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
Compliance Perspective: The Duty to Accommodate the Religious Beliefs of Employees & Job Applicants
From - G2 Compliance Advisor
SITUATION: A worker notifies management that he can't comply with hospital policy requiring all workers to get…
Compliance Perspective: Keeping Employee from Damaging Your Lab on Social Media
From - G2 Compliance Advisor
In the cyber age, protecting your lab from the potential threat posed by employee blogging, tweeting, Instagramming and…
Compliance Perspectives: Genetic Test Labs Face Growing Risk of Medical Malpractice Liability
From - G2 Compliance Advisor
Compliance managers of lab involved in the $3 billion consumer-based genetic testing business need to safeguard their flank against a growing legal risk…
The 10 Policies You Need to Stop Lab Employee PHI Breaches
From - G2 Compliance Advisor
Safeguarding personal health information (PHI) data from hackers, identity thieves and other cyber threats isn't just a legal obligation but…
Compliance Perspectives: The 12 Things to Include in Your Drug & Alcohol Testing Policy
From - G2 Compliance Advisor
No! No! No! The truth is that state laws on marijuana use and possession have little to no direct impact on workplace drug policies and the testing methods used…
PAMA Reimbursement: CMS Tells Labs How to Secure ADLT Status for New Tests
From - G2 Compliance Advisor
Although the 2018 market-based Clinical Laboratory Fee Schedule (CLFS) is officially in effect, implementation of the new…
Compliance Perspectives: New Stark Rules Offer Some Physician Kickback Relief but Not Nearly Enough
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Compliance Perspectives: Avoid Privacy Pitfalls in Pandemic Planning & Response
From - G2 Compliance Advisor
Although not officially a pandemic, the 2018 flu season has been the worst in nearly a decade. So why not use it as an opportunity to review your lab's pandemic preparations…
Compliance Perspectives: Can You Require Lab Workers to Get a Flu Shot?
From - G2 Compliance Advisor
Bottom Line on Top: Yes, a mandatory flu vaccination policy is legally justifiable as long as…
5 Common Sexual Harassment Policy Blind Spots & How to Fix Them
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