The Quality Improvement and PDSA Cycle

Self-Learning Packet

This material was prepared by Quality Insights of Pennsylvania, the Medicare Quality Improvement Organization for Pennsylvania, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy. Publication number 10SOW-PA-IIPC-KD-022813. App. 2/13.

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Content Page

Introduction ………………………………………………………………………….. 4

Quality Management Pioneers ……………………………………………………… 4

History of Health Care Quality Management……………………………………… 7

Keys of Quality Management…..….………………………………………………… 9

The Cycle of Quality Management, Structure, Process and Outcome …………… 12

The Process Approach ………………………………………………………………. 13

Process Variations …………………………………………………………………… 16

Quality Improvement, an Integral Part of the Organization …………………….. 18

The Role of Leadership in Quality Improvement …………………………………. 20

Team Process ………………………………………………………………………… 21

Phases of Team Development ………………………………………………………. 22

Team Roles …………………………………………………………………………… 24

The CQI Journey – PDSA Cycle

Plan …………………………………………………………. 26

Do …………………………………………………………… 32

Study ……………………………………………………….. 34

Act ………………………………………………………….. 34

The Model for Improvement ……………………………………………………….. 36

PDSA Worksheet Sample Cycle: 1 ………………………………………………… 38

Attachment A: Brainstorming and Flowcharting ………………………………… 40

Attachment B: Developing a Check Sheet …………………………………………. 42

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Objectives

1. Identify the cycle of quality management, structure and process 2. Compare quality assurance and quality improvement 3. Discuss the role of leadership in facilitating quality improvement 4. Describe the eight planning steps to initiate a quality improvement project 5. Identify the four components of the PDSA method.

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Introduction ,By reading this self-learning module the reader learns about the history and pioneers of quality management, landmark studies and findings by the Institute of Medicine, critical key quality concepts and theories, the Plan-Do-Study-Act (PDSA) improvement method, and how to apply basic continuous quality improvement (CQI) concepts to improve processes of care. Processes of care occur in various health care settings, from the physician’s office or the hospital, to nursing homes or the home health care setting. The work of continuous quality improvement is often like a puzzle: first one must decide to work on a puzzle, find a suitable location, examine all the component pieces of the puzzle, start the puzzle by fitting the pieces together, maintain the puzzle’s integrity while building the picture, and continue to make progress by trying different pieces in different spots until the puzzle is completed. This independent study activity will examine the Quality Improvement Process and Methods (PDSA cycles) used in quality improvement efforts. Quality Management Pioneers The human need for excellence has existed since the dawn of time. However, the means for meeting those needs – the processes of managing for quality – have undergone extensive and continuous change (Juran, 1977). Prior to the 20th century, the principles for managing quality had been based on the ancient principles of product inspection by customers and the craftsmanship concept. However, during the 20th century, quality management underwent drastic changes as pioneers emerged in industry. The most notable pioneers were Shewhart, Deming and Juran. Quality processes, methods and tools rooted in industry would be translated to significantly impact health care by the late 20th century. Shewhart Walter Shewhart was a quality engineer with Bell Laboratories in the 1920s and 1930s, and was also a professor at MIT. He is attributed with developing the Plan-Do-Study-Act, or PDSA, cycle. He also noted that there is normal variation in any task or process. Please try to write the letter “a” 10 times. You will find even though the writer (you), the pen, and the paper are the same, and you are writing the letter “a” at almost the same time, that they do not all look the same. This is a simple demonstration of “normal variation.” Shewhart studied variation and determined that developing standard procedures minimized the occurrence of events outside the normal variation. Later, Shewhart and W. Edwards Deming became colleagues and Deming used the PDSA as a central component of his teachings on quality. Deming W. Edwards Deming, who was a student of Walter Shewhart, was one of the most influential persons working in quality improvement in the last half century. A statistician, he worked with the people of Japan to improve their manufacturing processes. Because of his influence there, products from Japan changed from the perception of low quality goods to desirable commodities.

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Deming urged companies to concentrate on constant improvements, improved efficiency and doing it right the first time. Shewhart was a critical influence on Deming. Shewhart's idea of common and special causes of variation led directly to Deming's theory of management. Deming saw that these ideas could be applied not only to manufacturing processes but also to the processes by which enterprises are led and managed. This key insight made possible his enormous influence on the economics of the industrialized world after 1950. Later, Dr. Deming was able to share his philosophy and techniques to help move quality into the U.S. manufacturing world. In the later years, he also worked with health care organizations to improve quality of care. Deming is probably best known for his 14 points, which Dr. Batalden translated into a health care context (Batalden & Buchannan, 1989). Deming is noted for stating, “The 14 points all have one aim: to make it possible for people to work with joy.”

1. Create constancy of purpose for the improvement of product and service, with the aim to become competitive, stay in business and provide jobs.

2. Adopt the new philosophy of cooperation (win-win) in which everybody wins. Put it into practice and teach it to employees, customers and suppliers.

3. Cease dependence on mass inspection to achieve quality. Improve the process and build quality into the product in the first place.

4. End the practice of awarding business on the basis of price tag alone. Instead, minimize total cost in the long run. Move toward a single supplier for any one item, on a long-term relationship of loyalty and trust.

5. Improve constantly and forever the system of production, service, planning or any activity. This will improve quality and productivity and, thus, constantly decrease costs.

6. Institute training for skills. 7. Adopt and institute leadership for the management of people, recognizing their different

abilities, capabilities and aspirations. The aim of leadership should be to help people, machines and gadgets do a better job. Leadership of management is in need of overhaul, as well as leadership of production workers.

8. Drive out fear and build trust so that everyone can work effectively. 9. Break down barriers between departments. Abolish competition and build a win-win

system of cooperation within the organization. People in research, design, sales, and production must work as a team to foresee problems of production and in use that might be encountered with the product or service.

10. Eliminate slogans, exhortations, and targets asking for zero defects or new levels of productivity. Such exhortations only create adversarial relationships, as the bulk of the causes of low quality and low productivity belong to the system and thus lie beyond the power of the work force.

11. Eliminate numerical goals, numerical quotas and management by objectives. Substitute leadership.

12. Remove barriers that rob people of joy in their work. This will mean abolishing the annual rating or merit system that ranks people and creates competition and conflict.

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13. Institute a vigorous program of education and self-improvement. 14. Put everybody in the company to work to accomplish the transformation. The

transformation is everybody's job.

Quality improvement methods have continued to grow based on expanded manufacturing, service and health care experience. One model, known as the Lean Organization Process, uses a one-year model to improve an existing workflow process. Similarly, the Institute for Healthcare Improvement has established the Breakthrough Series Model for rapid cycle improvement. Juran J. M. Juran's major contribution to society was in the field of quality management, and he is often called the “father” of quality. Perhaps most importantly, he is recognized as the person who added the managerial dimension to quality, broadening it from its statistical origins. In 1937, Dr. Juran created the “Pareto Principle,” which millions of managers rely on to help separate the “vital few” from the “useful many” in their activities. This is commonly referred to as the 80-20 Principle. Its universal application makes it one of the most useful concepts and tools of modern-day management. This is now referred to as Juran's Pareto Principle. In 1951, Dr. Juran published the first standard reference work on quality management, the Quality Control Handbook, which is now in its sixth edition. This handbook is used by change agents as a reference for quality and performance improvement. It provides important how-to information on improving an organization's performance by improving the quality of its goods and services. His classic book, Managerial Breakthrough, first published in 1964, presented a more general theory of quality management. It was the first book to describe a step-by-step sequence for breakthrough improvement. This process has evolved into Lean and Six Sigma today and is the basis for quality initiatives worldwide. In 1979, Dr. Juran founded Juran Institute, an organization aimed at providing research and pragmatic solutions to enable organizations from any industry to learn the tools and techniques for managing quality. The Juran Trilogy®, published in 1986, identified and was accepted worldwide as the basis for quality management. After almost 50 years of research, his trilogy defined three management processes required by all organizations to improve. Quality control, quality improvement, and quality planning have become synonymous with Juran and Juran Institute, Inc. Juran describes quality from the customer perspective as having two aspects: higher quality means a greater number of features that meet customers' needs and “freedom from trouble” means higher quality consists of fewer defects.

