HMGT 420 WEEK 4
CHAPTER
185
TOOLS FOR IMPROVING QUALITY AND SAFETY
Learning Objectives
Upon completion of this chapter, you should be able to
• identify and describe the various tools available to facilitate quality and safety in healthcare;
• understand the key principles of Six Sigma and Lean; • explain why these tools are necessary for delivering value; • discuss cases in which such tools have been effectively deployed; • effectively employ these tools within a performance improvement (PI)
or quality improvement (QI) program at a health system; and • demonstrate the link between PI/QI tools and programs and a culture
of safety.
A s noted in the previous chapter, quality shortcomings in US healthcare have been well documented (Institute of Medicine 2000b; Casalino et al. 2016). Routine safety processes often fail, and preventable adverse
events—such as wrong-site surgery, hospital-acquired infections, medication errors, and retained objects during surgeries—occur with alarming frequency (Garrouste-Orgeas et al. 2012; de Vries et al. 2008). In response to these and other concerns, the movement toward value-based healthcare places a height- ened emphasis on quality, reliability, and accountability.
Increasingly, healthcare organizations are focusing on operational effec- tiveness as a means for improving quality while reducing costs—and thereby enhancing value. In particular, methodologies such as Six Sigma and Lean are helping organizations improve their processes while creating a culture of personal accountability, teamwork, open communication, trust, and zero patient harm. Six Sigma and Lean incorporate lessons from other industries and entities—such as airlines, nuclear power plants, amusement parks, and zoos—that have little room for error (Hughes 2008). Applied to healthcare, these approaches can provide durable solutions with the potential to transform patient care, produce sustainable improvement, and eliminate patient harm.
Six Sigma A process improvement framework that focuses on the elimination of error; it takes a statistical approach to imposing controls around a mean so that variability is reduced.
Lean An approach to quality and performance improvement, developed in other industries but adopted in healthcare, that focuses on the elimination of waste in processes.
9
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C o p y r i g h t 2 0 1 8 . H e a l t h A d m i n i s t r a t i o n P r e s s .
A l l r i g h t s r e s e r v e d . M a y n o t b e r e p r o d u c e d i n a n y f o r m w i t h o u t p e r m i s s i o n f r o m t h e p u b l i s h e r , e x c e p t f a i r u s e s p e r m i t t e d u n d e r U . S . o r a p p l i c a b l e c o p y r i g h t l a w .
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The Core Elements of Value in Healthcare186
The previous chapter established that value in healthcare can be enhanced by improving the quality of care delivered while controlling costs. This chapter will build on that knowledge with a focus on Six Sigma and Lean. Within the context of these frameworks, it will discuss such elements as root cause analysis, plan-do-study-act, and failure mode effects analysis. In doing so, it will provide a deeper understanding of the link between quality improvement and value delivery, while at the same time offering practical tools for sustainable change.
The Right Infrastructure: Program Structure and Function
An organization seeking to improve quality must take steps to institutional- ize the process. Performance improvement (PI) and quality improvement (QI) techniques can help organizations identify inefficiencies, avoid prevent- able errors, and eliminate ineffective care—all of which have a positive impact on quality and value (Hughes 2008). To be successful, however, these efforts require appropriate structure and reporting, human resources support, effec- tive communication, and the use of rewards and recognition, all geared toward creating a culture of safety and an organization-wide commitment to continu- ous improvement (Hughes 2008). For many organizations, a key step in this journey is the creation of a department specifically dedicated to PI and QI. Such departments are staffed by individuals who are trained in PI/QI processes and who serve as internal subject matter experts for the organization. Organizations may vary in where they choose to house their operations team, but the key is to provide the appropriate infrastructure for sustained improvement.
The operations team is responsible for coordinating activities that sup- port the Six Sigma and Lean processes described in this chapter. Although a PI/QI program begins as an initiative, the hope is that the tools and processes will eventually become part of the organization’s daily work. Sustained quality improvement requires effective infrastructure and management of day-to-day operations. Metrics that measure success and communicate progress are also important. Key measures may include return on investment, the number of staff members trained and certified, and the number of projects using Lean/ Six Sigma principles and other PI/QI tools. Implementation may benefit from the use of a cultural assessment that evaluates readiness, resistance, and support throughout the organization. Buy-in requires employee involvement, and staff should be encouraged to identify areas in need of improvement. Ideas from staff can contribute to a pipeline of improvement projects. To maintain staff involvement, key project information—including project charter, results, and templates or tools employed—should be shared on a regular basis (Joint Commission Center for Transforming Healthcare 2014).
An organization’s human resources (HR) department helps establish employee expectations and goals, and thus it plays an important role in ensuring
performance improvement (PI) Activity aimed at improving the performance of individuals and teams within the organization.
quality improvement (QI) Activity aimed at improving the quality of care being delivered, eliminating harmful processes, and reducing waste.
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Chapter 9: Tools for Improving Qual i ty and Safety 187
the sustainability of Six Sigma and Lean processes. The HR department should incorporate Six Sigma and Lean skills in the employee review process, and it should consider such skills when determining employee roles and advance- ment. Furthermore, when new employees are recruited into the organization, job descriptions should include the required Six Sigma and Lean skills (Joint Commission Center for Transforming Healthcare 2014). Even if a separate department is chiefly responsible for the PI/QI program, the HR depart- ment is an important part of efforts to disseminate the information about Six Sigma and Lean, to build commitment throughout the organization, and to embed continuous process improvement and quality enhancement into the organizational culture.
