ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
Areas to address when preparing for your next CLIA inspection, based on recent data on top CLIA deficiencies
The new rule, which goes into effect September 4, will ban noncompete agreements for most workers, including those in the lab industry.
How labs form an indispensable part of the CMS National Quality Strategy, helping to drive healthcare improvements and scientific growth.
Genetic testing related fraud was a theme in recent enforcement actions involving medical laboratories and lab testing
Quality expert Sten Westgard discusses the latest CLIA update: “It’s time to have performance goals built in this century”
Lighthouse Lab Services chief quality officer Anna Hill offers advice on keeping your lab compliant with the latest CLIA changes.
What clinical laboratory professionals need to know about healthcare provision for transgender and nonbinary patients
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions
How the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) came to be, what laboratory leaders should know about it, and how to comply
Examining DOJ and OIG investigations of labs and their owners: Recent cases show continued focus on the usual enforcement targets.