Commentary and Opinion by R. Lewis Dark

Lab Profession’s ‘Haves,’ ‘Have Nots,’ and Thieves

ONCE AGAIN, THE LATEST NEWS OF IMPORTANCE in the clinical laboratory industry includes disparate topics that include legal/regulatory, new technology in anatomic pathology, fraud involving lab testing, and more consolidation in the in vitro diagnostics (IVD) industry.  You will find coverage on all of these topics and more in this issue of The Dark Report. …

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Despite COVID-19, Regular Lab Testing Expands

TIMES ARE GOOD FOR THE REGULAR RANGE of clinical laboratory and anatomic pathology testing services. Despite the COVID-19 pandemic, the daily number of routine test specimens is near pre-pandemic levels and certain sectors of lab testing—particularly genetic tests and some high-cost assays—are showing substantial growth this year, compared to 2019.  It may surprise many clinical …

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Might Politics Sway California Lab’s CLIA Compliance?

IS IT A CONFLICT FOR A STATE GOVERNMENT TO BUILD AND OPERATE A CLIA high-complexity clinical laboratory and have the same department that manages this lab facility also conduct the CLIA-mandated inspections and oversight of the lab’s compliance, as required by the federal Clinical Laboratory Improvement Amendments (CLIA)?  That is the situation in California today. …

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Clinical Labs Have the Opportunity to Deliver Value

FOR DECADES, PATHOLOGISTS AND CLINICAL LABORATORY PROFESSIONALS have called attention to the single most powerful resource possessed by their lab organizations: patient lab test data. Everyone in lab medicine is familiar with the oft-repeated statement that the cost of lab testing is about 3¢ to 5¢ on the healthcare dollar, but lab test data is involved in 60% …

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2021 Opens with a Major Story … and It’s Not COVID!

On the pages that follow, you will learn about a major story in the clinical laboratory industry that has gone unreported and publicly unremarked by the lab profession at large. This story is how three large health systems that own 372 hospitals have switched to a different CLIA (Clinical Laboratory Improvement Amendments) accreditation organization over …

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Why Labs Operate in a ‘Duality’ during Pandemic

HAS IT OCCURRED TO MANY OF YOU THAT YOUR CLINICAL LABORATORIES today must operate in what I will describe as an operational “duality”?  On one side, your lab must deal with COVID-19 testing. This is true whether your lab performs molecular SARS-CoV-2 tests or simply handles specimens that you refer to other labs for testing. …

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COVID-19 or Not, Lab Market Enters ‘Twilight Zone’

Our healthcare system is in a most remarkable state. Even as all providers—including clinical laboratories and anatomic pathology groups—continue to devote considerable resources to meeting the urgent need for SARS-CoV-2 testing, health insurers and regulators continue to issue new requirements governing all aspects of “normal” lab testing activities.  Today, all clinical labs and pathology groups …

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Lab Leaders Say COVID-19 Tests Needed in 2021

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 …

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Lab Finances to Become More Challenging

When you finish reading our story about how Medicare spending for molecular and genetic tests jumped by as much as 700% in certain states during 2019, you’ll be among the first in the nation to understand why a financial crisis is soon to wash over those clinical laboratories and pathology groups that perform genetic tests. We thank Bruce Quinn, …

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