Preface

Healthcare professionals are doing the best they can, but there is tremendous room for improvement. In 2005, H. James Harrington reported that an estimated 2.2+ million people around the world die as a result of a healthcare error every year. One in seven Medicare beneficiaries suffers a preventable serious adverse event during a hospital stay. Every year, 2 million patients in the United States get an infection while hospitalized. Every six minutes, one of these patients dies as a result of a hospital-acquired infection (88,000 people per year), adding $5 billion to the cost of healthcare; 95 percent of these cases are preventable (83,500). Estimates for 2010 show that 99,000 people die of hospital-acquired infections (HAIs).

At the latest Institute for Healthcare Improvement conference in 2015, Memorial Hermann Health System reported zero HAIs in many of its hospitals for several years running. That's right—zero central line-associated bloodstream infections (CLABSIs), zero catheter-associated urinary tract infections (CAUTIs), zero ventilator-assisted pneumonia (VAP), zero surgical-site infections (SSIs), zero methicillin-resistant Staphylococcus aureus (MRSA) infections, and zero Clostridium difficile infections. The new standard is zero HAIs! How did they do it? By becoming a high-reliability organization (HRO). High reliability involves simplifying systems and processes so that they can be performed consistently. This is what Lean Six Sigma can do—simplify, streamline, and optimize performance. HROs have mastered three methodologies: Lean, Six Sigma, and change management.

Based on my experience at the Institute for Healthcare Improvement's 2015 conference, the future of healthcare quality involves becoming an HRO. HROs use methods from commercial aviation and nuclear power to eliminate mistakes and errors or respond aggressively to keep them from escalating. Memorial Hermann gives out zero awards for hospitals sustaining zero harm over 12 months. Over the past two years, South Carolina Hospital Association hospitals have earned 148 zero harm awards (www.scha.org/public/care).

The new standard arising from these efforts is zero harm.

What is an HRO? HROs manage the unexpected using a point of view that may not be familiar to most people. HROs use doubt as a mindset. HROs are:

• Preoccupied with failure. They detect and respond to weak signals and small failures before they escalate. Fixing problems when they are small is easier than when they begin to combine in catastrophic ways. In healthcare, we see this in rapid-response teams that respond to small declines in a patient's vital signs. HROs also anticipate significant mistakes and prevent them. But we haven't seen this kind of thinking across the hospital. Memorial Hermann uses a one-second stop—called STAR (Stop, Think, Act, and Review)—before taking an action such as injecting a medication. This one-second stop has reduced errors by 90 percent.

• Reluctant to accept simplifications. The first insight about a problem may be wrong or incomplete. Simplification can hide details that prevent successful response. HROs look more deeply to identify underlying disturbances and respond. HROs look for complexity hidden under simplicity (data analysis).

• Sensitive to operations. HROs interpret close calls as danger signs. A near miss is not a success but a sign that the system is vulnerable. It's a clue.

• Committed to resilience. HROs rapidly adapt and bounce back from mistakes and errors—especially those that are totally unexpected.

• Defer to experts. No matter their rank or credentials. HROs push decision making down to the front line. At Virginia Mason Medical Center, anyone can call a patient safety alert (PSA). It's important for everyone to speak up because you may see something that others do not.

Managing adaptive change involves five steps for discussing and responding to surprises:

1. Situation. Here's what's going on.

2. Task. Here's what we should do about it.

3. Intent. Here's why we should do it.

4. Concerns. Here's what could go wrong.

5. Calibrate. Tell me if you don't understand or see something I don't.

Does your hospital actively focus on failures as an opportunity to learn, or does it hide failures? Can everyone talk freely about problems and have their concerns addressed? Is questioning encouraged?

HROs consider values to be core beliefs about how they do business. Memorial Hermann set its core value as safety (patients and employees) and then moved everything into alignment with that value. It was not easy. Transforming how people do things to an HRO culture takes time and commitment. It takes

• Top-management commitment and consistency of action. Leadership has to walk the talk.

• Reward systems have to align to reward people who embrace high reliability and punish those who don't.

Sustaining the change is always the hardest part of any change initiative. I've heard many stories of successful improvements eroding over a few months and falling back to previous levels. HROs continue to examine failure as a "window on the health of the system" and adapt and respond. While HROs may never achieve total safety, they pursue it relentlessly.

Ask yourself, "What problems am I trying to solve?" Then ask, "Does the culture support or hinder the solutions?" If the culture hinders response, consider how to use existing strengths to transform reluctance.

