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 pathologist’s misdiagnoses contributed to the deaths of 15 patients. The pathologist had
Tag: quality control
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.
THE DARK REPORT provided its first coverage of these developments in its previous
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 number of physicians who were worried about patient harm. After reviewing the concerns about
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
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 its analyzer as a complement to central labs. Basic diagnostics would be
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 recent weeks, a client notified Invitae genetics lab of discordant
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 daily operations, a batch of samples produced unreliable or inaccurate results. These discoveries are made as
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 only 2 to 15 patients received a false negative test
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 adoption of genetic test prior-authorization programs by health
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 on her company’s analysis of the payer price data