Lessons in Laboratory Compliance from a $30 Million Settlement
‘Lean lab’ setup appears to have caught the eyes of investigators
Already a member? Log in here
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
Subscribe today for access to
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
Already a member? Log in here
How to Effectively Manage Indoor Air Quality in Clinical Labs
These core steps are fundamental for protecting laboratory workers from airborne contamination
Already a member? Log in here
Attention Lab Directors: Four CLIA Updates from the Past Year to Examine
CMS tweaked its CE, documentation, and on-site visit requirements for directors
Already a member? Log in here
Prospective Changes to HIPAA Rules Would Affect Clinical Labs
With new modifications to HIPAA potentially on the horizon, we hear from experts on HHS’ proposal
Already a member? Log in here
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
Already a member? Log in here
The Cost of Not Keeping Legacy Clinical Laboratory Technology Up to Date
By not modernizing legacy systems and software, labs risk incurring hidden costs
Already a member? Log in here
Clinical Lab Training Documentation Becomes More Important with CMS Revision
Third-party verification of lab personnel experience is now a CLIA requirement
Already a member? Log in here
PAMA Cuts to Clinical Labs Get Brief Delay Through January 30, 2026
Bill that ended government shutdown includes provision to hold off PAMA cuts
Already a member? Log in here
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
Already a member? Log in here
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
Already a member? Log in here
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
Already a member? Log in here
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
Already a member? Log in here
