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
Targeted Sequencing Panel May Aid Diagnosis of Movement Disorders
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FDA Issues Warning for ‘Over Reliance’ on Rupture of Membrane Tests
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Mailed Kits Can Up Colorectal Screening at Community Health Clinics
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With New FDA Input, Momentum for LDT Regulation Accelerating
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OIG Backs CMS on PAMA Market Rate Setting—and the Lab Industry Is None Too Pleased
From - National Intelligence Report
CMS did it right and saved Medicare a boatload of money in the process, concludes a new OIG report examining the agency's work in carrying out…
High-Sensitivity Troponin Test Rules Out Heart Attacks Faster
From - Diagnostic Testing & Emerging Technologies
Use of a high-sensitivity cardiac troponin test (hs-cTnT) may be able to more quickly determine whether emergency department patients are having…
Compliance Perspective: Keeping Employee from Damaging Your Lab on Social Media
From - G2 Compliance Advisor
In the cyber age, protecting your lab from the potential threat posed by employee blogging, tweeting, Instagramming and…
Changes in laboratory waste management
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
In the past, if a laboratory or a facility generated less than 220 pounds (or 100 kilograms) of hazardous (chemical) waste each month…
Cybersecurity: LabCorp Reports What Could Be a Major Data Breach
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Industry Report: Venture Capitalists Remain High on Healthcare
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