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What is Alternative Proficiency Testing? Understanding CLIA Requirements

What is Alternative Proficiency Testing? Understanding CLIA Requirements

by Alex Mitchell | Jun 3, 2025 | Adding Lab Testing & LDTs, Lab Operations & Management, Industry Insights, Clinical Laboratory

00:00 1X   Federal regulations require clinical laboratories to routinely assess the accuracy and reliability of their testing processes. But what happens when no commercial Proficiency Testing (PT) program exists for a particular analyte your lab performs? In...
Guide: Efficient Infectious Disease Testing & New Diagnostic Strategies

Guide: Efficient Infectious Disease Testing & New Diagnostic Strategies

by Alex Mitchell | May 9, 2025 | Adding Lab Testing & LDTs, Lab Operations & Management, Industry Insights, Clinical Laboratory

As infectious diseases continue to pose serious threats to public health worldwide, the demand for accurate, rapid, and scalable diagnostic testing has never been greater. From managing common infections to responding to global health emergencies, laboratories play a...
Developing a Custom Test Menu for Urine Drug Testing

Developing a Custom Test Menu for Urine Drug Testing

by lighthouselab | May 7, 2025 | Clinical Laboratory, Adding Lab Testing & LDTs, Lab Operations & Management, Tips for New Lab Owners, Industry Insights

Creating an effective toxicology urine drug test menu tailored to your practice’s patient population is a multifaceted process. It requires balancing clinical needs, regulatory compliance, and effective use of resources to ensure that testing contributes...
What Is CLIA-Waived Testing? A Guide for Physicians

What Is CLIA-Waived Testing? A Guide for Physicians

by Alex Mitchell | Apr 16, 2025 | Adding Lab Testing & LDTs, Lab Operations & Management, Tips for New Lab Owners, Industry Insights, Clinical Laboratory

00:00 1X   As more physicians explore whether to bring diagnostic testing in-house, understanding the difference between CLIA-waived and moderately complex testing is critical. Whether you’re operating a physician office lab (POL), an urgent care center, a...
FDA’s Final Rule on LDTs Vacated and New Lab Policy Updates

FDA’s Final Rule on LDTs Vacated and New Lab Policy Updates

by Alex Mitchell | Apr 8, 2025 | Adding Lab Testing & LDTs, Industry Insights, Lab Acquisitions and Transactions, Clinical Laboratory

In a rapidly shifting regulatory landscape brought on by changes from the new Trump Administration, clinical laboratories are navigating a host of challenges ranging from legal battles over testing oversight to shrinking reimbursement rates and rising operational...
How to Commercialize a Laboratory Test

How to Commercialize a Laboratory Test

by lighthouselab | Mar 10, 2025 | Clinical Laboratory, Adding Lab Testing & LDTs, Lab Operations & Management, Industry Insights

UPDATE: On May 6, 2024, FDA issued a new rule amending the regulatory definition of in vitro diagnostic (IVD) device to include laboratory-developed tests (LDTs) and ending the agency’s longstanding policy of generalized enforcement discretion. However, on March 31,...
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