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ISO 15189 accreditation

ISO 15189 accreditation is the gateway to the effective use of the quality management system (QMS) that is an integral part of all ISO standards. These standards range from the basic ISO 9001 to ISO 15189–Medical Laboratories and ISO 17025–Competence of Testing and Calibration Laboratories.

ISO 15189 specifies the quality management system requirements particular to medical laboratories. ISO 15189 is one of the fastest growing international quality standards in the world.

Clinical laboratories and pathology groups experience many benefits by achieving ISO 15189 accreditation. Use of quality management systems by innovative clinical laboratories and pathology groups enables them to drive impressive gains in quality, customer satisfaction, and financial performance. This is a key development at a time when medical laboratory budgets are shrinking and more cuts in lab test prices are expected.

As explained by MedLab, ISO 15189 accreditation also reduces risks, encourages the sharing of best practices and stimulates innovation. For payers and healthcare providers, accreditation is a tool that provides assurance that clinical lab services are safe, reliable and good value for patients. It also provides a mechanism for measuring quality improvements and supporting consistency.

For patients, accreditation gives confidence that the services they receive are competent and safe, which can be a significant selling point for a medical laboratory.

One of the main benefits of ISO 15189 accreditation is that it is globally recognized. A series of Mulitlateral Mutual Recognition Arrangements within the International Laboratory Accreditation Cooperation (ILAC) means that laboratories accredited to ISO 15189 will have their certificates and test reports accepted in over 80 different economies across the world, representing 95% of global GDP.

The accreditation to ISO 15189 is in addition to CLIA ‘88 accreditation and does not replace it.

Anyone can self‐declare competence in offering ISO 15189 accreditations. However, organizations such as the American Association of Laboratory Accreditation (A2LA), the College of American Pathologists (CAP) are among the leading accreditors for ISO 15189 in the U.S.

Accreditation is also done by the Joint Commission, College of American Pathologists, AAB (American Association of Bioanalysts), and other state and federal agencies.

A2LA offers accreditation to clinical testing laboratories in 34 specialties and subspecialties. A2LA is also the only accreditor in the United States that is recognized internationally.

The CAP says it is the largest and most experienced accreditor in the world in the specialty of medical laboratory accreditation, leading and enhancing laboratory accreditation for more than 50 years. Pathologists from CAP have been instrumental in crafting the ISO 15189 standard.

ARUP Laboratories Earns CAP’s ISO 15189 Accreditation

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

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 Laboratory Division Combines Lean with ISO 15189

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

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

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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Labs Share Successes in Delivering More Value

CEO SUMMARY: As the number of accountable care organizations and patient-centered medical homes grows monthly, a handful of innovative labs are seizing the opportunity to develop and deliver lab testing services that add more value to physicians and patients. These early-adopter labs reco…

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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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