Red Flags in Clinical Lab Operations Rise from Recent Court Cases
Guilty plea points to patient data collection, while settlement implicates an undisclosed relationship
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Articles and Reports
FDA Watch: OraSure’s Collection Device for Cobas STI Testing Receives Approval
At-home sample collections can be mailed to a clinical laboratory
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Dx Deals: Danaher Acquires StatLab in Deal Valued at More than $1 Billion
The company will fold into Leica Biosystems after the transaction closes at the end of this year
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Updates to CLIA Personnel Requirements May Lengthen Hiring Times
Changes ‘have had a significant impact on the recruitment process for laboratory directors and technical supervisors,’ recruiter says
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Clinical Lab Efficiency Gains May Be Best Achieved Through a Tailored Approach
Optimizing efficiency unfortunately is not straightforward in medical laboratories
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XiFin’s Payor Rate Transparency Monitor Helps Clinical Labs Compare In-Network Rates
The free online tool can set a foundation for renewed reimbursement strategies and contract negotiations with insurance carriers
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Recent Decision in FCA Case Has Key Implications for Labs
The decision deepens a split among circuit courts regarding how to determine liability for false claims
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MeMed Sepsis Test Gains Breakthrough Device Designation
The 15-minute assay to detect sepsis and assess its severity and risk is expected to get full FDA approval by 2026
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Dx Deals: Could Health Coaching Be a New Opportunity for Labs?
Quest Diagnostics will find out as it launches a new health coaching business that relies on lab testing, via its Pack Health subsidiary
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Reimbursement Top Challenge for Labs in 2025
ACLA president Susan Van Meter discusses some of the key issues labs faced in 2024, along with work to address these developments through 2025
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Which Recent FDA Webinars Are Most Useful for the LDT Rule?
Regulatory expert Julie Ballard shares her thoughts on the most useful resources for labs as they get ready to comply with Stage 1
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Reimbursing Genetic Counselors in the Clinical Lab
Sara Pirzadeh-Miller offers advice on overcoming the reimbursement barriers genetic counselors face in the clinical lab and beyond
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POC Testing: More FDA Approved Tests Than Ever, But Will Labs Be Reimbursed?
Revenue cycle management leaders provide their thoughts on how lab leaders may want to proceed when it comes to POC tests
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