R. Lewis Dark
Articles by R. Lewis Dark
Halfway Through 2022, More Changes Come at Labs
APPROACHING THE MIDWAY MARK OF 2022, some clinical laboratory directors and pathologists might feel like they’ve already experienced enough changes to last the whole year. For example, since the start of 2022, we’ve seen SARS-CoV-2 testing surges co…
Data Innovation Plays a Key Role on Future Fronts
BETTER COLLECTION AND USE OF CLINICAL DATA WAS A PROMINENT THEME discussed by attendees at last month’s annual Executive War College Conference on Laboratory and Pathology Management in New Orleans. Laboratory directors and pathologists have lo…
Despite the Challenges, Labs Are Prevailing
EVENTS IN THE WORLD, THE UNITED STATE, AND THE U.S. HEALTHCARE SYSTEM over the past two years have challenged clinical laboratories and anatomic pathology groups in unprecedented ways. Stand back for a moment and consider what has unfolded since Jan. 1,…
COVID-19: a Fork in the Road for Future Lab Testing?
We have all experienced a pandemic unique in the history of the world. Two elements, in particular, distinguished this pandemic from earlier global outbreaks. First, genetic technologies allowed scientists to almost instantly sequence the DNA of the novel coronavirus, once it was recognized as a uniq…
Artificial Intelligence ‘Invades’ Pathology, Billing
Predictions about the potential of artificial intelligence (AI) to transform nearly every area of healthcare are about to become reality. For the profession of laboratory medicine, AI is making speedy inroads into two areas. The first is anato…
Witness the Land Grab to Control Healthcare Data
LIKE MOST OF YOU, IT CERTAINLY CAUGHT MY ATTENTION WHEN I LEARNED in December that Oracle will pay $28 billion—with a B!—to buy Cerner Corporation. I don’t question the value of Cerner’s products; the company has an EHR product tha…
2021 Closes with Two Major Lab Industry Events
Normally, the time around Christmas and New Year passes quietly, typically without any significant developments. Such was not the case for the clinical laboratory industry in the last month of 2021 because of two announcements, each of which confirms ongoing market trends in healthcare and the lab te…
Congress Votes: No PAMA Price Cuts for 2022
IT’S WELCOME NEWS THAT CONGRESS VOTED EARLIER THIS MONTH to defer the PAMA price cuts to the Clinical Laboratory Fee Schedule (CLFS) that were scheduled to take place in 2022. This is a positive development for the finances of the nation’s clinical labs, particularly the smaller, independent labs t…
VALID Act vs. VITAL Act: Day of Reckoning for LDTs
TWO DISTINCTLY DIFFERENT BILLS HAVE SURFACED IN CONGRESS, each with the potential to have substantial impact on how laboratory-developed tests (LDTs) are regulated by agencies of the federal government. One bill even creates a new acronym for the lab industry: IVCT for in vitro clinical tests….
It’s Flu Season and COVID-19 Cases Continue
SUBSTANTIAL NUMBERS OF NEW COVID-19 CASES CONTINUE to be reported weekly. No one yet understands whether SARS-CoV-2 may disappear at some future date (as did the 1918 influenza pandemic and SARS outbreak in 2003) or whether SARS-CoV-2 will become endemic and stay with us for years….
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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