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History of Health Care Quality Management In 1916, Ernest Codman, a surgeon, called for a systematic evaluation process with a view toward improving care after observing variability in patient outcomes among several hospitals. Taking up the call for action, The American College of Surgeons (1917) established quality standards using a five-part “minimum standard,” and the Hospital Standardization Program (Roberts, Redman & Coate, 1987). Health care pioneers include Donald Berwick, MD; Paul Batalden, MD; and Brent James, MD, who went beyond quality assurance practices and researched industrial methods. Dr. Berwick and Dr. Batalden began publishing classic articles based on theory taken from industry. Initially focused on the administrative aspects of health care delivery, Dr. James pioneered applying quality management directly to patients and clinical outcomes. More than 30 years ago, a physician named Avedis Donabedian proposed a model for assessing health care quality based on structures, processes and outcomes. He defined structure as the environment in which health care is provided, process as the method by which health care is provided, and outcome as the consequence of the health care provided. As a result, process management is limited, and often temporary, when the structure isn't also improved. Two decades later health care adopted continuous quality improvement, which uses teams to improve processes. According to Donabedian's model, processes are constrained by the structures in which they operate. To date, few health care organizations have addressed these structures because health care senior managers have replicated the behavior of most industrial senior managers by focusing on the process level. The popularity of Robert S. Kaplan and David P. Norton's balanced scorecard method, popularized in their book, The Balanced Scorecard (1996, Harvard Business School Press), expanded health care organization measures beyond financial analysis. This led to the development of measures in four or more areas, including patient/customer, financial, internal operations and clinical. However, in creating a balanced scorecard, many organizations failed to do the critical, difficult part: develop a cause-and-effect relationship among these measures. Consequently, health care organizations typically generate lists of strategies and goals as if they are independent of each other.

KEY POINTS:

• Shewhart: Plan-Do-Study-Act (PDSA) Cycle • Deming: continuous quality improvement, 14 points aimed

at people working with joy, applied rapid change cycle • Juran: Pareto Principle (80/20 Rule). Trilogy - quality

planning, improvement and control/measurement

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An additional impetus for health care organizations to adopt quality principles has been the Joint Commission on Accreditation of Healthcare Organizations' standards. While the JCAHO standards have evolved during the past decade, swayed in part by the Baldrige Criteria, health care organizations have been slow to use this organizational assessment as a way to drive performance improvement. The demand from JCAHO for performance improvement drove many health care organizations to learn as much as possible about continuous quality improvement. They began implementing ideas such as: teams and facilitators with training on conflict resolution; problem solving with use of statistical tools and standardized problem-solving procedures; data collection, including patient, physician and employee satisfaction surveys; process management using clinical algorithms and practice guidelines with training on pathway development; and planning using balanced scorecards and performance measurements. With continuous quality improvement often delegated to levels below senior management, organizations struggled to integrate and justify their many initiatives. Institute of Medicine Reports In 1999, the Institute of Medicine (IOM) in Washington, D.C., released To Err Is Human: Building a Safer Health System, an alarming report that brought tremendous public attention to the crisis of patient safety in the United States. In 2001, IOM followed up with Crossing the Quality Chasm: A New Health System for the 21st Century, a more detailed examination of the immense divide between what we know to be good health care and the health care that people actually receive. The report calls the divide not just a gap, but a chasm, and the difference between those two metaphors is quantitative as well as qualitative. Not only is the current health care system lagging behind the ideal in large and numerous ways, but the system is fundamentally and incurably unable to reach the ideal. In order to begin achieving real improvement in health care, the whole system has to change. The report identified six aims as critical to addressing the gap and closing the chasm. The following is a brief overview of the aims for health care quality improvement. Six Aims for Improvement First, the health care must be safe. This means much more than the ancient maxim, “First, do no harm,” which makes it the individual caregiver’s responsibility to somehow try extra hard to be more careful (a requirement modern human factors theory has shown to be unproductive). Instead, the aim means that safety must be a property of the system. No one should ever be harmed by health care again. Second, health care must be effective. It should match science, with neither underuse nor overuse of the best available techniques — every elderly heart patient who would benefit from beta-blockers should get them, and no child with a simple ear infection should get advanced antibiotics.

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Third, health care should be patient-centered. The individual patient’s culture, social context, and specific needs deserve respect, and patients should play an active role in making decisions about their own care. That concept is especially vital today, as more people require chronic rather than acute care. Fourth, care should be timely. Unintended waiting that doesn’t provide information or time to heal is a system defect. Prompt attention benefits both the patient and the caregiver. Fifth, the health care system should be efficient, constantly seeking to reduce the waste — and hence, the cost — of supplies, equipment, space, capital, ideas, time and opportunities. Sixth, health care should be equitable. Race, ethnicity, gender, and income should not prevent anyone in the world from receiving high quality care. We need advances in health care delivery to match the advances in medical science so the benefits of that science may reach everyone equally. We cannot hope to cross the chasm and achieve these aims until we make fundamental changes to the whole health care system. All levels require dramatic improvement, from the patient’s experience — probably the most important level of all — up to the vast environment of policy, payment, regulation, accreditation, litigation, and professional training that ultimately shapes the behavior, interests, and opportunities of health care. Keys of Quality Management Total quality is best defined as an attitude, an orientation that permeates the entire organization, and the way that an organization performs internal and external business. People accept individual responsibility for the quality of their work, and achieve genuine commitment and active involvement from enlightened leadership. The organization’s drive will constantly strive for excellence and continuous improvement throughout all processes within the system. The organization focuses on doing the “right things right the first time.” Processes help facilitate meeting the needs and expectations of the customer, measure quality, and continuously strive to

KEY POINTS:

• Safe: Avoid injuries to patients from the care that is intended to help them.

• Effective: Match care to science; avoid overuse of ineffective care and underuse of effective care.

• Patient-Centered: Honor the individual and respect choice. • Timely: Reduce waiting for both patients and those who

give care. • Efficient: Reduce waste. • Equitable: Close racial and ethnic gaps in health status.

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improve services/care and outcomes. Staff is empowered to join in the efforts to implement change impacting both service and care. An organization that is committed to quality provides an environment where staff feels vested in their work and proud to be a part of the organization. Further, the environment fosters teamwork and continually asks the question, “How can we do better?” The quality management process encompasses the entire organization and identifies problems that are caused by inefficiencies. The key elements of quality management are: creation of a supportive, customer-focused, and quality-driven internal environment fueled by leadership commitment; systematic identification of the processes that are critical to meeting customer needs and expectations; and use of statistical tools to describe, measure, and continuously improve the efficiency and effectiveness of the key processes. Quality activities to improve organizational performance should involve more than clinical aspects of care. Total quality management is applicable to all health care settings including, but not limited to, the physician’s office, hospital, nursing home and the home health agency. Doing the Right Things Right Old assumption: quality fails when people do the right things wrong New assumption: more often, people do the wrong things right In health care, the delivery process is not the same as manufacturing because the customer, the patient/resident, receives the product as it is being produced. There is little or no opportunity to inspect it before delivery. Therefore, the “product” needs to be planned carefully so that it meets standards and expectations. Quality in health care means doing the right things right and making continuous improvements. The process that meets customer expectations is the right thing. People and departments, whose performance conforms to those processes, are doing things right. When you clarify and improve processes, performance improves.

Wrong things

done right

Right things

done right

Wrong things done

wrong

Right things done

wrong

+

-

Performance

Process -

+

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Quality Improvement vs. Quality Assurance Continuous quality improvement (CQI) is a paradigmatic shift when compared to traditional quality assurance. Quality assurance (QA) functions have been shaped by accreditation requirements promulgated through regulatory bodies. Organizations committed to the process of continuous quality improvement are motivated to not only meet regulations imposed by outside regulators but are also driven to meet the expectations of their customers. Their goal is to provide high quality care, compete and excel, and not just meet regulatory expectations. Traditional QA function is defensive and reactive, compared to the CQI approach that is proactive and deliberate. In QA, organizations measure performance against an established set of standards. They inspect performance and repair or correct performance that is below standard. In CQI, prevention – not inspection – is the primary method used. Even if the organization meets national and local performance standards, it strives to improve its performance, always driven by a “good is never enough” mentality. In QA the focus is on identifying outliers as “bad apples” and improving their performances so they meet standards. The emphasis is on monitoring to see that things are done correctly. It looks at individual performance and makes correction to that performance to improve results. Whereas, CQI focuses not only on special causes of low performance by low-performing people and departments, but energy and resources are also directed to identifying and acting on the common causes of current performance level. In other words, the focus is on improving processes and reducing variation of the process so that performance increases for all staff. CQI emphasizes doing the right things right. If problems are identified, the attention is directed to the process, not the people. Improvement efforts investigate and attempt to identify the root cause of the problem. Once identified, you would reduce or eliminate the causes, then take steps to correct the process. Doing it Right for the Customer There are many different groups of customers such as patients, family, friends, payors, external and internal customers, and the community who judge quality of health care services. Each has different expectations of service. Patients want choice, convenience, timely service, and compassionate treatment by staff. Families and friends want access to patients/residents, accurate information, and responsiveness of staff. Payors want billing and financial information in a timely manner. Internal customers need to be recognized and have their expectations met. Customers judge quality by how well you meet their expectations and requirements. When their expectations are not met, service is perceived as lacking in quality. If you are not meeting the customer’s expectations of quality, you are doing the wrong things. Doing it Right for the Staff Another outcome of doing the right things right and making continuous improvements is attracting and retaining competent staff. When staff actively contributes to improving processes and embraces a customer-friendly attitude, turf conflicts will be reduced, and in turn they feel good about their work and are loyal to the organization.