Two-way communication between leadership and staff helps sustain and nurture a culture committed to quality improvement. Leaders should be able to share priorities with staff, and staff should have an easy way to provide feedback. Members of the senior leadership team should attend regular sessions with staff to signal their commitment. Information about projects, people, and processes should be disseminated as appropriate, with the staff consistently informed about ongoing projects, their statuses, and results. Because people are what make processes successful, the organization should be aware of the individual roles that people play and the training or certification they possess. Finally, the process of project selection, and the selection process for employees, should be transparent (Joint Commission Center for Transforming Healthcare 2014).
The recognition and celebration of successful projects help engage the staff and foster a sense of mission. The organization should have a formal plan for communicating these successes—for instance, by spotlighting success stories in a newsletter or on the intranet. An incentive program that rewards teams involved with successful projects that reduce cost or improve safety will create a virtuous cycle. Certification in improvement methodologies should be valued by employees, and certification processes should be meaningful and clear. The requirements for certification may involve classroom time, project work, and ongoing education. A certification council can help keep the process on track and ensure that the initiative remains an integral part of the organization (Joint Commission Center for Transforming Healthcare 2014).
Case Example: Infrastructure Around Process and Quality Improvement Citrus Valley Health Partners (CVHP) is a three-hospital system with an affiliated home health and hospice system. The system has 625 acute-care beds, generates $500 million in annual revenue, and serves almost 1 million residents of the Los Angeles County area. CVHP is accredited by The Joint Commission and undergoes audits by the organization.
(continued)
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The Core Elements of Value in Healthcare188
In the movement toward value-based healthcare, CVHP’s leader- ship explored ways in which waste could be eliminated, controls could be put in place, and a culture of quality could become firmly established. As part of this effort, the PI department led an organization-wide initiative to ensure that appropriate data were collected, analyzed, and distributed to stakeholders. Consumers of this information included executive leadership, management, the board of directors, the quality subcommittee, clinical departments, operating departments, and the financial divisions. The data indicated that, although the processes were working, gaps often existed between the goals of quality initiatives and the actual outcomes of the ini- tiatives. For instance, heart-failure readmission rates were slightly above the national average, and the rate of surgical site infections was stable but high, without showing a sustained downward trend. Never events—those lapses in safety and quality deemed so serious that they should never occur—still occurred, though only on rare occasion, and had been reported to regulatory agencies.
In collaboration with The Joint Commission, CVHP embarked on an initiative to introduce Lean and Six Sigma principles to the organization. Senior management underwent training in the methodologies, and executive sponsorship for the initiative was developed. Initially, each member of the executive team sponsored a project, and the projects were selected based on their expected impacts on quality, safety, financial sustainability, and elimina- tion of waste. Once the projects and their sponsors were determined, teams were established. The teams included a team leader, subject matter experts, a data analyst, a PI team member, and frontline staff members who had expressed an interest in the project and who had applied to receive training in Lean and Six Sigma principles. The Joint Commission provided the formal training and certification for employees. Evaluation metrics were adjusted so that future professional advancement would depend on such training.
Over a 12-week period, the teams evaluated projects, received train- ing, developed solutions, and implemented the findings. Results were tracked independently, evaluated, and then shared with the organization. The whole process was celebrated across the organization. Over time, addi- tional projects were identified, allowing for more employees to gain experi- ence with Lean and Six Sigma techniques. Several employees underwent formal training and were recognized with certification. This certification enabled them to lead new projects and train new employees, making the improvement process self-perpetuating and sustainable.
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Chapter 9: Tools for Improving Qual i ty and Safety 189
Six Sigma
The concept of Six Sigma originates from a fundamental statistical principle. Any situation in which multiple outputs of a process are possible has a chance of error. If the process is plotted on a graph, the spread of outcomes can be described in relation to a normal distribution. The mean of the data is the mathematical average, and the range of distribution around this mean is defined in terms of a standard deviation.1 Standard deviation provides a measure of the spread of numbers around an average. It indicates how tightly all numerical observations in a set of data are clustered around the mean (Sall, Creighton, and Lehman 2005). One standard deviation from the mean in either direction accounts for approximately 68 percent of the data points in the group. Two standard devia- tions away from the mean account for about 95 percent of the observations.
Each standard deviation is termed a sigma, after the Greek letter. The greater the number of standard deviations that fits within acceptable process limits, the more reliable the process is. Thus, a “six-sigma” process is highly reliable and has a low fallout or error frequency. For instance, if a pharmacy is distributing 10 million medications, it can have no more than 34 errors for the process to have a six-sigma level of reliability. Exhibit 9.1 illustrates what a sigma level implies in terms of defects per million.
Six Sigma uses statistical tools to identify the most important factors for improving the quality of processes and outcomes. The methodology is facilitated by the define, measure, analyze, improve, and control (DMAIC) approach (Hughes 2008). Stakeholders define the projects, goals, and deliverables; mea- sure the current performance of the process under consideration; analyze and determine the root causes of defects; improve the process to eliminate defects; and control the performance of the process. In doing so, Six Sigma eliminates process variation (Brue 2002).
standard deviation A measure of data spread around an average; it is defined as the square root of the variance.
sigma The Greek letter used as a symbol for one standard deviation around the mean.
define, measure, analyze, improve, and control (DMAIC) A Six Sigma cycle in which stakeholders define the projects, goals, and deliverables; measure the current performance of a process; analyze the root causes of defects; improve the process to eliminate defects; and control the performance of the process.
Sigma Level Defects per Million Yield
1 690,000 <50%
2 308,537 69.10%
3 66,807 93.32%
4 6,210 99.379%
5 233 99.9767%
6 3.4 99.99966%
Source: Brue (2002).
EXHIBIT 9.1 Sigma Level and Defects per Million
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The Core Elements of Value in Healthcare190
Define The define phase of DMAIC focuses on identifying the significant issues that need resolution. Problems need to be defined clearly and accurately. In this phase, stakeholders try to determine the input and independent variables that define the output or dependent variable. They identify factors that are critical to quality (often abbreviated CTQ), and they delineate the cause-and-effect relationship between inputs and outputs (Brue 2002).
