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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
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…
How Much Time Does OSHA Have to Cite Labs for Recordkeeping Violations?
From - G2 Compliance Advisor
OSHA Recordkeeping Regulations (Section 1904.33) require labs and other employers to retain accurate illness and injury records) for 5 years…
Getting a new lab space? Design it for safety now and save thousands later
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Let me tell you a story. Once upon a time, there was a laboratory manager who worked in a hospital that was designing a new stand-alone emergency department building which would include a…
Another Decision in the HDL Case Highlights Kickback Risks of Patient Responsibility Waivers Involving Private Payers
From - G2 Compliance Advisor
The Health Diagnostics Laboratory, Inc. (HDL) and Singulex saga continues. The latest chapter involves not the labs themselves but…
5 ways to end generational stereotyping in your lab
By Dr. William A. Schiemann bio
These days, the Millennial Generation is hyped, perhaps even more than Baby Boomers were hyped in the 1950s and 1960s. As I meet with executives around the globe, there is widespread confusion and…
Brief Your CEO: Explaining How Trump Budget Will Affect Your Lab
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Labs In Court:
A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Quest to Pay $1.15 Million Case:for Self-Disclosed CMP Violations
Quest Diagnostics, Inc., New Jersey has agreed to fork over $1.151 million for a trio of…
8 Tips for Investigating Sexual Harassment
From - G2 Compliance Advisor
President Trump declared April National Sexual Assault Awareness and Prevention Month. Sexual harassment is a related problem that all employers must proactively address and…