Healthcare Quality Movement into the 21st Century PDF

# Healthcare Quality Movement into the 21st Century ## Box 5.1 Key Points: Evolution of Performance Improvement - Key leaders in healthcare quality laid the foundation for current frameworks that stand the test of time. - Values and philosophy derive from long-standing quality leaders. - Learning...

# Healthcare Quality Movement into the 21st Century ## Box 5.1 Key Points: Evolution of Performance Improvement - Key leaders in healthcare quality laid the foundation for current frameworks that stand the test of time. - Values and philosophy derive from long-standing quality leaders. - Learning comes from theory and experience. ## Healthcare Quality Movement into the 21st Century The U.S. healthcare quality movement began in the 19th century and continues into the 21st century. ### The First Era: Nightingale, Codman, and the American College of Surgeons - In 1863, Nightingale noted that patients seemed to fare better in some London hospitals than in others. She was the first to call for systematic inquiry into the nature of care processes that could be related to outcome variability. - Although there is little evidence that Nightingale's quality vision came to fruition during her lifetime, Boston surgeon Codman's early 20th-century efforts had a more direct impact. Codman, who also observed variability in patient outcomes among several hospitals, called for a systematic evaluation process with a view toward improving care. - These efforts met considerable resistance at the time, Codman's ideas were embodied in the founding of the American College of Surgeons in 1913. Codman's body of work set about the task of establishing quality standards and focus on outcomes. - In 1917, the College established a five-part minimum standard, and the Hospital Standardization Program was born. This was the early beginning for hospital accreditation based on standards. - The Program was based on Codman's end-result system of standardization in which hospitals would track every patient treated for long enough to determine if the treatment was effective. When treatment was found to be ineffective, the hospital would attempt to determine how similar cases could be treated with success in the future. ### The Second Era: Legal Decisions, Donabedian, and The Joint Commission's Monitoring and Evaluation Process - Definitions and requirements for quality in healthcare evolved over the past decades. - In the early 1950s, quality care review was conducted exclusively by individual physicians using an unstructured and subjective process that relied on the practitioner's knowledge and experiences. - Between 1950 and 1960, the responsibility for quality of care expanded beyond the physician to include both the hospital and the board of directors. - Two significant legal decisions marked this transition period: - *Bing v. Thunig (1957)*. In this case, the New York Court of Appeals ruled that the doctrine of charitable immunity no longer applied to hospitals; hospitals are liable for patient injuries sustained through negligence of employees. - *Darling v. Charleston Community Memorial Hospital (1965)*. In this important corporate negligence case, the court ruled that the hospital had a legal responsibility to protect a patient from harm by others by overseeing the quality of patient care. - Accreditation standards evolved slowly throughout the 1950s and early 1960s. - At the academic level, the University of Michigan's Donabedian examined existing research, formulating a theoretical framework for patient care evaluation. He is best recognized for the "structure, process, outcomes" model of quality evaluation. This model suggests the importance of relating healthcare structures (qualifications of practitioners and facilities and technology available to them) and processes (activities involved in prevention, diagnosis, and treatment) to outcomes (how patients fare because of their care). - In the past, The Joint Commission accreditation standards reflected the structure and process elements of this model. - Surveyors, who reviewed the structures and processes, assessed hospital plans and technology, qualifications of clinicians and administrators, and organizational structures against the annually updated requirements contained in the Comprehensive Accreditation Manual for Hospitals. Specialized standards for behavioral health and other services were also developed. - Surveyors inferred process from documentation and discussion. They reviewed minutes and interviewed clinical and administrative leaders to ascertain whether designated individuals were following procedures and compliant with quality evaluation processes. ### The Third Era: Berwick, Batalden, and Deming, Juran, and "Japan, Inc." - The names of Berwick, Batalden, and James are eminent in the field of healthcare quality. Like many of their colleagues, these physicians were dissatisfied with traditional healthcare quality assurance practices. - These pioneering physicians, however, went beyond a mere critique of existing quality