The primary tools for this phase are basic statistical measurements such as the mean, median, and mode, as well as graphical analysis and simple correla- tion studies. The graphical analysis often incorporates histograms to show the distribution of data and run charts to identify trends over time. Scatter plots can be used to determine a positive or negative correlation—or absence of cor- relation—between two variables. Process maps provide an illustrated description of the way a process works, and flowcharts can show the intermediate steps in a process. By providing a comprehensive pictorial of a process, process maps can help identify steps that add value, take away value, or add no value (Brue 2002).
Exhibit 9.2 presents data, both in a table and a scatter plot, from a hypothetical analysis of readmission rates for congestive heart failure. The scatter plot, on which risk of readmission is plotted in relation to patient age, presents the data in an accessible manner and allows for easy recognition of patterns. The diagram clearly shows that the risk of readmission increases as a patient’s age increases, and the organization can use this finding to tailor its strategies to reduce readmissions. For instance, it might choose to concentrate its efforts on older patients who are being discharged.
Scatter plots are highly useful, though they do have some shortcomings. In particular, they can be inaccurate or misleading when data points are too few. Conclusions must be drawn with care, because the associations displayed may be caused by chance or another underlying reason.
Measure The second part of DMAIC is the measure phase. Once characteristics that are critical to quality have been identified, the defects generated by the pro- cess—and the effects of those defects on the output—can be measured. Once the defects have been measured, the savings or gains in quality that will result from the elimination of those defects can be quantified.
A gauge repeatability and reproducibility study helps ensure that the measurement systems being used are statistically sound (Morrow 2012). It assesses the quality of the measurements to ensure that the appropriate issues are being evaluated. For example, nursing home staff might measure a patient’s body temperature twice within a 20-minute period, and the temperature read- ings might vary because of thermometer specifications or readings by the nurse. A gauge repeatability and reproducibility study can help stakeholders understand the stability of the measuring tool and of the readings by staff.
scatter plot A diagram on which data points are plotted to show a possible correlation between two variables.
gauge repeatability and reproducibility study A study to ensure that measurement systems are statistically sound.
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Chapter 9: Tools for Improving Qual i ty and Safety 191
A fishbone diagram—also known as a cause-and-effect diagram or an Ishikawa diagram—helps identify the relationship between a problem and its possible causes (Joshi et al. 2014). Exhibit 9.3 shows a fishbone diagram of the potential causes of a surgical site infection. The central line of the diagram represents the effect being studied—in this case, a surgical site infection. Each major branch from this line corresponds with a cause, or a class of causes, for the effect—in other words, a procedure or technique contributing to a surgi- cal site infection. Minor branches may be included in a fishbone diagram to represent additional causal factors.
A fishbone diagram allows analysis of the most likely causative factors for an event. Several of the factors included in the diagram may have a direct or indirect effect on the observed outcome; other factors may not play a role. All of the factors, however, should be considered in a comprehensive analysis. In the example presented in exhibit 9.3, surgical site infections had been a source of significant morbidity, and antibiotic dosing and timing, equipment sterilization, organizational culture, traffic in the operating rooms, hand-washing practices, surgical technique, and preparation before surgery were all being considered as possible causes. The analysis allowed the organization to consider all of these elements in a standardized and exhaustive manner.
A Pareto chart provides a pictorial representation of the factors that are contributing to a flawed process (Michael et al. 2013). It demonstrates
fishbone diagram A diagram that helps identify the relationship between a problem and its possible causes; also known as a cause- and-effect diagram or an Ishikawa diagram.
Pareto chart A pictorial representation of the factors that are contributing to a flawed process. It demonstrates the relative importance of various factors, based on the idea that 80 percent of results are accounted for by 20 percent of the factors.
Age of Patient CHF Readmission
27 32 33 34 45 56 63 66 67 70 78 78 79 81 83 85 88 89 90
0.04 0.04 0.06 0.08 0.11 0.1 0.12 0.15 0.14 0.16 0.17 0.18 0.18 0.2 0.22 0.23 0.24 0.25 0.26
0
0.1
0.2
0.3
0 20 40 60 80 100
CHF Readmission
Note: CHF = congestive heart failure.
EXHIBIT 9.2 Scatter Plot Showing the Relationship Between Patient Age and Readmission Risk
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The Core Elements of Value in Healthcare192
the relative importance of the various factors, based on the principle that 80 percent of the results are accounted for by 20 percent of the factors. The Pareto chart helps identify the factors that are having the greatest cumulative effect. Continuing the example from the previous exhibit, the chart in exhibit 9.4 shows the major causes of surgical site infections. Hand-washing, inadequate dosing, and late administration of antibiotics combine to account for more than 80 percent of the infections. Efforts to reduce surgical site infections should therefore focus on these three factors first.
Analyze The analyze phase of DMAIC is a brainstorming phase that statistically evaluates the inputs that have a meaningful effect on the output. It aims to determine why defects are being generated and to identify the vital few factors that have the greatest impact on the process (Brue 2002). Multivariate analysis allows for the evaluation of multiple causes of an outcome and identifies those that have a significant impact on the observed effect (George et al. 2005). Through regression models and transformation of the data, an analyst can develop a better understanding of causal relationships and of the significance of different causes (Rothman 2002).
Failure mode and effects analysis (FMEA) helps the analyst identify, anticipate, and prevent possible failures in a process (Morrow 2012). The vari- ous ways in which a process might fail are called failure modes. By preventing failure modes, defects can be avoided. The FMEA process considers the cause of a defect, the probability of the defect occurring, and the defect’s impact on the customer. It also considers whether systems are in place to detect the defect and prevent it. As the analysis is completed, the defect is assigned a risk
multivariate analysis A statistical technique used to analyze data arising from more than one variable.
failure mode and effects analysis (FMEA) An analysis aimed at anticipating, identifying, and preventing potential failures in a process.
