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 catalysts for quality...
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 samples are handled to...
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 that commercial tests...
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 is method validation,...
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 results. The path to...
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 clinical background, there...
