Welcome to episode three, in which we will focus on the quality improvement process itself. Although much of what we have addressed so far are essential preliminary steps, we'll use the term quality improvement as an overarching term that includes a broad array of improvement activities including those related to enhancing safety. Within the modern era, systematic efforts to address improvement in safety and quality can be traced back to Western Electric in the early 1900s. Western Electric was an electrical engineering company that manufactured parts for communications and was the supplier of parts to Bell Telephone, and subsequently to AT&T. Western Electric was regarded as an incubator of ideas that created projects such as the loudspeaker, brought sound to motion pictures, and even invented the practical vacuum tube. The company not only fostered innovation, they also focused on quality and spawned three notable leaders of quality improvement who transformed business practices worldwide. Walter Shewart came to Western Electric first and was joined by and greatly influenced Edward Deming and Joseph Juran, who then spent their lifetimes advancing and adding to Shewart's work. Shewart is credited with developing the statistical process control system and the control chart. He also created the short cycle of quality improvement that is the essence of the Plan-Do-Study-Act, or PDSA process. It's important to note that while the PDSA process has roots in Shewart's work at Western Electric, in recent years, Dr. Don Berwick and his Institute for Healthcare Improvement have adapted the use of the PDSA for healthcare, and in doing so have helped to revolutionize quality improvement in our field. Edward Deming promoted Shewart's work and also developed 14 principles to help managers transform their businesses to be highly effective. More information about these 14 principles is included with your resources for this module. Deming was a primary driver of the remarkable transformation of Japanese manufacturing, especially in the production of automobiles. Joseph Juran stayed at Western Electric until after World War II and afterward became a consultant, actively promoting the quality improvement methods. He integrated the Pareto principle into quality, which essentially says 80% of a problem is caused by 20% of the potential causes, which is an overestimate. But he eventually referred to problems as the vital few and the useful many, noting that 80% of potential problems should not be ignored, but should not necessarily be the initial or primary focus. He's also credited with bringing more attention to human factors in the workplace, that people are not simply machines and thus require a set of approaches to engage them in successful improvement efforts. While these three men are largely credited as the fathers of quality improvement, it should be noted that one of the first people to institute quality improvement processes was Florence Nightingale during the Crimean War. She set standards, collected data, and instituted change to help reduce the mortality of the soldiers, particularly from infection. She was also among the first to promote use of the structured medical record and organized patient information using a pie chart to display data in a way that was understandable. Each of these historic figures in quality improvement work recognized that in order to continually improve products and services, there needs to be constant and consistent engagement with the systematic approach to assess quality, identify problems and reasons for the problems, and then decide on an intervention that would best address the problem, followed by evaluating the effectiveness of the intervention. One of the most critical advances that came with using the PDSA cycle is that it provides a framework for systematic, ordered sets relying on careful planning, doing small pilot tests of change, carefully monitoring results, and only if successful, expanding the intervention to a broader setting and ultimately disseminated throughout an organization and beyond. If not successful at any step, the process can be sent back to the drawing board in the planning stage. Let's take a closer look at each stage in the PDSA cycle. The Plan stage is centered on a very careful and complete definition of the problem, which might involve detailed mapping of the entire process that surrounds the identified problem. Defining the specific objective for the intervention. Identifying the most promising changes or interventions. Deciding who's going to do what, where, and when. And planning for data collection. This is by far the most complex and critical step of the process. And many books and journal articles have been written related to how and how not to plan change and interventions with healthcare settings. A final step is to make predictions of what we think the impact of the intervention will be and define what we will regard as a clinically significant change. The Do stage involves all of the many steps of implementing and carrying out the plan, including documenting observations of both the process of intervention as well as recording data related to how the intervention affects the problem. During the Study phase, we analyze the data, compare the results to our predictions, and then summarize what was learned. All of this then provides the bases for the Act phase, determining what changes need to be made, and what the next cycle will be, either a full redesign, or modifying the existing intervention and redoing a pilot test, expanding the intervention to one or more other sites or full-scale implementation throughout the organization. The PDSA process is intended to be an iterative process. If after implementation a change is determined to be successful, it would be integrated into regular practice. After