Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Sequencing-Based Panel May Improve Evaluation of Thyroid Nodules
From - Diagnostic Testing & Emerging Technologies
A genetic test panel can help patients avoid unnecessary diagnostic thyroid surgeries, according to a study published Nov. 8 in…
Jail for Urine Drug Testing Kickback Co-Conspirators
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At-Home, Smartphone-Based Urine Testing Now a Clinical Reality
From - Diagnostic Testing & Emerging Technologies
In what has been called the "era of the medical selfie," at-home, smartphone-based urine testing is now a reality. In a short timeframe, the…
Feds Continue Roundup of Physicians on Receiving End of Millennium Labs Test Cups Freebie
From - National Intelligence Report
The Millennium Laboratories free point of care test (POCT) cups scandal has been described as the biggest kickback scandal involving…
OIG Monthly Work Plan Review: November 2018
From - G2 Compliance Advisor
This month, there were six new Work Plan items, two of which have implications for at least some labs…
Q&A on Lab Waste Management
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Understanding the proper separation and disposal of the various waste types generated in the lab setting is an important piece of managing the…
Free Testing Supplies to Physicians Costs Massachusetts Lab $1.374 Million
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Despite 23andMe Authorization, FDA Cautious About PGx Testing
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Ideal Age of Last Cervical Cancer Screening Depends on Test Type
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