Henry Ford Health System Laboratory Division Combines Lean with ISO 15189

Metrics Show Improved Quality and Greater Revenue

CEO SUMMARY: As healthcare transitions away from fee-for-service payment and adopts new models of reimbursement, every clinical lab will need to deliver more value with its lab testing services. At Henry Ford Health System in Detroit, the laboratory division has blazed a path of improving lab performance specifically to enable it to add value to the health system, physicians, patients, and providers it services. Part one of this multi-year journey was to introduce Lean throughout the laboratory. Part two was to adopt the QMS of ISO 15189. Now comes part three, where these accomplishments position the lab to add value to improve patient care.

LABS ACROSS THE COUNTRY MUST DEAL with the twin squeeze of shrinking budgets and the need to test more specimens with those reduced resources. This is why some innovative lab organizations are adopting the quality management system of ISO 15189.

The benefits of a quality management system (QMS) are substantial. Labs that have incorporated ISO 15189 into their daily operations report significantly lower costs because of the ability of lab teams to identify systemic sources of errors and reduce or eliminate them. Revenue at these labs typically increases because the lab does a better job meeting and exceeding the service expectations of physicians and its other clients.

Of equal importance, labs using ISO 15189 today report that this QMS is now the essential foundation that supports the lab team’s effort to deliver more value to the stakeholders it serves, including hospitals, physicians, patients, and payers.

Lower costs, improved quality, and increased revenue are among the major benefits that resulted from what is believed to be the nation’s largest deployment of ISO 15189 in a major laboratory organization. At Henry Ford Health System, in Detroit, its five largest hospitals are now accredited to CAP 15189.

It is important to understand that the implementation of ISO 15189 across all of these HFHS laboratory sites is no one-off management strategy. “Rather, this step was taken after a full 10-year journey to introduce Lean, Six Sigma, and process improvement techniques into the daily operations of our labs,” explained John Waugh, the System Vice President of Pathology and Laboratory Medicine at HFHS.

“Currently, we have outside ISO inspections at the laboratories of our five largest hospitals,” he said. “We operate to ISO standards at a total of 34 laboratory sites in our health system.”

According to Waugh, use of this QMS has measurably improved the productivity and performance of the clinical laboratory division at HFHS. “Our lab outreach program increased net revenue by $2 million,” he said. “Meanwhile, rates of errors—a metric to which we rigorously manage each day—decreased by 73%. For example, complaints associated with phlebotomy dropped by 64%.”

What makes these performance metrics impressive is the size of the laboratory division at Henry Ford Health System. Staffed by more than 700 people, the labs perform millions of tests annually for the system’s acute-care hospitals, nine emergency rooms, and 30 clinics in and around Detroit.

“In 2005, we began our Lean journey with a vision to create a world-class laboratory organization,” he stated. “One year later, in 2006, we developed the Henry Ford Production System.

“We started with three goals,” he continued. “One, to become a world-class laboratory organization. Two, to adopt a culture of relentless improvement; and three, to establish a culture in which the staff are taught Lean and empowered to use Lean.”

Implementing Lean Culture

Waugh described the first steps taken in 2005 to introduce, train, and sustain a Lean culture in the HFHS laboratories. “Our strategy was to establish visual environments throughout each area of the labs,” he noted. “We used simple visual controls and standardized work processes to accomplish this.

“At all times, we supported the goal of having laboratories that were safe, while also teaching the staff to understand the philosophies of Lean thinking, which means the language and the lexicon,” continued Waugh. “This was done by teaching them about 5S workspace and visual controls, and related techniques.

“Staff and managers were taught about the need to capture defects, make quick fixes, and use the plan-do-check-act (PDCA) cycle,” he said. “We also have standardized work, value stream mapping, single piece and unidirectional flow, kanbans, and we are trained to recognize and eliminate waste.

“All our lab’s Lean and process improvement team leaders go through two-day lean training courses that are taught by our staff and Richard J. Zarbo, MD,” added Waugh. “Zarbo is the Chair of Pathology at HFHS and Senior Vice President for Pathology and Laboratory Medicine.

“Additionally, our entire staff is trained in Lean,” he emphasized. “That means every pathologist, every technical and support staff, every secretary, every courier driver! Even our informatics people go through a minimum of eight hours of Lean training and we regularly conduct 15-minute Lean refresher modules.

