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lab industry
Of Theranos, ADLTs, and Surgical Pathology Errors
By R. Lewis Dark | From the Volume XXIII No. 10 – July 25, 2016 Issue
THESE DAYS, IT SURE FEELS LIKE CLINICAL LABS AND PATHOLOGY GROUPS are under constant siege. Every month seems to bring one or more new developments that rock the clinical lab industry. Thera…
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…
What will the future hold for Theranos?
By R. Lewis Dark | From the Volume XXIII No. 10 – July 25, 2016 Issue
This is an excerpt from a 1,900-word article in the July 25 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …
Is CMS about to Create New Lab Winners, Losers?
By R. Lewis Dark | From the Volume XXIII No. 9 – July 5, 2016 Issue
FROM ITS INCEPTION IN 1966, THE MEDICARE PROGRAM WAS DESIGNED to give beneficiaries easy access to healthcare services while allowing any qualified provider to provide those clinical services. That is about to change for…
AACC reveals details of its invitation to Theranos CEO
By Mary Van Doren | From the Volume XXIII No. 7 – May 23, 2016 Issue
This is an excerpt from a 925-word article in the May 23 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …
Attorney Cautions Laboratories Against Waiving Patient Fees
By Joseph Burns | From the Volume XXIII No. 6 – May 2, 2016 Issue
WHEN A CLINICAL LAB WAIVES patients’ fees in exchange for lab test referrals, competing labs face a legal dilemma. If the competing lab does not match the offer, it could lose volume to this aggressive sales technique. But if the lab does match the offer, it could run afoul of health plan requirem…
CMS Update Plans for Medicare Clinical Lab Fee Schedule Could Be in Trouble
By Mary Van Doren | From the Volume XXIII No. 5 – April 11, 2016 Issue
This is an excerpt from a 1,400-word article in the April 11 issue of THE DARK REPORT. Full details of the California program are included in the original article, available to paid members. CEO SUMMARY: Evidence from California shows that national la…
Marshfield Clinic Lab Tackles Phlebotomy Workflow Redesign
By Joseph Burns | From the Volume XXIII No. 5 – April 11, 2016 Issue
CEO SUMMARY: Before a redesign of phlebotomy workflow at Marshfield Clinic, patients might wait as long as an hour, particularly before noon when phlebotomists would see 75% of each day’s patients. After the redesign, the number of draw sites was reduced from five to two while hand…
Just 66 of 742 Labs Submit Rate Data to California Department of Health Care Services
By Joseph Burns | From the Volume XXIII No. 5 – April 11, 2016 Issue
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Accumen Acquires Chi To Beef Up Lab Consulting
By Joseph Burns | From the Volume XXIII No. 5 – April 11, 2016 Issue
CEO SUMMARY: Two different business models of clinical laboratory consulting have now been brought together. Chi consultants have long focused on analytics and improving outreach performance, among other areas of lab performance. By contrast, Accumen’s business model is nontradition…
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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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