A Look at How CLIA-Exempt States Operate and Why This Setup Exists
Washington State’s Department of Health details how its medical testing site program meets federal standards
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Articles and Reports
FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
2024 Laboratory Reimbursement Trends and What to Expect in 2025
Revenue cycle management experts weigh in on the biggest developments of 2024 and how labs can best prepare for 2025 and beyond
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
