Ancef

A Six Sigma project at Sewickley (PA) Valley Hospital has achieved dramatic results--including 100% compliance in one process--in just three short months.

The project is part of an overall initiative in the Heritage Valley Health System (HVHS), which includes Sewickley Valley, Heritage Valley Hospital, 49 physician offices, the Moon Surgery Center, and 14 community satellite facilities. It was rolled out in 2001, in partnership with Air Academy Associates.

After educating its executive leadership team on Six Sigma, a few pilot projects were implemented, including efforts in evaluating the patient admission process to observation or inpatient status, and a study of operating room utilization. After positive results, the next step was to train all leaders to the Champion level.

In August 2002, 22 employees were sent off campus for Black Belt training. At the same time, two half-day Six Sigma education sessions were provided to the board of directors and physician leaders.

A number of projects with clinical goals (five or six to date) have been undertaken, including the aforementioned initiative, which was one of several projects for which training took place in December 2003. "This was a midproject report," notes Richard Beaver, vice president of quality for HVHS. "They have until July to submit their final reports." (Beaver completed leadership training at the Center for Creative Leadership and obtained Six Sigma Black Belt status at Sony and Nova Chemicals under the curriculum and mentoring of Air Academy Associates.)

The project's overall objective was the prevention of surgical site infections by proper timing of the appropriate prophylactic antibiotic. Critical areas identified were:

* Use of appropriate prophylactic antibiotic.

* Antibiotic received within one hour before surgical incision.

* Prophylactic antibiotics discontinued within 24 hours of surgery end time.

Prolonged antibiotics, the team said, are "expensive, promote resistance, and subject the patient to increased antibiotic-associated morbidity."

The first target group was joint replacement procedures, which at Sewickley were high-volume, high-cost procedures. Compliance in "antibiotic administered within one hour of surgical incision" was 19% when the project began, and 100% when the interim report was prepared. "Antibiotic discontinued within 24 hours of surgery" showed 3% pre-measurement compliance and 79% post-measurement.

As with all the Six Sigma projects at HVHS, in this Sewickley initiative, the DMAIC (define-measure-analyze-improve-control) methodology was followed. The first two weeks of the HVHS program are designed to cover all five phases of DMAIC. The first week provides the basic tools needed to identify issues, gather data through the measure phase, and analyze them for potential root causes of process performance problems. The second week--which occurs after a five-week period during which students apply DMAIC methods to their projects--includes the improvement phase as well as understanding project management and how to sustain the gains received from their efforts.

* Define.

This phase involved identifying the project, its general goals and objectives, what the team thinks it already knows, business benefits of the project, and a time line. In this case, the goals/objectives included benchmarking against previous administration of pre/postoperative prophylactic antibiotics and benchmarking internally against previous nosocomial infection rates.

* Measure.

The measure phase starts with a process flow diagram and cause and effect and input/output diagrams for individual contributions around the process that cause problems and might be subjects of experimentation. "Then, we use (P)FMEA," Beaver continues. The "P," he explains, represents "the potential failures in the process flow we just reviewed."

* Analyze.

Analysis, in this particular project, would involve asking what percentage of physicians actually "did it correctly" one hour before and 24 hours after surgery, with proper use of antibiotics (the orthopedic surgeons designated Ancef as the drug of choice and eliminated Vancomycin). "We used a data table kept in the OR and plugged it into the software we have called SPC-XL from Air Academy," notes Beaver.

Analysis also involves learning what the diagrams in the measure phase told you. "FMEA tells you the potential failure modes; you pull them out, rank them, and analyze them to see if you identified the top three, four, or 10 causes with regard to the problem," Beaver explains. "As part of the analysis, you ask how difficult these will be. For example, can we truly change the behavior of surgeons? Now that we know they are not compliant, how do we take things to the improve phase to generate that improvement?"

For one thing, Beaver says, no clinical improvement project can be successful without a physician leader or mentor. "This project had our lead mentor on it; it was his interaction that drove it," he asserts.

Integrating physicians into performance improvement is an ongoing struggle in health care, Beaver continues. At HVHS, "we team them up with four hours of very difficult-to-get CME credit in Six Sigma," he observes. So far, 100 physicians have been trained, and 11 of them have said they want to be a leader or a mentor. "This is an important piece for clinical quality in Six Sigma," says Beaver. "If you don't have the physician, you will not have an outcome."