assurance. Both Berwick and Batalden researched the industrial methods publicized by the Japanese experience. - Arising from this research, Berwick's article describing healthcare quality assurance as based upon the theory of the bad apples became a classic. - Among his many contributions, Batalden translated Deming's 14 points into a healthcare context. - In 1987, these two physicians played key roles in linking with the Juran Institute and a variety of industrial quality consultants to create the National Demonstration Project on Quality Improvement in Healthcare. This multiyear project and its original 21 forward-looking healthcare organizations conclusively demonstrated the applicability of performance improvement processes to healthcare. - James, of the Intermountain Health System, was also a pioneer in applying quality improvement processes directly to patients and clinical outcomes. The success of James and his team measured not only improved results in a single hospital but also across the entire multihospital system. - In 1991, Berwick established the Institute for Healthcare Improvement (IHI), a not-for-profit organization that began driving improvements in healthcare. - It accomplished this by supporting national projects focused on the six aims-safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity. 17 Collaboratives are one approach involving many organizations trying to affect the same issue and using rapid cycle improvement efforts to implement change. - A major benefit of this approach is that the collaborating organizations share their experiences and improvements spread quickly. Projects initiated include improvements in patient safety, chronic care, critical care, falls, and end-of-life care. Berwick was appointed administrator of the Centers for Medicare & Medicaid Services (CMS) in 2010 and served for 18 months in President Obama's administration. - While in office, Berwick inculcated the Triple Aim into health policy: improving the patient care experience, improving population health, and reducing health costs. - Dr. Berwick was also responsible for initiating major changes under the new health reform legislation known as the Affordable Care Act. ### The Fourth Era: Patient is Front and Center with Growth of Advocacy, Engagement, and Activation - Healthcare reform stresses an imperative to engage families in their own care. - Enhancing patient-centered care that results in empowerment, engagement, and activation is everyone's job. - Patients and their families need to understand their role and responsibilities related to quality and safety. - Patient-centered communication is shown to improve clinical outcomes. - More patient-centric technology tools and applications are available and have been found to be most useful in managing chronic disease. - Patient advocacy includes addressing the rights and responsibilities of patients and involving them in shared decision making, obtaining informed consent for treatment, and disclosing unanticipated outcomes. - An advocate or ombudsman is often available to manage inquiries, requests, complaints, and grievances, with a process to document and track reported issues to resolution. - An ethical framework is often applied with ethics consultation to respond to issues that may create conflict with the rights of the patient and the organization or others. ## Box 5.2 Key Points: Healthcare Quality Movement in the 21st Century - Adaptation is vital to knowledge acquisition and use of changing models for performance improvement. - Continuous learning is essential at the individual and organizational level. - Regulatory and accreditation requirements have matured over time. - Attention to quality increased the focus on consumer rights-what matters to the patient is most important and healthcare delivery must be person-centered. ## Performance Improvement Approaches There are a variety of performance improvement (PI) approaches, and they each have value and usefulness depending on the type of problem, scope, and solution needed. The process for determining which performance improvement model or models to use in an organization requires an analysis of the organization and its history of success with current and previous models, level of maturity, and resources. - How will the model be communicated across the organization? - Are all staff members expected to know how to use it? - Which model or models are a good fit with the culture and the current strategies that are working? ### Quality Assurance - Audits led to a preoccupation with meeting audit number requirements. - Thus, in 198O, the Joint Commission on Accreditation of Hospitals, now known as The Joint Commission, developed the first quality assurance standards requiring a problem-focused approach to measuring quality. This approach required organizations to identify and monitor problem areas. - The combined strengths of criteria-based audits and the epidemiologic approach used in infection control in the 1980s resulted in a new focus on systematic monitoring and evaluation in 1985. - From this, a 10-step