ISO 15189 Accreditation Earned by Spectra Labs

Adoption of ISO 15189 and its QMS directly improves lab test quality for Spectra’s renal patients

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. It also provides clinical trial testing for pharmaceutical companies. Spectra officials stated that the laboratory wanted to adopt the quality management system (QMS) that is the foundation of ISO 15189.

EARLIER THIS MONTH, it was announced that Spectra Laboratories Inc., in Rockleigh, New Jersey, had earned accreditation to ISO 15189:2007 Medical Laboratories.
With this accomplishment, Spectra Laboratories is the first U.S.-based clinical laboratory to earn this accreditation from the American Association for Laboratory Accreditation (A2LA) in Frederick, Maryland.

Spectra Laboratories is owned by Fresenius Medical Care North America. It is a high-volume lab with more than 500 employees at the Rockleigh site, handling approximately 109,000 accessions each week and performing almost 40 million tests annually. Established in 1982, Spectra Laboratories is the nation’s largest provider of end-stage renal disease (ESRD) laboratory testing services.

Its two labs (one in Rockleigh and the other in Milpitas, California), provide laboratory testing for 168,000 renal patients in 2,300 free-standing or hospital-based dialysis facilities. Spectra also does clinical trials testing for pharmaceutical companies.

“Obtaining accreditation to ISO 15189 is significant for three reasons,” stated Chinu Jani, General Manager and Vice President at Spectra’s Rockleigh laboratory. “First, it directly improves how we serve our patients. Because our patients are on dialysis, managing this lab is very different than managing a lab working to diagnose illness in an ambulatory population.

“The patient population in our dialysis centers is very sick,” he explained. “Every patient that we serve has multiple co-morbid conditions. To support high quality care, we have to aim for ultra precision with our analytes. A 0.1 or 0.2 unit change in albumin, for example, can make a big difference in how these patients are classified. In that way, this is not just a regular laboratory. The introduction of ISO 15189 into our laboratory provides the right framework and environment to assure the highest quality across every process and activity of our laboratory.

International Recognition

“The second reason was to earn an accreditation recognized by our corporate clients and internationally,” explained Jani. “Our lab here in Rockleigh supports a clinical trial business for several pharmaceutical companies. Those companies recognize the value of our being accredited to ISO 15189.

“Further, we have a partner laboratory in Europe,” he explained. “One requirement of our partner lab is to have the ISO accreditation. Now that Spectra Laboratories is accredited to ISO 15189, it means our laboratory here, our partner lab in Europe, and the companies with whom we work all meet the same global standards for medical laboratory testing. These standards are more rigorous and demanding in their execution than those to which the average commercial lab or hospital-based laboratory is accustomed.

“By saying this, I’m not taking anything away from commercial labs or hospital-based labs,” he added. “I’m simply saying that the level of quality management and the documentation of quality management is much more rigorous in a lab accredited to ISO 15189 than it is in a lab that is not accredited to ISO 15189.

“The third reason why this accreditation is important to us relates to the basics of ISO 15189,” observed Jani. “The true areas of emphasis are Quality Management Systems (QMS) and technical competency. This requires everyone on the staff in every department to have technical proficiency in every phase of what we do, meaning pre- analytical, analytical, and post-analytical.

“It also means that the QMS is the basis for every process that we do in our laboratory,” he added. “The QMS maps out every process in the lab.

“When Spectra Laboratories started this journey in 2005, we reached out to every employee in this facility—and particularly to every one in the laboratory area—to ensure that each one could map out the processes and procedures that they do,” he said. “The QMS of ISO 15189 calls for each staff member to be, not just competent in each procedure he/she performs, but also knowledgeable on how it impacts and fits into the whole process.

“This has a practical consequence in our laboratory,” Jani stated. “Regardless of the project or activity—whether it’s processing the normal workload of tests each day or adding more instrumentation to a particular department—everyone involved looks at the processes as he/she goes about their individual tasks, and the whole lab works like a well-oiled machine.

Compliance With Every Step

“When this is done for every process every day; when there is compliance with every step in every process, the inevitable consequence is a better laboratory which is more efficient and more productive,” Jani said. “That translates to excellence in service to our clients and new heights of morale among the employees.”

Betty Lim, Spectra Laboratories’s Director of Quality Systems and Regulatory Affairs, agreed, saying, “The goal of this five-year project was not simply to pass the assessment process, earn acceditation to ISO 15189, and stop there. From the start, our goal was to adopt and apply ISO 15189 to build a strong QMS.

“Effective training and competency programs help us continuously improve and sustain the performance of our laboratory in every activity,” she continued. “Getting the accreditation, i.e., getting the stamp of approval and recognition for what we have done, is not the end of the road. The journey continues.

“There are least four major lessons we learned during this project,” noted Lim. “The first lesson is to engage the entire laboratory staff from day one. Communication and involvement are essential.

“At the start of our effort to achieve ISO 15189 accreditation, we established our ISO Core Team” stated Lim. “This was, and still is, a ten-member committee. It includes a representative from each key department in our business. The representative or ‘ISO Leader’ is the liaison between the Core Team and the staff.

