Third Laboratory Earns ISO 15189 Accreditation

Empowered lab staff, continuous improvement are two benefits for Blanchard Valley Hospital lab

CEO SUMMARY: In June, the laboratory at Blanchard Valley Hospital became third in the nation to be accredited to ISO 15189:2007. The 150-bed acute facility in Findlay, Ohio, is the only hospital laboratory of its size to achieve accreditation to the ISO 15189 standard. Implementing these standards directly benefited the lab by lifting what was already a top-performing organization to a higher level of achievement. The ISO standards also support an effective culture of continuous improvement that challenges the lab to repeatedly raise the bar.

LAST JUNE, THE LABORATORY at 150-bed Blanchard Valley Hospital (BVH) in Findlay, Ohio, became the third lab in the nation to be accredited to ISO 15189:2007.

The lab is using its new ISO accreditation to further expand its laboratory outreach program. “We intend to market the outreach program as one that meets and exceeds higher standards of quality than any other lab in Northwest Ohio,” said Bonnie Van Schoik, MT (ASCP), Administrative Director of the Blanchard Valley Hospital Laboratory. The laboratory was already CLIA certified, accredited by the American Association of Blood Banks (AABB), the College of American Pathologists (CAP), and The Joint Commission. It used the program offered by the CAP to achieve its ISO 15189 accreditation.

To date, the key benefit from the ISO 15189 experience has been to ratchet up an already top-performing laboratory to a higher level of operational excellence. “The process began in December 2007, when CAP invited us to be a part of the pilot program for ISO 15189 accreditation,” Van Schoik said.

“The ISO process enabled our staff to learn a great deal about ourselves, our processes, and the quality of our laboratory,” she commented. “It was productive to dissect our procedures and determine how we could improve our laboratory operations. The journey to becoming ISO 15189 compliant has been great for team-building. It taught us how be effective change agents; the Blanchard Valley Hospital Laboratory is an outstanding quality laboratory because of this process.”

Lessons Learned

During an interview with THE DARK REPORT, members of the lab staff identified four significant lessons for other laboratories considering ISO 15189 accreditation. First, the lab found it needed the full support of both hospital administration and laboratory staff. Second, it recognized how software was an effective way to support documentation. Third, it learned the value of empowering staff to serve as problem solvers and change agents; and fourth, the lab eliminated a surprising number of process inefficiencies.

“Our hospital administration was supportive of this project to become ISO 15189 compliant,” noted Van Schoik. “That included an investment of $25,000 in software to support documentation, along with an annual investment of $9,000 to maintain the software and provide upgrades as needed.” “The upfront buy-in of both hospital administration and laboratory management is essential,” noted Lisa Selhorst, MT (AMT), Regulatory Compliance Quality Manager. “That’s because it takes significant resources, including staff as well as financial support, to implement ISO 15189.”

No Outside Consultants

The BVH laboratory opted to not hire outside consultants, but to pursue its ISO 15189 accreditation as a “do it yourself ” project. “Labs that do this work on their own—as we did— are likely to learn more about the ISO standards,” stated Selhorst. “We think that it makes it easier for laboratory staff to become more engaged in the process, since an outside consultant is not dictating what needs to be done. We found our staff would embrace changes more easily when they were directly involved in process improvements.”

One major benefit to adoption of ISO standards is how it unlocks further productivity gains in the laboratory. “As laboratory staff identifies ways to improve individual processes, the results are often remarkable,” observed Doug Hughes, MT (ASCP), Laboratory Information Systems Coordinator. “That’s true for two reasons.

“First, ISO standards require our lab staff to break down, analyze, and improve what is done in the laboratory in a way that we had never done before,” he explained. “Second, this review and improvement process will be continuous as long as our laboratory is involved with ISO accreditation.

“This is a notable difference—and a major benefit to ISO 15189,” added Hughes. “With other accrediting standards, once the lab meets the standards, it is finished. The great thing about ISO 15189 is that your lab continually improves.

“Probably the most useful tool we used in achieving accreditation was a document management control system,” said Hughes. “This is a tertiary piece of software that we run on our Meditech System.

