ARUP Laboratories Earns CAP’s ISO 15189 Accreditation

By Joseph Burns | From the Volume XXIV No. 5 – April 3, 2017 Issue

CEO SUMMARY: Being accredited to this internationally recognized standard for quality and competence communicates to clients and prospective clients that one of the nation’s largest clinical labs is committed to the highest standards of quality. Clients already knew about that commitmen…

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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…

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Henry Ford Health System Labs Show How Lean Methodology in Healthcare Increases Revenues

By Mary Van Doren | From the Volume XXIII No. 3 – February 29, 2016 Issue

EXECUTIVE SUMMARY:  Here’s a major accomplishment by the lab division of a nationally-recognized health system that has gone unreported until this DARK REPORT intelligence briefing. This article explains how using the quality management system of ISO 15189 and the Lean methodology in …

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Henry Ford Health System Laboratory Division Combines Lean with ISO 15189

By Joseph Burns | From the Volume XXIII No. 3 – February 29, 2016 Issue

CEO SUMMARY: As healthcare transitions away from fee-for-service payment and adopts new models of reimbursement, every clinical lab will need to deliver more value with its lab testing services. At Henry Ford Health System in Detroit, the laboratory division has blazed a path of improving…

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December 7, 2015 Intelligence: Late Breaking Lab News

By Robert Michel | From the Volume XXII, Number 17 – December 7, 2015 Issue

Last week, a joint laboratory accreditation agreement was announced by AABB and the American Association for Laboratory Accreditation (A2LA). The two associations will now collaborate to allow labs to obtain three assessments under one effort, including AABB accredit…

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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…

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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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ISO 15189 Accreditation Earned by Spectra Labs

By Robert Michel | From the Volume XVII No. 9 – June 21, 2010 Issue

CEO SUMMARY: Spectra Laboratories Inc., recently announced that it had earned accreditation to the ISO 15189:2007 standard, following an assessment by a team from the Association for Laboratory Accreditation (A2LA). Spectra is a high-volume laboratory that serves renal patients. …

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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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Explaining Certification Versus Accreditation

By Robert Michel | From the Volume XVI No. 16 – November 23, 2009 Issue

CEO SUMMARY: Early signs are that the quality management systems (QMS) most likely to find favor with hospitals and clinical laboratories in the United States will be those that meet standards developed by the International Organization for Standardization (ISO). Many hospitals and clinic…

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