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Doing the right things right also pays off financially. By improving processes, the results will be a reduction of costs. The bottom line will reflect increases in revenue from increased occupancy, and reduction of staff turnover and recruitment costs. Doing the right things right leads to cost reduction and increases business. The Cycle of Quality Management, Structure, Process and Outcome The quality management cycle, also known as the “Juran Trilogy” (Juran and Godfrey, 1999), does not work in a linear specific event or time order. The approach is circular, and each part of the circle is dependent upon the other for information. The components of the quality cycle include the following:

Quality Planning – team focus is on a specific organization function and uses information generated by quality control/measurement (customer perceptions, processes, and outcomes) and quality improvement to identify important priorities, determine if a process exists, and to monitor the effectiveness of any new or completely redesigned process. Quality Improvement – teams use quality control/measurement information, collecting additional information, and performing in-depth evaluation to achieve specific performance goals determined in quality planning or to improve or further improve an existing process. The team analyzes causes of existing process failure, dysfunctional or inefficient processes and systematically institutes solutions to chronic problems. Quality improvement teams routinely analyze and disseminate variance and/or “best practice” information to patients, families, and staff and utilize the scientific/problem-solving method to improve process performance and achieve stated goals. Quality Control/Measurement – performed organization-wide by all departments and encompasses all ongoing activities designed to measure actual performances. Quality control/measurement activities include data collection, data aggregation and analysis. Findings are distributed to the team so that everyone involved in analyzing, understanding, interpreting, and acting upon measurement information is included. The information can relate to either a particular existing or new process or global indicators of organizational performance. Organizational functions and related processes, and measurement indicators may change over time based on the assessment of findings.

Thinking of a circle, the quality process starts with the planning phase and moves into the quality improvement phase, which gets information from the planning phase to implement changes to a process. The process is then studied by gathering data and analyzing it to identify improvement. This is the third phase of the cycle. Each relies on information provided by the other parts. Since the cycle is circular and continuous, it does not start and stop. Another component of the quality cycle is structure, process, and outcome. According to Avedes Donabedian, who developed the Structure – Process – Outcome paradigm, structure process and outcome are merely kinds of information used to draw conclusions about quality of care. They are valuable to understanding quality because they are causally related:

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Structure, process, and outcome each represent complex sets of events and how each relates to the other and needs to be understood before quality measurement and assessment starts. Even when these causal relationships are understood, they should be looked at as probabilities, not certainties. There are individual variables called patients and practitioners in the process, and even the probability that a particular outcome is an indicator of quality can vary widely.

Structure – refers to the attributes of the settings in which providers deliver health care, including material resources (e.g., electronic health records), human resources (e.g., staff expertise), and organizational structure (e.g., hospitals vs. clinics). For example, a cardiologist may use a disease registry to track whether a patient with cardiovascular disease is receiving drugs for lowering cholesterol.

Process – denotes what is actually done to the patient in the giving and receiving of care. Building on the example above, the provider could review whether an eligible patient has been placed on an angiotensin-converting enzyme inhibitor to help prevent future heart attacks.

Outcome – is the direct result of a patient’s health status as a consequence of contact with the health care system. In the above example, the patient’s receiving the preventive medications mentioned above could decrease the chance of dying from a heart attack.

The Process Approach In quality management, an effective approach is the result of having organizational commitment to quality, a team of believers, a clear understanding of the needs and issues, and a plan of action. Health care quality has to include all key management, clinical, and support functions. Four factors that influence the degree to which services can achieve desired outcomes are disease process and severity, processes of care, patient/resident compliance, and random and unidentified variables. We have the greatest control over processes of care. Processes are sequentially related steps intended to produce specific outcomes (Goonan, Juran Institute, 1993). The more complex the process, the more difficult it is to manage its quality and the greater the opportunity for deficiencies. The Process of Quality within the System To better understand how to apply quality improvement concepts, it is essential to understand what a process is and how it functions within a system.

Structure Process Outcomes

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A process is best described as a series of steps that begins with a demand (input), some action resulting in a product or service (output), delivered to a customer. It can be summarized as a series of steps that changes supplier inputs into outputs for a customer. Health care providers like doctors, nurses, medical assistants, laboratory persons, admitting clerks, etc., are the suppliers to our patients or clients. We provide some product or service to the customer.

An example of a patient care process may be a home health nurse, who visits the patient at home and provides assessment and care for an infected wound. The nurse is the supplier, and the patient or client is the customer. The assessment and wound care are the action steps that use nursing skills and provide a professional evaluation and record of the wound’s progress. There are also customer-supplier relationships that occur within a health care organization before the ultimate product or service gets to the patient. An example of this would be the education of a new patient care employee. Once an employee has completed the interview process, and has accepted the job, there are multiple processes to educate and train the new employee. They often spend several days learning about their new employer. They may complete a formal orientation program, followed by a specific orientation to the area in which they will be working. This orientation may include the process for teaching about the organization’s mission, vision, etc., the job evaluation (or performance) process, the process for giving patients medications, the process for admitting a patient, and so on. All of these separate processes are integrated into the system of new employee orientation.

A series of processes form a system. What Dr. Deming stressed was that all of these processes are interrelated within a system. The interrelationship is very important because a defect in one process can result in a defect in other parts of the system. For example: if the new employee does not understand the process for obtaining new medications, then the system that provides the correct medication at the correct time, to the right patient, may break down. Therefore, trying to improve one part of a system (or one process) has an affect on other parts of the system, and may not always result in an improvement. A visual representation of this may be squeezing a balloon. The balloon gets thinner at one end while the opposite end is under stress and may burst.

Supplier Input Actions Output Customer

Nurse Nursing skills Assess and

provide wound care

Evaluate and record wound

progress Patient

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Deming wanted management and workers to view the organization as a system with dependencies and interdependencies. An example of this could be a hospital that changes the discharge/transfer forms for patients going to a nursing home. The use of this form in the hospital may affect many different people in many departments (discharge planners, the ambulance transport team, the discharge nurse, the pharmacy, etc.). Likewise, the nursing home that is receiving the patient may have changes because the form is different (the admissions department, the nurses receiving the patient, the pharmacy, etc.). System To further define the connections between processes and systems, multiple processes are how the work within a system is accomplished. Let’s consider a patient coming to a hospital for surgery. There are processes that the admissions department follows to admit a patient for surgery (these processes may be different than those for a patient being admitted for care of pneumonia). The operating room and laboratory also have processes to get the right patient the right procedures and tests to prepare the patient for a safe surgical experience. Your quality improvement efforts will be most effective by focusing efforts on the processes performed each day. It is important to define the area for quality improvement and realize the impact of a change in one process may have on other processes and within a system. Experts believe that 70 to 90 percent of all quality problems are built into the work process and systems. Inefficient and ineffective processes are at the heart of quality problems. Many processes become overly complex as an organization grows, develops, and changes over time. Example of Processes in a System Aim: to improve the number of patients who receive preventive tests according to guidelines

Registration Process:

•Patient registers

•Record pulled •Patient info

checked

History and Physical Process:

•Patient put in exam room

•Vital signs checked

•Meds verified •Complaints

documented

Examination Process:

•Patient seen by physician

•Patient examined

•Prescriptions

Laboratory Process:

•Lab specimen obtained

•Analysis done •Results sent to

office

System

Output Input Output Input Output Input Action Action Action

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The above diagram is an example of multiple systems in the physician office setting. Noted here are the registration process, the process for patient assessment of history and physical, the examination process, and the laboratory process. In summary, a process can be defined as a group of smaller tasks performed each day to bring about an end result such as registering patients, identifying needed health services, refilling prescriptions, ordering tests, etc. An example of interrelated systems would be in the physician office, where they provide multiple processes that are interrelated, and considered the system. Furthermore, a physician’s office may be one of many offices owned by a health care organization, and in this circumstance would be considered a system within a system. Process Variations Process variation occurs in all processes, and no process functions exactly the same way over time. How do we meet the demands for accountability and improvement when processes always vary? First we must understand variation. Random or Common Cause: is intrinsic to the process itself. It is the naturally occurring “noise” of the process. An example of common cause: the patient/resident response to medication will always vary within a group of patients/residents and even for one patient/resident over time. Common causes refer to situations that are usually within care systems and processes (within the normal bell-shaped curve) that are ongoing, chronic, and persistent. These common causes may contribute to what is considered to be a “normal range of variation” within a process. The goal of quality improvement is not to eliminate, but to reduce variation in a process enough to produce and sustain stability. Common causes may also contribute to what are considered to be the less than desirable parts of a process. Usually finding and resolving common causes of problems or variation is more time-consuming and may be more difficult for departments, services, and QI teams. The resolution of common causes of problems is important to continuous, incremental improvement of quality of care and services.

