How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
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: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
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…
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…
Compliance Perspective: How to Comply with New OSHA Electronic Injury Recordkeeping & Reporting Rules
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
Brief Your CEO: Explaining How Trump Budget Will Affect Your Lab
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here