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
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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
Does a Concierge Business Model Make Sense for Your Lab?
Factors to consider when determining if the concierge business model is best for your laboratory.
How to Regulate Workplace Romance in Your Lab
Labs and other companies need a proactive strategy for dealing with romance and fraternization between employees.
Model Conflict of Interest Policy for Employees Romantically Involved with Co-Workers
Here’s a template for a conflict of interest policy that you can adapt for your lab based on its specific situation and HR policies.
Model Workplace Romance ‘Love Contract’
Having employees involved in office romances disclose their relationship and follow key ground rules can help avoid negative impacts on the lab.
Model Workplace Romance & Fraternization Policy
It’s important to implement a policy that allows you to keep control over the potential issues romantic relationships can cause in the lab.
Courts Dismiss Two Whistleblower Lawsuits
In this month’s Labs in Court roundup, a medical device company and genetic testing company each win key victories.
Eleven Things Labs Must Know to Comply with PAMA
An overview of PAMA and key aspects lab compliance officers should be aware of to help ensure compliance.
CMS to Crack Down on Unnecessary COVID-19 Add-on Tests
Recent OIG report suggests some labs might have gamed Medicare coverage rules in 2020 by billing for unusually high numbers of such tests.
COVID-19, Genetic Tests Wipe Out Medicare Part B Lab Test Savings
Even though PAMA has slashed reimbursement rates for many tests, overall Medicare Part B spending on lab tests continues to increase.
Empowered Dx in Hot Water with FDA Again Over COVID-19 Test Kits
At the end of 2022, the agency sent a new warning letter to Empowered for unauthorized distribution of COVID-19 test kits.
