TAG:
proficiency testing
FDA Official Outlines Need for Federal Regulation of LDTs
AT A CONGRESSIONAL BRIEFING LAST WEEK, a federal official charged with regulating laboratory-developed tests made the case that LDTs are inconsistently reliable and thus put patients at risk, according to MedPage Today. “If you take the same patient sample and you send it to different la…
Why Theranos Is a Big Test for CMS and CLIA
OFFICIALS AT THE FEDERAL CENTERS FOR MEDICARE & MEDICAID SERVICES are at what may be the most important crossroads in the history of clinical laboratory regulation since Congress passed the CLIA 1988 legislation. Will CMS pursue the severe sanctions it disclosed to Theranos, Inc.,…
Washington Post: Theranos Approached Military in 2012
SINCE THE WALL STREET JOURNAL published its exposé of Theranos Inc. in October, other media outlets have published the findings of their own investigations into various aspects of the lab company’s practices. One example is the disclosure by The Wall Street …
WSJ ‘Sticks’ Theranos, Raises Serious Questions
CEO SUMMARY: Following months of investigation, reporter John Carreyrou of The Wall Street Journal published back-to-back reports about aspects of Theranos that the…
Medi-Cal to Cut Lab Pay on July 1 by 25% to 30%
CEO SUMMARY: Since 2011, state officials in California have aggressively cut laboratory testing fees for Medi-Cal, the state’s Medicaid program. Now state officials say they will implement a new methodology next month for determining lab testing fees. The new methodology is based…
March 30, 2015 Intelligence: Late Breaking Lab News
Last Friday, at Geisinger Medical Center in Danville, Pennsylvania, members of the health systems’s authority board were given tours of the new $63.4 million clinical laboratory facility. It is scheduled to open on May 4 and will feature the latest state-of-the art analyzers and lab automation system…
July 21, 2014 “Intelligence: Late Breaking Lab News”
Consolidation of private pathology group practices continues. On July 8, NeoGenomics of Fort Myers, Florida, announced that it had acquired Path Logic of Sacramento. Then, one day later, Incyte Diagnostics of Spokane, Washington, disclosed that it wa…
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…
Quality Assurance Regs to Tighten for UK Labs
CEO SUMMARY: In the United Kingdom, a window of opportunity has opened for improving the quality assurance activities of pathology and histopathology laboratories. Last week, at the Frontiers in Laboratory Medicine conference, the newly-published “Pathology Quality Assurance Review” w…
Nation’s Lab Innovators Attack Systemic Errors
CEO SUMMARY: One keynote speaker at this year’s Lab Quality Confab meeting tackled the sensitive subject of recurring bad quality within the lab and the costs associated with it. Lucia M. Berte, MA, MT(ASCP), showed a rapt audience how many sources of recurring bad quality exist and why…
CURRENT ISSUE
Volume XXXII, No. 9 – June 23, 2025
In part one of an analysis about the state of AI in clinical laboratories, The Dark Report explores how frontline workers, especially younger ones, are using AI tools like ChatGPT far more than lab leaders. Recent reports elsewhere in the business world show executives underestimate staff AI use, raising concerns about a leadership gap in tech adoption. Clinical lab leaders must get more familiar with AI use cases. Also, in this issue of The Dark Report, there is discussion on how Medicaid cuts may affect clinical labs, an examination of the lab industry fallout from CLIAC termination, an analysis of AMP’s reports that provide crucial insights for Hiring Managers, and notes that regional health systems are new dominant players in M&A.
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