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.

OIG Work Plan Monthly Review: January 2018

By Glenn S. Demby | Jan 29, 2018 | 1 min read

From - G2 Compliance Advisor
Opioid drug-related issues continue to command the lion's share of OIG Work Plan attention, including two of this month's six new items. While none of the new…

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Brief Your CEO: After 36 Years, CLIA Comes Under CMS Review

By Glenn S. Demby | Jan 22, 2018 | 1 min read

From - G2 Compliance Advisor
Even as your lab makes the transition to the new, supposedly market-based PAMA Medicare Part B fee schedule for tests, big changes may be in store for another rock of…

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Emergency Staffing ABCs

By Glenn S. Demby | Jan 22, 2018 | 3 min read

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
When I was growing up near Buffalo, New York, experiencing two snow storms in three weeks was no big deal; in fact, it was rather commonplace. When I…

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Case of the Month: Feds Turn Up the Heat on False Billing of Nuclear Stress Tests

By Glenn S. Demby | Jan 16, 2018 | 1 min read

From - G2 Compliance Advisor
While the feds have made urine drug testing of opioid drug patients their number one target for lab-related False Claims Act (FCA) charges this year, nuclear stress tests …

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You Make the Call: Self-Disclosing Non-Compliant Arrangements with Large Physician Groups

By Glenn S. Demby | Jan 9, 2018 | 1 min read

From - G2 Compliance Advisor
SITUATION
Fictional Med (FM), a large physician-owned clinic, is one of your lab's biggest customers. So your heart sinks when…

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