“From 2005, when we started to introduce and train the staff in Lean,” said Waugh, “it took us until 2012 to achieve a culture of Lean and continuous improvement. That was the foundation for our next phase in this journey, which took three years.

“Going forward from 2012, having trained all the staff in Lean, our goal was for everyone on the lab staff to become owners. By that, we mean, ‘find your place. You’ve got a role here.’

Lessons From Manufacturing

“To do that, we borrowed a lot of examples from the automotive world,” recalled Waugh. “For example, on many occasions, we went on the Ford factory tour at the Ford F150 pickup truck assembly plant. We found excellent lessons from outside of healthcare and we’ve imported those in our laboratory environment and also into our health system.

“We are continually fascinated at the similarities between a manufacturing environment and what we do in clinical labs,” he said. “In manufacturing, they put things together. In clinical labs, it’s the reverse. We take apart tissue and blood and look at cells, proteins, biomarkers, and DNA.

“In many respects, it is a perfect fit if you run the factory model backwards in your laboratory workflow,” noted Waugh.

“By doing that, it is both easy and effective to adopt and apply those concepts within the laboratory to make process improvements that improve quality and contribute to better patient care.

“As is true in manufacturing, our lab formed a quality systems division,” he said. “Just as your lab needs experts in blood banking, chemistry, and microbiology, your lab also need experts in quality. This is an important lesson that’s easy to overlook.

Training Lab Staff In Lean

“Every lab needs people trained in Lean to do prep work, to gather data, to observe work processes, to plan meetings, and to teach new people how to work in this environment,” Waugh said. “The effort to improve quality is important work and, in a lab, it’s just as important as microbiology or chemistry.

“Our lab conducts monthly quality meetings that run 90 minutes long,” he continued. “Attendance is either in person or by dial-in. Typically 45 or 50 people participate each month.

“This is highly important because, if your lab does not spend enough time to have quality meetings once a month, it is not spending enough time on quality,” advised Waugh. “You have to put your money where your mouth is and make this investment in time for the Lean culture to take root in your lab and become a core value for the entire staff.

“As you can see, we did all this work in order to get Lean in place, but it was clear to all of us that we had to take it to the next level and create value,” he explained. “For our lab division, that next level was ISO 15189.

“Thus, in 2012, our next step in our quality journey was to get our labs accredited to ISO 15189 under the College of American Pathology,” stated Waugh. “Having already established a quality culture built around Lean, much of the preparatory work for an ISO accreditation was already in place. Thus, we invited a team from CAP to come in and conduct an ISO gap inspection.

“The gap analysis team was impressed with what we had done but they also found a number of gaps that we needed to close,” he recalled. “At that meeting to report those gaps, they looked at us and said, ‘You’re ready. We’ll see you in six months.’

accreditation assessment

“That meant they were coming back for the real ISO 15189 inspection in six months and our lab still had a lot of gaps to fill,” explained Waugh. “Having reached this point, we were determined to succeed in our effort to earn the ISO accreditation,” Waugh explained.

This was an opportunity for yet another lesson learned. “The lab staff and the lab leaders were already engaged in the daily application of Lean methods,” he said. “Now, the ISO accreditation initiative would require them to address and fill all the gaps during the next six months.

“Thus, staff began to pepper us with such questions as, ‘Is ISO 15189 important? Do we really need to do this?’” continued Waugh. “Our management team always had a consistent answer, ‘Yes, we really do have to do this. ISO 15189 is the train we’re on. It has left the station. We’re going. If you can’t do it Tuesday, do it on Wednesday. If you don’t think you can do it, we have people to help and if that doesn’t work, we’ll help you. I’ll help you get there because earning ISO 15189 accreditation is important.’

“In fact, how we engaged the entire lab staff during this time was an important take-home lesson for all of us,” emphasized Waugh. “The lesson is that we had great quality leaders and we paired them with people that lead operations.

“By doing this, we created partnerships within all sections of the lab, which is important because this work is hard for any one group to do alone,” he explained. “Partnership is one ingredient in a successful Lean journey for a clinical laboratory. In fact, I consider partnership to be the ‘secret sauce’ in achieving these ambitious goals.”

Use of huddle Boards

Waugh then described another strategy borrowed from industry that played a important role in the HFHS lab’s ISO implementation. “We created what we call huddle boards. That was another tactic that we took from manufacturing,” he said. “Huddle boards started with the idea that we need to focus on five elements: quality, timeliness, inventory, productivity, and safety. Or ‘QTIPS’ as everyone in our lab calls these elements.

