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How to Prevent the Top 10 CLIA Deficiencies

How to Prevent the Top 10 CLIA Deficiencies

by Dan Scungio, MLS (ASCP), SLS, CQA (ASQ) | Jul 2, 2024 | CLIA-lca, Compliance Perspectives-lca, Essential, Lab Industry Advisor

A laboratory safety expert shares the most common CLIA citations from recent lab inspections, and how your lab can avoid similar problems.

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ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas

ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas

by Ron Shinkman | Jun 28, 2024 | Essential, FDA-lca, Lab Industry Advisor

The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.

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Getting Started with the FDA’s New LDT Rule

Getting Started with the FDA’s New LDT Rule

by Michael Schubert, PhD | Jun 26, 2024 | Enforcement-lca, Essential, FDA-lca, Lab Industry Advisor, LDTs-lir, Top of the News-lir

Experts explain what the phase-in process will look like—and how labs can get ahead of the game.

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Compliance Tool: Checklist for Avoiding 10 Top CLIA Deficiencies for Labs

Compliance Tool: Checklist for Avoiding 10 Top CLIA Deficiencies for Labs

by Tara Cepull, MA | Jun 25, 2024 | CLIA-lca, Compliance-lca, Essential, Lab Industry Advisor, Tool

Even the best labs can incur CLIA deficiencies when unprepared; this checklist can help your lab avoid some of the most common

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10 Top CLIA Deficiencies for Labs and How to Avoid Them

10 Top CLIA Deficiencies for Labs and How to Avoid Them

by Tara Cepull, MA | Jun 25, 2024 | CLIA-lca, Compliance Perspectives-lca, Essential, Lab Industry Advisor

Areas to address when preparing for your next CLIA inspection, based on recent data on top CLIA deficiencies

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