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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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
Compliance Perspectives: Avoid Kickback Liability by Steering Clear of MD Processing Fees
From - G2 Compliance Advisor
Editor's Note: Two months ago, we talked about paying referring physicians a fee for collecting and processing blood, urine, tissue and…
LDTs: FDA Approves First NGS Residual Cancer Detection Test
From - National Intelligence Report
The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for…
Sequencing-Based Panel May Improve Evaluation of Thyroid Nodules
From - Diagnostic Testing & Emerging Technologies
A genetic test panel can help patients avoid unnecessary diagnostic thyroid surgeries, according to a study published Nov. 8 in…
At-Home, Smartphone-Based Urine Testing Now a Clinical Reality
From - Diagnostic Testing & Emerging Technologies
In what has been called the "era of the medical selfie," at-home, smartphone-based urine testing is now a reality. In a short timeframe, the…
Feds Continue Roundup of Physicians on Receiving End of Millennium Labs Test Cups Freebie
From - National Intelligence Report
The Millennium Laboratories free point of care test (POCT) cups scandal has been described as the biggest kickback scandal involving…
OIG Monthly Work Plan Review: November 2018
From - G2 Compliance Advisor
This month, there were six new Work Plan items, two of which have implications for at least some labs…
Q&A on Lab Waste Management
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Understanding the proper separation and disposal of the various waste types generated in the lab setting is an important piece of managing the…