ISO 15189 Is the Goal at Avera McKennan Lab

Lab is using four years experience with Lean as cornerstone for ISO 15189:2007 accreditation

CEO SUMMARY: Now entering its ninth month on the path to accreditation under ISO 15189:2007 Medical Laboratories, Avera McKennan’s lab recently completed its “gap analysis.” This important step prepared the laboratory for the pre-assessment and assessment steps that will result in accreditation. Leaders at Avera McKennan expect this achievement will provide competitive advantage to the laboratory, as well as reinforce the health system’s public reputation for quality.

HAVING INTRODUCED LEAN INTO THE LABORATORY more than four years ago, achieving accreditation under ISO 15189:2007 was viewed as a desirable next step in the laboratory’s quality management efforts at Avera McKennan Hospital and University Health Center in Sioux Falls, South Dakota.

Competition was another important factor motivating laboratory leadership to seek accreditation under ISO 15189:2007. “I expect that having the ISO 15189:2007 accreditation will provide us with a competitive advantage,” observed Leo Serrano, Director of Laboratory Services for Avera McKennan. “Here in South Dakota, we have an unusually competitive environment, and we compete not on price but on quality of care! In fact, we compete very aggressively on quality.”

Meeting High Standards

“The market here in eastern South Dakota is the most competitive healthcare environment I’ve ever seen in my 44 years of working in healthcare,” noted Serrano. “There are two major healthcare systems: Avera and Sanford Health. Particularly in the Sioux Falls metro, these health systems have a strong community orientation toward quality and both healthcare systems are top notch. Quality is such an important element here that it’s not enough to be average, or even good.

“For that reason, Avera McKennan has pursued quality and won a number of quality awards,” he added. “We were the first magnet hospital and the first burn center in the Dakotas. We were the first and only transplant center for bone marrow, kidney, and pancreas. The Sanford system has also emphasized quality.”

Such an emphasis on quality helped Serrano gain approval for the laboratory’s goal of achieving ISO 15189:2007 accreditation. “There’s been incredible support from the administration and the board of directors at Avera,” said Serrano. “The Presentation Sisters and the Benedictine Sisters are equally supportive of our lab’s pursuit of this accreditation.

“Avera’s support for improving the quality of health services can be seen in how this proposal was approved,” he continued. “It did not require board approval. I proposed this to my boss, the COO and, in a meeting with the COO and CEO, they both said, ‘Go for it!’ A cost-benefit analysis wasn’t required because the benefits of this accreditation were obvious to an organization focused on quality.

“At Avera, we are in our fourth year as a Lean laboratory and we’ve taken Lean to the Nth degree,” Serrano continued. “We’ve also been a Lean showplace and have hosted more than 100 to 150 site visits in this facility over four years. That’s an average of more than 25 site visits a year.

“We might even have a slight advantage over other labs in that our lab is accredited not only by the College of American Pathologists (CAP), but also by the American Association of Blood Banks (AABB) and, because we are a transplant center, we have the Foundation for Accreditation of Cellular Therapy (FACT) accreditation,” Serrano said. “Several of these certifications—particularly FACT’s accreditation—mimic the ISO 15189 format in many ways. It is one reason our laboratory has very high quality results and low error rates.

“But ISO 15189:2007 accreditation takes quality to a whole different level,” he explained. “From our perspective in the lab and here at Avera McKennan, achieving accreditation under ISO 15189:2007 is the ultimate badge of laboratory quality.

“But no lab director or pathologist should underestimate the level of effort required to achieve accreditation under ISO 15189:2007,” said Serrano. “Our laboratory already had high standards of quality. However, since last January, when we started the process of applying for ISO 15189:2007 accreditation, this experience has caused us to see quality and work processes in the lab from a different and valuable perspective.

Revising Process Maps

“These insights have led us to revise and rewrite all of our policies, procedures, and documentation to make them more robust,” he added. “We also revised, distilled, and clarified our process maps, which is a significant step.

“The lab already had process maps, but they weren’t in the ISO-required format,” stated Serrano. “The extensive time spent reformatting these process maps turned out to be quite useful because it helped us identify and improve gaps in our existing processes.

