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
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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
When & How to Use Changed Clinical Laboratory Consult Codes
Use of these codes has frequently raised concerns for compliance due to a lack of clarity regarding when they’re appropriate.
The 14-Day Rule & Billing Medicare for Tests on Stored Specimens
While this reimbursement rule has been in effect since 2018, it can still be quite confusing; this article provides a guide to the basics.
Court Refuses to Dismiss EKRA Charges against Former Arrayit CEO
In this month’s Labs in Court roundup, Arrayit’s former president loses his bid to have EKRA charges dismissed, and more.
Take 14 Steps to Protect Lab Staff from Workplace Violence
While rules differ by state, the basic measures required to protect employees from workplace violence are pretty much the same everywhere.
Provide Lab Staff Training on Workplace Violence and Active Shooter Events
Part of the duty to protect workers is to ensure those at risk receive proper training on what to do if an active shooter incident occurs.
Theranos In Court: Balwani Lawyers Lose Bid to Exclude Damning Evidence
Legal team’s bid to dismiss part of CMS inspector’s testimony as hearsay is denied by the Northern District of California federal court.
HIPAA vs OSHA: What to Do When Laws Collide
What happens when lab personnel’s OSHA rights to access illness and injury records seemingly clash with HIPAA privacy laws?
OIG Gives the OK to Free Genetic Testing & Counseling Arrangement
New OIG Advisory Opinion offers valuable insight into where the agency draws the line on free genetic tests.
Recent Kickback Cases Range from $300 Million Scheme to a Free Service
Of this month’s four Labs in Court cases, three involved kickbacks resulting in widely varying penalties.
Billing & Coding of Outside Pathology Consultations
A briefing of the current requirements you can use to avoid billing and coding errors at your own lab or pathology practice.
