TAG:
accredited laboratory
CMS Gives Deemed Status to A2LA under CLIA Law
CEO SUMMARY: Quietly published in the March 25 issue of the Federal Register was a notice that CMS had granted deeming authority for CLIA to the American Association for Laboratory Accreditation (A2LA). This action gives laboratories in the United States a new choice to meet the accredita…
New Mass Spectrometry Toxicology Test Delivers Clinical Benefits
CEO SUMMARY: Researchers at the University of Colorado in Aurora used mass spectrometry technology to create a paradigm-shifting toxicology test. It uses a urine specimen and can identify 112 compounds and more than 500 illicit and brand-name drugs in a single assay. For pain management t…
Lab Testing, Pathology Is Fast-Growing in China
CEO SUMMARY: It was record attendance at the major pathology congress which took place in Hangzhou, China, last month. Because of the ongoing growth of China’s economy, the demand for healthcare—and for high-quality clinical lab and pathology testing—is rising at an accelerated pace…
French Company Buys Pittsburgh-Based RedPath
CEO SUMMARY: Here’s a deal that is all about proprietary molecular assays and access to new markets. With its purchase of RedPath Integrated Pathology, ExonHit Therapeutics, S.A., of Paris, France, gains a CLIA laboratory and access to the U.S. market, even as the new owner ope…
First U.S. Labs Nearing ISO:15189 Accreditation
CEO SUMMARY: Laboratories, hospitals, and other health-care providers in the United States will increasingly be required to adopt quality management systems (QMS) as part of their regular operational routine. This is consistent with trends in other developed countries. Several U.S. labora…
MT/MLT Distance Learning Goal of Collaboration
CEO SUMMARY: To encourage more students to pursue medical technology (MT) and medical laboratory technician (MLT) degrees, ARUP Laboratories and Weber State University (WSU) are collaborating to promote the distance learning programs offered at WSU. Online students can work any shift and …
Labs Should Prepare for Tighter CLIA Enforcement
CEO SUMMARY: Lab directors and pathologists should take notice of disturbing new developments in enforcement of CLIA regulations. During the past year, CMS officials have revoked the CLIA certification of several hospital laboratories for what are, essentially, inadvertent violations of p…
FL Medicaid Lab Bid Gets Slammed By Foes
CEO SUMMARY: Florida laboratories were caught by surprise last month when state Medicaid officials announced a 28-day process to award one lab with the state’s non-hospital Medicaid testing. To fight this RFP, a growing coalition of laboratories, lab industry trade groups, and the Flori…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.