clia accreditation Archives

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clia accreditation

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…

First CAP 15189 Accreditation for a Children’s Hospital Lab

By Joseph Burns | From the Volume XXIII No. 13 – September 26, 2016 Issue

CEO SUMMARY: It’s now official. St. Jude Children’s Research Hospital is the first children’s hospital to earn accreditation to ISO 15189 under the College of American Pathologists. What is more interesting, however, is how lab leadership used the quality management system of ISO 15…

COLA Questions UHC on BeaconLBS Accredit Rules

By Joseph Burns | From the Volume XXII No. 6 – April 20, 2015 Issue

CEO SUMMARY: UnitedHealthcare’s ‘Laboratories of Choice’ network in Florida accepts only labs accredited by the College of American Pathologists and The Joint Commission. In March, COLA wrote to UnitedHealth to question this policy which excludes labs accredited by the five other…

Achieving CLIA, ISO 15189 at Same Time with A2LA

By Joseph Burns | From the Volume XXII No. 3 – February 17, 2015 Issue

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…

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…

ISO 15189 Accreditation Program Offered by CAP

By Robert Michel | From the Volume XV No. 3 – March 3, 2008 Issue

CEO SUMMARY: Two strong trends in laboratory management can be seen in the College of American Pathologists’ (CAP) move to offer accreditation to ISO 15189:2007. The first trend is the movement toward quality management systems such as Lean and Six Sigma. The second trend is the global …

Volume XXXI, No. 5 – April 8, 2024

The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.

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