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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
FDA Watch: Monkeypox, COVID-19, and MDD Tests
While new test approvals were scarce in October, they were particularly impactful; here are three approvals you should know about.
Getlabs Continues In-Home Phlebotomy Services Advance
The Miami-based startup has secured major in-home phlebotomy services contracts from some of the nation’s biggest lab companies.
Labs in Court: Could Elizabeth Holmes Get a New Trial?
In this month’s roundup of key lab-related cases, a bizarre twist in the Theranos saga leads to a slim chance of a mistrial.
November 2022 Enforcement Scorecard: UDTs and Genetic Tests
Most of the recent settlements and enforcement actions involving labs related to medically unnecessary UDTs and genetic tests.
How to Use and Report ICD Codes
An overview and general briefing on some of the most common ICD codes concerns for labs.
Compliance Tool: Whistleblower Non-Retaliation Policy
How to create a written policy banning retaliation for whistleblowing and for investigating retaliation complaints.
When Qui Tam Retaliation Lawsuits Get Tricky
What happens when a compliance officer is the whistleblower in a qui tam retaliation lawsuit?
Model Policy on Employee Time Theft
This useful template can be used to develop a clear written policy on time theft for your lab in order to help prevent it.
Managing Lab Staff: How to Crack Down on Employee Time Theft
Six common forms of time theft to be on the lookout for, and how lab leaders can stop each one.
Lab Institute Who’s Who: Danielle Tangorre
Learn about the current state of the No Surprises Act, challenges in compliance, and how to navigate the law.