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
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
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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
Perfect Partners: Healthcare Quality and the Clinical Lab
How labs form an indispensable part of the CMS National Quality Strategy, helping to drive healthcare improvements and scientific growth.
July 2024 Labs in Court
Genetic testing related fraud was a theme in recent enforcement actions involving medical laboratories and lab testing
Becoming Proficient in Proficiency Testing
Quality expert Sten Westgard discusses the latest CLIA update: “It’s time to have performance goals built in this century”
Expert Q&A: Quality, Proficiency, and CLIA Updates
Lighthouse Lab Services chief quality officer Anna Hill offers advice on keeping your lab compliant with the latest CLIA changes.
Transitioning the Clinical Lab
What clinical laboratory professionals need to know about healthcare provision for transgender and nonbinary patients
LDTs Around the World
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions
EKRA 101: A Brief Backgrounder and How to Stay Compliant
How the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) came to be, what laboratory leaders should know about it, and how to comply
June 2024 Labs in Court
Examining DOJ and OIG investigations of labs and their owners: Recent cases show continued focus on the usual enforcement targets.
FDA Issues Four Warning Letters to Lab Companies in Less Than Two Months
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
Compliance Tool: Addressing EKRA When Selling Your Lab
Key steps to follow when selling your lab to ensure compliance with the Eliminating Kickbacks in Recovery Act of 2018 (EKRA)
