earlier than the first case diagnosed on Jan. 19, 2020? A newly-published study in Clinical Infectious Diseases, says there is evidence of COVID-19 infections in December 2019. The research team included scientists from the National Institutes of Health. The source of the specimens was the …

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Volume XXVIII, No. 9 – July 6, 2021

A pathology lab company in New Jersey has sued UnitedHealthcare, seeking payment for 46,400 molecular COVID-19 test claims that are unpaid, representing about $20 million in reimbursement. Also, Labcorp is successfully using AI in its lab operations to improve work processes and gain real-time insights from vast amounts of data.

New Primary Care Providers May Change Who Buys & Who Orders Lab Tests

TDR Insider / By Robert Michel

This is an excerpt of a 2,445-word article in the June 14, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: This first installment in our series describes why market forces are at work to create a new player in healthcare that will …

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Whistleblower Lab Manager Files Response to PerkinElmer Lawsuit

Laboratory Compliance / By Robert Michel

IN A DAVID-VERSUS-GOLIATH-LIKE BATTLE, perhaps the most unusual lawsuit in decades involving clinical laboratory operations and compliance is unfolding in a federal courthouse in California. In this case, a multi-billion-dollar in vitro diagnostics (IVD) company is suing a laboratory manager who was once in a leadership position at a lab the plaintiff company operated, and …

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New Players May Alter Who Buys & Who Orders Lab Tests

Clinical Laboratory Trends / By Robert Michel

CEO SUMMARY: This first installment in our series describes why market forces are at work to create a new player in healthcare that will transform the lab testing marketplace as we know it today in two ways. First, a new category of primary care providers has the potential to eventually order as many lab tests …

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June 14, 2021 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

Is it possible to use a genetic test to predict an individual’s risk of severe infection requiring hospitalization or death from SARS-CoV-2? That is the claim of Australian-based molecular diagnostics company Genetic Technologies Limited. It recently announced an agreement with U.S.-based Infinity BiologiX LLC (IBX) to sell its “COVID-19 Severe Disease Risk Test” to consumers …

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Goodbye Pandemic! Hello Ransomware!

Commentary and Opinion by R. Lewis Dark / By R. Lewis Dark

Being first to predict an important trend’s arrival or departure can bring accolades for perceptive foresight or rebukes for getting it wrong. This issue of The Dark Report puts us on the record for making early predictions on two trends, each with the potential to financially make or break your clinical laboratory or pathology group. …

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Pandemic Complicates Sales for Lab Info System Companies

IVD/Lab Informatics, Laboratory Information Systems / By Robert Michel

HEALTHCARE INFORMATION TECHNOLOGY (IT) COMPANIES serving clinical laboratories and providers with laboratory information systems (LISs) and electronic health records (EHRs) shared recent financial reports on their businesses. It is challenging to obtain information about the revenue growth and market share of the leading vendors of laboratory information systems because these LIS businesses are either a division …

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May 24, 2021 Intelligence: Late-Breaking Lab News

Lab Intelligence, Late Breaking Lab News / By Robert Michel

With little fanfare, the company that was incorporated as Laboratory Corporation of America Holdings rebranded itself. It is now officially called Labcorp (with a lower case c). This won’t be much of a change for the clinical laboratory profession, which has long seen the company use LabCorp (with an upper case C) in most marketing …

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