TAG:
proficiency testing
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…
Hospital Lab Takes CMS To Court in CLIA Case
CEO SUMMARY: A California hospital challenged CMS in federal court over the threatened loss of its lab’s CLIA certificate. CMS threatened to revoke the certificate in 2007 and stop paying the hospital’s Medicare and Medi-Cal lab bills. In January, Victor Valley Community Hospital won …
Growing NeoGenomics Offers FISH Test TC/PC
CEO SUMMARY: This specialty lab testing company now has laboratories in Fort Meyers, Florida; Nashville, Tennessee; and Irvine, California. It recently beefed up its executive ranks and is adding to its menu of genetic and molecular assays. In December, 2006, NeoGenomics …
CDC Seeks to Identify Best Laboratory Practices
CEO SUMMARY: To advance the goal of enhancing the practice of laboratory medicine, the CDC has organized two teams of laboratory experts. They will study best practices and proficiency testing in medical labs nationwide. Such approaches as lab standards, voluntary reporting of adverse eve…
Key Trends Drive Change for Clinical Laboratories
CEO SUMMARY: Technology plays an ever-growing role in reshaping the organization and operation of clinical laboratories. New technologies figure prominently in THE DARK REPORT’S 2007 list of key trends in the clinical laboratory industry. Technological advances in instr…
Victorville Community Hospital, Quest Diagnostics, ASCP, MIME
ASCP ACQUIRES MIME’S CYTOLOGY TRAINING AND PROFICIENCY TESTING IT WAS A BIG BREAK for pathologists and cytotechnologists involved in Pap testing. In a deal announced at the end of February, the American Society for Clinical Pathology (ASCP) has acquired “the complete cyt…
Congressional Bill Introduced On Cytology Proficiency Testing
THERE’S A NEW CHALLENGE to the near-monopoly on cytology proficiency testing held by Midwest Institute of Medical Education(MIME) of Indianapolis, Indiana. Last Friday, the College of American Pathologists (CAP) announced a new bill in the House of Representatives…
“July 11, 2005 Intelligence: Late Breaking Lab News”
There’s been strong growth at two companies featured in Fortune Magazine’s 2005 list of “America’s Fastest-Growing Small Public Companies.” Ventana Medical Systems, Inc. earned a ranking as number 28 on the list. Bio-Reference Laboratories, Inc. was ranked …
International Tempest in Lab Industry Teapot
MAYBE ALL OF US IN THE LABORATORY PROFESSION GOT A GOOD LESSON in the deficiencies of the national and international media during the past month. I am referring to the screaming headlines last month about how four laboratory proficiency testing (PT) programs sent 4,000 laboratories virology PT kits w…
“May 9, 2005 Intelligence: Late Breaking Lab News”
Tight-lipped executives at Meridian Bioscience, Inc. have yet to speak in public on any aspect of how live H2N2 influenza virus found its way into the virology proficiency test kits it shipped to thousands of labs on behalf of four lab proficiency testing organizations. Meridian, bas…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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