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CAP 15189: Elevating Medical Laboratory Management

CAP 15189 (Accreditation to ISO 15189)
CAP 15189 (Accreditation to ISO 15189)

The CAP culture is one of partnership and collaboration that embraces members, staff, clinical partners, health care executives, government agencies, and many others. Collaboration has been an important quality driver in the CAP’s hallmark proficiency testing (PT) and accreditation programs. In 2008, the CAP innovated once again with the launch of CAP accreditation to the ISO 15189 standard: CAP 15189.

CAP laboratory accreditation and the CAP 15189 accreditation program to the ISO 15189 standard take complementary approaches to initiative, efficiency, risk awareness, and economy in medical laboratories. Distinctions relate to models and methods: CAP laboratory accreditation is procedure driven while ISO 15189 is process oriented. According to pathologists whose laboratories are both CAP and CAP 15189 accredited, when both are present, the whole is greater than the sum of its parts. And that’s a good thing—technology won’t be heading backward anytime soon, and with every new level of complexity the stakes seem to get higher.

CAP laboratory accreditation is focused on ensuring that laboratory teams execute against a continually revised checklist that is, in effect, a textbook of current practice. Consistency and rigor across laboratories are key: What holds sway in Seattle, Washington, has to play in Peoria, Illinois. Routine PT and oversight from CAP scientific committees ensure that all those moving parts stay in sync.

ISO 15189, on the other hand, looks at processes and cultural supports that enable continuous improvement and underpin a quality culture that sparks innovation, creates risk awareness, and encourages collaborative problem solving. ISO 15189 takes a “50,000-foot view” to capture quality processes end-to-end. It builds laboratory teams whose members know when to speak up and how to see a nonconformance as a learning opportunity.

For laboratories grappling with high demand for urgent COVID-19 testing, the ability to capture, communicate, and implement priorities is a survival skill. Team members in a CAP 15189-accredited laboratory are exposed to group decision-making and other collaborative exercises that help them to communicate more effectively with external partners, too.

Mike Crossey, MD, PhD, chief executive officer at Tricore Reference Laboratories, sees CAP 15189 accreditation as a badge of industrial rigor. A laboratory that is very standard in delivery of results, he says, becomes the laboratory that everybody wants to use.

“CAP 15189 forced us to standardize every single analyte, every single result, so they’re all recorded the same way,” Dr. Crossey says. “A lot of what the laboratory is doing now is looking for ways to improve patient care and population health by using aggregate data, and the only way you can do that is with standardized data.” Plus, enhanced uniformity, efficiency, and oversight put downward pressure on operating costs and enabled flexibility when needed…which proved to be sooner than later.

“Our CAP 15189 accreditation and training kept us in compliance and efficient as we brought up four different molecular platforms and transitioned from a staff of eight on one shift to a staff of 28 on three shifts to cover our 24/7 COVID testing,” Dr. Crossey says. “There is such huge benefit to thinking in terms of standards and minimizing variation and nonconformities.”

“The culture change is something that does not happen overnight,” adds Cordelia E. Sever, MD, FCAP, the director of clinical pathology at Pathology Associates of Albuquerque, a clinical professor at University of New Mexico’s Department of Pathology, and a former chair of the CAP 15189 Committee. “It’s a process.”

As a process-driven model, ISO 15189 looks for cultural cues. Routine internal audits encourage everyone to “rock the boat” when they see signs that quality supports are under stress. The decision to adopt an integrated quality system acknowledges vulnerability to error without judgment (also known as Just Practice) and employs tools, such as internal audits and root cause analysis (RCA) that will trigger an early warning when something is amiss. When everyone is on the same page, it can be vanishingly difficult to make a mistake.

“The regulatory rigor of the CAP laboratory accreditation program is something that ISO is not focused to do,” explains Caroline Maurer, MT(ASCP), director of the CAP 15189 program. “The programs operate from two different altitudes. One employs very rigorous, procedural detail: CAP accreditation with the scientific committees behind them. ISO is about process—it gives laboratories visibility to how they operate, drives continual improvement, and produces results. Together they bring the best of both worlds.”

The ISO 15189 standard is well suited to laboratories with a variety of customers. “I think the main value for us has been to tie, at a cultural level, all these varied projects, assays, and dedicated employees into a singular construct,” says Peter Bryant-Greenwood, MD, MBA, FCAP, medical director for advanced diagnostic laboratories, National Jewish Health. “You have to pull them all together in a single quality management system, and that’s the system that 15189 represents.”

“When the metric is turnaround time, that’s how we judge success,” Dr. Bryant-Greenwood says. “With CAP 15189, you’re looking at how the information is deployed and whether or not the end user is actually finding utility in that data point. That’s a huge difference.”

While earning accreditation to the ISO 15189 standard is challenging, the payoff is substantial. When a CAP-accredited laboratory signs on to pursue it, professional full-time assessors take a wide-angle lens to overall laboratory function. They endeavor to cultivate support for the nature and pace of continuous quality improvement over time and in context, to meet the team members where they are, and to stay with them across the journey to accreditation.

