What Labs Need to Know About Upcoming Regulatory Changes for Lab Directors
As December 2024 approaches, new regulatory changes for laboratory director requirements under the Clinical Laboratory Improvement Amendments (CLIA) will come into effect. These updates, introduced by the Centers for Medicare and Medicaid Services (CMS), aim to improve the quality and oversight of clinical laboratories. Here’s an overview of the changes, their impact on labs, and […]
Navigating the Transition: ISO 15189 Quality Requirements by December 2025
The landscape of medical laboratory accreditation is undergoing a significant transformation with the updated ISO 15189:2022 standard. This new standard, which must be fully implemented by December 2025, introduces several key changes aimed at enhancing the quality and competence of medical laboratories. In this newsletter, we will explore the major updates and their potential impact […]
Navigating the New FDA LDT Regulations: A Guide for Labs
The landscape of laboratory-developed tests (LDTs) is about to undergo a significant transformation with the FDA’s upcoming regulations. These changes, aimed at enhancing patient safety and ensuring consistency in diagnostic testing, will have profound implications for labs. Here’s what you need to know to prepare for these changes. Understanding the New Regulations The FDA’s final […]
How Technology is Revolutionizing Labs
Is your lab keeping up of falling behind?
3 Ways to Improve the Lab Staffing Crisis
Where have all the people gone?
How CLIA’s Revised Regulations Affect Your Lab in 2025
Did you know that training documents can now be shared between institutions?
The hidden crisis of staff burnout in medical laboratories
Medical labs are essential part of the healthcare system, but the significant and increasing burnout that many lab professionals are facing could have a significant impact on the quality and safety of patient care. If this problem persists, it could also impede the ability of labs to retain and recruit qualified individuals. What causes staff burnout in medical […]
Summary of changes to training, competency, and testing personnel requirements
