By Joseph Burns, from the Volume XXV No. 17 – December 3, 2018 issue
CEO SUMMARY: Legislation signed into law on Oct. 24 was designed to stem the nation’s opioid crisis. But in addition to applying to sober homes and addiction treatment centers, the law also applies to clinical laboratories. Called the ‘Support for Patients and Communities Act,’ the law could authorize criminal penalties for labs that pay sales
By Joseph Burns, from the Volume XXV No. 12 – August 20, 2018 issue
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
By Joseph Burns, from the Volume XXV No. 10 – July 9, 2018 issue
CEO SUMMARY: As health networks and hospitals consider outsourcing their lab outreach programs, the lab team at Dartmouth-Hitchcock Medical Center (D-H) offers lessons about the value of retaining outreach. D-H is now in the eighth year of a sustained expansion of its laboratory outreach business. It has combined its lab outreach strategy with a proven
By Joseph Burns, from the Volume XXV No. 9 – June 18, 2018 issue
CEO SUMMARY: Rulings from Judge Amy Berman Jackson of the U.S. District Court in Washington, D.C., are expected soon in the ACLA’s lawsuit against HHS concerning the PAMA final rule that set the course for the new Medicare CLFS rates implemented in January 2018. One lawyer following the lawsuit explains that ACLA has presented strong
By Joseph Burns, from the Volume XXV No. 8 – May 29, 2018 issue
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
By Joseph Burns, from the Volume XXV No. 8 – May 29, 2018 issue
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
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
IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He also explained some of the ways that the agency could be more flexible
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