The first step is a gap analysis to get their arms around the distance to be traveled. From there, internal audits and mistake-proofing techniques come into play. These tools (among others) enable laboratory teams to dig deeper and institute preventive measures so that time spent putting out fires is freed up to improve quality, enhance efficiency, reduce costs, and explore new markets.

In an ISO 15189 laboratory, creating a quality culture means connecting the dots between risk management and quality improvement. The success of what is sometimes called “the journey from blame to gain” begins with a social contract that incorporates collaborative decision-making. Process improvement becomes first a solution and then a philosophy. Laboratory team members come to see that 1) anyone can make a mistake, 2) mutual support will promote patient safety, and 3) patients benefit when decision-making is respectful and transparent.

“In a CAP laboratory that is accredited to the 15189 standard, everyone recognizes that the quality of processes and systems will impact performance, risk awareness, and operations within the laboratory and with their partners,” said Gaurav Sharma, MD, FCAP, one of the laboratory medical directors at Henry Ford Health System in Detroit, Michigan, who is also the CAP 15189 Committee chair. “You need to ask questions like: Is the climate one of respect and mutual support? Does the leadership take oversight responsibilities to heart? Is every member of the team alert to signs that a failure-resistant system has degraded in some way, and are they comfortable about speaking up? Do their managers support them when they do?”

A 15189 laboratory team might employ RCA for collective problem solving. They may use the Lean Six Sigma 5 Whys to retrace the steps to a nonconformance and ask why each choice was (or was not) made. There may be an inservice to introduce the tenets of Just Practice (also known as the journey from blame to gain). Laboratory directors will often incorporate MBWA (management by walking around) in their weekly routines. All of these tools foster a culture of professional respect within which drivers of error can be pursued without fear of retribution.

CAP 15189 Committee member Vipul A. Trivedi, MD, FCAP, who chairs the Department of Pathology and Division of Community Laboratory Medicine at the Mayo Clinic Health System in Eau Claire, Wisconsin, has seen this dynamic play out. Culture is not just how you interact with people; it’s how you approach things,” he says, adding that not so long ago, the response to a nonconformance was to launch a search for the immediate solve.

“When a deficiency was found, it was fairly common to ask who did it,” Dr. Trivedi says. “With ISO, we moved from who did it to how did that happen…to asking why and using the 5 Whys and saying let’s figure out what the actual root cause of that problem was. That was pretty much a total culture shift. And now it’s just how we do things.”

Frank Schneider, MD, FCAP, associate professor in the Department of Pathology and Laboratory Medicine at Emory University School of Medicine in Atlanta, Georgia, and former chair of the CAP 15189 Committee, tells a story about how his laboratory dealt with a near-miss when the team was validating a new test method for HER2 stains, and slides intended for the patient stack somehow showed up in the validation pile. After contacting the accreditor to report the mistake and being assured that they could repeat the exercise without penalty, the team sat down to talk about it.

“I noticed that people actually didn’t like to discuss it,” Dr. Schneider says wryly. “There was a sense that something important had gone terribly wrong. And while that notion is certainly justified when you talk about proficiency testing, that’s not how I want to live life in our laboratory. So instead, I encouraged them to celebrate this mistake and see what we could do to make sure it doesn’t happen again.”

The team settled in to map out their PT processes only to discover that there were none in place. “It turned out that our staff had a lot of fun doing it,” Dr. Schneider says. “We looked at every step the sample goes to, and at every step we brainstormed what could go wrong. It was a great experience because the focus was not on any one person accidentally routing that sample into the wrong pile and feeling bad about it. It showed us that there are 20 steps in the process, and at every step something could have gone wrong. We realized that there is a lot of potential for error, and this was just one of them. If we don’t celebrate mistakes, we don’t learn from them. You should not live life in the laboratory with fear of retribution or of doing anything wrong because you’ll never get better.”

In an RCA drill down, everyone understands that the process, not those involved, needs to be repaired. Making the repair a group endeavor further mistake-proofs the enterprise, ensuring continuing improvement and cementing shared goals. Over time, a new culture takes root to build risk awareness across the board and leverage arguments for novel ways to make it easier to do the right thing. Process outcomes in a laboratory that combines CAP accreditation and CAP 15189 thinking will drive improvements in precision, workflow, and turnaround time that enhance overall efficiency and boost morale. More energy goes into looking at constructive initiatives, considering cost-effective innovations, and coming up with ways to communicate more clearly with customers and clinical partners.

Traditional CAP accreditation and CAP accreditation to the ISO 15189 standard share a foundational ethic (excellence driven, patient centered) and compatible goals (efficiency, economy, risk mitigation). Accreditation to the ISO 15189 standard builds on the rigor of CAP laboratory accreditation with a process-oriented, systems-focused lens that captures how smoothly the laboratory supports its staff, serves its patients, and communicates with new and established customers. Working in tandem, these complementary systems keep patients safe, limit risk, control costs, encourage new business, and build a respectful, resilient culture.

Read more about CAP accreditation to the ISO 15189 standard.


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