Tag: clia

FDA Issues Response to Draft Legislation to Regulate LDTs

DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA authority to regulate laboratory developed and in vitro diagnostic tests. At

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WSJ Reporter Tells All About Downfall of Troubled Theranos

CEO SUMMARY: While Theranos was a darling of the business and national media, Wall Street Journal reporter John Carreyrou was hearing troubling reports about patients who got incongruent lab results that put them at risk for inappropriate medical treatments. His investigation of Theranos and its celebrated founder, Elizabeth Holmes, revealed that the company’s much-touted lab

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Wake Forest Baptist Lab’s Path Errors Teach Lessons

CEO SUMMARY: For medical directors and pathologists interested in improving their labs’ compliance with CLIA regulations, a report from federal and state inspectors of an inspection of the pathology lab at the Wake Forest Baptist Medical Center offers insights into what issues caught the inspectors’ attention. During their visit in February, the government lab inspectors

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Wake Forest Baptist Hospital Reviewing Path Lab Deficiencies

CEO SUMMARY: In response to information the staff provided to Wake Forest Baptist Hospital’s risk manager last fall, and following a federal Centers for Medicare and Medicaid Services inspection in February, CMS describes deficiencies found as “an immediate jeopardy to the health and safety of patients” at the 885-bed hospital. THE DARK REPORT’s analysis shows

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CMS Report, News Stories Describe Pathology Issues

CEO SUMMARY: In response to information the pathology lab staff provided to the hospital’s risk manager last fall, and following a federal Centers for Medicare and Medicaid Services inspection in February, the Wake Forest Baptist Medical Center is taking corrective action to fix serious deficiencies in its anatomic pathology laboratory. In reports issued in February

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