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
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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
Ergonomics in the Laboratory Setting
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Sometimes when I am talking about lab safety and the topic turns to ergonomics, I get an unusual reaction from the audience…
Compliance Perspectives: Feds Using Medicare Laws to Prosecute Non-Medicare Arrangements
From - Lab Compliance Advisor
Myth: Risk of federal prosecution for health fraud and abuse applies only when you deal with…
Healthcare ‘Trial of the Century’ Ends in Guilty Verdict against Esformes
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OIG Monthly Work Plan Review: June 2019
From - Lab Compliance Advisor
This month, there were seven new Work Plan items. Two of these, detailed below, may have implications for some labs…
Florida Providers Shell Out $733K+ for Self-Disclosed Lab Test Kickbacks
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Trap to Avoid: Asking Lab Employees about Their Latex Allergies
From - Lab Compliance Advisor
"Are you allergic to latex?"
It seems like a perfectly legitimate thing to ask, especially to an employee who's…
Federal Jury Finds Trio Guilty of $3.5 Million Lab Kickback Conspiracy
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Top 4 trends shaping the healthcare industry
By Leora Borgenicht bio
Before the healthcare industry can ambitiously transform to offer more accurate and personalized patient care, certain stepping stones must…
Device Company Pays Nearly $20 Million to Settle MD Bribe Claims
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Enforcement Trends: DOJ Changes to Yates Memo Make It Easier for Labs to Get Credit for Cooperating with Investigators
From - Lab Compliance Advisor
For the past five years, the DOJ has followed an enforcement policy designed to hold directors, officers and other top…