Staff Involvement

“Throughout this process, we’ve been teaching our staff to understand what we were doing and how quality management is improving many aspects of our laboratory,” he explained. “This step was possibly the most challenging part of the process because we have a staff of 125 to 130 people and every individual needs to understand every part of the process.

“Sustaining this high level of communication and interaction is a significant challenge,” Serrano observed. “Laboratory staff ranges from phlebotomists, clerks, and couriers to professionals with graduate and doctoral degrees, along with all the physicians in our pathology group. Every member of the laboratory staff needs to be on the same page, which is challenging for any lab. And, because our staff pathologists are an independent group practice, we needed their commitment for the ISO 15189:2007 accreditation effort to succeed.

“This educational process is about both competency and ensuring the entire staff is involved and understands what ISO 15189:2007 accreditation means to the lab, to our patients, and to their work environment,” Serrano explained.

“Since our laboratory had completed that step, our next step was the gap assessment,” he said. “For that, the assessors talked to the staff in the lab—and did not just talk to the directors—to verify that staff conducts their work daily in a manner that follows written policies and procedures. Simply stated, the gap assessment is a check to confirm that we do and act every day consistent with the quality management methods and principles articulated and defined in our written materials.

“ISO 15189:2007 accreditation assessments are highly detailed and thorough,” stated Serrano. “We expected our lab’s gap assessment to be different from all the other inspection visits we have had over the years, and it was.

“The gap assessment is the first indication of how we measure up against the standards,” he explained. “It gave the lab an understanding of its level of readiness and what corrections need to be made to prepare for the next step, which will be pre-assessment. Pre-assessment is a dress rehearsal before the actual accreditation assessment. The gap assessment permits us to revalidate our process, make corrections, and move forward to the accreditation assessment with greater confidence.

Beyond Policies, Procedures

“For this reason, everyone on staff needs to understand the policies and procedures, the resources, and the mechanisms that we have throughout our laboratory’s operation,” he explained. “The entire ISO process focuses on operational activities.

“This is a notable difference from most other healthcare accreditations that generally involve a review of our lab’s policies and procedures to make sure we have dotted all the ‘i’s and crossed all the ‘t’s,” Serrano added. “ISO does that as well, but then ISO goes several steps further by verifying that: 1) your staff knows exactly what the policies are; 2) your staff understands why these policies are in place; and, 3) assessors confirm your lab’s staff consistently follow these procedures each day.

“For lab administrators and pathologists considering this accreditation for their laboratory, I can state that one important difference about ISO 15189:2007 is that it is not simply a paper exercise,” advised Serrano. “ISO 15189:2007 is a true, thorough, and deep evaluation of your facility to make sure that quality is ingrained in the very essence of the laboratory.”

Serrano also emphasized that it requires staff time and other resources to undertake the goal of achieving ISO 15189:2007 accreditation. “To get our laboratory to the point where we could conduct the gap assessment, I estimate that we’ve had two full-time equivalent staff on this project since January,” he said. “It’s a full-time job for our Quality Systems Manager, Sheryl Wildermuth. It’s also required considerable involvement by our Medical Director, Raed A. Sulaiman, M.D.; our blood bank Medical Director, Henry Travers, M.D.; and our technical specialists and supervisors. Of course, the entire staff has contributed an inordinate amount of time to support this accreditation effort.”

Serrano hopes that the pre-assessment and the accreditation assessment can be completed before year’s end. His laboratory is working with the College of American Pathologists (CAP) as the ISO 15189:2007 accreditation body.

“As a laboratory committed to continuous improvement, in a health system committed to quality and patient care, our decision to become accredited under ISO 15189:2007 represents our desire to move to the next higher level of performance,” summarized Serrano. “With healthcare transforming into a patient-centered care model in which outcomes are closely monitored, we want our lab to raise the competitive bar. To do that, we must be bold at introducing new quality management tools and methods that allow our lab team to achieve more.”

More Labs May Chose ISO

THE DARK REPORT observes that it is significant that Avera McKennan sees a competitive advantage in pursuing ISO 15189:2007 accreditation. While the Sioux Falls market may be different from most, it may nonetheless foretell what is to come in other regions across the United States. If laboratories in such markets need to demonstrate that they can deliver high quality lab results and lab services, then they may also opt to pursue ISO 15189:2007 accreditation.


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