Surgical Site Infection
Equipment Pre-op Preparation Staff
Patient Characteristics Post-operativeProcedure Type
Age Nutrition Diabetes
Manufacturer Sterilization
Antibiotic Dosing Antibiotic Type Antibiotic Timing Sterile Prep Used
Replacement Cardiac GI
Wound Care Follow-Up Discharge Instructions
Training Level Full-Time Temporary Traffic in OR
Source: Reprinted with permission from Citrus Valley Health Partners (2015).
EXHIBIT 9.3 Fishbone
Diagram to Evaluate
Factors Causing Surgical Site
Infections
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Chapter 9: Tools for Improving Qual i ty and Safety 193
priority number (RPN), which rates its likelihood of occurrence, likelihood of detection, and severity (Joshi et al. 2014). The formula for calculating the RPN is shown in exhibit 9.5. When the team clearly understands the rela- tive risk associated with potential causes of failure, it can effectively prioritize actions to mitigate those risks. The goal of the FMEA process is to identify the ways in which a solution can fail, to develop a clear understanding of the failure’s severity, and to prevent failures from occurring (Tilburg et al. 2006). The specific steps of the FMEA evolve, and they will continue to change as implementation advances and improvements become sustainable. The FMEA process can be somewhat labor intensive, but it is easier than trying to recover after a failure has occurred.
0%
20%
40%
60%
80%
100%
Handwash ing
In adequate
D osin
g
La te
Antib iotic
Administ ra
tio n
Early Antib
iotic Administ
ra tio
n
In co
rre ct
Antib iotic
Heavy O
R Tra ffi
c
In effe
cti ve
In str
ument S te
ril iza
tio n
In co
mplete Term
inal C lean in
O R
Causes of Surgical Site Infection
Source: Reprinted with permission from Citrus Valley Health Partners (2015).
EXHIBIT 9.4 Pareto Chart Showing the Causes of Surgical Site Infection
The RPN is calculated as follows:
Severity of effect (importance of effect on customer)
× Occurrence of cause (frequency of a given cause)
× Detection of failure (ability of current control scheme to detect/prevent)
1 = Not severe 1 = Not likely 1 = Likely to detect
8 = Very severe 10 = Very likely 10 = Not likely to detect
EXHIBIT 9.5 Risk Prioritization Number
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The Core Elements of Value in Healthcare194
Case Example: Hospital Readmissions Reduction The all-cause readmission rate for heart failure patients at Citrus Valley Health Partners (CVHP) at 30 days after discharge was 23.4 percent. This high readmission rate had led to an $84,000 penalty from Medicare when value-based programs were initiated. Setting out to improve its performance, CVHP set a goal of reducing the readmission rate to 17 percent within a six- month period. The system assembled a multidisciplinary team that included an executive sponsor; a champion; a core team of nurses, physicians, and pharmacists; a financial analyst; and subject matter experts. The project scope covered the period from admission to 30 days postdischarge.
Using a fishbone diagram, the team identified several causative factors that can lead to readmissions, such as an incomplete discharge assessment, problems with medication reconciliation, or lack of a timely physician appointment. The team then used an FMEA tool to identify solu- tions. The team assessed the severity, occurrence frequency, and likelihood of detection of the various factors and calculated RPNs, which helped the team identify the most important interventions warranting the maximum resources. Exhibit 9.6 shows part of the FMEA tool used by the team. Failure to coordinate physician appointments scored a high RPN, so the team cre- ated a process whereby the case manager set up an appointment before the patient was discharged from the hospital. This solution was deemed important because process analysis had revealed that lack of care coordina- tion was preventing consistent appointment setup.
The program was implemented over a six-week period, and it was well received by the health system, staff, and patients. The readmission rate soon dropped below the national benchmark. The success of this pilot program allowed CVHP to apply for a major grant to expand the program. The grant application was successful.
Solutions
Potential
Failure Mode
Potential
Effect of
Failure
Se ve
ri ty Potential
Mechanism
of Failure O cc
ur re
nc e Current
Process
Controls—
Prevention
Current
Process
Controls—
Detection
D et
ec ti
on
R PN
Action
Assigning
MD appoint-
ment before
discharge
Patient not
seeing the
physician
Appointment
not coordi-
nated, con-
tributing to
readmission
7 Inconsistent
process
followed by
the care
coordination
team
9 Coordinate
between
ED nurses
and case
managers to
ensure that
appointments
are set
Pharmacist
calls the
patient or
family to
inquire if
appointment
was set
9 567 Case manager
to set up
appointment
Source: Adapted with permission from Citrus Valley Health Partners (2015).
EXHIBIT 9.6 Failure Mode
and Effects Analysis at
Citrus Valley Health Partners
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Chapter 9: Tools for Improving Qual i ty and Safety 195
Improve Once the situation has been defined, measured, and analyzed, the key vari- ables can be altered within a specified range to determine whether the output improves. The change in the outcome is then measured to determine the extent of improvement (George et al. 2005). Multivariate analysis can identify the most influential factors in an efficient manner to identify the changes that lead to the most improvement (Brue 2002).
A pilot study at Citrus Valley Health Partners provides an example of this process. Surgical site infections had been a cause of significant patient morbidity and cost of care at CVHP, and they were also contributing to an increase in postsurgical length of stay. Root cause analysis identified several possible sources of infections, and a multivariable model helped identify five key factors for reducing the rate of infections. These factors included appropriate antibiotic selection, antibiotic dosing, antibiotic redosing, discharge education, and patient education related to postoperative care (including control of blood glucose levels in diabetic patients).
