Expert Q&A: Labs Must Take a Greater Role in Guiding Clinicians About Abnormal Data
Lee Fleisher, MD, advocates for clearer interpretation of test results by medical laboratory scientists
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Articles and Reports
FDA Watch: Could Guardant Health’s Colon Cancer Assay Be a Blockbuster?
The company is hiring at least 100 sales representatives this year to spread awareness and uptake of its recently FDA-approved Shield test
At-Home Genetic Testing: The Good, The Bad, and The Ugly
Direct-to-consumer (DTC) genetic testing has risen in popularity in recent years—but is it all it’s cracked up to be?
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.
Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Compliance Tool: Checklist for Avoiding 10 Top CLIA Deficiencies for Labs
Even the best labs can incur CLIA deficiencies when unprepared; this checklist can help your lab avoid some of the most common
10 Top CLIA Deficiencies for Labs and How to Avoid Them
Areas to address when preparing for your next CLIA inspection, based on recent data on top CLIA deficiencies
What the FTC’s New Noncompete Rule Means for Your Lab
The new rule, slated to go into effect September 4, will ban noncompete agreements for most workers, including those in the lab industry
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.
When Hiring Laboratory Sales Reps, Managers May Want to Consider Non-Sales Backgrounds
Clinical laboratory sales training expert Peter Francis shares qualities to look for when hiring laboratory sales reps
