You searched for COVID-19 - Page 4 of 35

CLIA Lab Inspections Different Because of COVID-19 Pandemic

WITH THE ONSET OF THE COVID-19 PANDEMIC IN MARCH, three of the major organizations deemed to have CLIA status suspended inspections of clinical laboratories for several months. Inspections and assessments of laboratories have restarted, but with significant changes because of the SARS-CoV-2 outbreak. These changes to the CLIA lab assessment and accreditation process were the […]

To access this post, you must purchase The Dark Report.

CLIA Lab Inspections Different Because of COVID-19 Pandemic Read More »

Lab Leaders Say COVID-19 Tests Needed in 2021

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

How long into the future will clinical laboratories need to offer COVID-19 tests on a large scale? That is the number one question confronting labs in every region of the United States. Last week, three nationally-known lab CEOs answered that question during the general session of the Virtual Executive War College. It was a panel discussion moderated by Robert

To access this post, you must purchase The Dark Report.

Lab Leaders Say COVID-19 Tests Needed in 2021 Read More »

High-Complexity Mobile Labs for COVID-19 Testing

Clinical Laboratory Trends / Robert Michel

CEO SUMMARY: Demand for high-complexity mobile coronavirus testing facilities is high, according to the CEO of a start-up company building 25 clinical labs in mobile trailers that can do hundreds of tests per eight-hour day. Employers, schools, event organizers, and other entities all have high interest in contracting with this California company for mobile on-site testing that can deliver rapid results

To access this post, you must purchase The Dark Report.

High-Complexity Mobile Labs for COVID-19 Testing Read More »

Will HHS Ruling on COVID-19 LDTs Be Good or Bad for Lab Reimbursement?

TDR Insider / Robert Michel

This is an excerpt of a 1,028-word article in the September 14, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. WHILE SOME LABS CELEBRATE THE PERCEIVED FLEXIBILITY that comes from not having to get an emergency use authorization (EUA) for COVID-19 laboratory-developed tests (LDTs), there is a potential

To access this post, you must purchase The Dark Report.

Will HHS Ruling on COVID-19 LDTs Be Good or Bad for Lab Reimbursement? Read More »

Understanding COVID-19’s Changes to Lab Industry

Clinical Laboratory Trends / Robert Michel

CEO SUMMARY: With the SARS-CoV-2 pandemic about to enter its eighth month in the United States, it remains difficult to predict whether the pandemic will strengthen with the fall influenza season or steadily diminish. What is clear to most pathologists and clinical laboratory executives is that the COVID-19 pandemic has already changed several aspects of how laboratories select suppliers, purchase supplies,

To access this post, you must purchase The Dark Report.

Understanding COVID-19’s Changes to Lab Industry Read More »

Covid-19 Pandemic May Be Creating New IVD Winners and Losers

In Vitro Diagnostics / Robert Michel

WITH THE PANDEMIC NOW IN ITS NINTH MONTH, in vitro diagnostics (IVD) company executives and industry consultants recognize the market for clinical laboratory instruments, tests, and products is changing in fundamental ways. “Evidence accumulates that the pandemic is helping create new winners and new losers among big and little IVD companies,” stated Peter van Overwalle, who is Head of Marketing and Partner at LiquidSMARTS

To access this post, you must purchase The Dark Report.

Covid-19 Pandemic May Be Creating New IVD Winners and Losers Read More »

Is HHS Ruling on COVID-19 LDTs Negative for Lab Reimbursement?

Laboratory Compliance / Robert Michel

WHILE SOME LABS CELEBRATE THE PERCEIVED FLEXIBILITY that comes from not having to get an emergency use authorization (EUA) for COVID-19 laboratory-developed tests (LDTs), there is a potential downside—difficulty getting reimbursed for the test. On Aug. 19, the Department of Health and Human Services (HHS) issued a new directive that said clinical laboratories are no longer required to obtain an EUA from the Food

To access this post, you must purchase The Dark Report.

Is HHS Ruling on COVID-19 LDTs Negative for Lab Reimbursement? Read More »

Labs Adjust to COVID-19 as a Regular Part of Care

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

ONE INTERESTING NEW DEVELOPMENT NOT REPORTED MUCH BY THE NATIONAL MEDIA is that the daily number of new COVID-19 cases in the United States has declined steadily in the past month. It is too early to understand the implications of this development, but clinical lab administrators and pathologists may want to follow a basic statistic. Here at The Dark

To access this post, you must purchase The Dark Report.

Labs Adjust to COVID-19 as a Regular Part of Care Read More »

Amazon Targets COVID-19 Testing in its New Lab-Building Venture

TDR Insider / Robert Michel

This is an excerpt of a 1,980-word article in the August 3, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: For pathologists and clinical lab directors, Amazon’s nascent COVID-19 testing venture for employees could be a significant concern given that the e-commerce company could disrupt

To access this post, you must purchase The Dark Report.

Amazon Targets COVID-19 Testing in its New Lab-Building Venture Read More »

COVID-19 Changes Lab and Pathology Profession

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

WE ARE ENTERING THE SEVENTH MONTH OF THE SARS-COV-2 OUTBREAK and some public health authorities predict that new cases of COVID-19 will continue through the fall and into 2021. If true, this will not be auspicious for the nation’s clinical laboratories and anatomic pathology groups. The current clinical and business model of clinical laboratory and anatomic pathology operations

To access this post, you must purchase The Dark Report.

COVID-19 Changes Lab and Pathology Profession Read More »

Search Results for: COVID-19