New Business Models for Pathology, Clinical Labs

By R. Lewis Dark | From the Volume XXIV No. 7 – May 15, 2017 Issue

EXPERTS OFTEN PROCLAIM THAT THE U.S. HEALTHCARE SYSTEM is slow to change and slow to adopt the management approaches, operational innovations, and new technologies that other industries use. One example is adoption of the quality management techniques that W. Edwards Deming and the Japanese develope…

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Much Disruption for Labs In 2016’s Top 10 Stories

By Robert Michel | From the Volume XXIII, No. 17 – December 19, 2016 Issue

CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab indust…

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Top 10 2014 Biggest News Stories

By Robert Michel | From the Volume XXI No. 17 – December 15, 2014 Issue

Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…

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October 13, 2014 “Intelligence: Late-Breaking Lab News”

By Robert Michel | From the Volume XXI No. 14 – October 13, 2014 Issue

Quality management systems (QMS) have made inroads in some of the organizations that accredit clinical laboratories in the United States to the requirements of CLIA. Last month, COLA of Columbia, Maryland, acknowledged that it had recertified to the standards of ISO 9001: 2008. The r…

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CMS Gives Deemed Status to A2LA under CLIA Law

By Joseph Burns | From the Volume XXI No. 5 – April 7, 2014 Issue

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…

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First-Mover Labs Reveal Success with Lean & QMS

By Robert Michel | From the Volume XIX No. 16 – November 19, 2012 Issue

CEO SUMMARY: There is good news for those clinical labs and pathology groups currently operating robust Lean, Six Sigma, and process improvement programs. The Institute of Medicine’s new report calls for all healthcare providers to rapidly transform themselves into ‘continuously learn…

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October 29, 2012 “Intelligence: Late Breaking Lab News”

By Robert Michel | From the Volume XIX No. 15 – October 29, 2012 Issue

OURLab and its parent company, Prost Data, Inc., of Nashville, Tennessee, entered into an agreement to be sold to Opko Health Inc., of Miami, Florida. The purchase price of $40 million will be paid as $9.4 million in cash and $30.6 million in stock. …

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ISO 15189 Accreditation Requires Specific Steps For Global Recognition

By Robert Michel | From the Volume XVII No. 6 – April 19, 2010 Issue

CEO SUMMARY: This intelligence briefing is the third in an ongoing series about quality management systems (QMS) and their role in advancing the performance of clinical laboratories and improving the quality of the testing services they provide. ISO 15189 is a set of standards for medical…

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New Clinical Lab Trends To Shape Events in 2010

By Robert Michel | From the Volume XVII No. 1 – January 4, 2010 Issue

CEO SUMMARY: In presenting this list of macro trends for clinical laboratories, several themes are in play. They range from a continued emphasis on improving lab operations to the need to acquire and deploy sophisticated information technology. During the next few years, the long…

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DNV Offers Accreditation For Both CMS and ISO

By Robert Michel | From the Volume XVI No. 17 – December 14, 2009 Issue

CEO SUMMARY: For about a year, hospitals and health systems have had a new choice for meeting the Medicare Conditions of Participation. This new choice is Det Norske Veritas (DNV). Because DNV offers a dual process for achieving Medicare accreditation and ISO 9001 certification, it brings…

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