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
56 Months’ Jail for Lab Technician Caught in Texas Toxicology Scam
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Changes in hazardous waste management: the Generator Improvement Rule
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
If you haven't heard by now, you should know that the EPA published its Generator Improvement Rule (GIR) in 2016. It is an update to the…
Surviving a Medicare Audit: Warn Lab Staffers Not to Lie to Auditors
From - Lab Compliance Advisor
As a lab compliance director, you understand the dangers of obstructing a Medicare audit. The problem is…
PacBio Settles Lawsuits with Shareholders Over Illumina Acquisition
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Case of the Month: U.S. Supreme Court Gives Whistleblowers Four More Years to Sue
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OIG Monthly Work Plan Review: May 2019
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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HIPAA Compliance: The Pitfalls of PHI De-Identification & How to Avoid Them
From - G2 Compliance Advisor
In 2016, the Australian government released medical billing records of 2.9 million people. They tried to protect patient privacy by…
Tennessee Pain Doctor Faces Jail for Opioid Abuses, Medicare Fraud
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - Lab Compliance Advisor
Case: A new DOJ lawsuit accuses a West Virginia non-profit hospital and its business consultant of seeking to dominate the Ohio Valley market by…