Tag: clinical laboratory improvement amendments

Theranos Saga Just Keeps Getting More Intriguing

IT’S BEEN AN EVENTFUL COUPLE OF MONTHS for Theranos, the lab testing company that says its goal is to disrupt the clinical laboratory industry. Novelists cannot write fiction as compelling as the unfolding real story about this controversial company.

During March and April, The Wall Street Journal published a series of articles that revealed the extent of the problems Theranos had with CLIA inspections of its clinical laboratory in Newark, California. The Journal published its analysis of the CLIA inspection report and the serious deficiencies identified during lab inspections that happened last fall and earlier this year.

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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 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

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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Test Utilization Targeted by UnitedHealth, LabCorp

CEO SUMMARY: Many independent laboratories serving patients in Florida are unhappy about the decision by UnitedHealth (UNH) to initiate a pilot program that calls for LabCorp’s BeaconLBS subsidiary to handle prior authorization for certain lab tests. UNH’s laboratory benefit management program will commence on October 1, 2014. Just 13 laboratories are currently listed as network

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