* Improve.

In the improve phase, the message is driven home peer-to-peer, using evidence-based data. "Once adopted, it was presented at the surgery committee, which was a very good methodical process to get it shared," Beaver says. "It was also done as part of grand rounds."

The results speak for themselves. Total potential savings for one year for preoperative antibiotics were $1,323, and for postoperative, $6,501; potential antibiotic savings were $7,824 per year.

"And that's just one service line in orthopedic surgery on one campus," Beaver notes. "It's now being spread and adopted by our larger sister facility; we believe the impact will be over $50,000 in medication savings. Also, we expect reduced Vancomycin-resistant infections in patients."

In addition, he notes, instead of giving eight doses per surgery of two meds, three doses of one med are now being given. "This reduces the number of times a doctor has to write orders, for the nurse to take them and for the pharmacist to fill them--all opportunities for errors."

* Control.

In the control phase, the improvement is sustained.

Need More Information?

For more information, contact:

* Richard Beaver, Vice President of Quality, Heritage Valley Health System, Sewickley, PA. Phone: (412)302-9900. E-mail: rbeaver@hvhs.org.

Key Points

* Success demonstrates applicability to improving clinical performance.

* The define-measure-analyze-improve-control methodology is critical to impact of the program.

* Savings in single service line now are spreading to entire system.

Six Sigma: How it's different

A Six Sigma project is not just another QI initiative, says Richard Beaver, vice president of quality for Heritage Valley Health System, which includes Sewickley (PA) Valley Hospital, Heritage Valley Hospital, 49 physician offices, the Moon Surgery Center, and 14 community satellite facilities.

"It's a very interesting dynamic," he observes. "If you do TQM or something like that, you'd say, 'That Six Sigma stuff is the same thing we do.' Here, they had a five-step TQM process. You defined the problem, applied a quick fix, but no one could tell you the next three steps. The old ways weren't the closed-loop processes I believe Six Sigma delivers."

In this antibiotic project (see article, p. 52), Beaver says the surgeons felt they already were doing well.

"But when you see the data that 3% of every case gets it right, that means 97% are getting it wrong. The other thing is, the guidelines did not say anything about the application of two antibiotics; just the timing. Information from the CDC [Centers for Disease Control and Prevention] helped us tell the surgeons about proper antibiotic use." In fact, he notes, after most surgeons had successfully adopted the new procedures, there was one surgeon who kept refusing to change. "He felt it was appropriate to do two or three more days of drug administration," Beaver says.

That's when the team leader, Sandy Silvestri, RN, BSN, CIC-infection control coordinator, stepped in. "She said, 'I have a friend at the CDC who will call him to discuss proper administration'; now that's closing the loop," says Beaver.

Another strength of the Six Sigma approach is the DMAIC (define-measure-analyze-improve-control) methodology, says Beaver. 'Where is an imaginary wall between A [analyze] and I [improve]," he explains. "You can't go to the improve phase with Six Sigma until you have presented your data. This tells you that you don't go into the control phase [sustaining the change] until there's enough improvement."

The success at Sewickley also shows that, contrary to popular belief, the Six Sigma approach can be applied to clinical process improvement.

"Yes, there is some variation; the patient does provide much more variation than you would find in an industrial system," Beaver concedes. "But our argument is, once you know what the patient has, there are national standards of treatment--like ACE inhibitors upon discharge if not contraindicated. There are data."

Six Sigma also has brought discipline to his entire organization, Beaver says. "People who have seen our projects will write any presentation in DMAIC format," he notes. "And when someone comes in to present to senior management and the executive doesn't see those slides, they ask why they are not being provided."

The changes at Heritage Valley have been so dramatic that Beaver has spun off a business venture, teaching Six Sigma techniques to other facilities. "The reason we've done this is that there is a piece of Six Sigma we don't think anybody does," he explains. "They don't teach you how to set up the organization and the students so they are fully energized and have understanding of what Six Sigma means to them."

Beaver's partner teaches the Black Belt course, injecting real-world examples. "But before he even touches a student, I work with them for two months so that the senior managers and the team are ready," he says. "Most people don't really talk about the extreme importance of all leaders really being aligned with the flow of what's coming."

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