All Areas Represented

“These functional areas are represented: quality systems, laboratory operations, customer service, human resources, billing and accounting, materials management, and information technology,” she said. “Because the ISO standards cover everything from pre-analytical to post-analytical, all departments involved in getting the results out the door are represented. The ‘ISO Leaders’ spread the word within each department.”

“The second key lesson is the importance of encouraging the ongoing engagement of middle management and of all laboratorians, the rank and file,” Jani agreed. “We think the best way is to consistently send the message that the laboratory is on a path to transform quality and take it to the next level.”

“The third major lesson is to have the absolute support of senior management to make this work,” explained Lim. “All leaders in the organization need to understand how ISO 15189 and the QMS underpin ongoing operations and contribute to continuous improvement in quality, in productivity, and in the integrity of the service provided.

“The fourth lesson is to start off with the necessary expertise to put your lab directly on the correct ISO path from day one,” stated Lim. “After this program launched in February 2005, we decided to go outside for a consultant and we hired Lucia Berte, the founder of Laboratories Made Better, in Broomfield, Colorado.”

“Lucia is a nationally known consultant with expertise in quality management systems,” explained Jani. “Her guidance during the first two years of our implementation of the ISO standards and QMS gave the project structure and direction. Her services were invaluable. It was a smart investment for us.

“Don’t forget that, five years ago, there was no clinical lab in the United States that had implemented ISO 15189, let alone achieved accreditation,” he added. “In that sense, we were totally on our own in learn- ing how to apply the QMS in our lab.”

“Once we established the basics of the QMS across our laboratory, we found it was important to stick with the process regardless of how long it takes,” Lim said. “During the life of this project, several other priorities required attention.

Compliance With Every Step

“For example, we implemented a new laboratory information system (LIS) during this time,” she said. “So, even though ISO 15189 was not always immediately in front of us, we did not stop working toward that goal. We kept moving forward step-by- step to embed ISO thinking in our day-to-day functions.

“Earlier this year, the ISO 15189 assessors came to the laboratory,” said Lim. “Overall, that assessment went well and we responded quickly to address the deficiencies. Led by our ISO Core Team, the staff throughout the laboratory made the necessary improvements so that our final assessment was successful.”

Several aspects of Spectra Laboratories’ ISO 15189 accreditation are noteworthy. First, as a U.S.-based division of an international healthcare corporation, it had a motive to implement a quality management system that is internationally accepted. ISO 15189 and its quality management system (QMS), as accredited through A2LA, allowed it to meet that goal.

Second, as a clinical laboratory serving a patient population with significant comorbidities, it was seeking a way to further improve the analytical accuracy and quality of the lab testing services it performs. Spectra Laboratories decided that ISO 15189 was the option that would best deliver that outcome. This may be an early sign of how ISO 15189-accredited clinical laboratories could raise the competitive bar.

ISO 15189 Accreditation Unlocks Many Benefits and Improved Processes At Spectra Laboratories

STAFF AT SPECTRA LABORATORIES INC., IS very clear on the outcomes from achieving accreditation to ISO 15189:2007.

“From its inception, ISO gave us the incentive at all levels to strive to be a top quality laboratory that produces the highest quality results and is continuously improving,” commented Maria Sarcona, Spectra’s ISO Coordinator, Quality Systems.

“Using the ‘Path of Workflow’ for our processes and procedures is now the fundamental basis for organizing projects,” she added. “The QMS of ISO 15189 emphasizes training personnel to use the step-action based procedures. It ensures that everyone follows standard operating procedures in the correct way and does not change processes at will. Having a good document management system helps sustain this compliance.

“Process mapping was a tremendous tool that aided us in focusing on standardization, paying attention to the smallest details, and ensuring validation,” continued Sarcona. “On the quality systems side, it supports us in working toward correcting errors and—more importantly—preventing errors with the use of a structured program. It also helps us sustain these improvements while keeping the patient as the primary focus.”

Spectra Labs is First Clinical Lab to Earn ISO 15189 via American Association of Laboratory Accreditation

WHEN IT EARNED ACCREDITATION to the ISO 15189:2007 standard earlier this month, Spectra Laboratories Inc., became the first medical laboratory in the United States to use the American Association of Laboratory Accreditation (A2LA) for its ISO designation.

There are two reasons why Spectra Laboratories opted for A2LA for its ISO accreditation, and both are based on international activities involving laboratory testing. First, Spectra does some clinical trails testing on behalf of pharmaceutical companies which operate in multiple countries. Second, Spectra coordinates some of these testing activities with a partner laboratory in Europe.

By earning its ISO 15189 accreditation through A2LA, Spectra Laboratories gains recognition of its quality and its quality management systems in a number of countries across the globe. That is because Frederick, Maryland-based A2LA is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA).

“For Spectra Laboratories, this means that its test and calibration data will be accepted by all international accreditation bodies that are signatories to the ILAC mutual-recognition agreement and by 46 economies around the world,” observed Ray Minnick, Accreditation Officer for A2LA. “This includes countries in Europe, Africa, Asia, Australia, New Zealand, and North, South, and Central America.”


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