process for quality and performance improvement evolved in 1986, requiring organizations to evaluate important aspects of care and then use the results to identify opportunities for improvement. - Early work focused on this 10-step model and has since evolved into more mainstream tools with Lean and Six Sigma. ## Table 5.1 The DMAIC Methodology | Phase | Key Questions | Common Tools | |---|---|---| | Define | What is the problem? - Why are we working on this project? - Who is going to be working on this project? - What resources do we need to complete this project? - What is the scope? - By when must the project be completed? - Who is the customer? - Who are key stakeholders? - What key metrics are important? | Project Charter - SIPOC (supplier-input-process-output-customer) - Voice of the Customer - Run Chart - Process/Flow Map | | Measure | What does the current process look like? - How can we measure the process or performance? - What data sources are available, and what is the data collection method? - What is our current or baseline performance of the process? What data display (graphs) is useful? - What does our customer define as a defect? - How can we stratify data or measure defects? - What benefits do we hope to achieve through solving this problem? | Control Charts - Pareto - Histogram - Other Analysis | | Analyze | Why is there a gap between current performance and customer expectations? - What are the root causes of variability in our processes and have they been verified? - What root causes are the highest priority to focus efforts? - Where is waste in the process and what type of waste? | Process Map - Value Stream Map - Risk Analysis - Cause and Effect Diagram (Fishbone/Ishikawa Diagram) | | Improve | What are potential solutions to the root causes? - What solutions have been verified and are the highest priority? - How will we track implementation? - Are there any anticipated barriers to improvement? - How can we best translate the details into standard work expectations? - What will the redesigned process look like, and how will it be tested, measured, and validated? - Does the redesigned process reduce waste or variation? | Brainstorming - Risk Analysis - Standard Work - Mistake Proofing - Visual Workplace Tools | | Control | How will the improved process be sustained? - Who will be responsible for maintaining/monitoring the improvements and measures? - How will we communicate the new process expectations? - How will we eliminate deviations from standard work and prevent backsliding? - How will we share best practices and lessons learned? - What were the benefits realized from the project? | Control Plan - Control Charts - Dashboard - Standard Operating Procedures and Policy Revision - Checklist/Audits | ## Figure 5.4 DMAIC with Steps and Tools - **Define** - Step 1: Define problem and scope - Step 2: Determine project objectives - Step 3: Create project charter in database - Step 4: Create visualization of process - **Measure** - Step 5: Refine operational definitions - Step 6: Develop data collection plan - Step 7: Collect baseline data - Step 8: Update database - **Analyze** - Step 9: Identify VA/NVA steps - Step 10: Identify potential causes (X’s) and wastes - Step 11: Validate and prioritize X's - Step 12: Update database - **Improve** - Step 13: Generate prioritized solutions - Step 14: Develop pilot plan and execute - Step 15: Validate and implement solutions - Step 16: Update database - **Control** - Step 17: Create control plan - Step 18: Publish revised process documentation - Step 19: Finalize handoff to owner and follow-up plan - Step 20: Close project in database ## Reengineering and System Redesign - In the 1990s, reengineering was one of the major initiatives in hospitals with efforts focused on workforce redesign. - There was typically a focus on restructuring or redesigning systems and departments into more efficient processes. - For example, hospitals experimented with creating new positions that combined work from different areas. - A focus on cross-functional capabilities led to the dissolution of departmental silos. - A patient service associate or technical associate would deliver meals, clean patient rooms, stock supplies, and provide patient transportation. - Many hospitals thought that reengineering would increase profit margins and create financial stability. - The problem was that reengineering often became associated with mergers, acquisitions, downsizing, and layoffs. - When this happened, employee morale declined, and productivity suffered. - Because of these negative connotations, reengineering fell out of vogue and was replaced by other improvement models and initiatives. - The newer approach is to consider adopting the Lean Enterprise method to increase financial stability by eliminating waste. ## Lean Enterprise - The key components and tools of Lean Enterprise include identifying value (value stream mapping and voice of the customer), eliminating waste, establishing smooth flow, enabling pull (instead of push) systems, and pursuing perfection. - The Six Sigma