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In the Past, Labs Used Courts to Thwart Feds
CEO SUMMARY: A federal judge’s recent decision to vacate the FDA’s final rule on laboratory developed tests harkens back to a 2008 case where clinical labs stopped a CMS competitive bidding project. In the earlier case, legal risks led the government to back down. The …
COLA Summit to Address Lab Staffing Shortages
CEO SUMMARY: An upcoming gathering of COLA’s Workforce Action Alliance will focus on three staffing challenges: improving data needed to understand the current clinical laboratory workforce; promoting career paths for new professionals in the field; and identifying ways …
Medical Robotics Developer Says It’s Time to Transform Phlebotomy
“Our innovation aims to make blood draws fully autonomous, safer, faster, more accurate, less painful, and more accessible.” —Brian Joseph, co-founder, Vitestro CEO SUMMARY: Phlebotomy and collection of veinous blood is one important procedure in clinical…
Why Labs Should Comply with FDA’s Final Rule on LDTs
CEO SUMMARY: Even as lawsuits challenging the Laboratory Developed Test (LDT rule) issued by the federal Food and Drug Administration (FDA) progress in federal court, clinical labs performing LDTs face an interesting decision. Should they invest the staff time and money to comply with the…
Labs: Why it Pays to Know Your Customers
WOULD IT SURPRISE YOU TO LEARN THAT THERE ARE DOCTORS WHO ARE SERI…
Pathology Compensation in Different Settings, including Hospitals
CEO SUMMARY: This second installment on the series about boosting pathologist compensation uses data collected during a survey of 1,400 pathologists in 230 pathology practices by the Panel of National Pathology Leaders (PNPL). Two experienced pathology consultants identify the most effect…
Top 10 Lab Stories for 2024 Reflect Important Trends
CEO SUMMARY: Most clinical laboratory managers will agree that the Food and Drug Administration’s (FDA) final rule to regulate laboratory developed tests (LDTs) is the biggest lab industry story for 2024. Every laboratory performing LDTs must now devote money and time to comply with the…
Pathologist Frederick Kiechle, MD, Molecular Pioneer, Dies at 78
Clinical pathology lost one of its greatest practitioners when pathologist Frederick L. Kiechle, MD, PhD, FCAP, of Cooper City, Fla., died on July 30, 2024, at the age of 78. …
Change Healthcare Cyberattack Involved 100 Million Americans
AFTER EXPERIENCING WHAT MANY CYBERSECURITY EXPERTS consider to be one of the largest, most disruptive ransomware attacks ev…
Allina Doctors Express Concerns after Quest Acquires Lab Outreach
IN RECENT YEARS, QUEST DIAGNOSTICS AND LABCORP, the two behemoths of the U.S. clinical laboratory market, have been aggressively acquiring lab businesses from health systems across the country. They say that patients and providers will benefit from lower costs and be…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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