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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
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
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The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
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Compliance Perspectives: Private Sector Joins the Battle against Lab Fraud
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Lean Six Sigma is Not Quality
By Jennifer Dawson, MHA, LSSBB, DLM(ASCP) bio
Now before the entire industry lynches me for the sacrilege of the title of this article, let me explain what I mean. I have known Lean Six Sigma skeptics and outright haters and trust me…
Two App Marketplaces Ramping Up Consumer Genomics Offerings
From - National Intelligence Report
Two personal genome app marketplaces — Sequencing.com (San Francisco, Calif.) and Helix (San Carlos, Calif.)— are now up and running offering…
FDA Watch: Two More Zika Tests Get Emergency Use Authorization
From - Laboratory Industry Report
Zika made the FDA headlines this month, with two more tests receiving emergency use authorization…
Consortium Releases New Interoperability Standard for Lab IT Systems
From - G2 Compliance Advisor
With the release of a new information technology (IT) standard, the dream of true interoperability of electronic health care information has gotten…
Protein Patterns Investigated for Markers of Early Ovarian Cancer
From - Diagnostic Testing & Emerging Technologies
The combination of liquid chromatography and tandem mass spectrometry enabled the discovery of four biomarkers holding promise to become…
OIG Switches from Semi-Annual to Monthly Work Plan Strategy
From - G2 Compliance Advisor
New OIG Work Plans every six months are a thing of the past. In June, the agency announced plans to update its Work Plan website monthly. The self-proclaimed…
By the Numbers: Lab Injury and Exposure Data
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Finding information about the number of Laboratory Acquired Infections (LAIs) and other laboratory injuries in the United States is difficult…