Quality Improvement in Anesthesia Practice and Patient Safety

Model for Improvement

The journey toward improvement can be made more efficient and more effective with a systematic approach. The Model for Improvement, developed by the training and management consulting company Associates in Process Improvement ( http://www.apiweb.org ), is one such approach adopted by organizations across varied disciplines and is currently the approach used by IHI. It is a structured, dynamic model that applies the scientific method to testing and implementing a change. In 1939, Walter A. Shewhart, a physicist, engineer, and statistician, introduced the science of modern QI. He introduced a three-step scientific process of specification, production, and inspection, stating that “these three steps must go in a circle instead of in a straight line.” In the 1940s, his protégé, W. Edwards Deming, applied these concepts to government and industry and developed the Plan, Do, Study, Act (PDSA) cycle ( Table 5.1 ). A modification of the PDSA by the addition of three fundamental questions (as explained in the next paragraph) resulted in the Model for Improvement ( Fig. 5.1 ).

Beginning an improvement project with the three fundamental questions for improvement helps set a clear direction for the project, define what success will look like, and hypothesize successful interventions. The three fundamental questions for improvement are:

• 1.

  Aim: “What are we trying to accomplish?” The aim (or objective) for improvement should be specific, measurable, actionable, relevant, and time-specific (also referred to as a SMART aim). Ideas for improvements may come from interviewing those involved or affected by the process, such as staff or patients. Ideas may also come from examining previous data on operational, clinical, or financial processes.

• 2.

  Measure: “How will we know if change is an improvement?” Ideally, measures should be linked directly to the aim or goal of the project and should ensure that the interests of the stakeholders of the process are represented. Quantitative measures should be used when possible to measure change over time. These measures provide the feedback that enables one to know whether or not the change is an improvement. However, not all projects have an easily quantifiable outcome and the outcome may be more qualitative. It is worth the time and effort to identify opportunities to translate goals into quantifiable outcomes if possible. These can be easier to use to communicate success.

• 3.

  Changes: “What changes can we make that will result in improvement?” Ideas for changes that result in improvement often start with observations, modeling the success of others, and brainstorming. The more intimate the understanding of a process and its key drivers, the higher the likelihood of generating successful changes.

The three fundamental questions are followed by a PDSA cycle, which is the framework for testing and implementing previously generated ideas for change. Improvement may require multiple cycles of preferably small tests of change over time. By testing changes on a small scale before implementation, risk is mitigated. Small tests of change may also help overcome individuals’ resistance to change. Through repeated cycles, increased knowledge is acquired, and actions are continuously modified or changed. Measures defined in the first part of the model help determine whether or not a change is a success. These measures are often plotted over time on run charts or control charts ( Figs. 5.2 and 5.3 ). Knowledge can be gained from both successful and unsuccessful tests! Finally, PDSA cycles both test a change and implement a successful change on a larger scale or in diverse clinical areas.

Lean Methodology and Six Sigma

In addition to the Model for Improvement, CQI initiatives have many other frameworks. Two of these frameworks, Lean Production and Six Sigma, are briefly discussed here. These frameworks are sometimes combined, as in “Lean Six Sigma.” Regardless of which framework is employed, benefits are gained by retaining a structured and consistent approach to CQI.

Lean methodology has its roots in Japanese manufacturing, particularly in the Toyota Production System. More recently, Lean has found success in the healthcare industry. Two notable examples of its use are Virginia Mason Medical Center and ThedaCare, Inc., both of which have transformed their organizations through the application of Lean principles. In fact, ThedaCare reported $3.3 million in savings in 2004 with reduced accounts receivable, redeployed staff, reduced phone triage times, reduced time spent on paperwork, and decreased medication distribution time.

Lean methodology is focused on creating more value for the customer (i.e., the patient) with fewer resources. Every step in a process is evaluated to differentiate those steps that add value from those that do not. The ultimate goal is to eliminate all waste so that every step adds value to a process. Other key components of Lean include reducing unevenness of workflow—for instance, what we might find in intensive care unit (ICU) admissions or emergency cases—and eliminating the overburdening of people and equipment. Five principles govern Lean improvement:

• 1.

  Define the value that the customer is seeking. Virginia Mason Medical Center has a “patient-first” focus for all its processes.

• 2.

  Identify and map the value stream. If evaluating preoperative assessment, map the physical flow of a patient from the scheduling of a procedure through the day of surgery (history and physical, preoperative counseling, laboratory tests, imaging, consultations). In this process, all of the steps are accounted for, including the back-and-forth flow of the patient to the front desk, to the laboratory, and so on. Time spent during each step of the process should be documented.

• 3.

  Smooth the flow between value-added steps. Eliminate steps that do not add value to the overall process and are likely a poor use of time or effort on the part of the caregivers or the patient. An example of this process might be eliminating unnecessary tests or consultations in a patient’s preoperative evaluation and reducing excess wait times that are the result of correctable inefficiencies.

• 4.

  Create pull between steps. Customer demand should trigger the start of a downstream process. Examples include opening operating rooms (ORs) or increasing staffing based on surgical demand, as opposed to having a fixed amount of time for each surgeon or surgical division.

