FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Clinical Laboratories Continue to Figure Less Prominently in New OIG Enforcement Report
From - G2 Compliance Advisor
The Office of Inspector General just published its most recent Semiannual Report to Congress. To the untrained eye, the newest OIG Report, which covers Oct. 1, 2016 through March 31, 2017, is not substantially different from…
CMS Dished Out $729.4 Million in Wrongful EHR Incentive Payments & We’re Going to Get that Money Back
From - G2 Compliance Advisor
Wrongful payments of Electronic Health Records (EHR) incentives are at the focus of two of the month's biggest stories in health care compliance. The first came down on…
The eClinicalWorks EHR Settlement—Big Fines & Unprecedented CIA Obligations
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10 Traps to Avoid When Investigating Potential Whistleblower Complaints
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Fixing a Hole in Whistleblower Retaliation Protection
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Tool: Model Hotline Allegations Investigation Procedure
From - G2 Compliance Advisor
The OIG Model Compliance Plan for Clinical Laboratories requires labs to establish mechanisms for not only receiving but promptly investigating…
Why Your Best Talent is Leaving and Four Ways to Win Them Back
By William A. Schiemann, Ph.D bio
Most leaders of companies today recognize the importance of having engaged people at work. Yet research from the Metrus Institute, Gallup, and others say that…
Employment Law Update for HR Managers
By Mike O'Brien bio
This is my periodic update prepared for interested HR professionals trying to deal with the complex American employment laws…
Medical Necessity Requirement Bites Anatomic Pathologists
By Robert Mazer bio
The DOJ has announced two separate settlements involving claims for allegedly unnecessary special stains…
