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Volume XXIII No. 10 - July 25, 2016

Of Theranos, ADLTs, and Surgical Pathology Errors

Commentary and Opinion by R. Lewis Dark / By

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. Theranos, Inc. is a prime example of this phenomenon. Almost every month there are new disclosures about problems plaguing this high-profile lab company. As …

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Theranos Now Scrambling To Save What It Can

Clinical Laboratory / By

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 clinical lab testing business strategy and back to …

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CMS CLIA Sanction Letter Sent To Theranos Raises Questions

Laboratory Compliance / By

CITING PRACTICES THAT JEOPARDIZE PATIENT SAFETY, the federal Centers for Medicare & Medicaid Services decided earlier this month to revoke the CLIA certificate that it granted to Theranos Inc. to operate a clinical laboratory in Newark, Calif., and to ban the lab company’s founder and CEO Elizabeth Holmes from the operating a clinical laboratory for …

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ADLT Final Rule Creates Tough Questions for Labs

Laboratory Compliance / By

IT’S GOING TO BE A DIFFERENT AND TOUGHER WORLD for laboratory companies that market proprietary molecular and genetic tests. That’s the opinion of experts who have studied the final rule governing Advanced Diagnostic Laboratory Tests (ADLTs) that the federal Centers for Medicare & Medicaid Services issued in June. The final rule implements Section 216 of …

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Cover-Up Charged After Alleged Surgical Pathology Error

Anatomic Pathology / By

CEO SUMMARY: In an explosive civil case, documents show a pathologist erroneously diagnosed a patient as having cancer of an essential body organ and that the organ was removed unnecessarily, stated an attorney for the whistleblower. The patient has not yet been told of the misdiagnosis or that the essential organ was not cancerous, said …

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What Is CAP’s Role When Lab Has a Serious Medical Error?

Laboratory Compliance / By

IT IS CERTAINLY SIGNIFICANT NEWS FOR THE PATHOLOGY PROFESSION that a respected pathologist—indeed a pathology chair—is alleged to be involved in covering up a misdiagnosis of cancer for a patient who then had a healthy essential organ surgically removed. And the story doesn’t end there. It is further alleged in court documents that, when a …

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July 25, 2016 Intelligence: Late Breaking Lab News

Late Breaking Lab News / By

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 rule would expand APRNs’ authority, currently limited to ordering and interpreting lab tests. In an …

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