LDT Regulation: New Survey Asks Readers for Their Views About Two Bills Before Congress

Survey respondents can give their opinions about the proposed VALID and VITAL acts Two bills are pending in Congress, and each is written to change the current regulatory scheme for laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs). The bills go by the acronyms of the VALID Act and VITAL Act. Many clinical laboratories offering LDTs today may be unaware of the details within each bill as currently written. An LDT is a proprietary diagnostic test developed and performed by...

Federal Prosecutors Signal That Accuracy of Theranos’ Blood Tests Will Be Centerstage in August Fraud Trial

Pregnant former Theranos CEO Elizabeth Holmes makes her first court appearance in 15 months as pre-trial maneuvering continues in court case involving clinical laboratory tests During pre-trial hearings for the August fraud trial of former Theranos CEO, Elizabeth Holmes, federal prosecutors signaled that the accuracy of Theranos’ blood tests will be center stage in their arguments. This latest installment in the continuing saga of defunct medical laboratory testing company Theranos took place...

Multiple Pathology and Other Healthcare Organizations Request CDC Include Clinical Laboratory Personnel in First Round of COVID-19 Vaccinations

CAP president maintains medical laboratory staff are ‘indispensable’ in pandemic fight and should be in ‘top tier’ for vaccination As COVID-19 vaccinations continue to roll out, the College of American Pathologists (CAP) is lobbying for clinical pathologists and medical laboratory staff to be moved up the priority list for vaccinations, stating they are “indispensable” in the pandemic fight. In a news release, CAP’s President Patrick Godbey, MD, FCAP argued for the early vaccination of...

Mayo Clinic Laboratories Used Ingenuity, Flexibility, and Teamwork to Fast-Track COVID-19 Testing Capacity, Including Hiring Hundreds of Lab Workers

As coronavirus pandemic emerged, the Minnesota reference laboratory surged its testing capacity from 2,600 to 20,000 samples per day in an effort to meet ever-increasing demand Over the past several years, medical laboratory workforce shortages worldwide have challenged clinical laboratory managers to process increasing numbers of clinical laboratory tests with fewer staff. But that did not prepare them for the Herculean task of processing millions of tests each week! According to the CDC’s...

Clinical Laboratories Need Creative Staffing Strategies to Keep and Attract Hard-to-Find Medical Technologists, as Demand for COVID-19 Testing Increases

Critical shortages in medical laboratory workers and supplies are yet to be offset by new applicants and improved supply chains. But there is cause for hope. Medical laboratory scientists (aka, medical technologists) can be hard to find and retain under normal circumstances. During the current coronavirus pandemic, that’s becoming even more challenging. As demand for COVID-19 tests increases, clinical laboratories need more technologists and lab scientists with certifications, skills, and...
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