KEY POINTS:

• Process: a series of related tasks that results in a specific outcome

• Processes: how the work within a system is accomplished

• System: a group of related processes • Focus quality improvement efforts on a process

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Variances within the lines

Common Cause Special cause is extrinsic to the process and related to identifiable patient/resident or clinical characteristics, idiosyncratic practice patterns, or other factors that can be tracked or assigned to root causes. Special causes refer to sentinel events, one-time occurrences, or other unique, out-of-the-ordinary circumstances that give rise to a variation from what are normally expected. Special causes are more easily identified and resolved by QI teams. Special causes account for what are called “outliers” – problems that happen in the “tails” of a normal, bell-shaped curve representing a particular process. Case review and root cause analysis are needed to identify special cause and take action. Such variations, if negative (referred to as a Sentinel Event), can be quickly changed, and eliminated. Positive variations can be analyzed for replication as better or best practice.

Variance is at the tails

Special Cause

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The Customer Quality is defined by the customer and that customer may be internal to the organization. Likewise, the customer may be the ultimate receiver of products or services provided by an organization or company. Excellence in quality and customer favoritism (which helps the organization to flourish) requires continuous quality improvement. If organizations fail to examine and act on their opportunities to improve systems and processes, they may be left behind their competition. Customers will choose to go elsewhere for their goods and services. It is health care professionals who can make the difference by becoming involved in making the health care environment a more effective and efficient business. That is, a safer environment where we do the right things and we do things right. Quality Improvement, an Integral Part of the Organization Continuous improvement is best accomplished by improving processes in which people work and not just correcting the shortcomings of the people doing the work. An effective method for getting the job done is to eliminate inefficiencies and to ensure that quality is built into the way things are done. This means looking at out-of-date systems and processes – replacing old-fashioned methods with new methods that get the appropriate results. Through continuous quality improvement, the gap will narrow between performance and expectations. It will push the standards upward that will result in better outcomes. Staff should be competent to follow processes and procedures so that things are done correctly. In the clinical area, doing the right things right is analogous to doing appropriate things effectively. Understanding the variability of processes is a key to improving quality. In health care, there are uncontrollable variations related to differences among individuals, organ systems, and diseases. Quality improvement stresses understanding complex processes, measuring performance using reliable statistical methods, and using the resulting information to build quality into the process. According to Juran, 80 percent

KEY POINTS:

• Process variations are always present in processes. o Common Cause Variation

Intrinsic, natural noise of the process Goal is to reduce variation, NOT eliminate it Time consuming Incremental quality improvement

o Special Cause Variation Extrinsic, out-of-the-ordinary, sentinel event Goal is to eliminate negative variance or

replicate positive variance Quickly changed Root cause analysis and take action

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of an organization’s quality problems center on work processes and not people. It is the work processes that should be the primary target for continuous improvement initiatives. Quality and continuous improvement must be an integral part of the job of everyone in the organization. There is no short term or quick fix approach to make quality and continuous improvement happen. Pioneers in quality improvement have shown that it takes between five and 10 years to achieve breakthroughs in quality and to build continuous improvement into an organization’s culture. Strategies must be long term and enduring. John Guaspari, an expert on quality states, “Make no mistake, realizing significant improvements…. is hard, hard work involving a serious amount of grunting and sweating and heavy lifting on the part of all. It will also mean ‘doing things differently’ – which is to say, it will mean change.” Change is a constant in health care. Services, techniques, and rules are continually changing. Turnover and evolution in the workforce is continuous. Relationships are constantly changing. These changes can be barriers to quality improvement. Turf wars can prevent people from crossing department lines to solve problems that can impact team process. Staffing and time can also be a barrier to quality improvement. If staff does not have the time to participate on quality improvement teams, it can have a demoralizing effect. However, some changes make quality improvement easier, such as regulatory requirements and the demand of payors for data regarding quality. Positive change through empowerment and staff inclusion in decision-making can have a significant impact on the quality improvement process. Organizations that embrace quality improvement look at processes across the entire organization and do not compartmentalize issues into silos. Implementing a culture of continuous quality improvement means that changes can take place anywhere and at any level within the organization. As stated by Phillip B. Crosby, “Quality is the result of a carefully constructed culture; it has to be the fabric of the organization – not part of the fabric, but the actual fabric. It is not hard for a modern management team to produce quality if they are willing to learn how to change and implement.” (Crosby, 1979)

KEY POINTS:

• The customer (patient) defines quality. • In the work setting, each employee is a customer for

work done by other employees or suppliers. • All work is a part of a process that creates a product or

service for a customer. • Quality excellence requires continuous process

improvement. • People provide the intelligence and actions that are

necessary to make improvement happen.

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The Role of Leadership in Quality Improvement Leadership (CEO, COO, physician, medical director, administrator, assistant administrator, chief nursing officer and assistant nursing officer, department heads) in an organization has a significant role in the quality improvement process. The role of leadership is to embrace the principles of quality improvement and support the process. Senior leadership (CEO, COO, physician, medical director, administrator, assistant administrator, chief nursing officer and assistant nursing officer) plays a key role in fostering quality improvement throughout the entire organization both horizontally and vertically. Senior leaders are responsible for developing and fostering the organization’s mission and vision statements, which are the foundation for the organization’s commitment. Quality should be a primary focus to send everyone a strong message of quality endorsement. The central responsibility of leadership is to develop a quality culture that may include redefining core values and beliefs. Senior leaders need to link quality to the strategic plan by incorporating it into their short- and long-term goals. Quality is the strategy rather than something that is nice to do but can be jettisoned if the organization comes under pressure. Upper management (department heads, managers) must clarify organizational purpose, give quality a high priority, integrate quality objectives into regular business practices, develop skills for listening to people and for gathering and using data, and be dedicated to having the customer receive what was promised. They need to be accessible to all staff and customers. They need to emphasize that quality is first in bringing up the downside of any problems that occur. Dr. Deming has been noted to be extremely critical of management, attributing 94 percent of quality problems to management. He believes, “The first step is for management to remove the barriers that rob the worker of his right to do a good job.” Dr. Deming frequently asks how the worker can be expected to do it right the first time when not given the resources to do the job right. Top management needs to understand their role in quality. This means executive education. Top management is also responsible to see that the board of directors understand and are educated on the quality improvement process. Senior leaders must let everyone know that quality improvement is not optional. Communicating facility policy on quality to everyone lets staff know that management is committed to quality. Individual approaches to quality improvement should be encouraged. Quality improvement has to be taken seriously and has to be a management process; otherwise, the goals assigned will never be achieved. Senior leaders need to support department heads in incorporating quality improvement in their areas; otherwise, the whole process will be ineffective. Leaders need to be committed to quality by demonstrating investments of time, funds, and education. Leaders should be trained and be knowledgeable in the principles, methods and techniques of quality improvement and team development. Their role is finding the right people for the right jobs. Leaders should direct action for improvement by setting priorities for improvement, review and act on reports of activities and be able to interpret data, formulate actions, and reevaluate priorities for monitoring. Dr. Joseph Juran was the first to stress the need for broad management for quality improvement. Juran believes top management must be involved, as “all major quality problems are interdepartmental.” He sees less than 20 percent of quality problems due to the workers, with 80 percent caused by management.

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Middle managers are the ones who have to do the actual work, and they need to be reassured of the commitment of senior management. Middle management needs to transmit that credibility to the rest of the employees. The determination they show is what will convince people that the facility is really serious about quality. Improvement should occur at the process and systems levels simultaneously. The cycles of improvement need to be incorporated into everyone’s daily work life. It should not be thought of as just another project. Teams should actively seek new ideas, try ideas quickly and focus on results. Leadership needs to support the improvement process by enrolling all staff in the process. Support also means providing resources such as training, materials, and equipment as well as freeing up staff to participate on teams. The leadership must oversee the process to ensure that the teams are able to accomplish their goals. Leaders should not delegate this process to other staff members without providing oversight, which includes sitting on teams and requiring ongoing reporting. Senior leaders should require team leaders to report their progress and findings to the quality improvement committee.

Team Process Developing a Team Organizations that have implemented teams have a competitive advantage over those who do not. Teams are now considered to be a superior way to organize work. Teams are more flexible than the traditional department and can respond faster to issues. Teamwork creates synergy, which generates better ideas. A team is a small group of people who come together to share ideas and make decisions in order to achieve a goal. The team may include staff nurses, nursing or medical assistants, housekeepers, dietary staff, social workers, rehab staff, front office staff, back office staff and management. Teams should not consist only of management staff. A team is usually made up of six to seven people; however, in smaller organizations this may be less. The benefits of teamwork include shared knowledge and experience, and more creativity and flexibility. Teams create a learning culture, increase the likelihood that errors will be discovered sooner, and increase commitment and accountability. They also reduce the need for supervision.

