Lean Used to Lay Groundwork for Lab’s 15189 Accreditation

Henry Ford Health is largest system to have all labs working with ISO QMS

CEO SUMMARY: Henry Ford Health System’s laboratory organization has become first in the nation to have all its laboratory sites “standardized under one source of leadership” and accredited to the standards of ISO 15189: Medical Laboratories. The journey to achieve this current state has taken almost 10 years and started with the development of a Lean culture throughout the health system’s labs, followed by accreditation to ISO 15189 during 2013. Now the lab team is aligned in how it implements changes.

IT’S AN IMPORTANT MILESTONE for the laboratory medicine profession. For the first time, a major health system in the United States has earned accreditation of its constituent laboratory sites to the standards of ISO 15189: Medical Laboratories.

The honor belongs to Henry Ford Health System (HFHS), based in Detroit, Michigan. It fulfills a goal of Richard J. Zarbo, M.D., D.M.D, the Senior Vice President and Chair of Pathology and Lab Medicine at Henry Ford. During 2013, Henry Ford became the “only integrated delivery system, where all laboratories are standardized under one source of leadership,” to gain this accreditation.

The achievement is notable, particularly at a time when laboratories across the nation are under financial stress, yet must perform more testing in the face of shrinking budgets and mandated higher standards of quality.

There is competitive advantage to be gained from a lab that has introduced a quality management system (QMS) such as ISO 15189 across its organization. During a presentation last fall on why the clinical laboratories at HFH became accredited to ISO 15189, Zarbo quoted Henry Ford himself.The great industrialist once said, “The competitor to be feared is one who never bothers about you at all, but goes on making his own business better all the time.”

“Our accreditation to CAP 15189 is a way for us to be the best we can be, while using that achievement to attract new business and retain customers,” observed Zarbo during his presentation at Lab Quality Confab last fall in New Orleans.

In 2013, the clinical labs at all four lab sites at HFHS achieved accreditation to ISO 15189. Zarbo believes HFHS is the largest such health system to have its labs earn accreditation to ISO 15189 and is the only integrated delivery system in which all laboratories are standardized under one source of leadership to gain this accreditation, as he told CAP Today in an article in November.

“Accreditation to this respected quality management system (QMS) is necessary because the clinical lab business today is about the pursuit of survival,” he added. “We had six acute care hospitals a couple of years ago. Now we are down to four. As well, within our health system we are consolidating not just the labs, but we are also consolidating hospitals.”

Consequently, specimen volume is rising within the HFHS labs, even as head count declines and the health system administration asks the labs to do more with less.

Several years ago, when the lab team recognized how these trends were likely to play out, HFHS established a two-pronged strategy. First, it would introduce Lean techniques into the labs and establish a Lean culture that would support continuous improvement.

Second, using the knowledge the lab staff had mastered about process improvement and Lean methods, the second step was to implement the QMS of ISO 15189 throughout the lab services organization at Henry Ford Health System. Zarbo was convinced that the labs needed to do both in order to continuously reduce errors and boost efficiency in an environment of declining lab test revenues.

“Earning the ISO 15189 accreditation was a challenge for us, but it was made just a bit easier because we had already completed the task of introducing Lean into the operation,” recalled Zarbo. “We had also integrated or consolidated our laboratories before we began the process of becoming accredited to CAP 15189.

“Everyone knew that this was a long-range strategy,” he continued. “It began as far back as 2004, when we started introducing Lean into our main hospital laboratories. After all these years of introducing Lean into each of our lab’s work processes, we had established competence in Lean and the laboratory staff was comfortable with the Lean culture within our organization.

“During that same time, we were also dealing with significant integration and consolidation activities in our health system,” explained Zarbo. “For example, the number of hospitals dropped from six to four and we moved more laboratory testing into our core laboratory.

“It was a four-year timeline,” noted Zarbo. “During the four years of 2009 through 2012, we progressed through Lean first at our community hospitals, then to integration and consolidation. Beginning in 2012, we undertook the ISO 15189 journey at all sites now that we were standardized.

“It’s important to understand that where we started was just like where many labs begin: in a state of entropy or chaos,” emphasized Zarbo. “In other words, even after the introduction of Lean, there were still many opportunities for significant improvement. We saw ways to both reduce costs and improve the clinical value of our lab services.

“Fortunately, we had a couple of years to become proficient with Lean and its techniques,” recalled Zarbo. “That allowed us to start integrating laboratories within our health system. Integration helped us to eliminate many silos that existed. The benefit was that all lab sites became fully participating parts of our system-wide Laboratory Quality Management System.

“Once that integration was achieved, we continued to use Lean to identify ISO gaps and we began preparing to introduce the ISO QMS by creating electronic document control systems.” he continued. “We used that document control system to standardize 10,000 documents in a paperless system across the entire healthcare enterprise.

