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
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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
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
Five Things Labs Need to Know About the Trump Travel Ban
From - G2 Compliance Advisor
We'll leave it to others to argue whether it's legal, moral or wise. What we can tell you is that President Trump issued an Executive Order Jan. 27, 2017, establishing a…
10 Things to Include in Your HIPAA Breach Notification Policy
From - G2 Compliance Advisor
Earlier this month we told you about a $475,000 settlement one provider reached in a HIPAA breach notification case. Privacy lapses can occur despite…
How to Create a HIPAA Breach Notification Policy
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Crosswalked Codes in 2017 Clinical Laboratory Fee Schedule
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2017 Medicare Lab Payments: The 9 Changes that May Affect Your Reimbursements
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Zero Tolerance of Workplace Violence: From Moral Stand to Workable Policy
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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 Perspectives: PAMA—What We Know So Far, What You Need to Know to Comply
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CMS Latest Data Release Offers Labs a Tool to Spot Potential Compliance Red Flags
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Even Small Labs Can Yield Big Results from Simple, Low-Cost Informatics Strategies
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