KEY POINTS:

• Leadership o Key role is fostering quality improvement throughout the

organization o Central responsibility to develop a quality culture o Responsible for developing and fostering the organization’s

mission and vision statements o Provides oversight of the quality improvement processes and

team o Communicates quality improvement is not optional o Demonstrates commitment to quality improvement through

investment of time, funds and education

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In spite of their many advantages, there are some disadvantages to teams. They are finding time to meet, some members hate going to meetings, relationship building is hard for team members, decision-making can be a slow and painful process, and overall corporate culture may not be supportive to team decisions. What makes a good team? What a team does is think! Think of your team as a collective brain that comes together to make decisions. If the team is a thinking brain, the output is ideas and solutions that are arrived at by collaboration of the whole team. Members need to form an atmosphere of cooperation rather than competition. There needs to be participation by all members of the team and a belief that each member is accountable for the success or failure of the team. Members need to feel a sense of trust so that there can be communication and a free expression of opinion. The team needs to recognize that disagreement may be a positive factor. A good team evaluates the performance of the team periodically to see if it is on target. Phases of Team Development When someone joins a team, he or she needs to understand that teams go through a series of stages in development. Teams behave differently at each stage. Those stages are forming, storming, norming, and performing. The team leader who is developing a new team needs to pay attention to each of the stages.

Stage 1: Forming – When the team first forms, team members feel excitement, anxiety and uncertainty. Because of this uncertainty, most new members will sit back and size up the situation. Very few will take the initiative to jump right in. They will depend on the team leader to give them direction and structure. New members want to fit in or find a position on the team. The team leader needs to recognize what people want and provide structure. The team leader needs to provide the members with a sound orientation, a clear framework for the team to operate, a definition of goals and clarification of the roles so the team has a clear understanding of what they will be doing. This is a stage where the individual moves to a team member. Stage II: Storming – Storming is an expected part of team formation. Storming is the most difficult stage that the team goes through. After the team forms and starts to meet, the members realize that it’s not as easy as it seems, and they may become disappointed and disillusioned. They may become frustrated with the amount of work that is expected of them. Teams can storm about any part of the process, the work, the timeframe or meeting time. They argue with each other and become testy or overzealous. Cliques can form. Power struggles are also common and could be directed at the team leader. At this stage, it’s understandable to think the team will dissolve. It should be looked at as teenagers spreading their wings. The members are expressing resistance to working collaboratively with each other. They are beginning to understand each other. An effective leader will become the facilitator and use this opportunity to allow members to problem-solve their issues. If the leader has specific goals and plans, this stage may be

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less severe. The worst thing the team leader can do at this stage is to jump in and solve the problems for the team. During this period, the productivity of the team will stall. The team becomes distracted because of its internal problems. When the team works through these tough times, they develop self-esteem and confidence in their ability. They begin to work together and share control. Stage III: Norming – During this stage, the members become a team. Individual roles become clear and team members are more satisfied. Animosities are replaced with trust, respect and support. They are accepting the ground rules, understanding their roles in the team structure and the other members. There is an increased level of satisfaction as the team begins to solve major problems. The team develops cohesion, a common goal. They accept membership in the team. There is a relief that everything is going to work out. The team leader should implement correct interventions to solve issues and to help members develop new skills, including providing support as the team makes improvements. Through facilitation, the team leader gradually shifts the power from themselves to the team. The team starts to make progress. Stage IV: Performing – In this stage, the team is ready to get on with the work of the organization. Team members are now experienced at working together and feel progress is being made. They start to solve problems and implement change. There is a return of the excitement and energy in participating in team activities as members feel confident in their abilities and share in the leadership role. The team satisfaction increases with the progress made as they work interdependently and recognize each others’ strengths and weaknesses. There is constructive self-change. The team leader needs to be careful not to take back control as the team members begin sharing the leadership role. Mutual respect and a letting go of power should be a dominant theme in this stage. The team leader needs to build openness to change by updating methods and procedures to support cooperation, help the team to understand and manage change, advocate for the team to senior management and other teams, and monitor the team’s work progress and celebrate its achievements.

Teams move though these stages at different speeds. Some teams can go through the stages in several meetings or it could take some teams several months. It is not unusual for a team to go through the stages several times if members change. The team leader should be persistent and patient with the team as they move through the stages. These individuals will grow into a team.

Team members need to be aware of the stages the group will go through as it may relieve some fears that the team will not succeed, including emphasis on the point that all teams have high and low cycles. The mood of the team usually reflects its fortune. No matter how well a team works together, progress is never smooth. It’s the team leader’s responsibility to provide the direction and support, which allow the team to become a high performance team.

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Team Roles Now that a goal has been set, the next step is establishing team roles. Formal roles are roles with explicit responsibilities that are set prior to the team’s forming. They include the team leader who directs the group’s efforts and runs the meetings. If the team leader is unavailable, the facilitator can assume the role. The recorder/note taker takes notes and records decisions. The timekeeper keeps the team on schedule. Informal roles are roles that members take on themselves. These include the initiator, the person who proposes new ideas, the synthesizer who blends the ideas together, the coordinator who leads in coordinating activities, the harmonizer who resolves differences by finding common ground, the supporter who offers praise and builds solidarity and the clarifier who summarizes what’s been done. Team Rules To encourage a positive team environment, team members need a clear set of rules or “norms.” Usually the only rules that work for a team are the ones they create for themselves, and these should be posted each time there is a meeting. A few examples of team rules are:

• Everyone’s opinion counts. • One person speaks at a time. • Members must attend all meetings. • All information is confidential. • Meetings start on time. • No phone calls or interruptions during the meetings.

Decision-making A team needs to learn to make effective decisions. Besides voting, there are other decision-making approaches that can be used. The team needs to decide which option is best prior to any decision-making discussions. There are advantages and disadvantages for each option. Examples are:

Unanimous – These decisions are usually made quickly and they occur with more simple issues. One person decides – The team decides to defer to one person on the team to make this decision. Not all decisions need to be made by the entire team. Input from other team members may be considered before the decision is made. Compromise – This is the negotiated approach when team members are polarized. A middle position is found between the two sides. Multi-voting – This is a way of rank ordering a long list of options based on a set of criteria. All choices are ranked in order of priority, with one being the best. Majority voting – Team members choose the option they favor and the option with the most votes is considered the best choice. The quality of this method is enhanced if there is discussion and idea sharing prior to the vote.

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Consensus – This is a conversational approach that involves everyone understanding the situation, analyzing the facts and jointly developing solutions.

Team Problem Solving Sometimes team members view the situation in entirely different ways. By defining the problem, the team clarifies the goal. If the problem is complicated, the team may need more information, and each fact may need to be analyzed. An effective team will attempt to identify several methods to solve the problem. Brainstorming is a process that is used by many teams to identify as many solutions as possible. Other tools that can be used include the affinity diagram, multi-voting and nominal group technique. Creativity and dissenting views are encouraged and all options need to be considered. A good team will have many discussions regarding each possibility. Team members need to have a sense of trust in order to speak freely while alternatives are considered. After discussing all alternatives, the team chooses the best option, and evaluates the outcome of its plan.

Team Leadership Today’s work environment needs a leader who can energize and coordinate the team. A team leader needs to be knowledgeable, persistent, organized, creative, adaptive, tactful, a good communicator and have a willingness to accept responsibility. The leader inspires the team vision and sets the tone that will support all team members. An effective leader will empower others by sharing responsibility and power. The leader coaches and mentors team members, resolves difficulties, takes on the role of mediator if a conflict arises, maintains the team norms, and recognizes and praises members’ successes. A team leader builds team spirit, monitors progress toward the goal, keeps people on track, and directs the decision-making process by encouraging the team to review alternatives and choose the best solution.

The CQI Journey – PDSA Cycle Now, let us consider the PDSA cycle for quality improvement. Continuous quality improvement (CQI) refers to the ongoing journey of improving processes. It is a journey, not a quick fix. Like putting a puzzle together, it requires continuous observation, assessment of where there are gaps, trial and error in making the picture complete, evaluating where pieces fit, or what will make the picture better, and so on.

KEY POINTS:

• Teams o Collective brain that comes together to make decisions o Develop through phases: Forming, Storming, Norming,

Performing o Establish team roles and team rules o Learn to make effective decisions o Use several methods to effectively problem-solve

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The P is for Plan. When beginning a QI journey, planning is the most important, intense, and longest piece of the cycle. This learning module will review the components of planning in detail. The D is for the Do phase when the QI team actually implements a change and collects information about the change. Sometimes this change is a test or a pilot, to learn what are the best methods and changes to make. The S, or Study phase, requires the team to examine the effects of the “do” phase, analyzing and evaluating the data and observations about the change that was made. The A, or the Act phase, means that the QI team will decide what the next step is in its QI puzzle. Based on what they learned, should they continue on the journey, alter the plan to improve the results, or abandon this plan and make a fresh attempt during the next PDSA cycle?