The Institute for Healthcare Improvement (IHI) calls the process of developing a high-reliability organization Robust Process Improvement. It involves using Lean Six Sigma and change management to continuously simplify, streamline, analyze, and optimize hospital performance clinically and operationally. Lean accelerates patient flow by eliminating delays and unnecessary motion. Lean alone will reduce mistakes and errors by half. Six Sigma systematically identifies the most frequent or costly type of error and eliminates it. Together, Lean Six Sigma can lead a hospital to zero harm. Learn more about HROs at archive.ahrq.gov/professionals/quality-patient-safety/quality-resources/tools/hroadvice/hroadvice.pdf.

Why is zero harm important? Of the 3 billion prescriptions filled each year, 150 million are filled incorrectly. Two hospital patients out of every 100 (660,000) suffer adverse drug reactions resulting in increased length of stay (LOS) and $4,000 in additional costs. An estimated 7,000 patients will die as a result of a medication error. In addition, 2.5 percent of hospitalized patients suffer preventable adverse events, and 1,500 surgical patients per year suffer from "left-ins" such as sponges or instruments. A 2003 New England Journal of Medicine study estimated that this happens once in every 1,000 surgeries. One in five orthopedic surgeons will conduct a wrong-site surgery during his or her career. One of my wife's sister's father-in-laws died after having the wrong leg amputated.

One New England hospital had three wrong-side brain surgeries in one year. In 2008, a doctor failed to diagnose my mother's colon cancer for four months. My wife's sister has had extended complications from a perforated colon caused by a colonoscopy. My wife's father died from a botched back surgery. Most healthcare workers tell me that medical mistakes are underreported by a factor of 2 or 4.

The IHI says that 50 patients out of every 100 will suffer some form of preventable "harm" while hospitalized. That's over 17 million patients a year.

And patients aren't the only people affected by healthcare problems. It is reported that 50 percent of hospitals have financial difficulties. Between 1986 and 1989, financial distress forced 231 acute-care hospitals to close, whereas 70 percent of rural hospitals and 50 percent of urban institutions were fighting to stay afloat. With 70 to 80 hospitals expected to close each year through the 1990s, the outlook was grim. The Journal of Healthcare Management reported that between 2000 and 2006, 42 U.S. acute-care hospitals filed for bankruptcy protection under federal law, and 67 percent of those hospitals stopped operating. The Internet even has articles about how to file for bankruptcy as a hospital. How can an industry producing 20 percent of the gross domestic product (GDP) be so sick?

Moreover, the costs of healthcare don't only affect the industry; they threaten the livelihood of patients and their families. From a patient's perspective, medical bills were involved in 60 percent of personal bankruptcy cases in 2007. The Portland Tribune reported in 2008 that Oregon hospitals wrote off nearly $450 million in debts from bills that patients were unable to pay. The high cost of healthcare is pushing patients into bankruptcy, and poor management of costs and receivables is pushing hospitals into bankruptcy. Lean Six Sigma can lower costs for both hospitals and patients while delivering superior profits, performance, and patient outcomes.

Having consulted with many hospitals and healthcare systems, I have seen that the problems of patient flow, clinical mistakes, and operational errors are the same across the industry. Fortunately, Lean Six Sigma can solve these problems. The hard part is getting the hospital culture to adopt the improvements of Lean Six Sigma and sustain them.

A 2009 American Society for Quality study of 77 hospitals found that:

• 53 percent use some form of Lean.

• Only 4 percent had fully implemented Lean.

• 42 percent had some form of Six Sigma.

• Only 8 percent had fully implemented Six Sigma.

• 11 percent were unfamiliar with either Lean or Six Sigma.

Most healthcare systems have gone through a number of implementations of process improvement (PI) or total quality management (TQM). While most healthcare workers have been dipped in some method for quality improvement, few have applied it successfully. This book is about applied Lean Six Sigma, not theoretical Lean Six Sigma.

Sister Mary Jean Ryan of SSM Health Care says that with Lean Six Sigma, it's possible to achieve "breathtakingly better health care." She also says that it takes "superhuman tenacity" to make Lean Six Sigma part of a hospital culture.

With healthcare reform all the buzz in Washington, most healthcare workers are hoping that they can just keep on going about their business and that the government will find a way to pay for universal healthcare for tens of millions of uninsured patients. To make healthcare affordable for all, however, healthcare will have to contribute dramatic cost savings.

Healthcare in America costs over $2.7 trillion dollars (Figure 1) and is expected to climb to $3.1 trillion by 2020, according to the National Coalition on Healthcare. Two point seven trillion dollars is a stack of $1,000 bills towering 168 miles high—essentially what the space administration considers low-earth orbit. The costs of waste and rework in any business, including healthcare, will range from 25 to 40 percent of the total ($800 billion to $1 trillion says Paul O'Neill, former U.S. Treasury Secretary).

