TAG:
clinical testing
Achieving CLIA, ISO 15189 at Same Time with A2LA
CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the America…
PAMA, LDTs and Theranos Top 2014 Biggest News
CEO SUMMARY: Not in recent memory has a single calendar year brought such a cascade of news stories that have the potential to affect nearly every clinical lab and pathology group in the United States. Blame it on the lack of money to fund healthcare and how it is motivating government an…
Top 10 2014 Biggest News Stories
Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…
Theranos Pursues Different Business Plan in Arizona
CEO SUMMARY: Since its big public debut in late 2013, Theranos has been the subject of keen interest and much skepticism among pathologists and clinical laboratory professionals. Theranos is expanding its presence in Phoenix, Arizona. However, as it does, it looks more like a conventional…
Ignoring Lab Industry, Theranos Goes Its Way
CEO SUMMARY: With each passing month, Theranos pulls open the curtain a bit more on its business structure and its market growth plans. Its clinical lab tests are now offered in Walgreens pharmacies in Palo Alto, California, and Phoenix, Arizona. Recent news coverage in Fortune and USATod…
Dealing with Realities of Changing Market
CEO SUMMARY: Swift transformation of the American healthcare system is causing financial challenges for those clinical labs and pathology groups that have been slow to react to these developments. At NorDx Laboratories in Scarborough, Maine, the team is following the classic five rules fo…
Caris Life Sciences Achieves Accreditation to ISO 15189
IN DECIDING TO PURSUE ACCREDITATION TO ISO 15189: Medical Laboratories, Caris Life Sciences considered the international benefits of this designation. It was December when Caris Life Sciences of Irving, Texas, announced that it had earned accreditation to ISO 15189 from the …
Mass Spectrometry Is Finding Larger Role in Clinical Labs
CEO SUMMARY: Mass spectrometry is a diagnostic technology that is transforming clinical labs and improving care at a rapid pace. The current generation of instruments is capable of supporting a faster time-to-answer and provides improved accuracy and specificity over many existing methods…
Anticipating Washington’s Next Blows to Lab Testing
CEO SUMMARY: With the advent of 2013, almost every lab was responding to some type of price cut. Clinical labs are dealing with the sequential, multi-year cuts to the Medicare Part B Lab Test Price Schedule. Anatomic pathology labs are still adjusting to the expiration of the TC Grandfath…
BRLI’s Spanish-Language Lab To Serve Hispanic Americans
THIS MONTH, Laboratorio Buena Salud, a new division of Bio-Reference Laboratories Inc. (BRLI), becomes the first national laboratory for Spanish-speaking patients. BRLI, of Elmwood Park, New Jersey, says that all services will be customized to the Hispanic community…
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.
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