CMS Proposes to Modernize CLIA in Broad Rule
What clinical labs need to know about virtual access, director qualifications, and more
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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: Agency Restructures Submission Protocols for Several ISH Tests
The FDA is reclassifying product codes NYQ, MVD, OWE, and PNK so they can be approved using the 510(k) submission process
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What New Prior Authorization Metrics Mean for Clinical Labs
KFF looks into payer claims denials, which continue to be scrutinized
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FDA Watch: CND Life Sciences Wins Breakthrough Device Designation for Skin-Based Neurodegenerative Test
The Syn-One assay can diagnose multiple conditions without needing a lumbar puncture
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The Cost of Not Keeping Legacy Clinical Laboratory Technology Up to Date
By not modernizing legacy systems and software, labs risk incurring hidden costs
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Clinical Lab Training Documentation Becomes More Important with CMS Revision
Third-party verification of lab personnel experience is now a CLIA requirement
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PAMA Cuts to Clinical Labs Get Brief Delay Through January 30, 2026
Bill that ended government shutdown includes provision to hold off PAMA cuts
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2026 Predictions for Clinical Labs: AI, Audits, and Increased Enforcement
How clinical laboratories should prepare for the next wave of oversight in the new year
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The Most Common Chemical Waste Management Mistakes for Clinical Labs to Avoid
How laboratory staff can steer clear of common mistakes when handling and storing chemical waste
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Chevron Doctrine’s Dismissal Has Yet to Upend Regulatory Environment
However, clinical laboratories may have more say in future laws and guidance thanks to 2024 decision
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FDA Watch: Mass Spectrometry Test Receives First Moderate Complexity Designation
Roche’s vitamin D assay includes internal quality controls that allowed it to obtain the CLIA designation
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A Primer on Who Regulates Hazardous Waste in the Lab
We explain the fundamentals of hazardous waste generation, classification, and management
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FDA Watch: BD Receives FDA Approval for Veritor, a Pandemic Staple
The assay was widely used during the early months of COVID-19 and was a significant source of revenue growth for a time
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