Control The control phase aims to ensure that the changes made through the DMAIC cycle are sustained. Statistical process control (SPC) tracks data to ensure that the new process is providing a higher level of quality and productivity (Joshi et al. 2014). Effective SPC requires a change in thinking from error detec- tion to error prevention. The control chart is a key tool of SPC that provides information about the stability of a process (Morrow 2012). The chart displays the variability of a process over time, relative to an upper control limit (UCL) and a lower control limit (LCL). The UCL and LCL are typically set at three standard deviations. Data points that fall outside these limits are a signal that the process is out of control (Joshi et al. 2014).
A control chart may show common cause variability, which is completely random and lacks an obvious source, or it can show special cause variation related to such issues as faulty equipment, operator fatigue, or process break- down due to a switch to a new computer system (Brue 2002). Exhibit 9.7 provides an example of a control chart showing the delinquency rate for medical records. The chart indicates that delinquency was out of control in November and December of 2013. In this case, the special cause variation was identified and addressed, subsequently bringing the process back under control.
Lean
Whereas Six Sigma improvement programs focus on removing variation, Lean processes aim to eliminate waste. Under the Lean approach, waste is defined as
statistical process control (SPC) A method for using data to track processes to ensure appropriate quality.
control chart A tool that shows the variability of a process over time, between upper and lower control limits.
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The Core Elements of Value in Healthcare196
anything that is not necessary to produce the product or service (Nave 2002). Lean thinking emphasizes flow—the efficient, uninterrupted movement of products and services through the system to the customer.
The Five Steps Five steps are at the heart of the Lean process:
1. Identify value 2. Identify the value stream 3. Improve flow 4. Allow customer pull 5. Pursue process perfection
Identify Value The determination of value is made by the customer. A process, product, or service will deliver value if it meets the customer’s expectations for performance, price, and availability.
Identify the Value Stream Value stream mapping, which involves identifying the steps that are critical to the success of a process, is a helpful tool in Lean. The value stream refers to the set of actions necessary to bring a product from concept to reality. The activities of the value stream should be aimed at the customer, and they should be recognized by the customer to have value (Toussaint and Berry 2013). A value-added activity changes the form, fit, or function of the service or product
flow The efficient, uninterrupted movement of products and services through the system to the customer.
value stream mapping Identification of the steps that are critical to the success of a process.
0%
5%
10%
15%
20%
25%
30%
35%
40%
Ju l-1
3
Aug-13
Sep- 13
Oct -13
Nov-1 3
Dec-1 3
Jan-14
Fe b-14
M ar-1
4
Apr -1
4
M ay-14
Ju n-1
4 Ju
l-1 4
Delinquency Rate
Mean=20%
LCL=11%
UCL=29%
Source: Adapted with permission from Citrus Valley Health Partners (2015).
EXHIBIT 9.7 Hypothetical
Control Chart Showing
Delinquency Rate
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Chapter 9: Tools for Improving Qual i ty and Safety 197
toward something the customer expects. The activity is done correctly the first time, and the customer is willing to pay for it. A non-value-added activity lacks the benefits of the value-added activity, and it might not be necessary for the business. Such activities should be eliminated, simplified, reduced, or consolidated, because they contribute to waste.
Typically, waste in a process or activity can be divided into eight categories:
1. Defects. If the work output is defective and requires rework or correction, then resources must be used to correct the poor quality.
2. Motion. Often, an activity requires a lot of motion within a process; if such motion is not adding value, it should be reduced.
3. Wait. Any activity that requires idling adds to the waste. 4. Inventory. The use of resources to acquire inventory that is not used
immediately may prevent investment in activities that have a higher return. Unused inventory represents assets that no one needs or wants.
5. Intellect. When the capabilities of human resources are not effectively leveraged, human potential is wasted.
6. Overprocessing. If too much effort is being expended without generating value, resources are being wasted.
7. Transportation/conveyance. The excessive movement of people, materials, and equipment can cause wastes of time, effort, and resources.
8. Overproduction. When the amount of output produced is greater than what the customer needs, resources are wasted.
The elimination of waste can generate significant value in healthcare. At a minimum, the same quality of care can be delivered while reducing costs. More likely, both waste and cost can be reduced while quality is improved (Toussaint and Berry 2013).
Improve Flow Once the value-added and non-value-added steps have been identified, efforts should focus on improving flow—in other words, ensuring the uninterrupted movement of a product or service through the system to the customer (Nave 2002). Brakes on this flow include queues, batch processing, and transporta- tion. Poor flow adds to cost and reduces efficiency.
Allow Customer Pull After waste removal and flow optimization have been achieved, the customer should be able to “pull” the product from the supplier. The supplier should provide the product or service when the customer needs it, not before or after.
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Pursue Process Perfection The pursuit of perfection is an iterative process that focuses on continually eliminating waste and non-value-added steps. Healthcare organizations such as the Mayo Clinic, Virginia Mason Medical Center, and ThedaCare have success- fully implemented Lean principles to improve quality, reduce harm, reduce the cost structure, and improve profitability (Womack et al. 2005; Toussaint and Gerard 2010; Taninecz 2006). As more and more organizations adopt these principles, they too should be able to achieve improved quality, reduced costs, and better outcomes, thereby enhancing the delivery of value in healthcare.
Case Example: Virginia Mason Medical Center This case example has been adapted from Bohmer and Ferlins (2008).
Virginia Mason Medical Center (VMMC) is a world-renowned health- care organization based in Seattle, Washington (VMMC 2010). The VMMC system has a 336-bed hospital with 5,000 employees and nine locations; a medical staff of more than 400 physicians; a graduate medical education program; and a research center.
