ENFORCEMENT

Theranos Faces More Questions and Challenges And Ramps Up Efforts to Improve Compliance

Both the Centers for Medicare & Medicaid Services (CMS) and some high ranking Democratic Committee members had some bad news for Theranos at the start of this month. The company itself issued a … [Read more...]

ENFORCEMENT

Theranos Faces New Challenges and Increasing Federal Scrutiny

Theranos continues to face challenges concerning its Newark, Calif., laboratory as its initial response to Centers for Medicare & Medicaid Services (CMS) failed to resolve inspection issues and … [Read more...]

CLIA

CMS Issues Deficiency Letter to Theranos

Theranos is once again in the media spotlight due to negative attention it has received from a government regulatory agency. Last year, the U.S. Food and Drug Administration (FDA) released documents … [Read more...]

FDA’s 2016 Guidance Plans Include LDTs and Other Diagnostics Topics

In a series of three recent FDA Voice blog articles, the U.S. Food and Drug Administration (FDA) surveyed its accomplishments in 2015 and detailed its 2016 agenda. The FDA also separately issued its … [Read more...]

FDA and CMS Address LDT Regulation Before Energy and Commerce Committee

Last week, the U.S. House of Representatives Energy and Commerce Committee heard testimony about oversight of laboratory developed tests (LDTs) from representatives of the U.S. Food and Drug … [Read more...]

AMP Offers Proposal for Regulation of Laboratory Developed Tests

Last month in Compliance Perspectives, we highlighted the current status of the Food and Drug Administration's proposed regulation of laboratory-developed tests (LDTs). While the FDA's proposed … [Read more...]

Outcome of LDT Regulation Controversy Defies Forecasting

Few, if any, device regulatory issues are as controversial or as important as FDA's proposal to regulate Laboratory-Developed Tests (LDTs). If FDA LDT regulation does occur, it would represent the … [Read more...]

Don’t Overlook Free Resources When Preparing Your Laboratory for ICD-10

The transition to ICD-10 is approaching fast and laboratories need to ensure they are prepared. While the Centers for Medicare and Medicaid Services (CMS) has indicated in answers to Frequently Asked … [Read more...]

Don’t Overlook Varying State Requirements Applicable to Independent Clinical Labs

Through acquisition, merger, or organic growth, labs may find their operations expanding regionally or nationally. If your lab is operating facilities in multiple states or testing specimens … [Read more...]

Ohio State Medical Center Reaches Settlement Over PT Violations; Lab to Stay Open

Ohio State University’s Wexner Medical Center will pay the federal government $268,000 to settle allegations that its lab violated proficiency testing laws. The agreement will allow the lab to stay … [Read more...]


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