While a relatively small number of clinical laboratories have achieved ISO 15189 accreditation, industry experts predict this number will continue to increase as healthcare executives understand not only the competitive advantage the accreditation confers but also the potential cost savings that labs can achieve through quality improvement (See Sidebar).
The College of American Pathologists (CAP) has accredited 54 laboratories under its ISO 15189 program since it launched in 2008. The American Association for Laboratory Accreditation (A2LA) has accredited 11. A few other organizations also offer accreditation.
“ISO 15189 accreditation is still cutting edge, with a relatively small number of laboratories getting it, although it has been picking up in recent years,” said David Wolfe, a lead assessor for the CAP 15189 program. “I see a lot more market awareness of it now, and more laboratories are expressing interest in pursuing it.”
Why is accreditation to the ISO 15189 standard significant? Jennifer Dawson, MHA, DLM(ASCP)SLS, QIHC, senior director of quality for Human Longevity Clinical Laboratories in San Diego and a laboratory quality thought leader, says the accreditation shows that a laboratory has elevated its quality program to a higher level. “Complying to CLIA is the minimum standard,” Dawson said. “That’s not good enough. Labs need to start thinking about better quality and holding themselves to a higher standard. It’s really a step above CLIA certification and CAP accreditation.”
According to CAP, the ISO 15189 program complements CAP’s laboratory accreditation program: ISO 15189 focuses more on laboratory management systems and processes whereas the laboratory accreditation program focuses more on technical procedures involved in testing.
Wolfe likes to use an altitude metaphor in describing the differences between the two programs. “The laboratory accreditation program looks at a great amount of detail at a low altitude, say 500 feet,” he explained. “CAP 15189 is looking at the same system from 20,000 feet. At a lower altitude, you see a lot of detail but not a broad view. CAP 15189 takes a broader view—we’re not looking at the dots but how you connect the dots.”
There are other key differences between the two programs at CAP. For example, the laboratory accreditation program uses volunteer peer assessors while ISO 15189 has full-time assessors with backgrounds in quality management. Also, the laboratory accreditation program operates on a 2-year inspection cycle while ISO 15189 is on a 3-year cycle.
While achieving ISO 15189 accreditation can be costly—well over $100,000 in some cases—the resulting cost
savings from improved quality will more than offset these costs, maintained Dawson, who has developed a calculator for laboratories to estimate the cost of poor quality in their laboratories
and potential savings (available at http://lableaders.com/copq/tool).
“There can be significant financial benefits associated with ISO 15189 accreditation,” Dawson said. “Financial decision-makers often struggle to see past the short-term costs and recognize the long-term financial benefits of a quality program, but the long-term benefits are definitely there.” Dawson encourages laboratory leadership to capture the cost of poor quality and quantitate the financial benefit of quality initiatives. “Approaching executive management armed not only with quality and patient safety benefits, but also with an indication of financial benefit, will allow the lab to sell proposed quality initiatives effectively. Assigning a monetary value to that waste provides the motivation to eliminate it,” she added.
Since achieving ISO 15189 accreditation in May 2015, Lancaster General Health’s (LGH) two laboratories in Lancaster, Pennsylvania, have seen significant improvement in quality processes, emphasized Brian Stambaugh, MPA, MT(ASCP)SBB, the labs’ enterprise diagnostics manager. “Before ISO, we thought we did quality well,” he explained. “But what we were doing was just remedial action. If something was missed, we would call the patient back and take care of it that way. We needed to go to the next level. What we needed to do was root cause analysis, so we could put effective corrective action in place. ISO got us to that next level.”
The entire process took about 3 years to implement with an initial 5-year project cost between $150,000 and $200,000, but the cost was well worth it, he believes. “By eliminating errors, by eliminating rework, we have been able to break even,” he explained. “I think we’re at a point now where we can actually begin to quantify the cost savings, but we are still on our journey.”
As LGH worked on improving processes, the organization was also implementing lean Six Sigma. Lean is more concerned with creating a continuous improvement culture and improving efficiencies and reducing waste, while ISO is more focused on eliminating errors. However, ultimately the two process improvement systems complement each other, Stambaugh said.
“I think the systems we have put in place will help drive better outcomes and results,” he noted. “We have better corrective action processes in place now. It helps us add additional value to our services, which is becoming more important to customers and payers. It’s a real feather in our cap.”
At ARUP Laboratories in Salt Lake City, the accreditation process took about 1½ years, noted Janice Pinterics, quality manager for the lab. One of the biggest changes ARUP made was in its nonconformance investigation process. “We increased the robustness of the process,” Pinterics explained. “We trained people on how to do a root cause analysis. Now we have minor and major nonconformance investigations. It definitely has improved the quality of the services we offer.”
The most difficult part of achieving ISO 15189 accreditation was standardizing processes across the entire laboratory, which is quite large. “Size was an issue in our case,” she said. “Our labs are so busy, and we were asking our employees to take on the process of standardizing. We had to get staff buy-in for the process, which is critical to making this work.”
For labs considering pursuing ISO 15189 accreditation, Pinterics advises giving the lab enough time to put processes in place and not being overly aggressive in pursuit of accreditation.
“Keep expectations reasonable for your organization,” she commented. “The assessors don’t expect perfection—they just want to see that you are putting systems in place. The CAP assessment team was very reasonable. We probably didn’t need to be as stressed as we were.”
The ISO 15189 accreditation process is very collaborative, Wolfe said, noting that assessors work closely with laboratory personnel to ensure the proper processes are developed and implemented. “We want to make sure that when we set an accreditation date, the laboratory has a good chance of success,” he said. “The time frame is completely flexible. Some laboratories can achieve accreditation in a matter of months, but some take longer. Most do it in about a year, but we’ve had some take up to 24 months.”
Why don’t more laboratories pursue accreditation to the ISO 15189 standard? One reason may be the cost, but according to Wolfe, many laboratories feel they can’t achieve the accreditation, that it is just too overwhelming. However, he believes that most can achieve ISO accreditation if they are willing to commit to the effort it will take.
“The mountain is tall, but you do it one step at a time,” he said. “We have a number of laboratories that have been able to climb the mountain. But you want to make sure you’re doing it for the right reason. You don’t want to do it just to get a certificate on the wall. You want to do it to make your laboratory better and improve patient service.”
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