Plan Planning is the beginning of the journey and the most important and longest part of the journey. Planning for a successful QI project involves eight steps. Like getting organized to put together a 1,000-piece puzzle, we must develop a concrete plan for the QI project. There are multiple steps in developing a well-organized, comprehensive plan. Planning Step 1: Focus - Determine the Focus of the Project Keeping in mind that we cannot improve everything at the same time, strategic questions should be asked:

• What will be the target of the improvement effort? • What needs to be improved? • What causes the most problems? • What are the high cost areas? • What data do we have? • What might be quick and easy? • What are the investment time, resources and money?

P

D

S

A

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It is helpful to examine many aspects of what you may think needs improvement. For some, the area of focus will be determined by what causes the most problems or is associated with the highest costs. It is important to look at what information or data might be available to help define the problem as high cost, high volume or problem prone. Sometimes the focus of improvement is mandated by administration or regulatory agencies. Sometimes it is a quick and easy fix, which is what some call “the low hanging fruit.” This is something that has the potential to be improved or fixed with minimum effort, cost (resources, time and personnel) and disruption. Once the improvement focus has been determined, the next step is to organize a quality improvement team. Planning Step 2: Establish a Quality Improvement Team Keeping in mind the team concepts presented previously, formation of a quality improvement team begins during the planning phase. The team is defined as a designated group of people in a system that comes together for a period of time to focus on improving a process. All QI teams usually consist of a leader and a QI facilitator with additional team members determined by the size of the organization and the size of the project. Often the leader of the QI team is assigned this accountability by the organization. The facilitator is a person skilled in quality improvement techniques who supports the improvement process. For example, some larger physician offices, nursing homes orhealth care systems may have a permanent quality improvement team or committee established, while in a smaller physician’s office, hospital or nursing home, a team may consist of just two or three people. Whether your team is large or small, quality improvement is the result of team members working together to make a positive difference. The composition of your team depends primarily on the focus of the improvement effort and the size of your organization, agency or office. It is important when forming a team that many of the members represent persons knowledgeable about the process being improved. Equally important to successful health care QI is support from physicians and administration. Any process improvement that impacts the work of the health care providers or needs financial backing is best served by obtaining that support during the planning phase. Although physicians and administrators may not be able to attend every team meeting, providing frequent communication and keeping them updated will help to keep the team’s work running smoothly. Many teams include a patient or client. As the ultimate customer of the process, patients can offer some unique perspectives on the QI effort and its impact. Important questions to consider in selecting the right team are:

• Who knows the work? • Who will be impacted? • Who would be a good champion? • Who has veto power?

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• Who has power to make things work?

It is critical to involve some people who know the work that is being evaluated. They have insights from living in the “real world” that others would not be able to contribute. Also critical is to include those people who have the power to make things work in the organization, or the power to veto (reject or derail) the entire QI effort. A champion is someone who will help to promote the QI project. This person should be invested in the need to improve, have the respect of others, be willing to take risks, and be respected by others in leadership positions. As explained earlier, when we change one process it usually affects other processes or parts of the system. Therefore, it is very helpful to include a representative from areas that will be affected by the quality improvement change. Sometimes it is best to have these representatives be ad hoc members who participate in the team meetings, as needed. Critical to the team function is defining and clarifying team responsibilities. All of the team members should be committed to improving the area of focus. Some teams establish ground rules to promote teamwork. Establishing ground rules in the beginning will assist the team in functioning in a consistent manner. Other team responsibilities include reviewing the literature and gathering data for making quality improvement decisions. Many strategies for effective team meetings can be found in the book The Team Handbook by Scholtes.(2003) (See reference list at the end of independent study module.) Keeping leadership advised of the team’s progress is an important element. By preparing brief summary reports on a monthly basis, the QI team can keep the project in the minds of busy leaders. Good communication will greatly enhance the project’s implementation and early adaptation of a new process by the staff. Planning Step 3: Establish the Goals – The AIM Statement The third step is to set a goal or a target. Goals help to keep everyone on track. Goals define the desired result or purpose and are guides to action. Everyone should know their accountability for the goal(s) and meet those expectations. In their text The Model for Improvement, Langley, (1996) et al., describe three questions for quality improvement. (See the reference list at the end of independent study module.) They recommend that the QI team constantly ask, “What are we trying to accomplish?” to keep everyone focused on the goal. With active committed team members who are energized to make things right, teams often get sidetracked into areas that need improvement, but that are not the focus of this team at this time. A good strategy is to validate side issues by noting them in a “parking lot.” A parking lot can be a part of the team’s meeting minutes. This way the concern is noted and documented. This method often allows the team to move forward with the current goal.

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Setting SMART Goals Goals should be stated in specific, concrete terms, not in vague generalities. Anyone should be able to understand them and be able to form an image of the desired outcome. Making goals measurable allows the team to know when they have accomplished the task. Attainable means that the goal is reasonable and possible. Realistic means that the goals can be accomplished by this team, in this setting. Defining a timeframe helps keep the energy going and limits “process paralysis.” Process paralysis occurs when teams become so involved with the details that they never get to the “Do” stage of quality improvement. Planning Step 4: Define the Current Process Defining what happens in the current process is the fourth step in planning and helps the team to understand the issues with the current situation. A flow chart identifies the steps in a process and may point out areas for improvement. There may be a variety of interpretations of the process. Sometimes, as workers, we create shortcuts or develop “work-arounds” when there are barriers. These “work-arounds” become part of the process even after the barrier has disappeared. You may have heard the story of Susie watching her mother baking the Easter ham. Before putting the ham in the large roasting pan, mother cut off both ends of the ham. When Susie asked why, she was told, “Grandma always did it that way, and she is the best cook in the county.” Later, when Grandma arrived, Susie asked her why good cooks cut off the ends of a ham. Grandma laughed and laughed and then told Susie, “I cut off the ends because I didn’t have a pot big enough for the whole ham!” Grandma created a “work-around” that became a traditional process for baking ham. It is surprising how many “work-arounds” can be found in health care processes. Consider the following actions:

• Interview workers about the steps in the current process – how do they do it? • Get the patient’s/resident’s point of view – how do they see it? • Make a process flow chart of all the steps – use a sticky note for each step. • Look for variations (differences) in the processes. • Check for unnecessary steps (such as charting the same thing in multiple places).

Once the current process has been charted and examined, the team should look for areas of redundancy, variation and steps that are not necessary. (Refer to Appendix A for Brainstorming and Flow Charting Procedure Guidelines.) Planning Step 5: Examine Solutions The fifth step in planning is sometimes the most fun – brainstorming solutions. The QI team may examine the quick and easy fixes, the “low hanging fruit.” One of these might be to remove redundancy identified in the process flow chart. One trap that many have tried is to “do more of the same.” With this approach they add more people, more steps in a process, or more time. This does not really improve the process and often only adds cost. This is the time to use your creativity. Look beyond the obvious solutions. Do not be limited by the seemingly impossible. Sometimes great changes come from thinking broadly and using one’s imagination. Consider the hospital that eliminated the admitting department. They designated a

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bed manager position who assigned rooms to patients, and the unit secretary completed the admission paperwork when the patient arrived in the room. This enhanced patient satisfaction, eliminated wait times in admitting, and facilitated getting admitting paperwork started. A good strategy is to ask, “What if …?” or pretend you are starting from scratch or that you have an unlimited budget. These methods often stimulate the creative side of problem solving. It is best to list all ideas, even those that are outrageous, because they help stimulate others to think outside the normal boundaries. Planning Step 6: Select a Change After generating and examining the possible solutions to improve quality, the team must decide what they will do next. Do not eliminate all of the possibilities. If the first change does not work out, the others may be very useful in redesigning an improvement. There are two questions that are recommended by the authors of The Model for Improvement (Langley, 1996 et al.) that the team can ask: • What are we trying to accomplish? (Remember this question from earlier in the module?

This will keep the QI team focused on the priorities.) • What change can we make that will result in improvement?

Furthermore, the team may decide to implement the change as a test or pilot. Testing the change on a small scale allows the QI team to gain knowledge about how the change will work with minimal risk. The knowledge gained with each test will facilitate acceptance when the final change is implemented. Doing a pilot test permits the team to check out different alternatives and explore the possibility of combining several points with a small risk for negative results. Planning Step 7: Determine Measures Types of data defined:

Measurement – This is the measurement of data by the number of each observation or unit. Examples: time, overtime hours, costs Count – This data consists of counts of observations by categories. Rates or percentages that are calculated using “count” data in the numerator fall into this type of data. Examples: medication errors, daily census, falls, pressure sores, weight loss Subjective Data – This is often used to measure courtesy, level of quality or customer service satisfaction. It is the customer’s perceptions or reactions to a process, product or services.

