Lessons in Laboratory Compliance from a $30 Million Settlement
‘Lean lab’ setup appears to have caught the eyes of investigators
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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: Zepto Life Technology Receives FDA Breakthrough Designation for Blood-Based Mold Test
Its FungiFlex assay can make determining the cause of fungal infections vastly more accurate
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How to Effectively Manage Indoor Air Quality in Clinical Labs
These core steps are fundamental for protecting laboratory workers from airborne contamination
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New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
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How to Stay Ahead of Anticipated CLIA Deficiencies
Consultant Nora Hess offers suggestions for clinical labs to navigate these problems
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FDA Watch: Natera, Valar Labs Receive FDA Clearances for Bladder Cancer Tests
Natera’s assay focuses on the need for adjuvant therapy, while Valar’s test stratifies risk of recurrence
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Four Federal Efforts to Monitor, Including RESULTS Act Progress
Other proposals aim to increase fraud enforcement, temper prior authorization, and modernize CLIA
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FDA Watch: New RAPID Coverage Pathway Would Enable Some Lab Tests to Pursue Clearance and Medicare Coverage Simultaneously
FDA-CMS collaboration aims to accelerate Medicare coverage determinations of certain medical devices
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RCM Strategies to Explore for Genetic Testing Compliance
Expert Ashley Zarling details nuances for clinical lab directors and compliance teams
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OSHA Under the Trump Administration: A Year in Review for Clinical Labs
A closer look at what changed in OSHA’s operations that could affect medical laboratories
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FDA Watch: MeMed and NG Biotech Receive FDA Breakthrough Device Designations for Rapid Infection Tests
In both cases, the diagnostic tests report results back within 15 minutes
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ADLM Calls on Feds to Regulate AI in the Clinical Lab Sector
But anti-regulatory stance taken by Trump administration could serve as a potential obstacle in the effort
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Recent MD Labs Ruling Has Implications for Test Requisitions and Commissions
A federal appeals court upheld the idea that clinical laboratories can rely on physician orders to justify medical necessity
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