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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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
Routine Mass Spectrometry in Clinical Labs: A Competitive Advantage?
How a new automated system bringing MS to routine lab testing could help set laboratories apart from their competitors
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
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
Labs in Court: Alleged Stark Law Violations Lead to $10m Settlement with DOJ
Other recent legal actions include a self-disclosure settlement and punishment for alleged improper diagnostic test add-ons
A Practical Mentoring Checklist for Clinical Labs
Steps that lab leaders, mentors, and mentees can take when establishing mentorships
Mentoring Clinical Lab Staff: Learning from Those Further Ahead
Tips for mentors and mentees in medical laboratories on how to establish these professional relationships
Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Image-Based AI Touted as a New Weapon Against Rare Cancers
Studies by Paige demonstrate the greater accuracy that artificial intelligence potentially offers for pathologists
Are We in a ‘Quademic’? COVID-19, Flu, RSV, and Norovirus Infections Surge
The pandemic may have set the stage for a jump in infections from these four nemeses
Bringing Clinical Mass Spectrometry into Routine Medical Laboratory Testing
Roche experts discuss the company’s recently launched automated solution and how it will bring mass spec to more patients
Diagnostics Pipeline: Roche’s New Cobas Liat Panel Can Test for Multiple STIs Simultaneously
The PCR-driven test provides results in about 20 minutes in non-laboratory settings
