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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
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Emergency Staffing ABCs
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
When I was growing up near Buffalo, New York, experiencing two snow storms in three weeks was no big deal; in fact, it was rather commonplace. When I…
Case of the Month: Feds Turn Up the Heat on False Billing of Nuclear Stress Tests
From - G2 Compliance Advisor
While the feds have made urine drug testing of opioid drug patients their number one target for lab-related False Claims Act (FCA) charges this year, nuclear stress tests …
You Make the Call: Self-Disclosing Non-Compliant Arrangements with Large Physician Groups
From - G2 Compliance Advisor
SITUATION
Fictional Med (FM), a large physician-owned clinic, is one of your lab's biggest customers. So your heart sinks when…
Brief Your CEO: 5 Takeaways from OIG’s New Semiannual Report
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Tool: Model Sexual Harassment Policy
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5 Common Sexual Harassment Policy Blind Spots & How to Fix Them
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FDA Warns About Biotin Interference With Lab Tests
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PAMA-Geddon: Lab Industry Takes CMS to Court
From - G2 Compliance Advisor
The nearly three-year struggle between HHS and the lab industry over PAMA has entered a new phase. On December 11, the American Clinical Laboratory Association (ACLA) filed…