Tag: laboratory accreditation

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

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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 conspiracy. After a whistle-blowing pathologist filed an earlier lawsuit,

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

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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 acceptable evidence that their genetic test is accurate and that it produces information

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December 7, 2015 Intelligence: Late Breaking Lab News

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Intelligence Late & Latent 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 accreditation, ISO 15189 accreditation, and CLIA requirements. In their statement about the benefits of the new arrangement, the

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March 30, 2015 Intelligence: Late Breaking Lab News

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Intelligence Late & Latent 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 systems. Located in a new building of 162,378 square feet, it will be home to more than 350 lab employees.

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Achieving CLIA, ISO 15189 at Same Time with A2LA

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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 American Association of Laboratory Accreditation (A2LA). While it was undergoing ISO 15189 accreditation, the organization began to prepare for CLIA accreditation through A2LA, both for a single price.

See additional Dark Daily coverge on CLIA and A2LA certification

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Public Comment Started on FDA LDT Regulations

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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 bureaucratic oversight of LDTs. The FDA said that this new layer of regulation will be phased

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October 13, 2014 “Intelligence: Late-Breaking Lab News”

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Quality management systems (QMS) have made inroads in some of the organizations that accredit clinical laboratories in the United States to the requirements of CLIA. Last month, COLA of Columbia, Maryland, acknowledged that it had recertified to the standards of ISO 9001: 2008. The recertification was obtained through the British Standards Institute. COLA earned its

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