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
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
CEO SUMMARY: For labs and all healthcare providers, the risk of an audit is growing because the number of auditors seeking overpayments is rising. In their efforts to eliminate waste and make the Medicare and state Medicaid programs more efficient, federal officials have introduced several different audit programs in recent years. A consultant who helps
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
CEO SUMMARY: For years, severe penalties in cases where a laboratory has inadvertently erred in handling proficiency testing (PT) specimens have been a point of contention between the Centers for Medicare & Medicaid Services (CMS) and the clinical laboratory profession. Two bills proposed in Congress would give CMS more discretion in how it interprets the
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
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
Larry Siedlick resigned as CEO of Sunrise Medical Laboratories in Hauppauge, New York, effective June 30. It was 2007 when Siedlick and partner Pat Lanza sold their interest in the laboratory they founded back in 1972 to Sonic Healthcare, Ltd. Siedlick tells THE DARK REPORT that he will be developing two laboratory service companies. One
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
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.