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First CAP 15189 Accreditation for a Children’s Hospital Lab
CEO SUMMARY: It’s now official. St. Jude Children’s Research Hospital is the first children’s hospital to earn accreditation to ISO 15189 under the College of American Pathologists. What is more interesting, however, is how lab leadership used the quality management system of ISO 15…
Strategy Lowers CalPERS’ Price of Joint Surgeries
CEO SUMMARY: Probably the most-watched reference pricing program in healthcare to date was initiated by CalPERS. It focused on the variability in the prices of knee and hip replacement surgeries. Just as Safeway experienced a drop in clinical lab test prices of 32% in its reference pricin…
Reference Pricing’s New Lab Winners and Losers
CEO SUMMARY: Expanded use of reference pricing by employers in coming years could trigger a cycle of cuts to lab test prices that would put the most pressure on the lab companies with the highest prices. Many hospital labs are viewed as having high prices. But because they run outreach sp…
Castlight Health’s Data Should Concern Lab Executives
CEO SUMMARY: Transparency tools, such as those from Castlight Health, help consumers see the significant variation in clinical laboratory test prices. In this analysis, THE DARK REPORT argues that lab executives and pathologists should recognize how two factors are poised to change the st…
Labs Caught Between Employer Hammer, Payer Anvil
STARTING ON JANUARY 1, 2017, THE CLINICAL LABORATORY INDUSTRY will undergo a new experiment in price-setting (and price-cutting) by the federal Centers for Medicare & Medicaid Services. On that date, certain labs must begin reporting market price data for each test and each payer…
Score for Theranos after AACC: Fail.
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. …
August 15, 2016 Intelligence: Late Breaking Lab News
One of the nation’s largest private pathology group practices completed a successful recapitalization, thus ensuring its independence for another five to seven years. On August 1, PathGroup, Inc., of Nashville, Tenn., announced an investment by Pritzker Group Private Capit…
Ohio State University Medical Center Inks Pact To Adopt Digital Pathology
CEO SUMMARY: For years, the adoption of digital pathology has lagged behind the predictions of its advocates. That has encouraged one digital pathology company—Inspirata, Inc., of Tampa—to come up with a different business strategy designed to help anatomic pathology labs address the …
Elizabeth Holmes of Theranos Speaks at AACC To Skeptical PhDs, Pathologists, and Press
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…
Theranos Now Scrambling To Save What It Can
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…
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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