method includes a five-step process: define, measure, analyze, improve, and control (DMAIC). Lean Enterprise and Six Sigma are complementary tools. - Lean focuses on dramatically improving flow in the value stream and eliminating waste to improve efficiency and speed. - Six Sigma focuses on eliminating defects and reducing variation in processes to improve effectiveness. - Both are extremely effective in and of themselves, but together they offer a powerful approach to improvement. ## Rapid Cycle Improvement - IHI developed the collaborative approach, termed the Breakthrough Series, to bring about rapid cycle improvements. ## Table 5.1 The DMAIC Methodology (cont.) | Phase | Key Questions | Common Tools | |---|---|---| | Improve | What are potential solutions to the root causes? - What solutions have been verified and are the highest priority? - How will we track implementation? - Are there any anticipated barriers to improvement? - How can we best translate the details into standard work expectations? - What will the redesigned process look like, and how will it be tested, measured, and validated? - Does the redesigned process reduce waste or variation? | Brainstorming - Risk Analysis - Standard Work - Mistake Proofing - Visual Workplace Tools | | Control | How will the improved process be sustained? - Who will be responsible for maintaining/monitoring the improvements and measures? - How will we communicate the new process expectations? - How will we eliminate deviations from standard work and prevent backsliding? - How will we share best practices and lessons learned? - What were the benefits realized from the project? | Control Plan - Control Charts - Dashboard - Standard Operating Procedures and Policy Revision - Checklist/Audits | ## Figure 5.4 DMAIC with Steps and Tools (cont.) - **Define** - Step 1: Define problem and scope - Step 2: Determine project objectives - Step 3: Create project charter in database - Step 4: Create visualization of process - **Measure** - Step 5: Refine operational definitions - Step 6: Develop data collection plan - Step 7: Collect baseline data - Step 8: Update database - **Analyze** - Step 9: Identify VA/NVA steps - Step 10: Identify potential causes (X’s) and wastes - Step 11: Validate and prioritize X's - Step 12: Update database - **Improve** - Step 13: Generate prioritized solutions - Step 14: Develop pilot plan and execute - Step 15: Validate and implement solutions - Step 16: Update database - **Control** - Step 17: Create control plan - Step 18: Publish revised process documentation - Step 19: Finalize handoff to owner and follow-up plan - Step 20: Close project in database ## Quality Assurance - Audits led to a preoccupation with meeting audit number requirements. - Thus, in 198O, the Joint Commission on Accreditation of Hospitals, now known as The Joint Commission, developed the first quality assurance standards requiring a problem-focused approach to measuring quality. This approach required organizations to identify and monitor problem areas. - The combined strengths of criteria-based audits and the epidemiologic approach used in infection control in the 1980s resulted in a new focus on systematic monitoring and evaluation in 1985. - From this, a 10-step process for quality and performance improvement evolved in 1986, requiring organizations to evaluate important aspects of care and then use the results to identify opportunities for improvement. - Early work focused on this 10-step model and has since evolved into more mainstream tools with Lean and Six Sigma. ## Retrospective Audits - A shift from physician review to medical audits occurred in 1955. - Medical audits included a systematic procedure using objective, valid criteria with an orientation on outcomes. - In 1966, there was a major change whereby the Joint Commission on Accreditation of Hospitals (as it was called then) focused on optimal, not minimal, standards of care. - In 1975, it published the quality of professional services standards, requiring hospitals to demonstrate optimal care using valid and reliable measures. - Although optimal was never defined, this new focus led to one-time audits of care, known as performance evaluation program audits. - During that period, monitoring quality was focused on the acute care setting. - Later, as care in the outpatient and homecare setting grew, additional monitoring and performance measures were established. - Specialty organizations and accreditations also grew to meet this need. - However, some office and outpatient settings were not accredited and had less oversight by regulatory agencies. - Quality monitoring was slower to mature in these settings. - Additionally, the major costs in healthcare occurred in the hospital setting. - Audits continue to be a useful tool to collect data for analysis and compliance, but more real-time data allow for timely quality care and assessment of that care. ## Table 5.2 Types of Waste in Lean Production Systems | Type of Waste | Waste Description | Lean Strategy to Eliminate Waste | |---|---|---| | Transportation | Moving