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
Lab Compliance Advisor
Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice
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Articles and Reports
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.
No Signs of the DOJ Letting Off the Pedal with Medicare Fraud Investigations
However, a new memo instructs federal prosecutors to ‘avoid overreach’ when parties cooperate with authorities
Six Sigma Can Help Monitor New CLIA Proficiency Testing Changes
A PT update went into effect on January 1, focusing on revised acceptance limits, among other modifications
Compliance Concerns: Laboratory Regulations in 2024 and Beyond
Earle S. Collum, chair of the CAP Council on Accreditation, talks through regulatory changes in 2024 and what to expect from 2025
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
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
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
