Commentary and Opinion by R. Lewis Dark

Goodbye Clinical Labs! Hello Genetic Testing Labs!

IS THE CLASSIC MODEL OF THE INDEPENDENT PATHOLOGIST-OWNED CLINICAL LABORATORY that is the sole source provider of all routine, reference, and esoteric testing to physicians in its community on its way to extinction? There is strong evidence to support a “yes” answer to that question.  The heyday of the local, pathologist-owned independent lab company was …

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Interesting New Surprises for Lab Leaders

Unexpected and surprising things continue to happen in the clinical laboratory industry. You might consider that to be one unifying theme to the intelligence briefings we present in this issue of The Dark Report.  For example, a pathology lab company in New Jersey sued UnitedHealthcare (UHC) seeking payment for 46,400 molecular COVID- 19 test claims …

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Lab Professions ‘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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