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
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Articles and Reports
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
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
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
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.
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
Understanding and Avoiding Compliance Errors
Know where labs may fall foul of compliance requirements—and discover the actions your lab can take to mitigate the risk of noncompliance
Choosing and Using the Right Compliance Solution
Factors laboratories should consider when evaluating their compliance challenges, needs, and goals to select compliance solutions
Billing and Coding: The Secrets of Effective Queries
Formulating queries that are compliant, informative, and effective—even in tricky situations.
Special Report: 5 Lab Kickback Risks Involving Incentives
Strategies to avoid compliance issues related to registries, space rentals, and other common incentives.
How to Ensure Retention of Safety Training, from Onboarding and Beyond
In order for lab safety training to be effective and lasting, it must be engaging and become part of the lab’s culture.
Compliance Tool: 8 Questions to Ask About Digital Pathology Business Arrangements
This checklist can help labs monitor their organization’s business arrangements that concern digital pathology to ensure compliance.
