Pinkus DermPath Earns ISO-9000 Certification

Inspired by early-adopter laboratories, pathology lab implements quality system

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CEO SUMMARY: After learning about quality management systems at a recent Executive War College, the lab director at Pinkus Dermatopathology recognized how such techniques could be used in his lab to improve quality, reduce errors, and create a better working environment for both pathologists and lab staff. ISO-9000 was the quality system of choice because of its wide use by businesses throughout Greater Detroit.

MOTIVATED TO CONTINUALLY improve their work proceses in the laboratory, Pinkus Dermatopathology Laboratory, PC, of Monroe, Michigan recently passed its audit and was certified as ISO-9001:2000 compliant.

Pathologists and laboratory administrators will find this story interesting for at least three reasons. One, it demonstrates the importance of continual access to cutting-edge ideas on laboratory management. Two, it is a useful case study on the benefits of quality management systems in laboratory operations. Three, it connects the strategic decision to implement a quality improvement program to the bigger picture of the revolutionary changes already set in motion by the consumer-driven healthcare trend.

“We were quite interested in improving the processes at our lab,” recalled Darius Mehregan, M.D., Laboratory Director at Pinkus. “We recognized that too many resources were devoted to responding to problems regularly generated by our existing work processes,” he said. “We wanted a solution that would permanently eliminate those problems and allow us to redirect those resources to higher-value purposes.

“In 2003, while attending the Executive War College, I learned of innovative lab management techniques that I had not been aware of before,” said Mehregan. “These techniques could have a powerful impact in our dermatopathology laboratory. Imple- menting a quality improvement system in our lab was a strategy to improve work processes and raise the quality of our services.”

Looking For Expertise

Having made the decision to “go quality,” Pinkus faced two specific challenges. First, it needed to select a specific quality improvement program. Next, it wanted to find an experienced consultant to help it implement its quality project.

“When I returned to Monroe after the War College, I noticed how most large employers in the Detroit area were ISO-certified,” stated Mehregan. “We looked into Lean and Six Sigma, as well, but ultimately chose ISO-9000. We knew this quality system was recognized and understood by consumers in Detroit. After all, many Detroit-area residents are employed in auto industry companies with ISO-9000 certification. Pinkus Dermatopathology wanted to take advantage of that existing “brand recognition” among our patients and client-physicians.

The Pinkus laboratory was originally founded in the 1940s by Hermann Pinkus, M.D. and serves southeastern Michigan and northern Ohio. It handles an annual volume of 75,000 cases and has reference clients throughout the United States.

Attacking Common Issues

“Our staff consists of four dermatopathologists and 35 full-time and part-time technical and support staff, including about ten lab techs,” stated Mehregan. “We faced the usual administrative problems common to most laboratories. Nothing really major—just a daily flow of little time-consuming problems that gnaw away at productivity—and profits.”

Pinkus decided to implement the ISO-9001:2000 quality system. It next faced the challenge of finding the right consultant. “Because so few providers have implemented some type of quality system, it is not easy to find an ISO- 9000 consultant with experience in healthcare applications, much less laboratories,” noted Mehregan. “We finally chose a consultant based on her familiarity with the Healthcare ISO Guidelines and compatibility with our laboratory personnel.”

“The first step in the consulting process took three or four days,” explained Mehregan. “The consultant asked questions and observed work processes in the laboratory. “The consultant worked primarily with our laboratory supervisor. She observed laboratory tests from intake to manufacturing of the slides, supply ordering, and sending results to the physicians.

Analysis of Work Flow

“The consultant also observed our pathologists—how they read slides, what they did with the slides, how they made their reports, and how they handled phone calls. She observed the processes in our reporting and billing departments, as well as those of the business manager,” he added.

“Following this observation period, we met with the consultant to review her recommendations and time lines,” Mehregan said. “We committed the next several months to learning and implementing the ISO techniques. Each department had a list of goals to accomplish by a specified date.

“The first task of each department was to provide more information on its processes,” he noted. “Throughout the remainder of the sequence, we had a full-day meeting with the consultant every two to three weeks. This time was spent reviewing our progress and establishing new goals. The entire assessment, training and implementation took about six months.

Used Existing Staff

“ISO certification did put additional demands on our workforce,” stated Mehregan, “but not unreasonably so. We achieved ISO certification with our existing staff, and without utilizing any temporary help. Much of the quality improvement process consists of identifying procedures, writing them down, and revising work practices to conform to quality standards.

“The bulk of this work, revising our administrative procedures, was handled by our general administrator,” he noted. “Our head technician reformatted the technical portion of our manual and did the editing, with my assistance. To help produce the manuals which resulted from this work, we temporarily drafted an assistant from our reporting department.

“There was varied reaction by our staff to this quality improvement initiative. Some of our senior employees were more resistant to the changes. Others were very proactive and enthusiastic. For example, one-half of our employees volunteered to show up on a Saturday for training on how to conduct mock inspections,” said Mehregan.

“It took us about five months to begin fully ‘living’ the ISO standards in our daily work habits,” Mehregan continued. “We spent an additional 12 weeks practicing the techniques in preparation for the final stage—the inspection process. The biggest milestone occurred when our employees, assisted by the consultant, conducted a mock inspection in anticipation of the real inspection by the ISO certifying organization.

Easier Accreditation

“The drill served us well. Our consultant proved to be much more demanding than the actual inspectors, so we passed our certification easily,” he recalled. “We found the ISO inspection to be similar to a JCAHO inspection. Fortunately, we had integrated all the CAP and JCAHO requirements into our ISO standards. That has made this year’s inspections by CAP and JCAHO a relatively simple and easy process. This was an unexpected benefit of the ISO- 9001:2000 certification program.

“Our strategic decision to adopt a quality improvement system meant a number of changes in our laboratory,” reflected Mehregan. “While we did not make any changes to our equipment, we did have to change a couple of our stain and chemical vendors. That is because ISO certification requires that all vendors be ISO-certified.

“There were no changes in work- force. The main change in our work- flow process involves how we deal with non-conforming specimens— such as bottles sent in without sheets, sheets sent in without bottles, and bottles sent in empty,” he explained. “Prior to ISO standards, each non-conforming case was handled ad hoc by the chief technician, who would alert the physician. Now there is a documented procedure to follow for this event. It works more smoothly, takes less time, and is less frustrating for physicians, staff, and clients.”

“Because our work processes now perform at a higher level of efficiency and quality, we have significantly fewer client complaints.”

“While it will take at least 24 months to recoup the $30,000 to $40,000 we spent to become ISO-certified, the real benefit is the increased efficiency in our operational processes,” stated Mehregan. “Because our work processes now perform at a higher level of efficiency and quality, we have significantly fewer client complaints. All of this translates into a happier workforce, a more stable customer base, and greater growth for our laboratory.”

The benefits which resulted from the ISO-9000 certification of Pinkus Dermatopathology Laboratory show how pathology laboratories can benefit from introduction of a quality management system. By taking this step, Pinkus joins the growing number of labs which have “gone quality” in their management systems.


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