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…
Dartmouth-Hitchcock Builds Strong Lab Outreach Business
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 …
In Lawsuit Against HHS, ACLA Has Strong Positions
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…
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…
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 …
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 th…
Response to FDA’s Gottlieb on Reducing Regulatory Burden
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 …
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…
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 …
NC Hospital Reviewing Path Lab Deficiencies
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 mo…
CURRENT ISSUE
Volume XXXII, No. 7 – May 12, 2025
Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.