First CAP 15189 Accreditation for a Children’s Hospital Lab

Lab leadership used ISO 15189 as challenge for the lab team to raise its already-high quality

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 15189 to help lab staff to raise the quality of lab services. The motivation was the need to be ahead of such trends as declining lab budgets, higher standards of patient care, and less tolerance for errors by patients and payers.

EARLIER THIS YEAR, the Department of Pathology at St. Jude Children’s Research Hospital in Memphis was accredited to the ISO 15189 standard under the College of American Pathologists (CAP). St. Jude is the first—and so far only—children’s hospital in the nation to achieve this accreditation.

Richard Warren, MHA, DLM(ASCP), the Administrative Director of the Department of Pathology, explained that the lab staff pursued the ISO 15189 accreditation in response to a challenge in 2012 from David Ellison, MD, PhD, who, at that time, had just recently been appointed department chairman.

“ISO inspectors were systematic and thorough in their approach, as you would expect,” he noted. “But what we didn’t expect was that the inspectors would not accept a superficial fix or a process modification that was not well thought out. This approach differs from some standard accreditation processes that may accept minimal demonstration of compliance.

“From my perspective and for our lab, the whole ISO 15189 accreditation process was not about meeting the ISO standard specifically,” stated Warren. “Rather, it was about building a foundation of processes to support our quality management system and help our staff and management provide world-class laboratory services to our patients and other customers.”

Clinical Lab Staff

The St. Jude lab has a staff of 325 FTEs, about 200 of whom work in the clinical pathology division and 125 in research. Also, the lab has 10 pathologists with subspecialties. It performs 800,000 billable tests each year and about 1.7 million reportable tests, said Warren.

“We already operated a high level, but Dr. Ellison felt that we still had opportunities to improve some of our infrastructure, our ability to communicate among our labs more effectively, and do more robust risk management,” explained Warren. “Pursuing 15189 was the path we chose to raise our level of quality to the next level. Our ultimate goal is to become a world class laboratory.

“In terms of adapting to change, probably our biggest challenge involved adopting the ISO 15189 approach to risk management,” stated Warren. “It specifies a robust way to identify the steps we could take to prevent problems before they happen and to implement the subsequent corrective actions that follow when a problem is identified.

“This is an important reason why I recommend that lab managers be able to accept input into processes from all levels of stakeholders and be flexible in how they approach compliance with these standards,” advised Warren. “Compliance cannot always be pushed down from the top. This is why we built consensus across our management team and lab staff.”

The St. Jude lab team shared three lessons from its 15189 accreditation. “The first lesson was our realization that labs seeking accreditation to ISO 15189 should carefully proceed if the management staff are averse to change,” commented Warren. “This is why we slowly pursued this accreditation.

“Lesson number two is that, even though our lab had a robust management system founded in its CLIA accreditation processes, some members of the leadership team still tended to operate independently,” he explained. “They were unaccustomed to working in a different way that is consistent with a truly integrated quality management system. This relates to the first lesson that management must be ready to accept the changes inherent with ISO 15189.

Becoming Team players

“More specifically, autonomous managers needed to become team players,” continued Warren. “Before being accredited to ISO 15189, the medical directors and the managers of each laboratory section had much autonomy in how they approached solving problems, structuring areas of compliance, or conducting validations.

“As soon as we implemented quality oversight, our directors and managers had to get used to the idea that they were subject to a higher level of scrutiny and accountability within their operations,” added Warren. “It was a big change for everyone to have a greater level of involvement in quality management within their lab sections. This quality oversight has tremendously benefited our operations by providing an ‘outsiders’ viewpoint.’

“Third was the recognition by our clinical laboratory’s managers and staff that ISO 15189 standards directly resulted in improved processes,” added Julie McGowan, MA, DLM(ASCP), CMQ/OE (ASQ), Quality Program Manager for the Department of Pathology. McGowan was hired in 2012 to head up the accreditation project. “This was particularly true for processes used by the lab staff to identify and solve problems.”

Finding problems earlier

Improved processes meant that use of ISO 15189 made it easier to identify problems earlier. “As one example, there was a new manager on the second shift where all but one or two of the staff on that shift were new employees too,” recalled McGowan. “The new manager reported that the staff was making a lot of mistakes typical of newly-hired staff.

“That told me there was something wrong with our processes,” McGowan com- mented. “After we evaluated our processes as a group, we decided to review our training program. If all members of the staff were making the same mistakes, that showed we needed to revise our training process. Once we did that, we fixed the problem.”

“Our leadership team was adaptive to change, but we grossly underestimated the level of detail and precision required to address some of the management and technical standards within 15189,” concluded Warren. “Compared to our existing rigorous quality management, ISO 15189 required us to be more specific, thorough, and precise in all of our documents and management processes.”

Contact Richard Warren at 901-595-3642 or


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