The seventh step in the Plan portion of PDSA is to plan for data needs. The Model for Improvement authors give us a third and final question to evaluate this: “How will we know that a change is an improvement?” (Langley, 1996, et al.) If we do not make observations about the change, we will not be sure that the change we made was a good change. All we will know is that it is different. To make our test of a change as objective (free from bias or opinion) as possible, we need to gather objective information about the change. When we only use personal

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observations, we may influence the results by seeing what we want to see or what we expect to happen. Objective data means that personal or subjective influence has been minimized, or eliminated. If personal, subjective or opinion information is used, it must be noted as such and carries less weight than objective data. To decrease bias, the QI team may decide to develop an assessment form in order to consistently gain information about the change from affected workers, or use patient or staff satisfaction surveys. (See Attachment B: Developing a Check Sheet) To gain objective data, the QI team may decide to use before and after measures like time to complete a process, number of people involved in a process, number of forms completed accurately, scores on tests, quality indicator rates, etc. Determine who will collect the data, what type of data collection form will they use, when the data collection will occur, etc. An experienced person should plan to collate and review the data, and then present the information to the team. Planning Step 8: Detail the “Test” Plan The final step in the planning phase is to develop a detailed plan for the change or test. The QI team should identify the work efforts required for the test of change. From this list of work, they should develop an implementation action plan that notes who is responsible for what activities during the test of change. Each QI team member needs to be involved and take accountability. Sometimes posting a flowchart of the new process is helpful. However, if the flow chart is too complicated, it may just raise anxiety. If the QI team discusses possible barriers that may arise, then they will be more prepared for those surprises that always happen. Having discussed them will facilitate rapid response and solutions. The personnel involved in the test will feel more positive about the stress of a change if they are kept informed, if the QI team is visible and concerned about the test personnel, and if they are recognized for their efforts. Sometimes a treat for the test personnel (like pizza or candy) buys a lot more than a thank you snack. It often says, “We know this is stressful, and we appreciate your commitment to make this work and to improve patient care, and we care about you.” At the end of planning, the QI team is very focused on the work of improvement and is able to work together as a team. Specific purpose and goals have been determined and sanctioned by the team and by administration. The QI team has detailed knowledge of the process they are improving, and a plan that will test a change. The team has developed a concrete plan to evaluate the change with measurement tools and a plan for analyzing the data that they collect.

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The team is now ready to “Do,” or implement, the plan.

Do The test or change is implemented at this time. The QI team should follow the detailed action plan developed in the planning phase. Consider the following:

• Pilot the plan on a small scale. • Make adjustments as necessary. • Support the implementation site, unit, department, or team. • Monitor the change process.

The change should be monitored closely while gathering information about the change process. Data collection forms should be completed as the change is being carried out. This data should be reviewed as soon as possible to allow the QI team to make any necessary changes quickly. Tracking successes and barriers that occur during the change will help the team to develop lessons learned from the change process. These data will be most helpful in the next PDSA cycle and in future QI projects.

P

D

S

A

KEY POINTS:

After planning, the quality improvement team should have a:

• Well functioning team • Specific purpose and goal(s) • Clear understanding of the process • Detailed implementation plan • Measurement plan and tools

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Important to the success of the PDSA methodology is that a team should not wait for a proposed process to become perfected before trying it. The PDSA methodology supports trying changes early on a small scale and making adjustments based on what is learned during each trial. Some tips to keep in mind as you test your quality improvement change are:

• Try the change. • Observe the consequences. • Learn from the trials. • Run small cycles soon rather than large cycles later.

First, go ahead and try the change. Do not wait until it has been perfected. Observe the consequences of your trial, and improve the process as you go. Remember to start with small-scale trials. As you improve the new process, increase the size of your trials. As noted during planning, data needs to be collected during the implementation phase. The goal is to make data collection easy to do and focused on the important information needed to determine success or failure. Some data may already be available. Information on the number of patients or clients is usually available. In the home care arena, times for patients’ visits are already tracked, the number of laboratory studies would be easy to capture, the number of cases in an Emergency Department is routinely tracked, etc. The KISS rule applies here: Keep It Short and Simple; or some may call it Keep It Simple, Silly. Consider the following:

• What might be quick and easy? • What data may be routinely collected? • What is the investment in time, resources, and money?

Upon conclusion of the “Do” phase, The QI team should have data and information about the change. The outcomes of the Do phase of PDSA should include an identified list of driving and restraining forces. Driving forces are things, people, or conditions that help the change be successful, while restraining forces are those that prevent positive progress and become barriers.

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D

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Study The team will examine and evaluate the data to determine what was learned from the test or change. Studying the result means that the team will examine all aspects of the change. They will focus on: • What did we learn and why? • What went wrong? Why did it go wrong? • What went right? What made it successful? • What happened that was unexpected? Why did this happen? • What does the data tell us about the test or change? • Are there other ways to look at the data?

Each pilot test allows the team to learn about the change process and add to the knowledge they have gained. QI team members should be able to understand the data results and have a clearer understanding of the issues with changing a process. The team develops a statement regarding the success or failure of the change and can make recommendations for further improvement. After studying the results, the team should have:

• Analyzed data with tables, graphs, etc. • A list of lessons learned • A clearer understanding of the process • A conclusion statement about the results of the test or change

Act Here the team decides the next steps for the project. There are several options the team needs to consider before taking the next step.

P

D

S

A

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After evaluating all the information and data collected about the change, the project QI team usually makes one of the following three decisions:

Adopt the change as it was conducted. This occurs when the change resulted in improvement. The next PDSA cycles would be focused on making the change a permanent part of the process and spreading it to other areas.

After the final change has been determined by pilot testing, the decision to adopt the change is made. The improvement will be implemented on a larger scale and the new process must gain acceptance and be fully integrated into the system through a spread initiative. There are several steps to consider when planning for spread within the organization. First, senior leadership must assess the organization’s readiness to undertake a spread initiative and provide the support and resources for success. There should be alignment between the goals of the initiative and the organization’s key strategic objectives. Development of the spread team with an executive leader, day-to-day manager, representatives from the pilot areas and other clinical experts, as well as IT and support staff is critical for agreement on the key strategies that are to be spread. This team will be responsible for the communication and measurement plans. Lessons learned from full system implementation will help with future quality improvement initiatives.

As the change is made permanent, a method to evaluate the change over a period of time must be developed by the team. The purpose of this monitoring and evaluation is to make sure that the goal is being maintained or sustained, also known as “holding the gain.”

It is human nature to return to the comfortable and familiar way of doing things. With a plan to monitor the change, the QI team will have information to assess the permanence of the change. The team may determine to measure and evaluate the change weekly or monthly at first and then fall back to a quarterly or yearly review. Whatever method or time period is selected, it is important to review the data periodically to ensure that your change is still an improvement over time.

Here are a few suggestions:

• Make reversal to the previous way of doing things as difficult as possible. Most of us do not like to change at first. Make it difficult to slip back into the old way of doing things.

• Make someone responsible for reviewing the process and the data on a regular basis.

• Establish the new process as the standard operating procedure. It needs to be documented as a procedure or expectation; the way things are done.

• Encourage staff to use the new process by posting the data showing before and after results, followed by periodic updates from monitoring.

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Adapt (or alter) the current change based on what was learned. This often means “tweaking” the change, or making some small improvements, or some additions to the original plan based on what was learned. The next PDSA cycle would be to revise the plan, implement the revised plan, gather and evaluate data, and decide again to adopt, adapt or abandon the change. This process is repeated until the team is satisfied with the results and ready to make the change permanent.

Abandon the change as perhaps there was not much to salvage from the first PDSA cycle. Sometimes it is easier to start fresh, than to do major reconstruction of a plan. Depending on the change results and the evaluation of driving and restraining forces affecting the change, perhaps a new test site should be selected, or resurrect one of the other solutions identified in the planning phase. Sometimes interviewing the workers from the test site can give the team valuable insights and positive suggestions.

The Model for Improvement

This diagram is a picture of The Model for Improvement by Langley, (1996) et al. The three important questions at the top of the model were discussed during the Plan and Do phases of PDSA. The three questions are: • What are we trying to accomplish? • How will we know that a change is an improvement? • What change can we make that will result in an improvement?

Plan

Do Study

Act

What are we trying to accomplish?

How will we know that a change is an improvement?

What change can we make that will result in an improvement?

