TAG:
clia laboratory
Problems at Theranos Described in Balwani Trial
CEO SUMMARY: Former Theranos President and COO Ramesh Balwani is now being tried in federal court in San Jose, Calif. As with the earlier trial of Elizabeth Holmes, questions will arise about whether executives or clinical lab directors bear ultimate responsibility for lab test resu…
Theranos, Capital Blue Sign Lab Test Agreement
CEO SUMMARY: With each passing month, Theranos is looking more like a traditional clinical laboratory company, based on how it is expanding its patient service center network and courier/logistics system into different regions while pursuing managed care contracts with health ins…
What’s New at Theranos? Lab Firm Expands in AZ
CEO SUMMARY: Over the past 18 months, Theranos has taken steps to enter the clinical lab marketplace. Across Greater Phoenix, Theranos now has specimen collection centers in about 40 Walgreens pharmacies. It is opening a CLIA lab facility in Scottsdale. Now that it is delivering…
PerkinElmer Launches Lab Venture in China
CEO SUMMARY: PerkinElmer is the latest U.S. organization to open a clinical laboratory business in China. Last December, it formally opened its new Suzhou PerkinElmer Medical Laboratory. The new lab is located about 60 kilometers (37 miles) west of Shanghai. It will provide neona…
Pathologist Raises Questions about Theranos’ Business Model
Dear Editor: I read your two articles on Theranos in the August 11 issue of THE DARK REPORT, and concur in large part with your thoughtful conclusions. For several years, I have closely followed Theranos and have been quoted in trade publications speaking favorably…
April 28, 2014 Intelligence: Late Breaking Lab News”
In recent years, a series of decisions involving molecular diagnostics tests made by Medicare officials and the Medicare Administrative Contractors (MACs) have caused much disruption in the clinical laboratory industry. In response to these developments, on April 16, the California Clinical L…
CMS and CAP Comment On CLIA PT Matters
CEO SUMMARY: Federal regulators rely on interpretations from administrative law judges (ALJ) for guidance in how to apply the Clinical Laboratory Improvement Amendments (CLIA) as they pertain to proficiency testing (PT) and the issue of inadvertent PT referrals. Representatives of the Cen…
CLIA’s Catch-22 Involving Proficiency Testing
THERE’S A REGULATORY TRAP awaiting the unwary laboratory organization. It involves language in CLIA rules for proficiency testing (PT). All medical directors and lab administrators will want to fully understand the implications of what appears to be an emerging trend in CLIA laboratory enforcement….
French Company Buys Pittsburgh-Based RedPath
CEO SUMMARY: Here’s a deal that is all about proprietary molecular assays and access to new markets. With its purchase of RedPath Integrated Pathology, ExonHit Therapeutics, S.A., of Paris, France, gains a CLIA laboratory and access to the U.S. market, even as the new owner ope…
Current Review of CLIA Standards Intended to Address Laboratory PT
EFFORTS ARE UNDER WAY TO REVIEW existing requirements for laboratory certification under the federal Clinical Laboratory Improvement Act (CLIA). CLIA legislation was a response by Congress to widely-publicized failings in the quality and performance of certain cytology and office laboratories during …
CURRENT ISSUE
Volume XXXII, No. 1 – January 6, 2025
The Dark Report examines how AI is being used to predict the outcomes of FDA LDT lawsuits. Also, this issue is Part Two of a series about boosting pathology compensation in different settings, including hospitals. Two experienced pathology consultants identify the most effective approaches when negotiating Part A pathology agreements with hospitals and health systems, along with how to use data to bolster these negotiations.
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