TAG:

quality control

Arkansas Pathologist Faces 3 Manslaughter Charges

CEO SUMMARY: Federal prosecutors in Arkansas charged a former Veterans Administration pathologist with three counts of involuntary manslaughter and 28 other criminal counts related to his work at the Veterans Health Care System of the Ozarks. In the indictment, officials charged that the …

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Quest, Sonic Issue Statements about Pap Test Issues in Ireland

PROBLEMS WITH CERVICAL CANCER SCREENING IN IRELAND continue to make headlines in the Irish newspapers and roil the Irish health system. Caught up in this story are two billion-dollar lab companies that performed cervical cancer screening under contract to the Irish Health Service. T…

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How Many Patients Were Harmed at Theranos?

CEO SUMMARY: Reporting in The Wall Street Journal shows that some physicians in Arizona were concerned about the harm from erroneous test results from Theranos Inc. But those physicians who expressed concern may have been only a small set of the …

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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…

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FDA Clears Waived CBC For Near-Patient Testing

CEO SUMMARY: Market clearance of the first-ever CLIA-waived analyzer for complete blood count and three-part differential tests could cut time-to-answer from days to mere minutes for one of the top 20 tests by volume performed at core laboratories. Developer Sysmex America, Inc., foresees…

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Big Payers Want to Bring Order to Genetic Testing

IMPORTANT CHANGES ARE POISED TO TRANSFORM genetic testing. As this happens, there will be a new crop of winners and losers among genetic testing labs. Recent events can be interpreted as favoring two trends that most genetic testing companies consider as unfavorable to their interests. One trend is …

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50,000 Patients to Retest After Invitae Finds Errors

CEO SUMMARY: In recent weeks, a client notified Invitae of discordant results on a patient. The notification caused the genetic testing company to discover it had a systemic error that failed to test for a specific rare mutation associated with inherited cancer. Company officials believe …

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Estimating Total Costs When Genetic Tests Must Be Retested

INVITAE, A GENETIC TESTING COMPANY IN San Francisco, has begun a retest program involving 50,000 patients. Such a large retest effort is without precedent in the still-nascent genetic testing marketplace. Clinical laboratories and genetic testing companies commonly find that, in dai…

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Invitae genetics lab to retest 50,000 patients after finding errors

This is an excerpt from a 1,400-word article in the August 28, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: In…

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Hospital Lab Data Essential For CMS Market Price Study

CEO SUMMARY: In five months, Medicare officials will implement a new Part B clinical laboratory fee schedule based on private payer lab price data submitted by certain medical laboratories required to report that data. At this year’s Executive War College, the CEO of XIFIN, Inc., reported o…

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