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laboratory testing
The newest threat to lab revenues: reference pricing in healthcare
By Mary Van Doren | From the Volume XXIII No. 12 – September 6, 2016 Issue
This is an excerpt from a 1,600-word article in the September 6 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …
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…
Score for Theranos after AACC: Fail.
By Mary Van Doren | From the Volume XXIII No. 11 – August 15, 2016 Issue
This is an excerpt from a 1,600-word article in the August 15 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …
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…
July 25, 2016 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXIII No. 10 – July 25, 2016 Issue
Throughout the profession of laboratory medicine, concern is surfacing following publication of a proposed rule by the Department of Veterans Affairs (VA) that would expand the authority of Advanced Practice Registered Nurses (APRNs) to supervise and perform laboratory testing. This …
PAMA Final Rule a Threat To Community Lab Survival
By Joseph Burns | From the Volume XXIII No. 9 – July 5, 2016 Issue
CEO SUMMARY: Will implementation of the final PAMA private payment rate reporting rule for labs put smaller, community labs at financial risk? Yes, says the National Independent Laboratory Association (NILA). By deliberately setting a standard to exclude private payer payment data from ho…
Quest to Manage Six Labs at HCA HealthONE Hospitals
By Joseph Burns | From the Volume XXIII No. 8 – June 13, 2016 Issue
CEO SUMMARY: For decades, hospitals were reluctant to allow any outside lab company to run their inpatient lab operations because they preferred to maintain control over quality results and turnaround times. That attitude may be changing as health systems face increasing margin compressio…
Is Theranos Kowtowing To CMS over Pending CLIA Sanctions?
By Robert Michel | From the Volume XXIII No. 7 – May 23, 2016 Issue
CEO SUMMARY: Having ignored the profession of laboratory medicine for nearly all of its 13-year corporate life, Theranos suddenly began engaging with expert laboratorians last month. The timing of this new outreach coincides with public disclosure that CMS proposed the severest sanctions …
At Executive War College 2016, Two Big Lab Market Trends
By Robert Michel | From the Volume XXIII No. 6 – May 2, 2016 Issue
CEO SUMMARY: What happens when 100 lab experts interact with an audience of more than 850 lab administrators, pathologists, and IVD executives from across the United States and seven other nations? A consensus of sorts emerges and during this 2016 edition of the Executive War College on L…
Henry Ford Health System Laboratory Division Combines Lean with ISO 15189
By Joseph Burns | From the Volume XXIII No. 3 – February 29, 2016 Issue
CEO SUMMARY: As healthcare transitions away from fee-for-service payment and adopts new models of reimbursement, every clinical lab will need to deliver more value with its lab testing services. At Henry Ford Health System in Detroit, the laboratory division has blazed a path of improving…
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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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