CEO SUMMARY: Being accredited to this internationally recognized standard for quality and competence communicates to clients and prospective clients that one of the nation’s largest clinical labs is committed to the highest standards of quality. Clients already knew about that commitment but now have definitive proof, ARUP said. Also, lab administrators believed that gaining accreditation would be one way to address concern about the FDA’s proposed regulations of laboratory-developed tests.
WITH LITTLE FANFARE or public notice, ARUP Laboratories, one of the nation’s biggest and most-respected lab companies, has earned accreditation to the ISO 15189 standard through CAP.
The accreditation was awarded in December to the lab company in Salt Lake City. It was the culmination of years of planning, implementation, and culture change.
This is a significant development in the clinical laboratory marketplace because ARUP’s adoption of the quality management system of ISO 15189 will help it raise the bar on its quality, cost-effectiveness, and ability to better meet and exceed the expectations of its lab clients and customers. As this happens, ARUP will improve its competitive position as the American healthcare system continues its transition to integrated care, value-based payment, and precision medicine.
For more than a decade, ARUP has actively used Lean, Six Sigma, and process improvement methods to help it boost quality, raise productivity, and reduce costs. To support this effort, the lab has industrial engineers, certified Lean/Six Sigma practitioners, and clinical laboratory scientists trained in promoting these techniques. These quality management professionals have spoken regularly at national meetings, including THE DARK REPORT’S Lab Quality Confab.
But any organization can only go so far in its pursuit of quality if it just uses the methods and tools of Lean and Six Sigma. The leadership at ARUP recognized the opportunity to use ISO 15189 to take the organization even further and faster down the path of quality improvement.
Moreover, “We knew people were watching to see what we did regarding 15189,” stated Jonathan Carr, ARUP’s Director of Compliance, Quality, Privacy and Risk. “There was this idea in the lab industry that the high-quality labs would pursue 15189 accreditation and the question was when. For us, the need became obvious in 2014 for three reasons.
“First, we felt that the ISO standards would help us improve and maintain our high quality at ARUP,” commented Carr. “Second the market has become more demanding. Of course, our clients want high quality and they ask for evidence of that high quality. Among the questions potential clients ask is, ‘What can you tell us about the accreditations you have?’ Actually, this question about accreditations has become an element of the bid process for prospective clients.
“Questions about accreditations come through almost as a list,” he added. “They want us to check certain boxes, such as, ‘Are you CAP accredited? Are you ISO accredited?’ Increasingly, clients ask for quality reports and customized metrics, as well as some reporting about our quality systems. ARUP’s accreditation to ISO 15189 by CAP answers those questions.
“In addition, we recognized the accreditation to ISO 15189 might mean something to potential international clients,” he added. “We occasionally engage with international entities and the value of the 15189 standard is familiar to them.
“We also felt that accreditation to ISO 15189 gave ARUP a good way of describing our quality management system,” Carr explained. “In the past, we described ourselves as being CAP-accredited and described our quality management system. But now we can use the framework of ISO 15189 accreditation to more concisely describe our system, and that sends a message to the entire clinical lab industry that we have set a high-level standard of quality.
“The third reason is that we were concerned about the uncertainty that the FDA would regulate laboratory-developed tests,” he added. “In 2014, when we started considering 15189 accreditation, the FDA had issued a proposal to regulate LDTs.
“We know the ISO standard isn’t designed to address the issues that concern the FDA about LDTs,” noted Carr. “But we thought that our lab’s adherence to the ISO standards would bring ARUP one step closer to what we thought might be coming from the FDA in terms of LDT regulation.”
The decision was made in 2014 to explore accreditation to CAP 15189. That started with the first gap assessment. “The ISO 15189 team did that assessment at ARUP in August 2014,” Carr explained. “Then, just 24 months later, in August, 2016, the accreditation assessment was done. ARUP received its certificate of accreditation on Dec. 13, 2016.
A Big problem To Solve
“The initial gap assessment was important because we didn’t actually decide to go forward with ISO accreditation until a couple of months after that first gap assessment,” he said. “We looked at the gap assessment as almost a feasibility assessment. At the time of the gap assessment, ARUP’s executive team had not yet decided whether this initiative would be a new corporate-wide commitment or not.
“Looking back on what’s happened since our accreditation, I can say that having the ISO 15189 accreditation through CAP appears to make a difference with clients and prospective clients,” Carr added. “I say that because quality is always a topic that comes up during client meetings. Clients or prospects ask about our accreditations and they are impressed, interested, and pleased to know that ARUP takes quality seriously.
“The ISO 15189 accreditation seems to give us a step up in discussions about our quality management system,” he said. “They typically know of our reputation for high quality and want to hear how we do it.
“In addition, they want to take our ideas back to their labs,” he explained. “They use ARUP as an example of how to staff their labs. They’re interested in what kind of personnel we have in our quality department, what led us to seek ISO accreditation, and what it has done for us.
