TAG:

laboratory accreditation

September 23, 2019 Intelligence: Late Breaking Lab News

Spectra Laboratories, a division of the national dialysis company Fresenius Medical Care, will soon open a new 200,000 square foot laboratory facility in Memphis. The new lab will employ more than 300 people and will be located only 15 minutes from the Memphis Intern…

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Pathologist’s Error and Hospital’s Cover-up Lead to CMS Investigation

CEO SUMMARY: In the latest chapter of an explosive case at the University of Kansas Medical Center that includes claims of a cancer misdiagnosis, an unnecessary surgery, and a cover-up that involves the former chair of pathology, the patient has sued for fraud, negligence, and civil consp…

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Health Insurers Want More Data On Clinical Utility of Molecular, Genetic Tests

CEO SUMMARY: Genetic tests that lack two essentials are troublesome for the nation’s health insurers. Those essentials are clinical validity and clinical utility. During a recent webinar, two executives from major health insurers stressed the need for genetic testing labs to provide acc…

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Much Disruption for Labs In 2016’s Top 10 Stories

CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab indust…

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Lab Benefit Management Bill Advances in FL Senate

CEO SUMMARY: To date, a bill to restrict how health insurers use lab benefit management systems such as UnitedHealthcare’s BeaconLBS, has been favorably received in the Florida Senate. But the bill may face opposition when presented to the Senate’s Appropriations Committee. In a repor…

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December 7, 2015 Intelligence: Late Breaking Lab News

Last week, a joint laboratory accreditation agreement was announced by AABB and the American Association for Laboratory Accreditation (A2LA). The two associations will now collaborate to allow labs to obtain three assessments under one effort, including AABB accredit…

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March 30, 2015 Intelligence: Late Breaking Lab News

Last Friday, at Geisinger Medical Center in Danville, Pennsylvania, members of the health systems’s authority board were given tours of the new $63.4 million clinical laboratory facility. It is scheduled to open on May 4 and will feature the latest state-of-the art analyzers and lab automation system…

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Achieving CLIA, ISO 15189 at Same Time with A2LA

CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the America…

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Top 10 2014 Biggest News Stories

Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…

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Public Comment Started on FDA LDT Regulations

CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…

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