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An in-office laboratory can provide numerous benefits to a medical practice, improving patient care, efficiency, and profitability. Here are several key advantages: Enhanced Patient Care Faster Diagnostics: Immediate access to lab results can lead to quicker diagnosis and treatment, improving patient outcomes. Convenience: Patients can have tests done during their appointment, reducing the need for...

The FDA has issued a significant final rule that changes the regulatory landscape for Lab Developed Tests (LDTs). This new rule, which takes effect on July 5, 2024, ends the agency’s long-standing practice of exercising enforcement discretion for most LDTs. The FDA now explicitly includes LDTs under the definition of in vitro diagnostic (IVD) devices...

Keeping up with CMS (Centers for Medicare & Medicaid Services) regulatory changes can be challenging due to the frequent updates and the complexity of the regulations.   Hiring a laboratory consultant who specializes in laboratory compliance can greatly enhance your lab’s ability to stay current with changing regulations. Key Considerations for Selecting the Right Consultant...

Lab tests play a crucial role in the diagnostic process by providing valuable information about a person’s health. They help healthcare professionals gather objective data about a patient’s condition, confirm or rule out potential diagnoses, monitor disease progression, and guide treatment decisions. Here are some ways in which lab tests aid in diagnosis: Screening and...

Molecular testing has revolutionized laboratory medicine and has already made a significant impact on healthcare. The future of molecular testing in the laboratory is expected to be even more promising, with continued advancements in technology and increasing demand for personalized medicine. One area of significant growth is the development of new assays that can identify...

Compliance is a vital aspect within the laboratory. Maintaining compliance is time consuming and can be difficult. Below are some of the compliance areas in the laboratory. Safety: Compliance with laboratory regulations and standards ensures that laboratory staff work in a safe environment. Non-compliance can result in accidents, injuries, and even fatalities. Compliance measures such...