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
Florida Lab Pays $100K to Settle Claims of Violating Bioterrorism Law
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OIG Work Plan Monthly Review: July 2018
From - G2 Compliance Advisor
None of the six new items that OIG added to its Work Plan last month directly impact labs…
Former Patients Join the Legal Posse on the Trail of Theranos
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Brief Your CEO: Real Stark Law Relief Might Actually Happen
From - G2 Compliance Advisor
Fool me once, shame on you; fool me twice, shame on me.
That may have been your reaction when you first heard about the new CMS Request for Information (RFI) seeking input on ways to…
Ex-CEO of HDL Settles Bankruptcy Claims for $10 Million
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Compliance Perspectives: Genetic Test Labs Face Growing Risk of Medical Malpractice Liability
From - G2 Compliance Advisor
Compliance managers of lab involved in the $3 billion consumer-based genetic testing business need to safeguard their flank against a growing legal risk…
Where’s your lab safety manual?
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Laboratory leadership should be committed to providing a safe working environment, and they should believe their employees have a right to know…
Health Care CEO Charged with Paying Kickbacks to Pill Mill Doctor
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HIPAA Briefing: Can Patients Sue Labs for Privacy Breaches?
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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