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
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Here's a summary of the key product launches from late April to late May, 2019…
Compliance Perspectives: How to Implement a Respiratory Protection Program at Your Lab
From - Lab Compliance Advisor
Worker exposure to infection and hazardous substances is a constant and pressing challenge for lab managers. And if yours is among the many labs where workers are required…
Atlanta Medical Group Execs Jailed for $8.5 Million Allergy Testing Scheme
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Business Best Practices: The 5 Essential Components of a Marketing Plan
From - Laboratory Industry Report
Although there's no single formula for marketing a lab, there are five basic elements a marketing plan should include&…
Partnerships, IT Solutions Improve Infectious Disease Diagnostic Stewardship
From - Diagnostic Testing & Emerging Technologies
Appropriate use of testing is becoming a greater challenge, given the growing number of available diagnostic tests and their increasing complexity&…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - National Intelligence Report
Case: One of the biggest Medicaid diagnostics fraud schemes in recent memory has resulted in multiple convictions, including&…
Brief Your CEO: Explain How New DOJ Guidance Can Get Your Lab Out of FCA Hot Water
From - Lab Compliance Advisor
New guidance from the DOJ lays out sheds light on a crucial matter that many high-ranking lab executives are forced to&…
56 Months’ Jail for Lab Technician Caught in Texas Toxicology Scam
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HPV DNA from Oral Rinse Samples May Be Prognostic Marker for Head, Neck Cancer
From - Diagnostic Testing & Emerging Technologies
Samples collected from a mouth rinse can detect human papillomavirus (HPV) DNA. These easily collected samples might provide important monitoring information for…
Changes in hazardous waste management: the Generator Improvement Rule
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
If you haven't heard by now, you should know that the EPA published its Generator Improvement Rule (GIR) in 2016. It is an update to the…