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”
News
The latest regulatory, legal, compliance, and technology news for labs and pathology practices.
Subscribe today for access to
Articles and Reports
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
Emergency Staffing ABCs
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
When I was growing up near Buffalo, New York, experiencing two snow storms in three weeks was no big deal; in fact, it was rather commonplace. When I…
Safety lapses continue with select agents
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
The approach of the holiday season signals the end of another year. Was this just another year in a long line of them for you in lab safety, or was it…
Employment Law Update for HR Managers October 2017
By Mike O'Brien bio
Here is my periodic update prepared for interested HR professionals trying to deal with the complex American employment laws…
FDA Reports Advances in Diagnostics Development
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the Food and Drug Administration Safety and Innovation Act, says the…
Watch Out for Resume Fraud
By Lynne Curry, Ph.D bio
You know that new laboratory assistant you just hired—the one with the terrific resume and reference? It turns out she never worked for the employers named on the resume or…
Making Laboratory Safety as Simple as ABC
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
When it comes to safety in the laboratory, there are several rules, regulations, and guidelines to keep track of from multiple organizations. If your responsibilities for lab safety are…
Role of Healthcare AI in the Lab: Today & Tomorrow
By Jason Bhan, MD, Co-Founder, Chief Medical Officer at Prognos bio
Laboratories have traditionally directed their information technology (IT) focus to support their main business of testing. The IT infrastructure they have invested in allows them to…
The New Overtime Rules are Put on Hold. What Does That Mean for You?
By Mike O'Brien bio
As most of you know by now, I'm sure, the United States Department of Labor (DOL) has finalized a new Fair Labor Standards Act (FLSA) rule that, among other things, raises the minimum salary threshold required to qualify for…