Issue: Volume XXI No. 5 - April 7, 2014

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Congress Raises Stakes in Lab Test Pricing Game

EACH OF YOU READERS KNOW that there is always a story behind the story. This is particularly true in Congress and the federal government, where lobbying and influence can often have their own role in shaping how laws and regulations are written. Keep that in mind as you learn more about the new law passed …

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New Federal Law Changes How CMS Sets Lab Prices

CEO SUMMARY: CMS wanted more power to cut the prices it pays for clinical lab testing. A significant part of the lab industry wanted more transparency and consistency in how CMS established coverage guidelines and prices for new lab tests. Congress appears to have attempted to craft a law intended to support both objectives. Now, …

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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 accreditation requirements of CLIA. Founded in 1978, A2LA is …

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New ISO 15189 Book Published to Help Clinical Lab Managers

THERE IS NOW A COMPREHENSIVE GUIDE for lab executives and lab managers interested in learning more about ISO 15189:2012, the latest version of the quality management system (QMS) for medical laboratories. It is a book titled: “A Practical Guide to ISO 15189 in Laboratory Medicine” and was published last fall by a division of the …

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Whole Genome Sequencing Is Poised for Clinical Use

CEO SUMMARY: Pathologists and clinical lab managers interested in following the advances in use of whole human genome sequencing for clinical purposes should follow the money. Within weeks of obtaining FDA clearance for its MiSeqDx system and reagents, Illumina had inked major agreements with Quest Diagnostics Incorporated and Laboratory Corporation of America. Both national lab …

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April 07, 2014 “Intelligence: Late Breaking Lab News”

In the United Kingdom, the National Health Service’s (NHS) biggest consolidation of clinical laboratory services is expected to take place in May, after the government’s Office of Fair Trading said it will conduct no further investigation into the project. Six health trusts are collaborating on this project and will create a new provider organization to …

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