All organizations are sick.
— BOAZ RONEN
Health care is a terminal illness for America's governments and businesses. We are in big trouble.
—CLAYTON M. CHRISTENSEN
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.
Zero defects is the only acceptable goal in health care.
—GARY S KAPLAN, MD, CEO OF VIRGINIA MASON MEDICAL CENTER
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.
You need to plan the way a fire department plans: It cannot anticipate where the next fire will be, so it has to shape an energetic and efficient team that is capable of responding to the unanticipated as well as to any ordinary event.
—ANDREW S. GROVE, ONLY THE PARANOID SURVIVE
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:
Situation. Here's what's going on.
Task. Here's what we should do about it.
Intent. Here's why we should do it.
Concerns. Here's what could go wrong.
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
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.