material or information | One-piece flow, avoid batching | | Inventory (overproduction) | Having more material than you need | Standard work, 6S tool | | Motion | Moving people to access or process material or information | Quick changeover, work cell, standard work | | Waiting | People waiting for material or information, or material or information waiting to be processed | Quick changeover, one-piece flow, avoid batching | | Overproduction | Creating too much material or information | Standard work, one-piece flow, avoid batching | | Overprocessing | Processing more than necessary to achieve the desired output | Mistake-proofing, standard work | | Defects (necessitating rework) | Errors or mistakes necessitating rework to correct the problem | Mistake-proofing, standard work | | Underutilizing resources | Not utilizing or underutilizing the talent (scope) of employees or use of resources, staff not involved in improvement projects | Process mapping and Value Stream mapping to identify key resources needed | ## The Fourth Era: Patient Is Front and Center with Growth of Advocacy, Engagement, and Activation - Healthcare reform stresses an imperative to engage families in their own care. - Enhancing patient-centered care that results in empowerment, engagement, and activation is everyone's job. - Patients and their families need to understand their role and responsibilities related to quality and safety. - Patient-centered communication is shown to improve clinical outcomes. - More patient-centric technology tools and applications are available and have been found to be most useful in managing chronic disease. - Patient advocacy includes addressing the rights and responsibilities of patients and involving them in shared decision making, obtaining informed consent for treatment, and disclosing unanticipated outcomes. - An advocate or ombudsman is often available to manage inquiries, requests, complaints, and grievances, with a process to document and track reported issues to resolution. - An ethical framework is often applied with ethics consultation to respond to issues that may create conflict with the rights of the patient and the organization or others. ## Box 5.2 Key Points: Healthcare Quality Movement in the 21st Century (cont.) - Adaptation is vital to knowledge acquisition and use of changing models for performance improvement. - Continuous learning is essential at the individual and organizational level. - Regulatory and accreditation requirements have matured over time. - Attention to quality increased the focus on consumer rights-what matters to the patient is most important and healthcare delivery must be person-centered. ## Performance Improvement Approaches There are a variety of performance improvement (PI) approaches, and they each have value and usefulness depending on the type of problem, scope, and solution needed. The process for determining which performance improvement model or models to use in an organization requires an analysis of the organization and its history of success with current and previous models, level of maturity, and resources. - How will the model be communicated across the organization? - Are all staff members expected to know how to use it? - Which model or models are a good fit with the culture and the current strategies that are working? ## Quality Assurance - Audits led to a preoccupation with meeting audit number requirements. - Thus, in 198O, the Joint Commission on Accreditation of Hospitals, now known as The Joint Commission, developed the first quality assurance standards requiring a problem-focused approach to measuring quality. This approach required organizations to identify and monitor problem areas. - The combined strengths of criteria-based audits and the epidemiologic approach used in infection control in the 1980s resulted in a new focus on systematic monitoring and evaluation in 1985. - From this, a 10-step process for quality and performance improvement evolved in 1986, requiring organizations to evaluate important aspects of care and then use the results to identify opportunities for improvement. - Early work focused on this 10-step model and has since evolved into more mainstream tools with Lean and Six Sigma. ## Retrospective Audits - A shift from physician review to medical audits occurred in 1955. - Medical audits included a systematic procedure using objective, valid criteria with an orientation on outcomes. - In 1966, there was a major change whereby the Joint Commission on Accreditation of Hospitals (as it was called then) focused on optimal, not minimal, standards of care. - In 1975, it published the quality of professional services standards, requiring hospitals to demonstrate optimal care using valid and reliable measures. - Although optimal was never defined, this new focus led to one-time audits of care, known as performance evaluation program audits. - During that period, monitoring quality was focused on the acute care setting. - Later, as care in the outpatient and homecare setting grew, additional monitoring and performance measures were