Lean Six Sigma Methodology and the Future of Quality Improvement Education in Anesthesiology

“Management of a system requires knowledge of the interrelationships between all of the components within the system and of everybody that works in it.” These famous words by Dr W. Edwards Deming,1 one of the leaders of the quality revolution in the post-World War II industrial boom era, still ring true in the field of medicine today. In many ways, Deming1 obsession with systems improvement and the development of a clear purpose for one’s work can even be applied to education in the field of anesthesiology to this day. The ability of an anesthesiology trainee to not only understand a process but also improve the process is what will continue to allow the field to adapt and innovate in the future. Standardization and strengthening of Accreditation Council for Graduate Medical Education (ACGME) requirements in the quality improvement arena can help trainees develop the skill set needed to lead hospitals and anesthesiology departments in the practice management and process improvement domains. Anesthesiologists are part of a team of individuals who are uniquely positioned to help hospital management reduce the cost of health care delivery. Anesthesiologists work with a perioperative management team consisting of surgeons, nurses, and surgical technicians to allocate resources (equipment and personnel) appropriately in the operating room and evaluate patients perioperatively. Anesthesiologists often control throughput in the operating room and govern decisions on resource utilization, which can affect patient flow and efficiency and health care expenditures. Surgical procedures accounted for 48% of health care expenditures in 2011, and 40%–70% of hospital revenues are from hospital procedures.2 Macario et al3 performed an evaluation of hospital charges and costs for inpatient surgical care and determined that intraoperative anesthetic management accounts for 5.6% of total hospital costs (professional fees of anesthesia personnel were not included); however, half of these costs were variable costs (medications, supplies, inhalational anesthetics, etc.) However, anesthesiologists play a role in ordering preoperative lab and imaging testing as well as postoperative recovery management, which utilize services that are a cost to the hospital. Although the overall contribution of anesthesia resources to hospital costs may appear small, given the volume of anesthetics, small savings can have substantial savings when aggregated.3 With the passing of the Affordable Care Act, it is evident that the new wave of health care is placing a larger emphasis on patient outcomes and not just the services provided. With payment tied to patient satisfaction scores and outcomes, hospital management is highly focused on achieving standards of quality and increasing productivity while minimizing costs. This provides opportunity for all perioperative physicians, including anesthesiologists, to rise to positions of leadership within operating room committees, hospital board of directors, and beyond. Our unique perspective on patient flow, resource utilization, patient safety, and quality is an invaluable resource. In the last decade, there is increasing demand of health services and cost of health care delivery leading to an acute rise health care–associated cost. In 2017, the US government spent $3.5 trillion on health care, a 3.9% increase from the prior year. Health care was 17.9% of the United States Gross Domestic Product. Hospital care (33%) and physician and clinical services (20%) composed of 53% of the total expenditure.4 Anesthetics represent 3% to 5% of total health care costs (estimated $800 billion annually).5 Among the health care costs, it is well documented that operating rooms and their associated staffing are expensive—perioperative labor costs (physicians and advanced practice professionals) alone are 70% of a hospital’s expenses.5 Improvements in efficiency and waste reduction can help improve quality of care. Efficiency can be improved in many ways including but not limited to improved scheduling models of anesthesia personnel, better operating room utilization between various surgical services, and more streamlined approaches to evaluating complex patients presenting for complex procedures. Waste reduction includes removing activities that do not provide value such as unnecessary preoperative testing, redundant paperwork in the perioperative period, streamlined placement of patients to minimize transport times to and from the operating room, and much more. Quality improvement initiatives will be at a cornerstone to meet the goals of high-quality care at low cost. For years, other sectors such as business and engineering have utilized a comprehensive approach to quality improvement called the Lean Six Sigma methodology. Lean Six Sigma is a well-structured methodology that aims to eliminate waste and activities that do not add value, focuses on reducing variation