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August 2026

CMS and CDC Consider Major Updates to CLIA Regulations

Lab Risk & Compliance, Laboratory Compliance, The Dark Report /

CEO Summary: CMS and CDC are weighing updates to CLIA that could reshape oversight of laboratory developed tests, AI tools, molecular testing, and clinical laboratory compliance. A healthcare attorney notes that CLIA modernization is needed, but future changes could also bring added costs for labs. Clinical laboratories could face new requirements covering laboratory developed tests […]

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CMS Proposal Could Redefine Medicare Payment for Software-Based Lab Testing

Laboratory Compliance, Laboratory Information Systems, The Dark Report /

CEO SUMMARY: The proposed 2027 OPPS rule would move certain algorithm-driven analyses off the Clinical Laboratory Fee Schedule, potentially creating a new reimbursement framework for AI-enabled diagnostics. For clinical laboratories, it could shift how reimbursement weaves into software-driven insight of diagnostic tests. Clinical laboratory leaders who are looking now for clues about future diagnostic test

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Intelligence Briefs August 2026

Lab Intelligence /

Report: Metro Areas Seeking Medical Talent Healthcare continues to dominate hiring in many of the nation’s fastest-growing job markets, creating opportunities for clinical laboratories competing for skilled talent. LinkedIn’s 2026 Cities on the Rise ranking found that healthcare ranked among the top three hiring industries in 23 of the 25 fastest-growing midsize metro areas, including

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Breaking the Traveler Cycle: A 90-Day Roadmap to Build a Sustainable Clinical Lab Workforce

Lab Intelligence, Laboratory Management, People, The Dark Report /

CEO SUMMARY: Fairbanks Memorial Hospital eliminated traveler dependence by implementing a 30-60-90-day workforce strategy centered on data analysis, internal talent development, education partnerships, and employee retention. For many clinical laboratory leaders, contracted traveling lab scientists and technicians  have become an accepted part of doing business. While travelers can provide critical short-term staffing relief, long-term dependence

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ASCP’s New Pathology Analytics Platform Aims to Improve Workflows

Clinical Laboratory Trends, Laboratory Information Systems, Laboratory Management, The Dark Report /

CEO SUMMARY: During a recent webinar, Sachin Gupta, PhD, of the American Society for Clinical Pathology demonstrated the organization’s new Performance and Diagnostics Insights (PDI)  analytics and benchmarking platform. PDI provides extensive reports based on near real-time data from laboratory information systems and other sources. The University of Nebraska Medical Center is among the early

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Datavant Touts Tokenization Approach to Protect Sensitive Data

Laboratory Information Systems, The Dark Report /

CEO SUMMARY: Labcorp’s plan to launch a platform for Alzheimer’s disease data analysis will use technology from Datavant to guard digital personally identifiable information. A key aspect is tokenization, in which patient data is encrypted but can still be matched to other datasets, such as hospital admissions. In a prior briefing, The Dark Report outlined

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How Clinical Lab Leaders Can Take Advantage of C-Suite Priorities

Clinical Laboratory Trends, Lab Intelligence, Laboratory Management, People, The Dark Report /

CEO SUMMARY: A new industry survey by Siemens Healthineers indicates that hospital executives increasingly recognize medical laboratories as vital clinical assets. However, securing capital based on that good will requires lab leaders to align diagnostic priorities with broader health system goals. Clinical laboratories typically account for 2% to 5% of total hospital operating budgets. Yet,

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CMS Proposals on Software Create a Storm for Labs

Commentary and Opinion by R. Lewis Dark, The Dark Report /

Our August 2026 issue outlines two federal requests for information (RFI) that share a theme: modernization of the clinical laboratory. And if lab leaders aren’t paying attention, they will be left behind. Look at what the Centers for Medicare & Medicaid Services (CMS) slipped into its 2027 Hospital Outpatient Prospective Payment System proposal: a brand-new

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