Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry   Lab’s ‘False Positive’ Drug Test Report ≠ Defamation of Employee  Case: An Arkansas nurse got fired … [Read more...]

HIPAA Compliance: Quest Pays $195K to Settle Class Action for HIV Data Breach

Government fines, public embarrassment, loss of provider and patient trust. As if these consequences weren’t scary enough, massive PHI breaches can expose your lab to a new kind of risk: class action … [Read more...]

Compliance Corner: Must Employee Notify Lab of DUI?

QUESTION If one of our employees gets a DUI, do they have to notify us? ANSWER It depends. EXPLANATION There are at least four factors affecting whether the employee would have to come … [Read more...]

Marketing Pitfalls to Avoid: Deceptive Advertising—the Other Kind of “False Claims”

We all know that marketing activity is a breeding ground for potential lab liability. But while most labs are sensitive to the risks posed by the Antikickback Statute, Stark Law and False Claims Act, … [Read more...]

ENFORCEMENT

Quest Pays $88.7K to Settle Specimen Collection Fee Kickback Charges Against Its Subsidiary

Case: After self-disclosing, Quest has settled kickback claims against its wholly-owned subsidiary, Quest Diagnostics TB LLC, for $88,780. The OIG alleges that from June 2011 to December 2016, the lab … [Read more...]

FDA WATCH

FDA Watch: Agency Resounds the Alarm on Biotin Test Interference

In early November 2019, the U.S. Food and Drug Administration (FDA) updated a previous safety communication about the potential of biotin to significantly interfere with diagnostic tests. The … [Read more...]

TESTING TRENDS

Testing Trends: The Debate Continues Over Regular Colorectal Screening for Average Risk Adults

Should adults age 50 to 75 who are at average risk and show no symptoms of colorectal cancer have regular colorectal screening exams? Last month, a major medical journal came out against regular … [Read more...]

EMERGING TESTS

Zika Antibody Detection Tests Go from Emergency to Commercial Clearance

 Over the past several years, the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did … [Read more...]

TEST UTILIZATION

Test Utilization: ‘Cascades of Care’ Cause Wasteful, Unnecessary and Anxiety-Producing Testing

Experts estimate that $200 billion is wasted annually on excessive testing and treatment. The typical dynamic is a chain reaction: Something “comes up” on diagnostic tests or screenings and triggers … [Read more...]

EMERGING TESTS

Emerging Tests: New Genetic Tests May Be Better than PSA Screening in Assessing Prostate Cancer Risk

The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening based on their specific circumstances. The reason that the USPTF does not directly … [Read more...]


(-00000g2)