LEARNING
Research & News
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...
Getting CLIA-Certified: Navigating the Application and Inspection Process
Securing CLIA (Clinical Laboratory Improvement Amendments) certification is a pivotal milestone for any new clinical laboratory. It signals to patients, providers, and regulators that you meet the essential standards for delivering reliable test...
The New Lab Startup Checklist: Key Milestones for a Successful Launch
Starting a new clinical laboratory can be both exciting and daunting, especially if you’re new to the nuances of this specialized field. Whether you’re transitioning from a larger healthcare organization or venturing into diagnostics from a...