Laboratory-developed tests (LDTs) are a powerful tool for in vitro diagnostics. Your clinical lab can develop and perform its own validated LDTs to provide proper patient care. Read on to find out more about lab developed tests and how they work. Commercial...
Lighthouse Lab Services is the industry leader for starting and growing medical laboratories. We give lab start-ups a firm foundation in six steps: initial consultation, resources allotment, credentialing, staffing, implementation, and launch. Find out more about some...
In a win for laboratory innovation, the VALID Act, which would have created a new risk-based framework for regulating lab developed tests (LDTs), was excluded from the year-end omnibus spending package recently finalized by Congress, meaning the legislation...
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. Learn more about these...
Before your upcoming CLIA, COLA, or CAP inspection, hire a clinical lab consultant to identify deficiencies in your lab. Discover the importance of inspection preparation consultations. Prepare To Pass Inspection It’s critical for a clinical laboratory to meet...
UPDATE: Cuts for Labs, Pathology Again Proposed in 2024 MPFS The 2023 Medicare Physician Fee Schedule Final Rule was released by CMS late Thursday, Nov 3. After two consecutive years of Congress delaying a number of anticipated reimbursement cuts due to the impact of...
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