Around 2000, VMMC had begun to lose money, staff morale was low, and the system faced increasing challenges from other area hospitals. In response to these concerns, the system adopted a new performance review system and an incentive compensation plan that was tied to performance and outcomes. It also set out to embrace evidence-based medicine and participate in organizational change and improvement. VMMC decided to use the Lean system for improving the patient experience, quality, and safety, while reducing costs. The methodology was approved by the board without resistance. The organization communicated to the staff that the Lean program would not involve layoffs, which neutralized resistance to the program.
As the Lean effort moved forward, VMMC used value-stream mapping to visually display the organization’s processes, to provide a clear under- standing of the work, and to identify opportunities to eliminate waste. The system applied this tool to the patient check-in process and the flow of equipment and inventory, and it adapted the process to involve all depart- ments. VMMC also used rapid process improvement in a targeted manner over short time periods to iteratively improve processes such as inventory turns and to shorten staff walking distance. More than 300 such projects were undertaken over a three-year period, leading to a variety of improve- ments, including more timely rooming of patients at a clinic. The system
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Chapter 9: Tools for Improving Qual i ty and Safety 199
Tools for Lean Important Lean tools include spaghetti diagrams, rapid cycle testing, and the 5S processes.
Spaghetti Diagram A spaghetti diagram is a visual display in which a continuous line represents the path of an activity within a process. This type of display can help identify steps that are unnecessary and repetitious, contribute to delays, and do not add value. Exhibit 9.8 shows a pair of spaghetti diagrams from Citrus Valley Health Part- ners in Los Angeles. As part of an effort to reduce patient waiting time, Citrus Valley mapped out the steps taken by people in a busy emergency department. In doing so, the system noticed a large number of unnecessary steps by clinical staff and patients, which was hindering throughput and causing some patients to leave without being seen. The diagrams revealed opportunities to reduce the number of steps by more than 300 percent, resulting in improved throughput.
spaghetti diagram A visual display in which a continuous line represents the path of an activity within a process.
used additional tools, such as the 5S system discussed later in the chapter, to make work spaces more orderly.
VMMC prioritized improvements in processes that involved patients, providers, medications, supplies, equipment, information, and instruments. In doing so, the system saved more than $10 million in capital expenses. The Lean process led to a clinic redesign that created a circular space with treatment rooms on the periphery and exam rooms, offices, nurse stations, and administrative areas centrally arranged to increase communication and reduce travel time. As a result, daily patient visits increased by 75 percent while patient travel per visit decreased by 76 percent (Robeznieks 2014).
The culture at VMMC evolved to the point that Lean was integrated into everyday practice. Staff were empowered to call out unsafe situations and to quickly stop faulty processes, such as potential medication errors. Root cause analyses were used to reduce patient harm. Bundles of care—in which evidence-based best practices were incorporated into protocols for care—were established and used to address ventilator-acquired pneumo- nias, surgical site infections, and central line infections. VMMC established the infrastructure to support the Lean process at its facilities. Operations managers became Lean process experts. All employees and physicians received training in value stream mapping, root cause analysis, and process improvement. Over a two-year period, margins improved, walking distances within the medical center came down by 38 percent, inventory was halved, and productivity went up 44 percent.
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Rapid Cycle Testing Rapid cycle testing is a quality improvement tool centered around an itera- tive process of plan-do-study-act (PDSA). First, a change or test is planned to determine how something works (plan). Next, the plan is carried out (do), and the results are evaluated and the lessons learned (study). Then, a decision is made about what actions can be taken to bring about further improvement (act). The cycle is repeated until the desired goal is achieved (Joshi et al. 2014). The PDSA methodology can be extremely effective in implementing rapid pilot programs, which can later be expanded. The iterative process propels continuous improvement.
At Citrus Valley Health Partners in Los Angeles County, the door- to-balloon time for angioplasty exceeded the recommended 90 minutes for patients with ST-elevation myocardial infarctions (O’Gara et al. 2013). Analysis of the situation indicated that the delay was caused by a requirement that the cardiologist make the diagnosis based on an electrocardiogram (EKG). Because of this requirement, several minutes were being wasted when a patient arrived with chest pain. The EKG would have to be taken and faxed to the cardiolo- gist, who would then call back to confirm the diagnosis; thereafter, the team would be activated sequentially to arrive at the cardiac laboratory. To address this problem, the health system planned to allow the emergency room (ER) doctor to make the diagnosis. Under the new arrangement, the EKG would be performed and analyzed by the ER physician, who would activate the team and inform the cardiologist. False positives were minimal in this new arrange- ment, and the protocol was formalized. The whole PDSA cycle was completed within three weeks, with no further fallouts noted in the door-to-balloon time.2
rapid cycle testing A quality improvement tool centered around an iterative process of plan-do- study-act (PDSA); the PDSA cycle is repeated until the goal is achieved.
Before—900 Steps After—900 Steps
Room 1
Room 2
Room 3
Room 4
Radiology suite
N ur
se s
st at
io n
Restroom
Triage
Room 1
Room 2
Room 3
Room 4
Radiology suite
N ur
se s
st at
io n
Restroom
Triage
Source: Adapted with permission from Citrus Valley Health Partners (2015).
EXHIBIT 9.8 Spaghetti
Diagrams of Steps Taken in an Emergency
Department
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Chapter 9: Tools for Improving Qual i ty and Safety 201
5s A Lean tool known as 5S seeks to ensure that the workplace is set up in a way that facilitates orderliness, continuous improvement, and self-regulation. In Lean thinking, workers are expected and encouraged to take control of the workplace, and they seek to implement visual systems that do away with clutter, minimize wasted time and resources, and eliminate activities that do not add value. The name 5S references five Japanese terms (Joshi et al. 2014; AHRQ 2007):
• Seiri (organization) focuses on keeping only what is necessary and removing superfluous equipment.
