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
FDA Watch: Congress Kills Trump Plan to ‘Recalibrate’ User Fees
From - Laboratory Industry Report
Instead of the budget cuts the President asked for, the newly approved federal government spending plan increases FDA funding by…
How Much Time Does OSHA Have to Cite Labs for Recordkeeping Violations?
From - G2 Compliance Advisor
OSHA Recordkeeping Regulations (Section 1904.33) require labs and other employers to retain accurate illness and injury records) for 5 years…
Phone-Based Genetic Counseling Supports Healthy Genome Sequencing
From - Diagnostic Testing & Emerging Technologies
Also at the ACMG meeting, researchers from Illumina (San Diego, Calif.) reported on a pilot project conducted at the San Diego Blood Bank where…
Strategic Alliances, Partnerships & Collaborations Analysis – June 2017
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Mergers, Acquisitions & Asset Sales Analysis – June 2017
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Getting a new lab space? Design it for safety now and save thousands later
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Let me tell you a story. Once upon a time, there was a laboratory manager who worked in a hospital that was designing a new stand-alone emergency department building which would include a…
Another Decision in the HDL Case Highlights Kickback Risks of Patient Responsibility Waivers Involving Private Payers
From - G2 Compliance Advisor
The Health Diagnostics Laboratory, Inc. (HDL) and Singulex saga continues. The latest chapter involves not the labs themselves but…
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
From - Laboratory Industry Report
The big story of April wasn't any particular new deal but the apparent resolution of an old one—the Abbott-Alere merger. Deal volume remained…
FDA Sends 14 Warning Letters Regarding Cancer Products
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) continues to focus on direct-to-consumer marketing and sale of products and has issued warning letters in an effort to…
5 ways to end generational stereotyping in your lab
By Dr. William A. Schiemann bio
These days, the Millennial Generation is hyped, perhaps even more than Baby Boomers were hyped in the 1950s and 1960s. As I meet with executives around the globe, there is widespread confusion and…