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August 24, 2020 Intelligence: Late-Breaking Lab News

Currently at least 15 veterinary laboratories in the United States perform COVID-19 tests. This fact was confirmed by Adm. Brett Giroir, MD, the Assistant Secretary of the Department of Health and Human Services (HHS), during an interview last month conducted by CNN. Officials at HHS confirmed this development and explained that these labs had received CLIA certification and that the federal agency is expediting its review of the applications submitted by other …

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Volume XXVII, No. 11 – August 3, 2020

WILL RETAIL BEHEMOTH AMAZON become a competitor in the clinical lab industry? With its plans to build COVID-19 testing labs and history of disrupting the marketplace, this is a distinct possibility, and it’s not just THE DARK REPORT that thinks so. Also, UHC is about to do some disrupting of its own with its new test code protocol.

UHC Ready to Implement New Lab Test Registry

CEO SUMMARY: UnitedHealthcare announced that its new Test-Registry Protocol will become effective on Jan. 1, 2021, creating a major billing hurdle for labs and pathology groups. By that date, a lab must register each type of test before it can submit claims for these tests to the nation’s largest health insurer. In some ways, UHC’s test registry resembles the Medicare …

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UHC Issues Details about How Labs Register Tests

CEO SUMMARY: As of January 1, UnitedHealthcare will require all clinical laboratories and anatomic pathology groups to register every type of test before labs can bill for those tests. Not only is the COVID-19 pandemic disrupting normal activity, but the administrative burden UHC is imposing will be substantial for all of UHC’s in-network labs and pathology groups, as well as for …

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Employers, Others Looking to Build New Clinical Labs

CEO SUMMARY: Employers, universities, municipalities, and other large organizations are interested in building their own clinical laboratories. In addition, entrepreneurs—many with no prior experience in laboratory medicine—want to make money providing COVID-19 testing. Many of these entities seek to provide a safe work environment and limit their legal liability associated with COVID-19, and they want their own clinical laboratories to ensure adequate …

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In Just 13 Days, Lab Buys, Validates & Uses Analyzer

CEO SUMMARY: In response to the nationwide outbreak of SARS-CoV-2, clinical labs are introducing new analyzers whenever possible to boost testing capacity. Pre-pandemic, buying and installing new instruments could take at least two months, and that timeline can go longer now. But because of advance planning, working closely with its instrument vendor, and adjusting on the fly when needed, a 161-bed …

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Volume XXVII No. 10 – July 13, 2020

IS POOLED TESTING the answer to COVID-19 testing shortages? Yes and no. THE DARK REPORT analyzes the pros and cons of this suddenly-popular old idea, with experts from across the industry offering their input. Also in this issue is the case for why local labs should be getting more testing supplies, and how the government has damaged the supply chain.

It’s a Clinical Lab Moment … But No Advocates!

Nearly every day since the onset of the SARS-C0V-2 outbreak, there have been stories in the national news about clinical laboratory testing for COVID-19. No laboratory professional alive today has seen such an endless stream of news stories about clinical lab testing. This is a once-in-a-lifetime event that could be quite favorable to the clinical lab profession. Unfortunately, …

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Government Officials Intensify Broad Chaos In Clinical Lab Supply Chain

CEO SUMMARY: Clinical labs throughout the United States are ready to meet the challenges of the COVID-19 pandemic. At the same time, there is widespread recognition that many barriers to increasing labs’ COVID-19 testing capacity are caused by the inappropriate actions of government officials at all levels. This is particularly true of ongoing disruptions to the supply chain of the …

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Labs Still Confront New Supply Shortages Daily

CEO SUMMARY: For three lab directors in the Midwest, a seemingly endless cycle of COVID-19 lab-supply shortages crops up almost daily. These labs might not have enough test kits one day, and be short of reagents, transport vials, or specimen collection swabs the next. To address these problems, the lab directors have cobbled together a variety of solutions, but they …

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