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.

ACHIEVING  RETURN ON INVESTMENT

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.

TAKING  IT TO THE NEXT LEVEL

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.”

SETTING  REASONABLE EXPECTATIONS

At  ARUP Laboratories in Salt Lake City, the accreditation process took about 1? 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.”

ENCOURAGING  A COLLABORATIVE PROCESS

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.”