"The U.S. healthcare system wastes $700 billion annually on the kinds of systemic inefficiencies that would make a quality management guru cringe," says Robert Kelly, vice president of healthcare analytics at Thomson Reuters. "About one-third of the country's total healthcare spending may be for unnecessary treatments, medical errors, redundant tests, administrative inefficiencies, and fraud." And that's just the cost to the healthcare industry; it doesn't include the cost to patients, their families, and society, which is perhaps 10 times higher ($10 trillion).

Years ago, my friend Janet was diagnosed with breast cancer. At the time, doctors were pushing $50,000 to $150,000 bone marrow transplants as a treatment to reboot the immune system. Clinical trials found that the treatment didn't work. Janet eventually opted for a mastectomy, although clinical trials have shown lumpectomies to work equally well.

In a 2007 IHI speech, "Eating Soup with a Fork," Don Berwick discussed existing treatments such as radical mastectomy for breast cancer. Although radical mastectomy has been the standard for over 80 years, there's no systematic evidence that it actually works. "Get out of storytelling. Get into data."

In a 2003 IHI speech, "My Right Knee," Don Berwick described his own experience with having an unnecessary knee surgery when he was a medical student that led to unnecessary pain and a potential joint replacement. From his experience, he points out the IHI's results-oriented goals: no needless death (don't kill me) or pain (don't hurt me), no helplessness (share information and give me choices), no unwanted waiting (don't waste my time), and no waste (no unnecessary tests or treatment).

An estimated 400,000 angioplasties each year are unnecessary according to Harvard Medical School's Dr. Roger J. Laham. According to IHI, $210 billion is wasted each year on overtreatment. Medicare found that aggressive treatment unnecessarily kills 30,000 patients a year.

Hospitals represent almost a third of healthcare costs (Figure 2). Hospitals are expected to deliver $113 billion of the $196 billion in savings mandated by "Obamacare." Each of the nation's hospitals must cut $2.6 million a year.

• One patient out of 100 admitted to a hospital will die as a result of a medical mistake (To Err Is Human, National Academy Press, 2000). With over 41 million admissions, this means that there could be 410,000 preventable deaths each year, making healthcare one of the top 10 causes of death in the United States. The 2008 National Healthcare Quality Report found "that patient safety has actually been getting worse instead of better…. One in seven Medicare patients experiences one or more adverse events, and thousands of patients develop central-line-associated bloodstream infections each year." While the IHI's "100,000 Lives" campaign hoped to reduce the preventable mortality rate, John Eisenberg, late director of the Agency for Healthcare Research and Quality (AHRQ), likened the problem of medical errors to an epidemic. A 2009 Joint Commission Journal article stated that healthcare doesn't know if preventable deaths are actually any better because healthcare doesn't measure them.

• Another 6 out of 100 patients will be permanently disabled as a result of a medical mistake.

• The IHI found that one patient out of every two (50 percent) suffered some form of preventable harm in the hospital. The IHI's "5 Million Lives" campaign hoped to reduce this.

• Fifteen out of every 100 diagnoses are incorrect.

• Twenty to fifty out of 100 diagnostic procedures (e.g., imaging) should never have been done because their results did not help to diagnose ailments or treat patients.

• Five to ten out of every 100 admitted patients acquire an infection.

• Three patients out of every 100 have an incorrect ID band.

• The average hospital spends one-quarter of its budget on billing and administration.

Get the idea? Healthcare is rife with possibilities for improvement. Lean Six Sigma can help to minimize or eliminate all these problems. But healthcare clinicians and operational personnel have got to want to face the issues head-on and change the way healthcare is delivered to ensure better patient outcomes, faster service, and a better all-around experience.

The Institute of Medicine (IOM) set out six achievable goals:

• Patient safety. Error-free care.

• Effective treatment.

• Patient-centered care (rather than physician-centered care) that optimizes the patient's experience, not the clinician's time.

• Timeliness. Reducing wait times and dangerous delays using Lean.

• Efficiency. Removing "waste" from the process using Lean.

• Equitable care.

While most visits to the emergency room (ER; many hospitals call it the Emergency Department) take two hours or more, Robert Wood Johnson Hospital in New Jersey (Baldridge Award winner in 2004) does it in 38 minutes, on average. The hospital offers a 30-minute door-to-doctor guarantee. The hospital did it by rethinking the emergency experience from the patient's point of view. For busy soccer moms with a sick kid, the choice between ERs is easy; they can save 80 minutes by going to the fastest ER.

And the clinical side isn't the only issue. Healthcare operations—billing, ordering, etc.—waste even more money. Insurance companies are quick to reject claims and slow to pay, which causes more problems. I worked with one company that found ways to reduce denied claims from a single insurer and to start reaping an extra $5 million a year.