established. - Specialty organizations and accreditations also grew to meet this need. - However, some office and outpatient settings were not accredited and had less oversight by regulatory agencies. - Quality monitoring was slower to mature in these settings. - Additionally, the major costs in healthcare occurred in the hospital setting. - Audits continue to be a useful tool to collect data for analysis and compliance, but more real-time data allow for timely quality care and assessment of that care. ## Table 5.2 Types of Waste in Lean Production Systems (cont.) | Type of Waste | Waste Description | Lean Strategy to Eliminate Waste | |---|---|---| | Transportation | Moving material or information | One-piece flow, avoid batching | | Inventory (overproduction) | Having more material than you need | Standard work, 6S tool | | Motion | Moving people to access or process material or information | Quick changeover, work cell, standard work | | Waiting | People waiting for material or information, or material or information waiting to be processed | Quick changeover, one-piece flow, avoid batching | | Overproduction | Creating too much material or information | Standard work, one-piece flow, avoid batching | | Overprocessing | Processing more than necessary to achieve the desired output | Mistake-proofing, standard work | | Defects (necessitating rework) | Errors or mistakes necessitating rework to correct the problem | Mistake-proofing, standard work | | Underutilizing resources | Not utilizing or underutilizing the talent (scope) of employees or use of resources, staff not involved in improvement projects | Process mapping and Value Stream mapping to identify key resources needed | ## The Second Era: Legal Decisions, Donabedian, and The Joint Commission's Monitoring and Evaluation Process (cont.) - Definitions and requirements for quality in healthcare evolved over the past decades. - In the early 1950s, quality care review was conducted exclusively by individual physicians using an unstructured and subjective process that relied on the practitioner's knowledge and experiences. - Between 1950 and 1960, the responsibility for quality of care expanded beyond the physician to include both the hospital and the board of directors. - Two significant legal decisions marked this transition period: - *Bing v. Thunig (1957)*. In this case, the New York Court of Appeals ruled that the doctrine of charitable immunity no longer applied to hospitals; hospitals are liable for patient injuries sustained through negligence of employees. - *Darling v. Charleston Community Memorial Hospital (1965)*. In this important corporate negligence case, the court ruled that the hospital had a legal responsibility to protect a patient from harm by others by overseeing the quality of patient care. - Accreditation standards evolved slowly throughout the 1950s and early 1960s. - At the academic level, the University of Michigan's Donabedian examined existing research, formulating a theoretical framework for patient care evaluation. He is best recognized for the "structure, process, outcomes" model of quality evaluation. This model suggests the importance of relating healthcare structures (qualifications of practitioners and facilities and technology available to them) and processes (activities involved in prevention, diagnosis, and treatment) to outcomes (how patients fare because of their care). - In the past, The Joint Commission accreditation standards reflected the structure and process elements of this model. - Surveyors, who reviewed the structures and processes, assessed hospital plans and technology, qualifications of clinicians and administrators, and organizational structures against the annually updated requirements contained in the Comprehensive Accreditation Manual for Hospitals. Specialized standards for behavioral health and other services were also developed. - Surveyors inferred process from documentation and discussion. They reviewed minutes and interviewed clinical and administrative leaders to ascertain whether designated individuals were following procedures and compliant with quality evaluation processes. ## The Third Era: Berwick, Batalden, and Deming, Juran, and "Japan, Inc." (cont.) - The names of Berwick, Batalden, and James are eminent in the field of healthcare quality. Like many of their colleagues, these physicians were dissatisfied with traditional healthcare quality assurance practices. - These pioneering physicians, however, went beyond a mere critique of existing quality assurance. Both Berwick and Batalden researched the industrial methods publicized by the Japanese experience. - Arising from this research, Berwick's article describing healthcare quality assurance as based upon the theory of the bad apples became a classic. - Among his many contributions, Batalden translated Deming's 14 points into a healthcare context. - In 1987, these two physicians played key roles in linking with the Juran Institute and a variety of industrial quality consultants to create the National Demonstration Project on Quality Improvement