TAG:

clinical laboratory industry

Regulators Acted Slowly as Labs Developed Tests for Coronavirus

WHEN THE FIRST DEATHS FROM THE NOVEL CORONAVIRUS were reported in Seattle beginning on Feb. 29, Helen Chu, MD, MPH, took notice. An infectious disease expert at the University of Washington School of Medicine, Chu is a director with the Seattle Flu Study. Since…

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In New York, Lab Offers Mobile Virus Sample Collections

CEO SUMMARY: To allow patients and physicians to order at-home specimen collections of the novel coronavirus, Northwell Labs trained its 12-member mobile phlebotomy service in the procedures needed to collect samples using nasopharyngeal (NP) swabs. Since training occurred in …

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This Coronavirus Outbreak Will Change Lab Industry

CEO SUMMARY: COVID-19 is causing a level of global disruption not seen since the influenza outbreak of 1918. This new infectious disease exposes flaws in the strategies and planning of public health officials and governments in the United States and abroad. In this country…

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COVID-19 Patient? Northwell Has Mobile Phlebotomy App

>CEO SUMMARY: What better way to limit the spread of a deadly novel coronavirus than to allow patients who suspect they have the COVID-19 illness to use a mobile phone to book an appointment with a phlebotomist who makes house calls? Northwell Laboratories started this service in Novem…

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First EKRA Guilty Plea Involves Lab Kickback

>CEO SUMMARY: Federal investigators wasted little time in using the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) to prosecute fraud involving clinical laboratories and providers. The manager of an opioid treatment center in Kentucky pleaded guilty last month to three co…

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33 Groups Cooperated to Get PAMA-Related LAB Act Passed

>CEO SUMMARY: At the end of 2019, the Laboratory Access for Beneficiaries (LAB) Act became law and addressed two of the three most onerous requirements in the Protecting Access to Medicare Act (PAMA) of 2014. It delays the data-reporting requirements under PAMA, an…

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2019’s Top 10 Lab Stories Reveal Major Laboratory Industry Trends

This is an excerpt of a 3,163-word article in the Dec. 16, 2019 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: There was plenty of bad news in 2019 for clinical labs and pathology groups. Yet lurking inside this new…

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September 23, 2019 Intelligence: Late Breaking Lab News

Spectra Laboratories, a division of the national dialysis company Fresenius Medical Care, will soon open a new 200,000 square foot laboratory facility in Memphis. The new lab will employ more than 300 people and will be located only 15 minutes from the Memphis Intern…

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PGx Testing Labs Concerned by FDA’s Statements, Actions

This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…

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PGx Labs Concerned by FDA’s Statements, Actions

CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…

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