“Recently, we had a client visit us here in Salt Lake City,” stated Carr. “They wanted to get their leadership onboard with starting the journey to CAP 15189. They wanted to understand 15189 and the benefits it brings. We were asked about how and why we did it and what results we’ve seen.
Hosting Lab Site Visits
“It’s gratifying to see clients have that keen interest in what we’ve done,” he added. “Many clients just see the end result of accreditation and may not appreciate the process we went through to achieve it.
“That process involved the specific sites we would prepare for accreditation and which staff members would be involved in achieving accreditation,” Carr explained. “For example, not all testing sites are included in the accreditation.
“In fact, the sites that are accredited are our main reference lab—meaning our core lab here in Salt Lake City, and the lab at the University of Utah Hospital,” he noted. “Not included are the outlying clinics that do point-of-care testing.
“Thus, we have accreditation in those labs that do our reference lab work for hospitals and other clients but we do not have accreditation in the handful of smaller labs,” continued Carr. “We have discussed seeking accreditation for those point-of-care testing labs, but we haven’t made that decision yet.”
To implement ISO’s quality management system and teach staff about the principles and methods of the QMS, ARUP organized staff resources in a specific way. “Leadership was provided by the ISO Steering Committee, which numbered 10 to 15 people,” he said. “Our existing quality team was involved and that’s about 30 people.
“At the outset, we formed at least six teams of people to address the gaps identified in the 2014 assessment,” Carr added. “Altogether, I would estimate that between 90 and 100 people were involved on all of the teams.”
Janice Pinterics, ARUP’s Quality Manager, agreed that about 90 to 100 people participated on the teams assigned to address the gaps. “Early on, we had six to seven gap teams of various sizes depending on what it would take to fix each gap,” she said. “On one team, we had 40 people. Then over time, we narrowed down the teams as we got closer to writing and revising our policies and procedures. Toward the end, we had six to 10 people on a team versus 40 or more when we started.”
Approximately 100 staff members out of a total of 3,500 employees is a small percent- age working on one project but was a large undertaking nonetheless, commented Carr.
“For this project, the staffing—meaning employee’s time—was probably the largest cost,” he said. “I can’t disclose what our budget was for the project, but the chief line item on the budget was primarily people, and some of them were the five to 10 new positions created for ISO implementation and maintenance.”
One necessary step was to get staff aligned with the goals of this project. “The implementation of ISO 15189 through CAP confirmed some of what we already knew about ARUP,” acknowledged Carr. “First, we’re an incredibly complex organization, and that made harmonization difficult.
“At the same time, we have a lot of smart, successful, and great people at ARUP who are totally dedicated to quality patient care,” he continued. “Simply by having that commitment, they saw the value in what we were doing and helped to see it through.
“The process of harmonization also confirmed the importance of communication,” he said. “By that I mean we learned the importance of walking through the lab and talking to the people who were going to see the impact of these changes on the front lines.
“It wasn’t until we got closer to the accreditation assessment that we learned that lesson,” emphasized Carr. “When we did, we started to communicate more with people and began to see that they were ready for the assessment because they understood what we were doing and the reasons behind it.
“Even the CAP assessors saw the commitment the staff had,” he added. “They were impressed to the point where they acknowledged that the staff knew the quality policy, were familiar with the quality manual, and understood the benefit of it all. That didn’t happen by accident. That took a lot of effort on everyone’s part to communicate that message to all 3,500 people at ARUP.
“That’s not to say we didn’t have any pushback,” added Carr. “With a project like this you expect to get some complaints. People wanted to know if it was necessary to go to the extent that we were proposing. And they wanted to know if we were going beyond what the 15189 standard requires.”
Harmonizing Was Key To Implementing 15189
FOR JONATHAN CARR AND JANICE PINTERICS, implementing ISO 15189 through CAP at ARUP Laboratories was a project designed to get everyone on staff—all 3,500 ARUP employees—working toward the same goal, they said. “We have a word for that,” Carr commented. “It’s what we call harmonization.”
“In a large organization such as ARUP, harmonization is challenging and complex because of the diversity and esoteric nature of many of our tests,” Pinterics explained. “Our various divisions have evolved a lot of effective ways to handle the issues they face every day, and all of those ways are different, as they should be for each different type of test we run. Therefore, staff may not see the value in changing their workflow.
“At the same time, absolutely everyone sees the benefits of harmonization and agreed doing so was in the best interest of ARUP,” she added. “They saw that doing so would make us more efficient, agile, and better able to handle large volumes of tests.
“But the difficult part was convincing people to change their ways,” said Pinterics. “Everyone is in favor of harmonization as long as it is done their way. That’s to be expected and it’s also one of the most important lessons we learned through this process.
