Fig. 9.1
The plan-do-study-act cycle
Fig. 9.2
The model for improvement, which incorporates the plan-do-study-act cycle
The wide use of the PDSA cycle and the model for improvement in health care is the direct result of their elegance and simplicity, as well as the transferability and application of these approaches across multiple care and nonhealth settings.
In the 1980s the Motorola Corporation developed the Six Sigma methodology [12]. Six Sigma starts with a process-mapping activity that involves elements of defining what a business does, assigning responsibilities, identifying performance standards, and deciding how success will be determined (see below). After these critical elements have been defined, Six Sigma analyzes each through the DMAIC methodology (improve, and control) [13, 14].
“Lean,” also known as “lean manufacturing,” “lean enterprise,” or “lean production ,” is a CQI approach that considers as wasteful any resources that are allocated to any goal other than creating value for the customer and that are thus targets for elimination [15]. Value is defined from the customer’s perspective and includes any action or process for which a customer would be willing to pay.
For many, lean is an approach to improvement that helps to identify and steadily eliminate waste in processes (or muda, in Japanese). As waste is eliminated, quality improves and production time and costs are reduced. Essentially, lean is centered on preserving value with less work. Lean should optimize the trade-off between productivity and quality and highlights the axiom that improved quality translates to improved profitability, or good quality is good business.
Quality Improvement Tools
Several CQI tools can help understand and improve surgical care [16]. The most relevant tools for surgical settings are checklists, process flow maps, Ishikawa diagrams (cause-and-effect diagram), run charts, and control charts.
Checklists
Among the basic tools of quality, the checklist has received the most attention (and press) for improving patient safety. Evidence supports greater adoption of checklists in surgery [17] and in other medical specialties [18–20]. In June 2008, the Safe Surgery Saves Lives Initiative of the World Health Organization (WHO) released the WHO Surgical Safety Checklist. In a little more than 2 years, more than 3900 hospitals in more than 122 countries were registered in the initiative. Of these 3900 hospitals, more than 1800 have reported using a checklist in at least one operating room [21, 22].
The Dutch SURPASS study, conducted from October 2007 to March 2009, found that hospitals using checklists had surgical complication rates that were more than one-third lower, and death rates that were almost one-half lower (from 1.5 to 0.8 %), than they were in hospitals not using checklists [23].
Researchers at Stanford found that the observed-to-expected mortality ratio declined from 0.88 in quarter one to 0.80 in quarter two, with the use of a modified version of the WHO Surgical Safety Checklist [21, 22]. The use of checklists also improved communication among the surgical team, and thus the quality of care. Quality was measured by the frequency with which staff reported “Patient Safety Never Events” (i.e., the kind of events that should “never happen”). The number of Patient Safety Never Events related to errors or complications decreased from 35.2 to 24.3 %.
The website Safesurg.org provides resources for implementing the WHO checklist or for modifying an existing checklist. Modified checklists created by other institutions can also be downloaded (Fig. 9.3) [24]. Modifying checklists to fit local practices and needs is encouraged to enhance acceptance.
Fig. 9.3
A surgical safety checklist template modified from the World Health Organization
Although checklists have been widely adopted, their effectiveness has been highly variable if they are casually applied only as tick-box forms and in a top-down approach [25]. Ineffective top-down engagement and inauthentic partnering and engagement with clinicians inhibit positive behavior change and encourage normalized deviance [26]. Introducing a checklist in an environment characterized by a lack of trust causes clinicians to feel jeopardized professionally and personally , and encourages gaming of clinical metrics and measurements [27]. Effective adoption requires local championship, sustained clinician engagement, and a commitment to teamwork [28, 29].
Process Maps
A process map or flowchart is a visual representation of the care process that is created with information provided by team members. The process mapping exercise can help clinicians clarify through visualization what they know about their environment and determine what they want to improve about it [30]. The process maps use common flowchart symbols and can describe the current state or baseline, the improved state in transition, and the optimal state [31]. The exercise helps clinicians make assumptions and expectations explicit and can provide insights into reflecting on their current state and, importantly, into how to improve the process of care or to overcome barriers they perceive to its improvement [32]. Working with clinicians to understand their clinical sensemaking is essential if they are to become and sustain their interest and engagement in long-term continuous improvement [27].
A high degree of process awareness often drives the design changes needed to sustain improvement. Process mapping describes precisely what an individual provider is required to do and when, in terms of cognitive processes, actions, or both, to achieve the system’s goal. Data are collected from observations or interviews that carefully break down complex clinical processes into discrete, measurable, and clear tasks [32]. Team members can gain insights into how they and their colleagues perceive the same tasks and hopefully come to a shared understanding of the process.
Ultimately, improving patient outcomes requires appreciating the inherent links between process and results. Process maps help focus improvement efforts, not for the individual, but for the entire clinical microsystem [33]. Visualizing the process can also help identify inefficiencies (e.g., parallel or redundant processes that have emerged for whatever reason), clarify roles, and reduce ambiguity among team members, all of which can help coordinate patient care. This process is particularly useful in improving surgical patient transitions of care and avoiding readmissions and bounce back to the intensive care and high-dependency units [34, 35].
Process maps show how interactions occur, uncover variations, and make the invisible process visible. Process maps can be created at different levels of detail to illustrate the major phases or detailed activities in that process. It is important to map the current process, not the desired process, to identify opportunities for improvement. We have used process mapping in multiple settings to better understand the processes of care, including pediatric cardiac surgery (Figs. 9.4, 9.5, and 9.6), and to summarize the data on near misses and adverse events (Fig. 9.7) [32, 37].
Fig. 9.4
A process map of pediatric cardiac and cardiac surgical care. Preoperative processes
Fig. 9.5
A process map of pediatric cardiac and cardiac surgical care. Operative processes
Fig. 9.6
A process map of pediatric cardiac and cardiac surgical care. Postoperative processes
Ishikawa Diagrams
Ishikawa diagrams , also known as “cause-and-effect diagrams,” “fishbone diagrams ,” and “root-cause analyses,” are visual representations of the sources of variation in a process [38]. The diagram is often created by brainstorming with key stakeholders to identify the causes of the effects of a process. The causes are generally allocated to five general main headers/categories: place (environment), equipment, procedures and methods (processes), people (patients and providers), and policies (Fig. 9.8) [39]. Routine root cause analysis with Ishikawa diagrams can be very powerful in analyzing surgical adverse events. A detailed analysis in one major hospital over 4 years (Table 9.1) established the fact that excellent surgical outcomes depend on integrating individual, team, technical, and organizational factors [40].
Table 9.1
Results of a surgical adverse event root cause analysis
Theme | Issues identified |
---|---|
Failure to recognize or respond appropriately to the deteriorating patient within the required time frame | • Postsurgery complications |
• Postoperative sepsis | |
• Postoperative hyponatremia | |
Workforce availability and skills | • Orientation, training, and supervising new or junior members of the surgical team, especially outside normal working hours |
Transfer of patients for surgery | • Difficulty in organizing an OR for surgery |
• Failure to hand over information about patient acuity | |
Trauma management | • Coordination and response of trauma teams
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