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lab medicine
Lab Utilization Is Healthcare’s Ticking Time Bomb
By R. Lewis Dark | From the Volume XVI No. 17 – December 14, 2009 Issue
TODAY I WOULD LIKE TO SPEAK TO ONE OF THE ELEPHANTS IN THE LAB INDUSTRY’S ROOM. It is the ticking time bomb of lab utilization. Sometime in the next 36 to 60 months, this time bomb will go off. It will catch both health policy makers and payers unprepared and, the consequences will be corrosive to …
Getting Vitamin D Right for the Doctor and Patient
By R. Lewis Dark | From the Volume XVI No. 11 – August 10, 2009 Issue
MOST OF YOU ARE FAMILIAR with how W. Edwards Deming and Japanese manufacturers demonstrated the power of understanding customer expectations and organizing one’s business to deliver products and services which meet and exceed those expectations. For the past four decades, one thing that many of th…
Our Editor Gets His Vitamin D Test Results From 9 Different Labs
By Robert Michel | From the Volume XVI No. 11 – August 10, 2009 Issue
CEO Summary: Editor-In-Chief Robert L. Michel gave blood for the cause and it’s another laboratory industry first! To understand what doctors and patients see as national labs use different methodologies and reference ranges to report Vitamin 25(OH) D results, his blood was tes…
Inaccurate Results + Quest Dominates News Cycle
By R. Lewis Dark | From the Volume XVI No. 1 – January 12, 2009 Issue
CEO SUMMARY: Most laboratory professionals don’t know it yet, but significant changes occurred to the entire lab industry last week. After Quest Diagnostics Incorporated acknowledged that it was retesting tens of thousands of patients because 7% of the Vitamin D results it repo…
A Common Future for Pathology & Radiology?
By R. Lewis Dark | From the Volume XV No. 16 – December 01, 2008 Issue
DO RADIOLOGISTS AND PATHOLOGISTS have a common future in the age of personalized medicine? That’s not an idle question as new technologies help both medical specialties to better understand how molecular processes play a role in various diseases. Oncology may prove to be the powerful force that en…
NY & Calif. Act to Stop Web Gene Testing Firms
By Robert Michel | From the Volume XV No. 9 – July 7, 2008 Issue
CEO SUMMARY: Events in the past month indicate that a war is developing between Internet-based companies offering genetic tests to consumers and state and federal health regulators. New York state authorities have sent letters to at least 31 such companies in recent month…
Labs Should Prepare for Tighter CLIA Enforcement
By Robert Michel | From the Volume XV No. 4 – March 24, 2008 Issue
CEO SUMMARY: Lab directors and pathologists should take notice of disturbing new developments in enforcement of CLIA regulations. During the past year, CMS officials have revoked the CLIA certification of several hospital laboratories for what are, essentially, inadvertent violations of p…
Analyzing Lab Bid Demo To Predict Its Outcome
By Robert Michel | From the Volume XIV No. 18 – December 31, 2007 Issue
CEO SUMMARY: After two decades of study and preparation, the Centers for Medicare & Medicaid Services (CMS) is pushing the laboratory profession toward the first pilot site in the Congressionally-mandated Medicare Clinical Laboratory Services Competitive Demonstration Project. Designe…
Call to Action Is Needed For Lab Test Profession
By Robert Michel | From the Volume XIV No. 18 – December 31, 2007 Issue
CEO SUMMARY: Is a laboratory test simply a commodity, like wheat or coal? Or is it a complex scientific service of unique value that delivers personalized results and clinical knowledge on behalf of millions of patients every day in the United States? The fundamental assumption of competi…
Busy Year Demonstrated By Top Ten Lab Stories
By Robert Michel | From the Volume XIV No. 17 – December 10, 2007 Issue
CEO SUMMARY: As it turns out, 2007 has been an action-packed year with lots of events, plenty of changes, and the promise of even faster evolution across all sectors of the lab testing marketplace. THE D…
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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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