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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
Medical Necessity Requirement Bites Anatomic Pathologists
By Robert Mazer bio
The DOJ has announced two separate settlements involving claims for allegedly unnecessary special stains…
Signs Point to Expansion of Provider-Initiated Personal Genomic Testing
From - Diagnostic Testing & Emerging Technologies
Since 2013 when the U.S. Food and Drug Administration (FDA) effectively stopped direct-to-consumer personal genomic testing, there has been pent up demand among healthy individuals for…
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…
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…