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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
OIG and DOJ Offer Tips for Evaluating Compliance Effectiveness
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23andMe Gains FDA Approval for DTC Test
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8 Traps to Avoid When Investigating a Sexual Harassment Complaint
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Watch Out for Resume Fraud
By Lynne Curry, Ph.D bio
You know that new laboratory assistant you just hired—the one with the terrific resume and reference? It turns out she never worked for the employers named on the resume or…
Avoid Liability for Commission-Based Marketing Arrangements
From - G2 Compliance Advisor
Contracts between labs and sales and marketing firms raise red flags under both the Anti-Kickback Statute (AKS) and Stark Law, especially when payment is by commission or based on…
Making Laboratory Safety as Simple as ABC
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
When it comes to safety in the laboratory, there are several rules, regulations, and guidelines to keep track of from multiple organizations. If your responsibilities for lab safety are…
CMS Exercises Enforcement Discretion for PAMA Reporting
From - G2 Compliance Advisor
As we previously reported, the Centers for Medicare & Medicaid Services (CMS) has indicated that laboratories had sought relief from the March 31 deadline for reporting applicable information under the…
CMS, OIG Reps Address Attendees at ACLA Annual Meeting
From - G2 Compliance Advisor
At the American Clinical Laboratory Association annual meeting in Washington, D.C. March 23, representatives of the Centers for Medicare & Medicaid Services (CMS) and the…
OSHA Fines Address Bloodborne Pathogen and Violence Hazards
From - G2 Compliance Advisor
Case: OSHA fined a Pennsylvania mental health hospital $32,158 for a trio of safety violations, including failing to protect nurses, medical technicians and other…