“These five terms are used every day, particularly during team huddles,” Waugh continued. “Huddle boards are built around these terms. However, staff build their own huddle boards according to what they think are the most important factors for their area of work.

“Each team builds their own version,” he said. “We gave them the tools and said they didn’t even have to use the term QTIPS. And, some used QTIPS and some didn’t. Either way, it was for them to use in their work area. Remember, people who are closest to the work know how to fix things, but only if management gets out of their way!

“To support this independent problem-solving and process improvement, huddle boards are always posted closest to where the staff participates in that daily huddle work,” he stated.

Unique Milestone

Because of this focused effort, the example the lab administration set, and the engagement of the entire laboratory staff, the laboratory division at Henry Ford Health System achieved a milestone unique among laboratories in the United States. “In September 2013, we earned accreditation to CAP 15189,” noted Waugh. “This accreditation covered the laboratories at the five largest hospitals operated by HFHS. This is the first multi-hospital lab 15189 accreditation in the United States.”

As noted earlier, in parallel with the effort to implement the QMS of ISO 15189 in the eight hospitals, this same QMS was implemented in the other 34 laboratory sites within the HFHS laboratory division. “There were a number of reasons why we opted for this approach, including cost and the added time required to accommodate accreditation activities,” stated Waugh. “What was important for us was that every laboratory site in our system now operates from a single QMS. Our staff understands these requirements and this adds flexibility when staff members work at other laboratory sites.”

adding Value For Clinicians

Having achieved the goal of accreditation to ISO 15189, lab administration was ready to look for ways to add value to its lab testing services. “It took a lot of work to implement Lean and get accredited to CAP’s version of ISO 15189,” recalled Waugh. “Yet, these remarkable accomplishments were just the first major steps. It was time to leverage the talents and expertise of our lab team to achieve a higher level of quality in how our lab contributes to patient care.

“One starting point was to assess how we could improve our lab’s targets,” noted Waugh. “For example, did we have any targets that were at 90%? If your car started 90% of the time, you’d walk home, once every two weeks!

“Quality management teaches that the best way to set your targets is to base them on the needs of your customers,” he said. “This is not what happens in most of healthcare. In healthcare, we hear a lot about being at the median and stretching to get to the 75th percentile. It is time for the clinical lab industry to stop focusing on yesterday’s level of quality. That was great for yesterday, but it won’t get our labs to the level needed to support the reforms now happening in healthcare.

“Here’s an example. In our critical values area, each day we make 150 calls from the laboratory to the ordering physicians,” observed Waugh. “The people in that area of the laboratory know that these calls are about patients.

addressing Critical Values

“We make these calls to ensure patient safety and it’s important that 100% of critical values are called,” he explained. “We have a visible system to ensure we call 100% of critical values. If this team misses one call out of 150, they got a red dot for the day.

“This is not a computer-generated thing,” Waugh noted. “A felt-tip marker is used to color in the chart used in the daily huddles. This is so the staff in that department can own the process right where they work. Behind every red dot is a patient. That’s what makes this work critically important.

“Patient safety is an area of critical concern to clinicians,” emphasized Waugh. “We know that. And we know that an area of critical concern to healthcare executives is reimbursement, which is healthcare’s 900-pound gorilla.

“We can track increased revenue to our lab because of our Lean culture and how we use Lean tools throughout the system,” he noted. “We can measure how these capabilities, along with our lab’s accreditation to ISO 15189, all contribute to better lab reimbursement.”

Waugh said that one essential requirement when looking for opportunities to add value is to understand the lab’s current performance level with its individual work processes. “Take the pre-analytical and analytical stages in lab testing,” he commented. “We are diligent about measuring the performance of the processes within these stages. This allows our lab team to internally benchmark themselves and understand how to drive performance to higher levels.

“Since 2005, we’ve devoted considerable attention and resources to improve our lab’s performance in the pre-analytic, analytic, and post-analytic stages,” continued Waugh. “Now our focus is on increasing the value of our lab testing services to our clinicians and our parent health system.

“One area in which we recognized the opportunity to add value involved our post-analytic processes to deliver outpatient results,” he stated. “Improvements to our work processes for lab test reporting meant that we began to have physicians tell us their patients got their lab results before the physicians did!

