TAG:
proficiency testing
Health Insurers Want More Data On Clinical Utility of Molecular, Genetic Tests
CEO SUMMARY: Genetic tests that lack two essentials are troublesome for the nationâs health insurers. Those essentials are clinical validity and clinical utility. During a recent webinar, two executives from major health insurers stressed the need for genetic testing labs to provide acc…
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. âIf 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 exposĂ© of Theranos Inc. in October, other media outlets have published the findings of their own investigations into various aspects of the lab companyâs practices. One example is the disclosure by The Wall Street …
WSJ âSticksâ 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 âPathology Quality Assurance Reviewâ w…
CURRENT ISSUE
Volume XXXIII, No. 1 – January 19, 2026
The Dark Report looks at the FDA’s move to reclassify Oncology companion diagnostics as Class II medical devices and considers how labs can benefit. Also, observers are concerned about the effect of PAMA cuts on rural clinical laboratories.
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