Adopting Best Practices

“In other words, we were installing some of the antecedents that we would need for accreditation to ISO 15189,” stated Zarbo. “It was a way to begin educating all staff members about ISO accreditation in preparation for the first ISO gap inspection. That gap inspection took place in January 2013. The final accreditation inspection was performed in June of 2013.

“Notice that we went from the gap inspection in January to the accreditation itself in less than six months,” stated Zarbo. “We could move quickly from gap inspection to accreditation because our implementation of Lean principles and their use in integrating and consolidating labs had established many of the operational requirements of the ISO QMS. In effect, throughout the prior four years, our Lean initiatives were conducted in such a way as to fully conform to ISO 15189 standards.

Role of Long-Range Plans

“It’s important to note how we used long- range planning to lay the groundwork for our CAP 15189 accreditation,” he added. “All the improvements we made in our labs over the prior four years and even going back further to 2004—so 10 years really—came as a result of our long-range plans.

“We didn’t just wake up one morning and say, ‘We’re going to tackle Lean today and get it done immediately,’” stated Zarbo. “And we certainly didn’t do that with our ISO 15189 accreditation.

“I emphasize the multi-year span of our lab’s journey because earning ISO accreditation requires preparation,” he said. “Plus, it represents change to the working culture in the laboratory.

“It means implementing something new and asking people to do things that they ordinarily do not do,” continued Zarbo. “To help our lab staff through the transition to Lean and the accreditation to ISO 15189, we followed the eight steps of change management described in the book written by John Kotter, titled ‘On What Leaders Really Do.’”

“Further, during implementation, we recognized that in order to achieve higher levels of quality, it could be perceived that we were layering an additional job on top of the work that the staff was doing already,” he continued. “Our goal was to introduce ISO while at the same time helping people understand that we were not truly adding a new job on top of their daily responsibilities.

“This could be done because we had already restructured the lab so that Lean had become a normal way of life,” he added. “We envisioned that ISO 15189 would become a way of life as well. In that way, neither Lean nor ISO 15189 were viewed as additional jobs.

“What leaders do is drive change,” he continued. “We worked with the lab staff on these changes so that Lean and ISO 15189 became a natural way to address daily work in the lab. That is critical to the success of a lab’s ISO journey.

“However, the rewards are substantial and ongoing,” said Zarbo, “because it is always people who do the work. In fact, the simple truth about a quality management system is that the QMS does not produce quality. Rather, the QMS is the foundation that enables the staff to produce quality work.”

Sustaining change is always an issue for clinical labs and pathology groups. HFHS lab leaders anticipated this challenge and addressed it directly. “We have both horizontal and vertical management for quality,” added Zarbo. “That means we needed a Quality Technical Team for the laboratories. This technical team is composed of physicians, pathologists, directors, quality assurance champions, managers, and supervisors.

Quality Technical Team

“The Quality Technical Team meets via a monthly standing conference call,” he said. “About 50 people participate on the call. Some individuals work on the main campus, but most call in from remote locations.”

HFHS utilizes these conference calls more frequently, as needed. “For example, during the first six months of 2013 when we were closing the ISO inspection gaps, we had these conference calls once a week.” observed Zarbo. “That allowed us to work together as a team to close each gap.

“Remember, the ISO QMS gaps had to be closed in a standardized fashion at all sites,” he explained. “It was essential that all 28 medical centers and the four acute care hospitals worked collaboratively to close these gaps in the same fashion.

“Certain members of the laboratory’s leadership team were critical to this process,” commented Zarbo. “One such leader was Aaron Lupovitch, M.D., our 84-year-old Emeritus Chair and Director of Regulatory Quality Initiatives in our Quality Systems Division. He toiled tirelessly for years helping us to integrate the CAP accreditation requirements for ISO 15189.

“Another key contributor was Gaurav Sharma, M.D., senior staff pathologist, Associate Director of Clinical Core Laboratories, and Director of Compliance and Regulatory Affairs,” he continued. “But it was our Queen of Quality, Quality Manager Rita D’Angelo, who oversaw the entire project as the chief architect of our Lean culture from its inception. She devised the rapid path used by teams to address gaps and helped engage all 800 lab employees to win the ISO accreditation.”

Why Pursue ISO?

The decision to implement Lean and earn accreditation to ISO 15189 was based on the desire to harvest certain benefits and achieve key outcomes. “The first and most important result was deviation management,” noted Zarbo. “As a result of becoming accredited to the QMS of ISO 15189:2007, we now record all deviations and all non-conformances that occur everywhere.

“The workforce tabulates them daily as they occur and they’re recorded according to a classification scheme,” noted Zarbo. “These are tracked with our internal trackers that are accessed on a shared website.

“By developing methods to control non-conformities, our lab’s corrective-preventive action system is now more robust compared to what it was previously,” he added. “Today, we immediately document the steps we take to resolve problems. In addition, we can document the steps we take when a deviation requires a root cause analysis.

