Spectra Lab in Milpitas Accredits to ISO 15189

Spectra Laboratories benefits from operating ISO 15189-accredited labs on both coasts

CEO SUMMARY: Spectra Laboratories, Inc., a renal-specific testing services company with labs in New Jersey and California, announced earlier this month that the American Association for Laboratory Accreditation awarded accreditation to ISO 1589 to its laboratory in Milpitas, California. It was in May 2010 when Spectra’s laboratory in Rockleigh, New Jersey, earned ISO 15189 accreditation. Spectra is using the quality management system (QMS) of ISO 15189 to create a standardized service experience at both laboratory sites.

THERE’S A NEW CHAPTER in the ISO 15189 journey of Spectra Laboratories Inc. On December 6, it announced that its Milpitas, California, laboratory facility had successfully become accredited to ISO 15189:2007 Medical Laboratories.

The first chapter in this ISO story was written in May 2010. That is when Spectra’s laboratory facility in Rockleigh, New Jersey, earned its accreditation to ISO 15189. Spectra Laboratories is owned by Fresenius Medical Care North America, of Waltham, Massachusetts. For both laboratory locations, Spectra Labs used the American Association for Laboratory Accreditation (A2LA) as its accrediting body.

By achieving ISO 15189 accreditation at both laboratory sites, Spectra is realizing one of its major strategic business goals. “We want to deliver identical service for any specimen collected and tested at either laboratory facility,” stated Curtis Johnson, General Manager and Vice President of Spectra’s Milpitas facility.

“The quality management system (QMS) of ISO 15189 helps our laboratories at both locations to adopt common work processes and documentation,” he noted. “Having standardized processes and practices across both laboratories is important as Spectra markets its lab testing services naationally and internationally.

“Our customers also recognize that ISO 15189 accreditation from A2LA supports the quality commitments that we have to our customers,” added Johnson. “This is particularly true for our overseas customers.”

Ensuring Consistency

“Our Milpitas lab does about 21 million tests per year and has 393 employees,” observed Patricia Hui-Ng, Director of Quality and Regulatory. “The Rockleigh lab handles about 33 million tests annually. The equipment at both laboratories is nearly identical and many of the methods are the same at the two locations.”

“It was in 2005 when both labs chose to go down this path,” recalled Johnson. “Our goal was to raise the bar internally and achieve the most stringent standards that we could apply to the quality of testing services that we deliver.”

This desire to lift quality to higher levels was an important element in the management decision at Spectra Laboratories to pursue accreditation to ISO 15189. As Hui-Ng noted, state and federal requirements emphasize compliance and are, by design, set as a minimum to ensure public safety and basic quality.

Regulatory Standards

“In the United States, a lab can be accredited to, or compliant with, many different standards, just as we are,” noted Hui-Ng. “These standards are mostly all about compliance. But after compliance, how do you lift your lab to a higher standard of quality and achievement?

“ISO 15189 accreditation from A2LA was selected because its QMS goes beyond the guidance of most federal and state requirements,” she continued. “Both Spectra laboratory facilities have accreditation from The Joint Commission and accreditation from the College of American Pathology. We also are licensed in a number of states, including California, Florida, and New York.

Going Beyond Compliance

“We saw ISO 15189 and its QMS as a way to help us attain that mindset of continuous improvement and total commitment to quality,” added Hui-Ng. “This gave us the tools and the structure to help our staff meet these objectives.

“This was also a team-building journey for all managers and all employees,” emphasized Hui-Ng. “In one fashion or another, everyone took part in the effort of becoming accredited to ISO 15189. Now that we are accredited, we’re not finished. This was simply one milestone in our ongoing journey as a quality organization.”

For every clinical laboratory and pathology group that wants to perform at higher levels of performance, there is a need for a management system that can guide and support that environment. ISO 15189 has the quality management system to provide the structure and the management tools required to understand quality, to measure quality, and to improve quality.

It is for that reason that a growing number of first-adopter clinical laboratory organizations are turning to ISO 15189 accreditation as a way to realize their strategic goals of raising quality in specific ways that add value to customers and increases customer satisfaction.

Global Recognition of ISO Accreditation

BECAUSE IT PERFORMS TESTING for specimens that originate outside the United States, it was important for Spectra Laboratories, Inc., to become accredited to an international standard that would be recognized by many other nations.

“One important factor that prompted us to look into ISO 15189 was the need to support international customers, particularly for our clinical trials work,” said Curtis Johnson, General Manager & Vice President at Spectra’s Milpitas Lab.

“Spectra considered both sources that offer ISO 15189 accreditation here in the United States,” he explained. “We chose the American Association for Laboratory Accreditation (A2LA) because our labs’ accreditation to ISO 15189 through this source would be recognized internationally by all countries that also participate in this ISO arrangement.

“The broad recognition of ISO 15189 was important to us because of the business Spectra handles that originates outside the United States,” added Johnson. “In addition, our parent corporation, Fresenius Medical Care, is a German company. That gives internal value to our labs’ accreditation to ISO 15189 as well.”

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