How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
Lab Compliance Advisor
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FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Compliance Perspectives: Use New DOJ Criteria to Vet the Effectiveness of Your Lab Compliance Program
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Case of the Month: Feds Target Doctors Who Took Kickbacks from HDL
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Co-Owner of Kentucky Lab Pleads Guilty to Reference Lab Conspiracy
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Compliance Heads Up: New Kickback Safe Harbors Rule Is Almost Ready
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New OIG Report Confirms that Labs Are Still on the Enforcement Radar
From - Lab Compliance Advisor
After a recent dip, OIG enforcement activity has seemingly rebounded, at least in terms of total recoveries. That's the…
Authors of Genetic Testing Conspiracy Jailed for Preying on Seniors
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Compliance Perspectives: How to Implement a Respiratory Protection Program at Your Lab
From - Lab Compliance Advisor
Worker exposure to infection and hazardous substances is a constant and pressing challenge for lab managers. And if yours is among the many labs where workers are required…
Atlanta Medical Group Execs Jailed for $8.5 Million Allergy Testing Scheme
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Brief Your CEO: Explain How New DOJ Guidance Can Get Your Lab Out of FCA Hot Water
From - Lab Compliance Advisor
New guidance from the DOJ lays out sheds light on a crucial matter that many high-ranking lab executives are forced to&…