New CLIA e-Notifications: Here’s What Clinical Labs Need to Know
As of March 1, 2026, CMS will move CLIA away from paper-based transactions to improve efficiency and payments
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Articles and Reports
Reporting Noncompliance in Clinical Labs Requires the Right Channels and Culture
A lawyer advises medical laboratories on how to improve their avenues for reporting unethical behavior
FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
Labs in Court: A Full Circle
Cases filed or resolved by the U.S. Department of Justice in the fourth quarter reveal the same compliance issues from early in 2024
Staffing: 2024’s Biggest Lab Operations Challenge
ADLM president Anthony Killeen looks at labs’ staffing struggles in 2024 and what can be done to alleviate them in the coming year
Digital Pathology and AI: Now and in 2025
Experts Nathan Buchbinder and Julianna Ianni discuss digital pathology and AI trends in 2024—and what the next year may hold
FDA Watch: EU’s New IVD Regulations Could Drive More Firms to Seek FDA Approval
Although the timelines have been extended several times, IVDR complexity has created a concerning bottleneck in the approval process
Labs in Court: A Focus on Individual Accountability
Recent False Claims Act settlements underscore the government’s emphasis on individual accountability in healthcare fraud matters
Keeping Your AI Tools Safe
The potential occupational safety pros and cons of artificial intelligence implementation into the clinical lab
Clinical Lab Data: Unlocking Profit Potential for Health Systems
How labs can better use their valuable data and highlight that data’s benefits to the health systems they serve
Common OSHA Violations: What Could Go Wrong?
What lab safety violations are most common? What happens when lab safety is overlooked? And how can your lab avoid becoming a statistic?
Keys to a Successful OSHA Annual Review of Your Lab’s Health & Safety Plan
A solid health and safety plan in the lab not only meets regulatory requirements, but also fosters a secure environment for staff
Dx Deals: New Premerger Regulations Could Slow Down Pace of Transactions
The new rules, which were approved by the FTC in October and will go into effect in mid-January, aim to put a damper on consolidation