in Healthcare. This multiyear project and its original 21 forward-looking healthcare organizations conclusively demonstrated the applicability of performance improvement processes to healthcare. - James, of the Intermountain Health System, was also a pioneer in applying quality improvement processes directly to patients and clinical outcomes. The success of James and his team measured not only improved results in a single hospital but also across the entire multihospital system. - In 1991, Berwick established the Institute for Healthcare Improvement (IHI), a not-for-profit organization that began driving improvements in healthcare. - It accomplished this by supporting national projects focused on the six aims-safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity. Collaboratives are one approach involving many organizations trying to affect the same issue and using rapid cycle improvement efforts to implement change. - A major benefit of this approach is that the collaborating organizations share their experiences and improvements spread quickly. Projects initiated include improvements in patient safety, chronic care, critical care, falls, and end-of-life care. Berwick was appointed administrator of the Centers for Medicare & Medicaid Services (CMS) in 2010 and served for 18 months in President Obama's administration. - While in office, Berwick inculcated the Triple Aim into health policy: improving the patient care experience, improving population health, and reducing health costs. - Dr. Berwick was also responsible for initiating major changes under the new health reform legislation known as the Affordable Care Act. ## The Fourth Era: Patient is Front and Center with Growth of Advocacy, Engagement, and Activation (cont.) - Healthcare reform stresses an imperative to engage families in their own care. - Enhancing patient-centered care that results in empowerment, engagement, and activation is everyone's job. - Patients and their families need to understand their role and responsibilities related to quality and safety. - Patient-centered communication is shown to improve clinical outcomes. - More patient-centric technology tools and applications are available and have been found to be most useful in managing chronic disease. - Patient advocacy includes addressing the rights and responsibilities of patients and involving them in shared decision making, obtaining informed consent for treatment, and disclosing unanticipated outcomes. - An advocate or ombudsman is often available to manage inquiries, requests, complaints, and grievances, with a process to document and track reported issues to resolution. - An ethical framework is often applied with ethics consultation to respond to issues that may create conflict with the rights of the patient and the organization or others. ## Table 5.1 The DMAIC Methodology (cont.) | Phase | Key Questions | Common Tools | |---|---|---| | Improve | What are potential solutions to the root causes? - What solutions have been verified and are the highest priority? - How will we track implementation? - Are there any anticipated barriers to improvement? - How can we best translate the details into standard work expectations? - What will the redesigned process look like, and how will it be tested, measured, and validated? - Does the redesigned process reduce waste or variation? | Brainstorming - Risk Analysis - Standard Work - Mistake Proofing - Visual Workplace Tools | | Control | How will the improved process be sustained? - Who will be responsible for maintaining/monitoring the improvements and measures? - How will we communicate the new process expectations? - How will we eliminate deviations from standard work and prevent backsliding? - How will we share best practices and lessons learned? - What were the benefits realized from the project? | Control Plan - Control Charts - Dashboard - Standard Operating Procedures and Policy Revision - Checklist/Audits | ## Box 5.2 Key Points: Healthcare Quality Movement in the 21st Century (cont.) - Adaptation is vital to knowledge acquisition and use of changing models for performance improvement. - Continuous learning is essential at the individual and organizational level. - Regulatory and accreditation requirements have matured over time. - Attention to quality increased the focus on consumer rights-what matters to the patient is most important and healthcare delivery must be person-centered. ## Performance Improvement Approaches There are a variety of performance improvement (PI) approaches, and they each have value and usefulness depending on the type of problem, scope, and solution needed. The process for determining which performance improvement model or models to use in an organization requires an analysis of the organization and its history of success with current and previous models, level of maturity, and resources. - How will the model be communicated across the organization? - Are all staff members expected to know how to use it? - Which model or models are a good fit with the culture and the current strategies that are