LEARNING
Research & News
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...
PAMA Reporting Delayed Another Year as a Permanent Fix is Found
Good news for labs this month! The potential cuts to Clinical Lab Fee Schedule (CLFS) and changes in test reimbursement due to the Protecting Access to Medicare Act (PAMA) have been delayed until 2025. This is the fifth time Congress has stepped in...
How to Determine Complexity Designation for Lab Testing
Through clinical laboratory tests, healthcare providers can diagnose specific diseases or conditions, monitor patient health, and make decisions for patient care. The tests themselves undergo evaluation that includes ratings for the complexity of...
Seven Most Common and Costly Laboratory Compliance Issues
While there are 18 areas of lab business that are most targeted by the OIG, CMS, and DOJ for investigation, most lab investigations will focus on one of the seven mentioned below. If your lab is selected, odds are the investigation will focus on...