"Laboratory Management Update "

Beaumont Reference Labs Earns ISO-9000 for Outreach

MOTIVATED BY THE GOAL of improving all aspects of its laboratory outreach program, Beaumont Reference Laboratories (BRL) of Royal Oaks, Michigan recently earned its ISO-9000:2001 certification.

“In the competitive market for lab testing, we wanted to raise the bar,” stated Joseph E. Skrisson, Director of Business Development and Operations at BRL. “We believed ISO-9000 was an effective way to instill a quality culture in all aspects of our laboratory outreach business.

The interesting twist on this story is why BRL’s leadership team introduced ISO-9000 only to the outreach portion of its lab. “Inpatient laboratory activities are well-covered by existing accreditation programs, like CAP (College of American Pathologists),” noted Skrisson. “But when it comes to outreach, we felt there is no comparable emphasis.

Strategic Decision

“Yet laboratory outreach programs are complex businesses,” he explained. “We have 304 employees responsible for such functions as courier services, processing, client services, billing, support for electronic ordering and resulting for physician office clients, marketing, and sales.

“From a strategic perspective, we decided it was time to stop reacting to those daily problems common to all lab- oratories,” he explained. “Our goal was to develop work processes that prevent problems and help us continuously improve the quality of our services.”

Skrisson and his administrative team recognized that, since few people working in medical laboratories have been exposed to formal training in quality process improvement programs, BRL faced two business challenges. First, it needed to embrace a proven quality management system. Second, it would make it easier to train laboratory staff if this quality management system came with a well-established program of education.

Competitive Marketing Edge

“We opted for ISO-9000 because it met both of these criteria, plus it offered us another benefit,” observed Skrisson. “Because of the auto companies and the heavy manufacturing base in Michigan, payers and patients view ISO-9000 certification as a sign of higher quality. As Michigan’s first ISO-certified clinical laboratory, BRL gains an advantage in our marketing efforts.”

Employee reaction to the management methods of ISO-9000 was surprisingly positive. “In normal times, many people in the laboratory feel invisible,” noted Skrisson. “ISO certification motivated our team and gave it a measurable goal with high visibility within our parent health system. At the same time, ISO-9000 instilled a quality culture in our outreach activities and is proving to be a platform for productivity gains that we expect to sustain over many years.”

ISO-9000 is famous for requiring documentation, but that didn’t prove to be a burden at BRL. “As a fast-growing laboratory, there were many activities which lacked written procedures and documentation,” Skrisson said. “In our lab, we found it useful to go through the steps needed to evaluate work processes and create the documentation to support them. It’s helped reduce variability and differences in how various people do the same task.”

Solving Problems

One result of the ISO certification effort is a change in how management and lab staff view daily work flow. “ISO places major emphasis on identifying repetitive problems, then putting solutions in place which prevent those problems from happening,” explained Skrisson.

“I think that this is unique and new for most clinical laboratories,” he added. “As an industry, we’re great at responding to issues. We’re great at QA/QC. But we’re not good at looking at how to design our work processes with an eye to preventing problems.

“ISO encourages our people to work in teams and look for process improvements in their operations,” Skrisson said. “It gives them the knowledge and the tools to identify and implement solutions, then move on to find other problems that can be eliminated by redesigning the appropriate work processes. In fact, ISO forces you to constantly look at what you’re doing, make improvements, and immediately move on to the next improvement opportunity.”

Enthusiastic Support

Within the BRL outreach program, staff support has been enthusiastic. “There’s enthusiasm because employees see problems that they spent time on each day getting permanently fixed! And they realize there’s an important difference from the past. Because the system itself is fixed, they have treated the root cause and not the symptoms.”

Skrisson offers a few management lessons for lab directors and pathologists considering ISO-9000 or similar types of quality management systems. “First, it was not expensive for us to implement ISO-9000 and become certified,” he offered. “Out-of-pocket, we spent about $50,000 on implementation and registration and another $50,000 for consulting services. We also incurred staff time in training and similar types of expenses. In most cases, improvements in quality and productivity traced back to these pro- grams means that payback is speedy.

“Second, at BRL, we tackled three other projects at the same time,” Skrisson said. “This included moving our laboratory to a new five-story building and bringing up major automated systems. We are proud of our accomplishments, but normally an ISO implementation can be in 12 to 18 months. It took us approximately 23 months.

Experienced Consultants

“I recommend that ISO certification should be done as the major management initiative,” he continued. “Also, should you want to use a consultant, find one with experience implementing ISO-9000 in a clinical laboratory. In our case, less time would have been spent in translating our existing laboratory documents into ISO documents if our ISO consultants were experienced in clinical laboratory operations.”

THE DARK REPORT observes that Beaumont Reference Laboratories pursued ISO-9000 certification because it wanted to become more competitive—while boosting quality and increasing productivity. BRL is another example of an early-adopter laboratory embracing a management philosophy of continuous improvement. “That’s certainly true,” said Skrisson. “It’s becoming a way of life around here. People like having the knowledge, the power, and the support to fix problems throughout our laboratory organization.

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