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ISO 15189 (Medical laboratories — Particular requirements for quality and competence) specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardizations’s Technical Committee 212 (ISO/TC 212).

ISO 15189 focuses on the continuum of care directly connected with improved patient safety, risk mitigation and operational efficiency.

The International Organization for Standardization has released three versions of the standard. The first two were released in 2003 and 2007. In 2012, the organization released a revised and updated version of the standard, ISO 15189: 2012 (Medical laboratories – Requirements for quality and competence). The standard is often referred to without the version, simply as “ISO 15189.”

ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories. This working group included provision of advice to users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab’s role in the education and training of health care staff.

While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the clinical laboratory to patient care.

ISO 15189 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

Software solutions designed specifically for medical laboratories can aid in achieving ISO 15189 accreditation. In particular, document control software can help by improving turnaround time (TAT) for document reviews, increasing efficiency of staff and improving overall quality.

ISO 15189 is one of the fastest growing international quality standards in the world. Twenty-three countries around the world adopted the standard within a year of publication, and by 2013, the standard was adopted by medical laboratories in over 60 countries.

Québec’s Laboratory Consolidation Plan Aims to Save $13.5M

CEO SUMMARY: In the Province of Québec, an ambitious project is under-way to consolidate the clinical laboratory testing of 123 laboratories into 11 centralized lab clusters. It is one of the largest lab consolidation projects nowhappening in the world. Among the goals of this project is to improve qualityand efficiency while incurring no additional costs.

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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 commitment but now have definitive proof, ARUP said. Also, lab administrators believed that gaining accreditation

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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 lab performance specifically to enable it to add value to

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

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 healthcare allow it to absorb shrinking lab budgets while improving quality, and, at the

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December 7, 2015 Intelligence: Late Breaking Lab News

Intelligence Late & Latent 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 accreditation, ISO 15189 accreditation, and CLIA requirements. In their statement about the benefits of the new arrangement, the

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Benchmarking with the Best To Be a World Class Laboratory

laboratory management pyramid levels level 4

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 delivering substantial measurable value to all stakeholders and it will have the metrics to substantiate this value. At the same time, the performance of a level four lab can be validated by its use of recognized third-party benchmarks that show it is performing equal to the best labs in the United States and across the globe. It will also have customer survey data showing it meets and exceeds its customers’ expectations.

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