• 5.

  Pursue perfection by continuing the process until you have achieved ultimate value with no waste.

The transformation of Motorola in the 1980s from a struggling company to a high-quality, high-profit organization helped give rise to the Six Sigma methodology. Two key fundamental objectives of Six Sigma are a virtually error-free process and a large focus on reducing variation. In fact, a Six Sigma process, or a process whose frequency falls six deviations from the mean, corresponds to just 3.4 errors per million.

Health care often falls far short of this standard. In a 1998 report, Chassin reported that hospitalized patients harmed by negligence were at a four sigma level (10,000/million), patients inadequately treated for depression were at a two sigma level (580,000/million), and eligible heart attack survivors who failed to receive β-adrenergic blockers were at a one sigma level (790,000/million). In contrast, Chassin found that anesthesiology was the one healthcare specialty that approached the six sigma level, with deaths caused by anesthesia as low as 5.4/million. In comparison with health care, airline fatalities were a two sigma process (230/million) and a traditional company operated around four sigma, the equivalent of 6200 errors/million. Considering that errors are often tied directly to cost, this error rate has significant financial implications.

Six Sigma is similar to the Model for Improvement in that it makes use of a simple framework to guide improvement, in this case using Define, Measure, Analyze, Improve, Control (DMAIC). The DMAIC steps are described in Table 5.2 . As mentioned earlier, many organizations have found the greatest benefit by combining elements of different methodologies in their CQI work. One popular example of this is Lean Six Sigma, which combines improvements in flow and value with reduction in error and variation. Furthermore, individual tools from these strategies, such as PDSA cycles or DMAIC processes, can be applied where appropriate.

The Value Framework in Health Care

Since quality in health care is focused on patient outcomes, another approach to quality is the value framework. Quality relative to cost determines value. Hence, in health care, value is defined as the patient health outcomes achieved per dollar spent. Value should define the framework for performance improvement in health care. Value includes goals already embraced by health care such as quality, safety, patient centeredness, and cost containment; the value framework allows for a way to integrate these goals.

Because value is always defined around the customer, in the healthcare industry it is what matters most to patients, and unites the interests of all the stakeholders in the healthcare system. Thus, when value improves, not only do patients, payers, providers, and suppliers all benefit, but the economic sustainability of the healthcare system also improves. As such, value should be the overarching goal of healthcare delivery. According to Porter, the failure to adopt value as the central goal in health care and the failure to measure it, are the most serious failures of the medical community.

Value measurement today is limited and highly imperfect. Value should be measured by outputs not inputs. Thus, value is dependent on patient health outcomes and not the volume of services delivered. The only way to accurately measure value is to track individual patient outcomes and costs longitudinally over the full cycle of care, which can vary from 30 to 90 days for hospital care and 1 year for chronic care.

Value is not measured by processes of care utilized by a patient. While process measurement is an important component of improvement, it should not be substituted for measurement of patient outcomes. Outcomes and cost should be measured separately. Outcomes, the numerator of the value equation, refer to the actual results of care in terms of patient health and should consist of a set of multidimensional outcomes that, when considered together, constitute patient benefit. Cost, the denominator of the value equation, should include total costs involved in the full cycle of care for the patient’s medical condition. Most physicians do not know the full costs of caring for a patient, thus they lack the information to make real efficiency improvements.

Outcomes measurement is critical to driving rapid improvements in health care. Without a feedback loop that includes the outcomes achieved, providers lack the information they require to learn and improve. Effective outcome measurement is hampered by several problems. First, there is a lack of consensus as to what constitutes an outcome. Second, electronic medical record (EMR) systems often do not facilitate the capture of longitudinal outcomes measures with appropriate scope; these systems may focus too narrowly or too broadly, giving only a partial view of patient outcomes. Third, outcomes such as infection rates may vary substantially by medical condition. Finally, true outcome measurement has been limited because the cost of gathering longitudinal patient results is high, due in part to fragmented organizational structures and poor EMR interoperability.

Cost is the most pressing issue in health care. Current cost measurement approaches have not only hampered our understanding of costs but also contributed to approaches involving cost-containment. A focus on cost-containment rather than value improvement can be dangerous and is often self-defeating. Two major problems associated with cost measurement include: (a) cost aggregation, wherein we often measure and accumulate costs based on how care is organized and billed for, that is, costs for departments, discrete service areas, and line items such as supplies or drugs and (b) cost allocation where the costs of healthcare delivery are shared costs, involving shared resources and as such are normally calculated as the average cost over all patients for a department. A good example of this is the hourly charge for the OR. However, to truly understand costs, they must be aggregated around the patient, rather than discrete services, and shared costs must be allocated to individual patients on the basis of each patient’s actual use of the resources involved. Finally, the perspective used to calculate costs matters and patient costs including lost work may not be included in the analysis.

Proper measurement of outcomes and costs is the single most powerful lever for improving healthcare delivery and although current measurements are highly imperfect, the process of measurement has begun. As Michael Porter outlines in the framework papers underpinning his value commentary in the New England Journal of Medicine , if all the stakeholders in health care were to embrace value as the central goal and measure it, the resulting improvements would be enormous.