Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
How the Opioid Crackdown Is Affecting Lab Enforcement & Test Utilization
From - National Intelligence Report
The alarming finding that a person is now more statistically likely to die of an opioid overdose than a motor vehicle crash comes from…
Cybersecurity: The 10 Things HHS Says You Should Be Doing to Stop Phishing, Ransomware and Other Threats
From - Lab Compliance Advisor
HHS published guidance on cybersecurity for healthcare organizations. Even though it's voluntary, the new HHS Guidance is significant to the extent it lays out the…
Study Showing PGx Testing Improves Depression Outcomes, Key to Myriad’s Reimbursement Strategy
From - Diagnostic Testing & Emerging Technologies
Pharmacogenomic testing (PGx) provides clinically meaningful improvement in response and remission rates for difficult-to-treat depression patients over standard of care, according to…
When Your Lab Has to Work through a Weather Emergency
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
I read a written Laboratory Emergency Management Plan, and at the end of the document there was a short section called…
HIPAA ePHI Violation Costs Colorado Hospital $111,400
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Case of the Month: Hospital Employees’ Wage Class Action Lawsuit Goes Terribly Wrong
From - Lab Compliance Advisor
It wasn't the outcome the four hospital employees envisioned when they filed their lawsuit charging the…
PreOp Point-of-Care HbA1c Screening May Cut Complications
From - Diagnostic Testing & Emerging Technologies
Point-of-care (POC) HbA1c measurements show a high level of agreement with central laboratory test in the outpatient setting…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Late December through January was fairly slow for new product launches in terms of both volume and impactful-ness. Here's a rundown of…
ASCP Agreement with G2 Broadens Member Access to Quality Pathology and Diagnostics Content
From - National Intelligence Report
Collaboration Allows ASCP to Better Meet Member Needs
ASCP has entered into an agreement with G2 Intelligence, a division of Plain Language Media LLP, a leading provider of…
Despite Vigorous Denial, Molecular Lab Pays $1.8 Million to Settle Fraud Charges
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