“Therefore, the art of negotiation and consensus building was critical to making harmonization work. And it’s still a work in progress,” she noted. “But we learned that the more we discussed best practices that we could adopt throughout the organization, the clearer it became to staff on how they could do it. It wasn’t always easy, but we could see that it was possible.”
Pinterics concurred, explaining that ARUP is already a top-quality lab, which inevitably led staff to question the need for accreditation to CAP 15189. “Someone might say, ‘We’re known for our level of quality throughout the country. So why are you making us do this extra work, especially when the lab is so busy?’” she said. “When that happened, we knew we needed to do more education about the value of the process.”
The need for educating the staff at every step in the process was another lesson learned. “We incorporated education in a variety of ways,” explained Pinterics. “We produced videos, for example, and had an ISO 15189 accreditation fair to explain the process.
“Those efforts were successful in helping to explain the goal of the program,” she said. “During the fair, for example, we had games, such as a trivia contest, to explain what the gaps were and how we were closing those gaps. And we gave out prizes.”
Another Important Lesson
One other lesson learned was not to expect results right away but that the staff would see results over time, she said. “For example, it’s too early to see costs coming down, because we’re still in the front-loading part of ISO 15189 and we’re still in the first year,” noted Pinterics.
“I told people that ARUP would see a return on investment, but probably not right away. It’s difficult to state precisely how long it will take to see the return; it could take several months,” she added. “But one result we can identify right now is the excitement and engagement we see when we give the technologists a voice in determining how problems are solved. In the past, this wouldn’t consistently happen. ARUP has always been very good at identifying and correcting problems in a quick and efficient manner.
“But now we want to take more time and ensure we’re thoroughly evaluating the situation to identify the true root cause,” she explained. “We want to analyze whether we have a good process and whether the staff has the proper training to do the job at hand. Understanding the root cause is critical to establishing an effective corrective action so we don’t have superficial fixes. And we are doing that now.
“In the past, there could be some degree of reluctance for a technologist to have a discussion with someone from compliance and quality systems when a problem was identified,” she said. “A technologist might be a little nervous and ask, ‘what should I say?’
“We tell them exactly what we’ve said repeatedly in this program,” she added. “This is an opportunity for you to tell us how we can improve the process. We want to give them a voice so that they can tell us how to prevent problems going forward.
To Accelerate ISO 15189 Implementation, Consultant With QMS Experience Was Engaged
WHEN ARUP LABORATORIES MADE THE DECISION TO PURSUE ACCREDITATION to CAP 15189, it also decided to contract with a consultant who had extensive experience in quality management systems. That consultant was Rita D’Angelo, the principal consultant for D’Angelo Advantage LLC.
ARUP recognized the value of contracting with a consultant familiar with how to implement and sustain a quality management system in a clinical laboratory. Engaging someone with such extensive experience allowed ARUP to work with an expert who could help to plan the steps needed and to implement those steps to address the issues identified in the gap assessment.
“ARUP was interested in working with someone who had experience with Lean, quality management systems, and CAP 15189,” D’Angelo said. “I had implemented Lean in multiple organizations and that’s basically what they needed. They were adopting a Lean culture with a regulatory component to it. And with my background, I could do that and train the staff as well.
“What was great about working there for a year was that the lab staff at ARUP Laboratories was fully committed to making 15189 work,” she added. “Once we started the ISO initiative, many managers, supervisors, and leads were assigned to the project while many people volunteered to work on the teams. The overall team consisted of close to 100 people. These individuals served on 15 different sub-teams to address the gaps identified by the gap-assessment.”
Before starting her own consulting company, D’Angelo was formerly the Manager of the Quality Systems Division of Pathology and Laboratory Medicine at Henry Ford Health System in Detroit. In that role, D’Angelo developed a robust quality systems framework, initiated and helped lead the ISO 15189 initiative, and co-founded the Henry Ford Production System LEAN enterprise. That system was modeled on, and adapted from, the Toyota Production System, which is a globally-respected approach to industrial standardization, system of prevention, and continuous improvement.
Making One Simple Change
“Just making that simple change has generated enthusiasm from the various departments that are involved in fixing non-conformance by asking everyone to contribute to developing a solution,” she said.
In conclusion, Carr explained that, with any new process that a lab puts in place, maintaining that process is the important next step. “On that point, I would say that everyone knows the assessors are coming back. This wasn’t a one-time ramp up where we put on a show for the accreditation assessors and then go back to how we worked before,” he said.
“We often remind people that we need to meet these commitments every day because it’s the right thing to do for quality and for patient care,” he said. “But also the assessors will be back and they’ll want to see what we’ve done to improve in that year. What they saw first time around may have been good enough, but it might not be what they would expect the second time around. So, that makes accreditation to ISO 15189 an ongoing commitment to quality.”
Contact Cyndee Privitt Holden at 801-583- 2787, ext. 1-3318 or email@example.com.