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Research & News
Henry Schein Medical Expands SolutionsHub with Colaborate
Henry Schein Medical, the U.S. medical business of Henry Schein, Inc., has expanded its SolutionsHub™ with the addition of Colaborate, a full-service management consulting firm dedicated to serving independent and hospital-based medical laboratories. Together…
Ensuring Safety and Biosecurity: Lab Design and Operational Best Practices
Within the realm of clinical diagnostics, safety and biosecurity aren’t just regulatory mandates—they’re foundational pillars that protect both lab personnel and the public. A single incident involving hazardous materials or a lapse in infection...
Staffing a Modern Lab: Recruiting, Training, and Retaining Top Talent
Behind every efficient clinical laboratory lies a team of skilled, motivated professionals who keep operations running smoothly and ensure patient safety at every turn. Even the most advanced instruments and robust quality management…
Lab Instrumentation and Technology: Choosing the Right Partners for Growth
Clinical laboratories rely on a complex ecosystem of instruments, software solutions, and vendor partnerships to deliver accurate, efficient, and timely results. Whether you’re launching a new facility or considering upgrades to accommodate growth…
Navigating CMS’s Latest Updates to Lab Personnel Requirements
It’s been over three decades since the Centers for Medicare & Medicaid Services (CMS) last significantly revised its Clinical Laboratory Improvement Amendments (CLIA) personnel requirements. With rapid advancements in laboratory…
Building a Culture of Quality and Compliance: Internal Audits & Continuous Improvement
In the clinical laboratory world, achieving regulatory compliance is only half the battle. Long-term success hinges on creating a culture of quality—an environment in which every team member takes ownership of…
Pre-Inspection Preparation: How to Ace Your Next Regulatory Visit
Navigating a regulatory inspection can be intimidating, especially for newer clinical laboratories still finding their footing. Yet with adequate preparation and a proactive mindset, inspections can become far less daunting—and even serve as...
Developing Comprehensive SOPs: The Backbone of a Compliant Laboratory
Setting up a clinical laboratory involves countless moving parts, but one element stands out as the unifying thread that holds everything together: Standard Operating Procedures (SOPs). These documents shape your lab’s daily practices, from how...
Court Strikes Down FDA’s LDT Rule: What Labs Need to Know
Laboratory Developed Tests (LDTs) are essential diagnostic tools created and performed within a single clinical laboratory. They play a critical role in patient care, allowing labs to rapidly develop tests for rare diseases and specialized needs...
Validations 101: Ensuring Your Laboratory Testing Is Ready for Prime Time
Launching new laboratory tests—or adopting advanced methodologies—carries critical responsibilities that extend beyond simply acquiring top-tier instruments and hiring skilled personnel. One of the most pivotal yet frequently overlooked processes...