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Search Results for: COVID-19

COVID-19 Patient? Northwell Has Mobile Phlebotomy App

Clinical Laboratory Trends / Joseph Burns

>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 November and now views this option as a […]

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Northwell Lab Team Validates COVID-19 Test on Fast Timeline

Clinical Laboratory Trends / Joseph Burns

CEO SUMMARY: Clinical labs are working with haste to test for the novel coronavirus, also called nCoV and SARS-CoV-2. Their efforts to prepare for high capacity testing for viral respiratory illness include validating molecular tests for the newly-identified virus and making those tests available for testing patients who may have the COVID-19 illness. At Northwell

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With LDT Rule Vacated, Labs Await FDA Retort

Laboratory Compliance / Robert Michel

CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form is likely. In part one of our report about

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Global IVD Companies Issue Fourth Quarter 2024 Earnings

In Vitro Diagnostics / Robert Michel

OVERALL, IN VITRO DIAGNOSTICS (IVD) COMPANIES REPORTED A MIXED BAG of financial results for the quarter ending Dec. 31, 2024, with Becton, Dickinson and Company, Abbott Laboratories, and Siemens Healthineers showing the most momentum based on recent earnings. Generally, IVD manufacturers did not experience double-digit growth or drops year over year, indicating that some stability

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COLA Summit to Address Lab Staffing Shortages

Clinical Laboratory Trends / Robert Michel

CEO SUMMARY: An upcoming gathering of COLA’s Workforce Action Alliance will focus on three staffing challenges: improving data needed to understand the current clinical laboratory workforce; promoting career paths for new professionals in the field; and identifying ways to better recognize these workers. Workforce shortages have long been a challenge for clinical laboratories, but the

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Quest Acquires ‘Select Assets’ of Fresenius Medical Care

Lab Marketplace / Robert Michel

FRESENIUS MEDICAL CARE AND QUEST DIAGNOSTICS AGREED TO A DEAL in which Quest will provide laboratory testing services for the latter’s dialysis clinics in the United States. Separately, Quest Diagnostics will acquire “select assets” of Spectra Laboratories, a wholly owned FMC subsidiary that currently provides those services. FMC is one of the two dominant providers

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OIG Issues New Report on Medicare 2023 Lab Spending

TDR Insider / Robert Michel

WITHIN THE LATEST REPORT ON MEDICARE PART A CLINICAL LABORATORY SPENDING during 2023 is information about the financial impact that price cuts to the Clinical Laboratory Fee Schedule (CLFS) have had on clinical laboratories. As mandated by the Protecting Access to Medicare Act of 2014 (PAMA), the report is prepared annually by the Office of

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OIG Issues New Report on Medicare 2023 Lab Spend

Clinical Laboratory Trends / Robert Michel

CEO SUMMARY: When the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) issued its latest report on Medicare spending in 2023 for clinical laboratory tests, it attracted relatively little attention from the lab industry. Maybe other issues—such as compliance with the FDA’s LDT rule—are getting more attention at

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Global IVD Companies Issue Third Quarter 2024 Earnings

In Vitro Diagnostics / Robert Michel

HERE IS A SUMMARY OF THE THIRD QUARTER FINANCIAL PERFORMANCE of the largest IVD manufacturers serving clinical laboratories. Lab managers and pathologists can use this information to track the market successes or setbacks by the different IVD vendors. These insights can be particularly helpful when considering different companies when it is time to replace or

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Federal Cases against Labs Result in Convictions

Laboratory Compliance / Robert Michel

CEO SUMMARY: Over the past 24 months, federal prosecutors have announced a steady parade of criminal convictions, guilty pleas, and settlement agreements involving fraud and clinical laboratory testing. Not only are these cases numerous, but some resolve legal actions initiated by the federal Department of Justice six to eight years ago—for fraudulent acts by defendants

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