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quality management system

Benchmarking with the Best To Be a World Class Laboratory

CEO SUMMARY: This fourth installment of this special series about the laboratory value pyramid introduces “Level Four: Use Benchmarks to Achieve Best-in-Class.” This is the highest level of the four level pyramid. When a lab organization performs at this level, it will be deliver…

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Top laboratory management requires top business skills

Every lab organization should aspire to achieve the attributes of Level Four: Use Benchmarks to Achieve Best-in-Class because this is the level of performance where the lab is delivering optimal clinical value at highest quality and lowest cost. This is an effort in which the business skills…

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Gearing Up the Laboratory to Exceed Expectations of External Customers

CEO SUMMARY: This is the third installment of THE DARK REPORT’S description of the Laboratory Value Pyramid. It describes “Level Three: Deliver Value that Exceeds Expectations.” This is the level where the laboratory organization now shifts its emphasis from internal operation of…

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Achieving CLIA, ISO 15189 at Same Time with A2LA

CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the America…

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Top 10 2014 Biggest News Stories

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”

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

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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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 publis…

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Caris Life Sciences Achieves Accreditation to ISO 15189

IN DECIDING TO PURSUE ACCREDITATION TO ISO 15189: Medical Laboratories, Caris Life Sciences considered the international benefits of this designation. It was December when Caris Life Sciences of Irving, Texas, announced that it had earned accreditation to ISO 15189 from the …

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Quality Assurance Regs to Tighten for UK Labs

CEO SUMMARY: In the United Kingdom, a window of opportunity has opened for improving the quality assurance activities of pathology and histopathology laboratories. Last week, at the Frontiers in Laboratory Medicine conference, the newly-published “Pathology Quality Assurance Review” w…

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