Labs in Court

CLIA Lab Subject to HIPAA Not Necessarily Exempt from State Medical Privacy Law

Case: Plasma donors filed a class action claiming that a plasma donation company’s use of a donor-identification system based on a donor’s fingerprints and biometric information without consent … [Read more...]


After Nearly 3 Decades, CMS Proposes Updates to Proficiency Testing Rules

When the CLIA (the Clinical Laboratory Improvement Amendments of 1988) proficiency testing (PT) regulations were first implemented in 1992, George H.W. Bush was President, gas cost about $1.05 per … [Read more...]


Brief Your CEO: After 36 Years, CLIA Comes Under CMS Review

Brace yourself—and your C-suite—for more sweeping legal changes. Even as your lab makes the transition to the new, supposedly market-based PAMA Medicare Part B fee schedule for tests, big changes may … [Read more...]


CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency

The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA's primary role in the CLIA system is to categorize IVDs. Test … [Read more...]


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...]


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...]


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...]