Managing Change Effectively

“By focusing on deviation management, we not only accept education and process change as a solution, but we also monitor the effectiveness of whatever process was changed to eliminate that deviation,” stated Zarbo. “Another benefit is that we closely document our system of continuous improvement and the changes we make to protocols and lab operations. This centers upon our digital document control system and that is something we didn’t have before. All posted documents and job aids are filed under document control and that mirrors everything that occurs in our 32 laboratory sites.

“There was also substantial improvement in the operational quality outcomes we achieved,” stated Zarbo. “Operational quality outcomes are particularly important to our lab because we’ve consolidated everything into our main hospital core laboratories. That means our volume on the main campus has increased, even though, at the same time, we experienced a sharp decline in our number of full-time equivalent employees.

“Even accounting for the reduction in our lab staffing, we have continued to pursue high goals,” commented Zarbo. “They are ambitious and we are starting to reach those levels.

“For example, we have a goal to complete all tests for the emergency room in less than 30 minutes,” he said. “We recently began to meet that goal, and it is noteworthy that we’ve achieved this even as the number of core lab employees declined significantly.

Establishing Benchmarks

“In the area of outpatient test turnaround times, we established three distinct benchmarks,” continued Zarbo. “First, we want to report 98% of test results by 6 a.m. the next morning, which is essential for out- patient settings.

“Second, for outpatient specimens received by 5 p.m., we want to complete 95% of testing by midnight,” he said. “Third, for outpatient specimens received between 5 p.m. and 8 p.m., we want to report 90% of those test results by midnight. We are starting to achieve these goals.

“For biopsies, our goal is a two-day turnaround time for all biopsies from all sites, including outreach,” continued Zarbo. “We are achieving this goal despite the loss of one pathologist and several histotechnologists.

“This brings us to the most important outcome: cost reduction,” said Zarbo. “Our lab has demonstrated continuous cost reduction. For example, year after year, the overall expense of the core lab has declined.

“At the same time, we have tracked the costs that are charged back to the community hospitals for doing work in the core lab,” he continued. “These are fully loaded expenses such as blood, information technology, couriers, and pathologists and they have also declined steadily.

“The bottom line in this discussion is that Lean and accreditation to ISO 15189:2007 allow us to be more efficient,” concluded Zarbo. “This means we produce more tests with fewer staff and we continue to do so with lower costs and fewer defects. As you can imagine for an urban hospital system, these are impressive results.”

Goals for 32 Lab Sites at Henry Ford Health

HERE ARE THE GOALS the clinical laboratories set for themselves at the Henry Ford Health System:

  • All specimens from any operating room within the Henry Ford Health System are to be transported, grossed, and processed within the day of surgery at the Core Anatomic Pathology Lab.
  • There will be continuous flow processing for biopsies and large specimens using Lean processes with short cycle times.
  • For biopsy reports, 80% will be done within two days.
  • For large specimens, all reports will be done within three days.
  • Production in the lab should strive for the ideal condition, meaning work processes are:

…defect free (a goal of zero defects meets customers’ expectations).

…done on demand (meaning they are supplied when customers want the work done).

…done immediately so that there is no waiting.

…done one at a time (meaning there is single-piece flow and batch size equals one).

…done in a continuous flow (meaning no batches or queues).

…producing minimal waste in materials, labor, energy, and other resources.

…done safely for every employee.

‘Daily Management’ Is Important Tool Used to Sustain Change at Henry Ford Lab Division

SUSTAINING CHANGES IN THE LAB FOLLOWING IMPROVEMENT PROJECTS is always a challenge. One effective method to sustain change is the use of short “daily management” meetings, such as is currently done by the laboratory team at Henry Ford Health System. “Daily management” is credited with helping nurture the culture of continuous improvement.

“Everyone in the laboratory organization at Henry Ford Health System understands the concept of ‘daily management,’” stated Richard Zarbo, M.D., D.M.D., Senior Vice President and Chair of Pathology and Lab Medicine at Henry Ford. “These are short, quick-hitting meetings that help people stay focused on their team’s daily metrics and the progress they are making toward their goals.”

Zarbo noted that “daily management” (DM) is the ultimate in true “visual manage- ment” in the workplace. He explained that each DM meeting includes the following:

  • Selected critical metrics define daily performance.
  • Information must be simple to collect and easy to understand.
  • Data needs to tell you at a glance in three seconds whether you are “winning” or “losing” today.
  • Is visible at a distance to all involved in the meeting.
  • Is directed toward a group, not individuals.
  • Shows the standard and your team’s performance toward sustaining it.
  • Involves all physicians, administrative managers, supervisors, and tech leaders in the management process.
  • Focuses the team on just a few critical metrics for success each day.
  • Is used to drive PDCA problem solving in a blameless environment.

“Each lab team conducting its DM meetings looks at the metrics that we call “Q-T-I-P-S,” added Zarbo. “This stands for quality, time, inventory, productivity, and safety. Emphasizing Q-T-I-P-S at each DM meeting has created a common understanding of what drives our business. It also provides the framework for each team in the lab to apply the Lean and process improvement tools to their particular area of responsibility.”



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