TAG:

clia laboratory

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…

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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…

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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…

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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…

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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…

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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…

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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….

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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…

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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 …

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Geisinger’s Coag Clinics Located in Docs’ Offices

CEO SUMMARY: It was six years ago when Geisinger Health System pushed laboratory testing and pharmacy services closer to the patients and referring physicians. By establishing coagulation clinics in six multi-specialty clinic sites, Geisinger ha…

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