Tag: clma

FDA Issues Response to Draft Legislation to Regulate LDTs

DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA authority to regulate laboratory developed and in vitro diagnostic tests. At

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January 22, 2013 “Intelligence: Late Breaking Lab News”

Not-for-profit Boston Children’s Hospital will have majority interest in a new lab testing company. Claritas Genomics will be based in Waltham, Massachusetts, and will develop genetic and molecular diagnostic testing solutions. Life Technologies Corporation is a partner in the new company. Boston Children’s Hospital is incorporating into Claritas the “expertise, assets and personnel of the

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CLMA Asks Labs for Examples of RAC Auditor Overreach

STORIES ABOUT HOW PRIVATE MEDICARE AUDITORS are overreaching in their zeal to identify fraud have caught the attention of the U.S. Senate Finance Committee. It is asking providers to submit examples of overzealous RAC auditors.

For its part, the Clinical Laboratory Management Association (CLMA) is collecting examples of recovery audit contractor (RAC) auditors behaving badly when

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Thermo Fisher, Intrinsic Bioprobes, Kaiser Permanente, UCSF, CLMA, ASCLS

THERMO FISHER BUYS INTRINSIC BIOPROBES, CONTINUES BUYING SPREE
IT’S ANOTHER ACQUISITION FOR Thermo Fisher Scientific, Inc., of Waltham, Massachusetts. It purchased Intrinsic Bioprobes, Inc., of Rochester, New York, earlier this month.

A manufacturer of immuno-enrichment and sample-preparation tools for quantitative mass spectrometry, Intrinsic Bioprobes’ products will allow Thermo Fisher to offer improved quantitative protein biomarker detection, the

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December 14, 2009 “Intelligence: Late Breaking Lab News”

In Nigeria, there is an aggressive effort underway to raise the quality of medical laboratory testing. One major element involves inspection of clinical laboratories throughout the nation by teams of laboratory professionals working with the Medical Laboratory Science Council of Nigeria (MLSCN). During 2009, MLSCN has closed 938 substandard and unregistered medical laboratories in all

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Analyzing Lab Bid Demo To Predict Its Outcome

CEO SUMMARY: After two decades of study and preparation, the Centers for Medicare & Medicaid Services (CMS) is pushing the laboratory profession toward the first pilot site in the Congressionally-mandated Medicare Clinical Laboratory Services Competitive Demonstration Project. Designed to drive down the price Medicare pays for laboratory tests, the plan CMS described at the December

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Phlebotomists in Calif. Undergoing Certification

CEO SUMMARY: State certification of phlebotomists is under way in the Golden State. By April 9, 2006, all phlebotomists in California will need to maintain state certification. This development adds complexity to laboratory management in California. However, there are no signs that other states intend to follow California’s lead in requiring certification of phlebotomists.

WHEN IT

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