working? ## Quality Assurance - Audits led to a preoccupation with meeting audit number requirements. - Thus, in 198O, the Joint Commission on Accreditation of Hospitals, now known as The Joint Commission, developed the first quality assurance standards requiring a problem-focused approach to measuring quality. This approach required organizations to identify and monitor problem areas. - The combined strengths of criteria-based audits and the epidemiologic approach used in infection control in the 1980s resulted in a new focus on systematic monitoring and evaluation in 1985. From this, a 10-step process for quality and performance improvement evolved in 1986, requiring organizations to evaluate important aspects of care and then use the results to identify opportunities for improvement. Early work focused on this 10-step model and has since evolved into more mainstream tools with Lean and Six Sigma. ## Retrospective Audits - A shift from physician review to medical audits occurred in 1955. Medical audits included a systematic procedure using objective, valid criteria with an orientation on outcomes. In 1966, there was a major change whereby the Joint Commission on Accreditation of Hospitals (as it was called then) focused on optimal, not minimal, standards of care. In 1975, it published the quality of professional services standards, requiring hospitals to demonstrate optimal care using valid and reliable measures. Although optimal was never defined, this new focus led to one-time audits of care, known as performance evaluation program audits. During that period, monitoring quality was focused on the acute care setting. Later, as care in the outpatient and homecare setting grew, additional monitoring and performance measures were established. Specialty organizations and accreditations also grew to meet this need. However, some office and outpatient settings were not accredited and had less oversight by regulatory agencies. Quality monitoring was slower to mature in these settings. Additionally, the major costs in healthcare occurred in the hospital setting. Audits continue to be a useful tool to collect data for analysis and compliance, but more real-time data allow for timely quality care and assessment of that care. ## Table 5.2 Types of Waste in Lean Production Systems (cont.) | Type of Waste | Waste Description | Lean Strategy to Eliminate Waste | |---|---|---| | Transportation | Moving material or information | One-piece flow, avoid batching | | Inventory (overproduction) | Having more material than you need | Standard work, 6S tool | | Motion | Moving people to access or process material or information | Quick changeover, work cell, standard work | | Waiting | People waiting for material or information, or material or information waiting to be processed | Quick changeover, one-piece flow, avoid batching | | Overproduction | Creating too much material or information | Standard work, one-piece flow, avoid batching | | Overprocessing | Processing more than necessary to achieve the desired output | Mistake-proofing, standard work | | Defects (necessitating rework) | Errors or mistakes necessitating rework to correct the problem | Mistake-proofing, standard work | | Underutilizing resources | Not utilizing or underutilizing the talent (scope) of employees or use of resources, staff not involved in improvement projects | Process mapping and Value Stream mapping to identify key resources needed | ## The Fourth Era: Patient Is Front and Center with Growth of Advocacy, Engagement, and Activation (cont.) - Healthcare reform stresses an imperative to engage families in their own care. Enhancing patient-centered care that results in empowerment, engagement, and activation is everyone's job. Patients and their families need to understand their role and responsibilities related to quality and safety. Patient-centered communication is shown to improve clinical outcomes. More patient-centric technology tools and applications are available and have been found to be most useful in managing chronic disease. Patient advocacy includes addressing the rights and responsibilities of patients and involving them in shared decision making, obtaining informed consent for treatment, and disclosing unanticipated outcomes. An advocate or ombudsman is often available to manage inquiries, requests, complaints, and grievances, with a process to document and track reported issues to resolution. An ethical framework is often applied with ethics consultation to respond to issues that may create conflict with the rights of the patient and the organization or others. ## Reengineering and System Redesign - In the 1990s, reengineering was one of the major initiatives in hospitals with efforts focused on workforce redesign. There was typically a focus on restructuring or redesigning systems and departments into more efficient processes. For example, hospitals experimented with creating new positions that combined work from different areas. A focus on cross-functional capabilities led to the dissolution of departmental silos. A patient service associate or