Physicians told us that their patients were calling on the phone to ask for an explanation of their test results,” noted Waugh. “The patients wanted to know, ‘What is this bun [lab test result]?’

reporting results Faster

“This happened because our process improvement efforts enabled us to report those tests which were not cultures or send-out tests on the same day we received the specimen,” said Waugh. “Outpatient tests reported by midnight went from 50% to 90%! Even better, we improved to the point where we were pushing 98% of our results out by 6 AM the next morning. We’ve been doing that for five years. Those are very good turnaround times.

“Here’s another example, also from our lab outreach program,” observed Waugh. “Because of the increased efficiency and productivity of our lab, we were able to grow our net revenue by about $2 million in just over 24 months. That is tangible value creation for our health system.

“We also cut turnaround times for emergency department and for inpatient lab testing,” he noted. “Our lab went from delivering 90% of our emergency room stat tests within 60 minutes to delivering 90% those tests within 30 to 35 minutes. Troponin TAT was cut to just 35 minutes with 95% performance. For inpatient lab testing, the time it took us to deliver 90% of inpatient stat tests fell from 90 minutes to just 45 minutes.

phlebotomy Dashboard

“By introducing a phlebotomy dashboard we cut phlebotomy wait times sharply and now we’re introducing online appointment scheduling for patients who need to have blood drawn. Now they can schedule that in advance,” explained Waugh.

“In summary, along the way, we had our share of missteps in introducing Lean and achieving ISO 15189 accreditation,” recalled Waugh. “But most of what we did, we did well for several reasons.

“First, we gathered accurate data and used it to inform improvement efforts,” he said. “Second, the partnerships we developed between lab management and lab staff were an important and lasting achievement.

“Third, and probably the most important element in our success, is something many clinical labs and pathology groups fail to recognize: There are great tactics and strategies outside of healthcare that we can adapt to healthcare and to clinical laboratory testing.

“That is why I advise labs to steal shamelessly from anybody they can,” advised Waugh. “Here at HFHS labs, we will give your company full credit as long as we can adapt your ideas to solve problems in our lab that contribute to improved patient care and lower healthcare costs!”

Contact John Waugh at 313-916-2323 or jwaugh1@hfhs.org.

Multi-Year Journey to Develop Lean Culture At Henry Ford Health System Laboratories

Screenshot 2016-03-04 10.40.40

Accreditation to ISO 15189 happened at the Henry Ford Health System laboratories only after the lab staff had been trained in the principles of Lean and Lean methods were in use in every department of every laboratory. The Lean effort began in 2005 and, by 2012, the lab leadership considered the timing right to introduce ISO 15189.

Lab Uses New Diagnostic Technology to Cut Turnaround Times and Hospital Length of Stay

WHEN MAKING PROCESS IMPROVEMENTS in any clinical lab, pathologists and lab directors are likely to introduce new analyzers. That’s just what happened at the Henry Ford Health System.

“Right now, we have the coolest new tools in the laboratory of anybody in healthcare,” said John Waugh, HFHS’ System Vice President of Pathology and Laboratory Medicine. “That includes equipment for next-generation sequencing and mass spectrometry with matrix-assisted laser desorption ionization time-of-flight. We use MALDI-TOF MS as an analytical method for microbial identification and characterization based on the fast and precise assessment of the mass of molecules in pathogens.

“Under the leadership of pathologist Gurav Sharma, MD, we use the results from these new tools to reduce length of stay from bloodstream infections and reduce medication costs,” he noted. “Sharma is a Senior Staff Pathologist and Associate Medical Director of the Core Laboratory, Quality Systems and Regulatory Affairs at HFHS.

“With MALDI-TOF we have improved workflow by about 50%,” Waugh explained. “We did so by cutting the time required to identify a bacterial-infection pathogen from 2.2 days to one day and by slashing the time required to identify yeast infections from four days to 1.4 days.

“Since 2014, these improvements in our microorganism identification time enabled us to go from reporting 50% of outpatient tests by midnight of the same day to 90% by midnight of the same day,” stated Waugh. “Further, we report 98% of these pathogens by 6 am the next day.

“Cutting the time to identify infections allows us to decrease length of stay for sepsis patients by 33%,” he said. “This is significant given how much it costs for a patient to spend one day in a hospital.

“Candida is a good example,” added Waugh. “For patients with candida, we found that use of MALDI-TOF MS allowed us to reduce the length of stay by 30%, saving $4,500 per day for these patients!”


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