By Joseph Burns, from the Volume XXVI No. 3 – February 25, 2019 issue
CEO SUMMARY: Inform Diagnostics, formerly Miraca Life Sciences, settled the federal qui tam case while denying wrongdoing. The $63.5 million settlement will by paid by the former owner, Miraca Holdings, a Japanese company. The federal Department of Justice alleged that the company—then known as Miraca Life Sciences—violated the False Claims Act by engaging in what
CEO SUMMARY: Two trends are driving a movement to standardize laboratory operations across large regions: the integration of clinical care and the need for hospitals and health networks to continuously improve patient outcomes. THE DARK REPORT outlines an ambitious program in Michigan, where Ascension Health is working to align itself with an integrated health system
By Joseph Burns, from the Volume XXV No. 13 – September 10, 2018 issue
CEO SUMMARY: Two trends are driving a movement to standardize laboratory operations across large regions: the integration of clinical care and the need for hospitals and health networks to improve patient outcomes continuously. In Michigan, Ascension Health is an example of a lab team working to standardize lab testing activities among seven organizations, 14 hospitals,
By Robert Michel, from the Volume XXV No. 11 – July 30, 2018 issue
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
By Joseph Burns, from the Volume XXV No. 10 – July 9, 2018 issue
CEO SUMMARY: In Ireland, the big story in healthcare at the moment is the discovery that the nation’s cervical cancer screening program has failed hundreds of women who had pre-cancerous conditions or cervical cancer, but, as alleged in numerous court cases, their tests were inaccurate or the results not communicated to their physicians, or both.
By Joseph Burns, from the Volume XXV No. 7 – May 7, 2018 issue
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
By maryv
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
By Joseph Burns, from the Volume XXV No. 6 – April 16, 2018 issue
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
By Robert Michel, from the Volume XXV No. 6 – April 16, 2018 issue
CEO SUMMARY: Discovery of multiple diagnostic errors occurring in an anatomic pathology department triggered a complaint investigation and a 54-page report from the federal Centers for Medicare and Medicaid Services. The report shows that Wake Forest Baptist Medical Center is reviewing more than 9,000 pathology cases to identify incorrect cancer diagnoses. Last month, the medical
By R. Lewis Dark, from the Volume XXV No. 6 – April 16, 2018 issue
MOST PATHOLOGISTS WOULD AGREE THAT PATIENTS AND THEIR PHYSICIANS have every right to expect a timely, accurate lab test result. Stated differently, patients and physicians implicitly trust that a pathology laboratory in the United States will not make errors in specimen processing (technical component) and diagnosis (professional component).
For these reasons, the recent federal Centers for
