Appropriately implemented, Six Sigma clearly produces benefits in terms of better operational efficiency, cost effectiveness and higher process quality. Perhaps less obvious – and until recently less documented – is the impact it can make in clinical areas such as infection control and medication delivery.

Clinicians are often receptive to Six Sigma given its familiar scientific and evidence-based foundation – adherents, however, must acknowledge the unique nature of patient care delivery requiring some translation of the methodology from manufacturing to medicine.

Defining Healthcare Quality and the Need for Improvement

Quality in healthcare has come to mean many things to many stakeholders – from satisfaction with service to the clinical outcome of the patient’s treatment. The most widely accepted definition was stated by the Institute of Medicine in the publication Medicare: A Strategy for Quality Assurance. The IOM defined quality of care as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.” The terminology is carefully chosen to include all points along the continuum of care. The IOM also identified three basic quality-of-care issues in medicine: overuse, underuse and misuse.

Defects in any business carry an associated expense, but medical errors also carry significant human costs. And the IOM report estimates that medical errors cost the nation approximately $37.6 billion each year, with roughly $17 billion of those costs associated with preventable errors.

For a multitude of reasons, improving healthcare quality is paramount. Communities today are not only demanding access to the best technology and treatment available, but also assurances that medical encounters will be both safe and effective. In this competitive, quality-driven and cost-conscious environment, one of the most effective solutions healthcare professionals have found has been the adoption of Six Sigma methodology and related change management techniques.

Mounting evidence illustrates that using Six Sigma to design and refine patient care processes eliminates the need to retrace steps, correct reporting errors, re-do examinations or re-schedule appointments. Such redundancies and waste are costly both in financial terms as well as discomfort and dissatisfaction to the patient.

A Better Approach

The use of statistical tools to measure and improve quality is not a new concept and certainly not exclusive to Six Sigma. Other quality initiatives, such as TQM (Total Quality Management) or CQI (Continuous Quality Improvement) also involve the use of statistics and data collection.

The edge that Six Sigma seems to enjoy, and the distinction the methodology has achieved can be attributed to several differentiating factors, in that it:

• Instills a common language and shared techniques
• Demands and provides a rigorous control mechanism
• Requires leadership support while driven by those closest to the process
• Targets process variability instead of aiming at averages
• Supports and aligns with organizational vision and strategy

Since people feel variability more than averages, Six Sigma focuses first on reducing process variation and then on improving the capability of that process. A logical healthcare example can be found in patient wait time. If a patient waits to be seen by the doctor five minutes one time and 50 minutes the next, they won’t base their satisfaction level on the average of the two wait times, but the impact of the wide variability and corollary unpredictability of the process.

During initial phases, a key step involves scoping a project into manageable and measurable segments. For instance, a large-scale effort to improve the emergency department may break down into several smaller projects targeting specific areas such as admissions, charting, equipment availability and patients leaving without being seen (LWBS). Tackling all areas at once could make the initiative seem overwhelming and the obstacles to change insurmountable.

Once a project is selected, the contributing factors must be prioritized. Rather than viewing all factors as equal, it’s important to identify and address critical to quality elements that drive the most variability or defects. In other words, although 15 potential causal factors could impact the safe, timely and appropriate delivery of medication, it may be determined that only three of those factors are responsible for 75 percent of the errors or defects. Concentrating on the critical few versus the trivial many will yield more significant results in a shorter timeframe.

Examples of Clinical Six Sigma Projects

The following offers a brief look at projects targeting patient safety, medical error reduction, clinical process improvement, patient satisfaction and outcomes.

Summary: Confronting Barriers and Identifying Keys to Using Six Sigma for Clinical Improvement

Six Sigma is scalable to organizations of every size and demography and as the results above illustrate, it can be effectively applied to many areas and issues in healthcare, addressing clinical as well as operational challenges.

Data collection: One obstacle in bringing Six Sigma to healthcare has been the ability to collect the right data, due to insufficient IT infrastructures and a shortage of resources. Providers are often data-rich, but information poor – lacking the ability to effectively analyze the data they have. Many processes that have been automated in other industries remain manual in healthcare. Such shortcomings must be addressed to achieve system-wide clinical quality improvement.

Medical error reporting: Given a litigious and punitive climate, providers are understandably hesitant to report medical errors. Peer protection and internal hierarchies also obscure such data and radical reformation is not impending. Some organizations, however, are moving away from a culture of blame and shifting the focus from the person to the process. Some have anonymous hotlines, and others use electronic programs at each nursing station to capture events as they occur without necessarily assigning individual responsibility.

Organizational alignment: To produce positive, cumulative effects on the well-being of a community, Six Sigma projects must also align with the organization’s mission and business imperatives. Leaders must be sure that a bloodstream infection project, for example, supports the hospital’s mission for better patient safety. Establishing an equitable and harmonic balance across the organization is imperative. Projects should be weighed for their potential impact on other departments, using control measurements to ensure ongoing equilibrium in clinical quality, cost effectiveness, patient satisfaction and other key indicators.

Healthcare is still in the early stages of evolution with regard to Six Sigma. Clinicians should seek professional guidance for training and implementation, but must also rely on their own expertise to further extend the approach into true clinical applications. The horizon is nearly limitless…lessons learned through the successful execution of simpler projects will enable practitioners to tackle tougher initiatives in the future and create clinical change on a broad scale.