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Research & News
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...
EKRA Compliance & Labs
Originally created to eliminate kickbacks in toxicology labs, the EKRA law is now being used by the Department of Justice to target various entities in healthcare, including all types of laboratories. Whether you are a research, diagnostic, or...