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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How the LDT Final Rule’s Exemptions Apply to Oncology Labs

By Scott Wallask | Nov 7, 2024 | 1 min read

Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines

A closeup image of a female laboratory assistant in PPE typing on a laptop at the laboratory bench

FDA Watch: FDA Approves Enhanced Cologuard Cancer Test

By Ron Shinkman | Nov 1, 2024 | 1 min read

Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent

An illustration of the human colon with cancerous mass.

What Labs Need to Know About Reporting Adverse Events to the FDA

By Tara Cepull, MA | Nov 1, 2024 | 1 min read

Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events

Closeup of a laboratory professional in PPE sitting at a desk with a computer monitor and filling out a form on a clipboard.

Lab Uses Billing Info of Another Lab to Get Around Payment Restrictions

By Glenn S. Demby | Jan 20, 2020 | 1 min read

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Massachusetts Practice Busted for Taking Free POCT Cups from Millennium

By Glenn S. Demby | Jan 15, 2020 | 1 min read

Case: A northern Massachusetts medical practice and Detroit pain clinic became the latest downstream providers to pay the OIG a five-figure fine to settle kickback claims in the form of accepting free point of care test cups from