a period of time, the team may want to return to stage one to examine how the change has been working and see if there are opportunities for further improvement, targeting yet another set in a process or using another intervention. If a change is not initially successful, the cycle would repeat with the team planning, implementing, and studying a different approach. Let's now apply this process to a problem that you might identify in an emergency room setting. Your Wait time is 50 minutes, and the average wait time in your state is 48 minutes. However, your biggest competitor has a wait time of 35 minutes. And the next major competitor has a wait time of 38 minutes. You need to decide if your Wait time is a problem. If your wait time was 75 minutes, there would be probably a clearer problem. However, you may decide that a wait time of 50 minutes is okay. And there are other measures that suggest a deep problem elsewhere. But let's say you decide that wait time is indeed an important problem to address. And have vetted this issue with the leadership of your organization and team members. You've looked at the patient experience surveys and it's clear that your longer waiting time is having a major deleterious effect on a number of important parameters. What are your next steps? First, you'll want to pull together a small, say, five to seven member team to begin to address the problem of wait time. Potential team members would include those who are directly involved with or affected by patient flow and waiting time. You'll want the team to help identify all the steps and issues in the processes related to patient wait time. Focusing especially on those steps that could be modified or eliminated as patients move through the care system without creating any potential harm to the patient. A frequently used approach to identifying potential reasons for the problem and planning potential improvements is to walk the team through a documentation of each step of the process, including different categories of patients. In this example from the time they enter the Or perhaps even call the Until the time they go home, are admitted, or perhaps die. Your team would also want to look at the literature and talk with colleagues from other ERs to see if there's useful information about possible ways to reduce the wait time. You might also want to look at the Agency for Healthcare Research and Quality's exchange project information related to Wait times. And you could also get your team together and brainstorm reasons for delayed wait time. Another approach to identifying reasons for the problem would be to use a technique called the 5 Whys. This was developed as part of the Toyota production system to get to the root cause or causes of the delay. This technique involves asking a series of questions about why a problem maybe happening and gathering as much information as possible about possible causes especially those that are core or at a deep level. This approach is similar to the technique of root cause analysis used by the Joint Commission in safety work, which keeps asking if one has reached the most elemental cause of an event or error. Five why questions applied to the Wait time problem could be, why do we have a delayed wait time compared to our competitors? Possible answer might be because we have to board too many patients in the. The second question would follow. Why do we board so many patients in the? Answer might be that rooms in the units have not been cleaned in a timely way. Third question, so why haven't the rooms been cleaned in a timely way? And a possible answer might be that housekeeping is not notified of a discharge, or anticipate a discharge in a timely way. Fourth question, why isn't housekeeping notified of patient discharge in a timely way? And the answer could be that nursing staff do not notify housekeeping of a discharge in a timely way. And then, question number 5, why are the nurses not notifying housekeeping in a timely way? Well, I'm going to leave you to think about possible answers to question 5. As the series of problems are identified, one can then move on to addressing the problem of boarding patients in the That lead to long wait times. Beginning with the deepest why. Using the PDSA cycle, one could start by developing a plan for a pilot intervention by working with the supervising nurse on one unit of the hospital. To implement program of notifying housekeeping of an anticipated and actual discharge. As soon as the discharge is confirmed. A plan may also include an electronic flagging system that enables nursing to easily send an alert to housekeeping about a discharge. The data collection plan might include gathering data about the amount of time a room is vacant until it's cleaned and occupied by a new admission. As well as, of course, monitoring any change in the Waiting time. The prediction would be that there would be a small decrease in the waiting time since the test of change is on one unit. One could improve the odds of seeing a substantial change, if for example, the target unit was a medical unit and you could specifically look at wait times for medical patients who were admitted. Along with a decrease in the time from when a patient is discharged, to the time the room is clean and ready for an admission, on a unit by unit basis. The do phase is exactly that. You carry out the plan that the team has developed and make sure that you document key observations and data. The next step is to analyze data and pair results to predictions and summarize what you've learned. Your analysis could include comparison of time from discharge to the room being cleaned with a baseline measure of the unit. There could also be comparison with other similar units in the hospital. During the Act stage, you would either expand the small test of