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the laboratory
September 6, 2016 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXIII No. 12 – September 6, 2016 Issue
During the widespread floods in Louisiana last month, Pathology Group of Louisiana (PGL) activated its disaster preparedness plan and managed to avoid any interruption of its pathology services. One vital element of that plan was a telephone tree that kept managers and staff in commu…
Lead Researcher Outlines New Details Of Laboratory Test Price Study
By Joseph Burns | From the Volume XXIII No. 12 – September 6, 2016 Issue
CEO SUMMARY: There is always a story behind the story, and THE DARK REPORT went to the lead researcher of the reference pricing study published in JAMA Internal Medicine to get it. In this interview, James C. Robinson, PhD, of the University of C…
Why Lab Prices Declined 32% During 3-Year Study
By Joseph Burns | From the Volume XXIII No. 12 – September 6, 2016 Issue
CEO SUMMARY: Researchers studied the effect reference pricing had on an employer’s efforts to steer consumers to low-cost clinical labs. The study showed that patients were particularly sensitive to lab test prices—in part because those prices varied widely. Over the course of the …
Elizabeth Holmes of Theranos Speaks at AACC To Skeptical PhDs, Pathologists, and Press
By Robert Michel | From the Volume XXIII No. 11 – August 15, 2016 Issue
CEO SUMMARY: Elizabeth Holmes, Founder and CEO of Theranos, Inc., was given the ideal platform by AACC to show the science behind her lab company’s much-touted diagnostic technologies. But in a surprise to the assembled audience, Holmes, accompanied by three PhDs on her team, chose to d…
What Is CAP’s Role When Lab Has a Serious Medical Error?
By Joseph Burns | From the Volume XXIII No. 10 – July 25, 2016 Issue
IT IS CERTAINLY SIGNIFICANT NEWS FOR THE PATHOLOGY PROFESSION that a respected pathologist—indeed a pathology chair—is alleged to be involved in covering up a misdiagnosis of cancer for a patient who then had a healthy essential organ surgically removed. And the story doesn’t end there. It is …
Cover-Up Charged After Alleged Surgical Pathology Error
By Joseph Burns | From the Volume XXIII No. 10 – July 25, 2016 Issue
CEO SUMMARY: In an explosive civil case, documents show a pathologist erroneously diagnosed a patient as having cancer of an essential body organ and that the organ was removed unnecessarily, stated an attorney for the whistleblower. The patient has not yet been told of the misdiagnosis o…
Theranos Now Scrambling To Save What It Can
By Joseph Burns | From the Volume XXIII No. 10 – July 25, 2016 Issue
CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a c…
ADLT Final Rule Creates Tough Questions for Labs
By Joseph Burns | From the Volume XXIII No. 10 – July 25, 2016 Issue
IT’S GOING TO BE A DIFFERENT AND TOUGHER WORLD for laboratory companies that market proprietary molecular and genetic tests. That’s the opinion of experts who have studied the final rule governing Advanced Diagnostic Laboratory Tests (ADLTs) that the federal Centers for Medicare & Med…
CMS CLIA Sanction Letter Sent To Theranos Raises Questions
By Joseph Burns | From the Volume XXIII No. 10 – July 25, 2016 Issue
CITING PRACTICES THAT JEOPARDIZE PATIENT SAFETY, the federal Centers for Medicare & Medicaid Services decided earlier this month to revoke the CLIA certificate that it granted to Theranos Inc. to operate a clinical laboratory in Newark, Calif., and to ban the lab…
Florida Pathology Group Lost Volume After BeaconLBS Started
By Joseph Burns | From the Volume XXIII No. 9 – July 5, 2016 Issue
CEO SUMMARY: A 22-physician pathology group in Tampa has complied with rules for lab test ordering that UnitedHealthcare and BeaconLBS established, yet has experienced a steep decline in the volume of specimens it receives. Physicians told the pathologists that other labs were not using t…
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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