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U.S. Medical Testing Laboratory Earns Second Global Accreditation For Quality And Competency

Spectra Laboratories, Inc., a leading provider of renal-specific testing services, announced today that the American Association for Laboratory Accreditation (A2LA) awarded its Milpitas, California facility an accreditation in accordance with stringent international requirements of ISO 15189:2007 Medical Laboratories – Particular requirements for quality and competence. This is the second ISO 15189 accreditation from A2LA to be earned by a medical testing laboratory in the United States. The first ISO 15189 accreditation from A2LA was awarded to Spectra’s partner laboratory in Rockleigh, New Jersey on May 20, 2010. Spectra Laboratories is a unit of Fresenius Medical Care North America (NYSE:FMS).

By fulfilling A2LA’s ISO 15189 requirements, Spectra has demonstrated its ability to meet both the technical competence and quality system requirements that are necessary to consistently deliver timely and reliable results. Furthermore, this internationally-recognized accreditation demonstrates that Spectra has established benchmarks for performance and has standardized its operational processes and procedures to best meet the needs of its clients.

Nicholas Brownlee, president, Spectra Laboratories commented, “We are very pleased to be once again awarded the A2LA ISO 15189 accreditation. It reinforces our ongoing commitment to delivering high quality services that are seamless across both our Rockleigh and Milpitas laboratories. We believe that the ISO 15189 accreditation through A2LA further validates our market leadership position as a clinical laboratory service provider and increases our visibility within the international healthcare community.”

“This milestone is a testament to the dedication and hard work put forth by each Spectra employee,” added Curtis Johnson, general manager and vice president, Spectra Laboratories (Milpitas, California). “This accreditation positions us to further demonstrate our ability to meet the growing needs of our customers and their patients,” Johnson continued.

A2LA is a nonprofit, non-governmental, public service, membership society, whose stated mission is “to provide comprehensive accreditation services for laboratories, inspection bodies, proficiency testing providers, and reference material producers.” Services are available to any type of laboratory or inspection body, product certification body, reference material provider, and proficiency testing provider, whether governmental or private. It is the largest multi-discipline accreditation body in the United States. For more information, visit www.a2la.org.

About Spectra Laboratories, Inc.

Established in 1982, Spectra Laboratories, Inc. is the leading provider of renal-specific laboratory testing services in the United States. The company’s state-of-the-art analytical equipment, automated specimen processing, and reporting applications provide more than 54 million rapid and reliable test results annually, reaching over 162,000 renal patients and 2,300 free-standing and hospital-based dialysis facilities across the United States. Spectra also supplies laboratory services to the clinical research and correctional healthcare communities through its Spectra Clinical Research and Spectra Diagnostics divisions. Fresenius Medical Care North America is the world’s leading provider of services and products for individuals undergoing dialysis because of chronic kidney failure, a condition that affects about 2 million people worldwide. For more information, visit www.spectra-labs.com.



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