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The large arrows indicate that the QI team needs to continually ask these questions as they progress through the PDSA cycles. The model emphasizes rapid trial and learning from each PDSA test. This integration of the three questions helps to guide the QI team throughout the improvement work. They keep the team focused on the specific goal and help the team to plan and evaluate the change for improvement. Quick small-scale trials are emphasized while continuing to improve the change as you go. The above model visually depicts the rapid trial and learn aspect of The Model for Improvement by Langley, (1996) et al. As you can see, the PDSA cycles continue to repeat until the change is ready to be implemented on a larger scale. The improvement ramp begins on the left with improvement ideas that were selected and developed by the QI team. As the team progresses through each PDSA cycle, they test and learn more about what works and why it works. For example, your QI team may desire to improve patient registration and design a new form. During the first PDSA cycle the new form is tested on a few patients. Several problems arise and are discussed in the study phase. The team decides (act phase) to adapt the first form. After making adjustments, the registration form is tested again (the second PDSA cycle), for an entire day. The registration process flow improves substantially but a few barriers remain. The team determines that it must make a few more changes, and returns to the planning stage for the third PDSA cycle. After a few cycles, the team implements a patient registration form that improves the overall patient registration process. With each “test and learn” PDSA cycle, more knowledge is gained about the best process for registration. Finally, at the top of the ramp, as more and more is known about the best process, the team has reached the goal: a change that resulted in improvement. The “act” decision is to adopt this final change.

Future Cycles

Cycle 1

P D

S A P D

S A P D

S A P D

S A Cycle 2

Cycle 3

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Project: Reduce MRSA Infection Objective for this PDSA Cycle: Test obtaining a nasal swab culture for MRSA on admission to the ICU.

PLAN: Questions: Will obtaining nasal cultures on admission to the ICU be easy? Will staff be willing to do this as part of the admission process? Predictions: Cultures will be easy to obtain on admission if the materials are available. Staff will be willing to collect the cultures if they understand why we are doing this. Plan for change or test – who, what, when, where: Who – Mary (ICU nurse) with Joann (ICU nurse) What – Test obtaining a nasal culture on the next admission to ICU When – Tuesday Where – ICU Plan for collection of data – who, what, when, where: Who and What – Joann will meet with Mary at the start of the shift and explain the purpose of and procedure for obtaining the culture. Joann will ensure that culture swabs are available. When – When next admission arrives in ICU DO: Carry out the change or test. Collect data and begin analysis. Mary received an admission around 11 a.m. Culture swabs were available in the utility room and she obtained a culture from the patient and sent it to the lab. The lab called Mary to ask about the culture as there was no order in the computer system for it. STUDY: Complete analysis of data: Mary told Joann that it was easy to do the culture, but that it would be easier if she did not have to go to the utility room for the swabs. She also suggested that it should be on the ICU admission checklist. The lab did not know what to do with the culture because no order had been entered into the computer system. How did or didn’t the results of this cycle agree with the predictions that we made earlier? The culture was easy to obtain, but the materials were not in a convenient location. The lab portion of the test had not been predicted. Summarize the new knowledge we gained by this cycle: The swabs need to be in the patient rooms. The lab needs to have an order in the system in order to process the culture. ACT: List actions we will take as a result of this cycle: Repeat the test with another admission, but store swabs in the ICU patient rooms. Joann will ask the intensivist, Dr. Jones, for permission to place an order in the computer for the culture. Plan for the next cycle (adapt change, another test, implementation cycle?): Test again tomorrow in the ICU with Mary. Also plan for possible revision to admission checklist if tests are successful.

PDSA Worksheet Sample Cycle: 1 Date:

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Barriers Teams working on reducing MRSA infections and transmission have learned a great deal about barriers to improvement and how to address them. Some common challenges and solutions:

1. Lack of support by leadership Solution: Use opinion leaders (physicians) and data, if possible; a business case for the project may help to win leadership support. 2. Uneven physician acceptance of new practices Solution: Use physician opinion leaders, review the medical literature and feedback data on a physician-specific level. Remember that physicians may fall anywhere on the “Adoption of Innovations” curve; work first with your early adopters and use their stories to convince the majority. 3. Lack of clear ownership for care practices Solution: Work with physician leaders to develop standard approaches to postoperative care, including clear designation of the physician owner.

Sample from: IHI, 5 Million Lives Campaign How-to Guide: Reduce Methicillin-Resistant Staphylococcus Aureus Infection This document is in the public domain and may be used and reprinted without permission provided appropriate reference is made to the Institute for Healthcare Improvement. Summary The QI with PDSA puzzle is complete. The purpose of this report was to provide health care providers with an opportunity to learn about the quality improvement process and the application of the PDSA cycle. Our goal was to assist you in supporting quality improvement efforts in your health care organization.

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ATTACHMENT A: Brainstorming and Flowcharting Brainstorming Brainstorming starts the flowcharting process. The team leader needs to involve the whole team – especially the members that are directly involved with the process. Brainstorming is the act of defining a problem or idea and coming up with anything related to the topic – no matter how remote a suggestion may sound. All of these ideas are recorded and then evaluated only after the brainstorming is completed.

Procedure 1) In a small or large group, select a leader and a recorder (they may be the same person).

2) Define the problem or idea to be brainstormed. Make sure everyone is clear on the topic

being explored. 3) Set up the rules for the session. They should include:

a) allowing everyone to contribute b) ensuring that no one will insult, demean, or evaluate another participant or his/her

response c) stating that no answer is wrong d) recording each answer unless it is a repeat e) setting a time limit and stopping when that time is up

4) Start the brainstorming. The leader will call on members of the group to share their answers.

The recorder should write down all responses, if possible, so everyone can see them. Once you have finished brainstorming, go through the results and begin evaluating the responses. Some initial qualities to look for when examining the responses include: a) any answers that are repeated or similar, grouping like concepts together b) eliminating responses that definitely do not fit c) discussing the remaining responses as a group (after list has been narrowed)

5) Use the list developed during brainstorming to start the flowchart process. Look for the

biggest hole in the process, whether it is education, documentation, or form design, and start there.

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Flowcharting After you have completed the brainstorming, the next step is to flowchart the current process to understand where the problem is occurring. It is important to flowchart the process as it is, not what you want or think it should be. This helps to provide understanding and allows the team to focus on the area that is not performing correctly. If you don’t have a process for the area you chose to improve, then flowchart what you think the process should be. A flowchart is a picture of the steps of a process, and it is used to examine the sequence of steps and identify repeated steps, unnecessary steps, and any inefficiency in the process. It creates a common understanding of the process flow. It assists in understanding the actual steps of a process and how one part can affect another part of the process. Procedure 1. Determine the frame or boundaries of the process. 2. Come to an agreement on where the process starts and where it ends. 3. Determine the steps. 4. After brainstorming, put each step on a sticky note. Have everyone on the team

participate. 5. Sequence the steps on a flipchart.

a. chronologically from the start of the process to the end of the process b. what it is, not what it should be

6. Draw the flowchart using the appropriate symbols. Start out simple, using oval (start, finish), box (action step), and diamond (decision) shapes. Connect the direction of the flow with arrows.

7. Test the flowchart for completeness. a. Review all the steps for completeness (correct symbols, closed loops, arrows

pointing in the right direction). b. Make sure the flowchart has enough detail to find improvement opportunities.

8. Finalize the flowchart. a. Look for problem areas and get feedback from the team.

9. Interpret the flowchart. a. Is the process functioning the way it should? b. Are people following it? c. Is there complexity? d. Are there redundancies? e. How different is the current from the ideal? f. Where can it be improved?

After completing and analyzing the flowchart and identifying the areas for improvement, the next step in the process might be doing a root cause analysis or, having identified the areas, select one area to work on.

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ATTACHMENT B: Developing a Check Sheet Developing a Check Sheet The Check Sheet is a data-gathering and interpretation tool that can be used to:

• Distinguish between fact and opinion (opinion example: How do residents perceive the quality of the meals prepared by the facility’s dietary department?)

• Gather data about how often a problem is occurring (fact example: How often are residents receiving meal trays with hot food that is less then 140 degrees and cold food that is greater than 40 degrees?)

• Gather data about the type of problem occurring (example: What is the average timeframe that residents’ trays are stored in carts on the nursing unit before being delivered? Or, what is the average timeframe that residents’ trays sit in carts in the kitchen before being delivered to the nursing unit?)

Procedure for Developing a Check Sheet 1. Clarify the measurement objectives by answering the following questions:

• What is the problem? • Why should data be collected? • Who will use the information being collected? • Who will collect the data?

2. Determine the specific things that will be measured and the time and/or place that the information will be collected.

3. Create a form for collecting data. The specific measures should be listed along the left side of the check sheet with the time or place being measured listed across the top of the column(s).

4. Collect the data for the item being measured. Record each occurrence directly on the check sheet as it happens.

5. Tally the data by totaling the number of occurrences for each category being measured. 6. Evaluate the information obtained from the data on the check sheet to determine:

• the scope of the problem • the severity of the problem

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