The solution is simple. Most healthcare processes are set up like an assembly line, where the patient moves from station to station for treatment. The methods of Lean manufacturing can be applied to healthcare to get a faster hospital in five days.

It's easy to get a better hospital (i.e., safer, less error prone) in five days using a few key tools from Six Sigma. When you count and categorize the medical mistakes and operational errors, it becomes easy to see where the process or procedures are broken and how to fix them. And problems aren't spread all over like butter on bread; they cluster in a few key areas.

The good news is that any hospital can start today; the bad news is that they will never be finished. With focused effort, healthcare easily could save $1 trillion by 2020.

Lean Six Sigma is, first of all, a mindset for solving specific problems surrounding the three demons of quality: delay, defects, and deviation. From a healthcare perspective, this means patient flow, turnaround times, medication errors, bloodstream infections, and so on.

Second, it's easy to apply the methods and tools of Lean Six Sigma. Using Post-it Notes, it's easy to diagnose unnecessary delays in patient diagnosis, treatment, and flow. Post-it Notes make it easy to diagnose delays in operational processes as well. Using Microsoft Excel, it's easy to diagnose the root causes of mistakes, errors, and defects in clinical and operational processes.

Now for the bad news: most businesses, while profitable, are barely at 3 sigma (6 percent error rate) in performance. And this includes healthcare.

And now the good news: a handful of tools will take you from 3 to 5 sigma (0.03 percent error rate) in as few as 24 months. Yes, there is some statistical stuff, but it's easily handled by simple software that you can download free for 90 days. The QI Macros Lean Six Sigma software is an add-on for Microsoft Excel that is so easy to use that most people say that they can learn it in about five minutes. Forget all the fancy formulas. The QI Macros will do that for you. Just focus on what the graphs are telling you about how to improve the hospital. Since most business data are already kept in Excel or easily exported to Excel, you can get started using the tools right away. Without software, Six Sigma becomes too laborious for even the smartest employee, so the QI Macros will make it easy. You can download your free 90-day trial from www.qimacros.com/trial/hospitalbook. There are even free webinars on Lean Six Sigma and the QI Macros at www.qimacros.com/training/lean-six-sigma-for-healthcare-webinar/.

Pioneering hospitals such as Virginia Mason, Cleveland Clinic, Mayo Clinic, Memorial Hermann, and many others have started using the Toyota Production System (aka Lean) and Six Sigma to make dramatic improvements in all aspects of healthcare. SSM Health Care in St. Louis and the Pittsburgh Regional Healthcare Initiative have used Lean Six Sigma to:

• Reduce coronary bypass readmissions by 4.7 percent, saving $1.7 million.

• Reduce coronary bypass mortality by 25 percent "using a 3-cent aspirin and a 50-cent beta blocker in the emergency room."

• Reduce hospital-acquired infections by 85 percent, saving $30,000 per infection.

• Reduce central-line infections by 63 percent.

• Reduce medication errors from 16 to 1 per 100,000.

Get the idea? Dramatic improvements are possible; most are simple, inexpensive, and good for patients as well as employee satisfaction and the bottom line.

The mindset, methods, and tools of Lean Six Sigma are simple and easy to learn. Getting your healthcare culture to adopt these methods, tools, and mindsets is the real challenge. If your employees are like most employees, they've experienced too many panaceas and programs of the month. Your hospital probably tried process improvement off and on all through the 1990s. It's hard to keep Lean Six Sigma from ending up in the junkyard of failed culture changes.

Most Lean Six Sigma books and programs dive into the top-down endless training required to implement Lean Six Sigma. I call this the wall-to-wall, floor-to-ceiling approach to Lean Six Sigma. Unfortunately, research has shown that this method fails at least half the time. There are better ways to use the tools of Lean Six Sigma to get the results and culture change so often needed.

The best way, I have found, is to focus key personnel on making healthcare faster, better, and cheaper using only a handful of tools from the Lean Six Sigma toolkit. A pad of Post-it Notes and a flipchart can help you to identify ways to cut turnaround times by 50 percent or more from the emergency department to discharge. Control charts and Pareto charts will take any facility from 3 to 5 sigma in 18 to 24 months. Most of these improvements can be discovered in two to four hours. It may take a few days to implement the changes, but the solutions can be discovered quickly.

Healthcare employees want to do a good job. Give them the experience of using the methods and tools of Lean Six Sigma to make big improvements in the speed and quality of care, and they will embrace it. People learn best by doing. Burden them with week-long trainings and you will lose them. I've worked with many teams in healthcare, and here's what I have learned:

This is why this book will focus on simple steps to start getting faster, better, and cheaper in five days or less while achieving the goal of fast, affordable, and flawless healthcare.