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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Articles and Reports
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
How to Reduce Liability Risk for Lab Sales and Marketing
A code of conduct for sales and marketing staff is essential to allow staff to do their jobs while avoiding liability risk.
How to Explain the Current State of EKRA to Your Lab Executives
How to explain the current state of EKRA to your lab executives.
March 2023 Labs in Court: Labcorp Wins One, Settles Another
In this month’s roundup of cases involving labs, Labcorp gets one lawsuit tossed and settles another.
Six Steps for a Bloodborne Pathogens Exposure Determination
The first phase in protecting your staff is to carry out an exposure determination to figure out which of your workers are at risk.
Model Code of Conduct for Laboratory Sales and Marketing
A template for creating a general code of conduct that sets out broad parameters and ground rules for compliance.
Six Lab Sales and Marketing Compliance Problem Areas and How to Address Them
It’s imperative for labs to establish and maintain an active corporate compliance program that augments the actual scientific testing.
OIG Green Lights Free Hospital NP Services for Referring Physicians
A new OIG Advisory Opinion sheds some light on how to properly structure these arrangements in a hospital inpatient setting.
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.