in processes, and eliminates the causes of the defect while improving performance.6 In 2009, the American Society of Quality (ASQ) surveyed 77 hospitals in the United States and found 53% of hospitals used Lean Six Sigma techniques. Among these institutions, Lean methodology was used at 37%, and Six Sigma methodology was used at 42%.7 This approach has led to a reduction in costs and an improvement in profits, which has spurred additional development and growth within health care for the past 30 years. Lean methodology was originally utilized by Taiichi Ohno from Toyota Production System in 1930s.8 In the Toyota Production System, specific types of manufacturing “waste,” which use personnel, resources, or time but do not add value to the overall process, are eliminated. Lean is a process that continually reduces waste and improves workflow to efficiently produce a product or service that is perceived to be of high value to those who use it. It focuses on 5 key areas: value, the value stream, flow, pull, and perfection. Over the years, lean methodology has evolved to a system that provides tools for analyzing process flows and delays in each process activity. Managers categorize activities as “value added” versus “nonvalue added” and delve into specifics to eliminate the root cause of activities that are deemed wasteful. There are 8 main areas of waste that can be eliminated (Table 1). Table 1. - Description of Lean Methodology’s 8 Key Areas of Waste Areas of waste Description Defects Mistakes or errors that need to be reworked Overproduction Doing work before it is needed Waiting Waiting for information, items, or personnel to arrive Unused potential Not using individuals’ talents, skills, and knowledge to their full Transport Moving items or information unnecessarily Inventory Excess products or materials that are not being used or processed Motion Unnecessary movements by people Processing Processing or activities that do not add value Six Sigma methodology focuses on improving the quality of the output by removing causes of defects (errors) and promoting a reduction in variability in manufacturing.9 It is a strategy developed by Motorola in 1981 and has been utilized in health care since 1990.6 Within health care, Six Sigma methodology aims to provide the same high quality of care to every individual. The Six Sigma error rate is 3.4 defects/million (99.99966% perfection rate). For companies such as Motorola that produce millions of products by utilizing Six Sigma methodology, they were able to reduce defects in their products and thus increase customer satisfaction. The other benefit of the Six Sigma methodology is that it creates a cultural infrastructure to achieve sustainable results. Six Sigma certification can be completed by a training and examination process through a number of organizations, such as the ASQ.10 Certification levels include the Yellow Belt, Green Belt, Black Belt, and Master Black Belt roles. Each increasing level comes with more responsibility in overseeing a quality improvement team and designing projects (Table 2). Certification often involves in-person or virtual training sessions, as well and the more advanced belts also require work experience and dedicated involvement in Six Sigma projects before sitting for a certifying examination. Table 2. - Description of Various Lean Six Sigma Belt Certifications and Associated Responsibilities Belt level Responsibilities Qualifications Yellow Understands basic Lean Six Sigma concepts specifically define, measure, and control components Pass a 60-question examination Understands how to implement, perform, and interpret Lean Six Sigma in a skilled but limited context No prerequisites needed to take examination Reports processes issues to Green Belts Participates on project teams and receives entry-level training to tasks Green Starts and manages Lean Six Sigma projects Pass a 100-question examination Understands all aspects of Lean Six Sigma including define, measure, control, analyze, and improve Must be Yellow Belt certified Has Lean Six Sigma expertise but in less detail than Black Belt Provides entry-level training to Yellow Belts Black Can report to Master Black belts Pass a 150-question examination Has advanced Lean Six Sigma expertise Must complete one Six Sigma project Functions as coach, mentor, teacher, and project leader for project teams Master Belt Works with leaders in institution to identify gaps and select projects Pass a 110-question examination Coaches, mentors, teaches, monitors, and leads projects 5-y experience as Black Belt or 10 Six Sigma projects completed Responsible for Lean Six Sigma implementation and culture changes Various certifying organizations have different requirements, but the above are adapted from American Society for Quality.10 To implement Six Sigma methodology, individuals and organizations need to follow a defined sequence, define, measure, analyze, improve, and control (DMAIC), to analyze an issue. DMAIC consists of 5 key steps (Table 3). Other Six Sigma tools include statistical process control (SPC), failure modes and effects analysis (FMEA), and control charts. Table 3. - Description of the 5 Key Elements of Analyzing a Problem to Apply Six Sigma Methodology Six Sigma DMAIC steps Description Define Definition of the problem Measure Measurement of current state Analyze Characterize the root of the problem Improve Develop and test an intervention Control Implement the changes Abbreviation: DMAIC, define, measure, analyze, improve, and control. Together, both Lean methodology and Six Sigma methodology (LSS) aim to reduce waste and improve quality in activities. Lean methodology maximizes customer value while minimizing wasteful activities, while six sigma methodology eliminates defects and is more data-driven. Lean Six Sigma has differentiated itself from the typical quality improvement standards. Lean Six Sigma expands beyond quality and is a whole philosophy that includes a uniform methodology (DMAIC approach), statistical tools and analysis, and waste reduction strategies. The successful application of Lean and Six Sigma and other similar management tools is not limited to manufacturing but has been applied in the customer and financial service industries and the government.8,9,11 These 2 methodologies had different origins but now are often described together as one methodology. Together these approaches allow organizations to reduce unnecessary components of their workflow while creating a process that focuses on a high-quality end product or service. While it appears that these methodologies serve different purposes, each has a place in the management of a successful organization. The decision is not either/or between these programs. They should be used synergistically to focus on quality improvement efforts that save both time and cost for the organization. Although Lean and Six Sigma methodology is common in the business sector and has been used in other medical specialties, these concepts have only recently been deployed in anesthesiology. Nonetheless, there are examples showing the power of utilizing Lean Six Sigma in health care and anesthesiology such as reducing operating room waste and creating a streamlined preoperative. In 2017, Hubbard et al12 showed that improvement in waste disposal in the operating room led to an estimated cost reduction of $2200/y. Stonemetz et al13 from Johns Hopkins University used LSS to reduce hospital waste and saved $500,000 while encouraging anesthesiologists to participate in improvement projects with financial gain. Other major areas within anesthesiology where LSS has been applied include improving pain control in hospitalized patients14 and improving the workflow within the postanesthesia care unit.15 One of the most impressive applications of LSS was done by the staff at Mayo Clinic in Rochester, MN. This team made a value stream map from the decision to proceed with surgery to patient’s hospital discharge. By utilizing LSS methodologies, they yielded significant improvement in on-time surgery starts, improved patient flow, and increased financial performance.16 In 2017, Kolarczyk17 utilized LSS to implement Enhanced Recovery After Surgery (ERAS) pathways within their system, which led to reduced hospital length of stay, decreased hospital expenses, and improvement in quality-of-care delivered. Given the importance of quality improvement, patient safety, and cost efficiency, it is imperative that anesthesiology residents are exposed to these topics during their training. It is evident that the accrediting bodies in anesthesiology place high emphasis on trainees having experience in quality improvement measures. For example, the ACGME states that the anesthesiologist must be “skilled in the leadership of health services delivery, prudent fiscal resource stewardship, and quality improvement.18” Knowledge of quality improvement processes, including Lean Six Sigma, is also part of the primary certification process of the American Board of Anesthesiology via the Objective Structured Clinical Examination (OSCE). Furthermore, current American Board of Anesthesiology Diplomates have a quality improvement requirement as part of their Maintenance of Certification (MOCA IV), where various activities have to be accomplished over a 10-year period of time to maintain board certification. These activities range from developing clinical pathways to being a quality improvement leader at one’s institution.19 Current evaluation of quality improvement–related educational content in anesthesiology residencies across the country showed that programs are addressing quality improvement through a combination of quality improvement rounds, patient safety seminars, and occasional lectures on fundamental topics. These topics include learning how to perform a root cause analysis and engaging in the plan/do/study/act (PDSA) method. For example, at Weill Cornell Medicine, anesthesiology residents participate in a full-day course covering