• Seiton (orderliness) involves arranging items so that they are easy to find, thereby eliminating unnecessary motion.
• Seisou (cleanliness) involves ensuring that the workplace is devoid of clutter and can effectively contain and communicate information.
• Seiketsu (standardization) focuses on proactive maintenance of the workplace to ensure that best practices are followed consistently.
• Shitsuke (sustain) involves maintaining the gains that have been made and aligning the culture with the new approaches to work.
Assessing the Use of Lean and Six Sigma in Healthcare
Fundamentally, both Lean and Six Sigma aim to improve quality, reduce waste, and increase efficiency; thus, both techniques should lead to an increase in profitability (Deming 1986). However, comprehensive research of both tech- niques as applied specifically to healthcare organizations is still incomplete.
Initial application of the Lean and Six Sigma methodologies was met with significant skepticism (Zbaracki 1998; Bigelow and Arndt 1995). Over time, however, the inherent strengths of both tools have become apparent. Lean can improve quality by ensuring that waste is eliminated and that processes are not unnecessarily long; such efforts help reduce damage and obsolescence. Simplified processes lead to reduced variation as well. Lean assumes that waste is the main restriction to profitability and that many small improvements in quick succession are more beneficial than prolonged analytical study (Nave 2002). One limitation is that Lean generally does not incorporate statistical or system evaluation. Six Sigma, meanwhile, takes a more statistical approach, though the way it approaches processes independently might fail to consider system interactions.
Given the strengths and limitations of both methodologies, healthcare is moving toward a blended approach, incorporating features of both tool sets. The combination of these approaches with change management and leadership
5S A Lean tool that seeks to ensure that the workplace is set up in a way that facilitates orderliness, continuous improvement, and self-regulation.
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innovation has fueled optimism that the quality movement in healthcare is a bur- geoning force (Joint Commission Center for Transforming Healthcare 2015).
Because complex processes require sophisticated problem-solving meth- ods, one promising approach to sustained change management involves the use of Lean principles with Six Sigma controls. This approach seeks to identify the most efficient manner to perform a process (Lean principles) and then rigorously records data and evaluates metrics (Six Sigma controls). When put into action, it represents a new way to problem solve. The problem is defined, its impact is measured, causes of failure are analyzed, and methods for improvement are assessed. Solutions are implemented, and the process is controlled to ensure sustainability (Joint Commission Center for Transforming Healthcare 2015). This iterative process—focused on eliminating wasteful steps, thoroughly mea- suring outcomes, acting on the data, and sustaining improvements—has been used to great effect in manufacturing industries; now it is showing promise in healthcare.
Lean and Six Sigma can help power an organization’s journey toward high reliability and enhanced value. However, successful use of these tools requires effective leadership. Senior leadership must demonstrate commitment to these initiatives and maintain active involvement in improvement projects. Leaders must ensure that the voice of the customer remains at the forefront, so that actual improvements are tangible to the end user. Leaders also must ensure that key roles are filled for each project. A project sponsor should have decision-making authority to solve cross-functional issues, and a project champion should be responsible for removing barriers to success. A process owner should be responsible for implementing and sustaining improvements. Financial analysis must also be incorporated to ensure that the financial impact of the projects can be validated. Finally, leaders must make sure that all projects align with the strategic goals of the organization (Joint Commission Center for Transforming Healthcare 2014).
The integration of Lean and Six Sigma concepts in change management requires an organization-wide effort. The human resources department, as well as QI and PI divisions, will play an important role. Criteria, guidelines, and expectations must be clearly established, and upcoming leaders must receive the necessary training and experience. Once continuous improvement becomes embedded in the culture, small improvements in efficiency and quality add up to larger changes over time, with a meaningful impact on value.
Summary
An expectation exists in healthcare that a certain level of quality will always be delivered. This expectation is driven by evidence, scientific data, regulations,
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Chapter 9: Tools for Improving Qual i ty and Safety 203
societal beliefs, and an inherent appreciation for what a service industry should provide. In assessing the healthcare landscape in the United States, stakeholders have determined that the quality of care must be improved. The Lean and Six Sigma methodologies, which have proved successful in manufacturing indus- tries, are increasingly being applied to healthcare, and they hold significant potential for quality improvement and the delivery of value.
Lean focuses on the elimination of waste and an iterative approach to constant improvement. Six Sigma, meanwhile, uses statistical methods to control processes and limit variability and error. Elements from both method- ologies can help organizations make sustainable gains in quality, productivity, and safety. Research and data about the impact of these techniques on overall profitability in healthcare is still incomplete; however, anecdotal information from organizations that have implemented Lean and Six Sigma tactics has been encouraging.
This chapter provides an overarching view of a variety of Lean and Six Sigma tools, such as value stream mapping, rapid cycle testing, failure mode and effects analysis, and statistical process control. It also describes ways in which these tools can be adapted for healthcare to drive improvement efforts. Such efforts can help eliminate waste, reduce costs, increase reliability, and improve safety, while also empowering workers to take control of their work.
Successful implementation of these methodologies requires considerable effort, effective leadership, and an organization-wide commitment. Financial stewardship is also necessary to ensure that operational improvements are sustainable and financially viable. When implemented effectively, the tools of Lean and Six Sigma can help build a culture of accountability, empowerment, and results, leading to improved quality, lower costs, and enhanced value.
Notes
1. For a random sample of 1,000 numbers between 0 and 1, the average might be 0.49. The standard deviation can be calculated from a selection of numbers and observations. For the numbers 0.74, 0.49, 0.54, 0.42, and 0.01, the average is 0.44 and the standard deviation is 0.24. The standard deviation is calculated using the formula below, where s = standard deviation, x = data point, x– = average, and n = number of observations.