“Because ISO 15189 requires documentation of every step in every process, document management is a significant part of the undertaking,” he stated. “This software guided us through the process. We were constantly surprised by its ability to identify what we needed to do at each step. More importantly, our use of this document control system helped us save time and money.”

In fact, putting all documents in a single document management system has itself unlocked major cost savings and helped improve productivity. “Before implementation of the document control system software, we had more than 85 policy and procedure manuals on paper in binders,” observed Van Schoik. “Now every policy is available via the search function on each computer. This new system saves an enormous amount of time.”

Empowering Staff

“One significant benefit of ISO 15189 is how it has empowered laboratory staff to continously improve laboratory processes,” commented Selhorst. “In turn, this contributes to greater productivity, fewer errors, and reduced costs. It also motivates our staff; they can see direct progress resulting from their efforts.

“It means each staff member must be vigilant about identifying deficiencies,” she continued. “One direct advantage of achieving accreditation is increased ownership of all laboratory processes. In a fundamental way, everyone who works in the lab now has a voice for improving any process. We also implemented problem logs, which increased everyone’s awareness about the issues we need to address.

“Empowering the entire staff is an important achievement, because now the staff realizes that we listen and take action to improve processes that affect them,” noted Selhorst. “Both lab staff and lab management want to know: what processes are working and what’s not working throughout the entire laboratory? This active role by our staff in day to day operations has made a powerful and posi- tive difference for our laboratory.”

“One visible aspect of this staff involvement was in the documentation process,” stated Laboratory Manager Jeanette Theis, MT (ASCP). “Everyone was involved in procedure writing… the med techs, the staff, and phlebotomists as well! Each policy or procedure throughout the entire laboratory needed to be either written or updated into the electronic document control system. Teams of associates from all shifts and job classifications conducted root cause analysis to help improve processes.”

Recognizing the effort required by lab staff to meet the ISO accreditation requirements, certain fun elements were introduced. “For example, we gave prizes for what we called ‘ISO-tizing,” explained Theis. “That’s a term we made up to describe when someone made a suggestion to help ‘ISO-tize’ our lab by fixing ISO nonconformities.

“For each contribution, the staff mem- ber could get an ‘I,’ ‘S,’ or ‘O.’ Once an individual got a full ISO, he/she earned a prize, along with a chance to win a week-long paid vacation. This was a way to add some fun to the project and reward staff.”

THE DARK REPORT observes that perhaps the most powerful result from the initiative is the staff has taken quality to a level no one believed was possible. Van Schoik agreed, stating, “Certainly we were a quality lab before we began our journey to become ISO 15189 compliant. But our adoption of ISO standards has been an impetus to push our quality performance to even higher levels.

Recognized By Community

“This achievement has given us positive exposure,” Van Schoik commented. “Business and industry recognizes that ISO is a quality marker. Members of our community can be assured that, as an ISO 15189 compliant laboratory, we are here for them, and want to exceed their expectations as their laboratory service provider. Compliance to the ISO 15189 standard sends a powerful message about our commitment to provide high quality laboratory testing for our patients.”

ISO 15189 Standards Drive Continuous Improvement

WHAT MAKES ISO 15189:2007 different from other laboratory accreditations is that it goes beyond a checklist. Thus, implementing ISO standards means ongoing effort.

“Generally, these standards are not prescriptive, meaning they don’t tell you how to do it,” said Lisa Selhorst MT (AMT), the lab’s Regulatory Compliance Quality Manager. “Rather, the standards describe what needs to be accomplished.

“Initially, our staff found working with these standards, to be a bit frustrating,” she added. “However, the genius of this approach is it allows you to mold each ISO standard to your laboratory’s unique needs, in ways that are a direct benefit.”

“Another advantage of ISO 15189 standards,” offered Bonnie Van Schoik, MT (ASCP), the lab’s Administrative Director, “is that our laboratory must regularly look at a standard and compare it to current practice. This approach results in ongoing and continual improvement to processes in the laboratory.”


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