methodologies necessary to conduct a successful quality improvement project. Residents subsequently work on a project over the year and present their work at a Quality Patient Safety Education Day.20 Other programs have a more robust curriculum. Beth Israel Deaconess Medical Center in Boston partnered with the Stoneman Center for Quality Improvement in 2000 and developed a quality improvement elective for residents. In this elective course, residents investigate a recent medical error, perform a root-cause analysis, and propose solutions. This has led to various improvements in workflow such has new heparin dosing regiments and systems for effective patient handoffs and discharge.21 Johns Hopkins University offers a program where residents and nurses partner on quality improvement projects during their training. However, even with the creation of robust quality improvement curriculum, researchers still found little evidence that current educational methods have clinical benefits.22 Quality improvement education should emphasize approaches and strategies such as Lean Six Sigma methodology. If today’s anesthesiology residents are going to tackle the future complexities of health care, their background in quality improvement, patient safety, and health care finance needs to be broader and more robust. They should be equipped with the skill to develop system processes that can integrate multiple specialties, innovative use of resources including personnel, and equipment while reducing the cost of health care delivery. At our institution, we are actively incorporating Lean Six Sigma methodology into our curriculum. All graduating residents at University of Pittsburgh Medical Center (UPMC) are required to complete a quality improvement project within the department and present their work at a symposium in the spring of their postgraduate year 4 (PGY4) of residency. Due to a heightened sense of awareness on Lean Six Sigma topics through recent Grand Rounds lecture, we plan to give our residents the opportunity to seek formal Yellow Belt Certification in Lean Six Sigma methodology and then apply these concepts toward more substantive quality improvement projects. Lean Six Sigma methodology will be incorporated in the postgraduate year 1 (PGY1) educational series as well as monthly Quality Improvement and Patient Safety meetings. Through this exposure, residents will obtain the groundwork on how to use Lean Six Sigma methodology when completing their final quality improvement project. For those residents who are interested in pursuing formal credentialing, these individuals can apply for the certification examination independently. Those residents who intend to pursue higher levels of certification can work with a faculty member within our Anesthesiology Department who is on the Patient Safety and Quality Improvement team for the entire health system and can design and implement projects to build a project portfolio. Regardless, all residents will be taught the basics of Lean Six Sigma methodology via a lecture series and will demonstrate understanding and application through their final quality improvement project. We plan on monitoring the number of residents who pursue formal certification and in the near future incorporating that certification process into the residency educational schedule. As seen above, LSS can be applied in a multitude of practice settings and has led to significant improvement in quality of health care as well as financial savings. As health care continues to evolve, residents will be tasked with developing innovative strategies to improve health care delivery in the future. To handle the increasing challenges posed to health care in the future, anesthesiologists’ training in quality improvement must go beyond the basics of root cause analysis and PDSA models. We must use a model that focuses on the application of rigorous statistical models to reduce error and waste while reducing costs. It is time for anesthesiology programs to rise up to the challenge of equipping young anesthesiologists with the tools to lead future quality improvement projects. Programs should start by introducing the concepts to the faculty and residents through small lecture series and adding opportunities for residents to utilize these skills through a required quality improvement project presentation. Ultimately, our hope is that anesthesiology residents should obtain Yellow Belt certification by the time they graduate. Developing a strong foundation in a proven methodology, Lean Six Sigma, will allow anesthesiologists to continue to be leaders in patient safety initiatives and health care. DISCLOSURES Name: Neal K. Shah, MD. Contribution: This author was the primary author and helped analyze the data, create the tables, and draft and edit the final manuscript. Name: Trent D. Emerick, MD, MBA. Contribution: This author helped analyze the data, create the tables, and draft and edit the final manuscript. This manuscript was handled by: Edward C. Nemergut, MD.