∑ )( =
−
− s
x x n 1
2
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The Core Elements of Value in Healthcare204
2. This pilot program was initiated at the behest of a practicing cardiologist at Citrus Valley Health Partners. The cardiologist proceeded to gain the support of the cardiology department and hospital administration to launch the program.
Discussion Questions
1. What does Lean mean for healthcare? Describe the methodology, evaluate its use in other industries, and discuss how it can be applied in healthcare.
2. How can the Six Sigma methodology be implemented in healthcare? How might this implementation enhance value?
3. What infrastructure is needed to help establish Lean and Six Sigma methodologies in healthcare organizations?
4. What kinds of leadership and cultural beliefs are necessary to ensure the pursuit of process improvement and quality improvement in healthcare?
5. Discuss the role of performance improvement and quality improvement departments in enhancing the delivery of value in healthcare.
6. Select three of the Lean or Six Sigma tools discussed in this chapter, and evaluate a case study in which these tools were implemented.
7. Consider the following case: PineStreet Hospital is a 720-bed acute care hospital in an urban area of Illinois. It serves more than 3 million residents. The hospital has a 50-bed emergency room, spread across two buildings, that is open 24 hours a day, seven days a week. The ER logged 30,000 visits in the last year, and its admission rate is 65 percent—considerably higher than the regional benchmark of 30 percent. The left-without-being-seen (LWBS) rate for patients is 6 percent, whereas the goal is less than 1 percent.
The ER is on the first floor, but the CT scanner dedicated to the ER is on the third floor. Typically, three physicians are in the ER, and they evaluate the patient when the patient has a bed assigned in the ER and is in that bed. The triage nurse evaluates the patients as they are checked in. Typically, the ER waiting room is overflowing, with some patients waiting more than ten hours to be seen. Many leave before being checked.
The average length of stay in the hospital is six days, whereas the benchmark is four days. Other metrics include the following:
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Chapter 9: Tools for Improving Qual i ty and Safety 205
Metric PineStreet Benchmark
11 a.m. discharge 10% 55%
Day-of-discharge dialysis 22% 10%
Patients per case manager 50 22
Patients per discharge planner — 50
Time from entering waiting room to being checked in
30 minutes 8 minutes
Time from check-in to triage 45 minutes 12 minutes
Time from triage to ER bed assignment
2 hours 9 minutes
Time from bed assignment to evaluation
2 hours 30 minutes
Time from evaluation to lab tests 45 minutes 3 minutes
Time from evaluation to CT scan 1 hour 10 minutes
Distance walked by each staff per 8-hour shift
2 miles 0.3 miles
PineStreet does not have a laborist program, which would make in-hospital obstetricians available to perform deliveries; a hospitalist program, which would ensure that physicians were on site at all times to evaluate admitted patients or admit patients from the ER; or an inten- sivist program, which would ensure that specialists were on site to man- age critically ill patients in the intensive care units.
You are the chief operating officer of PineStreet, and you have been asked to reduce the LWBS metric to the national benchmark. a. Identify potential causes of the high LWBS metric. Consider
factors within the ER, as well as in the inpatient and discharge departments.
b. Compose a memo to your CEO explaining why the high LWBS metric has a negative impact on revenue, profitability, quality, and outcomes.
c. Create a fishbone diagram that displays the potential causes of the high LWBS rate. Identify the top three causes of the high rate.
d. Hypothesize the ways in which these factors, either directly or indirectly, contribute to the LWBS rate. What can be done to mitigate these factors?
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The Core Elements of Value in Healthcare206
e. You have determined that a hospitalist program should be established. Draft a memo supporting this decision. Include an assessment of the cost of the program as well as of the savings generated. In addition, provide a timeline that indicates when the program would be expected to become self-sustaining—that is, the point where the savings generated would equal the cost of the program.
f. The average time of discharge of inpatients is 3 p.m. Interpret this metric as it relates to bed capacity. How would moving the discharge time to 11 a.m. facilitate clinical throughput? Consider the impact of the move on bed availability and ER wait times.
g. Develop a strategy to reduce the wait times and improve the metrics reported in the table. Draw a spaghetti diagram to show how the workflow can be decluttered and simplified.
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CHAPTER
207
ACCREDITATION AND HIGH RELIABILITY
Learning Objectives
Upon completion of this chapter, you should be able to
• discuss the use of accreditation for healthcare organizations, • identify the processes involved in a successful accreditation, • state the reasons for the development of accreditation, • evaluate whether accreditation has served its purpose, • describe the options available for accreditation bodies, • assess whether accreditation facilitates the delivery of value in
healthcare, • propose ways to strengthen the value proposition of accreditation, • explain the connection between accreditation and organizations with
reliable processes and resiliency, • appraise the underpinnings of error and harm in an organization, and • summarize the techniques that can be used to build high reliability.
A n organization’s pursuit of quality, safety, and improved patient outcomes depends in large part on its adoption of standardized, evidence-based processes. Such processes are complex and demanding, and organiza-
tions must expend significant organizational energy and resources to implement and sustain them. Organizational commitment is crucial, although the level of this commitment may vary from one entity to another. The concept of accredi- tation plays a key role in encouraging organizations to support and adhere to such processes. Accreditation can help foster a culture of high reliability, in which effective care is delivered with minimal breakdown in safety or quality, thus enhancing value.
Accreditation
Accreditation is a process in which healthcare organizations participate in an evaluation by an independent organization, or accreditation body, to
accreditation A process in which healthcare organizations participate in an evaluation by an independent organization to demonstrate their ability to meet predetermined criteria and standards.
10
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