change or go back to the drawing board to see if the plan needs to be changed. You might determine that housekeeping is not the problem, and find another problem that's more important. Even after you reduce your Wait time using one intervention, you might want to repeat the PDSA with another intervention aimed at Wait time. PDSA is a widely used approach to quality improvement. It's a core part of the approach used by the leading quality improvement organization in the US, the Institute for Healthcare Improvement. PDSA can be integrated into other approaches or philosophies of quality improvement. While there are many approaches, we are going to focus on two useful adjuncts to PDSA, Lean and Six Sigma. Information about several other commonly used approaches is included in your resources for this module. In looking at the Lean Approach, the Lean Approach to Quality Quality is based on the Toyota production system. It has its origins in the conceptual framework introduced in the 1930s by Hishiro Toyota, founder of the Toyota automobile company. He based his manufacturing approach on two major concepts, Jidoka and Just-in-time manufacturing. Jidoka means that work stops immediately when there's a problem, thus preventing defective goods. The work stoppage means that no further defects will occur, and the problem will be addressed immediately. Thus constantly improving the process and reducing any defects in the output. The Just-in-time approach is described as what is needed, when it's needed and the amount that is needed. This approach is focused on eliminating waste. Taiichi Ohno the chief engineer of Toyota after World War II, is credited with the introduction of the Toyota production system. In this system, Ohno identified seven wastes that were the basis for manufacturing inefficiencies and poor quality products. Wastes are defined as anything in the process that adds no value. Transportation waste is moving materials that have no value in the process. Inventory waste is having supplies that are not being used. Motion waste refers to the unnecessary movement of workers or machinery. And waiting is just that. Wasted time waiting for the next step in the production process. Overproduction is having more supply than demand. And over processing is putting more into a product than the consumer wants or values. And finally, defects involve ways related to looking for defective products and then having to fix them. You may hear the word kaizen related to lean. And kaizen refers to the improvement process to reduce waste and means change for good. I imagine you can identify wastes in each of these categories as they related to healthcare. The Toyota production system became associated with the lean quality improvement through Jim Womack at MIT's international motor vehicle program. He wrote the book in 1990, The Machine that Changed the World, and that was based on a five-year $5 million research project examining the future of the automobile manufacturing industry. Lean production was used to describe the Toyota production process because of the commitment to ferreting out waste. Since then, Womack started the Lean Enterprise Institute, and has been a leader of disseminating lean nationally and internationally. Lean has been integrated into several health systems and many healthcare organizations. There are numerous reports and considerable research on improvements in healthcare and reduction of waste based on the lean system. It's been very clear that there is considerable waste in the healthcare system, all the way from long phone wait times to making appointments to inefficiencies related to record-keeping requirements and poorly designed health settings that require staff to walk long distances. The second approach I want to talk about is six sigma. Six sigma has its roots at Motorola. In the 1900s, Motorola committed to improving quality and created a culture based on statistical monitoring of process capability. And product specification using a measure, which was defects per some number of opportunities. For example, one defective radio per million produced. This statistical method of measuring defects proved to be incredibly valuable to Motorola, saving them an estimated $16 billion over about 11 years. In addition, CEOs of other major organizations including General Electric and the Allied Signal, which is now Honeywell have adopted the six sigma approach. In a nutshell, the term sigma is taken from statistics and denotes a variation or error rate related to the standard error of the mean such that 1 sigma represents an error rate of 67%, 2 sigma, 31%, and 3, 6.7% with 6 sigma being only 3.4 errors per million events. The core of the approach is to use very careful monitoring of critical points, in a process, in attempting to reduce error rates at each step, as well as intervening when error rates are seen to increase. In some manufacturing processes, error rates of 6 or even 7 sigma, which would be 1.9 errors per billion operations, have been achieved. Six sigma actually builds on a longer history of work including that of Frederick Taylor and his scientific management and Henry Ford's assembly line as well as Short's statistical monitoring processes. It's important to note that there is significant overlap among the QY approaches. There are many healthcare institutions that have adopted a combination of lean and six sigma, which is an integration of the concepts of reducing waste and using statistical monitoring for identifying defects or problems in health care processes. All of the quality approaches recognize that there must be a culture of quality throughout the organization. And that there must be a systematic approach to measuring, identifying problems and then fixing them. The common goals are better goods and services as well as reduction of costs.