Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
Lab Compliance Advisor
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Articles and Reports
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
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
Zero Tolerance of Workplace Violence: From Moral Stand to Workable Policy
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G2 Compliance Corner
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Compliance Officers: Establish Credibility with Consistent, Well-Documented Decisionmaking
From - G2 Compliance Advisor
One of the tougher issues a non-lawyer compliance officer faces is a challenge to their decisions and recommendations by other members of…
Remember to Check Excluded Status
From - G2 Compliance Advisor
Background checks aren't just for spotting criminal records. Are you checking the Office of Inspector General's List of…
Don’t Overlook Bloodborne Pathogen Safety Issues
From - G2 Compliance Advisor
Violations of Medicare-related laws such as the Anti-Kickback Statute, self-referral law and the False Claims Act can cost…
Compliance Certification Keeps Staff Up-to-Date, Increases Compensation
From - G2 Compliance Advisor
Laboratories should encourage or even require their compliance professionals to obtain…
Why the New Massachusetts Law Matters, Regardless of Where Your Lab or Practice is Located
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Social Media and Hiring: Can You Use Facebook to Screen Job Applicants?
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Compliance Perspectives: PAMA—What We Know So Far, What You Need to Know to Comply
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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